際際滷

際際滷Share a Scribd company logo

HPAPI Summit- Poster Presentation - Philadelphia-July 2013

Ram Balani
Ram Balani

Presentation focus on emerging regions CMOs/CRAMs in the cytotoxic high potency API sector including India & China

1 of 1
Download to read offline
HPAPI Global Market Opportunity Challenges to HPAPI Manufacturing - India/China & Future HPAPI Investment, Expertise, Stringent Specification Small molecule HPAPI manufacturing is COMPLEX! High barrier to entry due to costs Sophisticated manufacturing & containment technologies-high level of personnel training/experience Demanding resources required for achieving health safety, environmental approvals-OELs, Containment validation ADC-Antibody Drug Conjugates even More COMPLEX! Cytotoxic molecule Bound to Monoclonal Antibody for more targeted delivery Complex air handling under negative pressure to prevent materials leaking into the environment, often requiring PPE-Personal Protective Equipment Requires fully contained sampling systems and testing methods with sophisticated engineering controls Requires constant medical monitoring on employee operators exposure Facility design: single-pass air, airlocks, safe-change filters, misting showers Oncology 59% Hormonal 19% Glaucoma 7% Others 15% 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 Asia HPAPIs growing 15.4 % between 2009 & 2015. Notable Asian CMO/CRAMS -Aptuit, Hovione, Eisai, Asymchem, Arch Pharmalabs, Nicholas Piramal, Dishman, Ranbaxy, Dr. Reddys West India Tech-Transfer-M&A: State-of-the-art HPAPI Category IV in Bavla, India designed by Dishman Groups Swiss-based Carbogen Amcis: category Occupational Exposure Limit (OEL) Toxicity I 0.5 mg/m続 Low II 10 袖g/m続 to 0.5 mg/m続 Moderate III 30 ng/m続 to 10 袖g/m続 Potent IV 30 ng/m続 Highly Potent 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 (SafeBridge Consultants, Inc. 4-Band Assessment) LOW OCCUPATIONAL EXPOSURE LIMITS REQUIRE COMPLETE CONTAINMENT AND SPECIAL HANDLING! USA Asymchems China HPAPI facility (Roche Most Valuable Partner Award): But: 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. Captive - Proprietary and Generic API 62% Outsourced - Proprietary API 19% Outsourced - Generic API 19% 2011 ROW, 7.47% China, 6.98% CAGR 12.6% India, 4.25% CAGR 10.3% US$109B High Potency drugs have become the darling for Big Pharma and MNCs globally. CMOs and CRAMs are following suit, i.e. gearing up to build new, sophisticated drug manufacturing that can handle the stringent demands of cytotoxic API manufacturing. Today, due to high investment costs, technology and process demands plus sophisticated containment ,that small club of CMOs are predominantly Western, but could India & China not be FAR behind? Although LOWER COST is not the sole reason for outsourcing manufacturing, it remains a BIG FACTOR in the process. China and India have the home advantage plus global growth in pharmaceutical markets are leaning towards serving emerging regions domestic markets. Will history repeat itself? (, i.e. India generics formulation take-over plus Chinas Global API production dominance) HPAPI Capable CMOs & CRAMS in Emerging Regions Here Comes India & China (Again) ? Source: Chemical Pharmaceutical Generic Association Source: GBI Research

More Related Content

HPAPI Summit- Poster Presentation - Philadelphia-July 2013

  • 1. HPAPI Global Market Opportunity Challenges to HPAPI Manufacturing - India/China & Future HPAPI Investment, Expertise, Stringent Specification Small molecule HPAPI manufacturing is COMPLEX! High barrier to entry due to costs Sophisticated manufacturing & containment technologies-high level of personnel training/experience Demanding resources required for achieving health safety, environmental approvals-OELs, Containment validation ADC-Antibody Drug Conjugates even More COMPLEX! Cytotoxic molecule Bound to Monoclonal Antibody for more targeted delivery Complex air handling under negative pressure to prevent materials leaking into the environment, often requiring PPE-Personal Protective Equipment Requires fully contained sampling systems and testing methods with sophisticated engineering controls Requires constant medical monitoring on employee operators exposure Facility design: single-pass air, airlocks, safe-change filters, misting showers Oncology 59% Hormonal 19% Glaucoma 7% Others 15% 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 Asia HPAPIs growing 15.4 % between 2009 & 2015. Notable Asian CMO/CRAMS -Aptuit, Hovione, Eisai, Asymchem, Arch Pharmalabs, Nicholas Piramal, Dishman, Ranbaxy, Dr. Reddys West India Tech-Transfer-M&A: State-of-the-art HPAPI Category IV in Bavla, India designed by Dishman Groups Swiss-based Carbogen Amcis: category Occupational Exposure Limit (OEL) Toxicity I 0.5 mg/m続 Low II 10 袖g/m続 to 0.5 mg/m続 Moderate III 30 ng/m続 to 10 袖g/m続 Potent IV 30 ng/m続 Highly Potent 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 (SafeBridge Consultants, Inc. 4-Band Assessment) LOW OCCUPATIONAL EXPOSURE LIMITS REQUIRE COMPLETE CONTAINMENT AND SPECIAL HANDLING! USA Asymchems China HPAPI facility (Roche Most Valuable Partner Award): But: 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. Captive - Proprietary and Generic API 62% Outsourced - Proprietary API 19% Outsourced - Generic API 19% 2011 ROW, 7.47% China, 6.98% CAGR 12.6% India, 4.25% CAGR 10.3% US$109B High Potency drugs have become the darling for Big Pharma and MNCs globally. CMOs and CRAMs are following suit, i.e. gearing up to build new, sophisticated drug manufacturing that can handle the stringent demands of cytotoxic API manufacturing. Today, due to high investment costs, technology and process demands plus sophisticated containment ,that small club of CMOs are predominantly Western, but could India & China not be FAR behind? Although LOWER COST is not the sole reason for outsourcing manufacturing, it remains a BIG FACTOR in the process. China and India have the home advantage plus global growth in pharmaceutical markets are leaning towards serving emerging regions domestic markets. Will history repeat itself? (, i.e. India generics formulation take-over plus Chinas Global API production dominance) HPAPI Capable CMOs & CRAMS in Emerging Regions Here Comes India & China (Again) ? Source: Chemical Pharmaceutical Generic Association Source: GBI Research