The Market for In Vitro Toxicology Testing

Table of Contents

• INTRODUCTION
  • STUDY GOALS AND OBJECTIVES
  • REASONS FOR DOING THIS STUDY
  • CONTRIBUTIONS TO THE STUDY AND FOR WHOM
  • SCOPE AND FORMAT
  • METHODOLOGY
  • INFORMATION SOURCES
  • ABOUT THE AUTHOR
  • RELATED BCC WORK CREDENTIALS
  • OTHER RELATED BCC REPORTS
  • DISCLAIMER
• SUMMARY
  • Summary Table:
  • U.S. MARKET FORECAST FOR IN VITRO TOXICITY TESTING BY TECHNOLOGY, THROUGH 2011 ($ MILLIONS)
  • Summary Figure:
  • SEGMENTATION BY TECHNOLOGY APPROACH, 2004-2011 ($ MILLIONS)
• OVERVIEW
  • OVERVIEW
  • INTRODUCTION TO TOXICOLOGY
    • BASIC PRINCIPLES OF TOXICOLOGY
    • AGENTS OF TOXICOLOGY AND THEIR CLASSIFICATION
  • Table 1 TYPES OF SYSTEMIC TOXICITY
    • FACTORS INFLUENCING TOXICITY OF A SUBSTANCE
      • Means of Exposure
      • Dose Expressions and Dose Response Functions
  • Table 2 TYPE OF DOSES
    • Disposition of Toxicants
  • DEVELOPMENT OF TOXICOLOGY
  • Figure 1 CLASSICAL APPROACH
    • DEVELOPMENT OF TOXICOLOGY (CONTINUED)
  • Figure 2 ALTERNATIVE APPROACH
    • CLASSES OF TESTS
      • DISTINGUISHED BY SPECIFIC END POINT
        • Reproductive and Developmental Toxicity
          • Screening Assays -Level Reproductive-Toxicity
          • Prenatal Developmental-Toxicity Study and Teratology Study
          • Generational Tests
          • Reproductive Assessment by Continuous Breeding
        • Neurotoxicity
        • Immunotoxicity
        • Genotoxicity
          • Gene or Point Mutations
          • Chromosomal Aberrations
          • DNA Damage
        • Carcinogenicity
  • Table 3 IN VITRO TESTS FOR DIFFERENT TOXICITY END POINTS
    • Acute Toxicity Testing
      • LD50
  • Table 4 EPA ACUTE-TOXICITY CATEGORIES
    • Chronic Toxicity Testing
    • Sub-Chronic or Repeated-Dose Toxicity Testing
    • Subacute Testing
  • TYPES OF TOXICOLOGY
  • Table 5 CLINICAL TOXICOLOGY IN THE HOSPITAL SETTING
  • Table 6 FORENSIC TOXICOLOGY, APPLICATION IN THE MEDICAL EXAMINER' S OFFICE
  • Table 7 INDUSTRIAL TOXICOLOGY
  • Table 8 PRODUCT DEVELOPMENT TOXICOLOGY, IN THE BUSINESS/CORPORATE ARENA
  • Table 9 REGULATORY TOXICOLOGY IN INDUSTRY AND GOVERNMENT SETTINGS
    • TECHNICAL OVERVIEW
      • TOXICITY TESTING STRATEGIES
  • Table 10 FOCAL POINTS FOR ALTERNATIVE APPROACHES IN TOXICITY TESTING
    • TYPES OF TOXICITY-TESTING STRATEGIES
  • Table 11 DIFFERENT APPROACHES TO IN VITRO TESTS
    • ALTERNATIVE TOXICOLOGY METHODS FOR DIFFERENT TOXICITY CATEGORIES
      • Cytotoxicity
      • In Vitro Tests for Cellular Toxicity and Other End points
  • Table 12 VALIDATED ASSAYS FOR CYTOTOXICITY EVALUATION
  • Table 12 (CONTINUED)
    • Specific Target End Point Toxicity
  • Table 13 COMPARISON OF IN VITRO SYSTEMS FOR HEPATOTOXICITY STUDIES
    • Ocular Toxicity
      • In Vitro Methods for Ocular Irritation
        • BCOP
        • HET-CAM
        • ICE Test
        • The IRE Test
  • Table 14 COMPARISON OF ALTERNATIVE IN VITRO APPROACHES TO THE CONVENTIONAL MODEL
