SPI Infoamtion

Table of Contents

1. Executive Summary
1.1 Global Biotech Market Review
1.2 Aims, Scope and Format of the Report

2. An Introduction to Biotechnology
2.1 What is Biotechnology?
2.1.1 The Major Focus Areas of Healthcare Biotechnology to Date
2.1.2 The Launch of Recombinant Insulin in 1982 - the First Commercial Biotech Drug
2.2 The Power of Biopharmaceuticals: Turning Medicine around Therapeutically and Commercially
2.3 Biotechnologies and their Applications in Pharmaceutical Medicine
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 The Number of Biotech Patents Granted from 1990 Onwards
2.5 Proteomics Constitutes the Next Step after Genomics
2.6 The Human Genome Project (HGP) and its Influence on Biotechnology
2.6.1 Overall Project Goals
2.6.2 Applications and Future Developments of the HGP

3. The Global Pharmaceutical Biotech Market, 2010-2025
3.1 The Global Pharmaceutical Biotech Market in 2009
3.2 The Pharmaceutical Biotech Market Out-Performs the Overall Pharmaceutical Market
3.3 The Global Pharmaceutical Biotech Market Forecast, 2010-2025
3.4 The Leading Biotech Therapy Classes, 2010-2025
3.5 The Oncology Class will Have the Greatest Market Share, 2010 to 2025.
3.6 Blockbuster Biotech Drugs in 2009
3.7 Which Drugs Will Show the Greatest Increases in Market Share?

4. The Leading Biotech Therapy Classes, 2010-2025
4.1 The Top 10 Biotech Therapy Classes in 2009
4.2 The Oncology Class Currently Leads the Biotech Market
4.2.1 Long-Term Prospects for the Oncology Class, 2015-2025
4.3 Will the Insulins Class Exhibit Strong Growth?
4.4 Immunosuppressive Agents, 2010-2025
4.5 The Autoimmune Agents Class Will Show Initial Growth - Will it Last?
4.6 Erythropoietin Products - How Will Reported Safety Affect Sales?
4.6.1 Erythropoietin Products Forecast, 2010-2025
4.7 Immunostimulating Agents - Will These Show Increase in Growth?
4.8 The Interferons Class: Sales, 2010-2025
4.8.1 Long-Term Forecast for the Interferons Class
4.9 Pure Vaccines: Sales, 2010-2025
4.9.1 Will Pure Vaccines Sales Decline after 2015?
4.10 Blood Coagulation Factors - Will These Show Steady Growth?
4.11 Growth Hormones Forecast, 2010-2025
4.12 Chapter Summary: The Top 10 Biotech Therapy Classes, 2010-2025

5. The Leading Pharma Biotech Products, 2010-2025
5.1 The 10 Leading Biotech Drugs Accounted for 40% of the Global Pharma Biotech Market Sales in 2009
5.2 Enbrel (Etanercept)
5.2.1 Enbrel Currently Leads the Global Biotech Market
5.2.2 Enbrel Will Show an Initial Increase in Sales
5.2.3 Study Eases Fears of TNF Blocker Cancer Risk
5.2.4 New Enbrel Delivery System
5.2.5 Enbrel Lifecycle Management
5.2.6 Sales of Enbrel Will Eventually Decline
5.2.7 Enbrel faces Competition from Several Other Biotech Drugs
5.2.8 Competition from Biosimilar Enbrel
5.3 Remicade (Infliximab)
5.3.1 Remicade Will Reach Peak Revenues in 2013
5.3.2 Remicade Revenues Will Decline from 2013 Onwards
5.3.3 Remicade's Major Competitors
5.4 Avastin (Bevacizumab)
5.4.1 Avastin Will Show High Growth - But Will it Last?
5.4.2 New Avastin Drug Delivery Method for Treatment of Brain Tumours
5.5 MabThera/ Rituxan (Rituximab)
5.5.1 MabThera/Rituxan Market Forecast, 2010-2015
5.5.2 Long-Term Prospects for MabThera/Rituxan, 2015-2025
5.5.3 Competition for MabThera/Rituxan
5.5.4 Biosimilar MabThera/Rituxan
5.6 Humira (adalimumab)
5.6.1 Humira - 2009's Fastest Growing Biotech Drug
5.6.2 Humira Market Forecast, 2010-2015
5.6.3 Long-Term Prospects for Humira
5.7 Herceptin (Trastuzumab)
5.7.1 Short Term Forecast for Herceptin
5.7.2 Long Term Prospects for Herceptin
5.7.3 Herceptin Main Competitors, 2010-2025
5.8 Lantus (Insulin Glargine)
5.8.1 Lantus Will Show an Initial Increase in Sales
5.8.2 Will Lantus Sales Continue to Increase?
5.9 Neulasta (Pegfilgrastim)
5.9.1 Neulasta Sales Forecast, 2010-2025
5.10 Glivec (Imatinib)
5.10.1 Glivec Sales Forecast, 2010-2025
5.11 Epogen, Procrit (Epoetin Alfa)
5.11.1 Epogen Sales Forecast, 2010-2025
5.11.2 Epogen Safety and Efficacy
5.11.3 Competition for Epogen
5.12 Chapter Summary - The Top 10 Leading Biotech Products, 2010-2025

