Market for Bioengineered Protein Drugs; The

Summary

This report updates BCC's report Market for Bioengineered Protein Drugs and reviews the global markets for the different types of protein drugs as well as forecasts for trends and sales through 2011. Important research developments, regulatory trends and other factors influencing demand will be discussed.

Protein drugs, as the name suggests, are pharmaceuticals based on proteins or portions of proteins. Also referred to as biologics, protein drugs have become increasingly important over the past 5 years with the advent of high throughput screening and proteomics combined with the changing (some would say declining) health status of the developed countries, particularly the United States.

Technologies included in this report are: protein therapeutics, proteomics, bioengineered protein drugs, recombinant protein drugs, protein arrays, protein expression and protein purification, and protein chips.

Drugs included in this report are insulin, coagulants, interferons, cytokines, bioengineered antibodies, enzymes, hormones (particularly growth hormones), growth factors, interleukins and angiogenesis inhibitors.

Diseases for which protein drugs are particularly amenable and that will be discussed in this report include: hemophilia, diabetes, cancer, cystic fibrosis, hepatitis, psoriasis and congenital diseases.

Scope Of Study

This report contains:

• Coverage of proteins that are used for therapeutic purposes, including an analysis of protein-based drugs in clinical trials
• Market trends and five-year forecasts with projections through 2011
• Examination of current technologies underlying the market and details the effects of new technologies on this market
• Profiles of the major companies involved in the production and modification of protein drugs.
• An analysis of the patent landscape in this field and the companies with the greatest breadth in their IP portfolios.

Report Highlights

• The total global market for protein drugs was $47.4 billion in 2006. The market will reach $55.7 billion by the end of 2011, an average annual growth rate (AAGR) of 3.3%.
• Modified and engineered antibodies present the largest share of the total global market. In 2006, this sector held almost 56% of the global market. By the end of 2011 its share will drop slightly but not significantly to 54%.
• Hormone protein drugs have the largest AAGR through the forecast period, averaging 5.1% through 2011 to reach $11.9 billion by 2011.

