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市場調査レポート

遺伝子改変による治療の市場

Therapeutics from Transgenic Sources

発行 BCC Research
出版日 2004年06月 商品コード 20178
ページ情報 英文 288 Pages
価格
こちらの商品の販売は終了いたしました。

当商品の販売は、2011年07月19日を持ちまして終了しました。

原文目次

REPORT HIGHLIGHTS

  • The current worldwide market for therapeutics from transgenic sources is zero, but is expected to exceed $1 billion in 2008 and reach $18.6 billion in 2013.
  • By 2008, between eight and 10 transgenically produced human therapeutics are expected to be on the market. By 2013, there should be at least 30 products on the market or substantially more.
  • If regulatory guidelines for the production of generic drugs using transgenic systems are developed, the number of product approvals could be two or three times the projection for 2013.
  • The manufacture of biopharmaceuticals in animal and plant transgenic systems represents a revolution in the production of human therapeutics. This is expected to generate products for as little as 1/1000th the cost of current methods.

INTRODUCTION

Recent advances in genomics and gene discovery have led to the identification of new biopharmaceuticals. As more genes are identified and proteins characterized, more biopharmaceutical targets will become available for drug discovery. As more protein products are developed to treat diseases, there is growing concern about the ability of the pharmaceutical industry to meet production demands.

This important BCC report provides insight into new technologies for producing drugs, biologics, cells, tissues and organs from transgenic animals and for producing biopharmaceuticals from transgenic plants. The primary products in development for human medicine using so-called biopharming or molecular pharming are protein-based drugs, including antibodies and vaccines.

The introduction of transgenic biopharmaceutical production technologies and transgenically produced human therapeutics will revolutionize the healthcare market in two ways. The first will be a significant reduction in the pricing of existing pharmaceuticals, which can be produced transgenically for as little as 1/1000th the cost of a product manufactured using mammalian cell culture systems. The second advantage of transgenic production is markedly higher profits for companies producing biopharmaceuticals using transgenic technology.

Transgenic animals already are in use for in vivo testing of drugs and vaccines designed for humans. Transgenic animals also are being used for the production of pharmaceuticals, in particular protein-based drugs, including antibodies that have yet to enter the marketplace.

SCOPE OF STUDY

The report contains:

  • discussion of the transgenic species and technologies involved in the production of human therapeutics
  • in-depth discussion of individual products currently in development
  • estimates of current markets for proteinbased products with forecasts through 2013
  • discussion of the impact of transgenically produced protein drugs and vaccines on the marketplace as well as the regulatory environment
  • profiles of companies focusing solely on the development of these products as well as companies that are including such products in a diverse product pipeline.

METHODOLOGY

The base year for this study is 2003. Market figures are based on revenues at the manufacturers' level and are projected at 2003-dollar value (i.e., inflation is not computed into the projection figures).

INFORMATION SOURCES

Data to prepare this study was derived from information obtained from interviews with management at transgenic products and services companies as well as with personnel working at pharmaceutical, biotech and contract manufacturing companies, and government agency spokespersons. Key information from business literature was used to obtain expert opinion on commercial potential and market sizes from industry professionals.

