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Biobetters in Key Markets - Opportunities for Biotechnology Companies to Sustain Innovation with Low Risk and High Value Offerings

Executive Summary

Biobetters: The Big Draw in the Pharma Market.

Biobetters, drugs that have been improved since their initial incarnations, are demonstrating fantastic growth and leaving their originators well behind, states new research by pharmaceutical business specialists GBI Research.

The new report* explains how the more advanced drugs are far outstripping their biologic predecessors in terms of sales and pricing, helping companies maintain revenue at a time when patent expiry is rife.

Examples presented in the report include Amgen's biobetter Neulasta, used for the treatment of neutropenia. It was launched in 2002, 11 years after originator product Neupogen, and grew at a Compound Annual Growth Rate (CAGR) of 94% between 2002 and 2004. During the same period, Neupogen declined at a negative CAGR of 8%.

Similarly, when Roche launched Pegasys, a biobetter therapy with an improved dosing regime for hepatitis C, it grew at a CAGR of 23% between 2003 and 2004 and reached $1.4 billion in 2011, whereas the originator product, Intron A, saw sales decline at a negative CAGR of 10% between 2003 and 2004.

Biologic therapies have existed in the market since the mid-1980s, and therefore many are nearing their patent expiry or are no longer protected. However, the advent of modern technological and analytical methods such as mass spectrometry and genome sequencing has made it possible to produce and characterize protein therapies that have undergone significant changes, and has also enabled the development of biologic therapies with better safety profiles, dosing regimens and efficacy.

The dominance of biobetters is set to continue in the future, thanks to a healthy looking therapeutics pipeline. Considering that 21% of pipeline medications are in late stage development, the biobetters market is expected to show strong market growth over the next few years, further attracting pharmaceutical and biotechnological companies.

The major players in the biobetters sector are those firms with considerable experience in this space which have released next generation therapeutics to protect and reinforce their position. The major stakeholder is Abbott, which controls 23% of the market thanks to its blockbuster therapy, Humira. Roche is not far behind with a 21% share, followed by Amgen with a 20% portion.

Biobetters in Key Markets - Opportunities for Biotechnology Companies to Sustain Innovation with Low Risk and High Value Offerings

This report provides insights into the impact of biobetter therapies on the top selling biologic therapeutics, the regulatory procedure surrounding entry in the biobetters market and includes recent technological advances that have driven advancement in the market.

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

Biobetters in Key Markets - Opportunities for Biotechnology Companies to Sustain Innovation with Low Risk and High Value Offerings

Summary

GBI Research, the leading business intelligence provider, has released its latest research on, "Biobetters in Key Markets - Opportunities for Biotechnology Companies to Sustain Innovation with Low Risk and High Value Offerings", which provides insights into the impact of biobetter therapies on the top selling biologic therapeutics, the regulatory procedure surrounding entry in the biobetters market and including recent technological advances that have driven advancement in the market. The report provides an in-depth analysis of top selling biobetter products covering top selling protein classes, erythropoietin's, granulocyte-colony stimulating factors (G-CSF), interferon-α, interferon-beta, insulin and insulin analogs, monoclonal antibodies (mAbs) and tumor Necrosis Factor-α (TNF-α). The report also includes insights into the biobetter therapeutics R&D pipeline. It analyzes the competitive landscape, including Mergers and Acquisitions (M&As), and licensing and co-development deals.

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.

GBI Research found that on average biobetter launches generate more revenues than their corresponding originator therapies. In some scenarios this extended to, the launch of a biobetter therapy substituting the sales from an existing originator product or biobetter therapy.

Scope

  • Data and analysis on the impact of biobetter therapeutics on the major top selling biologics erythropoietin's, granulocyte-colony stimulating factors (G-CSF), interferon-α, interferon-beta, insulin and insulin analogs, human growth hormone and monoclonal and mAbs.
  • Pipeline analysis of biobetter therapies in major protein classes erythropoietin's, G-CSF, interferon-α, interferon-beta, insulin and insulin analogs, mAbs and TNF-α.
  • Key drivers and restraints that have had a significant impact on the market.
  • The competitive landscape of the global biobetter therapeutics market, including companies such as Celgene, Amgen, Bristol-Myers Squibb, Amylin and Dainippon Sumitomo Pharma.
  • Key M&A activities and licensing and co-development agreements that took place from 2010-2012 in the global Biobetters market.

