The Global Biotech Report 2006 - The rise of the Biotech blockbusters

Chapter 1: Executive Summary of World Biotech Market, 2006
1.1 Abstract of Biotech, 2006
1.2 Aims, Scope and Format of Biotech, 2006

Chapter 2: Introduction to Biotechnology
2.1 What is Biotechnology?
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 Biopharmaceutical 2004 Market Capitalisation Worth $311bn
2.4.2 Over 7000 Biotechnology Patents Granted Per Annum Since 1998
2.4.3 2004 Witnessed 54 New Biopharmaceuticals Approved by the FDA
2.4.4 Biopharmaceuticals Share 12.5% of 2004 Global Prescriptions

Chapter 3: Diseases Treated by Biopharmaceuticals
3.1 Biopharmaceuticals Are Versatile Agents
3.2 Orphan Diseases Are A Major Target of Biotech: 3 Out of 10 2004 Orphan Disease Drug Approvals Were Biopharmaceuticals
3.3 Overview of Major and Orphan Diseases Treated By Biopharmaceuticals, 2005

Chapter 4: Overview of Biopharmaceuticals Market, 2004-2005
4.1 Monoclonal Antibodies: Leading Class of Biopharmaceuticals in 2005 With Sales of $20bn
4.2 Biopharmaceuticals by Therapy Class: Blood Disorders Share Over A Quarter of the 2004 Biopharmaceuticals Market
4.3 2005 Biopharmaceuticals Market Worth a Staggering $59.5bn
4.4 The Top 20 Selling Biopharma Drugs of 2005 Accounted For 69% of Total Revenues
4.5 The Top 3 Biopharmaceuticals Products of 2005 Sold Over $17bn
4.5.1 MAbs Lead the Market
4.5.2 Procrit/Eprex - 2004's Number One Biologic - Loses Top Spot in 2005

Chapter 5: Biotech Company Revenues and Market Share, 2005
5.1 Amgen: The Reign Continues With A 17% Share of 2005 Market
5.1.1 Who Are Amgen?
5.2 The Strong Partnership Flourishes Between Roche and Genentech
5.3 Collaborative Projects Grew by 30%
5.4 Biotech Company Winners and Losers in 2005

Chapter 6: Biopharmaceutical Pipeline
6.1 Technology Driving Biopharma Pipeline
6.2 Biotech Targeting Chronic Illness
6.3 Arthritis Biopharmaceutical Pipeline, 2006
6.4 MS Biopharmaceutical Pipeline, 2006
6.5 Late-Stage Biopharmaceutical Oncology Pipeline, 2006
6.6 Late Stage Biopharmaceutical Vaccine Pipeline, 2006
6.7 Blood Disorders Biopharmaceutical Pipeline, 2006
6.8 Late Stage Biopharmaceutical Endocrine Pipeline, 2006
6.9 Anti-Infectives Biopharmaceutical Pipeline, 2006 6.10 Enzyme Deficency Biopharmaceutical Pipeline, 2006
6.11 Late Stage Biopharmaceutical Opthalmic Pipeline, 2006
6.12 Late Stage Biopharmaceutical 'Other' Pipeline, 2006 Chapter 7: Biopharmaceutical Market Forecast by Therapeutic Area, 2005-2011
7.1 Blood Disorders
7.2 Endocrine Disorders
7.3 Multiple Sclerosis
7.4 Oncology
7.5 Hepatitis Treatments (inferon alpha)
7.6 Enzyme Deficiency Disorders
7.7 Vaccines
7.8 Arthritis
7.9 Others
7.10 Biopharmaceutical Market Set To Almost Double by 2011

Chapter 8: Summary of the 2011 Biopharmaceuticals Market
8.1 Enbrel Will Continue to Lead the World Biotech Market
8.2 Blood Disorders Will Remain Market Leaders

Chapter 9: Introduction to Biogenerics
9.1 The Emergence of Biogenerics
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

Chapter 10: The Potential Biogeneric Market
10.1 $11bn of Biopharmaceuticals To Lose Patent Protection By 2007
10.2 High-Revenue Generating Biopharmaceuticals Face Patent Expiry
10.3 Erythropoetins are the Most Attractive Target for Biogenerics
10.4.1 The Regulatory Authorities Will Require Extensive Data for EPO
10.4 Interferons are Going to Face High Competition from Biogenerics

