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

Table of Contents

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