Reasons to buy

  • Align your product portfolio to the markets with high growth potential.
  • Develop business strategies by understanding the trends shaping and driving technological advancements in the field of biobetter therapies.
  • Identify key molecules in development being used for biobetter therapies.
  • Reinforce R&D pipelines by identifying common drug class biobetters in the pipeline for top selling protein classes.
  • Accelerate and strengthen your market position by identifying key companies for mergers, acquisitions and strategic partnerships.

TOC

1 Table of Contents

1 Table of Contents 6

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

2 Introduction 9

3 Global Market Overview 11

  • 3.1 Biobetter Therapies Already on the Market 11
    • 3.1.1 Erythropoietins 12
    • 3.1.2 Granulocyte-colony Stimulating Factors 14
    • 3.1.3 Interferon-α, Interferon-β 15
    • 3.1.4 Insulin and Insulin Analogs 16
    • 3.1.5 Monoclonal Antibodies 19
    • 3.1.6 TNF-α Inhibitors 20
  • 3.2 Promising Drug Classes for Biobetter Therapies 21
    • 3.2.1 Human Growth Hormone 21
  • 3.3 Comparison of Biosimilars and Biobetters 23

4 Technology Analysis 26

  • 4.1 Introduction 26
    • 4.1.1 Host Cell 26
    • 4.1.2 Glycosylation 27
    • 4.1.3 PEGylation 28
    • 4.1.4 Polysialylation 28
    • 4.1.5 Fusion Protein 28
    • 4.1.6 PASylation 28
    • 4.1.7 HESylation 29

5 Challenges and Opportunities 30

  • 5.1 Opportunities 30
    • 5.1.1 Biobetter Therapies Gain Substantial Market Shares upon Launch 30
    • 5.1.2 Higher Success Rates in the Development of Biobetter Therapies 30
  • 5.2 Challenges 30
    • 5.2.1 Uncertainty Surrounding the Implementation of the Affordable Care Act will Limit Patient Access to Biobetter Drugs 30
    • 5.2.2 Growing Debts and the Slowing of the Economy will Drive Governmental Bodies and Healthcare Providers to Restrict the Use of Expensive Biobetter Therapies 31
    • 5.2.3 Regulatory Policies in Emerging Economies such as China and India do not Provide Enough Protection for the Development of Biobetter Therapies 31

6 Pipeline Analysis 32

  • 6.1 Introduction3 32
  • 6.2 Human Growth Hormone 32
  • 6.3 Erythropoietin 34
  • 6.4 Granulocyte-colony Stimulating Factor 35
  • 6.5 Interferon-α and Interferon-β 36
  • 6.6 Insulin and Insulin Analogs 38
  • 6.7 Monoclonal Antibodies 40
  • 6.8 Promising Drugs 42
    • 6.8.1 LB03002 - HGH 42
    • 6.8.2 Degludec - Insulin Analog 42
    • 6.8.3 Theracim - Monoclonal Antibody 43
    • 6.8.4 Pertuzumab - Monoclonal Antibody 43
    • 6.8.5 RG7159 - Monoclonal Antibody 44

7 The US Regulatory Environment and Approval Pathways 45

  • 7.1 Introduction 45
  • 7.2 Biobetter Therapies 45
  • 7.3 Biosimilar Therapies 46

8 The EU Regulatory Environment and Approval Pathways 47

  • 8.1 Introduction 47
  • 8.2 Biobetter Therapies 47
  • 8.3 Biosimilar Therapies 47

9 Japan Regulatory Environment and Approval Pathways 49

  • 9.1 Biobetter Therapies 49
  • 9.2 Biosimilar Therapies 50

10 Australia Regulatory Environment and Approval Pathways 51

  • 10.1 Biobetter Therapies 51
  • 10.2 Biosimilar Therapies 51

11 China Regulatory Environment and Approval Pathways 52

  • 11.1 Biobetter Therapies 52
  • 11.2 Biosimilar Therapies 52

12 India Regulatory Environment and Approval Pathways 53

  • 12.1 Biobetter Therapies 53
  • 12.2 Biosimilar Therapies 53

13 Biobetter Companies 54

  • 13.1 Key Players 54
    • 13.1.1 Amgen 54
    • 13.1.2 SWOT Analysis 55
    • 13.1.3 Merck 56
    • 13.1.4 SWOT Analysis 56
    • 13.1.5 Roche 57
    • 13.1.6 SWOT Analysis 58
    • 13.1.7 Novo Nordisk 59
    • 13.1.8 SWOT Analysis 59
    • 13.1.9 Sanofi-Aventis 60
    • 13.1.10 SWOT Analysis 61

