Stem Cell Therapy Market in Asia-Pacific to 2018

Stem Cell Therapy Market in Asia-Pacific to 2018 Commercialization Supported by Favorable Government Policies, Strong Pipeline and Increased Licensing...
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Stem Cell Therapy Market in Asia-Pacific to 2018 Commercialization Supported by Favorable Government Policies, Strong Pipeline and Increased Licensing Activity

GBI Research Report Guidance

GBI Research Report Guidance 

The second chapter provides an introduction to the stem cell therapy market in Asia-Pacific.



Chapter three provides an introduction and market characterization and forecasts. The chapter includes revenue forecasts, cost of therapy, share of autologous and allogeneic stem cell therapy, and the patient pool. The section also details the key drivers and barriers affecting the stem cell therapy market in Asia-Pacific.



Chapter four provides an introduction, regulatory landscape and market characterization and forecasts for CABG, LSCT and type 2 DM. It includes forecasts for the cost of therapy and patient pool from 20122018 for the three indications. The chapter also includes key drivers and barriers affecting the stem cell therapy market in India.



Chapter five provides an introduction, regulatory landscape and market characterization and forecasts for type 1 DM. It includes forecasts for the cost of therapy and patient pool from 2012-2018. The chapter also includes key drivers and barriers affecting the stem cell therapy market in China.



Chapter six provides an introduction, regulatory landscape and market characterization and forecasts for steroid refractory aGvHD. It includes forecasts for the cost of therapy and patient pool from 20122018. The chapter also includes key drivers and barriers affecting the stem cell therapy market in Japan.



Chapter seven provides an introduction, regulatory landscape and key drivers and barriers affecting the stem cell therapy market in Singapore.



Chapter eight provides an introduction, regulatory landscape and market characterization and forecasts for Cupistem, Hearticellgram-Acute Myocardial Infarction (HCG-AMI), Cartistem and Cerecellgram (CCG). It includes forecasts for the cost of therapy and patient pool from 2012-2018 for these products. The section also includes key drivers and barriers affecting the stem cell therapy market in South Korea.



Chapter nine provides pipeline analysis by phase, sponsors/collaborators and country. The section contains a list of stem cell molecules analyzed by phase.



Chapter 10 provides company profiles of nine companies.



Chapter 11 provides detailed descriptions of major M&A, licensing and co-developmental deals

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Stem Cell Therapy Market in Asia-Pacific to 2018 - Executive Summary

The stem cell therapy market was valued at $XXm in 2012, and is projected to grow at a Compound Annual Growth Rate (CAGR) of XX% from 2012 to 2018, to attain a value of XXm in 2018

Stem Cell Therapy Market in Asia-Pacific to 2018 - Executive Summary The Stem Cell Therapy Market in Asia-Pacific is in its Nascent Stage, but is Poised for Significant Growth in the Forecast Period The stem cell therapy market was valued at $XXm in 2012, and is projected to grow at a Compound Annual Growth Rate (CAGR) of XX% from 2012 to 2018, to attain a value of $XXm in 2018. The following graph shows the forecast revenues for the stem cell therapy market in Asia-Pacific. Stem Cell Therapy Market in Asia-Pacific to 2018, Revenue Forecasts ($m), 2012-2018

Revenues ($m)

CAGR (2012–2018) - XX%

Anticipated launch of JR031 for steroid refractory aGvHD to increase the revenues

2012

2013

2014

Anticipated launch of CCG in 2015 to increase stem cell therapy market revenues

2015

2016

2017

2018

Source: GBI Research; GBI Research Proprietary Database [Accessed August 10, 2012]

The market is poised for significant growth in the forecast period due to the anticipated launch of JCR Pharmaceuticals’ JR-031 (2014) in Japan and FCB Pharmicell’s Cerecellgram (CCG) (2015) in South Korea. The stem cell therapy market is poised to offer significant contributions in the forecast period, because of renewed interest by the respective governments of India, China, Japan, South Korea and Singapore to provide cures for a range of diseases. The growth in the stem cell therapy market will not only provide treatment options but will also contribute significantly to the countries’ Gross Domestic Product (GDP). The importance of stem cell therapy can be elucidated from the statement made by the President of South Korea in 2011, who stated that the stem cell field is a “new growth engine” for the nation’s economy.

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Table of Contents

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Table of Contents Table of Contents................................................................................................................................. 5 1.1 List of Tables............................................................................................................................. 9 1.2 List of Figures...........................................................................................................................12 Stem Cell Therapy Market in Asia-Pacific to 2018 - Introduction...........................................................14 Stem Cell Therapy Market in Asia-Pacific to 2018 - Overview ...............................................................15 3.1 Introduction ............................................................................................................................15 3.2 Market Characterization and Forecasts - Overview ...................................................................16 3.2.1 Revenue Forecasts ...........................................................................................................16 3.2.2 Cost of Therapy................................................................................................................17 3.2.3 Allogeneic and Autologous Share......................................................................................18 3.2.4 Stem Cell Therapy Patient Pool .........................................................................................19 3.3 Drivers and Barriers .................................................................................................................20 3.3.1 Drivers.............................................................................................................................21 3.3.2 Barriers............................................................................................................................21 Stem Cell Therapy Market in Asia-Pacific to 2018 - India ......................................................................22 4.1 Introduction ............................................................................................................................22 4.2 Regulatory Landscape ..............................................................................................................22 4.3 Market Characterization and Forecasts - Overview ...................................................................23 4.3.1 Revenue Forecasts ...........................................................................................................23 4.3.2 Cost of Therapy................................................................................................................24 4.3.3 Stem Cell Patient Pool ......................................................................................................24 4.4 CABG Market Characterization and Forecasts ...........................................................................25 4.4.1 Introduction.....................................................................................................................25 4.4.2 Revenue Forecasts ...........................................................................................................25 4.4.3 Cost of Therapy................................................................................................................26 4.4.4 Stem Cell Patient Pool ......................................................................................................27 4.5 Type 2 DM Market Characterization and Forecasts ...................................................................28 4.5.1 Introduction.....................................................................................................................28 4.5.2 Revenue Forecasts ...........................................................................................................29 4.5.3 Cost of Therapy................................................................................................................30 4.5.4 Stem Cell Patient Pool ......................................................................................................31 4.6 LSCT Market Characterization and Forecasts.............................................................................32 4.6.1 Introduction.....................................................................................................................32 4.6.2 Revenue Forecasts ...........................................................................................................32 4.6.3 Cost of Therapy................................................................................................................33 4.6.4 Stem Cell Patient Pool ......................................................................................................34 Stem Cell Therapy Market in Asia-Pacific to 2018 - China .....................................................................35 5.1 Introduction ............................................................................................................................35 5.2 Regulatory Landscape ..............................................................................................................35 5.3 Market Characterization and Forecasts - Overview ...................................................................36 5.3.1 Type 1 DM Market Characterization and Forecasts ...........................................................36 Stem Cell Therapy Market in Asia-Pacific to 2018 - Japan .....................................................................40 Introduction ............................................................................................................................40 6.1 6.2 Regulatory Landscape ..............................................................................................................40 6.3 Steroid Refractory aGvHD Market Characterization and Forecasts.............................................42 6.3.1 Overview .........................................................................................................................42 6.3.2 Revenue Forecasts ...........................................................................................................43 6.3.3 Cost of Therapy................................................................................................................44 6.3.4 Stem Cell Patient Pool ......................................................................................................45 Stem Cell Therapy Market in Asia-Pacific to 2018 - Singapore...............................................................46