Chapter 11: Biopharmaceutical Market Challenges
11.1 BioTech's Delivery Challenge
11.1.1 Pulmonary Delivery: An Innovative Alternative to the Needle?
11.1.2 The Major Issues of the Pulmonary Pathway
11.1.3 Does Protein Formulation Affect Pulmonary Delivery?
11.1.4 Does Pulmonary Drug Delivery Have a Future?
11.1.5 Pegylated Forms Set to Revolutionise Delivery
11.1.6 Pegylation Can Extend Patent Protection - The Case of Filgrastim
11.1.7 Transdermal Technologies
11.1.8 Microneedles for Transdermal Delivery of Vaccines
11.1.9 Nasal Delivery Is Demonstrating Promise 11.1.10 Moving Towards Pills - Altus' Unique Technology
11.1.11 New Delivery Technologies: A Pharmacy or Medical Benefit?
11.1.12 Innovative Insulin Delivery Technology: The Race is On
11.1.13 Numerous Potential Blockbusting NonInjected Insulins Set to Arrive 2005-2009
11.2 Manufacturing Capacity Shortfall
11.2.1 Why is There a Shortfall in Manufacturing Capacity for Biopharmaceuticals?
11.2.2 Make Vs. Buy: The 1980s BioIndustry
11.2.3 CMO Manufacturing Capacity was Adequate for the Supply of Clinical Materials Only
11.2.4 Late-Stage Products have absorbed CMO Clinical Manufacturing Capacity
11.2.5 How is the Manufacturing Capacity Shortfall Being Overcome?
11.2.6 Does The Future for Biopharmaceutical Manufacturing Lie with Transgenics?
11.3 The Cost of Biopharmaceutical
11.3.1 The Top Five Biopharmaceuticals Each Cost at Least $10K Per Patient Per Annum
11.3.2 Monoclonal Antibodies and CSF's High Costs Reflect Production Difficulties
11.3.3 Yeast-Based Systems May Bring Down the Cost of Therapeutic Proteins in the Future
11.4 Acquiring Capital
11.4.1 Financing of Biotech Companies in 2003 Approached $17bn
11.5 Reliance Upon University/Company Collaborations
11.5.1 The Need For Collaboration
11.5.2 Biotech's Increasing Role of Commercialising University Research
11.5.3 Future Biotech Innovation Lies With Academia
11.5.4 The Risky Path from Bench to Market
11.5.5 Collaboration Strategies & Becoming the Partner of Choice
11.5.5.1 Objectives That Support Strategic Goals
11.5.5.2 Understanding the Value Brought to an Alliance
11.5.5.3 Identifying and Understanding Potential Partners
11.5.5.4 Due Diligence
11.5.5.5 Promoting Capabilities to Potential Partners
11.5.5.6 Maintaining a Relationship Through Structured Interactions
11.5.5.7 Gaining Competitive Advantage
11.5.5.8 Collaboration Management: Developing and Maintaining A Deal
11.5.5.9 Strategic Goals to Consider
11.6 Regulatory Issues
11.6.1 Biopharmaceuticals and the FDA
11.6.2 FDA Improving Upon Biologics Approval Wait
11.7 Biogeneric Threat
11.8 Dependence upon Venture Capital Investment
11.9 Drivers and Restraints of Biopharmaceutical Market Growth
11.9.1 Drivers
11.9.2 Restraints

Chapter 12: Venture Capital Investment & Biotech
12.1 What is Venture Capital Investment?
12.2 What does VC Offer?
12.3 What Do Venture Capitalists Do?
12.4 Who Are Venture Capitalists?
12.4.1 Banks as Venture Capitalists
12.4.2 Business Angels (Wealthy Individuals) as Venture Capitalists
12.4.3 Corporate or Direct Investors as Venture Capitalists
12.4.4 Government Grants and Governments as Venture Capitalists
12.4.5 Venture Capital Firms
12.4.6 Other Types of Venture Capitalist
12.5 Why Do Biotech Companies Need VC Funding?
12.6 Venture Capital Investment in the US Biotech Market
12.6.1 US VC Investment Now Recovering Following Stockmarket Crash in 2000
12.6.2 329 US Biotech VC Investments Made in 2004, Providing Over $3.8bn
12.6.3 Synta Provides 2004's Largest US Investment Sum With $80m
12.6.4 MPM Capital 2004's Most Active US Biotech VC Firm
12.6.5 Company Expansion Stage is the Most Favourable for VC Investment
12.7 Increase in VC Funding of European Biotech
12.8 PE European Investments in Biotech Followed Similar Trends as in the US
12.9 European PE Biotech Investments are a Small part of the Funding Market

