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Biological Strategies in the Emerging Markets - BRIC Countries Will Underpin Future Pharma Growth

Executive Summary

BRIC Nations to Outgrow Traditional Markets in Biologics

Biologics industry growth in the BRIC countries (Brazil, Russia, India and China) is expected to outpace traditional markets, according to a new report by business intelligence providers GBI Research.

The report* states that, until recently, these emerging markets did not figure in the plans of the major pharmaceutical companies, but due to financial and political developments they are now seen as important countries in the pharmaceutical industry.

In terms of growth, it is anticipated that the BRIC countries will outstrip traditional markets like Europe and the US, albeit from a lower revenue base, in the years to come.

GBI Research reports these burgeoning economies are projected to account for over a quarter of the global biological market revenues by 2015.

The biologic sector is increasingly important to the pharma industry due to stagnation in R&D productivity and concerns over the so-called "patent cliff", with an established first generation of biologic therapies representing 24 of the top selling pharmaceutical products worldwide.

While the patent cliff has largely affected small-molecule synthetic drugs which have been the staple of pharmaceutical prosperity for decades, biologic treatments are emerging as a greater standard of care and are more difficult to replicate and manufacture.

These therapies are biological rather than chemical developments that promise greater effectiveness due to their capacity to target the underlying cause of disease and form personalized medicines.

Biological Strategies in the Emerging Markets - BRIC Countries Will Underpin Future Pharma Growth

This report discusses the growing importance of biologics and emerging markets. The key classes of biologic medicines are described, along with their therapeutic applications and importance.

In addition, significant pipeline developments in advanced clinical trials are identified. Selected companies that are already present in the biologic field are also profiled in this report.

Furthermore, the BRIC markets are described in detail. This covers their importance as pharmaceutical markets, including relevant background information such as pricing and government policies towards foreign companies, and provides a general country analysis for each.

Trends of importance to pharmaceutical market planners are also discussed, as well as strategies that are relevant for foreign companies seeking to gain a foothold in these markets.

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

Abstract

Biological Strategies in the Emerging Markets - BRIC Countries Will Underpin Future Pharma Growth

Summary

GBI Research, a leading business intelligence provider, has released its latest research "Biological Strategies in the Emerging Markets - BRIC Countries Will Underpin Future Pharma Growth" which examines two major trends already impacting on marketing strategies in the global pharmaceutical environment. These trends are the rise in importance of biologic products as replacements for the traditional small-molecule drugs in pharmaceutical pipelines, and the emergence of new national markets driven by seismic shifts now taking place among the leading national markets in the global economy. The report discusses the strategies the industry needs to embrace to address these internal and external challenges.

GBI Research analysis highlights the trends in the biologic sector, with their impact on the therapy of a wide range of diseases, and the routes taken by companies to improve their presence in the biologic sector and maximize their product lifecycle management to ensure future growth and shareholder value.

The report offers a thorough analysis of the newly-emerging national markets, including not only the leading BRIC economies but also those economies dubbed "fast followers". In an evolving market environment where an increasing proportion of products currently in late stage clinical development in pharmaceutical companies are biologics, this report discusses the opportunities for building success on these novel approaches in those markets which are set to feature prominently among the top national economies in the very near future.

Scope

  • The report describes major classes of biologic medicines, with their therapeutic applications and importance.
  • Significant pipeline developments now in advanced clinical trials are identified.
  • Major companies already present in the biologic arena are profiled.
  • The BRIC markets (Brazil, Russia, India and China) are described in detail, covering their importance as pharmaceutical markets.
  • Relevant background for each country, including healthcare provision, pricing and government policies towards foreign companies, is provided.
  • A general country analysis for each is also included, covering political, economic, social, technological, legislative and environmental aspects.
  • Four other "pharmerging" economies are also discussed in some detail.
  • Trends of importance to pharma market planners are discussed, as well as strategies important to foreign companies seeking a foothold in these markets.

Reasons to buy

  • Identify the key market opportunities with specific reference to the growth of biologics, so that you can align R&D portfolios to maximize growth
  • Develop optimal business strategies on a country-by-country basis, taking account of national market drivers and restraints
  • Devise a tailored R&D approach to address specific geographical and therapeutic demands
  • Develop key strategic initiatives based on your company's pharma R&D strengths and their best deployment in a changing pharmaceutical world
  • Re-evaluate and reassess investment decisions and explore ways in which to diversify and optimise market penetration vis-a-vis the pharmerging economies.