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7.1 Introduction ............................................................................................................................46 7.2 Regulatory Landscape ..............................................................................................................46 7.2.1 Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning (June 2002)..........................................................................................................47 7.2.2 Human Tissue Research (November 2002) ........................................................................48 7.2.3 Research Involving Human Subjects (November 2004).......................................................49 7.2.4 Genetic Testing and Genetic Research (November 2005) ...................................................50 7.2.5 Personal Information in Biomedical Research (May 2007) .................................................51 7.2.6 Donation of Human Eggs for Research (November 2008)...................................................51 7.2.7 Human-Animal Combinations in Stem Cell Research (September 2010)..............................51 8 Stem Cell Therapy Market in Asia-Pacific to 2018 - South Korea ...........................................................52 8.1 Introduction ............................................................................................................................52 8.2 Regulatory Landscape ..............................................................................................................52 8.3 Market Characterization and Forecasts - Overview ...................................................................54 8.3.1 Revenue Forecasts ...........................................................................................................54 8.3.2 Cost of Therapy................................................................................................................56 8.3.3 Stem Cell Patient Pool ......................................................................................................57 8.4 Cupistem Market Characterization and Forecasts .....................................................................58 8.4.1 Overview .........................................................................................................................58 8.4.2 Revenue Forecasts ...........................................................................................................59 8.4.3 Cost of Therapy................................................................................................................60 8.4.4 Stem Cell Patient Pool ......................................................................................................61 8.5 HCG-AMI Market Characterization and Forecasts .....................................................................62 8.5.1 Overview .........................................................................................................................62 8.5.2 Revenue Forecasts ...........................................................................................................63 8.5.3 Cost of Therapy................................................................................................................64 8.5.4 Stem Cell Patient Pool ......................................................................................................65 8.6 Cartistem Market Characterization and Forecasts.....................................................................66 8.6.1 Overview .........................................................................................................................66 8.6.2 Revenue Forecasts ...........................................................................................................67 8.6.3 Cost of Therapy................................................................................................................68 8.6.4 Stem Cell Patient Pool ......................................................................................................69 8.7 CCG Market Characterization and Forecasts .............................................................................70 8.7.1 Overview .........................................................................................................................70 8.7.2 Revenue Forecasts ...........................................................................................................70 8.7.3 Cost of Therapy................................................................................................................71 8.7.4 Stem Cell Patient Pool ......................................................................................................72 9 Stem Cell Therapy Market in Asia-Pacific to 2018 - Pipeline Analysis.....................................................73 9.1 Pipeline Analysis by Phase........................................................................................................73 9.2 Pipeline Analysis by Sponsors/Collaborators.............................................................................74 9.3 Pipeline Analysis by Country.....................................................................................................75 9.3.1 India Stem Cell R&D Pipeline.............................................................................................76 9.3.2 China Stem Cell R&D Pipeline............................................................................................78 9.3.3 Japan Stem Cell R&D Pipeline ...........................................................................................82 9.3.4 Singapore Stem Cell R&D Pipeline.....................................................................................86 9.3.5 South Korea Stem Cell R&D Pipeline..................................................................................87 Product Profiles of Promising Molecules............................................................................89 9.3.6 9.3.7 Product Profiles of Marketed Products..............................................................................90 10 Stem Cell Therapy Market in Asia-Pacific to 2018 - Competitive Landscape ..........................................92 10.1 Stempeutics Research..............................................................................................................92 10.1.1 Overview .........................................................................................................................92 10.1.2 Product Pipeline ...............................................................................................................93 © GBI Research. 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10.2 Reliance Life Sciences...............................................................................................................94 10.2.1 Overview .........................................................................................................................94 10.2.2 Product Pipeline ...............................................................................................................94 10.3 International Stem Cell Services ...............................................................................................95 10.3.1 Overview .........................................................................................................................95 10.3.2 Product Pipeline ...............................................................................................................95 10.4 Shenzhen Beike Biotechnology.................................................................................................96 10.4.1 Overview .........................................................................................................................96 10.4.2 Product Pipeline ...............................................................................................................96 10.5 JCR Pharmaceuticals ................................................................................................................97 10.5.1 Overview .........................................................................................................................97 10.5.2 Product Pipeline ...............................................................................................................97 10.6 ES Cells International (Subsidiary of BioTime, Inc) .....................................................................98 10.6.1 Overview .........................................................................................................................98 10.6.2 Product Pipeline ...............................................................................................................98 10.7 Stem Cell Technologies i...........................................................................................................99 10.7.1 Overview .........................................................................................................................99 10.7.2 Product Pipeline ...............................................................................................................99 10.8 Pharmicell .............................................................................................................................100 10.8.1 Overview .......................................................................................................................100 10.8.2 Product Pipeline .............................................................................................................100 10.9 Medipost...............................................................................................................................101 10.9.1 Overview .......................................................................................................................101 10.9.2 Product Pipeline .............................................................................................................101 11 Stem Cell Therapy Market in Asia-Pacific to 2018 - Strategic Consolidations .......................................102 11.1 Overview...............................................................................................................................102 11.2 M&A Deals ............................................................................................................................103 11.2.1 RNL BIO Acquired 10% Stake in Celltex Therapeutics for $10m - October 28, 2011...........103 11.2.2 BioTime Acquired ES Cell International - May 3, 2010......................................................103 11.2.3 BCCL Acquires Stake in Life Cell - May 1, 2007 .................................................................103 11.3 Licensing Deals ......................................................................................................................103 11.3.1 RNL BIO Forms Joint Venture to Develop Stem Cell Therapy - September 29, 2011...........103 11.3.2 Kiadis Pharma Enters into Licensing Agreement with Hospira for ATIR - January 4, 2011 ..103 11.3.3 Cipla Enters into Co-Marketing Agreement with Stempeutics - April 27, 2010..................103 11.3.4 Teijin Enters into Licensing Agreement with SanBio - March 2, 2010 ................................104 11.3.5 Cleveland BioLabs Enters into Licensing Agreement with Zhejiang Hisun Pharma - September 9, 2009 ..........................................................................................................................104 11.3.6 Merck Signs a Licensing Agreement with Japan Tobacco - September 25, 2008 ...............104 11.3.7 ES Cell Enters into Licensing Agreement with ITI Life Sciences - January 31, 2007.............104 11.4 Co-Development Deals...........................................................................................................105 11.4.1 JCR Pharma Enters into Co-Development Agreement with MediPal - September 13, 2011 105 11.4.2 Athersys Enters into Co-Development Agreement with Pfizer - December 21, 2009..........105 11.4.3 Genzyme Enters into Agreement with Osiris Therapeutics - November 4, 2008..................... .................................................................................................................................105 11.4.4 JCR Pharma Enters into Co-Development Agreement with Mochida Pharma - December 21, 2007 ..............................................................................................................................106 12 Stem Cell Therapy Market in Asia-Pacific to 2018 - Appendix..............................................................107 12.1 Market Definitions.................................................................................................................107 12.2 Abbreviations ........................................................................................................................107 12.3 Bibliography ..........................................................................................................................109 12.4 Research Methodology ..........................................................................................................110 12.4.1 Coverage .......................................................................................................................110

