市場調査報告書：バイオ工学によるタンパク医薬品

Abstract

INTRODUCTION

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.

METHODOLOGY AND SOURCES

This report uses a combination of direct and indirect sources. Direct sources include interviews and conversations with scientists, analysts and research consultants. Indirect sources include company news releases, governmental and nongovernmental agencies, scientific journals and the popular press.

Sales were gathered from the most recently available data and represent worldwide sales. In nearly all cases, this involved year-end 2005 sales. If these figures were not available, then the latest available figures were used.

In some cases, data was not available. In these cases estimates were made based on indirect data, such as patient populations, percentages treated with other drugs and average sales prices.

Estimates for future sales growth within individual markets depended upon: patent expirations, percentage of the market penetrated, generic competition, competing drug classes, the introduction of new drugs, demographic growth and shifts, recent study results, and other variables. In each case where a forecast is made, the most important factors are listed.

Sales are presented in millions of dollars, unless otherwise noted.

ANALYST CREDENTIALS

Gargi Talukder has a doctorate in Neuroscience from Stanford University and a law degree from the University of Chicago. She has over 10 years of experience in the biotechnology sector.

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

バイオ工学によるタンパク医薬品市場

The Market for Bioengineered Protein Drugs

Abstract

INTRODUCTION

SCOPE OF STUDY

METHODOLOGY AND SOURCES

ANALYST CREDENTIALS

Table of Contents