TOC

1 Table of Contents

1 Table of Contents 5

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

2 Biological Strategies in the Emerging Markets - Introduction 10

  • 2.1 Emergence of New National Markets 10
  • 2.2 Shift in Emphasis Towards Biologicals 10
  • 2.3 Obsolescence of Blockbusters 10
  • 2.4 What Defines a Biological Product? 10
  • 2.5 Why do Companies Want to Introduce Biologicals in BRIC Markets? 10
  • 2.6 What Biological Products are Currently Available and in What Therapy Areas? 11
    • 2.6.1 Monoclonal Antibodies 11
    • 2.6.2 Anti-cancer mAbs 12
    • 2.6.3 Anti-TNF 12
    • 2.6.4 Therapeutic Proteins 12
    • 2.6.5 Insulin 13
    • 2.6.6 Erythropoietin 13
    • 2.6.7 Growth Hormone 13
    • 2.6.8 Cytokines 13
    • 2.6.9 Blood Factors 14
    • 2.6.10 Market Status of Therapeutic Proteins 15
    • 2.6.11 Vaccines 16
  • 2.7 What are the Most Attractive Emerging Markets for Biologicals? 16
    • 2.7.1 Market Size 16
    • 2.7.2 Price Considerations 16
    • 2.7.3 Government Attitudes 16

3 Biological Strategies in the Emerging Markets - Market Characterization and Forecasts 17

  • 3.1 Market Size in BRIC Countries 17
    • 3.1.1 Brazil 17
    • 3.1.2 Russia 19
    • 3.1.3 India 21
    • 3.1.4 China 22
  • 3.2 Market Size in Second-tier Emerging Markets 26
    • 3.2.1 Mexico 26
    • 3.2.2 Turkey 26
    • 3.2.3 South Korea 26
    • 3.2.4 South Africa 27
    • 3.2.5 Other Emerging Markets 27
  • 3.3 BRIC Market Forecasts 27
  • 3.4 Conclusions 29

4 Biological Strategies in the Emerging Markets - Market Drivers And Restraints 30

  • 4.1 Summary of National Markets 30
    • 4.1.1 Brazil 30
    • 4.1.2 Russia 30
    • 4.1.3 India 30
    • 4.1.4 China 30
  • 4.2 Meeting Clinical Needs 31
  • 4.3 Government Controls - Price and Product Access 32
    • 4.3.1 Brazil 32
    • 4.3.2 Russia 32
    • 4.3.3 India 33
    • 4.3.4 China 33
  • 4.4 PESTLE Analyses 34
    • 4.4.1 Brazil 34
    • 4.4.2 Russia 36
    • 4.4.3 India 37
    • 4.4.4 China 39
  • 4.5 Overall Conclusions 41

5 Biological Strategies in the Emerging Markets - Regulatory Landscape 42

  • 5.1 Overview of Regulatory Environment in the BRIC countries 42
    • 5.1.1 Brazil 42
    • 5.1.2 Russia 43
    • 5.1.3 India 44
    • 5.1.4 China 45
  • 5.2 Regulations in Other Emerging Markets 46
    • 5.2.1 Turkey 46
    • 5.2.2 South Korea 46
  • 5.3 Intellectual Property in BRIC Markets 46
    • 5.3.1 Brazil 46
    • 5.3.2 Russia 47
    • 5.3.3 India 47
    • 5.3.4 China 48
  • 5.4 Future of IP in BRIC Markets 48
  • 5.5 Patents 48
  • 5.6 Conclusions 49

6 Biological Strategies in the Emerging Markets - Trend Analysis 50

  • 6.1 Demographic and Disease Trends 50
    • 6.1.1 Aging Populations 50
    • 6.1.2 Unmet Clinical Needs 50
    • 6.1.3 Immune Openings for Biologics 50
    • 6.1.4 Growing Incidence of Cancer 50
    • 6.1.5 R&D Challenges and Changes 51
    • 6.1.6 M&As Build Pipelines and Profitability 51
  • 6.2 Pricing Trends 51
    • 6.2.1 Flexibility 53
  • 6.3 Regulatory Trends 53
  • 6.4 National Market Trends 54
  • 6.5 Conclusions 55

7 Biological Strategies in the Emerging Markets - Pipeline Analysis 56

  • 7.1 Introduction 56
  • 7.2 Cancer 58
  • 7.3 Cancer mAbs 59
  • 7.4 Cancer - Therapeutic Proteins 61
  • 7.5 Diabetes 62
  • 7.6 Hormone Therapies 63
  • 7.7 Hemopoietic Therapies 64
  • 7.8 Immune Disease 64
  • 7.9 Overall Conclusions 66