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12.4.2 Secondary Research .......................................................................................................110 12.4.3 Primary Research ...........................................................................................................111 12.5 Therapeutic Landscape ..........................................................................................................111 12.5.2 Market Size by Geography..............................................................................................113 12.6 Geographical Landscape ........................................................................................................114 12.7 Pipeline Analysis ....................................................................................................................114 12.8 Competitive Landscape ..........................................................................................................114 12.8.1 Expert Panel Validation ..................................................................................................114 12.9 Contact Us.............................................................................................................................114 12.10 Disclaimer..............................................................................................................................114

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Table of Contents

1.1

List of Tables

Table 1: Table 2: Table 3: Table 4: Table 5: Table 6: Table 7: Table 8: Table 9: Table 10: Table 11: Table 12: Table 13: Table 14: Table 15: Table 16: Table 17: Table 18: Table 19: Table 20: Table 21: Table 22: Table 23: Table 24: Table 25: Table 26: Table 27: Table 28: Table 29:

Stem Cell Therapy Market in Asia-Pacific to 2018, Revenue Forecasts ($m), 2012-2018 ..............................................................................................................................16 Stem Cell Therapy Market in Asia-Pacific to 2018, Patient Pool for Stem Cell Therapy Forecasts (‘000), 2012-2018....................................................................................................................19 Stem Cell Therapy Market in Asia-Pacific to 2018, India, Revenue Forecasts ($m), 2012-2018...23 Stem Cell Therapy Market in Asia-Pacific to 2018, India, Patient Pool Forecasts (‘000), 2012-2018 ...............................................................................................................................................24 Stem Cell Therapy Market in Asia-Pacific to 2018, India, CABG Revenue Forecasts ($’000), 20122018.......................................................................................................................................25 Stem Cell Therapy Market in Asia-Pacific to 2018, India, CABG Cost of Therapy Forecasts ($), 2012-2018 ..............................................................................................................................26 Stem Cell Therapy Market in Asia-Pacific to 2018, India, CABG Patient Pool Forecasts (Absolute), 2012-2018 ..............................................................................................................................27 Stem Cell Therapy Market in Asia-Pacific to 2018, India, Type 2 DM Revenue Forecasts ($m), 2012-2018 ..............................................................................................................................29 Stem Cell Therapy Market in Asia-Pacific to 2018, India, Type 2 DM Cost of Therapy Forecasts ($), 2012-2018 ........................................................................................................................30 Stem Cell Therapy Market in Asia-Pacific to 2018, India, Type 2 DM Patient Pool Forecasts (‘000), 2012-2018 ..............................................................................................................................31 Stem Cell Therapy Market in Asia-Pacific to 2018, India, LSCT Revenue Forecasts ($’000), 20122018.......................................................................................................................................32 Stem Cell Therapy Market in Asia-Pacific to 2018, India, LSCT Cost of Therapy Forecasts ($), 2012-2018 ..............................................................................................................................33 Stem Cell Therapy Market in Asia-Pacific to 2018, India, LSCT Patient Pool Forecasts (Absolute), 2012-2018 ..............................................................................................................................34 Stem Cell Therapy Market in Asia-Pacific to 2018, China, Type 1 DM Revenue Forecasts ($m), 2012-2018 ..............................................................................................................................37 Stem Cell Therapy Market in Asia-Pacific to 2018, China, Type 1 DM Cost of Therapy Forecasts ($), 2012-2018 ........................................................................................................................38 Stem Cell Therapy Market in Asia-Pacific to 2018, China, Type 1 DM Patient Pool Forecasts (‘000), 2012-2018....................................................................................................................39 Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, aGvHD Revenue Forecasts ($m), 20142018.......................................................................................................................................43 Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, aGvHD Cost of Therapy Forecasts ($), 2014-2018 ..............................................................................................................................44 Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, aGvHD Patient Pool for Stem Cell Therapy Forecasts (Absolute), 2014-2018................................................................................45 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Revenue Forecasts ($m), 20122018.......................................................................................................................................54 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Patient Pool for Stem Cell Therapy, Forecasts (Absolute), 2012-2018 ...............................................................................57 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cupistem Revenue Forecasts ($m), 2012-2018 .....................................................................................................................59 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cupistem Cost of Therapy Forecasts ($), 2012-2018.........................................................................................................60 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cupistem Patient Pool Forecasts (Absolute), 2012-2018.............................................................................................................61 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, HCG-AMI Revenue Forecasts ($m), 2012-2018 .....................................................................................................................63 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, HCG-AMI Cost of Therapy Forecasts ($), 2012-2018.........................................................................................................64 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, HCG-AMI Patient Forecasts, 2012-2018 ..............................................................................................................................65 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cartistem Revenue Forecasts ($m), 2012-2018 .....................................................................................................................67 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cartistem Cost of Therapy Forecasts ($), 2012-2018.........................................................................................................68

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Table 30: Table 31: Table 32: Table 33: Table 34: Table 35: Table 36: Table 37: Table 38: Table 39: Table 40: Table 41: Table 42: Table 43: Table 44: Table 45: Table 46: Table 47: Table 48: Table 49: Table 50: Table 51: Table 52: Table 53: Table 54: Table 55: Table 56: Table 57: Table 58: Table 59: Table 60: Table 61: Table 62: Table 63: Table 64: Table 65: Table 66: Table 67:

Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cartistem Patient Pool Forecasts (Absolute), 2012-2018.............................................................................................................69 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, CCG Revenue Forecasts ($m), 2015-2018 ..............................................................................................................................70 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, CCG Cost of Therapy Forecasts ($), 2015-2018 ........................................................................................................................71 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, CCG Patient Pool Forecasts (Absolute), 2015-2018.............................................................................................................72 Stem Cell Therapy Market in Asia-Pacific to 2018, R&D Pipeline Analysis by Phase, 2012 ..........73 Stem Cell Therapy Market in Asia-Pacific to 2018, R&D Pipeline Analysis by Sponsors/Collaborators, 2012 .................................................................................................74 Stem Cell Therapy Market in Asia-Pacific to 2018, R&D Pipeline Analysis by Country, 2012.......75 Stem Cell Therapy Market in Asia-Pacific to 2018, India, R&D Pipeline Analysis by Phase, 2012.76 Stem Cell Therapy Market in Asia-Pacific to 2018, India, Phase II/III Pipeline Analysis, 2012 ......77 Stem Cell Therapy Market in Asia-Pacific to 2018, India, Phase II Pipeline Analysis, 2012 ..........77 Stem Cell Therapy Market in Asia-Pacific to 2018, India, Phase I/II Pipeline Analysis, 2012........77 Stem Cell Therapy Market in Asia-Pacific to 2018, India, Unknown Phase, 2012........................77 Stem Cell Therapy Market in Asia-Pacific to 2018, China, R&D Pipeline Analysis by Phase, 201278 Stem Cell Therapy Market in Asia-Pacific to 2018, China, Post-Market Pipeline Analysis, 2012 ..79 Stem Cell Therapy Market in Asia-Pacific to 2018, China, Phase II Pipeline Analysis, 2012 .........79 Stem Cell Therapy Market in Asia-Pacific to 2018, China, Phase I/II Pipeline Analysis, 2012.......80 Stem Cell Therapy Market in Asia-Pacific to 2018, China, Phase I Pipeline Analysis, 2012 ..........80 Stem Cell Therapy Market in Asia-Pacific to 2018, China, Clinical Pre-Test Pipeline Analysis, 2012 ...............................................................................................................................................81 Stem Cell Therapy Market in Asia-Pacific to 2018, China, Unknown Phase, 2012.......................81 Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, R&D Pipeline Analysis by Phase, 201282 Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, Phase III Stage Molecules Pipeline Analysis, 2012.........................................................................................................................83 Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, Phase II/III Stage Molecules Pipeline Analysis, 2012.........................................................................................................................83 Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, Phase II Stage Molecules Pipeline Analysis, 2012.........................................................................................................................84 Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, Phase I/II Stage Molecules Pipeline Analysis, 2012.........................................................................................................................85 Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, Phase I Stage Molecules Pipeline Analysis, 2012.........................................................................................................................85 Stem Cell Therapy Market in Asia-Pacific to 2018, Singapore, Phase I/II Stage Molecules Pipeline Analysis, 2012.........................................................................................................................86 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, R&D Pipeline Analysis by Phase, 2012.......................................................................................................................................87 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Phase III Molecules Pipeline Analysis, 2012.........................................................................................................................88 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Phase II/III Molecules Pipeline Analysis, 2012.........................................................................................................................88 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Phase II Molecules Pipeline Analysis, 2012.........................................................................................................................88 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Phase I/II Molecules Pipeline Analysis, 2012.........................................................................................................................88 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Phase I Molecules Pipeline Analysis, 2012.........................................................................................................................89 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Unknown Phase, 2012.............89 Stem Cell Therapy Market in Asia-Pacific to 2018, Stempeutics, R&D Pipeline, 2012 .................93 Stem Cell Therapy Market in Asia-Pacific to 2018, Reliance Life Sciences, R&D Pipeline, 2012...94 Stem Cell Therapy Market in Asia-Pacific to 2018, International Stem Cell Services Limited, R&D Pipeline, 2012.........................................................................................................................95 Stem Cell Therapy Market in Asia-Pacific to 2018, Shenzhen Beike Biotechnology R&D Pipeline, 2012.......................................................................................................................................96 Stem Cell Therapy Market in Asia-Pacific to 2018, JCR Pharmaceuticals Co. Ltd, R&D Pipeline, 2012.......................................................................................................................................97

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Table 68: Table 69: Table 70:

Stem Cell Therapy Market in Asia-Pacific to 2018, Pharmicell, R&D Pipeline, 2012..................100 Stem Cell Therapy Market in Asia-Pacific to 2018, Medipost, R&D Pipeline, 2012 ...................101 Stem Cell Therapy Market in Asia-Pacific to 2018, Strategic Consolidations Overview, 2007-2012 .............................................................................................................................................102

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Table of Contents

1.2

List of Figures

Figure 1: Figure 2: Figure 3: Figure 4: Figure 5: Figure 6: Figure 7: Figure 8: Figure 9: Figure 10: Figure 11: Figure 12: Figure 13: Figure 14: Figure 15: Figure 16: Figure 17: Figure 18: Figure 19: Figure 20: Figure 21: Figure 22: Figure 23: Figure 24: Figure 25: Figure 26: Figure 27: Figure 28: Figure 29: Figure 30: Figure 31: Figure 32:

Stem Cell Therapy Market in Asia-Pacific to 2018, Overview, 2012 ...........................................15 Stem Cell Therapy Market in Asia-Pacific to 2018, Revenue Forecasts ($m), 2012-2018 ..............................................................................................................................16 Stem Cell Therapy Market in Asia-Pacific to 2018, Cost of Therapy Overview ($), 2012 .............17 Stem Cell Therapy Market in Asia-Pacific to 2018, Allogeneic vs. Autologous (%), 2012.............18 Stem Cell Therapy Market in Asia-Pacific to 2018, Patient Pool for Stem Cell Therapy Forecasts (‘000), 2012-2018....................................................................................................................19 Stem Cell Therapy Market in Asia-Pacific to 2018, Drivers and Barriers, 2012 ...........................20 Stem Cell Therapy Market in Asia-Pacific to 2018, India, Revenue Forecasts ($m), 2012-2018...23 Stem Cell Therapy Market in Asia-Pacific to 2018, India, Cost of Therapy Overview ($), 2012....24 Stem Cell Therapy Market in Asia-Pacific to 2018, India, Patient Pool Forecasts (‘000), 2012-2018 ...............................................................................................................................................24 Stem Cell Therapy Market in Asia-Pacific to 2018, India, CABG Revenue Forecasts ($’000), 20122018.......................................................................................................................................25 Stem Cell Therapy Market in Asia-Pacific to 2018, India, CABG Cost of Therapy Forecasts ($), 2012-2018 ..............................................................................................................................26 Stem Cell Therapy Market in Asia-Pacific to 2018, India, CABG Patient Pool Forecasts (Absolute), 2012-2018 ..............................................................................................................................27 Stem Cell Therapy Market in Asia-Pacific to 2018, India, Type 2 DM Revenue Forecasts ($m), 2012-2018 ..............................................................................................................................29 Stem Cell Therapy Market in Asia-Pacific to 2018, India, Type 2 DM Cost of Therapy Forecasts ($), 2012-2018 ........................................................................................................................30 Stem Cell Therapy Market in Asia-Pacific to 2018, India, Type 2 DM Patient Pool Forecasts (‘000), 2012-2018 ..............................................................................................................................31 Stem Cell Therapy Market in Asia-Pacific to 2018, India, LSCT Revenue Forecasts ($’000), 20122018.......................................................................................................................................32 Stem Cell Therapy Market in Asia-Pacific to 2018, India, LSCT Cost of Therapy Forecasts ($), 2012-2018 ..............................................................................................................................33 Stem Cell Therapy Market in Asia-Pacific to 2018, India, LSCT Patient Pool Forecasts (Absolute), 2012-2018 ..............................................................................................................................34 Stem Cell Therapy Market in Asia-Pacific to 2018, China, Regulatory Framework Timeline, 19982009.......................................................................................................................................35 Stem Cell Therapy Market in Asia-Pacific to 2018, China, Type 1 DM Revenue Forecasts ($m), 2012-2018 ..............................................................................................................................37 Stem Cell Therapy Market in Asia-Pacific to 2018, China, Type 1 DM Cost of Therapy Forecasts ($), 2012-2018 ........................................................................................................................38 Stem Cell Therapy Market in Asia-Pacific to 2018, China, Type 1 DM Patient Pool Forecasts (‘000), 2012-2018....................................................................................................................39 Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, MHLW Stem Cell Guidelines, 2010.....40 Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, JR-031 Overview, 2012......................42 Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, aGvHD Revenue Forecasts ($m), 20142018.......................................................................................................................................43 Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, aGvHD Cost of Therapy Forecasts ($), 2014-2018 ..............................................................................................................................44 Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, aGvHD Patient Pool for Stem Cell Therapy Forecasts (Absolute), 2014-2018................................................................................45 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Stem Cell Therapeutics Approval Process, 2011..........................................................................................................................52 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Biopharmaceutical Implementation Strategies, 2011.............................................................................................53 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Revenue Forecasts ($m), 20122018.......................................................................................................................................54 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Autologous and Allogeneic Share (%), 2012 ................................................................................................................................55 Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Marketed Products Share (%), 2012 and 2018........................................................................................................................55

