Description
The protein therapeutics sector is a story of triumphant science, representing both life-saving treatments for millions and a multi-billion dollar industry. This report details both the scientific and business aspects of the protein therapeutics marketplace, including market size and growth, competitive market share, geographical segmentation, top products, and forecasts to 2010 for each of the following individual product areas:
- Monoclonal Antibodies
- Erythropoietins
- Insulin
- Interferons
- Growth Factors
- Interleukins
- Blood Clotting Factors
- Tissue Plasminogen Activator
- Human Growth Hormones
- Reproductive Hormones
- Recombinant BMP-2
- Replacement Enzymes
In addition, the report discusses the major operational and strategic challenges this market presents, including
- financing
- pricing and reimbursement,
- manufacturing
- marketing, and
- regulatory issues
Profiles of 21 key competitors—including their products, pipeline, technology platforms, and alliances—round out the comprehensive review.
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