6. Leading Companies in the Pharma Biotech Market
6.1 The Top Ten Pharma Biotechnology Companies Globally
6.2 Amgen - The Leading Pharma Biotech Company
6.3 Other Leading Companies in the Biotech Market
6.4 Leading Pharma Companies - Biotech Mergers and Acquisitions
6.4.1 Roche and Genentech
6.5 The Continuing Success of Multinational Biopharmaceutical Companies is Dependent upon Important Drivers and Restraints
6.6 Companies are Changing their Strategic Focus to Overcome Challenges in the Worldwide Market

7. Issues Affecting the Pharma Biotech Sector
7.1 SWOT Analysis of the Global Pharma Biotech Sector
7.2 Market Drivers
7.3 Market Restraints
7.4 The Biotech Market is Rapidly Expanding
7.5 The Benefits of Biotechnological Drugs
7.6 Access to Capital
7.7 R&D in Biopharma
7.8 Regulatory Issues
7.8.1 Biopharmaceuticals and the FDA
7.8.2 FDA Approval Times
7.8.3 High Regulatory Hurdles and Elevated Costs of Developing Biologic Drugs will Play to Whose Advantage?
7.9 Biotech's Delivery Challenge
7.9.1 New Delivery Technologies: Pharmacy or Medical Benefit?
7.10 Increasing Capacity for Biotech Manufacturing
7.10.1 Manufacturing Capacity Shortfall?
7.11 The Costs of Biopharmaceuticals
7.12 Time Taken to Develop a Biotech Drug
7.13 Significant Future Biopharma Innovation will Result from Academia
7.14 The Risky Path from Bench to Market
7.15 Biogeneric Threats
7.15.1 Bioequivalence Requirements Will Restrict the Rate and Volume of Market Entry for Biosimilar Drugs
7.15.2 Healthcare Costs are Rising and Biotech Drugs form a Large Part of those Costs in Leading Nations
7.15.3 Can the Next Generation of Biotech Drugs Restrain Growth of the Biosimilars Sector?
7.16 Dependence upon Venture Capital Investment
7.17 Challenges and Issues for the Future Biotech Industry

8. Global Pharma Biotech Market by Region
8.1 The World Pharma Biotech Market is Dominated by the US
8.2 The Japanese, Latin American and European Biotech World Market Shares are set to Increase by 2015
8.3 The US Biotech Market Will Retain its World Dominance

9. The Pharma Biotech R&D Pipeline
9.1 Technology Driving Biotech Pipeline
9.2 The Late-Stage Biotech Oncology Pipeline
9.3 The Late-Stage Human Insulin Pipeline
9.4 The Late-Stage Immunosuppressive Agents Pipeline
9.5 The Late-Stage Autoimmune Agents Pipeline
9.6 The Late-Stage Erythropoietin Products Pipeline
9.7 The Late-Stage Immunostimulating Agents Pipeline
9.8 The Late-Stage Interferons Pipeline
9.9 The Late-Stage Pipeline for Pure Vaccines
9.10 The Late-Stage Pipeline for Blood Coagulation Factors
9.11 The Late-Stage Pipeline for Growth Hormones
9.12 The Future of Biotech R&D

10. Venture Capital Investment in Healthcare Biotechnology
10.1 What is Venture Capital Investment?
10.2 What Do VC's Offer?
10.3 What Do Venture Capitalists Do?
10.4 Who are Venture Capitalists for Healthcare?
10.4.1 Banks as Venture Capitalists
10.4.2 Business Angels as Venture Capitalists
10.4.3 Corporate or Direct Investors as Venture Capitalists
10.4.4 Government Grants and Governments as Venture Capitalists
10.4.5 Venture Capital Firms
10.4.6 Other Types of Venture Capitalist
10.5 Why Do Many Biotech Companies Need VC Funding?

