analysis of european biosimilars market of european biosimilars ma… · trends global biosimilars...

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Analysis of European Biosimilars Market

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Analysis of European Biosimilars Market Huge Market Opportunity from Impending Patent Expiries of

Blockbuster Biologics

December 2011

3

Section Slide Numbers

Executive Summary 21

• Executive Summary 22

• Market Definitions 24

• Market Segmentation 25

• Geographic Segmentation 26

• Executive SummaryMarket Engineering Measurements 27

• Executive SummaryCEO’s Perspective 29

Total Biosimilars Market 30

• Market OverviewKey Questions This Study Will Attempt to Answer 31

• Market Overview 32

• Total Biosimilars MarketRegional Overview 34

• Forecast and TrendsGlobal Biosimilars Market 36

• Forecast Assumptions 37

• Market Engineering Measurements 38

Contents

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• Total Biosimilars MarketRevenue Forecast 39

• Market Share and Competitive AnalysisTotal Biosimilars Market 41

• Market ShareCompanies (Global) 42

European Biosimilars Market 44

• Market OverviewEuropean Biosimilars 45

Industry Challenges 47

• Key Industry Challenges 48

External Challenges: Drivers and RestraintsEuropean Biosimilars Market 52

• Drivers and Restraints 53

• European Biosimilars MarketImpact Mapping of Drivers and Restraints 58

Forecast and TrendsEuropean Biosimilars Market 59


• Europe Biosimilars MarketRevenue Forecast 61

• Market TrendsEuropean Biosimilars 63

Contents (continued)

5


• European Biosimilars MarketImpact Assessment of Top Trends 64

Demand AnalysisEuropean Biosimilars Market 65

• European Biosimilars MarketComparative Analysis: Generics, Biosimilars and Biologics 66

• BiosimilarsMarket Analysis 67

• European Biosimilars MarketBiosimilar Pricing Analysis 68

• European Biosimilars MarketPESTLE Analysis 70

Market Share and Competitive AnalysisEuropean Biosimilars Market 71

• Segment Breakdown Europe 72

• European BiosimilarsSegment Market Share Analysis 73

• European Biosimilars Companies Market Share Analysis 74

• Competitive Environment 76

• Competitive Landscape AnalysisEuropean Biosimilars Companies 77

• Competitive Landscape Analysis 78


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• Competitive Landscape AnalysisBiosimilars Characteristics 87

Regulatory GuidelinesEuropean Biosimilars Market 91

• Biosimilars Regulatory Guidelines 92

European Erythropoietin Biosimilars Market 93

• Market OverviewEuropean Erythropoietin Biosimilars 94

Forecast and TrendsEuropean Erythropoietin Biosimilars Market 95


• European Erythropoietin Biosimilars MarketRevenue Forecast 97

Market Share and Competitive AnalysisEuropean Erythropoietin Biosimilars Market 99

• Erythropoietin BiosimilarsMarket Analysis 100

• Erythropoietin Biosimilars Market Share Analysis 102

• Competitive LandscapeEuropean Erythropoietin Biosimilars 104

Regulatory GuidelinesEuropean Erythropoietin Biosimilars Market 106


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• EMEA GuidelinesBiosimilar Erythropoietin 107

European Granulocyte Colony Stimulating Factors Biosimilars Market 109

• Market OverviewEuropean Granulocyte Colony Stimulating Factors Biosimilars 110

Forecast and TrendsEuropean Granulocyte Colony Stimulating Factors Biosimilars Market

111


• Granulocyte Colony Stimulating Factor Biosimilars MarketRevenue Forecast 113

Market Share and Competitive AnalysisEuropean Granulocyte Colony Stimulating Factors Biosimilars Market

115

• Granulocyte Colony Stimulating Factors Biosimilars Market Analysis 116

• Granulocyte Colony Stimulating Factors Biosimilars Market Share Analysis 117

• Competitive LandscapeEuropean Granulocyte Colony Stimulating Factors Biosimilars 119

Regulatory GuidelinesEuropean Granulocyte Colony Stimulating Factors Biosimilars Market

121


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• EMEA GuidelinesBiosimilar Granulocyte Colony Stimulating Factors 122

European Human Growth Hormone Biosimilars Market 124

• Market OverviewEuropean Human Growth Hormone Biosimilars 125

Forecast and TrendsEuropean Human Growth Hormone Biosimilars Market 126


• Human Growth Hormone Biosimilars MarketRevenue Forecast 128

Market Share and Competitive AnalysisEuropean Human Growth Hormone Biosimilars Market