Contents

• Introduction
  • Study Objectives
  • Scope And Content
  • Methodology And Sources
  • Audience For This Report
  • Analyst Credentials
  • Related BCC Publications
  • BCC Online Services
  • Disclaimer
• Executive Summary
  • Summary Table: Worldwide Market For Protein Drugs, Through 2011 ($ Billion)
  • Summary Figure: Worldwide Sales Forecast For Protein Drugs, 2006 And 2011 ($ Billions)
• Overview
  • The Making Of A Protein
  • Advantages Of Protein-Based Drugs
  • Drawbacks To Protein-Based Drugs
    • Drug Delivery
      • Aerosol
      • Oral Administration
      • Implanted Drug Delivery
      • Smart Materials
      • Sustained Delivery
      • Injection/I.V.
  • Drug Discovery-Development Of Protein Based Drugs
    • Protein Immunogenicity
    • Proteomics
    • Protein Chips
    • Synthetic Biology
      • Directed Evolution
  • Sources
    • Recombinant Protein Therapeutics
    • Harvested Proteins
      • Human
      • Animal
      • Plant
      • Microbial
    • Types Of Protein Based Drugs
      • Replacement Proteins
      • Antibodies
      • Peptides Versus Whole Proteins
• Industry Background
  • The Pharmaceutical Industry
  • The Fda
  • Generics Market
  • Technological Advances Of Note
    • Real Time Monitoring Of Protein Production
    • Protein Folding
    • Protein Phosphorylation
  • Fda Approval Process
  • Dependent Industries: Research Tools
    • Automation
      • Expression
    • Cell Culture
    • Protein Assay Kits And Equipment
      • Protein Refolding
    • Protein Arrays
    • Microwell Plates
    • Imaging
      • Fluorescence
    • Ion Channels
      • Designer Cells
      • X-Ray Crystallography
      • Spectroscopy
    • Purification/ Separation
      • Separation
      • Spectroscopy
      • Flow Cytometry
      • Western Blots
    • Bioinformatics
    • Protein Databases
    • Effect Of Patenting/Trade Secrets Of Research Tools
• Protein Drugs
  • Protein Drugs
  • Replacement Proteins
    • Hormone Replacement
    • Growth Hormone
    • Other Recombinant Replacement Proteins
  • Therapeutic Enzymes
  • Recombinant Protein Drugs
  • Growth Factors
  • Peptide Drugs
    • Currently Marketed Peptide Drugs
      • Fuzeon
      • Integrilin
      • Cubicin
      • Prialt
    • Non-Natural Amino Acids
    • Peptide Drugs In Development
      • Oxytocin Analogs
      • Icatibant
      • Neurovax
    • Hurdles To Peptide Drug Development
  • Coagulants
  • Hormones
    • Estrogen Analogs
      • Raloxifene
      • Premarin
      • Gonal-F
    • Gonadal Steroids
      • Tibolone
    • Hormone Replacement Therapy (HRT)
    • Thyroid And Parathyroid Derived Hormones
      • Parathyroid Hormone (TERIPARATIDE)
  • Monoclonal Antibodies
    • Denosumab
    • Morphotek
  • Vaccines
    • Rotavirus
    • Heat Shock Proteins
• Diseases
  • Diabetes
    • Insulin Delivery Systems
      • Inhaled-Exubera
      • Inhaler-Nektar Therapeutic
      • Alternatives To Insulin
      • Byetta (Eli Lilly/Amylin)
      • Glucophage
    • Diabetic Retinopathy
  • Hemophilia
    • Anti-Coagulants
  • Heart Disease
    • Apoa-1
    • Lipitor
    • Raising Hdl
    • Vegf As A Treatment
  • Neurodegenerative Disease
  • Respiratory Diseases
    • Cystic Fibrosis
    • Emphysema
    • Pulmonary Fibrosis
  • Infectious Disease
    • Antibiotic Resistance
    • Fungal Diseases
    • Tweak
  • Skin Diseases/ Injuries
    • Psoriasis
    • Lesions
    • Wound Treatment
  • Arthritis
    • Rheumatoid Arthritis
    • Psoriatic Arthritis
    • Osteoarthritis
  • Congenital Disease
    • Orphan Drug Act
  • Cancer
    • Interferons
      • Interferon -2a (Roferon-A)
      • Interferon -2b (Intron A)
      • Interferon -N3 (Alferon N)
      • Interferon Con-1 (INFERGEN)
      • Interferon -1a (AVONEX)
      • Interferon -1b (BETASERON)
      • Interferon -1b (ACTIMMUNE)
    • Combination Therapy
    • Pegylated Interferons
      • Cytokines
    • Cancer Vaccines
    • Colorectal Cancer
    • Angiogenesis Inhibitors
    • Non-Small-Cell Lung Carcinoma
  • Autoimmune Disorders
    • Multiple Sclerosis
    • Pain
    • Aging
      • Growth Hormones Used To Help The Elderly
    • Age-Related Macular Degeneration
    • Obesity
• Company Profiles
  • Major Players-General Information
  • Mergers/ Acquisitions 2000-2005
    • Focus On Invitrogen
      • 2003
      • 2005
      • 2006
    • Merck-Serono
    • Corixa-Glaxo Smithkline
  • Strategic Alliances 2000-2006
    • Multispan And Molecular Devices
    • Sanofi-Aventis/Pfizer/Nektar Therapeutics
    • Millipore And Jpt Peptide Technologies
    • Apo2l/Trail-Genentech And Amgen
    • Juvenile Diabetes Research Foundation And Immune Tolerance Network
    • Helix Biopharma And Qsv Biologics
    • Aradigm And Novo Nordisk
    • Incyte Genomics And Lexicon Genetics
      • Incyte Co-Promotion Of Lexvision
