Report: The Market for Bioengineered Protein Drugs TOC

INTRODUCTION
- STUDY OBJECTIVES
- SCOPE AND CONTENT
- METHODOLOGY AND SOURCES
- AUDIENCE FOR THIS REPORT
- ANALYST CREDENTIALS
- RELATED BCC PUBLICATIONS
- 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
- Table 1 COMPANIES INVOLVED IN DEVELOPMENT OF PULMONARY DELIVERY SYSTEMS
  - 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
      - Directed Evolution (Continued)
- SOURCES
  - RECOMBINANT PROTEIN THERAPEUTICS
- Table 2 TOP TEN RECOMBINANT THERAPEUTIC PROTEINS AND THEIR GLOBAL SALES, 2001-2005 ($ MILLIONS)
  - HARVESTED PROTEINS
    - Human
    - Animal
    - Plant
    - Microbial
  - TYPES OF PROTEIN BASED DRUGS
    - Replacement proteins
    - Antibodies
    - Peptides versus whole proteins
INDUSTRY BACKGROUND
- THE PHARMACEUTICAL INDUSTRY
- Table 3 GLOBAL PHARMACEUTICAL SALES, 1998-2005 ($ BILLIONS)
- Table 4 LEADING PRODUCTS BY GLOBAL PHARMACEUTICAL SALES, 2005 ($ BILLIONS)
  - THE FDA
  - GENERICS MARKET
    - GENERICS MARKET (CONTINUED)
- Table 5 TOP PROTEIN DRUGS TO GO OFF PATENT, 2006-2010
- Table 6 U.S. GENERIC DRUG MARKET SHARE (DISPENSED PRESCRIPTIONS) (%)
  - TECHNOLOGICAL ADVANCES OF NOTE
    - REAL TIME MONITORING OF PROTEIN PRODUCTION
    - PROTEIN FOLDING
    - PROTEIN PHOSPHORYLATION
  - FDA APPROVAL PROCESS
- Table 7 COSTS OF EACH STAGE OF FDA APPROVAL PROCESS ($ MILLIONS)
  - DEPENDENT INDUSTRIES: RESEARCH TOOLS
    - AUTOMATION
      - Expression
    - CELL CULTURE
- 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
  - PROTEIN ASSAY KITS AND EQUIPMENT
- Table 10 MARKET SHARES OF COMPANIES SELLING PROTEIN ASSAY KITS AND EQUIPMENT (%)
  - Protein Refolding
    - PROTEIN ARRAYS
- Table 11 MARKET SHARE OF COMPANIES SELLING PROTEIN ARRAYS
  - PROTEIN ARRAYS (CONTINUED)
  - MICROWELL PLATES
- Table 12 COMPANIES INVOLVED IN PRODUCTION OF MICROWELL PLATES
  - IMAGING
    - Fluorescence
- Table 13 SALES OF COMPANIES OFFERING BIOLOGICAL STAINS, DYES AND OTHER IMAGING REAGENTS, 2003-2006 ($ MILLION)
  - ION CHANNELS
    - Ion Channels (Continued)
- Table 14 COMPANIES INVOLVED IN ION CHANNELS AND PATCH CLAMPING SYSTEMS
  - Designer Cells
  - X-ray Crystallography
  - Spectroscopy
- PURIFICATION/ SEPARATION
  - Separation
  - Spectroscopy
  - Flow Cytometry
- Table 15 COMPANIES INVOLVED IN FLOW CYTOMETRY TECHNOLOGY
  - Western Blots
  - BIOINFORMATICS
  - PROTEIN DATABASES
  - EFFECT OF PATENTING/TRADE SECRETS OF RESEARCH TOOLS
PROTEIN DRUGS
- PROTEIN DRUGS
- Table 16 TOP SELLING PROTEIN DRUGS WORLDWIDE, 2002-2005 ($ MILLION)
- Table 17 GLOBAL MARKET FORECAST FOR TYPES OF PROTEIN DRUGS, THROUGH 2011 ($ MILLIONS)
- Figure 1 GLOBAL MARKET FORECAST FOR TYPES OF PROTEIN DRUGS 2006 AND 2011 ($ MILLIONS)
  - PROTEIN DRUGS (CONTINUED)
  - REPLACEMENT PROTEINS
- Table 18 GLOBAL MARKET FORECAST OF REPLACEMENT PROTEINS, THROUGH 2011 ($ MILLION)
- Figure 2 GLOBAL MARKET FORECAST OF REPLACEMENT PROTEINS, 2006 AND 2011 ($ MILLION)
  - HORMONE REPLACEMENT
  - GROWTH HORMONE
  - OTHER RECOMBINANT REPLACEMENT PROTEINS
    - THERAPEUTIC ENZYMES
- Table 19 WORLDWIDE SALES OF THERAPEUTIC ENZYMES, 2003-2011 ($ MILLION)
  - RECOMBINANT PROTEIN DRUGS
- Table 20 WORLDWIDE SALES OF RECOMBINANT/BIOENGINEERED PROTEIN DRUGS, 2003-2005 ($ MILLION)
  - GROWTH FACTORS
- Table 21 GLOBAL MARKET SALES GROWTH FACTORS, 2003-2011 ($ MILLION)
- Figure 3 GLOBAL MARKET SALES GROWTH FACTORS, BY MANUFACTURER, 2006 AND 2011 ($ MILLION)
- Table 22 WORLDWIDE SALES GROWTH FACTOR INHIBITORS, 2003-2005 ($ MILLIONS)
  - 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
- Table 23 WORLDWIDE SALES OF COAGULANTS, THROUGH 2011 ($ MILLION)
  - HORMONES
- Table 24 WORLDWIDE SALES OF HORMONES, THROUGH 2011 ($ MILLION)
