The Global Active Pharmaceutical Ingredients (API) Market: Evaluating challenges, opportunities, innovations and the market environment

Date: February 22, 2010
Pages: 146
US$ 3,835.00
Publisher: Business Insights
Report type: Strategic Report
Delivery: E-mail Delivery (PDF), Hard Copy Mail Delivery, CD-ROM Mail Delivery

Download PDF Leaflet

The Global Active Pharmaceutical Ingredients (API) Market: Evaluating challenges, opportunities, innovations and the market environment
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.

Key features of this report

  • Forecasts to 2014 for the global APIs market, including forecasts for biotechnology-based APIs and third-party generic APIs (APIs sold to other companies as opposed to consumed in-house).
  • Evaluation and analysis of the key drivers and restraints impacting the global APIs market
  • Analysis of the competitive landscape including company profiles for 19 API companies
  • Analysis of the latest regulatory developments impacting the APIs market

  • Scope of this report

  • Understand the size the global APIs market and what the forecasted growth is between 2010-2014
  • Evaluate which market areas in the API industry have the most promise
  • Evaluate what new technology areas are driving the APIs market.
  • Understand the competitive landscape and the key strategies undertaken by the leading APIs companies

  • Key Market Issues

  • Outsourcing the production of APIs, or if already outsourced, finding a cheaper supplier, is a key way of saving money at the API manufacturing stage, whether it is for APIs for preclinical or clinical trials, or for the production of finished drugs.
  • Growth in the overall pharmaceutical market has slowed, as a result of patent expiries, generic encroachment, and price erosion, but growth is expected to revive from 2010, driven by increased demand for healthcare. Growth in the pharmaceutical market in-turn will drive expansion in the API market.
  • API producers in Europe and the US have the advantages of offering high levels of regulatory compliance, and having advanced technological capabilities. However, the major disadvantage of using these companies is higher costs. API producers from the Asia Pacific region are gaining similar advantages by acquiring facilities in Europe and the USA.

  • Key findings from this report

  • The overall growth rate for pharmaceuticals has slowed in the 2001-2008 period. Growth will accelerate from 2010 onwards, as the global economy begins to recover, although it will not hit pre-crisis levels.
  • Going forward an overall growth rate of around 7.3% is projected for the global APIs market, which is higher than the growth rate expected in the overall drug market.
  • The upcoming patent cliff is resulting in a surge in sales for generic APIs, which should comfortably outpace growth for innovator APIs over the next five years
  • In 2008, China was the largest API-producing country in the world. By 2010, India is predicted to be the second-largest market, growing from 6.5% of the global API market to around 10.5% by 2010.

  • Key questions answered

  • What is the size and growth rate of the global pharmaceutical market?
  • What are the main trends driving the growth of the APIs market?
  • How is the ‘patent cliff’ impacting API sales?
  • What impact is the growth in biotechnology and also the emerging biosimilars market having on the APIs sector?

  • 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


    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


    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


    Summary 55
    Introduction 56
    GMP requirements 56
    ICH Q7A 56
    US GMP - Federal Food Drug and Cosmetic Act Section 501(a)(2)(B) 57
    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


    Summary 71
    Introduction 72
    Patent expiries and the API market 75
    Case study - Cambrex 79


    Summary 83
    Introduction 84
    Biotechnology-based APIs – a definition 84
    Recombinant proteins 84
    Monoclonal antibodies 84
    Biosimilars 85
    The biologics market 85
    Biotechnology-based APIs – the market 88
    Biosimilars 92
    APIs for biosimilars 93
    Challenges 95
    Case study: Biobetters 96


    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


    Summary 125
    Introduction 126
    Key commercial opportunities and future drivers of growth 126
    Major challenges 129
    Glossary 132
    Index 137
    References 146


    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 ($bn), 2008-2014 43
    Figure 2.10: Sales of new medicines launched 2004-2008 44
    Figure 2.11: Changes in research sites 2001-2006 45
    Figure 2.12: API producers and manufacturing plants in Italy, 1991-2008 47
    Figure 2.13: Share of generic API exports to the US (%), 2008 48
    Figure 3.14: FDA Overseas Inspections, 2002-2007 59
    Figure 3.15: Total FDA Overseas Inspections, 2006-2009 60
    Figure 4.16: Sales of generic and innovative API sales ($bn) 76
    Figure 4.17: Sales growth in the generics market in the 12 months to September 2008 77
    Figure 5.18: Sales by technology 2000-2014 86
    Figure 5.19: Percentage of top 100 drugs 2000-2014 87
    Figure 5.20: Global sales of biotechnology-based APIs ($m), 2007-2014 89
    Figure 5.21: Global sales of biosimilar APIs and innovative biotechnology-based APIs ($bn), 2007-2014 94
    Figure 6.22: Albermarle’s fine chemicals division net sales 104
    Figure 6.23: Cambrex Gross sales 107
    Figure 6.24: DSM employees by region 111
    Figure 6.25: Ranbaxy API sales INRm 117
    Figure 6.26: Sumitomo fine chemicals sales 120


    Table 1.1: Key points in outsourcing 30
    Table 3.2: Foreign pharmaceutical manufacturers registered to supply drugs to the US, 2007 58
    Table 4.3: Selected patent expiries 2010-2015 73
    Table 4.4: GlaxoSmithKline patent portfolio: Key products 74
    Table 5.5: Selected biotechnology product patent expiries 2010-2018 90
    Table 5.6: Biosimilars launched in Europe 2006-2009 92
    Table 5.7: Selected biosimilar approvals expected in 2010 and later 93

    Skip to top

    Ask Your Question

    The Global Active Pharmaceutical Ingredients (API) Market: Evaluating challenges, opportunities, innovations and the market environment
    Company name*:
    Contact person*:
    Request invoice
    Your enquiry:
    Please click on a Check Box below to confirm you are not a robot: