The Protein Therapeutics Market: The Science and Business of a Growing Sector

Table of Contents

Chapter One: Executive Summary

• Background
• Size of the Market and Growth
• Geographical Distribution
• Leading Market Segments
• Leading Products
• Leading Players
• Key Industry Drivers
  • Strong Product Innovation
  • Lower Generic Threat
  • Better Pricing Power
  • Access to Capital
• Conclusions
• Scope And Methodology

CHAPTER TWO: Science as Value Creator

• Background
• Protein Synthesis
• Protein Glycosylation
• Proteins and their Types
• Therapeutic Proteins
  • Monoclonal Antibodies
  • Monoclonal Antibodies: Structures
  • Monoclonal Antibodies: Types
  • Erythropoietin
  • Glycosylated Erythropoietin
  • Insulin
  • Animal Source Insulin
  • Recombinant Technology Insulin
  • Inhaled Insulin
  • Cytokines
  • Interleukins
  • Interferons
  • Interferon Types
  • Therapeutic Uses of Interferons
  • Interferon Drug Names
  • Basic features of Key Interferons
  • Keratinocyte Growth Factor
  • Granulocyte-Colony Stimulating Factor
  • Growth Hormones
  • Somatotropin
  • Somatomedins (IGF)
  • Blood Factors
  • Enzyme Therapy
  • Glucocerebrosidase Enzyme Deficiency
  • Ceredase (Alglucerase injection)
  • Cerezyme (Imiglucerase for injection)
  • Bone Repair Proteins
  • Recombinant BMP
  • Reproductive Hormones
  • Luteinizing Hormone
  • Follicle-Stimulating Hormone
  • Human Chorionic Gonadotropin
  • Progestrone and Estrogen
  • Tissue Plasminogen Activators
  • Heart Attack
  • Stroke
  • Therapy Risks
  • Stem Cell Therapy
  • Challenges
  • Applications

CHAPTER THREE: Strategic Perspectives

• Background
  • High Entry Barrier
  • Low Threat of Substitutes
  • Niche Market
  • Low Bargaining Power of Buyers
• Research and Development Dynamics
  • Geographical Trends
  • Biological Agents in Clinical Trials
  • Current Challenges in R&D
  • Innovation Gaps in Drug sector
  • High R&D Costs
  • Low Probability of Success for Small Molecule Drugs
  • Biotechnology Innovation
  • Biological NCE Approval Rates
  • Approval Success Rates of Various Technological Classes
• Strategies to Enhance R&D Productivity for Biotechnology Firms
  • FDA Strategies
  • Communications
  • Fast Track Status Designation
  • Priority Review
  • Accelerated Approval
  • FDA Initiatives to Increase Industry R&D Productivity-Critical Path Initiative
  • R&D Process Improvisation Initiatives
  • Focus on Genomics, Proteomics, Toxicogenomics
  • Focus on Systems Biology
  • Current and Proposed Pre-Clinical Model
  • Current and Proposed Clinical Research
  • Clinical Trial Management: Strategic Options
  • Out-licensing
  • Internal Clinical Development
  • Clinical Outsourcing
  • Partnership Model
• Government Grants/Funds for Research and Development
  • CRADA
  • A Clinical Trial CRADA
• Manufacturing Dynamics
  • Protein Manufacturing Challenges
  • Supply Issues
  • Cost Issues
  • Protein Production
  • Microbial Cell Lines
  • Transgenic Plants
  • Animal Cell Cultures
  • Transgenic Animals
  • New Directions in Protein Manufacturing
  • Manufacturing Technology Platforms
  • Alternative Production Mediums
• Competitive Dynamics
  • Biosimilars
  • Pricing and Reimbursement
• Mergers, Acquisitions, Collaborations and Deal Dynamics
  • Deal Valuations and Trends
  • Mergers and Acquisitions
  • Deal Structures
  • Pharma-Biotech M&A
  • Biotech-Biotech M&A
  • Licensing and Alliances
• Industry Fundamentals and Valuations
  • Negative Drivers of Valuation
  • Industry Capital Sources
  • Public Sources
  • Private Sources
  • Total Sources
  • IPO financing
  • Venture Capital Financing
• Financial Performance