TABLE OF CONTENTS

INTRODUCTION

    • STUDY GOAL AND OBJECTIVES
    • REASONS FOR DOING THE STUDY
    • CONTRIBUTIONS OF THE STUDY AND FOR WHOM
    • SCOPE AND FORMAT
    • METHODOLOGY
    • INFORMATION SOURCES
    • AUTHOR'S CREDENTIALS
    • RELATED BCC REPORTS
    • BCC ONLINE SERVICES
SUMMARY
  • Summary Table:
    PROJECTED SALES OF TRANSGENICALLY PRODUCED THERAPEUTICS: WORLDWIDE SALES, THROUGH 2013 ($ MILLIONS)
  • Summary Figure:
    PROJECTED SALES OF TRANSGENICALLY PRODUCED THERAPEUTICS: WORLDWIDE SALES, 2003-2013 ($ MILLIONS)
OVERVIEW
    • THE MARKET OPPORTUNITY FOR TRANSGENIC PRODUCTION OF BIOPHARMACEUTICALS
    • THE HIGH COST OF PRODUCING PROTEIN DRUGS
    • THE GROWING CRISIS IN MEETING PRODUCTION DEMANDS FOR PROTEIN DRUGS
  • Table 1 U.S. DEMAND FOR BIOLOGICS, THROUGH 2008 ($ MILLIONS)
  • Figure 1 U.S. DEMAND FOR BIOLOGICS, 2002-2008 ($ MILLIONS)
  • Table 2 MONOCLONAL ANTIBODY BIOPROCESSING MARKET: U.S., THROUGH 2008 ($ MILLIONS)
  • Figure 2 MONOCLONAL ANTIBODY BIOPROCESSING MARKET: U.S., 2002-2008 ($ MILLIONS)
    • THE TRANSGENIC ADVANTAGE
    • TRADITIONAL PRODUCTION METHODS
      • MICROBIAL FERMENTATION
      • MAMMALIAN CELL CULTURE
        • Batch Fermentation
  • Table 3 SELECTED PROTEIN DRUGS AND THEIR SOURCE CELLS
        • Chinese Hamster Ovary Cells
        • Genentech
        • Boehringer Ingelheim
        • Other Market Leaders
        • Estimated Capacity Requirements
  • Table 4 ESTIMATED CAPACITY REQUIREMENTS FOR SELECTED CURRENTLY MARKETED PROTEIN PRODUCTS
  • Table 5 ESTIMATED MAMMALIAN CELL CULTURE MANUFACTURING CAPACITIES FOR SELECTED COMPANIES
    • THE CASE OF ENBREL
    • THE CRUNCH IN CAPACITY
      • THE CRUNCH IN CAPACITY (CONTINUED)
  • Table 6 REASONS FOR THE NEED TO INCREASE PROTEIN DRUG PRODUCTION
    • GENOMICS AND GENE DISCOVERY DRIVE THE EXPANDING DEVELOPMENT OF PROTEIN DRUGS
    • CONTRACT MANUFACTURING MARKET GROWING
      • OUTSOURCING MARKET
  • Table 7 U.S. BIOPHARMACEUTICALS CONTRACT MANUFACTURING MARKET, THROUGH 2008 ($ MILLIONS)
  • Figure 3 U.S. BIOPHARMACEUTICALS CONTRACT MANUFACTURING MARKET, 2002-2008 ($ MILLIONS)
        • Boehringer Ingelheim
        • Capacity Forecast
        • Market Drivers
      • INDUSTRY STRUCTURE
        • Sigma-Aldrich
    • TRANSGENIC SOURCES FOR PROTEIN DRUGS
      • DEFINITION OF A TRANSGENIC
      • ADVANTAGES OF TRANSGENIC SOURCES
        • Transgenic Animals
          • Milk as the Ideal Bioreactor
          • Producing Proteins in Blood
          • Patentability
        • Transgenic Plants
          • Modification of Medicinal Plants to Increase Drug Yields
          • Cost Advantages
  • Table 8 BENEFITS OF TRANSGENIC PLANT-BASED BIOTHERAPEUTICS PRODUCTION
          • Safety Advantages
          • The First Commercially Available Animal Protein Produced in a Plant
      • DISADVANTAGES OF TRANSGENIC SOURCES
        • Transgenic Animals
          • Infectious Viruses
          • Contamination of Other Organisms
          • Immunogenicity and Allergic Reactions
          • Biological Activity of Host Animal
          • Expense
          • Marketing Obstacles
          • Competition from Gene Therapy
        • Transgenic Plants
          • Concerns about Allergenicity
          • Lack of Glycosylation in Proteins Produced by Transgenic Plants
          • Low Expression of Proteins
          • Contamination Concerns
          • Containment Concerns
          • Creation of Superweeds
    • COST COMPARISON OF TRADITIONAL VERSUS TRANSGENIC PRODUCTION METHODS
      • MANUFACTURING COSTS
  • Table 9 MODEL FOR PRODUCTION COST COMPARISON OF TRADITIONAL MANUFACTURING TECHNOLOGIES VERSUS TRANSGENIC SOURCES TO PRODUCE A BIOPHARMACEUTICAL PRODUCT
  • Table 10 COST COMPARISON (INCLUDING CAPITAL AND OPERATING COSTS) OF TRADITIONAL VERSUS TRANSGENIC BIOPHARMACEUTICAL PRODUCTION METHODS ($ PER GRAM OF PROTEIN)
      • CELL CULTURE VERSUS GOAT TRANSGENIC COSTS
  • Table 11 COMPARISON OF CAPITAL COSTS FOR A THERAPEUTIC PROTEIN PRODUCED FROM CELL CULTURE VERSUS A THERAPEUTIC PROTEIN PRODUCED FROM THE MILK OF TRANSGENIC GOATS
  • Table 12 COMPARISON OF OPERATING COSTS FOR A THERAPEUTIC PROTEIN PRODUCED FROM CELL CULTURE VERSUS A THERAPEUTIC PROTEIN PRODUCED FROM THE MILK OF TRANSGENIC GOATS
    • PROJECTED PRICING OF TRANSGENICALLY PRODUCED THERAPEUTICS
    • MOLECULAR FARMING
  • Table 13 REASONS FOR THE POPULARITY OF MOLECULAR PHARMING TO PRODUCE BIOTHERAPEUTICS
      • TWO APPROACHES TO MOLECULAR FARMING
    • ANIMAL SPECIES USED IN MOLECULAR FARMING OF THERAPEUTICS
  • Table 14 CHARACTERISTICS OF SELECTED TRANSGENIC ANIMALS USED IN THERAPEUTIC HUMAN PROTEIN PRODUCTION
    • PLANT SPECIES USED IN MOLECULAR FARMING OF THERAPEUTICS
  • Table 15 CHARACTERISTICS OF DIFFERENT PLANT HOSTS
    • DRUGS UNDER DEVELOPMENT IN SPECIFIC SPECIES OF TRANSGENIC PLANTS
  • Table 16 SPECIFIC TRANSGENIC CROPS AND POTENTIALLY PRODUCIBLE HUMAN THERAPEUTICS
    • PROTEINS SUCCESSFULLY EXPRESSED IN TRANSGENIC PLANTS AND THEIR APPLICATIONS
  • Table 17 PROTEINS PRODUCED IN TRANSGENIC PLANTS BY APPLICATION AND PLANT HOST
    • TIMELINE FOR PRODUCTION OF THERAPEUTIC DRUGS FROM TRANSGENIC PLANTS
TECHNOLOGY
