1 Executive Summary
1.1 Global Biotech Market Review: Entering a Crucial Period
1.2 Aims, Scope and Format of the Report
2 Introduction to Biotechnology
2.1 What is Biotechnology?
2.1.1 The Major Focus of Biotech Research
2.1.2 The Launch of Recombinant Insulin in 1982 was the First Commercial Biotech Drug
2.2 The Uniqueness of Biopharmaceuticals: Turning Medicine Around
2.3 Biotechnologies Used and Their Applications to Pharma
2.3.1 Bioprocessing Technology
2.3.2 Monoclonal Antibodies
2.3.3 Recombinant DNA Technology
2.3.4 Cloning
2.3.4.1 Molecular Cloning
2.3.4.2 Cellular Cloning
2.3.4.3 Animal Cloning
2.3.4.4 Protein Engineering
2.4 The Future Biopharmaceutical Market
2.4.1 Over 7000 Biotechnology Patents Granted Per Annum Since 1998
2.4.2 2005 Witnessed 54 New Biopharmaceuticals Approved by the FDA
2.5 Proteomics Constitutes the "Next Step" After Genomics
2.6 The Human Genome Project (HGP) and its Influence on Biotech
2.6.1 Overall Project Goals
2.6.2 Applications and Future Developments of the HGP
2.7 Top 10 Biotech Companies, 2007
2.8 The Top 10 Selling Biotech Drugs in 2007
3 The Leading Biotech Therapy Classes Market Forecast 2008-2013, 2018 & 2023
3.1 The Top 10 Therapy Classes – Analysis & Forecasts
3.1.1 Erythropoietins Class Currently Leads the Biotech Market – But Will it Last?
3.1.2 How Will the Oncology Class Compete with the Erythropoietins in the Biotech Market?
3.1.3 Human Insulins Class Sales Outlook from 2008 Onwards
3.1.4 Autoimmune Agents Sales Outlook from 2008 Onwards
3.1.5 The Interferons Sales Outlook from 2008 Onwards
3.1.6 Immunostim Agents Sales Outlook from 2008 Onwards
3.1.7 Immunosuppressive Agents Sales Outlook from 2008 Onwards
3.1.8 Growth Hormones Sales Outlook from 2008 Onwards
3.1.9 Blood Factors Sales Outlook from 2008 Onwards
3.1.10 Pure Vaccines Sales Outlook from 2008 Onwards
3.2 Top 10 Therapy Classes: Summary of Forecasts
4 The Global Biotech Market 2008-2013, 2018 & 2023 – Top 10 Leading Products, Analysis and Forecasts
4.1 The Global Biotech Market Showed Impressive Revenues in 2007
4.2 The Top 10 Selling Biotech Drugs of 2007 Accounted for Half of Total Biotech Drug Sales
4.3 The Top 5 Biotech Products of 2007
4.4 Enbrel Currently Leads the World Biotech Market
4.4.1 Enbrel Q1 2008 US Sales Approach Blockbuster Figures
4.4.2 Recent Concerns for Enbrel
4.4.3 Development of Enbrel
4.5 Aranesp Sales Outlook from 2008 Onwards
4.5.1 Aranesp Other International Markets Grew by 2% In 2007
4.5.2 Development of Aranesp
4.6 Remicade Sales Outlook from 2008 Onwards
4.6.1 Remicade Associated With Adverse Immunogenic Reactions
4.6.2 UK's NICE Rejects Second "go" with Arthritis Drugs
4.7 MabThera/Rituxan Sales Outlook from 2008 Onwards
4.7.1 MabThera/Rituxan (rituximab)
4.7.2 Development of MabThera/Rituxan
4.8 Neulasta Sales Outlook from 2008 Onwards
4.8.1 Neulasta (pegfilgrastim)
