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Market Research Report

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

Published by GBI Research Product code 246722
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Biobetters in Key Markets - Opportunities for Biotechnology Companies to Sustain Innovation with Low Risk and High Value Offerings
Published: July 10, 2012 Content info: 82 Pages
Description

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.

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.

Table of Contents

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Introduction

3. Global Market Overview

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

4. Technology Analysis

  • 4.1. Introduction
    • 4.1.1. Host Cell
    • 4.1.2. Glycosylation
    • 4.1.3. PEGylation
    • 4.1.4. Polysialylation
    • 4.1.5. Fusion Protein
    • 4.1.6. PASylation
    • 4.1.7. HESylation

5. Challenges and Opportunities

  • 5.1. Opportunities
    • 5.1.1. Biobetter Therapies Gain Substantial Market Shares upon Launch
    • 5.1.2. Higher Success Rates in the Development of Biobetter Therapies
  • 5.2. Challenges
    • 5.2.1. Uncertainty Surrounding the Implementation of the Affordable Care Act will Limit Patient Access to Biobetter Drugs
    • 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
    • 5.2.3. Regulatory Policies in Emerging Economies such as China and India do not Provide Enough Protection for the Development of Biobetter Therapies

6. Pipeline Analysis

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

7. The US Regulatory Environment and Approval Pathways

  • 7.1. Introduction
  • 7.2. Biobetter Therapies
  • 7.3. Biosimilar Therapies

8. The EU Regulatory Environment and Approval Pathways

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

9. Japan Regulatory Environment and Approval Pathways

  • 9.1. Biobetter Therapies
  • 9.2. Biosimilar Therapies

10. Australia Regulatory Environment and Approval Pathways

  • 10.1. Biobetter Therapies
  • 10.2. Biosimilar Therapies

11. China Regulatory Environment and Approval Pathways

  • 11.1. Biobetter Therapies
  • 11.2. Biosimilar Therapies

12. India Regulatory Environment and Approval Pathways

  • 12.1. Biobetter Therapies
  • 12.2. Biosimilar Therapies

13. Biobetter Companies

  • 13.1. Key Players
    • 13.1.1. Amgen
    • 13.1.2. SWOT Analysis
    • 13.1.3. Merck
    • 13.1.4. SWOT Analysis
    • 13.1.5. Roche
    • 13.1.6. SWOT Analysis
    • 13.1.7. Novo Nordisk
    • 13.1.8. SWOT Analysis
    • 13.1.9. Sanofi-Aventis
    • 13.1.10. SWOT Analysis

14. Strategic Consolidations

  • 14.1. Deals Analysis
    • 14.1.1. Mergers and Acquisitions
    • 14.1.2. Licensing Agreements

15. Biobetters Therapeutics Market to 2018-Appendix

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

List of Tables

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

List of Figures

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