    • A BRIEF TIMELINE OF PLANT BIOTECHNOLOGY
    • TRADITIONAL MANUFACTURING SYSTEMS
  • Table 18 PRODUCTION OF PURE RECOMBINANT PROTEINS
      • PRODUCING MONOCLONAL ANTIBODIES
      • GUESSING CAPACITY
    • PROCESSES FOR INTRODUCING GENES INTO ANIMALS
      • NUCLEAR TRANSFER
      • PRONUCLEAR MICROINJECTION
      • OTHER PRODUCTION TECHNOLOGIES
    • PROCESSES FOR INTRODUCING GENES INTO PLANTS
      • STABLE INTEGRATION
      • TRANSIENT EXPRESSION
  • Table 19 TECHNOLOGY COMPARISON: STABLE TRANSFORMATION VERSUS TRANSIENT EXPRESSION
      • AGROBACTERIUM-MEDIATED TRANSFORMATION
      • THE BIOLISTIC OR GENE GUN METHOD
      • ELECTROPORATION
      • PLANT VIRAL VECTOR TRANSFER
      • TISSUE CULTURE
      • CHALLENGES TO BE MET
      • PROTECTING TRANSFORMED CELLS
      • REFINEMENT METHODS
        • Chloroplast Genetic Engineering
          • Chloroplast Genetic Engineering (Continued)
        • Promoters and Targeting Systems
      • PRODUCTION OF ANTIBODIES IN PLANTS
        • Plastids
        • Targeting and Compartmentalizing
        • Transgenic Seeds for Antibody Storage
    • TRANSGENIC ANIMAL PRODUCTION SYSTEMS
      • CATTLE
        • Milk
          • Milk (continued)
      • CHICKENS
        • Eggs
        • Competition in Avian Transgenics
          • Advanced Cell Technology
          • AviGenics
          • BioAgri
          • GeneWorks
          • Origen Therapeutics
          • TranXenoGen
          • Viragen
  • Table 20 LEADING COMPANIES INVOLVED IN AVIAN TRANSGENICS
      • GOATS
      • MICE
      • PIGS
      • RABBITS
      • SHEEP
    • TRANSGENIC PLANT PRODUCTION SYSTEMS
      • ALFALFA
      • BANANA
      • CORN
  • Table 21 BENEFITS OF TRANSGENIC CORN-BASED PRODUCTION
        • Products in Development
        • Traditional versus Transgenic Crop Costs
  • Table 22 COMPARISON OF COSTS FOR TRADITIONAL CORN CROPS AND TRANSGENIC CORN CROPS
  • Table 22 (CONTINUED)
      • LEMNA
      • OILSEEDS
      • POTATO
      • RUBBER
        • Rubber (Continued)
      • SUGAR CANE
      • TOBACCO
        • Companies Developing Therapeutic Proteins in Transgenic Tobacco
        • The Economics of Tobacco for Human Protein Production
      • TOMATO
    • ECONOMIC AND OTHER ADVANTAGES OF TRANSGENIC ANIMAL PRODUCTION OF THERAPEUTICS
    • ECONOMIC AND OTHER ADVANTAGES OF PLANT CULTURE VERSUS ANIMAL CELL CULTURE
    • EXTRACTION METHODS
    • PURIFICATION METHODS
    • SEPARATION PROCESSES
      • FILTRATION
      • CHROMATOGRAPHY
      • ECONOMICS OF PURIFICATION
        • Bioseparation Processes
        • Downstream Processing
        • Pall Corp. Separation Technology
        • Vibrating Membrane Technology
  • Table 23 CURRENT APPLICATIONS OF VIBRATING MEMBRANE FILTRATION TECHNOLOGY
          • Regulatory Environment
        • Other Production Systems
PRODUCTS
    • PROJECTED SALES OF BIOPHARMACEUTICALS PRODUCED FROM TRANSGENIC SOURCES
  • Table 24 PROJECTED SALES OF TRANSGENICALLY PRODUCED THERAPEUTICS: WORLDWIDE SALES, THROUGH 2013 ($ MILLIONS)
  • Figure 4 PROJECTED SALES OF TRANSGENICALLY PRODUCED THERAPEUTICS: WORLDWIDE SALES, 2003-2013 ($ MILLIONS)
    • THE WORLDWIDE MARKET FOR BIOPHARMACEUTICALS
  • Table 25 WORLDWIDE SALES OF BIOPHARMACEUTICALS, THROUGH 2008 ($ MILLIONS)
  • Figure 5 WORLDWIDE SALES OF BIOPHARMACEUTICALS, 2002-2008 ($ MILLIONS)
      • THERAPEUTIC PROTEIN MARKET
  • Table 26 THERAPEUTIC PROTEIN MARKET: WORLDWIDE SALES OF SELECTED AVAILABLE PRODUCTS, THROUGH 2013 ($ MILLIONS)
  • Table 26 (CONTINUED)
      • THE WORLDWIDE GLYCOPROTEIN MARKET
  • Table 27 WORLDWIDE SALES OF GLYCOPROTEIN DRUGS, THROUGH 2008 ($ MILLIONS)
  • Figure 6 WORLDWIDE SALES OF GLYCOPROTEIN DRUGS, 2002-2008 ($ MILLIONS)
      • THE MONOCLONAL ANTIBODY MARKET
  • Table 28 WORLDWIDE SALES OF MONOCLONAL ANTIBODY-BASED DRUGS, THROUGH 2008 ($ MILLIONS)
    • PROJECTED WORLDWIDE MARKET FOR SELECTED TRANSGENICALLY PRODUCED BIOPHARMACEUTICALS
      • STRUCTURAL PROTEINS
  • Table 29 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED STRUCTURAL PROTEINS, THROUGH 2013 ($ MILLIONS)
  • Figure 7 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED STRUCTURAL PROTEINS, 2003-2013 ($ MILLIONS)
      • BLOOD PRODUCTS
  • Table 30 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED BLOOD PRODUCTS, THROUGH 2013 ($ MILLIONS)
  • Figure 8 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED BLOOD PRODUCTS, 2003-2013 ($ MILLIONS)
      • COMPLEX PROTEINS
  • Table 31 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED COMPLEX PROTEINS, THROUGH 2013 ($ MILLIONS)
  • Figure 9 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED COMPLEX PROTEINS, 2003-2013 ($ MILLIONS)
      • ENZYMES
  • Table 32 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED ENZYMES, THROUGH 2013 ($ MILLIONS)
  • Figure 10 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED ENZYMES, 2003-2013 ($ MILLIONS)
      • MONOCLONAL ANTIBODIES
  • Table 33 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED MONOCLONAL ANTIBODIES, THROUGH 2013 ($ MILLIONS)
  • Table 33 (CONTINUED)
  • Figure 11 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED MONOCLONAL ANTIBODIES, 2003-2013 ($ MILLIONS)
