发布时间：2007.1
摘要
INTRODUCTION
This report updates our 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.
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.
目录及图表
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