4.9 Procrit/Erypo Sales Outlook from 2008 Onwards
4.9.1 Procrit/Erypo Safety Concerns
4.10 Herceptin Sales Outlook from 2008 Onwards
4.10.1 Herceptin (trastuzumab)
4.10.2 Development of Herceptin
4.11 Epogen Sales Outlook from 2008 Onwards
4.11.1 Epogen (Epoetin Alfa) - Recombinant Human Erythropoietin Product
4.12 Avastin Sales Outlook from 2008 Onwards
4.12.1 Avastin (bevacizumab)
4.12.2 Development of Avastin
4.13 Humira Sales Outlook from 2008 Onwards
4.13.1 Humira (adalimumab)
4.14 Top 10 Leading Products Summary
5 SWOT Analysis 2008-2013
5.1 SWOT Analysis of the Global Biotech Market
5.2 Market Drivers
5.3 Market Restraints
5.4 The Biotech Market is Rapidly Expanding
5.5 The Benefits of Biotechnological Products
5.6 Biotechnology is an Important and Fast-Growing Part of Healthcare R&D
5.7 Regulatory Issues
5.7.1 Biopharmaceuticals and the FDA
5.7.2 FDA Improving Upon Approval Wait
5.7.3 FDA and Other Regulatory Bodies Recommend Changes to Erythropoietin Stimulating Agents (ESAs) Labels
5.7.4 FDA Monitors ESAs over Two Decades
5.7.5 Rising Regulatory Hurdles and High Cost of Developing Biologic Drugs Will Play to the Advantage of Big Pharma
5.8 Biotech Market Challenges
5.8.1 Biotech’s Delivery Challenge
5.8.1.1 New Delivery Technologies: A Pharmacy or Medical Benefit?
5.8.2 Manufacturing Capacity Shortfall
5.8.2.1 Why is there a Shortfall in Manufacturing Capacity for Biopharmaceuticals?
5.8.2.2 How is the Manufacturing Capacity Shortfall Being Overcome?
5.8.3 The Costs of Biopharmaceuticals
5.8.3.1 The Top Five Biopharmaceuticals Each Cost Over $10,000 per Patient per Annum
5.8.4 The Need for Collaboration
5.8.4.1 Future Biotech Innovation and Academia
5.8.4.2 The Risky Path from Bench to Market
5.8.5 Biogeneric (Biosimilar) Threats
5.8.5.1 Strong Bioequivalence Hurdles Will Regulate the Fast Market Entry of Biogeneric Drugs
5.8.6 Dependence upon Venture Capital Investment
5.9 Biotech's Major Challenges: Biogenerics and Budgetary Restraints
5.9.1 Healthcare Costs Are Rising with Biotech Drugs Constituting a Large Part of these Costs
5.9.2 Biotech Drugs are Expensive to Develop
5.9.3 Smaller Biotech Companies Specialising in Biogenerics
5.9.4 The Next Generation of Biotech Drugs
5.10 Challenges and Issues for the Future in Healthcare Biotechnology
6 The Top 10 Leading Players in the Biotech Market
6.1 Amgen: The Reign Continues With a Prominent Share of 2007 Market
6.1.1 Amgen Background
6.1.2 Amgen - Like Other Companies - Could Benefit From Changes to Patent Laws
6.1.3 Amgen Will Continue to Compete With Big Pharma's Large Investment Trends in Biotech
6.2 The Strong Partnership Flourishes between Roche and Genentech
6.2.1 Roche in Talks to Buy Genentech Stock
6.2.2 Roche Gains Momentum in Amgen's Territory
6.3 The Continuing Success of International Biopharmaceuticals Companies is Dependent upon Important Drivers and Restraints
