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

Friday, April 2, 2010 Research News J E 4

NEW YORK, April 1 announces that a new market research report is available in its catalogue:

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?

Companies mentioned

Albemarle Corporation, Asymchem Laboratories, Boehringer Ingelheim, Cambrex Corporation, Daiichi Fine Chemicals, Dr Reddy's Laboratories, DSM, Grindeks, Lonza, Matrix Laboratories, Novasep, Pfizer CentreSource, Ranbaxy Laboratories, Recordati, SAFC Pharma, Sumitomo Chemical, Teva Active Pharmaceutical Ingredients, WuXi AppTec, Zhejiang Hisun Pharmaceutical

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


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) 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


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-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

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

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

List of Tables

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

To order this report:

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

More Market Research Report

Check our Company Profile, SWOT and Revenue Analysis!

Contact Nicolas Bombourg Reportlinker Email: US: (805)652-2626 Intl: +1 805-652-2626

SOURCE Reportlinker


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