11. Biosimilar Drugs
11.1 The Emergence of Biosimilars (Follow-on Biologics)
11.1.1 Patent Expiry for Key Biotech Drugs
11.1.2 Terms are Important
11.2 Improved Technology Has Strengthened the Case for Biosimilars
11.3 Bioequivalence Will Remain Challenging
11.4 Biotech Drugs are Expensive to Produce
11.5 Regulators and Patients are Cautious over Safety
11.6 The Next Generation of Biotech Drugs Will Restrain Growth in Biosimilars
11.7 Regulations are the Main Concern for Biosimilars
11.7.1 FDA Biogeneric/Biosimilar Approval Pathway?
11.8 The Key Question for Biosimilars

12. Conclusions
12.1 The Global Biotech Market: Summary
12.2 The Top 10 Biotech Products of 2009 Achieved Impressive Sales Results
12.3 Nine of the Current Top 10 Therapy Classes Will Show Growth in Future
12.4 Market Drivers
12.5 Market Restraints
12.6 Growth of the Biopharma Market Will Continue

List of Tables
Table 2.1 Definitions of Selected Biopharmaceuticals
Table 2.2 Summary of Biotechnologies, 2009
Table 3.1 Global Pharmaceutical Biotech Sales Forecast ($bn), 2010-2016
Table 3.2 Global Pharmaceutical Biotech Sales Forecast ($bn), 2017-2025
Table 3.3 Leading Biotech Therapy Classes Sales Forecast ($bn), 2010-2016
Table 3.4 Leading Biotech Therapy Classes Sales Forecast ($bn), 2017-2025
Table 3.5 Market Shares (%) of the Leading Therapeutic Classes, 2009, 2015 and 2025
Table 3.6 Leading Biotech Drugs Sales Forecast ($m), 2010-2016
Table 3.7 Leading Biotech Drugs Sales Forecast ($m), 2017-2025
Table 3.8 Market Shares (%) of the Top Ten Drugs, 2009, 2015 & 2025
Table 4.1 Oncology Class Sales Forecast ($bn), 2010-2016
Table 4.2 Oncology Class Sales Forecast ($bn), 2017-2025
Table 4.3 Human Insulins Class Sales Forecast ($bn), 2010-2016
Table 4.4 Human Insulins Class Sales Forecast ($bn), 2017-2025
Table 4.5 Immunosuppressive Agents Class Sales Forecast ($bn), 2010-2016
Table 4.6 Immunosuppressive Agents Class Sales Forecast ($bn), 2017-2025
Table 4.7 Autoimmune Agents Class Sales Forecast ($bn), 2010-2016
Table 4.8 Autoimmune Agents Class Sales Forecast ($bn), 2017-2025
Table 4.9 Erythropoietin Products Class Sales Forecast ($bn), 2010-2016
Table 4.10 Erythropoietin Products Class Sales Forecast ($bn), 2017-2025
Table 4.11 Immunostimulating Agents Class Sales Forecast ($bn), 2010-2016
Table 4.12 Immunostimulating Agents Class Sales Forecast ($bn), 2017-2025
Table 4.13 Interferons Class Sales Forecast ($bn), 2010-2016
Table 4.14 Interferons Class Sales Forecast ($bn), 2017-2025
Table 4.15 Pure Vaccines Class Sales Forecast ($bn), 2010-2016
Table 4.16 Pure Vaccines Class Sales Forecast ($bn), 2017-2025
Table 4.17 Blood Coagulation Factors Class Sales Forecast ($bn), 2010-2016
Table 4.18 Blood Coagulation Factors Class Sales Forecast ($bn), 2017-2025
Table 4.19 Growth Hormones Class Sales Forecast ($bn), 2010-2016
Table 4.20 Growth Hormones Class Sales Forecast ($bn), 2017-2025
Table 4.21 Top 10 Classes, Rank Comparison, 2009, 2015 & 2025
Table 5.1 Enbrel Sales Forecast ($m), 2009-2016
Table 5.2 Enbrel Sales Forecast ($m), 2017-2025
Table 5.3 Remicade Sales Forecast ($m), 2010-2016
Table 5.4 Remicade Sales Forecast ($m), 2017-2025
Table 5.5 Avastin Sales Forecast ($m), 2009-2016
Table 5.6 Avastin Sales Forecast ($m), 20017-2025
Table 5.7 MabThera/Rituxan Sales Forecast ($m), 2009-2016
Table 5.8 MabThera/Rituxan Sales Forecast ($m), 2017-2025
Table 5.9 Humira Sales Forecast ($m), 2009-2016
Table 5.10 Humira Sales Forecast ($m), 2017-2025
Table 5.11 Herceptin Sales Forecast ($m), 2009-2016
Table 5.12 Herceptin Sales Forecast ($m), 2017-2025
Table 5.13 Lantus Sales Forecast ($m), 2009-2016
Table 5.14 Lantus Sales Forecast ($m), 2017-2025
Table 5.15 Neulasta Sales Forecast ($m), 2009-2016
Table 5.16 Neulasta Sales Forecast ($m), 2017-2025
Table 5.17 Glivec Sales Forecast ($m), 2009-2016
Table 5.18 Glivec Sales Forecast ($m), 2017-2024
Table 5.19 Epogen Sales Forecast ($m), 2009-2016
Table 5.20 Epogen Sales Forecast ($m), 2017-2025
Table 5.21 Top 10 Products: Ranked Comparison, 2009, 2015 & 2025
Table 6.1 The Top 10 Biotech Companies: Revenues ($m) and Market Shares (%), 2008
Table 7.1 SWOT Analysis of the Global Pharma Biotech Market, 2010-2025
Table 8.1 Global Market Shares (%) & Revenues ($m) by Region/Country, 2009
Table 8.2 Pharma Biotech Sales Forecast ($m) by Country/Region, 2010-2016
Table 8.3 Pharma Biotech Sales Forecast ($m) by Country/Region, 2017-2025
Table 8.4 Market Shares (%) by Country/Region, 2009, 2015 & 2025
Table 9.1 The Late-Stage Oncology Pipeline, 2009
Table 9.2 The Late-Stage Human Insulins Pipeline, 2009
Table 9.3 The Late-Stage Immunosuppressive Agents Pipeline, 2009
Table 9.4 The Late-Stage Autoimmune Agents Pipeline, 2009
Table 9.5 The Late-Stage Erythropoietin Products Pipeline, 2009
Table 9.6 The Late-Stage Immunostimulating Agents Pipeline, 2009
Table 9.7 The Late-Stage Interferons Pipeline, 2009
Table 9.8 The Late-Stage Pipeline for Pure Vaccines, 2009
Table 9.9 The Late-Stage Pipeline for Blood Coagulation Factors, 2009
Table 9.10 The Late-Stage Pipeline for Growth Hormones, 2009

