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

NEW YORK, Nov. 15, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

http://www.reportlinker.com/p0935305/Biobetters-in-Key-Markets---Opportunities-for-Biotechnology-Companies-to-Sustain-Innovation-with-Low-Risk-and-High-Value-Offerings.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Biopharmaceutical

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.

1 Table of Contents1 Table of Contents 61.1 List of Tables 81.2 List of Figures 82 Introduction 93 Global Market Overview 113.1 Biobetter Therapies Already on the Market 113.1.1 Erythropoietins 123.1.2 Granulocyte-colony Stimulating Factors 143.1.3 Interferon-?, Interferon-? 153.1.4 Insulin and Insulin Analogs 163.1.5 Monoclonal Antibodies 193.1.6 TNF-? Inhibitors 203.2 Promising Drug Classes for Biobetter Therapies 213.2.1 Human Growth Hormone 213.3 Comparison of Biosimilars and Biobetters 234 Technology Analysis 264.1 Introduction 264.1.1 Host Cell 264.1.2 Glycosylation 274.1.3 PEGylation 284.1.4 Polysialylation 284.1.5 Fusion Protein 284.1.6 PASylation 284.1.7 HESylation 295 Challenges and Opportunities 305.1 Opportunities 305.1.1 Biobetter Therapies Gain Substantial Market Shares upon Launch 305.1.2 Higher Success Rates in the Development of Biobetter Therapies 305.2 Challenges 305.2.1 Uncertainty Surrounding the Implementation of the Affordable Care Act will Limit Patient Access to Biobetter Drugs 305.2.2 Growing Debts and the Slowing of the Economy will Drive Governmental Bodies and Healthcare Providers to Restrict the Use of Expensive Biobetter Therapies 315.2.3 Regulatory Policies in Emerging Economies such as China and India do not Provide Enough Protection for the Development of Biobetter Therapies 316 Pipeline Analysis 326.1 Introduction3 326.2 Human Growth Hormone 326.3 Erythropoietin 346.4 Granulocyte-colony Stimulating Factor 356.5 Interferon-? and Interferon-? 366.6 Insulin and Insulin Analogs 386.7 Monoclonal Antibodies 406.8 Promising Drugs 426.8.1 LB03002 - HGH 426.8.2 Degludec - Insulin Analog 426.8.3 Theracim - Monoclonal Antibody 436.8.4 Pertuzumab - Monoclonal Antibody 436.8.5 RG7159 - Monoclonal Antibody 447 The US Regulatory Environment and Approval Pathways 457.1 Introduction 457.2 Biobetter Therapies 457.3 Biosimilar Therapies 468 The EU Regulatory Environment and Approval Pathways 478.1 Introduction 478.2 Biobetter Therapies 478.3 Biosimilar Therapies 479 Japan Regulatory Environment and Approval Pathways 499.1 Biobetter Therapies 499.2 Biosimilar Therapies 5010 Australia Regulatory Environment and Approval Pathways 5110.1 Biobetter Therapies 5110.2 Biosimilar Therapies 5111 China Regulatory Environment and Approval Pathways 5211.1 Biobetter Therapies 5211.2 Biosimilar Therapies 5212 India Regulatory Environment and Approval Pathways 5312.1 Biobetter Therapies 5312.2 Biosimilar Therapies 5313 Biobetter Companies 5413.1 Key Players 5413.1.1 Amgen 5413.1.2 SWOT Analysis 5513.1.3 Merck 5613.1.4 SWOT Analysis 5613.1.5 Roche 5713.1.6 SWOT Analysis 5813.1.7 Novo Nordisk 5913.1.8 SWOT Analysis 5913.1.9 Sanofi-Aventis 6013.1.10 SWOT Analysis 6114 Strategic Consolidations 6214.1 Deals Analysis 6214.1.1 Mergers and Acquisitions 6214.1.2 Licensing Agreements 6915 Biobetters Therapeutics Market to 2018 - Appendix 7615.1 Abbreviations 7615.2 Sources 7815.3 Research Methodology 7815.3.1 Coverage 7915.3.2 Secondary Research 7915.3.3 Primary Research 7915.3.4 Forecasts 8015.3.5 Expert Panel Validation 8215.4 Contact Us 8215.5 Disclaimer 82

List of Tables

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

List of Figures

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

Companies Mentioned

AmgenMerckRocheNovo NordiskSanofi-Aventis

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