HPAPI Global Market Opportunity
Current Generic APIs

• Global API market valued at US $109 Billion in 2011- growing at 7.9% CAGR next 5 years

• 2011 Global API production- 62.4% in-house pharmaceutical companies, 37.6% CMO outsourced


Shift to High-Potency APIs

• 15% growth shift towards high potency APIs(HPAPI) manufacturing -CMO/CRAMS capability expansion & differentiation from generic APIs


• HPAPI market -$8.9 B in 2011, 80% in N. America/ Europe USA(45.6&)/Europe (35%) (2009), Asia at 9.35% only-but oncology market growing at 20%

♦ Oncology cytotoxic therapeutics, hormones prostaglandins.

• WESTERN CMO/CRAMS (for now?)

- USA-SAFC $75 Mil Wisconsin, new Israel bacterial HPAPIs

- France-Novasep US$12.7 mil HPAPI plant- Le Mans-50% Capacity increase


India/China & Future HPAPI
• Asia HPAPIs growing 15.4 % between 2009 & 2015.

• Notable Asian CMO/CRAMS -Aptuit, Hovione, Eisai, Asymchem, Arch Pharmalabs, Nicholas Piramal, Ranbaxy, Dr. Reddy’s

West --> India Tech-Transfer-M&A:

- India leads with its first mover advantage from past generic exports business with the West, US largest API (32%) global market

- but India 2nd only to China’s larger share of global API market ( at 18%) with India at 13% share


• USA Asymchem’s China HPAPI facility (Roche Most Valuable Partner Award):



• Escalating Labor Costs, increasing Environmental and Quality Regulatory oversight in China/India will DRIVE COST UP !

• Plus Productivity from skilled labor is 3x higher in the West than say India.