          • Monoclonal Antibodies (Continued)
      • VACCINES
  • Table 34 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF VACCINE PRODUCTS, THROUGH 2013 ($ MILLIONS)
  • Figure 12 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF VACCINE PRODUCTS, 2003-2013 ($ MILLIONS)
    • TRANSGENIC THERAPEUTIC PRODUCTS IN DEVELOPMENT
  • Table 35 THERAPEUTIC PROTEINS IN PHASE I OR LATER DEVELOPMENT FROM TRANSGENIC SOURCES
  • Table 35 (CONTINUED)
  • Table 36 OTHER DRUGS POTENTIALLY GENERATED FROM TRANSGENIC ANIMALS
      • ANTITHROMBIN III, HUMAN RECOMBINANT
      • ALPHA-1 ANTITRYPSIN
      • ANTIBODIES
        • Plantibodies in Development
  • Table 37 THERAPEUTIC PLANTIBODIES: APPLICATION AND SPECIFICITY, SIGNAL SEQUENCES AND PLANT SOURCE
  • Table 37 (CONTINUED)
        • Anti-Rabies Antibodies
        • CaroRx
        • Clostridium Difficile Toxin A and Toxin B
        • Other Therapeutic Antibodies in Development
        • Technology Issues with Plant-based Human Antibodies
      • CYTOKINES
        • Interferon
        • Interleukin
        • Granulocyte-Macrophage Colony Stimulating Factor
        • Concerns About Producing Cytokines in Transgenic Plants
      • GASTRIC LIPASE, RECOMBINANT
      • GLUCOCEREBROSIDASE
      • HUMAN SERUM ALBUMIN
  • Table 38 U.S. MARKET FOR HUMAN SERUM ALBUMIN, THROUGH 2008
      • HUMAN INSULIN
      • LACTOFERRIN
      • LYSOZYME
      • VACCINES
        • Infections
          • Malaria
        • Current and Future Products
  • Table 39 WORLDWIDE INCIDENCE/PREVALENCE OF SELECTED DISEASES AMENABLE TO PROPHYLACTIC OR THERAPEUTIC IMMUNIZATION
        • How Vaccines Work
          • Nonspecific Immunity
          • Specific Immunity
        • The Process of Immunization
        • Types of Vaccines
          • Killed Whole Organism Vaccines
          • Live Attenuated Microorganism Vaccines
          • Subunit Vaccines
          • Genetically Engineered Vaccines
          • Conjugate Vaccines
        • The Current Market for Vaccines
  • Table 40 THE MARKET FOR VACCINES: WORLDWIDE SALES, THROUGH 2008 ($ MILLIONS)
  • Figure 13 THE MARKET FOR VACCINES: WORLDWIDE SALES, 2002-2008 ($ MILLIONS)
  • Table 41 THE MARKET FOR ADULT HEPATITIS B VACCINES: WORLDWIDE SALES, THROUGH 2008 ($ MILLIONS)
  • Table 42 THE MARKET FOR RABIES VACCINES: WORLDWIDE SALES, THROUGH 2008 ($ MILLIONS)
        • The Potential for Plant-Derived Vaccines
  • Table 43 PROTEINS PRODUCED BY TRANSGENIC PLANTS WITH APPLICATION TO VACCINES
  • Table 43 (CONTINUED)
        • Current Challenges
        • Transient Expression Using Plant Viruses
        • NonHodgkin's Lymphoma Vaccine
        • Malaria Vaccine
        • Edible Vaccines
          • Advantages of Edible Vaccines
          • Challenges to Edible Vaccines
          • Successful Development of Edible Vaccines
            • Asthma Vaccine
            • Cholera Vaccine
            • Enterotoxigenic Escherichia coli Vaccine
            • Norwalk Vaccine
          • Prototype Vaccines in Nonfood Plants
            • Hepatitis B Vaccine
      • XENOGRAFTS
  • Table 44 NUMBER OF TRANSPLANTS PERFORMED BY TYPE: U.S., 2002
  • Table 45 NUMBER OF PATIENTS WAITING FOR TRANSPLANTS, BY ORGAN/TISSUE TYPE: U.S., NOVEMBER 2003
        • Reality Check
        • The Process of Transplant Rejection
          • The Process of Transplant Rejection (Continued)
        • Initial Trials of Xenotransplantation
        • Leading Competitors in the Development of Transgenic Pigs
          • Alexion Pharmaceuticals
          • Immerge BioTherapeutics
          • Infigen
          • Nextran
          • PPL Therapeutics
        • Competing Technologies in Development
          • Stem Cells
        • Nontransgenic Xenotransplantation
        • Concerns and Regulations Relating to Transgenic and Nontransgenic Transplantation
        • Ethical Concerns and Objections
        • The Potential Market for Transgenic Xenotransplantation
REGULATORY
    • REGULATORY AGENCY RESPONSE TO THERAPEUTICS GENERATED FROM TRANSGENIC SOURCES-THE GREAT UNKNOWN
      • OPPORTUNITIES FOR TRANSGENICALLY PRODUCED GENERIC BIOPHARMACEUTICALS
      • REGULATION IN THE U.S.
        • Proposal from the Bush Administration to Remove Food Products Contaminated with Pharmaceuticals
        • Regulation of Transgenic Animals
          • Points to Consider Relating to Transgenic Animals
            • Generation and Characterization of The Transgene Construct
            • Transgene and Expression System (Heterozygous Gain of Function)
            • Gene Targeting by Homologous Recombination (Homozygous Loss of Function)
          • Creation and Characterization of the Transgenic Founder (G0) Animal
            • Analysis of the Transgenic Founder
            • Genetic Stability and Expression
            • Establishment of a Reliable and Continuous Source of Transgenic Animals (Founder Strain)
            • Generation and Selection of the Production Herds
            • Animal History and Genealogy
            • Breeding Techniques
            • Adding New Animals to the Production Herd
            • Maintenance of Transgenic Animals
            • Monitoring the Health of Transgenic Animals
