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Active Pharmaceutical Ingredients (API) Market in Europe to 2017 - Pricing and Reimbursement Initiatives Supporting Generic Drug Growth, with CMOs Expected to Account for Majority of the Manufacturing Activity

Executive Summary

Austerity Pricing Tactics Support Generic Drug Growth in Europe.

Government initiatives to cut health expenditure are likely to encourage sales of generic medications in Europe, according to a new report by healthcare experts GBI Research.

The new report* predicts an increase in revenue made by generics in the region during the next five years, as cost-containment policies strongly support the consumption of generic drugs over innovative drug use.

Biosimilars are a category of generics, also referred to as generic biotech Active Pharmaceutical Ingredients (API), or follow-on biologics (FOB). API derived from biotechnology provide high-growth market potential, but are expensive to develop and manufacture compared to the production of regular small molecule generic API.

France, Germany and the UK have all tightened their healthcare budgets to tackle the economic crisis, resulting in pressure to reduce pharmaceutical prices. This is bringing about changes in healthcare pricing and reimbursement across the continent. Reimbursement restrictions are applied to drugs that are priced higher than the reference price, and will restrict the growth of the innovative and biologic API markets during the next few years.

However, while reimbursement cuts are expected to decrease the use of innovative, drugs and hinder API revenue, luckily API generics look set to remain popular.

The expiry of patents for major blockbuster drugs and the entry of low-priced generic versions are expected to increase the consumption of generic drugs, with the weak pipelines of major pharmaceutical companies amplifying this trend. With many patent expiries occurring during 2010-2012, generic consumption is expected to peak, and in turn increase the competition between pharmaceutical producers.

The European API market accounted for around 24.2% of the global API market revenue of $108.6 billion in 2011. Germany and France were the market leaders, with Italy and the UK trailing in third and fourth.

The remaining shares of the market depict the emergence of contract manufacturing organization (CMO) activity and improvement in GDP in Central and Eastern European economies, which have driven up the health care market during recent years. Most Eastern European countries possess good business infrastructure and offer excellent business opportunities for API manufacturing, which is expected to drive the API CMO market in the region during the forecast period. According to GBI Research estimates, the overall CMO market in Eastern and Central Europe countries is expected to witness a healthy CAGR of 14.1% to 2017. This increase in CMO activity is expected to capture most of the API manufacturing activity towards 2017.

The API market in Europe accounted for revenue of $19,868.39m in 2005, which grew at a CAGR of 4.8% to $26 billion in 2011. The market is expected to grow further at a CAGR of 6.5% to reach $38 billion by 2017. This will be supported by healthy demand from the generic and biotech API sectors.

Active Pharmaceutical Ingredients (API) Market in Europe to 2017 - Pricing and Reimbursement Initiatives Supporting Generic Drug Growth, with CMOs Expected to Account for Majority of the Manufacturing Activity

This report provides detailed insight into the Europe API market, and presents detailed analysis and forecasts of the major economic and market trends affecting the API markets in this region. The report contains market forecasts, product type analysis, drivers and restraints. In addition, it includes market forecasts, product type analysis, therapeutic categories analysis and CMO growth in the region and its influence on API manufacturing activity towards 2017. Overall, the report presents a comprehensive analysis of the Europe API market, covering all the major parameters.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts.

Abstract

Active Pharmaceutical Ingredients (API) Market in Europe to 2017 - Pricing and Reimbursement Initiatives Supporting Generic Drug Growth, with CMOs Expected to Account for Majority of the Manufacturing Activity

Summary

GBI Research's report, "Active Pharmaceutical Ingredients (API) Market in Europe to 2017 - Pricing and Reimbursement Initiatives Supporting Generic Drug Growth, with CMOs Expected to Account for Majority of the Manufacturing Activity" provides detailed insight into the Europe API market. The research presents detailed analysis and forecasts of the major economic and market trends affecting the API markets in this region. The report contains market forecasts, product type analysis, drivers and restraints. In addition, it includes market forecasts, product type analysis, therapeutic categories analysis and CMO growth in the region and its influence on API manufacturing activity towards 2017. Overall, the report presents a comprehensive analysis of the Europe API market, covering all the major parameters.

The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts.