List of Figures
Figure 3.1 Global Pharmaceutical Biotech Sales Forecast ($bn), 2010-2025
Figure 3.2 Leading Biotech Therapy Classes (Sales in $m), 2010-2025
Figure 3.3 Market Shares (%) of the Leading Therapy Classes, 2009
Figure 3.4 Market Shares (%) of the Leading Therapy Classes, 2015
Figure 3.5 Market Shares (%) of the Leading Therapy Classes, 2025
Figure 3.6 Top 10 Biotech Drugs Market Shares (%), 2009
Figure 3.7 Top 10 Biotech Drugs Market Shares (%), 2015
Figure 3.8 Top Ten Biotech Drugs Market Shares (%), 2025
Figure 4.1 Oncology Class Sales Forecast ($bn), 2010-2025
Figure 4.2 Human Insulins Class Sales Forecast ($bn), 2010-2025
Figure 4.3 Immunosuppressive Agents Class Sales Forecast ($bn), 2010-2025
Figure 4.4 Autoimmune Agents Class Sales Forecast ($bn), 2010-2025
Figure 4.5 Erythropoietin Products Class Sales Forecast ($bn), 2010-2025
Figure 4.6 Immunostimulating Agents Class Sales Forecast ($bn), 2010-2025
Figure 4.7 Interferons Class Sales Forecast ($bn), 2010-2025
Figure 4.8 Pure Vaccines Class Sales Forecast ($bn), 2010-2025
Figure 4.9 Blood Coagulation Factors Class Sales Forecast ($bn), 2010-2025
Figure 4.10 Growth Hormones Class Sales Forecast ($bn), 2010-2025
Figure 4.11 Top Ten Therapy Classes Sales ($bn), 2009, 2015 & 2025
Figure 5.1 Enbrel Sales Forecast ($m), 2010-2025
Figure 5.2 Remicade Sales Forecast ($m), 2010-2025
Figure 5.3 Avastin Sales Forecast ($m), 2010-2025
Figure 5.4 MabThera/Rituxan Sales Forecast ($m), 2010-2025
Figure 5.5 Humira Sales Forecast ($m), 2010-2025
Figure 5.6 Herceptin Sales Forecast ($m), 2010-2025
Figure 5.7 Lantus Sales Forecast ($m), 2010-2025
Figure 5.8 Neulasta Sales Forecast ($m), 2010-2025
Figure 5.9 Glivec Sales Forecast ($m), 2010-2025
Figure 5.10 Epogen Sales Forecast ($m), 2010-2025
Figure 5.11 Top Ten Biotech Drugs Sales ($m), 2009, 2015 & 2025
Figure 6.1 The Top Ten Biotech Companies, Revenues ($m), 2008
Figure 6.2 The Top Ten Biotech Companies, Market Shares (%), 2008
Figure 8.1 Pharma Biotech Market Shares (%) by Country/Region, 2009
Figure 8.2 Pharma Biotech Market Shares (%) by Country/Region, 2015
Figure 8.3 Pharma Biotech Market Shares (%) by Country/Region, 2025