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Figure 33: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cost of Therapy ($), Overview, 2012.......................................................................................................................................56 Figure 34: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Patient Pool for Stem Cell Therapy, Forecasts (Absolute), 2012-2018 ...............................................................................57 Figure 35: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cupistem Revenue Forecasts ($m), 2012-2018 .....................................................................................................................59 Figure 36: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cupistem Cost of Therapy Forecasts ($), 2012-2018.........................................................................................................60 Figure 37: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cupistem Patient Pool Forecasts (Absolute), 2012-2018.............................................................................................................61 Figure 38: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, HCG-AMI Revenue Forecasts ($m), 2012-2018 .....................................................................................................................63 Figure 39: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, HCG-AMI Cost of Therapy Forecasts ($), 2012-2018.........................................................................................................64 Figure 40: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, HCG-AMI Patient Forecasts (Absolute), 2012-2018.............................................................................................................65 Figure 41: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cartistem Revenue Forecasts ($m), 2012-2018 .....................................................................................................................67 Figure 42: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cartistem Cost of Therapy Forecasts ($), 2012-2018.........................................................................................................68 Figure 43: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cartistem Patient Pool Forecasts (Absolute), 2012-2018.............................................................................................................69 Figure 44: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, CCG Revenue Forecasts ($m), 2015-2018 ..............................................................................................................................70 Figure 45: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, CCG Cost of Therapy Forecasts ($), 2015-2018 ........................................................................................................................71 Figure 46: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, CCG Patient Pool Forecasts (Absolute), 2015-2018.............................................................................................................72 Figure 47: Stem Cell Therapy Market in Asia-Pacific to 2018, R&D Pipeline Analysis by Phase (%), 2012 ....73 Figure 48: Stem Cell Therapy Market in Asia-Pacific to 2018, R&D Pipeline Analysis by Sponsors/Collaborators (%), 2012............................................................................................74 Figure 49: Stem Cell Therapy Market in Asia-Pacific to 2018, R&D Pipeline Analysis by Country (%), 2012 .75 Figure 50: Stem Cell Therapy Market in Asia-Pacific to 2018, India, R&D Pipeline Analysis by Phase (%), 2012.......................................................................................................................................76 Figure 51: Stem Cell Therapy Market in Asia-Pacific to 2018, China, R&D Pipeline Analysis by Phase (%), 2012.......................................................................................................................................78 Figure 52: Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, R&D Pipeline Analysis by Phase (%), 2012.......................................................................................................................................82 Figure 53: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, R&D Pipeline Analysis by Phase (%), 2012 ................................................................................................................................87 Figure 54: Stem Cell Therapy Market in Asia-Pacific to 2018, Stempeutics, Overview, 2012.......................92 Figure 55: Stem Cell Therapy Market in Asia-Pacific to 2018, Reliance Life Sciences, Overview, 2012 ........94 Figure 56: Stem Cell Therapy Market in Asia-Pacific to 2018, International Stem Cell Services, Overview, 2012.......................................................................................................................................95 Figure 57: Stem Cell Therapy Market in Asia-Pacific to 2018, Shenzhen Beike Biotechnology Overview, 2012 ...............................................................................................................................................96 Figure 58: Stem Cell Therapy Market in Asia-Pacific to 2018, JCR Pharmaceuticals Overview, 2012 ...........97 Figure 59: Stem Cell Therapy Market in Asia-Pacific to 2018, ES Cells International, Overview, 2012 .........98 Figure 60: Stem Cell Therapy Market in Asia-Pacific to 2018, Stem Cell Technologies i, Overview, 2012.....99 Figure 61: Stem Cell Therapy Market in Asia-Pacific to 2018, Pharmicell Overview, 2012 ........................100 Figure 62: Stem Cell Therapy Market in Asia-Pacific to 2018, Medipost, Overview, 2012.........................101 Figure 63: Stem Cell Therapy Market in Asia-Pacific to 2018, Strategic Consolidations Overview (%), 20072012.....................................................................................................................................102 Figure 64: GBI Research Market Forecasting Model ...............................................................................113

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Stem Cell Therapy Market in Asia-Pacific to 2018 - Introduction

2

Stem Cell Therapy Market in Asia-Pacific to 2018 - Introduction

The stem cell therapy market in Asia-Pacific is in a nascent stage. The market was valued at $XXm in 2012, and is projected to grow at a CAGR of XX% to reach a value of $XXm in 2018. The high growth rate is attributable to the launch of new stem cell therapies for spinal cord injury (South Korea) and steroid refractory acute graft versus host disease (aGvHD (Japan). Stem cell research is dominated by autologous stem cell therapies, which use cells from the patient’s body and therefore face fewer regulatory hurdles. They contributed XX% of the revenues in 2012. Allogeneic stem cell therapies contribute XX% of the revenues. Autologous therapies are used for the treatment of various diseases, such as Coronary Artery Bypass Graft (CABG), Limbal Stem Cell Technology (LSCT), and type 1 diabetes mellitus (DM), among others. The product pipeline for stem cell research comprises XX molecules, with XX% of the molecules being in Phase II or Phase I/II stages. The pipeline is strong and witnesses the presence of both industry and academia. The emergence of institutional research has helped in the progress of stem cell research, particularly as fewer companies are participating in research due to uncertain therapeutic outcomes. This has also led to more licensing agreements during 2007-2012.

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GBIHC274MR / Published DEC 2012 Page 14

Stem Cell Therapy Market in Asia-Pacific to 2018 - Overview

3.2.4

Stem Cell Therapy Patient Pool

The figure below illustrates the patient pool forecasts for stem cell therapy in Asia-Pacific. Figure 5:

Stem Cell Therapy Market in Asia-Pacific to 2018, Patient Pool for Stem Cell Therapy Forecasts (‘000), 2012-2018

Number of Patients ('000)

CAGR (2012–2018) - XX%

2012

2013

2014

2015

2016

2017

2018

Source: GBI Research; GBI Research Proprietary Database [Accessed August 10, 2012]

Table 2:

Stem Cell Therapy Market in Asia-Pacific to 2018, Patient Pool for Stem Cell Therapy Forecasts (‘000), 2012-2018

Year

2012

2013

2014

2015

2016

2017

2018

CAGR (%)

Number of Patients (‘000) Source: GBI Research; GBI Research Proprietary Database [Accessed August 10, 2012]

The number of patients is projected to increase from XX million in 2012 to XX million in 2018, at a CAGR of XX%. The moderate nature of the growth is attributable to the high cost of therapy and low patient awareness.

