市場調査報告書：遺伝子改変による治療

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.

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
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
- 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)
- TRANSGENIC SOURCES FOR PROTEIN DRUGS
  - DEFINITION OF A TRANSGENIC
  - ADVANTAGES OF TRANSGENIC SOURCES
Table 8 BENEFITS OF TRANSGENIC PLANT-BASED BIOTHERAPEUTICS PRODUCTION
- 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)
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
- 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
- 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
- TRANSGENIC ANIMAL PRODUCTION SYSTEMS
  - CATTLE
  - CHICKENS
Table 20 LEADING COMPANIES INVOLVED IN AVIAN TRANSGENICS
- TRANSGENIC PLANT PRODUCTION SYSTEMS
  - ALFALFA
  - BANANA
  - CORN
Table 21 BENEFITS OF TRANSGENIC CORN-BASED PRODUCTION
Table 22 COMPARISON OF COSTS FOR TRADITIONAL CORN CROPS AND TRANSGENIC CORN CROPS
Table 22 (CONTINUED)
- 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
Table 23 CURRENT APPLICATIONS OF VIBRATING MEMBRANE FILTRATION TECHNOLOGY

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)
Table 26 THERAPEUTIC PROTEIN MARKET: WORLDWIDE SALES OF SELECTED AVAILABLE PRODUCTS, THROUGH 2013 ($ MILLIONS)
Table 26 (CONTINUED)
Table 27 WORLDWIDE SALES OF GLYCOPROTEIN DRUGS, THROUGH 2008 ($ MILLIONS)
Figure 6 WORLDWIDE SALES OF GLYCOPROTEIN DRUGS, 2002-2008 ($ MILLIONS)
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)
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)
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)
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)
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)
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
Table 37 THERAPEUTIC PLANTIBODIES: APPLICATION AND SPECIFICITY, SIGNAL SEQUENCES AND PLANT SOURCE
Table 37 (CONTINUED)
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)
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)
Table 43 PROTEINS PRODUCED BY TRANSGENIC PLANTS WITH APPLICATION TO VACCINES
Table 43 (CONTINUED)
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

REGULATORY

REGULATORY AGENCY RESPONSE TO THERAPEUTICS GENERATED FROM TRANSGENIC SOURCES-THE GREAT UNKNOWN
- OPPORTUNITIES FOR TRANSGENICALLY PRODUCED GENERIC BIOPHARMACEUTICALS
- REGULATION IN THE U.S.
- 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
- COMPETITION
- CONCERNS ABOUT TRANSGENIC PLANTS
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
- LEADING COMPANIES IN THE TRANSGENIC PLANT INDUSTRY

Table 47 SELECTED COMPANIES DEVELOPING TRANSGENIC PLANT-BASED HUMAN PHARMACEUTICALS
- 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
Table 50 ABGENIX'S CORPORATE PARTNERSHIPS
- 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
Table 51 UNIQUE TRANSGENIC PLANT ADVANTAGES OF THE LEX SYSTEM
- BIOPROTEIN TECHNOLOGIES
  - BUSINESS OVERVIEW
  - PRODUCTS IN DEVELOPMENT AND SERVICES
  - CORPORATE STRATEGY
  - PATENTS
- EPICYTE PHARMACEUTICALS
  - BUSINESS OVERVIEW
  - CORPORATE STRATEGY
- FARMACULE BIOINDUSTRIES PTY LTD.
  - BUSINESS OVERVIEW
  - PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
  - CORPORATE STRATEGY
  - PATENTS
- GTC BIOTHERAPEUTICS
  - BUSINESS OVERVIEW
  - FINANCIAL INFORMATION
  - PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
Table 52 GTC'S EXTERNAL PROGRAMS COLLABORATIONS
- INFIGEN
  - BUSINESS OVERVIEW
  - PRODUCTS IN DEVELOPMENT AND SERVICES
  - CORPORATE STRATEGY
  - PATENTS
- LARGE SCALE BIOLOGY CORP.
  - BUSINESS OVERVIEW
  - FINANCIAL INFORMATION
  - PRODUCTS IN DEVELOPMENT
  - TECHNOLOGY
  - SERVICES
  - CORPORATE STRATEGY
  - PATENTS
- MEDAREX, INC.
  - BUSINESS OVERVIEW
  - FINANCIAL INFORMATION
  - LEADING PRODUCT CANDIDATES
Table 53 MEDAREX'S PRODUCT PIPELINE
- 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
  - CORPORATE STRATEGY
  - PATENTS
- NEXGEN BIOTECHNOLOGIES
  - PRODUCTS IN DEVELOPMENT
  - CORPORATE STRATEGY
- NEXIA BIOTECHNOLOGIES INC.
  - BUSINESS OVERVIEW
  - FINANCIAL INFORMATION
  - PRODUCTS IN DEVELOPMENT
Table 54 NEXIA'S PRODUCT PIPELINE
- NEXTRAN
  - BUSINESS OVERVIEW
  - PRODUCTS IN DEVELOPMENT
  - CORPORATE STRATEGY
- PHARMING HOLDING NV
  - BUSINESS OVERVIEW
  - FINANCIAL INFORMATION
  - PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
Table 55 PHARMING'S PRODUCT PIPELINE
- PHYTOMEDICS, INC.
  - BUSINESS OVERVIEW
  - PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
  - CORPORATE STRATEGY
- PLANET BIOTECHNOLOGY, INC.
  - BUSINESS OVERVIEW
  - PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
  - PATENTS
- PPL THERAPEUTICS LLC
  - BUSINESS OVERVIEW
  - FINANCIAL INFORMATION
  - PRODUCTS IN DEVELOPMENT
  - TECHNOLOGY
  - CORPORATE STRATEGY
  - PATENTS
- PRODIGENE INC.
  - BUSINESS OVERVIEW
  - PRODUCTS IN DEVELOPMENT AND TECHNOLOGY
  - CORPORATE STRATEGY
  - PATENTS
- SEMBIOSYS GENETICS, INC.
  - BUSINESS OVERVIEW
  - TECHNOLOGY
  - 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
  - CORPORATE STRATEGY
- VIRAGEN, INC.
  - BUSINESS OVERVIEW
  - FINANCIAL INFORMATION
  - PRODUCTS AND TRANSGENICS TECHNOLOGY
  - CORPORATE STRATEGY
  - 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)

遺伝子改変による治療の市場

Therapeutics from Transgenic Sources

REPORT HIGHLIGHTS

INTRODUCTION

SCOPE OF STUDY

METHODOLOGY

INFORMATION SOURCES

TABLE OF CONTENTS

LIST OF TABLES

LIST OF FIGURES