6.3.1 Companies Are Gradually Changing their Strategic Focus to Overcome Challenges in the Worldwide Market
7 Global Biotech Market by Region
7.1 The World Biotech Market is Dominated by the US
7.2 Japanese and European Biotech World Market Shares – How will these Develop?
7.3 The US Biotech Market Will Retain World Dominance
7.4 The European Biotech Market Will See Reduced Growth
7.4.1 Biosimilars Approval Rises In the EU Market
7.5 Biocon and Abraxis Launch Breast Cancer Drug in India
8 Venture Capital Investment in Healthcare Biotechnology
8.1 What is Venture Capital Investment?
8.2 What Do VC’s Offer?
8.3 What Do Venture Capitalists Do?
8.4 Who are Venture Capitalists?
8.4.1 Banks as Venture Capitalists
8.4.2 Business Angels as Venture Capitalists
8.4.3 Corporate or Direct Investors as Venture Capitalists
8.4.4 Government Grants and Governments as Venture Capitalists
8.4.5 Venture Capital Firms
8.4.6 Other Types of Venture Capitalist
8.5 Why Do Biotech Companies Need VC Funding?
9 Biogenerics - Overview
9.1 The Emergence of Biogenerics (Biosimilars)
9.1.1 Patent Expiry for Key Biotech Drugs
9.1.2 Names are Important
9.2 Improved Technology Has Strengthened the Case for Biogenerics
9.3 Bioequivalence Will Remain Difficult to Demonstrate
9.4 Biotech Drugs are Expensive to Develop
9.5 Regulators and Patients are Cautious over Safety
9.6 The Next Generation of Biotech Drugs will Restrain Growth in Biogenerics
9.7 Regulations are the Main Concern for Biogenerics
9.8 The Key Question for Biogenerics - How Innovative Do You Need to Be?
10 Biotech Pipeline
10.1 Technology Driving Biopharma Pipeline
10.2 Biotech Targeting Chronic Illness
10.3 Late-Stage Erythropoietins Pipeline
10.4 Late Stage Oncology Pipeline
10.5 Late-Stage Human Insulins Pipeline
10.6 Late-Stage Arthritis Pipeline
10.7 Late-Stage Interferons Pipeline
10.8 Late-Stage Immunostims Pipeline
10.9 Late-Stage Immunosuppressives Pipeline
10.10 Late-Stage Growth Hormones Pipeline
10.11 Late-Stage Blood Factors Pipeline
10.12 Late-Stage Vaccines Pipeline
10.13 The Future of Biotech R&D
11 Conclusions - Biotech Comes of Age
11.1 The Global Biotech Market in 2007 - Summary
11.2 The Top 5 Biotech Products of 2007 Had Impressive Sales Figures
11.2.1 Top 10 Leading Products Rank - 2007 and 2013 Comparison
11.3 Erythropoietins Class Currently Leads the Biotech Market - But Will it Last?
11.3.1 Top 10 Therapy Classes Rank - 2007 and 2013 Comparison
11.4 Can Amgen Remain at the Forefront of the Global Biotech Industry and Continue to be a Strong Competitor in the Global Pharmaceutical Market?
11.5 Biotech Drugs Often Target Niche Markets
List of Tables
Table 2.1 Definitions of Selected Biopharmaceuticals
Table 2.2 Summary of Biotechnologies
Table 2.3 The Top 10 Global Biotech Companies, 2007
Table 2.4 The Top 10 Leading Biotech Products, 2007
Table 3.1 Revenues ($m) for the Top Ten Therapy Classes', 2008-2013, 2018 & 2023
Table 3.2 Revenues ($m), 6-Year CAGR (%) and Market Share (%) for Top Ten Therapy Classes, 2007 & 2013
Table 3.3 Top 10 Therapy Classes Rank Comparison, 2007 and 2013
Table 4.1 Top 10 Leading Drugs Revenue ($m) Forecast 2008-2013, 2018 & 2023
Table 4.2 Top 10 Drugs 6-Year CAGR (%) and Market Share (%), 2007 & 2013
Table 4.3 Top 10 Products Market Share (%) Comparison 2007 & 2013
Table 4.4 Enbrel Revenues ($m) 2008-2013, 2018 & 2023
Table 4.5 Aranesp Revenues ($m) 2008-2013, 2018 & 2023
Table 4.6 Remicade Revenues ($m) 2008-2013, 2018 & 2023
Table 4.7 MabThera/Rituxan Revenues ($m) 2008-2013, 2018 & 2023
Table 4.8 Neulasta Revenues ($m) 2008-2013, 2018 & 2023
Table 4.9 Procrit/Erypo Revenues ($m) 2008-2013, 2018 & 2023
Table 4.10 Herceptin Revenues ($m) 2008-2013, 2018 & 2023