8 Biological Strategies in the Emerging Markets - Company Analysis 67

  • 8.1 Introduction 67
  • 8.2 Hoffman-La Roche 68
    • 8.2.1 Biologics 68
    • 8.2.2 Presence in BRIC Markets 68
  • 8.3 Novo Nordisk 70
    • 8.3.1 Biologics 70
    • 8.3.2 Presence in BRIC Markets 70
  • 8.4 Johnson & Johnson 71
    • 8.4.1 Biologics 71
    • 8.4.2 Presence in BRIC Markets 72
  • 8.5 Sanofi 73
    • 8.5.1 Biologics 73
    • 8.5.2 Presence in BRIC Markets 74
  • 8.6 Eli Lilly 76
    • 8.6.1 Biologics 76
    • 8.6.2 Presence in BRIC Markets 76
  • 8.7 Sandoz 78
    • 8.7.1 Biologics 78
    • 8.7.2 Presence in BRIC Markets 78
  • 8.8 Teva 79
    • 8.8.1 Biologics 79
    • 8.8.2 Presence in BRIC Markets 80
  • 8.9 Conclusions 81

9 Biological Strategies in the Emerging Markets - Business Strategies 82

  • 9.1 Launch Strategies 82
    • 9.1.1 Timing of Launch 82
    • 9.1.2 Innovative Drug Launch 83
    • 9.1.3 Comprehensive Launch Plan 83
    • 9.1.4 Pricing Strategy versus Affordability 83
    • 9.1.5 Healthcare Access versus Uptake 83
    • 9.1.6 No "One Size Fits All" Policy 84
  • 9.2 Marketing Strategies 84
    • 9.2.1 Brazil 84
    • 9.2.2 Russia 84
    • 9.2.3 India 85
    • 9.2.4 China 85
  • 9.3 Pricing Strategies 86
    • 9.3.1 Brazil 86
    • 9.3.2 Russia 86
    • 9.3.3 India 86
    • 9.3.4 China 86
  • 9.4 Partnering Strategies 87
    • 9.4.1 Brazil 87
    • 9.4.2 Russia 87
    • 9.4.3 India 88
    • 9.4.4 China 89
  • 9.5 Manufacturing Strategies 89
  • 9.6 Competition 89
  • 9.7 Outlook 90
  • 9.8 Overall Conclusions 91

10 Biological Strategies in the Emerging Markets - Appendix 92

  • 10.1 Key Definitions 92
  • 10.2 Abbreviations (in alphabetical order) 92
  • 10.3 Sources 94
  • 10.4 Methodology 96
    • 10.4.1 Primary Research 96
    • 10.4.2 Secondary Research 96
  • 10.5 Contacts Us 96
  • 10.6 Disclaimer 97