            • Feeding of Animals Used in Production
            • Transgenic Animal Housing Facilities
            • Removal of Animals from Production
            • Disposal of Transgenic Animals or Use of Byproducts
            • Animal Sentinel Program
            • Purification and Characterization of the Transgenic Product
            • Defining a "Production Lot"
          • Endogenous and adventitious agents
            • The Host/Animal
            • Source Tissue
            • Pathogen Testing and Elimination
        • Analysis of Product Identity and Purity
        • Biochemical Identity, Purity and Potency
        • Product Heterogeneity
        • Lot Release Testing of the Final Product
        • Special Concerns for Transgenic Animals Intended as Tissue Donors
        • Preclinical Safety Evaluation
        • Regulation of Xenografts
        • Regulation of Transgenic Plants
          • Regulation of Transgenic Plants (Continued)
          • Changes in Field-Testing Permits
          • Containment
      • REGULATION IN THE EUROPEAN UNION
      • REGULATION IN CANADA
    • RISKS ASSOCIATED WITH THE MARKETING OF THERAPEUTICS FROM TRANSGENIC SOURCES
      • CONTAMINATION
      • MARKET ACCEPTANCE
      • DEPENDENCE ON ALLIANCES AND LICENSES WITH TRANSGENIC COMPANIES
      • REIMBURSEMENT
      • INTELLECTUAL PROPERTY ISSUES
        • Patent for Drug Derived from Transgenic Plant Sets Encouraging Precedent
      • COMPETITION
      • CONCERNS ABOUT TRANSGENIC PLANTS
        • Attitude of Other Countries toward Plant-Based Pharmaceuticals and the Means to Globalize Products
    • GROCERY MANUFACTURERS OF AMERICA AND NATIONAL FOOD PROCESSORS ATTITUDE TOWARD PLANT-BASED PHARMACEUTICALS
    • CONSUMER ATTITUDE TOWARD TRANSGENIC PLANT-BASED PHARMACEUTICALS
  • Table 46 CONSUMER OPINION ABOUT TRANSGENIC-PLANT BASED PHARMACEUTICALS: U.S. AND CANADA (%)
    • THE ATTITUDE OF ENVIRONMENTAL GROUPS TOWARD PLANT-BASED PHARMACEUTICALS
    • TRADE PACT ON GENE-ALTERED GOODS GOES INTO EFFECT
    • INDUSTRY AND GOVERNMENT ATTITUDE TOWARDS XENOGRAFTS
      • INDUSTRY AND GOVERNMENT ATTITUDE …(CONTINUED)
INDUSTRY
    • LEADING COMPANIES IN THE DEVELOPMENT OF THERAPEUTICS FROM TRANSGENIC SOURCES
      • LEADING COMPANIES IN THE TRANSGENIC ANIMAL INDUSTRY
        • Abgenix
        • AviGenics
        • GTC Biotherapeutics
        • Medarex
        • Nexia Biotechnologies
        • Origen
        • PPL Therapeutics
        • Pharming Holding
        • TranXenoGen
      • LEADING COMPANIES IN THE TRANSGENIC PLANT INDUSTRY
  • Table 47 SELECTED COMPANIES DEVELOPING TRANSGENIC PLANT-BASED HUMAN PHARMACEUTICALS
        • AltaGen Bioscience
        • Centocor
        • CropTech
        • Dow Agrosciences
        • Epicyte
        • Large Scale Biology
        • Meristem Therapeutics
        • Monsanto Protein Technologies
        • Phytomedics
        • Plant Research International
        • ProdiGene
    • A SNAPSHOT OF ISSUED PATENTS
  • Table 48 PATENTS RELATING TO PRODUCTION OF HUMAN THERAPEUTICS IN TRANSGENIC SOURCES ISSUED BY THE U.S. PATENT AND TRADEMARK OFFICE
    • INVESTMENT IN TRANSGENICALLY PRODUCED THERAPEUTICS BY PHARMACEUTICAL COMPANIES
    • MOLECULAR FARMING IN THE EUROPEAN UNION
    • THE UKRAINE OPTS FOR MOLECULAR FARMING IN AN EFFORT TO REDUCE HEALTHCARE COSTS
    • ATTITUDE OF THE INVESTMENT COMMUNITY ABOUT TRANSGENICALLY PRODUCED THERAPEUTICS
      • ATTITUDE OF THE INVESTMENT …(CONTINUED)
COMPANY PROFILES
    • ABGENIX, INC.
      • BUSINESS OVERVIEW
      • FINANCIAL INFORMATION
      • PRODUCTS IN DEVELOPMENT
  • Table 49 ABGENIX'S PRODUCT PIPELINE
      • TECHNOLOGY
        • Technology (Continued)
        • Advantages
          • Advantages (Continued)
      • CORPORATE STRATEGY
  • Table 50 ABGENIX'S CORPORATE PARTNERSHIPS
      • FACILITIES
      • PATENTS
    • AVIGENICS, INC.
      • BUSINESS OVERVIEW
      • PRODUCTS IN DEVELOPMENT AND SERVICES
      • CORPORATE STRATEGY
      • PATENTS
    • BIOAGRI CORP.
      • BUSINESS OVERVIEW
      • PRODUCTS IN DEVELOPMENT
      • CORPORATE STRATEGY
    • BIOLEX INC.
      • BUSINESS OVERVIEW
      • PRODUCTS IN DEVELOPMENT AND SERVICES
        • Science and Technology
  • Table 51 UNIQUE TRANSGENIC PLANT ADVANTAGES OF THE LEX SYSTEM
      • CORPORATE STRATEGY
        • Patents
    • BIOPROTEIN TECHNOLOGIES
      • BUSINESS OVERVIEW
      • PRODUCTS IN DEVELOPMENT AND SERVICES
        • Technology
        • Integrated Manufacturing Solutions
        • Research Services
      • CORPORATE STRATEGY
      • PATENTS
    • EPICYTE PHARMACEUTICALS
      • BUSINESS OVERVIEW
      • CORPORATE STRATEGY
    • FARMACULE BIOINDUSTRIES PTY LTD.
      • BUSINESS OVERVIEW
      • PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
        • Products in Development and Technology (Continued)
      • CORPORATE STRATEGY
      • PATENTS
    • GTC BIOTHERAPEUTICS
      • BUSINESS OVERVIEW
      • FINANCIAL INFORMATION
      • PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
        • Recombinant Human Antithrombin III (rhATIII)
        • Recombinant Human Serum Albumin (rhSA)
          • Recombinant Human Serum Albumin (rhSA) (Continued)