Chapter 13: The Global Biopharmaceutical Market by Country and Region, 2004-2011
13.1 The World Biopharmaceutical Market is Dominated by the US
13.2 Both the Japanese and European Biotech World Market Share Set to Fall by 2011
13.3 The US Biotech Market Will Retain Its World Dominance
13.4 The European Biotech Market Will See Reduced Growth
13.5 European Biotech Industry Faces VC Funding Drop
13.6 Price Cuts in Japanese Biotech Market
13.7 Asia-Pacific Region: A Dormant Giant?
13.8 Biotech Industries in the Asia-Pacific Region are Growing Rapidly
13.9 China has the Most Biotech Companies in the Asia-Pacific region
13.10 Other World Markets
13.10.1 Russia Will See Growth in Biopharma Generics
13.10.2 Israel is and Area of Biotech Industry More than Market for Biotech Drugs

Chapter 14: The Human Genome Project and Its Influence on the Biotech Industry

14.1 Overall Project Goals
14.2 The Findings of the HGP:
14.2.1 Gene Numbers
14.2.2 Protein Coding
14.2.3 Nucleotide Sequencing
14.2.4 Gene Distribution
14.2.5 Variations and Mutations
14.3 Applications and Future Developments of the HGP

Chapter 15 - Conclusions: Biotech Comes of Age
15.1 Big Pharma Sees Biotech as an Opportunity
15.2 Biotech's Major Challenges: Biogenerics and Budget Restraints

List of Tables and Figures:

Table 2.1 Definitions of Selected Biopharmaceuticals
Table 2.2 Summary of Biotechnologies
Table 3.1 Orphan Disease Biopharmaceuticals Approved By the FDA in 2004
Table 3.2 Overview to Major Diseases and Selected Orphan Diseases Treated by Biopharmaceuticals, 2005
Table 4.1 Biopharmaceuticals Revenue ($m) by Technology Class, 2005
Table 4.2 Monoclonal Antibody Products Growth Rates (%), 2005
Table 4.3 Biopharmaceuticals Revenues ($m) by Therapeutic Areas, 2005
Table 4.4 Blood Modifiers by Revenue ($m), 2005
Table 4.5 Biopharmaceutical Revenues ($m) in 2005 Top 400 by Drug Type, 2005
Table 4.6 Top 20 Selling ($m) Biopharmaceuticals, 2005
Table 5.1 Biotech Company Revenues ($m), 2004 & 2005, and 2005 Company Market Share (%)
Table 5.2 Amgen's Product Portfolio By Revenue ($m), 2005
Table 5.3 Amgen Total Revenue ($bn), 2002-2005
Table 5.4 Roche/Genentech Biopharmaceutical Portfolios By Revenue ($m), 2004 and 2005
Table 5.5 Revenues ($m) and Growth Rates (%) for Collaborative Biotech Projects, 2004-2005
Table 5.6 Revenues ($m) and Growth Rates (%) for Novo Nordisk Collaborative Biotech Projects, 2004-2005
Table 5.7 Wyeth's Product Portfolio By Revenue ($m), 2005
Table 6.1 Overview of Biotech Pipeline By Biotechnology Type, 2006
Table 6.2 Arthritis Biopharmaceutical Pipeline, 2006
Table 6.3 MS Biopharmaceutical Pipeline, 2006
Table 6.4 Late Stage Biopharmaceutical Oncology Pipelines 2006
Table 6.5 Late Stage Biopharmaceutical Vaccine Pipeline, 2006
Table 6.6 Blood Disorders Biopharmaceuticals Pipeline, 2006
Table 6.7 Late-Stage Biopharmaceutical Endocrine Pipeline, 2006
Table 6.8 Anti-Infective Biopharmaceutical Pipeline, 2006
Table 6.9 Enzyme Deficency Disorder Biopharmaceutical Pipeline, 2006
Table 6.10 Late-Stage Biopharmaceutical Ophthalmic Pipeline, 2006
Table 6.11 Late-Stage Biopharmaceutical Others Pipeline, 2006
Table 7.1 The Biopharmaceutical Treatment of Blood Disorder by Revenue ($m), 2004 and 2005
Table 7.2 Total World Biopharmaceutical Blood Disorder Market Forecast ($m), 2004-2011
Table 7.3 World Endocrine Biopharmaceutical by Revenue ($m), 2004 and 2005
Table 7.4 Total World Biopharmaceutical Endocrine Market Forecast ($m), 2004-2011
Table 7.5 Multiple Sclerosis Biopharmaceutical by Revenue ($m), 2004 and 2005
Table 7.6 Total World Biopharmaceutical Multiple Sclerosis Market Forecast ($m), 2004-2011
Table 7.7 Oncology Biopharmaceutical by Revenue ($m), 2004 and 2005
Table 7.8 Total World Biopharmaceutical Oncology Market Forecast ($m), 2004-2011
Table 7.9 Hepatitis Biopharmaceutical by Revenue ($m), 2004 and 2005
Table 7.10 Total World Biopharmaceutical Hepatitis Market Forecast ($m), 2004-2011
Table 7.11 Enzyme Replacement Biopharmaceutical by Revenue ($m), 2004 and 2005
Table 7.12 Total World Biopharmaceutical Enzyme Replacement Market Forecast ($m), 2004-2011
Table 7.13 Vaccine Biologics by Revenue ($m), 2004 and 2005
Table 7.14 Total World Biopharmaceutical Vaccine Market Forecast ($m), 2004-2011
Table 7.15 Arthritis Biopharmaceuticals Revenue ($m), 2004 and 2005
Table 7.16 Total World Biopharmaceutical Arthritis Market Forecast ($m), 2004-2011
Table 7.17 Other Biopharmaceuticals by Revenue ($m), 2005 and 2004
Table 7.18 Total World Biopharmaceutical Other Market Forecast ($m), 2004-2011
Table 7.19 Total Global Biopharmaceutical Market Revenue ($m) Forecast 2004-2011
Table 8.1 Top 10 Selling Biopharmaceuticals, 2011
Table 8.2 Total Global Biopharmaceutical Market Revenue ($bn) Forecast by Therapeutic Class, 2004-2011
Table 8.3 World Revenues ($bn) of Biopharmaceuticals By Therapeutic Class, 2005 & 2011Comparison
Table 8.4 Market Share (%) of Biopharmaceuticals By Therapeutic Class, 2004 & 2011 Comparison
Table 8.5 Biopharmaceuticals CAGR (%) By Therapeutic Class, 2004-2011
Table 10.1 Biopharmaceuticals facing patency expiry by 2007
Table 10.2 Revenue ($m) Forecast (2004-2011) of 6 High Profile Biopharmaceuticals Facing Patent Expiry Before 2007
Table 11.1 Mode of Administration of 2005's Top 5 Biopharmaceuticals
Table 11.2 Expected Blockbuster Noninjected Insulins From 2005
Table 11.3 Total European IPOs by Country, 2003 Table
12.1 US and European VC Investment ($m) Into Biotech Companies, 1997-2003
Table 12.2 Total US VC Investment ($bn), 1994-2004 Table 12.3US Biotech Venture Capital Investments By, 2003 vs. 2004
Table 12.4 Number of US Biotech Venture Capital Investments By Quarter, 2003 vs 2004
Table 12.5 Top 5 Largest US Biotech Investments ($m) by Company, 2004
Table 12.6 Most Active US Biotech Venture Capital Firms of 2004
Table 12.7 US VC Investments by Company Stage, 2003-2004
Table 12.8 PE European Investments ($m) in Biotech, 1997-2003
Table 13.1 Total Global Biopharmaceutical Market Revenue ($m) Forecast, 2004-2011
Table 13.2 Global Market Share (%) and Revenue ($bn) by Country/Region, 2005
Table 13.3 Global Market Share (%) and Revenue ($bn) by Country/Region, 2011
Table 13.4 US Biotech Market Revenue ($bn) Forecast, 2004-2011
Table 13.5 EU Biotech Market Revenue ($bn) Forecast, 2004-2011
Table 13.6 Asia-Pacific Biotech Market Revenue ($bn) Forecast, 2003-2010
Table 15.1Big Pharma Companies with Leading Biotech Drugs, 2005