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GBIHC274MR / Published DEC 2012 Page 19

Stem Cell Therapy Market in Asia-Pacific to 2018 - South Korea

8.3.3

Stem Cell Patient Pool

The figure below provides stem cell therapy patient pool forecasts.

Number of Patients (Absolute)

Figure 34:

Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Patient Pool for Stem Cell Therapy, Forecasts (Absolute), 2012-2018

HCG-AMI CAGR (2012–2018) - XX% Cartistem CAGR (2012–2018) - XX% Cupistem CAGR (2012–2018) - XX% CCG CAGR (2015–2018) - XX%

Anticipated launch of CCG is projected to increase the patients on stem cell therapy

2012

2013

HCG-AMI Stem Cell Patients

2014

2015

Cartistem Stem Cell Patients

2016

2017

Cupistem Stem Cell Patients

2018

CCG Stem Cell Patients

Source: GBI Research

Table 21: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Patient Pool for Stem Cell Therapy, Forecasts (Absolute), 2012-2018 Year

2012

2013

2014

2015

2016

2017

2018

CAGR (%)

HCG-AMI Stem Cell Patients (Absolute) Cartistem Stem Cell Patients (Absolute) Cupistem Stem Cell Patients (Absolute) CCG Stem Cell Patients (Absolute) Total Stem Cell Patients (Absolute) Source: GBI Research

The stem cell patient pool for various stem cell therapies in South Korea was XX in 2012. The patients seeking stem cell treatment are projected to increase to XX in 2018, at a CAGR of XX%. The high growth is attributed to the therapies becoming reimbursable in the forecast period, the launch of CCG, and the various advantages offered by these therapies (HCG-AMI, Cartistem, Cupistem and CCG).

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GBIHC274MR / Published DEC 2012 Page 57

Stem Cell Therapy Market in Asia-Pacific to 2018 - Pipeline Analysis

The research is in early stage with Phase I/II and Phase II contributing XX% of the pipeline

9

Stem Cell Therapy Market in Asia-Pacific to 2018 - Pipeline Analysis

9.1

Pipeline Analysis by Phase

The research is mainly in early stages, with the majority of the molecules being in early stages of development (Phase I/II and Phase II). Phase I/II and Phase II contribute XX% of the pipeline. The figure below provides pipeline analysis by phase. Figure 47:

Stem Cell Therapy Market in Asia-Pacific to 2018, R&D Pipeline Analysis by Phase (%), 2012 Post-Market Unknown Phase III Phase II/III Phase II

Clinical Pre-Test

Phase I

Phase I/II Source: GBI Research, Clinical Trial Registry India (CTRI) (2012), CHiCTR (2012), UMIN-CTR (2012), Clinical Research Information Service (CRiS) (2012)

Table 34: Stem Cell Therapy Market in Asia-Pacific to 2018, R&D Pipeline Analysis by Phase, 2012 Phase

Number of Molecules

Post-Market Unknown Phase III Phase II/III Clinical Pre-Test Phase I Phase I/II Phase II Total Source: GBI Research, CTRI (2012), CHiCTR (2012), UMIN-CTR (2012), CRiS (2012)

The stem cell pipeline for Asia-Pacific is in its nascent stage. Stem cell therapy is expected to provide benefits to patients suffering from diseases for which only symptomatic treatment or no treatment options are available.

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GBIHC274MR / Published DEC 2012 Page 73

Stem Cell Therapy Market in Asia-Pacific to 2018 - Appendix

12

Stem Cell Therapy Market in Asia-Pacific to 2018 - Appendix

12.1 Market Definitions Stem cell therapy research in Asia-Pacific includes five countries, namely China, India, Japan, Singapore and South Korea The stem cell therapy market for Asia-Pacific includes four countries, namely China, India, Japan and South Korea. The revenues are the addition of the stem cell therapy market of China, India, Japan and South Korea. Stem cell therapy market for Singapore is not estimated as the pipeline molecules are in the early stages of clinical development and are not anticipated to be launched during the forecast period.

12.2 Abbreviations A*STAR -

Agency for Science Technology and Research

ABMS -

Autologous Bone Marrow Stem Cells

ABMSCT -

Allogeneic Mesenchymal Stem Cells Transplantation

ACC -

The American College of Cardiology

aGvHD -

Acute Graft Versus Host Disease

AHA -

American Heart Association

AIIMS -

All India Institute of Medical Sciences

ALL -

Acute Lymphoblastic Leukemia

AMI -

Acute Myocardial Infarction

AML -

Acute myeloid Leukemia

AMSC -

Allogeneic Mesenchymal Stem Cells

AS -

Ankylosing Spondylitis

BAC -

Bioethics Advisory Committee

CABG -

Coronary Artery Bypass Graft

CAD -

Coronary Artery Disease

CAGR -

Compound Annual Growth Rate

CCG -

Cerecellgram

CCI -

Condrocyte Implantation

CD -

Crohn’s Disease

ChiCTR -

Chinese Clinical Trial Register

CIK -

Cytokine Induced Killer

CLL -

Chronic Lymphocytic Leukemia

CML -

Chronic Myelogenous Leukemia

COPD -

Chronic Obstructive Pulmonary Disease

DBT -

Department of Biotechnology

DM -

Diabetes Mellitus

DRDO -

Defense Research and Development Organization

ESC -

Embryonic Stem Cells

GDP -

Gross Domestic Product

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Stem Cell Therapy Market in Asia-Pacific to 2018 - Appendix

GMP -

Good Manufacturing Practice

GvHD -

Graft Versus Host Disease

HCG-AMI -

Hearticellgram-Acute Myocardial Infarction

hESCs -

Human Embryonic Stem Cells

HSC -

Hematopoietic Stem Cells

HSCT -

Hematopoietic Stem Cell Transplantation

IBD -

Inflammatory Bowel Disease

ICMR -

Indian Council of Medical Research

iPSC -

Induced Pluripotent Stem Cells

IRB -

Institutional Review Board

KFDA -

Korea Food and Drug Administration

KOL -

Key Opinion Leader

LSCT -

Limbal Stem Cell Transplantation

LVPEI -

LV Prasad Eye Institute

MDS -

Myelodysplastic Syndromes

MHLW -

Ministry of Health, Labour and Welfare

MoHW -

Ministry of Health and Welfare

MSC -

Mesenchymal Stem Cells

NAC-SCRT -

National Apex Committee for Stem Cell Research and Therapy

NIDDM -

Non-Insulin Dependent Diabetes

NMRC -

National Medical Research Council

OA -

Osteoarthritis

PCI -

Percutaneous Coronary Intervention

PGIMER -

Post Graduate Institute of Medical Education and Research

SCNT -

Somatic-Cell Nuclear Transfer

TKR -

Total Knee Replacement

UC -

Ulcerative Colitis

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GBIHC274MR / Published DEC 2012 Page 108

Stem Cell Therapy Market in Asia-Pacific to 2018 - Appendix

12.3 Bibliography 

BIONET (2010). Ethical Governance of Biological and Biomedical Research: Chinese - European Cooperation. Available From http://www2.lse.ac.uk/researchAndExpertise/units/BIONET/pdfs/BIONET%20Final%20Report1.pdf.



Bioethics Advisory Committee (2002a). Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning. Available From http://www.bioethicssingapore.org/uploadfile/60517%20PMHSC%20Research.pdf.



