Active pharmaceutical ingredients (APIs), also known as 'bulk drug substances', are defined by the US Food and Drugs Administration (FDA) as 'any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug becomes an active ingredient of the drug product'. Companies use APIs at a number of stages of pharmaceutical development, including in stability sample testing, general analytical testing and method development, as GMP (Good Manufacturing Practice) APIs in clinical trials, and as source materials for manufacturing marketed drugs. Sourcing APIs from low-cost suppliers is a key strategy for pharmaceutical companies pressured by the emerging 'patent cliff' . The model of vertical integration that dominated the pharmaceutical industry in the past century, characterized by tight control over all factions of the pharmaceutical manufacturing and development process is now being broken up. For example, UK-based AstraZeneca has stated that it is looking to outsource its entire API production between 2014 and 2019. There have been suggestions that this will be to China and India, although according to the company in November 2009, it has not yet made final decisions on outsourcing locations. Meanwhile, API producers are investing in new technologies to cut costs, reduce the environmental impact of manufacturing and improve efficacy. These include simulated-moving bed chromatography (SMB), a development of high-performance liquid chromatography (HPLC), as well as new product areas such as Highly Potent APIs (HPAPIs).
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Partial Table of Contents:
Challenges & Opportunities in the global APIs market Executive Summary 9
Introduction 9
World market outlook 10
Regulatory environment 11
Patent expiries and the rise of generics 12
Biotechnology 13
Competitive landscape 14
Future outlook 15
Chapter 1 Introduction 17
Summary 17
Introduction 18
New technology 18
Small molecule production technologies 18
HPAPIs 20
Antibody-drug conjugates 21
Changes in demographics and disease 22
Demographic pressure 22
Move from rural to urban living 23
Disease prevalence 25
Changes in healthcare spending 27
Rise of outsourcing 28
The counterfeit threat 30
Chapter 2 World Market Outlook 35
Summary 35
Introduction 36
The global API market 39
Therapeutic areas 40
API Sales by region 42
North America 42
Western Europe 45
Asia Pacific 49
Other regions 52
Chapter 3 Regulatory Environment 55
Summary 55
Introduction 56
GMP requirements 56
ICH Q7A 56
US GMP - Federal Food Drug and Cosmetic Act Section 501(a)(2)(B)
EU GMP - Directive 2004/27/EC 60
China GMP - GMP for pharmaceutical products 62
India GMP - Drugs and cosmetics rules Schedule M 64
Drug Price Competition and Patent Term Restoration Act ('Hatch-Waxman Act') 65
Supplementary protection certification (SPC) 65
REACH 66
The current regulatory environment for biosimilars 67
Chapter 4 Patent expiries and the rise of generics 71
Summary 71
Introduction 72
Patent expiries and the API market 75
Case study - Cambrex 79
Chapter 5 Biotechnology 83
Summary 83
Introduction 84
Biotechnology-
Recombinant proteins 84
Monoclonal antibodies 84
Biosimilars 85
The biologics market 85
Biotechnology-
Biosimilars 92
APIs for biosimilars 93
Challenges 95
Case study: Biobetters 96
Chapter 6 Competitive Landscape 99
Summary 99
Introduction 100
Competitive strategies 101
Company profiles 102
Albemarle Corporation 102
Asymchem Laboratories 104
Boehringer Ingelheim 105
Cambrex Corporation 106
Daiichi Fine Chemicals 108
Dr Reddy's Laboratories 108
Royal DSM 110
Grindeks 112
Lonza 113
Matrix Laboratories 114
Novasep 115
Pfizer CentreSource 116
Ranbaxy Laboratories 116
Recordati 118
SAFC Pharma 118
Sumitomo Chemical 119
Teva Active Pharmaceutical Ingredients 121
WuXi AppTec 122
Zhejiang Hisun Pharmaceutical 122
Chapter 7 Future Outlook 125
Summary 125
Introduction 126
Key commercial opportunities and future drivers of growth 126
Major challenges 129
Glossary 132
Index 137
References 146
List of Figures
Figure 1.1: Annual population growth rate (%), 1987-2007 22
Figure 1.2: Percentage of population living in urban areas, 1990-2007 24
Figure 1.3: Top ten global projections of mortality and burden of disease, 2008-2030 25
Figure 1.4: Per capita total expenditure on health at average exchange rate (US$), 2000 & 2006 27
Figure 2.5: Global pharmaceutical market value ($bn), 2008-2014 37
Figure 2.6: Pharmaceutical market share, 2009 38
Figure 2.7: Market value of APIs 2004-2014 40
Figure 2.8: World pharmaceutical market by ATC code, 2008 41
Figure 2.9: US APIs sales ($bn), 2008-2014 43
Figure 2.10: Sales of new medicines launched 2004-2008 44
Figure 2.11: Changes in research sites 2001-2006 45
Figure 2.12: API producers and manufacturing plants in Italy, 1991-2008 47
Figure 2.13: Share of generic API exports to the US (%), 2008 48
Figure 3.14: FDA Overseas Inspections, 2002-2007 59
Figure 3.15: Total FDA Overseas Inspections, 2006-2009 60
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