        • Malaria Vaccine
        • External Programs
          • External Programs (Continued)
  • Table 52 GTC'S EXTERNAL PROGRAMS COLLABORATIONS
          • Monoclonal Antibodies (MAB) and Immunoglobulin (Ig) Fusion Proteins
      • CORPORATE STRATEGY
        • Nuclear Transfer Technology
        • Internal and External Product Programs
        • Technology Platform
        • Economic and Technical Advantages
        • Licenses
        • Competitors
      • PATENTS
    • INFIGEN
      • BUSINESS OVERVIEW
      • PRODUCTS IN DEVELOPMENT AND SERVICES
        • Products in Development and Services (Continued)
      • CORPORATE STRATEGY
      • PATENTS
    • LARGE SCALE BIOLOGY CORP.
      • BUSINESS OVERVIEW
      • FINANCIAL INFORMATION
      • PRODUCTS IN DEVELOPMENT
        • Alpha-Galactosidase A
        • Aprotinin
        • Endothelial Cell-Derived Growth Factor
        • Non-Hodgkin's Lymphoma Vaccine
        • Hematologic Applications
      • TECHNOLOGY
        • Genomics and Proteomics
        • Bioinformatics
        • Biomanufacturing
      • SERVICES
        • Biomanufacturing
        • Proteomics
        • Agricultural Genomics
      • CORPORATE STRATEGY
        • Accomplishments
        • Collaborations
        • Research and Development Services
        • Government Funding
      • PATENTS
    • MEDAREX, INC.
      • BUSINESS OVERVIEW
      • FINANCIAL INFORMATION
      • LEADING PRODUCT CANDIDATES
  • Table 53 MEDAREX'S PRODUCT PIPELINE
      • CORPORATE STRATEGY
      • PATENTS
    • MEDICAGO INC.
      • BUSINESS OVERVIEW
      • CORPORATE STRATEGY
    • MERISTEM THERAPEUTICS
      • BUSINESS OVERVIEW
      • PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
      • CORPORATE STRATEGY
      • PATENTS
    • NEOSE TECHNOLOGIES, INC.
      • BUSINESS OVERVIEW
      • FINANCIAL INFORMATION
      • PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
        • GlycoAdvance
        • GlycoPEGylation
        • GlycoConjugation
      • CORPORATE STRATEGY
        • Erythropoietin
        • Other Products
        • Business Development Initiatives
        • Collaborations and Licenses
        • Intellectual Property
      • PATENTS
    • NEXGEN BIOTECHNOLOGIES
      • PRODUCTS IN DEVELOPMENT
      • CORPORATE STRATEGY
    • NEXIA BIOTECHNOLOGIES INC.
      • BUSINESS OVERVIEW
      • FINANCIAL INFORMATION
      • PRODUCTS IN DEVELOPMENT
        • BioSteel
  • Table 54 NEXIA'S PRODUCT PIPELINE
        • Biopharmaceuticals
      • TECHNOLOGY
        • Technology (Continued)
      • CORPORATE STRATEGY
        • Corporate Partnerships
          • Corporate Partnerships (Continued)
        • Licensing Partnerships
        • Patents
    • NEXTRAN
      • BUSINESS OVERVIEW
      • PRODUCTS IN DEVELOPMENT
      • CORPORATE STRATEGY
    • PHARMING HOLDING NV
      • BUSINESS OVERVIEW
      • FINANCIAL INFORMATION
      • PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
        • Products in Development and Technology (Continued)
  • Table 55 PHARMING'S PRODUCT PIPELINE
      • CORPORATE STRATEGY
        • Cohesion Technologies, Inc.
      • PATENTS
    • PHYTOMEDICS, INC.
      • BUSINESS OVERVIEW
      • PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
      • CORPORATE STRATEGY
    • PLANET BIOTECHNOLOGY, INC.
      • BUSINESS OVERVIEW
      • PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
        • Products in Development and Technology (Continued)
        • CaroRx
        • RhinoRx
        • DoxoRx
      • PATENTS
    • PPL THERAPEUTICS LLC
      • BUSINESS OVERVIEW
      • FINANCIAL INFORMATION
      • PRODUCTS IN DEVELOPMENT
        • Alpha-1 Antitrypsin
        • Fibrin Sealant
      • TECHNOLOGY
        • Technology (Continued)
      • CORPORATE STRATEGY
      • PATENTS
    • PRODIGENE INC.
      • BUSINESS OVERVIEW
      • PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
        • Products in Development and Technology (Continued)
      • CORPORATE STRATEGY
      • PATENTS
    • SEMBIOSYS GENETICS, INC.
      • BUSINESS OVERVIEW
      • TECHNOLOGY
        • Stratosome Biologics System
          • Advantages
      • CORPORATE STRATEGY
      • PATENTS
    • SIGMA-ALDRICH CORP.
      • BUSINESS OVERVIEW
      • FINANCIAL INFORMATION
      • PRODUCTS AND SERVICES
      • CORPORATE STRATEGY
    • SUNOL MOLECULAR CORP.
      • BUSINESS OVERVIEW
      • TRANSGENIC PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
      • CORPORATE STRATEGY
      • PATENTS
    • TRANXENOGEN, INC.
      • BUSINESS OVERVIEW
      • FINANCIAL INFORMATION
      • PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
      • CORPORATE STRATEGY
    • VENTRIA BIOSCIENCE
      • BUSINESS OVERVIEW
      • PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
        • Products in Development and Technology (Continued)
      • CORPORATE STRATEGY
    • VIRAGEN, INC.
      • BUSINESS OVERVIEW
      • FINANCIAL INFORMATION
      • PRODUCTS AND TRANSGENICS TECHNOLOGY
        • Avian Transgenics
        • Interferon
        • Oncology Therapies
      • CORPORATE STRATEGY
        • Recent Collaborative Agreements Related to Avian Transgenics
      • PATENTS