14 Strategic Consolidations 62

  • 14.1 Deals Analysis 62
    • 14.1.1 Mergers and Acquisitions 62
    • 14.1.2 Licensing Agreements 69

15 Biobetters Therapeutics Market to 2018 - Appendix 76

  • 15.1 Abbreviations 76
  • 15.2 Sources 78
  • 15.3 Research Methodology 78
    • 15.3.1 Coverage 79
    • 15.3.2 Secondary Research 79
    • 15.3.3 Primary Research 79
    • 15.3.4 Forecasts 80
    • 15.3.5 Expert Panel Validation 82
  • 15.4 Contact Us 82
  • 15.5 Disclaimer 82

List of Tables

1.1 List of Tables

  • Table 1: Biobetters in Key Markets, Human Growth Hormone Therapeutics Pipeline, Development-stage Molecules, 2012 33
  • Table 2: Biobetters in Key Markets, Erythropoietin Pipeline, Development-stage Molecules, 2012 34
  • Table 3: Biobetters in Key Markets, Granulocyte-colony Stimulating Factor Pipeline, Development-stage Molecules, 2012 35
  • Table 4: Biobetters in Key Markets, Interferon-α and β Pipeline, Development-stage Molecules, 2012 37
  • Table 5: Biobetters in Key Markets, Insulin Pipeline, Development-stage Molecules, 2012 39
  • Table 6: Biobetters in Key Markets, Monoclonal Antibodies Pipeline, Development-stage Molecules, 2012 40
  • Table 7: Biobetters in Key Markets, Monoclonal Antibodies Pipeline, Development-stage Molecules, 2012 (Contd.) 41

List of Figures

1.2 List of Figures

  • Figure 1: Biobetters in Key Markets, Erythropoietin, Global, Revenue Sales ($m), 2000-2011 13
  • Figure 2: Biobetters in Key Markets, Granulocyte-colony Stimulating Factor, Global, Revenue Sales ($m), 2000-2011 14
  • Figure 3: Biobetters in Key Markets, Interferon-alpha, Global, Revenue Sales ($m), 2000-2011 16
  • Figure 4: Biobetters in Key Markets, Insulin and Insulin Analogs, Global, Revenue Sales ($m), 2000-2011 18
  • Figure 5: Biobetters in Key Markets, Monoclonal Antibodies, Global, Revenue Sales ($m), 2004-2011 19
  • Figure 6: Biobetters in Key Markets, Monoclonal Antibodies (TNF-α) Global, Revenue Sales ($m), 2000-2011 20
  • Figure 7: Biobetters in Key Markets, Human Growth Hormone, Global, Revenue Sales ($m), 2000-2011 22
  • Figure 8: Biobetters in Key Markets, Human Growth Hormone Market, EU-5, Annual Cost of Treatment ($), 2011 24
  • Figure 9: Biobetters in Key Markets, Interferon-α Market, US, Annual Cost of Treatment ($), 2011 25
  • Figure 10: Biobetters in Key Markets, Human Growth Hormone Therapeutics, Global R&D Pipeline by Phase (%), 2011 32
  • Figure 11: Biobetters in Key Markets, Erythropoietin Therapeutics, Global R&D Pipeline by Phase (%), 2011 34
  • Figure 12: Biobetters in Key Markets, Granulocyte-colony Stimulating Factor Therapeutics, Global R&D Pipeline by Phase (%), 2011 35
  • Figure 13: Biobetters in Key Markets, Interferon-α Therapeutics, Global R&D Pipeline by Phase (%), 2011 36
  • Figure 14: Biobetters in Key Markets, Insulin and Insulin Analog Therapeutics, Global R&D Pipeline by Phase (%), 2011 38
  • Figure 15: Biobetters In Key Markets, Monoclonal Antibodies Therapeutics, Global R&D Pipeline by Phase (%), 2011 40
  • Figure 16: Biobetters in Key Markets, SWOT Analysis, Amgen, 2011 55
  • Figure 17: Biobetters in Key Markets, SWOT Analysis, Merck, 2011 56
  • Figure 18: Biobetters in Key Markets, SWOT Analysis, Roche, 2011 58
  • Figure 19: Biobetters in Key Markets, SWOT Analysis, Novo Nordisk, 2011 59
  • Figure 20: Biobetters in Key Markets, SWOT Analysis, Sanofi, 2011 61
  • Figure 21: GBI Research Market Forecasting Model 81
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