CHAPTER FOUR: Commercial Perspectives

• Industry Background
  • Initial Era (1970s)
  • Early Commercial Era (1980s)
  • 1990s
  • Early 2000s
• Commercial Outlook
  • Market Size and Growth
  • Geographical Distribution
  • Therapeutic Segmentation
  • Leading Protein Products
  • Leading Players
  • Future Market Size and Growth
• Market Segment Analysis
  • Monoclonal Antibody Market
  • Erythropoietin Market
  • Insulin Market
  • Interferon Market
  • Growth Factors Market
  • Interleukin Market
  • Blood Clotting Factors Market
  • Tissue Plasminogen Activator Market
  • Human Growth Hormone Market
  • Reproductive Hormones Market
  • Recombinant BMP-2 Market
  • Enzyme Replacement Market
  • Other Replacement Enzymes Market

CHAPTER FIVE: Company Profiles

• Amgen, Inc.
  • Background
  • Marketed Products
  • Research and Development
• Amylin Pharmaceuticals, Inc.
  • Background
  • Research and Development Expertise
  • Collaborations
• Biogen Idec
  • Background
  • Marketed Products
• BioMarin Pharmaceutical Inc.
  • Background
  • Marketed Products
  • Product Pipeline
• Chiron Corporation
  • Background
  • Marketed Products
  • Product Pipeline
• Cell Genesys, Inc.
  • Background
  • Product Platforms
  • Oncolytic Virus Therapies
• Coley Pharmaceutical Group
  • Background
  • Product Pipeline
• Dendreon Corporation
• Enzon
• Genentech, Inc.
  • Background
  • Marketed Products
• Genzyme Corp.
  • Background
  • Marketed Products
  • Human Genome Sciences
    • Background
    • Product Pipeline
  • OSI Pharmaceuticals, Inc
    • Background
    • Marketed Products
    • Product Pipeline
  • MedImmune
    • Background
    • Product Pipeline
  • PDL Biopharma
    • Background
    • Collaborations
  • Raven Biotechnologies, Inc.
    • Background
    • Discover Platform
    • Product Pipeline
  • Serono International S.A.
    • Background
    • Product Pipeline
    • Marketed Products
  • Seattle Genetics, Inc.
    • Background
    • Product Pipeline
    • Technology
  • Vernalis Pharmaceuticals Inc
    • Background
    • Product Pipeline
  • Wyeth
    • Background
    • Marketed Products
    • Product Pipeline
  • Xoma
    • Background
    • Technology
    • Licensees

List of Exhibits

Chapter One: Executive Summary

• Exhibit 1: Market Summary: Protein Therapeutics Market 2001-2005
• Exhibit 2: Market Summary: Protein Therapeutics Market to 2010
• Exhibit 3: Protein Therapeutics Revenue Distribution by Geography 2005
• Exhibit 4: Protein Therapeutics Sales by Drug Class 2005
• Exhibit 5: Sales and Growth of Top Ten Protein Therapeutics 2005
• Exhibit 6: Revenues, Growth, and Market Share of Top Ten Protein Therapeutics Suppliers 2004
• Exhibit 7: Protein Therapeutic Product Approvals (U.S.) 1996-2005
• Exhibit 8: Amount of Protein Therapeutics Capital Sources (U.S.) Financing and Partnering 1999-2005

CHAPTER TWO: Science as Value Creator

• Exhibit 9: Steps in Protein Synthesis
• Exhibit 10: Monoclonal Antibodies Used by Type (Chimeric, Murine, Humanized, Human) 2005
• Exhibit 11: Classification of Commercial Monoclonal Antibody Products by Type
• Exhibit 12: Commercially Available Insulins in the United States (Classification, Source, Brand, Manufacturer, Preparation)
• Exhibit 13: Types of Cytokines (Name, Principal Source, Primary Activity)

