THE WORLD BIOTECH MARKET REPORT 2005

Chapter 1: Executive Summary of World Biotech Market, 2005

1.1 Abstract of Biotech, 2005

1.2 Aims, Scope and Format of Biotech, 2005

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 Capatilisation 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, 2003-2004

4.1 Monoclonal Antibodies: Leading Class of Biopharmaceuticals in 2004 With Sales of $13bn

4.2 Biopharmceuticals by Therapy Class: Blood Disorders Share Over A Quarter of the 2004 Biopharmaceuticals Market

4.3 2004 Biopharmaceuticals Market Worth a Staggering $55.7bn

4.4 The Top 20 Selling Biopharma Drugs of 2004 Accounted For 62% of Total Revenues

4.5 The Top 3 Biopharmaceuticals Products of 2004 Sold Over $9bn

4.5.1 Procrit/Eprex - The Number One Biopharmaceutical Struggles at the Top

4.5.2 Risperdal Performs Well Thanks to New Delivery Technology

4.5.3 Epogen: The Third Best Selling BiopharmDrug of 2004

4.6 Santura: The Highest Earning Newcomer of 2004

Chapter 5: Company Revenues and Market Share, 2004

5.1 Amgen: The Reign Continues With A 17% Share of 2004 Market

5.1.1 Who Are Amgen?

5.2 Biotech Company Winners and Losers in 2004: Abbott, Sanofi-Aventis and Roche

5.3 BMS: The Best Company Newcomer of 2004

5.4 Biotech Companies Show High Growth Rates

Chapter 6: Biopharmaceutical Pipeline

6.1 Technology Driving Biopharma Pipeline

6.2 Biotech Targeting Chronic Illness

6.3 Arthritis Biopharmaceutical Pipeline, 2005

6.4 MS Biopharmaceutical Pipeline, 2005

6.5 Late-Stage Biopharmaceutical Oncology Pipeline, 2005

6.6 Late StageBiopharmaceutical Vaccine Pipeline, 2005

6.7 Blood Disorders Biopharmaceutical Pipeline, 2005

6.8 Late Stage Biopharmaceutical Endocrine Pipeline, 2005

6.9 Anti-Infectives Biopharmaceutical Pipeline, 2005

6.10 Enzyme Deficency Biopharmaceutical Pipeline, 2005

6.11 Late Stage Biopharmaceutical Opthalmic Pipeline, 2005

6.12 Late Stage Biopharmaceutical Other Pipeline, 2005

Chapter 7: Biopharmaceutical Market Forecast by Therapeutic Area, 2003-2010

7.1 Blood Disorders

7.2 Endocrine Disorders

7.3 Multiple Sclerosis

7.4 Oncology

7.5 Anti Infectives

7.6 Enzyme Deficiency Disorders

7.7 Vaccines

7.8 Arthritis

7.9 Opthalmics

7.10 Others

7.11 Biopharmaceutical Market Set To Almost Triple By 2010

Chapter 8: Summary of 2010 Biopharmaceuticals Market

8.1 Aransep: The Top Selling Biopharmaceutical of 2010 With Sales of $5.2bn

8.2 Blood Disorders Will Reamain Market Leaders

8.3 Ophthalmic Biopharmaceuticals: The Fastest Growing Therapeutic Class 2003-2010

8.4 By 2010 Biopharmaceuticals Will Account for Over 17% of All Drug Prescriptions

Chapter 9: Introduction to Biogenerics

9.1 What are Biogenerics?

9.2 The Biogeneric Threat Looms Large

9.3 All Change in 2003: CDER to CBER

9.4 How are Approval Pathways Limiting the Development of Biogenerics?

9.5 Omnitrope Approved in Australia, Will Europe and the US Follow?

9.6 High Cost of Market Entry

9.7 Manufacturing Capacity Problems

9.8 Biopharma Vs Biogenerics: The Fight Continues

9.8.1 Bioequivalence or Biosimilarity?

9.9 Will the Benefits of Biogenerics be as Great as Anticipated?

9.10 How Imminent is the Threat from Biogeneric Competition?

Chapter 10: The Potential Biogeneric Market

10.1 $13bn of Biopharmaceuticals To Lose Patency Protection By 2007

10.2 Eleven Biopharmaceuticals to Face Patent Expiry by 2007

10.3 High-Revenue Generating Biopharmaceuticals Face Patent Expiry Before 2007

10.4 High-Profile Biopharmaceuticals With Patent Expirations Before 2007 Revenue Forecast, 2003-2010

10.5 Erythropoiteins Are Most At Risk To Biogeneric Competition

Chapter 11: Biopharmaceutical Market Challenges

11.1 BioTechs 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 Patencies! The Filgrastim Example

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 Biopharmaceuitcal Manufacturing Lie with Transgenics?

11.3 The Cost of Biopharmaceuticals

11.3.1 The Top Five Biopharmaceuticals Each Cost at Least $10K Per Patient Per Annum

11.3.2 Monoclonal Antibodies and CSFs 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 Neared $17bn

11.5 Reliance Upon University/Company Collaborations

11.5.1 The Need For Collaboration

11.5.2 Biotechs 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 Maintain 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 Capitalists

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 2004s Largest US Investment Sum With $80m

12.6.4 MPM Capital 2004s 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 Region, 2003-2010

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 2010
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 a Market for Biotech Drugs

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

14.1 Applications and Future Developments of the HGP

Chapter 15: Conclusion: Big Pharma Must Invest into the Biotech Arena

15.1 Conclusion