Europe is the third largest regional market for APIs by revenue in the world. European active pharmaceutical ingredients (API) market revenue held a share of around 24.2% of global API market revenue of 108.6 $ billion in 2011. Total revenue generated by the European API market was $26,288.96 million in 2011 and is expected to grow at a CAGR of 6.5% to reach $38,255.67 million by 2017.This will be supported by healthy demand from generic and biotech API sectors.

Scope

  • Market revenue data for APIs from 2005 to 2011 and forecast for six years to 2017.
  • API markets in key countries in the region: Germany, France, Italy, the Uk, Spain
  • API industry structure and market trends such as a shift in manufacturing and growth in biotechnology for the Europe region.
  • Drivers of the API market, such as the growth of generic drugs, and restraints, such as patent expiries and government initiatives like price reimbursement cut.
  • Detailed historical, forecast trend and share analysis of API revenue based on product types (Synthetic and Biotech APIs) in the Europe market and in key countries of the region.
  • Detailed historical, forecast trend and share analysis of API revenue based on customer base (Generic and Innovative for Synthetic APIs) (Biosimilars and biologics for Biotech Apis) in the Europe market and in key countries of the region.
  • Analysis of API revenue based on therapeutic categories in the Europe and key countries.

Reasons to buy

  • Develop business strategies with the help of specific insights on the Europe API market.
  • Identify opportunities and challenges in the Europe API market.
  • Invest in the growing segments of the API market.
  • Increase future revenue and profitability with the help of insights on the future opportunities and critical success factors in the Europe API market.
  • Benchmark your operations and strategies against the major players in the global API market.
  • Keywords
  • API,Generic API, Branded API,Biotech, generic, innovator drug, therapeutic, Biologics, Biosimilars

TOC

1 Table of Contents

1 Table of Contents 6

  • 1.1 List of Tables 8
  • 1.2 List of Figures 9

2 Introduction 11

3 Contract Manufacturing Organizations (CMO) an Upcoming Trend in Europe API Manufacturing 12

  • 3.1 Introduction 12
    • 3.1.1 How Does Outsourcing to CMOs Take Place? 12
  • 3.2 Europe CMO Market Drivers 13
    • 3.2.1 Availability of Low-Cost Skilled Manpower 13
    • 3.2.2 Key Benefits of API Manufacturing Outsourcing in Europe 14
  • 3.3 The Eastern European CMO Market 15

4 Europe Active Pharmaceutical Ingredients Market 17

  • 4.1 Market Overview 17
  • 4.2 API Classification 17
    • 4.2.1 API Classification Based on Synthesis Routes 18
    • 4.2.2 Types based on Customer Base 18
  • 4.3 Industry Structure 19
  • 4.4 Europe API Market Drivers 20
    • 4.4.1 Increased CMO Opportunities is Expected to Improve the Production of Generics and Fuel the Revenues of API in the Region 20
    • 4.4.2 Overall Growth in the Pharmaceutical Industry and Increasing Elderly Population are Driving the Growth of the European API Market 20
    • 4.4.3 Attractiveness towards Biopharmaceutical Therapies Supports the Growth of the API Market in Europe 20
    • 4.4.4 European Regulatory Framework Facilitating Development of Biosimilars 20
    • 4.4.5 Differences in VAT rates on Pharma Products is Expected to Increase Parallel Trade in Europe 20
  • 4.5 Europe API Market Restraints 21
    • 4.5.1 Increased Consumption of Generics 21
    • 4.5.2 Increasing Patent Expiries Hamper the Growth of the European API Market 21
    • 4.5.3 Price Cuts Restrict the Revenue Growth of the European API Market 21
  • 4.6 Europe API Total Revenue Analysis 24
  • 4.7 Europe Revenue Share by Product Types 26
  • 4.8 Europe Synthetic API Market Analysis 27
    • 4.8.1 Europe Synthetic API Market Drivers 27
    • 4.8.2 Europe Synthetic API Market Restraints 27
    • 4.8.3 Europe Synthetic API Total Synthetic Revenue Analysis 2005-2017 28
    • 4.8.4 European Synthetic API Market Revenue Share Analysis Based on Customer Base in 2011 33
    • 4.8.5 Europe Synthetic API Revenue Trend Analysis 2005-2017 34
  • 4.9 Europe Biotech API Market Analysis 36
    • 4.9.1 Europe Biotech API Market Drivers 36
    • 4.9.2 Europe Biotech API Market Restraints 36
    • 4.9.3 Europe Biotech API Revenue Analysis 2005-2017 37
  • 4.10 Europe Biotech API Market Revenue Analysis by Customer Base 41
    • 4.10.1 Europe Biotech API Market Revenue Share Analysis by Customer Base 41
  • 4.11 Europe Patent Expiry of Leading Biologics 42
  • 4.12 Europe API Revenue Split Up by Therapeutic Applications 45