130

• Human Growth Hormone BiosimilarsMarket Analysis 131

• Competitive LandscapeEuropean Human Growth Hormone Biosimilars 132

Regulatory GuidelinesEuropean Human Growth Hormone Biosimilars Market 133

• EMEA GuidelinesBiosimilar Human Growth Hormone 134


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Key Emerging Biosimilars in Europe: Monoclonal Antibodies 136

• Market OverviewEuropean Monoclonal Antibodies Biosimilars 137

Market AnalysisEuropean Monoclonal Antibodies Biosimilars Market 138

• Monoclonal Antibodies Biosimilars Market Analysis 139

Regulatory GuidelinesEuropean Monoclonal Antibodies Biosimilars Market 140

• EMEA GuidelinesBiosimilar Monoclonal Antibodies 141

Key Emerging Biosimilars in Europe: Insulin 143

• Market OverviewEuropean Insulin Biosimilars 144

Market AnalysisEuropean Insulin Biosimilars Market 145

• Insulin BiosimilarsMarket Analysis 146

Regulatory GuidelinesEuropean Insulin Biosimilars Market 147

• EMEA GuidelinesBiosimilar Insulin 148


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Key Emerging Biosimilars in Europe: Interferon 150

• Market OverviewEuropean Interferon Biosimilars 151

Market AnalysisEuropean Interferon Biosimilars Market 152

• Interferon BiosimilarsMarket Analysis 153

Regulatory GuidelinesEuropean Interferon Biosimilars Market 155

• EMEA GuidelinesBiosimilar Interferon 156

Regional Analysis of European Biosimilars MarketThe United Kingdom 159

• Biosimilars Market OverviewThe United Kingdom 160

Forecast and TrendsThe United Kingdom Biosimilars Market 161


• The United Kingdom Biosimilars MarketRevenue Forecast 163

Biosimilars MarketGermany 165

• Biosimilars Market OverviewGermany 166


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Forecast and TrendsGermany Biosimilars Market 167


• Germany Biosimilars MarketRevenue Forecast 169

Biosimilars MarketFrance 171

• Biosimilars Market OverviewFrance 172

Forecast and TrendsFrance Biosimilars Market 173


• French Biosimilars MarketRevenue Forecast 175

Biosimilars MarketItaly 177

• Biosimilars Market OverviewItaly 178

Forecast and TrendsItaly Biosimilars Market 179


• Italian Biosimilars MarketRevenue Forecast 181


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Biosimilars MarketSpain 183

• Biosimilars Market OverviewSpain 184

Forecast and TrendsSpain Biosimilars Market 185


• Spanish Biosimilars MarketRevenue Forecast 187

Biosimilars MarketBenelux 189

• Biosimilars Market OverviewBenelux 190

Forecast and TrendsBenelux Biosimilars Market 191


• Benelux Biosimilars MarketRevenue Forecast 193

Biosimilars MarketScandinavia 195

• Biosimilars Market OverviewScandinavia 196

Forecast and TrendsScandinavia Biosimilars Market 197


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• Scandinavian Biosimilars MarketRevenue Forecast 199

Product Profiling 201

• Product ProfilingBiosimilars in Europe 202

• Product ProfilingBiologics 203

• Future Landscape Analysis 206

Conclusions and Strategic Recommendations 208

• Biosimilars MarketKey Success Factors 209

• Biosimilars MarketManufacturing Strategies 210

• Biosimilars MarketCommercialisation Strategies 211

• Conclusions 212

The Last Word 213


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Appendix 216

• Biotech Companies 217

• Government R&D Expenditure in Biotechnology 218

• Pharmaceutical R&D Expenditure 219

• Pharmaceutical R&D Expenditure as a Percentage of Pharmaceutical Market 220

• Government Healthcare Expenditure 221

• Abbreviations 222

Market Engineering Methodology 223


15


Biosimilars Market: Manufacturing and Development Process for Generics, Biosimilars and Biologics (Europe), 2010

33

Total Biosimilars Market: Company Market Share Analysis of Top 4 Participants (Global), 2010

43

Biosimilars Market: Time from Marketing Authorisation to Price Approval (Europe), 2010 68

