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

Published By :

GBI Research

Published Date : Jul 2012

Category :

No. of Pages : 82 Pages


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.
Table of Content

1 Table of Contents
1.2 List of Tables
1.3 List of Figures

2 Executive Summary
2.1 The Launch of Biobetter Therapies has Resulted in Considerable Gains in the Global Market
2.2 A Strong Pipeline and the Entry of New Players will Intensify Competition
2.3 The Top Seven Companies are Major Players in the Global Biobetters Market
2.4 Strategic Consolidations have Led to the Entry of New Players in the Biobetter Therapeutics Market

3 Introduction
3.1 GBI Research Report Guidance

4 Global Market Overview
4.1 Biobetter Therapies Already on the Market
4.1.1 Erythropoietins
4.1.2 Granulocyte-colony Stimulating Factors
4.1.3 Interferon-a, Interferon-ß
4.1.4 Insulin and Insulin Analogs
4.1.5 Monoclonal Antibodies
4.1.6 TNF-a Inhibitors
4.2 Promising Drug Classes for Biobetter Therapies
4.2.1 Human Growth Hormone
4.3 Comparison of Biosimilars and Biobetters

5 Technology Analysis
5.1 Introduction
5.1.1 Host Cell
5.1.2 Glycosylation
5.1.3 PEGylation
5.1.4 Polysialylation
5.1.5 Fusion Protein
5.1.6 PASylation
5.1.7 HESylation

6 Challenges and Opportunities
6.1 Opportunities
6.1.1 Biobetter Therapies Gain Substantial Market Shares upon Launch
6.1.2 Higher Success Rates in the Development of Biobetter Therapies
6.2 Challenges
6.2.1 Uncertainty Surrounding the Implementation of the Affordable Care Act will Limit Patient Access to Biobetter Drugs
6.2.2 Growing Debts and the Slowing of the Economy will Drive Governmental Bodies and Healthcare Providers to Restrict the Use of Expensive Biobetter Therapies
6.2.3 Regulatory Policies in Emerging Economies such as China and India do not Provide Enough Protection for the Development of Biobetter Therapies

7 Pipeline Analysis
7.1 Introduction
7.2 Human Growth Hormone
7.3 Erythropoietin
7.4 Granulocyte-colony Stimulating Factor
7.5 Interferon-a and Interferon-ß
7.6 Insulin and Insulin Analogs
7.7 Monoclonal Antibodies
7.8 Promising Drugs
7.8.1 LB03002 - HGH
7.8.2 Degludec - Insulin Analog
7.8.3 Theracim - Monoclonal Antibody
7.8.4 Pertuzumab - Monoclonal Antibody
7.8.5 RG7159 - Monoclonal Antibody

8 The US Regulatory Environment and Approval Pathways
8.1 Introduction
8.2 Biobetter Therapies
8.3 Biosimilar Therapies

9 The EU Regulatory Environment and Approval Pathways
9.1 Introduction
9.2 Biobetter Therapies
9.3 Biosimilar Therapies

10 Japan Regulatory Environment and Approval Pathways
10.1 Biobetter Therapies
10.2 Biosimilar Therapies

11 Australia Regulatory Environment and Approval Pathways
11.1 Biobetter Therapies
11.2 Biosimilar Therapies

12 China Regulatory Environment and Approval Pathways
12.1 Biobetter Therapies
12.2 Biosimilar Therapies

13 India Regulatory Environment and Approval Pathways
13.1 Biobetter Therapies
13.2 Biosimilar Therapies

14 Biobetter Companies
14.1 Key Players
14.1.1 Amgen
14.1.2 SWOT Analysis
14.1.3 Merck
14.1.4 SWOT Analysis
14.1.5 Roche
14.1.6 SWOT Analysis
14.1.7 Novo Nordisk
14.1.8 SWOT Analysis
14.1.9 Sanofi-Aventis
14.1.10 SWOT Analysis

15 Strategic Consolidations
15.1 Deals Analysis
15.1.1 Mergers and Acquisitions
15.1.2 Licensing Agreements

16 Biobetters Therapeutics Market to 2018: Appendix
16.1 Abbreviations
16.2 Sources
16.3 Research Methodology
16.3.1 Coverage
16.3.2 Secondary Research
16.3.3 Primary Research
16.3.4 Forecasts
16.3.5 Expert Panel Validation
16.4 Contact Us
16.5 Disclaimer 

List of Table


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-

List of Chart


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-

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