Bioethics Advisory Committee (2002b). Human Tissue Research. Available From http://www.bioethicssingapore.org/uploadfile/60104%20PMHT%20Research.pdf.



Bioethics Advisory Committee (2004). Research Involving Human Subjects: Guidelines for IRBs. Available From http://www.bioethics-singapore.org/uploadfile/55527%20PMHS%20Research.pdf.



Bioethics Advisory Committee (2005). Genetic Testing and Genetic Research. Available From http://www.bioethics-singapore.org/uploadfile/55211%20PMGT%20Research.pdf.



Bioethics Advisory Committee (2007). Personal Information in Biomedical Research. Available From www.bioethics-singapore.org/.../15654%20PMPI%20Report.pdf.



Bioethics Advisory Committee (2008). Donation of Human Eggs for Research. Available From http://www.bioethics-singapore.org/uploadfile/13144%20PMFull%20ED%20Report.pdf.



Bioethics Advisory Committee (2010). Human-Animal Combination in Stem Cell Research. Available From http://www.bioethics-singapore.org/uploadfile/54403%20PMHAC%20Report%20.pdf.



Chinese Clinical Trial Registry (ChiCTR) (2012). Clinical Trials, Stem Cells [database] Available From http://www.chictr.org/en/proj/search.aspx?title=stem%20cell &officialname=&secondaryid=&subjectid=&applier=&studyleader=ðicalcommitteesanction=&spon sor=&studyailment=&studyailmentcode=&studytype=0&studystage=0&studydesign=0&minstudyexecu tetime=&maxstudyexecutetime=&recruitmentstatus=0&gender=0&agreetosign=&secsponsor=®no =®status=0&country=&province=&city=&institution=&institutionlevel=&measure=&intercode=&so urceofspends=&createyear=0&page=1.



Kim E.S and Kim W.H (2010). Inflammatory Bowel Disease in Korea: Epidemiological, Genomic, Clinical, and Therapeutic Characteristics. Gut and Liver, Vol. 4, No. 1, March 2010, pp. 1-14.



ll-Hoan Oh (2012). Regulatory issues in stem cell therapeutics in Korea: efficacy or efficiency? Korean Journal of Hematology 2012 June; 47(2): 87-89.



ICMR-DBT Guidelines for Stem Cell Research (2012). Guidelines for Stem Cell Research. Available From http://icmr.nic.in/stem_cell_guidelines.pdf.



IDF Diabetes Atlas (2012). The Global Burden. Available From http://www.idf.org/diabetesatlas/5e/the-global-burden. [Accessed August 13, 2012]



LV Prasad Eye Institute (2012). What are Stem Cells? Available From http://patientcare.lvpei.org/eyehospital/clinical-services/stem-cell.html. [Accessed August 13, 2012]



Rellife (2012). CardioRel. Available From http://rellife.com/pdf/cardiorelinsert.pdf.



MHLW (2010a). Guidelines on clinical research using human stem cells. Available From http://www.mhlw.go.jp/english/policy/health-medical/medical-care/dl/guidelines.pdf.



MHLW (2010b). Guidelines on clinical research using human stem cells. Available From http://www.mhlw.go.jp/english/policy/health-medical/medical-care/dl/guidelines.pdf.



NovoNordisk (2011). The Global Diabetes Care market. Available From http://www.novonordisk.com/images/investors/investor_presentations/2011/CMD2011/03_The_glob al_diabetes_care_market_CMD2011.pdf.



The American Chamber of Commerce (2011a). Policy Direction for Innovative Biopharmaceuticals in KFDA. Available From http://www.amchamkorea.org/publications/upload/2011/hcseminar/YooMiKim.pdf.

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Stem Cell Therapy Market in Asia-Pacific to 2018 - Appendix



The American Chamber of Commerce (2011b). Policy Direction for Innovative Biopharmaceuticals in KFDA. Available From http://www.amchamkorea.org/publications/hcseminar/19_Yeowon%20Sohn.pdf.



UMIN Clinical Trials Registry [UMIN-CTR] (2012), Clinical Trials, Stem Cells [database] Available From https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi

12.4 Research Methodology GBI Research’s dedicated research and analysis teams consist of experienced professionals with a pedigree in marketing, market research, consulting backgrounds in the medical devices industry, and advanced statistical expertise. GBI Research adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and the Strategic and Competitive Intelligence Professionals (www.scip.org). All GBI Research databases are continuously updated and revised.

12.4.1

Coverage

The objective of updating GBI Research’s coverage is to ensure that it represents the most up-to-date vision of the industry possible. Changes to the industry taxonomy are decided on the basis of extensive research of company, association and competitor sources. Company coverage is based on three key factors: market capitalization, revenues, and media attention/innovation/market potential. 

An exhaustive search of 56 member exchanges is conducted, and companies are prioritized on the basis of their market capitalization;



The estimated revenues of all major companies, including private and governmental, are gathered and used to prioritize coverage; and,



Companies which are making the news, or which are of particular interest due to their innovative approach, are prioritized.

GBI Research aims to cover all major news events and deals in the medical industry, with its databases updated on a daily basis. The coverage is further streamlined and strengthened with additional inputs from GBI Research’s expert panel (see below).

12.4.2

Secondary Research

The research process begins with exhaustive secondary research on internal and external sources being carried out to source qualitative and quantitative information relating to each market. The secondary research sources that are typically referred to include, but are not limited to: 

Company websites, annual reports, financial reports, broker reports, investor presentations and US Securities and Exchanges Commission (SEC) filings.



Industry trade journals, scientific journals and other technical literature.



Internal and external proprietary databases.



Relevant patent and regulatory databases.



National government documents, statistical databases and market reports.



Procedure registries.



News articles, press releases and webcasts specific to the companies operating in the market.

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Stem Cell Therapy Market in Asia-Pacific to 2018 - Appendix

12.4.3

Primary Research

GBI Research conducts hundreds of primary interviews each year with industry participants and commentators, in order to validate its data and analysis. A typical research interview fulfills the following functions: 

It provides first-hand information on the market size, market trends, growth trends, competitive landscape, future outlook, etc.



Helps in validating and strengthening the secondary research findings; and



Further develops the analysis team’s expertise and market understanding.

Primary research involves email interactions, telephone interviews, and face-to-face interviews for each market, category, segment and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to: 

Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and national sales managers.



Hospital stores, laboratories, pharmacies, distributors and paramedics.



Outside experts: Investment bankers, valuation experts, research analysts specializing in specific medical equipment markets; and



Key Opinion Leaders: Physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of medical equipment.