Biosimilars Market: Market Share Analysis of Segments (Europe), 2010 73

Biosimilars Market: Company Market Share Analysis of Market Participants (Europe), 2010

75

Biosimilars Market: Competitive Structure (Europe), 2010 76

Erythropoietin Biosimilars Market: Retail Analysis (Europe), 2010 101

Erythropoietin Biosimilars Market: Company Market Share Analysis of Market Participants (Europe), 2010

103

Granulocyte Colony Stimulating Factor Biosimilars Market: Company Market Share Analysis of Market Participants (Europe), 2010

118

List of Figures

16


Decision Support Database: Biotech Companies (Western Europe), 2002-2012 217

Decision Support Database: Government R&D Expenditure in Biotechnology (Western Europe), 2002-2012

218

Decision Support Database: Pharmaceutical R&D Expenditure (Western Europe), 2002-2012

219

Decision Support Database: Pharmaceutical R&D Expenditure as a Percentage of Pharmaceutical Market (Western Europe), 2002-2012

220

Decision Support Database: Government Healthcare Expenditure (Western Europe), 2002-2012

221

List of Figures (continued)

17


Biosimilars Market: Market Segmentation (Europe), 2010 25

Biosimilars Market: Geographic Segmentation (Europe), 2010 26

Biosimilars Market: Market Engineering Measurements (Europe), 2010 27

Total Biosimilars Market: Market Share Percent by Country (Global), 2010 34

Total Biosimilars Market: Market Engineering Measurements (Global), 2010 38

Total Biosimilars Market: Revenue Forecast (Global), 2008-2017 39

Toatl Biosimilars Market: Company Market Share by Revenues (Global), 2010 42

Biosimilars Market: Key Stake Holders (Europe), 2010 45

Biosimilars Market: Key Industry Challenges (Europe), 2011-2017 48

Biosimilars Market: Key Market Drivers and Restraints (Europe), 2011-2017 53

European Biosimilars Market: Impact Mapping of Drivers and Restraints (Europe), 2011-2017

58

Biosimilars Market: Market Engineering Measurements (Europe), 2010 60

Biosimilars Market: Revenue Forecast (Europe), 2008-2017 61

List of Charts

18


Biosimilars Market: Impact Assessment of Top Trends (Europe), 2010 64

Biosimilars Market: Pricing Analysis (Europe), 2010 69

Biosimilars Market: PESTLE Analysis (Europe), 2010 70

Biosimilars Market: Market Share Percent by Segment (Europe), 2010 72

Biosimilars Market: Company Market Share by Revenues (Europe), 2010 74

Erythropoietin Biosimilars Market: Market Engineering Measurements (Europe), 2010 96

Erythropoietin Biosimilars Market: Revenue Forecast (Europe), 2008-2017 97

Erythropoietin Biosimilars Market: Market Share Percent by Companies (Europe), 2010 102

Granulocyte Colony Stimulating Factors Biosimilars Market: Market Engineering Measurements (Europe), 2010

112

Granulocyte Colony Stimulating Biosimilars Market: Revenue Forecast (Europe), 2008-2017

113

List of Charts (continued)

19


Granulocyte Colony Stimulating Biosimilars Market: Market Share Percent by Companies (Europe), 2010

117

Human Growth Hormone Biosimilars Market: Market Engineering Measurements (Europe), 2010

127

Human Growth Hormone Biosimilars Market: Revenue Forecast (Europe), 2008-2017 128

Biosimilars Market: Market Engineering Measurements (The United Kingdom), 2010 162

Biosimilars Market: Revenue Forecast (The United Kingdom), 2008-2017 163

Biosimilars Market: Market Engineering Measurements (Germany), 2010 168

Biosimilars Market: Revenue Forecast (Germany), 2008-2017 169


20


Biosimilars Market: Market Engineering Measurements (France), 2010 174

Biosimilars Market: Revenue Forecast (France), 2008-2017 175

Biosimilars Market: Market Engineering Measurements (Italy), 2010 180

Biosimilars Market: Revenue Forecast (Italy), 2008-2017 181

Biosimilars Market: Market Engineering Measurements (Spain), 2010 186

Biosimilars Market: Revenue Forecast (Spain), 2008-2017 187

Biosimilars Market: Market Engineering Measurements (Benelux), 2010 192

Biosimilars Market: Revenue Forecast (Benelux), 2008-2017 193

Biosimilars Market: Market Engineering Measurements (Benelux), 2010 192

Biosimilars Market: Revenue Forecast (Benelux), 2008-2017 193

Biosimilars Market: Market Engineering Measurements (Scandinavia), 2010 198

Biosimilars Market: Revenue Forecast (Scandinavia), 2008-2017 199


21

Executive Summary

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Executive Summary

• The biosimilars market is in its infancy. The period from 2013 2015 is considered to be the period of significance for higher growth, with new products and segments adding up during this year.