LIST OF TABLES

Summary Table:
PROJECTED SALES OF TRANSGENICALLY PRODUCED THERAPEUTICS: WORLDWIDE SALES, THROUGH 2013 ($ MILLIONS)
Table 1 U.S. DEMAND FOR BIOLOGICS, THROUGH 2008 ($ MILLIONS)
Table 2 MONOCLONAL ANTIBODY BIOPROCESSING MARKET: U.S., THROUGH 2008 ($ MILLIONS)
Table 3 SELECTED PROTEIN DRUGS AND THEIR SOURCE CELLS
Table 4 ESTIMATED CAPACITY REQUIREMENTS FOR SELECTED CURRENTLY MARKETED PROTEIN PRODUCTS
Table 5 ESTIMATED MAMMALIAN CELL CULTURE MANUFACTURING CAPACITIES FOR SELECTED COMPANIES
Table 6 REASONS FOR THE NEED TO INCREASE PROTEIN DRUG PRODUCTION
Table 7 U.S. BIOPHARMACEUTICALS CONTRACT MANUFACTURING MARKET, THROUGH 2008 ($ MILLIONS)
Table 8 BENEFITS OF TRANSGENIC PLANT-BASED BIOTHERAPEUTICS PRODUCTION
Table 9 MODEL FOR PRODUCTION COST COMPARISON OF TRADITIONAL MANUFACTURING TECHNOLOGIES VERSUS TRANSGENIC SOURCES TO PRODUCE A BIOPHARMACEUTICAL PRODUCT
Table 10 COST COMPARISON (INCLUDING CAPITAL AND OPERATING COSTS) OF TRADITIONAL VERSUS TRANSGENIC BIOPHARMACEUTICAL PRODUCTION METHODS ($ PER GRAM OF PROTEIN)
Table 11 COMPARISON OF CAPITAL COSTS FOR A THERAPEUTIC PROTEIN PRODUCED FROM CELL CULTURE VERSUS A THERAPEUTIC PROTEIN PRODUCED FROM THE MILK OF TRANSGENIC GOATS
Table 12 COMPARISON OF OPERATING COSTS FOR A THERAPEUTIC PROTEIN PRODUCED FROM CELL CULTURE VERSUS A THERAPEUTIC PROTEIN PRODUCED FROM THE MILK OF TRANSGENIC GOATS
Table 13 REASONS FOR THE POPULARITY OF MOLECULAR PHARMING TO PRODUCE BIOTHERAPEUTICS
Table 14 CHARACTERISTICS OF SELECTED TRANSGENIC ANIMALS USED IN THERAPEUTIC HUMAN PROTEIN PRODUCTION
Table 15 CHARACTERISTICS OF DIFFERENT PLANT HOSTS
Table 16 SPECIFIC TRANSGENIC CROPS AND POTENTIALLY PRODUCIBLE HUMAN THERAPEUTICS
Table 17 PROTEINS PRODUCED IN TRANSGENIC PLANTS BY APPLICATION AND PLANT HOST
Table 18 PRODUCTION OF PURE RECOMBINANT PROTEINS
Table 19 TECHNOLOGY COMPARISON: STABLE TRANSFORMATION VERSUS TRANSIENT EXPRESSION
Table 20 LEADING COMPANIES INVOLVED IN AVIAN TRANSGENICS
Table 21 BENEFITS OF TRANSGENIC CORN-BASED PRODUCTION
Table 22 COMPARISON OF COSTS FOR TRADITIONAL CORN CROPS AND TRANSGENIC CORN CROPS
Table 23 CURRENT APPLICATIONS OF VIBRATING MEMBRANE FILTRATION TECHNOLOGY
Table 24 PROJECTED SALES OF TRANSGENICALLY PRODUCED THERAPEUTICS: WORLDWIDE SALES, THROUGH 2013 ($ MILLIONS)
Table 25 WORLDWIDE SALES OF BIOPHARMACEUTICALS, THROUGH 2008 ($ MILLIONS)
Table 26 THERAPEUTIC PROTEIN MARKET: WORLDWIDE SALES OF SELECTED AVAILABLE PRODUCTS, THROUGH 2013 ($ MILLIONS)
Table 27 WORLDWIDE SALES OF GLYCOPROTEIN DRUGS, THROUGH 2008 ($ MILLIONS)
Table 28 WORLDWIDE SALES OF MONOCLONAL ANTIBODY-BASED DRUGS, THROUGH 2008 ($ MILLIONS)
Table 29 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED STRUCTURAL PROTEINS, THROUGH 2013 ($ MILLIONS)
Table 30 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED BLOOD PRODUCTS, THROUGH 2013 ($ MILLIONS)
Table 31 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED COMPLEX PROTEINS, THROUGH 2013 ($ MILLIONS)
Table 32 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED ENZYMES, THROUGH 2013 ($ MILLIONS)
Table 33 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED MONOCLONAL ANTIBODIES, THROUGH 2013 ($ MILLIONS)
Table 34 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF VACCINE PRODUCTS, THROUGH 2013 ($ MILLIONS)
Table 35 THERAPEUTIC PROTEINS IN PHASE I OR LATER DEVELOPMENT FROM TRANSGENIC SOURCES
Table 36 OTHER DRUGS POTENTIALLY GENERATED FROM TRANSGENIC ANIMALS
Table 37 THERAPEUTIC PLANTIBODIES: APPLICATION AND SPECIFICITY, SIGNAL SEQUENCES AND PLANT SOURCE
Table 38 U.S. MARKET FOR HUMAN SERUM ALBUMIN, THROUGH 2008
Table 39 WORLDWIDE INCIDENCE/PREVALENCE OF SELECTED DISEASES AMENABLE TO PROPHYLACTIC OR THERAPEUTIC IMMUNIZATION
Table 40 THE MARKET FOR VACCINES: WORLDWIDE SALES, THROUGH 2008 ($ MILLIONS)
Table 41 THE MARKET FOR ADULT HEPATITIS B VACCINES: WORLDWIDE SALES, THROUGH 2008 ($ MILLIONS)
Table 42 THE MARKET FOR RABIES VACCINES: WORLDWIDE SALES, THROUGH 2008 ($ MILLIONS)
Table 43 PROTEINS PRODUCED BY TRANSGENIC PLANTS WITH APPLICATION TO VACCINES
Table 44 NUMBER OF TRANSPLANTS PERFORMED BY TYPE: U.S., 2002
Table 45 NUMBER OF PATIENTS WAITING FOR TRANSPLANTS, BY ORGAN/TISSUE TYPE: U.S., NOVEMBER 2003
Table 46 CONSUMER OPINION ABOUT TRANSGENIC-PLANT BASED PHARMACEUTICALS: U.S. AND CANADA (%)
Table 47 SELECTED COMPANIES DEVELOPING TRANSGENIC PLANT-BASED HUMAN PHARMACEUTICALS
Table 48 PATENTS RELATING TO PRODUCTION OF HUMAN THERAPEUTICS IN TRANSGENIC SOURCES ISSUED BY THE U.S. PATENT AND TRADEMARK OFFICE
Table 49 ABGENIX'S PRODUCT PIPELINE
Table 50 ABGENIX'S CORPORATE PARTNERSHIPS
Table 51 UNIQUE TRANSGENIC PLANT ADVANTAGES OF THE LEX SYSTEM
Table 52 GTC'S EXTERNAL PROGRAMS COLLABORATIONS
Table 53 MEDAREX'S PRODUCT PIPELINE
Table 54 NEXIA'S PRODUCT PIPELINE
Table 55 PHARMING'S PRODUCT PIPELINE  