The report consists of the following four major sections: Geographic Landscape Therapeutic Landscape Pipeline Analysis Competitive Analysis

12.5 Therapeutic Landscape The revenues for each indication, by geography, are arrived at by utilizing the GBI Research market forecasting model. The global revenues for each indication are a summarized value of the revenues of all four countries. Only company sponsored molecules which are in late stages of clinical development and are anticipated to launch in the forecast period are considered for market estimation. The data for market estimation was based on extensive primary and secondary research and also from company websites, press releases and GBI Research’s proprietary databases. The annual cost of therapy for each indication is arrived at by considering the cost of the drugs, dosage of the drugs, and the duration of the therapy. The marketed drugs section contains an overview of the drugs, their mechanism of action, efficacy and safety issues related to the drugs. The drugs profiled in this section are chosen based on estimated revenues and their mechanism of action. GBI Research uses the epidemiology-based treatment flow model to forecast the market size for therapeutic indications. 12.5.1.1

Epidemiology-based Forecasting

The forecasting model used at GBI Research makes use of epidemiology data gathered from research publications and primary interviews with physicians to represent the treatment flow patterns for individual diseases and therapies. The market for any disease segment is directly proportional to the volume of units sold and the price per unit. Sales = Volume of units sold X Price per unit The volume of units sold is calculated based on the average dosage regimen for that disease, the duration of treatment, and the number of patients who are prescribed drug treatment (the prescription population). © GBI Research. This is a licensed product and is not to be photocopied

GBIHC274MR / Published DEC 2012 Page 111

Stem Cell Therapy Market in Asia-Pacific to 2018 - Appendix

The prescription population is calculated as a percentage of the population diagnosed with a disease (the diagnosis population). The diagnosis population is the population diagnosed with a disease expressed as a percentage of the population that is seeking treatment (the treatment seeking population). The prevalence of a disease (diseased population) is the percentage of the total population who suffer from a disease/condition. Data on treatment seeking rate, diagnosis rate and prescription rate, if unavailable from research publications, are gathered from interviews with physicians and are used to estimate the patient volumes for the disease under consideration. Therapy uptake and compliance data are fitted in the forecasting model to account for patient switching and compliance behavior. To account for differences in patient affordability of drugs across various geographies, macroeconomic data such as inflation and GDP, and healthcare indicators such as healthcare spending, insurance coverage and average income per individual, are used. Annual cost of treatment is calculated using product purchase frequency and the average price of the therapy. Product purchase frequency is calculated from the dosage data available for the therapies, and drug prices are gathered from public sources. The epidemiology-based forecasting model uses a bottom-up methodology, and makes use of estimations in the absence of data from research publications. Such estimations may result in a final market value that is different from the actual value. To correct this ‘gap’, the forecasting model uses triangulation, with the help of base year sales data (from company annual reports, internal and external databases) and sales estimations. Analogous Forecasting Methodology The analogous forecasting methodology is used to account for the introduction of new products, patent expiries of branded products, and the subsequent introduction of generics. Historic data for new product launches and generics penetration are used to arrive at robust forecasts. The increase or decrease of prevalence rates, treatment seeking rate, diagnosis rate and prescription rate are fitted into the forecasting model to estimate the market growth rate. The proprietary model enables GBI Research to account for the impact of individual drivers and restraints in the growth of the market. The year of impact and the extent of impact are quantified in the forecasting model to provide close-to-accurate data sets.

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Stem Cell Therapy Market in Asia-Pacific to 2018 - Appendix

12.5.2

Market Size by Geography

The treatment usage pattern and annual cost of treatment in each country has been factored in while deriving the individual country market size. Forecasting Model for Therapeutic Areas Figure 64:

GBI Research Market Forecasting Model G B I R es e ar ch M ar ke t Siz in g M o de l

D is ea s e P opu la ti on G e ne r a l Po pu la tio n

74 3 ,53 5 ,0 4 8

Q u alif yin g c on d itio n 1 (Ag e /S e x/O c c upa tio n e tc ) Q u alif yin g c on d itio n 2 (Ag e /S e x/O c c upa tio n e tc ) P re v a l e nc e t is su e v a l v e dis e a se

0 .2 %

1 ,78 4 ,4 8 4

Q u alif yin g c on d itio n (c om plic ation , s eve rity) D IS EA S E D P OP U LA T IO N

1 ,78 4 ,4 8 4

T r e atm e n t Fl ow P a tter n s T re a tm e nt S e ek i ng R at e (Sy m ptom s / Dis A wa re ne s s )

89 %

1 ,58 8 ,1 9 1

Dia gn os is Ra t e ( C lin ica l a nd D ia gn os tic Tes t s )

75 %

1 ,19 1 ,1 4 3

70 %

83 3 ,8 0 0

P re s c r ipti on R ate ( Ph y sic ia n P e rc ep t io n, Tr ea tm ent E ffe c tiv e n e s s ) Tis s ue V a lve O th e r T rea tm en t s fo r Va lv e (Su r g /M ed /N o ne )

-

F ulfill m en t A vaila b ilit y

NA

W illing n e ss to U s e (Pa tie nt Pe rc ep tio ns)

NA

R e ad y to U se (S u rg e ry e lig ib ility , R e us e e tc )

NA

Affo rd a bil it y a t Pr ic e H E as % of G D P s p en d A vera g e Inc om e (p er ind iv id u a l) P at ien t O ut-o f -p oc ke t B ud g e t (A nn u a l) Bu d g et a lloc a tio n to o n e-t im e s u rge ry Bu d g et a lloc a tio n to o th e r h e alt h n e ed s A vera g e P ay or C overa g e P at ien t L iab ility Ta rg e t P r ic e ( @ 20 % p a t lia b ) A S P f or C o s t of T h era p y T O TA L P AT IEN T V OLU M E S P ro du c t P urch a se Fr e qu en c y T OT A L U N IT VO LU M ES

P r ic in g pe r Un it

1

$

1 8 ,00 0

In flat ion P rice D ec re as e du e to c om p et it ion M a r k et Va lu e

Source: GBI Research

The above figure represents a typical forecasting model constructed by GBI Research. As discussed previously, the model is built on the treatment flow patterns. The model starts with the general population, then diseased population as a percentage of general population, and then follows the treatment seeking population as a percentage of the diseased population, and the diagnosed population as a percentage of the treatment seeking population. Finally, the total volume of units sold is calculated by multiplying the treated population by the average dosage per year per patient.

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Stem Cell Therapy Market in Asia-Pacific to 2018 - Appendix

12.6 Geographical Landscape GBI Research analyzes seven major geographies, namely, the India, China, Singapore, South Korea and Japan. The total market size for each country is provided, which is the summarized value of the market sizes of all the indications for that particular country.

12.7 Pipeline Analysis This section provides a list of molecules at different stages in the pipeline for various indications. The list is sourced from internal databases and validated for the accuracy of phase and mechanism of action at clinicaltrials.gov and company websites. The section also includes a list of promising molecules, which is narrowed down based on the results of the clinical trials at various stages and the novelty of the mechanism of action.

12.8 Competitive Landscape Profiles of leading players are provided, along with an overview of key products marketed by the companies for various indications. An analysis of strengths, weaknesses, opportunities and threats of each company with respect to various indications is also listed. GBI Research aims to cover all major M&A, licensing deals and co-development deals related to the market. This section is sourced from the companies’ websites and internal databases.

12.8.1

Expert Panel Validation

GBI Research uses a panel of experts to cross-verify its databases and forecasts. GBI Research’s expert panel comprises marketing managers, product specialists, international sales managers from medical device companies, academics from research universities, and key opinion leaders from hospitals. Historic data and forecasts are relayed to GBI Research’s expert panel for feedback and adjusted in accordance with their feedback.

12.10 Disclaimer All Rights Reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GBI Research.

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