Erythropoietin 2012 Edition September 2012

(EPO)

Market

Report:

Executive Summary With the advent of novel technologies, companies operating in the healthcare/science/pharmaceutical/therapeutic area are now scaling new heights. Also this industry is boosted by the rising number of incidences of health related issues emanating from the changing lifestyle and rapidly evolving surrounding environment. Among the respective industries of biological sciences, an upcoming industry is of EPO (Erythropoietin) and ESA (Erythropoietin Stimulating Agents). EPO is a glycoprotein hormone which regulates erythropoiesis i.e. the production of Red Blood Cells (RBC). EPO is mainly produced within the human kidneys by the interstitial fibroblasts in a close association with and tubular epithelial cells. But the production of endogenous EPO is marred in the case of people suffering with renal anemia as the kidney remains inflamed, and in the cases of anemia in cancer patients due to chemotherapy. EPO is also used for placating conditions, like neurological disorders, post cardiac surgery term, and other critical illness situations. The ESA market takes into account the EPO products and other EPO stimulating agents. The synthetic ESAs available in the market are known as rHuEPO (Recombinant Human Erythropoietin) manufactured using DNA. It is similar to the natural human EPO. In the pharmaceutical drug market, 5 variants of ESAs are most prevalent viz. epoetin-alfa, epoetin-beta, epoetin-omega, epoetin-delta and darbepoetin-alfa. This report provides a comprehensive analysis of the ESA/EPO product market of Japan and China. The competitive environment of the industry is quite fierce and challenging. On the global level, the top notch players in the EPO market include Amgen, Roche and Johnson & Johnson with Hospira being another potential constituent. Herein, the market dynamics viz. the key trends (strategic outlook for clinical trials, inclination towards polysialylation and focus on clinical differentiation), industry developments (development of improved biological molecules, ErepoXen Phase IIb intravenous trial underway in India and advent of biosimilars), growth drivers (increasing cases chronic kidney disease (CKD), global dialysis patient population, increasing prevalence of cancer, upcoming patent expiries of original bio drugs, rising adult population worldwide and rising healthcare expenditure) and challenges (risk of thrombosis and PRCA, requirement of extensive clinical trials for obtaining approval, abusive uses of EPO, adverse effects of EPO and escalating price pressure) are also explicated.

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2. ESA/EPO Product Market Size Table 2.1: Drugs for anemia associated with chronic renal failure in Japan Product Company Generic Launch Date Regimen Name Name (Dialysis) Dialysis PreDialysis Epogin Chugai Epoetin beta April March 1500 IU, 1990 1994 biw~tiw / 3000 IU, biw Nesp

Kyowa Hakko Kirin

Darbepoetin alpha

July 2007

April 2010

15~60μg, once a week

Espo

Kyowa Hakko Kirin

Epoetin alpha

April 1990

-

1500 IU, biw~tiw / 3000 IU, biw

Epoetin alpha BS

Kissei/JCR

Epoetin K

May 2010

-

1500 IU, biw~tiw / 3000 IU, biw

Mircera

Chugai/ Roche

Epoetin beta pegol

July 2011

July 2011

25~250μg, once every four weeks

-

Takeda/ Affymax

Peginesatide*

-

-

once every four weeks

Table 2.2: Mircera Assumptions (2010-2015E) 2010 2011 2012E Dialysis Penetration rate Estimated patients treated with Mircera (x1000) Pre-dialysis Penetration rate Estimated patients treated with Mircera (x1000)

2013E

2014E

2015E

-

Xx Xx

Xx xx

xx Xx

Xx xx

Xx Xx

-

Xx xx

Xx xx

Xx xx

Xx Xx

Xx Xx

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Figure 2.1: Japan’s ESA Market Size (2004-2010)

JPY Billion

US$ Billion

2004

2005

2006

2007 JPY

2008

2009

2010

US$

Figure 2.2: Japan’s ESA Market Size by Product (2010-2011)

Epoetin-alpha BS(Kissei/JCR) Espo (Kyowa Hakko Kirin)

Nesp (Kyowa Hakko Kirin) Mircera (Chugai/Roche) Epogin (Chugai/Roche) US$ Billion

Table 2.7: Japanese ESA Market Share Product and by Company 2011 by 2010 (2010-2015E) 2010 2011 2012E 2013E 2014E 2015E Marketed Products Epogin Mircera Nesp Espo Epoetin-alpha BS Company Chugai Total Kyowa Hakko Kirin Total Kissei/JCR Total New Drug

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Under Development Peginesatide by Takeda/Affymax

xx

xx

xx

xx

xx

Xx

US$ Billion

Figure 2.5: Japan’s ESA Market Size (2012E-2015E)

2012E

2013E

2014E

2015E

Figure 2.7: China’s EPO Market Growth (2005 and 2010)

US$ Billion

CAGR xx%

2005

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2010

5

US$ Million

Figure 2.9: China’s EPIAO Market Size by Usage Area (2007-2011)

2007

2008 ESRD

2009

2010

Pre- Dialysis

2011

Oncology

Table 2.9: China’s EPIAO Market Model for ESRD (2007-2011) 2007 2008 2009 2010 Renal Patients Population Patient Population Growth (y/y) Treated ESRD Patient Population ESRD Patients as % of Renal Patients EPO Patient Population EPO Penetration Rate EPO Market Size (In RMB million) (In US$ million) 3S Bio Market Share EPIAO Sales for ESRD treatment (In RMB million) (IN US$ million)

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2011

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