LIST OF FIGURES

Summary Figure:
PROJECTED SALES OF TRANSGENICALLY PRODUCED THERAPEUTICS: WORLDWIDE SALES, 2003-2013 ($ MILLIONS)
Figure 1 U.S. DEMAND FOR BIOLOGICS, 2002-2008 ($ MILLIONS)
Figure 2 MONOCLONAL ANTIBODY BIOPROCESSING MARKET: U.S., 2002-2008 ($ MILLIONS)
Figure 3 U.S. BIOPHARMACEUTICALS CONTRACT MANUFACTURING MARKET, 2002-2008 ($ MILLIONS)
Figure 4 PROJECTED SALES OF TRANSGENICALLY PRODUCED THERAPEUTICS: WORLDWIDE SALES, 2003-2013 ($ MILLIONS)
Figure 5 WORLDWIDE SALES OF BIOPHARMACEUTICALS, 2002-2008 ($ MILLIONS)
Figure 6 WORLDWIDE SALES OF GLYCOPROTEIN DRUGS, 2002-2008 ($ MILLIONS)
Figure 7 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED STRUCTURAL PROTEINS, 2003-2013 ($ MILLIONS)
Figure 8 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED BLOOD PRODUCTS, 2003-2013 ($ MILLIONS)
Figure 9 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED COMPLEX PROTEINS, 2003-2013 ($ MILLIONS)
Figure 10 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED ENZYMES, 2003-2013 ($ MILLIONS)
Figure 11 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF SELECTED MONOCLONAL ANTIBODIES, 2003-2013 ($ MILLIONS)
Figure 12 TRANSGENICALLY PRODUCED THERAPEUTIC PROTEIN MARKET: ESTIMATED WORLDWIDE SALES OF VACCINE PRODUCTS, 2003-2013 ($ MILLIONS)
Figure 13 THE MARKET FOR VACCINES: WORLDWIDE SALES, 2002-2008 ($ MILLIONS)
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