5 Germany Active Pharmaceutical Ingredients Market 47

  • 5.1 Germany API Market Overview 47
  • 5.2 Germany Total API Revenue Analysis based on the synthesis routes 2005-2017 47
  • 5.3 Germany API Revenue Share Analysis by Product Types 2005-2017 49
  • 5.4 Germany API Revenue Analysis based on Customer Base 50
    • 5.4.1 Germany Synthetic API Revenue Analysis by Customer Base, 2005-2017 50
    • 5.4.2 Germany Synthetic API Market Revenue Share Analysis by Customer Base, 2005-2017 52
    • 5.4.3 Germany Biotech API Revenue Analysis by Customer Base, 2005-2017 53
    • 5.4.4 Germany Biotech API Revenue Share Analysis by Customer Base, 2005-2017 55
  • 5.5 Germany API Revenue share Analysis by Therapeutic Applications 56

6 France Active Pharmaceutical Ingredients Market 58

  • 6.1 France API Market Overview 58
  • 6.2 France Total API Revenue Analysis Based on Synthesis Routes 2005-2017 58
  • 6.3 France API Revenue Share Analysis by Product Types 2005-2017 60
  • 6.4 France API Revenue Analysis based on Customer Base 61
    • 6.4.1 France Synthetic API Revenue Analysis by Customer Base, 2005-2017 61
    • 6.4.2 France Synthetic API Market Revenue Share Analysis by Customer Base, 2005-2017 63
    • 6.4.3 France Biotech API Revenue Analysis by Customer Base, 2005-2017 64
    • 6.4.4 France Biotech API Revenue Share Analysis by Customer Base, 2005-2017 66
  • 6.5 France API Revenue share Analysis by Therapeutic Applications 67

7 Italy Active Pharmaceutical Ingredients Market 69

  • 7.1 Italy API Market Overview 69
  • 7.2 Italy Total API Revenue Analysis based on Synthesis Routes 2005-2017 69
  • 7.3 Italy API Revenue Share Analysis by Product Types 2005-2017 71
  • 7.4 Italy API Revenue Analysis based on Customer Base 72
    • 7.4.1 Italy Synthetic API Revenue Analysis by Customer Base, 2005-2017 72
    • 7.4.2 Italy Synthetic API Market Revenue Share Analysis by Customer Base, 2005-2017 74
    • 7.4.3 Italy Biotech API Revenue Analysis by Customer Base, 2005-2017 75
    • 7.4.4 Italy Biotech API Revenue Share Analysis by Customer Base, 2005-2017 77
  • 7.5 Italy API Revenue share Analysis by Therapeutic Applications 78

8 The UK Active Pharmaceutical Ingredients Market 80

  • 8.1 The UK API Market Overview 80
  • 8.2 The UK Total API Revenue Analysis based on Synthesis Routes 2005-2017 80
  • 8.3 The UK API Revenue Share Analysis by Product Types 2005-2017 82
  • 8.4 The UK API Revenue Analysis based on Customer Base 83
    • 8.4.1 The UK Synthetic API Revenue Analysis by Customer Base, 2005-2017 83
    • 8.4.2 The UK Synthetic API Market Revenue Share Analysis by Customer Base, 2005-2017 85
    • 8.4.3 The UK Biotech API Revenue Analysis by Customer Base, 2005-2017 86
    • 8.4.4 The UK Biotech API Revenue Share Analysis by Customer Base, 2005-2017 88
  • 8.5 The UK API Revenue share Analysis by Therapeutic Applications 89

