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-?, interferon-beta, insulin and insulin analogs, monoclonal antibodies (mAbs) and tumor Necrosis Factor-? (TNF-?). 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-?, 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-?, interferon-beta, insulin and insulin analogs, mAbs and TNF-?.
- 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.

Table Of Contents

Table of Contents
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-?, Interferon-? 15
3.1.4 Insulin and Insulin Analogs 16
3.1.5 Monoclonal Antibodies 19
3.1.6 TNF-? 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-? and Interferon-? 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-? and ? 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 ($m), 2004-2011 19
Figure 6: Biobetters in Key Markets, Monoclonal Antibodies (TNF-?) Global, Revenue Sales ($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-? Market, US, Annual Cost of Treatment ($), 2011 25
Figure 10: Biobetters in Key Markets, Human Growth Hormone Therapeutics, Global RandD Pipeline by Phase (%), 2011 32
Figure 11: Biobetters in Key Markets, Erythropoietin Therapeutics, Global RandD Pipeline by Phase (%), 2011 34
Figure 12: Biobetters in Key Markets, Granulocyte-colony Stimulating Factor Therapeutics, Global RandD Pipeline by Phase (%), 2011 35
Figure 13: Biobetters in Key Markets, Interferon-? Therapeutics, Global RandD Pipeline by Phase (%), 2011 36
Figure 14: Biobetters in Key Markets, Insulin and Insulin Analog Therapeutics, Global RandD Pipeline by Phase (%), 2011 38
Figure 15: Biobetters In Key Markets, Monoclonal Antibodies Therapeutics, Global RandD 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

Companies Mentioned

Amgen
Merck
Roche
Novo Nordisk
Sanofi-Aventis

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