CHAPTER THREE: Strategic Perspectives

• Exhibit 14: Worldwide Biotechnology R&D Spending Distribution by Region 2005
• Exhibit 15: Worldwide Biotechnology R&D Investment Trends by Region 2003-2005
• Exhibit 16: Number of Biological Product Clinical Trials in the United States by Development Phase (Phase I through Filing) 2002-2006
• Exhibit 17: U.S. Pharmaceutical Industry R&D Spending and NME Approvals 1992-2005
• Exhibit 18: Total U.S. Drug Approvals (Priority vs Standard) 1984-2004
• Exhibit 19: Biotechnology Patents Issued in the United States 1989-2002
• Exhibit 20: Biotechnology Product Approvals in the United States 1996-2005
• Exhibit 21: U.S. Product Approval Rates by Class (Chimeric mAb, rDNA, Synthetic Peptide, NCE) and Therapy Type (Antineoplastic, Immunological, Endocrine) 1984-2004
• Exhibit 22: Current Pre-Clinical Research Model
• Exhibit 23: New Pre-Clinical Research Model
• Exhibit 24: Clinical Research Model
• Exhibit 25: New Clinical Research Model
• Exhibit 26: Big Pharma-Biotech Deal Trends Value of Deals Each Year in Millions of U.S. Dollars 1993-2005
• Exhibit 27: Leading Protein Therapeutic Deals by Dollar Value 2005
• Exhibit 28: Leading Protein Therapeutic M & A Transactions in the United States 2005
• Exhibit 29: Biotech Market Capitalization by Region 2003-2005
• Exhibit 30: U.S. Biotech Market Capitalization Trends 1994-2005
• Exhibit 31: U.S. Biotech Sector Financing by Type (Public Offering, Venture Funding, Other) 2005
• Exhibit 32: U.S. Biotech Public Funding by Type (IPOs, Follow-Ups, PIPEs, Debt) 1999-2005
• Exhibit 33: U.S. Biotech Private Funding by Type (Venture Capital, Other) 1999-2005
• Exhibit 34: Total Capital Sources for the U.S. Biotech Industry by Type (Financing, Partnering) 1999-2005
• Exhibit 35: U.S. Biotechnology Sector Initial Public Offerings (Number, Amount Raised, Performance Since IPO) 2003-2005
• Exhibit 36: Venture Capital Investments in U.S. Biotech as a Percentage of Total Venture Capital Investments 1999-2004
• Exhibit 37: Biotechnology Industry Financial Snapshot Revenues, R&D Spending, Number of Employees, Number of Public Companies, Number of Private Companies) by Region 2005

