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

2012-07-16
Published : Jul-2012

“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.”

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Report Details:

Published:July 2012

No.of Pages:105

Price: Single User License: US$3500        Corporate User License: US$7000

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

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

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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