List of Tables

1.1 List of Tables

  • Table 1: Biological Strategies in the Emerging Markets, Leading Cancer MAbs, 2011 12
  • Table 2: Biological Strategies in the Emerging Markets, Leading Approved Cytokines, 2010 14
  • Table 3: Biological Strategies in the Emerging Markets, Brazil, Core Statistics, 2010 17
  • Table 4: Biological Strategies in the Emerging Markets, Brazil, Foreign Investments, 2010 18
  • Table 5: Biological Strategies in the Emerging Markets, Russia, Core Statistics, 2010 19
  • Table 6: Biological Strategies in the Emerging Markets, Russia, Foreign Investments, 2010 20
  • Table 7: Biological Strategies in the Emerging Markets, India, Core Statistics 21
  • Table 8: Biological Strategies in the Emerging Markets, China, Core Statistics, 2010 22
  • Table 9: Biological Strategies in the Emerging Markets, China, Foreign Investments, 2010 25
  • Table 10: Biological Strategies in the Emerging Markets, Pharmaceutical Market and Biological Sector ($bn), 2010-2015 28
  • Table 11: Biological Strategies in the Emerging Markets, Russia, Most Harmful Diseases, 2010 31
  • Table 12: Biological Strategies in the Emerging Markets, Brazil, PESTLE Analysis Summary, 2010 35
  • Table 13: Biological Strategies in the Emerging Markets, Russia, PESTLE Analysis Summary, 2010 37
  • Table 14: Biological Strategies in the Emerging Markets, Russia, PESTLE Analysis Summary, 2010 39
  • Table 15: Biological Strategies in the Emerging Markets, China, PESTLE Analysis Summary, 2010 41
  • Table 16: Biological Strategies in the Emerging Markets, Brazil, Recognized Drug Classes, 2010 42
  • Table 17: Biological Strategies in the Emerging Markets, BRIC Nations, Pharmaceutical Expenditure By Payer, 2009 52
  • Table 18: Biological Strategies in the Emerging Markets, Global, Contribution of Pharmaceutical Market Growth, 2005, 2008, 2013 54
  • Table 19: Biological Strategies in the Emerging Markets, Global, Number of New General Drugs in Development, 2010 56
  • Table 20: Biological Strategies in the Emerging Markets, Global Therapeutic Biologics Pipeline (%), 2010 57
  • Table 21: Biological Strategies in the Emerging Markets, Leading Therapeutics Proteins in Clinical Development Worldwide to Treat Cancer, 2011 59
  • Table 22: Biological Strategies in the Emerging Markets, Leading Therapeutics Proteins in Clinical Development Worldwide to Treat Cancer, 2011 61
  • Table 23: Biological Strategies in the Emerging Markets, Leading Diabetes Molecules in Clinical Development Worldwide to Treat Cancer, 2011 62
  • Table 24: Biological Strategies in the Emerging Markets, Biopharmaceutical Drugs in Clinical Development Worldwide to Treat Hormonal Conditions, 2011 63
  • Table 25: Biological Strategies in the Emerging Markets, Biopharmaceutical Drugs in Clinical Development Worldwide to Treat Hemopoietic Conditions, 2011 64
  • Table 26: Biological Strategies in the Emerging Markets, Biopharmaceutical Drugs in Clinical Development Worldwide to Treat Immuno-inflammatory Diseases, 2011 65
  • Table 27: Biological Strategies in the Emerging Markets, Leading Biologics Sales ($bn), 2010 67
  • Table 28: Biological Strategies in the Emerging Markets, Sales of Roche's Leading Biologics ($bn), 2010 68
  • Table 29: Biological Strategies in the Emerging Markets, Sales of Novo's Leading Biologics ($bn), 2010 70
  • Table 30: Biological Strategies in the Emerging Markets, Sales of J&J's Leading Biologics ($bn), 2010 71
  • Table 31: Biological Strategies in the Emerging Markets, Sales of Sanofi's Leading Biologics ($bn), 2010 74
  • Table 32: Biological Strategies in the Emerging Markets ,Sales of Lilly's Leading Biologics ($bn), 2010 76
  • Table 33: Biological Strategies in the Emerging Markets, Sales of Sandoz's Leading Biologics ($bn), 2010 78
  • Table 34: Biological Strategies in the Emerging Markets, Sales of Teva's Leading Biologics ($bn), 2010 79
  • Table 35: Biological Strategies in the Emerging Markets , Recent Acquisitions in the Biologics Arena, 2011 81
  • Table 36: Biological Strategies in the Emerging Markets, Russia, Strategic Alliances, 2011 88
  • Table 37: Biological Strategies in the Emerging Markets, India, Strategic Alliances, 2011 88

List of Figures

1.2 List of Figures

  • Figure 1: Biological Strategies in the Emerging Markets, Global MAbs Therapeutic Sales Based on Prescription Usage, 2010 11
  • Figure 2: Biological Strategies in the Emerging Markets, Global , Market Share of Therapeutic Proteins (%), 2010 15
  • Figure 3: Biological Strategies in the Emerging Markets, China, Factors Stimulating Pharmaceutical Sales Growth, 2010 23
  • Figure 4: Biological Strategies in the Emerging Markets, Leading Chinese Companies with a Commitment to Developing R&D-Based Products, 2010 24
  • Figure 5: Biological Strategies in the Emerging Markets, BRIC Nations, Pharmaceutical Expenditure By Payer (%), 2009 52
  • Figure 6: Biological Strategies in the Emerging Markets, Global, Contribution of Pharmaceutical Market Growth (%), 2005, 2008, 2013 54
  • Figure 7: Biological Strategies in the Emerging Markets, Global Therapeutic Biologics Pipeline (%), 2010 57
  • Figure 8: Biological Strategies in the Emerging Markets, the US, Products in Development to Treat Cancer, 2010 58
  • Figure 9: Biological Strategies in the Emerging Markets, Important Factors for Launching Biologics, 2011 82
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