CHAPTER FOUR: Commercial Perspectives

• Exhibit 38: Protein Therapeutics Market Sales and Growth Rate 2001-2005
• Exhibit 39: Market Growth Comparison Protein Therapeutics Versus Total Pharma 2000-2005
• Exhibit 40: Protein Therapeutics Market Sales Distribution by Geography (France, Germany, Italy, Japan, Spain, U.K., U.S., ROW) 2005
• Exhibit 41: Protein Therapeutics Sales Distribution by Drug Class (mAbs, EPO, Insulin, IFRNs, CSF, IL, BCF, TPA, HGH, RHs, BMP-2, ERT, GD) 2005
• Exhibit 42: Protein Therapeutics Sales Distribution by Disease Area (CNS, Diabetes, Growth Disorders, Hematology, Inf. Disease, Inflammation, Oncology, Women's Health, Others) 2005
• Exhibit 43: Protein Therapeutics Market Segments and Leading Products
• Exhibit 44: Sales and Growth of Top Ten Protein Therapeutics 2005
• Exhibit 45: Revenues, Growth, and Market Share of Top Ten Protein Therapeutics Suppliers 2004
• Exhibit 46: Protein Therapeutics Market 2005, 2010
• Exhibit 47: Protein Therapeutics Sales Distribution by Drug Class (mAbs, EPO, Insulin, IFRNs, CSF, IL, BCF, TPA, HGH, RHs, BMP-2, ERT, GD) 2010
• Exhibit 48: World Monoclonal Antibody Market Total Dollar Volume by Region (U.S., Europe, ROW) 2001-2005, 2010
• Exhibit 49: Top Monoclonal Antibody Products (Product, Company, Sales, Market Share, Growth) 2005
• Exhibit 50: Market Shares of the Leading Monoclonal Antibody Players 2005
• Exhibit 51: World Erythropoietin Market Total Dollar Volume by Region (U.S., Europe, ROW) 2001-2005, 2010
• Exhibit 52: Top Erythropoietin Products (Product, Company, Sales, Market Share, Growth) 2005
• Exhibit 53: Market Shares of the Leading Erythropoietin Players 2005
• Exhibit 54: Insulin Market: Revenue Distribution by Class (Long Acting, Intermediate Acting, Rapid Acting) 2005
• Exhibit 55: World Insulin Market Total Dollar Volume by Region (U.S., Europe, ROW) 2001-2005, 2010
• Exhibit 56: Top Insulin Products (Product, Company, Sales, Market Share, Growth) 2005
• Exhibit 57: Market Shares of the Leading Insulin Players 2005
• Exhibit 58: World Interferon Market Total Dollar Volume by Region (U.S., Europe, ROW) 2001-2005, 2010
• Exhibit 59: Top Interferon Products (Product, Company, Sales, Market Share, Growth) 2005
• Exhibit 60: Market Shares of the Leading Interferon Players 2005
• Exhibit 61: World Growth Factors Market Total Dollar Volume by Region (U.S., Europe, ROW) 2001-2005, 2010
• Exhibit 62: Top Growth Factor Products (Product, Company, Sales, Market Share, Growth) 2005
• Exhibit 63: Market Shares of the Leading Growth Factor Players 2005
• Exhibit 64: World Interleukin Market Total Dollar Volume by Region (U.S., Europe, ROW) 2001-2005, 2010
• Exhibit 65: Leading Interleukin Products (Product, Company, Sales, Market Share, Growth) 2005
• Exhibit 66: Market Shares of the Leading Interleukin Players 2005
• Exhibit 67: World Clotting Factors Market Total Dollar Volume by Region (U.S., Europe, ROW) 2001-2005, 2010
• Exhibit 68: Top Clotting Factor Products (Product, Company, Sales, Market Share, Growth) 2005
• Exhibit 69: Market Shares of the Leading Clotting Factors Players 2005
• Exhibit 70: World Tissue Plasminogen Activators Market Total Dollar Volume by Region (U.S., Europe, ROW) 2001-2005, 2010
• Exhibit 71: Top Tissue Plasminogen Activator Products (Product, Company, Sales, Market Share, Growth) 2005
• Exhibit 72: Market Shares of the Leading Tissue Plasminogen Activators Players 2005
• Exhibit 73: World Human Growth Hormone Market Total Dollar Volume by Region (U.S., Europe, ROW) 2001-2005, 2010
• Exhibit 74: Top Human Growth Hormone Products (Product, Company, Sales, Market Share, Growth) 2005
• Exhibit 75: Market Shares of the Leading Human Growth Hormone Players 2005
• Exhibit 76: World Reproductive Hormones Market Total Dollar Volume by Region (U.S., Europe, ROW) 2001-2005, 2010
• Exhibit 77: Top Reproductive Hormone Products (Product, Company, Sales, Market Share, Growth) 2005
• Exhibit 78: Market Shares of the Leading Reproductive Hormone Players 2005
• Exhibit 79: World BMP-2 Market Total Dollar Volume by Region (U.S., Europe, ROW) 2001-2005, 2010
• Exhibit 80: Top BMP-2 Products (Product, Company, Sales, Market Share, Growth) 2005
• Exhibit 81: Market Shares of the Leading BMP-2 Players 2005
• Exhibit 82: World Enzyme Replacement Market Total Dollar Volume by Region (U.S., Europe, ROW) 2001-2005, 2010
• Exhibit 83: Top Enzyme Replacement Products (Product, Company, Sales, Market Share) 2005
• Exhibit 84: Market Shares of the Leading Enzyme Replacement Players 2005
• Exhibit 85: World Glucocerebrosidase Deficiency Enzyme Market Total Dollar Volume by Region (U.S., Europe, ROW) 2001-2005, 2010
• Exhibit 86: Top Glucocerebrosidase Deficiency Enzyme Products (Product, Company, Sales, Market Share, Growth) 2005