      • Access To Lexvision And Lifeseq Gold For Drug Discovery Research
  • Fda Approved Drugs
• Patent Landscape
  • Types Of Patents/Major Patent Portfolios
  • Future Drivers: Patent Expirations
  • Future Drivers: Research Initiatives
    • Pharmastart
    • Secreted Protein Discovery Initiative
  • Litigation
    • Cambridge Antibody Technology V. Abbott
    • Eli Lilly V. Ariad
    • Eli Lilly & Co V. Massachusetts Institute Of Technology And Harvard University
    • Novo Nordisk V. Pfizer
    • Bristol-Myers Squibb V. Apotex
    • Daiichi Pharmaceutical Co. V. Apotex Inc
  • Future Drivers: Funding
    • Bristol-Myers Squibb (BMS)
    • European Science Foundation
    • National Cancer Institute-Proteomics
  • Clinical Trial Trends
• List Of Figures
  • Summary Table: Worldwide Market For Protein Drugs, Through 2011 ($ Billion)
  • Table 1 Companies Involved In Development Of Pulmonary Delivery Systems
  • Table 2 Top Ten Recombinant Therapeutic Proteins And Their Global Sales, 2001-2005 ($ Millions)
  • Table 3 Global Pharmaceutical Sales, 1998-2005 ($ Billions)
  • Table 4 Leading Products By Global Pharmaceutical Sales, 2005 ($ Billions)
  • Table 5 Top Protein Drugs To Go Off Patent, 2006-2010
  • Table 6 U.S. Generic Drug Market Share (Dispensed Prescriptions)
  • Table 7 Costs Of Each Stage Of Fda Approval Process ($ Millions)
  • Table 8 Companies Involved In Providing Cell Culture Reagents, Equipment And Cell Lines, 2003-2005 ($ Million)
  • Table 9 Private Companies Selling Cell Culture Reagents And Equipment
  • Table 10 Market Shares Of Companies Selling Protein Assay Kits And Equipment (%)
  • Table 11 Market Share Of Companies Selling Protein Arrays
  • Table 12 Companies Involved In Production Of Microwell Plates
  • Table 13 Sales Of Companies Offering Biological Stains, Dyes And Other Imaging Reagents, 2003-2006 ($ Million)
  • Table 14 Companies Involved In Ion Channels And Patch Clamping Systems
  • Table 15 Companies Involved In Flow Cytometry Technology
  • Table 16 Top Selling Protein Drugs Worldwide, 2002-2005 ($ Million)
  • Table 17 Global Market Forecast For Types Of Protein Drugs, Through 2011 ($ Millions)
  • Table 18 Global Market Forecast Of Replacement Proteins, Through 2011 ($ Million)
  • Table 19 Worldwide Sales Of Therapeutic Enzymes, 2003-2011 ($ Million)
  • Table 20 Worldwide Sales Of Recombinant/Bioengineered Protein Drugs, 2003-2005 ($ Million)
  • Table 21 Global Market Sales Growth Factors, 2003-2011 ($ Million)
  • Table 22 Worldwide Sales Growth Factor Inhibitors, 2003-2005 ($ Millions)
  • Table 23 Worldwide Sales Coagulants, Through 2011 ($ Million)
  • Table 24 Worldwide Sales, Hormones, Through 2011 ($ Million)
  • Table 25 Currently Approved Therapeutic Monoclonal Antibodies, United States
  • Table 26 Worldwide Sales Of Monoclonal Antibodies Used As Therapeutics, 2003-2005 ($ Million)
  • Table 27 Global Market Sales Of Monoclonal Antibodies Used As Therapeutics, 2003-2011 ($ Million)
  • Table 28 Worldwide Sales Of Protein Drugs Used For Treatment Of Cardiovascular Disease, 2003-2005 ($ Million)
  • Table 29 Position In The Pipeline Of Biotechnology Therapies Targeting Alzheimer's Disease
  • Table 30 Worldwide Sales Protein Drugs For Arthritis, 2003-2005 ($ Million)
  • Table 31 Worldwide Sales By Type Of Cancer Drug, Through 2011 ($ Million)
  • Table 32 Global Market Forecast Of Interferon, Through 2011 ($ Million)
  • Table 33 Companies Involved In Development Of Cancer Vaccines Based On Protein Therapeutics
  • Table 34 Protein Therapeutics For The Treatment Of Colorectal Cancer
  • Table 35 Strategies Targeting Endothelial And Non-Endothelial Cells To Inhibit Tumor Angiogenesis
  • Table 36 Selected Breast Cancer Biotech Companies And Drug Candidates In The Clinic ($ Million)
  • Table 37 Ongoing First-Line Trials Of Protein Therapies For Non-Small Cell Lung Cancer
  • Table 38 Protein Drug Company Profiles
  • Table 39 Fda Approved Protein Drugs, By Company, Jan 2000-May 2006
  • Table 40 Patent Ownership, 2000-2006
  • Table 41 Recent Patents And Patent Applications For Protein Therapeutics, January 2000-June 2006
  • Table 42 Protein Therapeutics Losing Patent Protection
• List Of Figures
  • Summary Figure: Worldwide Sales Forecast For Protein Drugs, 2006 And 2011 ($ Billions)
  • Figure 1 Global Market Forecast For Types Of Protein Drugs 2006 And 2011 ($ Millions)
  • Figure 2 Global Market Forecast Of Replacement Proteins, 2006 And 2011 ($ Million)
  • Figure 3 Global Market Sales Growth Factors, By Manufacturer, 2006 And 2011 ($ Million)
  • Figure 4 Global Market Sales Of Monoclonal Antibodies Used As Therapeutics, 2006 And 2011 ($ Million)
  • Figure 5 Global Market Forecast Of Interferon, 2006 And 2011 ($ Million)
  • Figure 6 Chemotherapy Drug Targets That May Have Antiangiogenic Effects