• The global biosimilars market will continue to grow from approximately $xxx.x million in

2010 to approximately $xx,xxx.x million in 2017 at a compound annual growth rate

(CAGR) of xx.x percent. • The European biosimilars market will continue to grow from approximately $xxx.x million

in 2010 to approximately $x,xxx.x million in 2017 at a CAGR of xx.x percent. • Biosimilars is an interdisciplinary market. The growth of the biosimilars market will help

the growth of other pharmaceutical markets such as oncology, diabetes, etc.

• The market structure is predicted to grow higher, with new market segments such as monoclonal antibodies emerging by the year 2014.

• In 2010, there are more chances of licensing agreements between companies to develop products, and acquisitions will depend on the potential capabilities of the companies.

Source: Frost & Sullivan analysis.

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Executive Summary (continued)

• Improvements in biosimilar development have to take place with respect to manufacturing and clinical development processes.

• Regulatory guidelines have been drafted by European Medicines Agency (EMEA) for erythropoietins, Granulocyte Colony Stimulating Factors (G-CSF), and Human Growth Hormone. The guidelines for monoclonal antibodies is under review.


24

Market Definitions

Biosimilars Biosimilars are legally approved subsequent versions of innovator biopharmaceutical products following patent and exclusivity expiry.

Biologic A complex biopharmaceutical, produced using biotechnology (i.e., rDNA, antibody technologies).

Generic

A drug with the same active ingredients and equivalence as the original small-molecule pharmaceutical produced by using chemical synthesis.

Data Exclusivity 10 years for new biologic (8-year data exclusivity, 2-year market exclusivity), 1-year extension for new indication.

Interchangeability

Interchangeability refers to the medical practice of changing one medicine for another that is equivalent in a given clinical setting on the initiative or with the agreement of the prescriber.

Substitutability Substitutability refers to the practice of dispensing one medicine instead of another equivalent medicine at the pharmacy level without requiring consultation with the prescriber. Substitution is either allowed, required, or excluded according to national or local rules.

Automatic Substitution

Automatic substitution refers to the practice whereby a pharmacist is obliged to dispense one medicine instead of another equivalent medicine due to national or local requirements.


25

Market Segmentation

Existing Biosimilars

Erythropoietin

Human Growth Hormone

Granulocyte Colony Stimulating Factors

Monoclonal Antibodies

Interferons

Insulins

Emerging Biosimilars

Biosimilars Market: Market Segmentation (Europe), 2010

• Existing Biosimilars: Existing biosimilars market segments include those market segments which have approved products in Europe. These include erythropoietins (includes erythropoietins Alpha and Zeta only), G-CSFs, and Human Growth Hormone.

• Emerging Biosimilars: Emerging biosimilar market segments include those market segments with products which are being developed and are coming up in the future or waiting for approvals. These include monoclonal antibodies, insulins and interferons (includes interferons Alpha and Beta). Revenue Forecasts for emerging biosimilar market segments has not been included in the study.

• Note: This research service does not include drug delivery systems or diagnostic

instruments. It covers the biosimilar therapeutic drugs only. Source: Frost & Sullivan analysis.

26

Geographic Segmentation

The United Kingdom

France

Italy

Germany

Geographic Segmentation

Spain

Benelux

(Belgium, The Netherlands and

Luxembourg)

Scandinavia

(Denmark, Norway and Sweden)

Biosimilars Market: Geographic Segmentation (Europe), 2010

• Geographic Segmentation: This report covers biosimilar market overview, market engineering measurements and biosimilar market revenue forecasts of UK, Germany, France, Italy, Spain, Benelux and Scandinavia. The Benelux segmentation includes Belgium, Netherlands and Luxembourg. The Scandinavian segmentation includes Denmark, Norway and Sweden.

• This study does not cover Finland, Iceland,

Eastern Europe, or other European Regions.


analysis of european biosimilars market of european biosimilars ma… · trends global biosimilars...

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