9 Spain Active Pharmaceutical Ingredients Market 91

  • 9.1 Spain API Market Overview 91
  • 9.2 Spain Total API Revenue Analysis based on Synthesis Routes 2005-2017 91
  • 9.3 Spain API Revenue Share Analysis by Product Types 2005-2017 93
  • 9.4 Spain API Revenue Analysis based on Customer Base 94
    • 9.4.1 Spain Synthetic API Revenue Analysis by Customer Base, 2005-2017 94
    • 9.4.2 Spain Synthetic API Market Revenue Share Analysis by Customer Base, 2005-2017 96
    • 9.4.3 Spain Biotech API Revenue Analysis by Customer Base, 2005-2017 97
    • 9.4.4 Spain Biotech API Revenue Share Analysis by Customer Base, 2005-2017 99
  • 9.5 Spain API Revenue share Analysis by Therapeutic Applications 100

10 Appendix 102

  • 10.1 Abbreviations 102
  • 10.2 Market Definitions 102
  • 10.3 References 102
  • 10.4 Methodology 103
    • 10.4.1 Coverage 103
    • 10.4.2 Secondary Research 104
    • 10.4.3 Primary Research 104
    • 10.4.4 Expert Panel Validation 104
  • 10.5 Contact Us 104
  • 10.6 Disclaimer 105

List of Tables

1.1 List of Tables

  • Table 1: CMO Market, Europe, All Employees:Index of Hourly Compensation Costs (United States = 100), 13
  • Table 2: CMO Market, The Central and Eastern Europe, Revenue Analysis ($bn), 2005-2017 16
  • Table 3: Pricing and Reimbursement Mechanism in the Top Five Countries of Europe 22
  • Table 4: API, Europe , Total Revenue Analysis, $m, 2005-2017 25
  • Table 5: API, Europe, Revenue Share by Product Types, (%) 2011 26
  • Table 6: Synthetic API, Europe , Revenue Analysis, $m, 2005-2017 29
  • Table 7: Synthetic API, Europe, Revenue Share Analysis by Countries, (%) 2011 30
  • Table 8: Synthetic API, Europe, Revenue Share Trend, %, 2005-2017 32
  • Table 9: Synthetic API, Europe, Revenue Share by Customer Base, (%), 2011 33
  • Table 10: Synthetic API, Europe, Revenue Analysis by Customer Base, $m, 2005-2017 35
  • Table 11: Biotech API, Europe, Revenue Analysis, ($m), 2005-2017 37
  • Table 12: Biotech API, Europe, Revenue Share by Countries, %, 2011 38
  • Table 13: Biotech API, Europe, Revenue Share Trend, %, 2005-2017 40
  • Table 14: Europe Biotech API Market, Revenue Share Analysis by Sectors Based on Customer Base, 2011 41
  • Table 15: Biotech API, Europe, Key Patent Expiry of Leading Biologics , 2005 To 2017 42
  • Table 16: Biotech API, Europe, Revenue Analysis by Customer Base, $m, 2005-2017 44
  • Table 17: API, Europe, Revenue Split by Therapeutic Applications, %, 2011-2017 46
  • Table 18: API, Germany, Revenue Analysis by Product Types, $m, 2005-2017 48
  • Table 19: API, Germany, Revenue Share by Product Type, %, 2005-2017 49
  • Table 20: Synthetic API, Germany, Revenue Analysis by Customer Base, $m, 2005-2017 51