Table 4.11 Epogen Revenues ($m) 2008-2013, 2018 & 2023
Table 4.12 Avastin Revenues ($m) 2008-2013, 2018 & 2023
Table 4.13 Humira Revenues ($m) 2008-2013, 2018 & 2023
Table 4.14 Top 10 Products Rank Comparison, 2007 and 2013
Table 5.1 A SWOT Chart for the Biotech Market, 2008-2013
Table 6.1 Biotech Company Revenues ($m), Company Market Share (%) 2007
Table 7.1 Global Biotech Market Revenues ($m) Forecast 2008-2013, 2018 & 2023
Table 7.2 Global Market Share (%) and Revenue ($m) by Country/Region, 2007
Table 7.3 Global Market Share (%) by Country/Region Compared, 2007 and 2013
Table 7.4 Region/Country Revenue forecast ($m) 2008-2013, 2018 & 2023
Table 7.5 Competing Biosimilar Epoietin Launched in 2007-2008
Table 10.1 Late-Stage Erythropoietins Pipeline, 2008
Table 10.2 Late Stage Oncology Pipeline, 2008
Table 10.3 Late-Stage Human Insulin Pipeline, 2008
Table 10.4 Late-Stage Arthritis Pipeline, 2008
Table 10.5 Late-Stage Interferons Pipeline, 2008
Table 10.6 Late-Stage Immunostim Pipeline, 2008
Table 10.7 Late-Stage Immunosuppressive Pipeline, 2008
Table 10.8 Late-Stage Growth Hormone Pipeline, 2008
Table 10.9 Late-Stage Blood Factors Pipeline, 2008
Table 10.10 Late-Stage Vaccines Pipeline, 2008
Table 11.1 Global Biotech Market Revenues ($m) Forecast 2008-2013, 2018 & 2023
Table 11.2 Top 10 Products Rank Comparison, 2007 and 2013
Table 11.3 Top 10 Therapy Classes Rank Comparison, 2007 and 2013
List of Figures
Figure 2.1 Total Number of Biotechnology Patents Granted: 1992-2002
Figure 2.2 Number of New Biopharmaceutical FDA Approvals: 2000-2005
Figure 3.1 Top Ten Therapy Classes Revenue ($m) Comparison, 2007 & 2013
Figure 3.2 Top Ten Therapy Classes Market Share (%), 2007
Figure 3.3 Top Ten Therapy Classes Market Share (%), 2013
Figure 3.4 Erythropoietins Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
Figure 3.5 Oncology Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
Figure 3.6 Human Insulins Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
Figure 3.7 Autoimmune Agents Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
Figure 3.8 Interferons Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
Figure 3.9 Immunostim Agents Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
Figure 3.10 Immunosuppressive Agents Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
Figure 3.11 Growth Hormones Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
Figure 3.12 Blood Factors Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
Figure 3.13 Pure Vaccines Class Revenue ($m) Forecast 2008-2013, 2018 & 2023
Figure 4.1 Global Biotech Market Sales Breakdown ($m) 2008-2013, 2018 & 2023
Figure 4.2 Top 10 Drugs vs. the Rest of the Portfolio (%) Contribution of Revenues, 2007 & 2013
Figure 4.3 Top 10 Products Market Share (%) 2007
Figure 4.4 Top 10 Products Market Share (%) 2013
Figure 4.5 World Revenues ($m) for Enbrel 2008-2013, 2018 & 2023
Figure 4.6 World Revenues ($m) for Aranesp 2008-2013, 2018 & 2023
Figure 4.7 World Revenues ($m) for Remicade 2008-2013, 2018 & 2023
Figure 4.8 World Revenues ($m) for MabThera/Rituxan 2008-2013, 2018 & 2023
Figure 4.9 World Revenues ($m) for Neulasta 2008-2013, 2018 & 2023
Figure 4.10 World Revenues ($m) for Procrit/Erypo 2008-2013, 2018 & 2023
Figure 4.11 World Revenues ($m) for Herceptin 2008-2013, 2018 & 2023
Figure 4.12 World Revenues ($m) for Epogen 2008-2013, 2018 & 2023
Figure 4.13 World Revenues ($m) for Avastin 2008-2013, 2018 & 2023
Figure 4.14 World Revenues ($m) for Humira 2008-2013, 2018 & 2023
Figure 6.1 Company Revenues from Leading Biotech Drugs ($m), 2007
Figure 6.2 Top 10 Leading Biotech Companies Market Share (%) 2007
Figure 7.1 Global Market Share (%) by Region, 2007
Figure 7.2 Global Market Share (%) by Region, 2013