Figure 2.1 Biopharmaceutical Market Capitalisation ($bn), 1994-2004
Figure 2.2 Total Number of Biotechnology Patents Granted: 1992-2002
Figure 2.3 Number of New Biopharmaceutical FDA Approvals: 1994-2004
Figure 2.4 Biopharmaceuticals Share of Global Prescriptions Market 1999-2004
Figure 4.1 Biopharmaceutical Market Share (%) by Class, 2005
Figure 4.2 Global Sales ($m) of Biopharmaceuticals by Technology Class, 2005
Figure 4.3 Global Sales ($m) of Biopharmaceuticals by Therapeutic Area, 2004 & 2005
Figure 4.4 Biopharmaceutical Market Share (%) by Therapeutic Class, 2005
Figure 4.5 Top 20 Selling Biopharmaceuticals Share (%) of Total Biopharmaceuticals Market
Figure 4.6 Top 20 Selling Biopharmaceuticals ($m), 2005
Figure 4.7 Global Biotech Market Share (%) for the Top 5 Selling Biopharmaceuticals, 2005
Figure 4.8 Total Revenue ($m) for Enbrel, 2002-2005
Figure 4.9 Total Revenue ($m) for Remicade, 2002-2005
Figure 4.10 Total Revenue ($m) for Rituxan/MabThera, 2002-2005
Figure 4.11 Global Procrit/Eprex Sales ($m), 2002-2005
Figure 4.12 Global Epogen Sales ($m), 2002-2005
Figure 4.13 Global Aranesp Sales ($m), 2002-2005
Figure 5.1 Company Revenues from Leading Biotech Drugs ($m), 2004 & 2005
Figure 5.2 Amgen Company Revenue ($bn), 2002-2005
Figure 5.3 Amgen Growth of Revenue (%), 2002-2004
Figure 5.4 Revenues ($m) from leading Genentech Products, 2004 and 2005
Figure 5.5 Genentech Revenues ($m), 2002-2005
Figure 5.6 Company Growth (%) in Revenue, 2004-2005
Figure 5.7 Biotech Company Market Share (%), 2005
Figure 6.1 Biopharmaceutical Pipeline by Biotechnology Type, 2005
Figure 6.2 Duration of Therapies of Biotech Pipeline Products in Late- Stage Development, 2003
Figure 6.3 Pipeline share (%) of Biopharmaceuticals Duration of Therapy, 2003
Figure 7.1 Total World Biopharmaceutical Blood Disorder Market Forecast ($m), 2004-2011
Figure 7.2 Total World Biopharmaceutical Blood Disorder Market Revenue Growth Forecast (%), 2004-2011
Figure 7.3 Total World Biopharmaceutical Endocrine Market Forecast ($bn), 2004-2011
Figure 7.4 Total World Biopharmaceutical Endocrine Market Revenue Growth Forecast (%), 2004-2011
Figure 7.5 Total World Biopharmaceutical Multiple Sclerosis Market Forecast ($bn), 2004-2011
Figure 7.6 Total World Biopharmaceutical Multiple Sclerosis Market Revenue Growth Forecast (%), 2004-2011
Figure 7.7 Total World Biopharmaceutical Oncology Market Forecast ($m), 2004-2011
Figure 7.8 Total World Biopharmaceutical Oncology Market Revenue Growth Forecast (%), 2004-2011
Figure 7.9 Total World Biopharmaceutical Hepatitis Market Forecast ($m), 2004-2011
Figure 7.10 Total World Biopharmaceutical Hepatitis Market Revenue Growth Forecast (%), 2004-2011
Figure 7.11 Total World Biopharmaceutical Enzyme Replacement Market Forecast ($m), 2004-2011
Figure 7.12 Total World Biopharmaceutical Enzyme Replacement Market Revenue Growth Forecast (%), 2004-2011
Figure 7.13 Total World Biopharmaceutical Vaccine Market Forecast ($m), 2004-2011
Figure 7.14 Total World Biopharmaceutical Vaccine Market Revenue Growth Forecast (%), 2004-2010
Figure 7.15 Total World Biopharmaceutical Arthritis Market Forecast ($m), 2004-2011
Figure 7.16 Total World Biopharmaceutical Arthritis Market Revenue Growth Forecast (%), 2004-2011
Figure 7.17 Total World Biopharmaceutical Other Market Forecast ($bn), 2004-2011
Figure 7.18 Total World Biopharmaceutical Other Market Revenue Growth Forecast (%), 2005-2011
Figure 7.19 Total Global Biopharmaceutical Market Revenue ($bn) Forecast 2004-2011
Figure 7.20 Total Global Biopharmaceutical Market Revenue Growth (%), 2005-2011
Figure 8.1 Top-10 Selling Biopharmaceuticals of 2011 ($m)
Figure 8.2 Market Share of the Top-10 Selling Biopharmaceuticals (%), 2011
Figure 8.3 Biopharmaceutical Therapeutic Class Market Share (%), 2005
Figure 8.4 Biopharmaceutical Therapeutic Class Market Share (%), 2011
Figure 8.5