  - ESTROGEN ANALOGS
    - Raloxifene
    - Premarin
    - Gonal-F
  - GONADAL STEROIDS
    - Tibolone
  - HORMONE REPLACEMENT THERAPY (HRT)
  - THYROID AND PARATHYROID DERIVED HORMONES
    - Parathyroid Hormone (Teriparatide)
  - MONOCLONAL ANTIBODIES
- Table 25 CURRENTLY APPROVED THERAPEUTIC MONOCLONAL ANTIBODIES, UNITED STATES
- Table 26 WORLDWIDE SALES OF MONOCLONAL ANTIBODIES USED AS THERAPEUTICS, 2003-2005 ($ MILLION)
  - DENOSUMAB
  - MORPHOTEK
- Table 27 GLOBAL MARKET SALES OF MONOCLONAL ANTIBODIES USED AS THERAPEUTICS, 2003-2011 ($ MILLION)
- Figure 4 GLOBAL MARKET SALES OF MONOCLONAL ANTIBODIES USED AS THERAPEUTICS, 2006 AND 2011 ($ MILLION)
  - VACCINES
    - ROTAVIRUS
    - HEAT SHOCK PROTEINS
      - Heat Shock Proteins (Continued)
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
- Table 28 WORLDWIDE SALES OF PROTEIN DRUGS USED FOR TREATMENT OF CARDIOVASCULAR DISEASE, 2003-2005 ($ MILLION)
  - NEURODEGENERATIVE DISEASE
- Table 29 POSITION IN THE PIPELINE OF BIOTECHNOLOGY THERAPIES TARGETING ALZHEIMER' S DISEASE
- Table 29 (CONTINUED)
  - RESPIRATORY DISEASES
    - CYSTIC FIBROSIS
    - EMPHYSEMA
    - PULMONARY FIBROSIS
  - INFECTIOUS DISEASE
    - ANTIBIOTIC RESISTANCE
    - FUNGAL DISEASES
    - TWEAK
  - SKIN DISEASES/ INJURIES
    - PSORIASIS
      - Psoriasis (Continued)
    - LESIONS
    - WOUND TREATMENT
  - ARTHRITIS
    - RHEUMATOID ARTHRITIS
- Table 30 WORLDWIDE SALES OF PROTEIN DRUGS FOR ARTHRITIS, 2003-2005 ($ MILLION)
  - PSORIATIC ARTHRITIS
  - OSTEOARTHRITIS
- CONGENITAL DISEASE
  - ORPHAN DRUG ACT
- CANCER
- Table 31 WORLDWIDE SALES BY TYPE OF CANCER DRUGS, THROUGH 2011 ($ MILLION)
  - 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
- Table 32 GLOBAL MARKET FORECAST OF INTERFERON, THROUGH 2011 ($ MILLION)
- Figure 5 GLOBAL MARKET FORECAST OF INTERFERON, 2006 AND 2011 ($ MILLION)
  - Cytokines
- CANCER VACCINES
  - Cancer Vaccines (Continued)
- Table 33 COMPANIES INVOLVED IN DEVELOPMENT OF CANCER VACCINES BASED ON PROTEIN THERAPEUTICS
  - COLORECTAL CANCER
- Table 34 PROTEIN THERAPEUTICS FOR THE TREATMENT OF COLORECTAL CANCER
  - ANGIOGENESIS INHIBITORS
- Figure 6 CHEMOTHERAPY DRUG TARGETS THAT MAY HAVE ANTIANGIOGENIC EFFECTS
  - Angiogenesis Inhibitors (Continued)
  - Angiogenesis Inhibitors (Continued)
- 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)
  - NON-SMALL-CELL LUNG CARCINOMA
- Table 37 ONGOING FIRST-LINE TRIALS OF PROTEIN THERAPIES FOR NON-SMALL CELL LUNG CANCER
  - AUTOIMMUNE DISORDERS
    - MULTIPLE SCLEROSIS
    - PAIN
    - AGING
      - Growth Hormones Used to Help the Elderly
    - AGE-RELATED MACULAR DEGENERATION
    - OBESITY
COMPANY PROFILES
- MAJOR PLAYERS-GENERAL INFORMATION
- Table 38 PROTEIN DRUG COMPANY PROFILES
- Table 38 (CONTINUED)
- Table 38 (CONTINUED)
  - 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
- Table 39 FDA APPROVED PROTEIN DRUGS, BY COMPANY, JAN 2000-MAY 2006
PATENT LANDSCAPE
- TYPES OF PATENTS/MAJOR PATENT PORTFOLIOS
- Table 40 PATENT OWNERSHIP, 2000-2006
- Table 40 (CONTINUED)
- Table 40 (CONTINUED)
- Table 40 (CONTINUED)
- Table 40 (CONTINUED)
- Table 40 (CONTINUED)
- Table 40 (CONTINUED)
- Table 40 (CONTINUED)
- Table 40 (CONTINUED)
- Table 40 (CONTINUED)
- Table 40 (CONTINUED)
- Table 41 RECENT PATENTS AND PATENT APPLICATIONS FOR PROTEIN THERAPEUTICS, JANUARY 2000-JUNE 2006
- Table 41 (CONTINUED)
  - FUTURE DRIVERS: PATENT EXPIRATIONS
- Table 42 PROTEIN THERAPEUTICS LOSING PATENT PROTECTION
  - 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 TABLES
- 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

The Market for Bioengineered Protein Drugs

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