  • Table 21: Synthetic API, Germany, Revenue Share by Customer Base, %, 2005-2017 52
  • Table 22: Biotech API, Germany, Revenue Analysis by Customer Base, $m, 2005-2017 54
  • Table 23: Biotech API, Germany, Revenue Share by Customer Base, %, 2005-2017 55
  • Table 24: API, Germany, Revenue Split by Therapeutic Applications, %, 2011-2017 57
  • Table 25: API, France, Revenue Analysis by Product Types, $m, 2005-2017 59
  • Table 26: API, France, Revenue Share by Product Type, %, 2005-2017 60
  • Table 27: Synthetic API, France, Revenue Analysis by Customer Base, $m, 2005-2017 62
  • Table 28: Synthetic API, France, Revenue Share by Customer Base, %, 2005-2017 63
  • Table 29: Biotech API, France, Revenue Analysis by Customer Base, $m, 2005-2017 65
  • Table 30: Biotech API, France, Revenue Share by Customer Base, %, 2005-2017 66
  • Table 31: API, France, Revenue Split by Therapeutic Applications, %, 2011-2017 68
  • Table 32: API, Italy, Revenue Analysis by Product Types, $m, 2005-2017 70
  • Table 33: API, Italy, Revenue Share by Product Type, %, 2005-2017 71
  • Table 34: Synthetic API, Italy, Revenue Analysis by Customer Base, $m, 2005-2017 73
  • Table 35: Synthetic API, Italy, Revenue Share by Customer Base, %, 2005-2017 74
  • Table 36: Biotech API, Italy, Revenue Analysis by Customer Base, $m, 2005-2017 76
  • Table 37: Biotech API, Italy, Revenue Share by Customer Base, %, 2005-2017 77
  • Table 38: API, Italy, Revenue Split by Therapeutic Applications, %, 2011-2017 79
  • Table 39: API, The UK, Revenue Analysis by Product Types, $m, 2005-2017 81
  • Table 40: API, The UK, Revenue Share by Product Type, %, 2005-2017 82
  • Table 41: Synthetic API, The UK, Revenue Analysis by Customer Base, $m, 2005-2017 84
  • Table 42: Synthetic API, The UK, Revenue Share by Customer Base, %, 2005-2017 85
  • Table 43: Biotech API, The UK, Revenue Analysis by Customer Base, $m, 2005-2017 87
  • Table 44: Biotech API, The UK, Revenue Share by Customer Base, %, 2005-2017 88
  • Table 45: API, The UK, Revenue Split by Therapeutic Applications, %, 2011-2017 90
  • Table 46: API, Spain, Revenue Analysis by Product Types, $m, 2005-2017 92
  • Table 47: API, Spain, Revenue Share by Product Type, %, 2005-2017 93
  • Table 48: Synthetic API, Spain, Revenue Analysis by Customer Base, $m, 2005-2017 95
  • Table 49: Synthetic API, Spain, Revenue Share by Customer Base, %, 2005-2017 96
  • Table 50: Biotech API, Spain, Revenue Analysis by Customer Base, $m, 2005-2017 98
  • Table 51: Biotech API, Spain, Revenue Share by Customer Base, %, 2005-2017 99
  • Table 52: API, Spain, Revenue Split by Therapeutic Applications, %, 2011-2017 101

List of Figures

1.2 List of Figures

  • Figure 1: CMO Market, Europe, Difference in Hourly Wage Costs in Euro Area vs. Eastern Europe, 2009 13
  • Figure 2: API, Europe, Key Benefits of Outsourcing to CMOs, 2011 14
  • Figure 3: API, CMO Market in the Top Five European Countries Vs Central and Eastern Europe, (%), 2010 15
  • Figure 4: CMO Market, The Central and Eastern Europe, Revenue Analysis ($bn), 2005-2017 16
  • Figure 5: Europe API Market, Product Types 17
  • Figure 6: API, Europe, Value Chain, 2011 19
  • Figure 7: API, Europe , Total Revenue Analysis , $m, 2005-2017 24
  • Figure 8: API, Europe, Revenue Share by Product Types, (%), 2011 26
  • Figure 9: Synthetic API, Europe, Revenue Analysis, ($m), 2005-2017 28
  • Figure 10: Synthetic API, Europe, Revenue Share Analysis by Countries, (%), 2011 30
  • Figure 11: Synthetic API, Europe, Comparison of Countries by Revenue Growth Rates, 2011-2017 31
  • Figure 12: Synthetic API, Europe, Revenue Share Trend Analysis by Countries, (%), 2005-2017 32
  • Figure 13: Synthetic API, Europe, Revenue Share by Customer Base, (%), 2011 33
  • Figure 14: Synthetic API, Europe, Revenue Trend by Product Types, ($m), 2011 34
  • Figure 15: Biotech API, Europe, Revenue Analysis,($m), 2005-2017 37
  • Figure 16: Biotech API, Europe, Revenue Share by Countries, (%), 2011 38
  • Figure 17: Biotech API, Europe, Comparison of Revenue Growth Rates by Countries, 2005-2017 39
  • Figure 18: Biotech API, Europe, Revenue Share Trend, (%), 2005-2017 40
  • Figure 19: Biotech API, Europe, Revenue Share Analysis by Customer Base, (%), 2011 41
  • Figure 20: Biotech API, Europe , Revenue Trend Analysis by Product, ($m) Types, 2005-2017 43
  • Figure 21: API, Europe, Revenue Split by Therapeutic Applications, (%), 2011-2017 45
  • Figure 22: API, Germany, Revenue Analysis by Product Types, ($m), 2005-2017 48
  • Figure 23: API, Germany, Revenue Share by Product Type, (%), 2005-2017 49
  • Figure 24: Synthetic API, Germany, Revenue Analysis by Customer Base, ($m), 2005-2017 50
  • Figure 25: Synthetic API, Germany, Revenue Share by Customer Base, (%), 2005-2017 52
  • Figure 26: Biotech API, Germany, Revenue Analysis by Customer Base, ($m), 2005-2017 53
  • Figure 27: Biotech API, Germany, Revenue Share by Customer Base, (%), 2005-2017 55
  • Figure 28: API, Germany, Revenue Split by Therapeutic Applications, (%), 2011-2017 56
  • Figure 29: API, France, Revenue Analysis by Product Types, ($m), 2005-2017 58
  • Figure 30: API, France, Revenue Share by Product Type, (%), 2005-2017 60
  • Figure 31: Synthetic API, France, Revenue Analysis by Customer Base, ($m), 2005-2017 61
  • Figure 32: Synthetic API, France, Revenue Share by Customer Base, (%), 2005-2017 63
  • Figure 33: Biotech API, France, Revenue Analysis by Customer Base, ($m), 2005-2017 64
  • Figure 34: Biotech API, France, Revenue Share by Customer Base, (%), 2005-2017 66
  • Figure 35: API, France, Revenue Split by Therapeutic Applications, (%), 2011-2017 67
  • Figure 36: API, Italy, Revenue Analysis by Product Types, ($m), 2005-2017 69
  • Figure 37: API, Italy, Revenue Share by Product Type, (%), 2005-2017 71
  • Figure 38: Synthetic API, Italy, Revenue Analysis by Customer Base, ($m), 2005-2017 72
  • Figure 39: Synthetic API, Italy, Revenue Share by Customer Base, (%), 2005-2017 74
  • Figure 40: Biotech API, Italy, Revenue Analysis by Customer Base, ($m), 2005-2017 75
  • Figure 41: Biotech API, Italy, Revenue Share by Customer Base, (%), 2005-2017 77
  • Figure 42: API, Italy, Revenue Split by Therapeutic Applications, (%), 2011-2017 78
  • Figure 43: API, The UK, Revenue Analysis by Product Types, ($m), 2005-2017 80
  • Figure 44: API, The UK, Revenue Share by Product Type, (%), 2005-2017 82
  • Figure 45: Synthetic API, The UK, Revenue Analysis by Customer Base, ($m), 2005-2017 83
  • Figure 46: Synthetic API, The UK, Revenue Share by Customer Base, (%), 2005-2017 85
  • Figure 47: Biotech API, The UK, Revenue Analysis by Customer Base, ($m), 2005-2017 86
  • Figure 48: Biotech API, The UK, Revenue Share by Customer Base, (%), 2005-2017 88
  • Figure 49: API, The UK, Revenue Split by Therapeutic Applications, (%), 2011-2017 89
  • Figure 50: API, Spain, Revenue Analysis by Product Types, ($m), 2005-2017 91
  • Figure 51: API, Spain, Revenue Share by Product Type, (%), 2005-2017 93
  • Figure 52: Synthetic API, Spain, Revenue Analysis by Customer Base, ($m), 2005-2017 94
  • Figure 53: Synthetic API, Spain, Revenue Share by Customer Base, (%), 2005-2017 96
  • Figure 54: Biotech API, Spain, Revenue Analysis by Customer Base, ($m), 2005-2017 97
  • Figure 55: Biotech API, Spain, Revenue Share by Customer Base, (%), 2005-2017 99
  • Figure 56: API, Spain, Revenue Split by Therapeutic Applications, (%), 2011-2017 100
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