    • EpiOcular
  • In Vitro Tests for Dermal Corrosivity
    • CORROSITEX
    • TER ASSAY
  • Frog Embryo Teratogenesis Assay-Xenopus (FETAX ) Test Assay for Developmental Toxicity
  • In Vitro Endocrine Screening Disruptor Assays
  • The Local Lymph Node Assay (LLNA)
  • In Vitro 3T3 NRU Phototoxicity Test
  • In Vitro Tests for Pyrogenicity
• VALIDATION
  • SIGNIFICANCE OF VALIDATION
    • SIGNIFICANCE OF VALIDATION (CONTINUED)
    • SIGNIFICANCE OF VALIDATION (CONTINUED)
  • Figure 3 FLOWCHART ILLUSTRATING THE IMPORTANCE OF VALIDATION
    • SIGNIFICANCE OF VALIDATION (CONTINUED)
    • SIGNIFICANCE OF VALIDATION (CONTINUED)
  • CHALLENGES FACING VALIDATION
    • LOGISTICAL SIMPLIFICATION OF DATA GENERATION AND AVAILABILITY
    • LACK OF AVAILABLE GUIDANCE ON TESTING APPROACHES VIS-À-VIS TESTING METHODS
    • UNSTEADY FLOW OF NEW TEST METHODS FOR VALIDATION
    • UNSTEADY FLOW (CONTINUED)
• COMPANY PROFILES
  • ACCELRYS SOFTWARE, INC.
  • BIO-RAD LABORATORIES
  • BIORELIANCE INVITROGEN BIOSERVICES
  • CEETOX, INC.
  • COVANCE, INC.
  • GENEGO, INC.
  • GENE LOGIC, INC.
    • GENE LOGIC, INC. (CONTINUED)
  • HTG, ARIZONA
  • ICONIX BIOSCIENCES, INC.
  • IN VITRO INTERNATIONAL
  • IN VITRO TECHNOLOGIES
  • MATTEK CORPORATION
    • MATTEK CORPORATION (CONTINUED)
  • MOLECULAR TOXICOLOGY, INC.
  • TECAN GROUP AG
  • XENOBIOTIC DETECTION SYSTEMS (XDS)
  • XENOMETRIX
• MARKETS BY TECHNOLOGY
  • MARKETS BY TECHNOLOGY
  • Table 15 SEGMENTATION FOR ALTERNATIVE APPROACHES TO TOXICITY (PREDICTIVE TOXICITY TESTING)
    • SIGNIFICANT TECHNOLOGY DEVELOPMENTS
      • ALTERNATIVES METHODS IN TOXICOLOGY TESTING
        • 3R Approach
  • Table 16 ADVANTAGES AND LIMITATIONS OF IN VITRO ORGANOTYPIC CONSTRUCTS
    • Reduction Alternative
    • Replacement Alternative
    • Refinement
      • Use of Alternative Species
  • OVERVIEW OF HIGH ENABLING TECHNOLOGIES
    • Toxicogenomics
      • Toxicogenomics (Continued)
  • Table 17 MAJOR COMPANIES IN TOXICOGENOMICS RESEARCH
    • Microarrays
    • Proteomics
    • Metabolomics
    • Bioinformatics
    • Computational Toxicology
      • Structure-Activity Relationships
      • Physiologically Based Pharmacokinetic Models (PBPK)
  • Table 18 APPLICATIONS OF PBPK MODELS
    • Biologically Based Dose-Response (BBDR) Models
      • Computational Approaches to Predicting Metabolic Fate
  • Table 19 COMMERCIALLY AVAILABLE SYSTEMS FOR METABOLIC FATE PREDICTION
    • Future Uses of Computational Toxicology
      • In Silico Modeling
      • Technology Hurdles
      • Standardization of Data Sets: A Critical Barrier Needing Immense Attention
      • Dynamic Complex Biological Processes
      • Statistical Techniques Face Some Impediments
      • Toxicogenomics Techniques Face Economic Realities
  • Table 20 CHALLENGES FACED BY TOXICOGENOMICS
  • Table 21 STRENGTHS, WEAKNESSES, OPPORTUNITIES, AND THREATS (SWOT) TO OMICS TECHNOLOGIES
  • Table 21 (CONTINUED)
    • ROADMAP FOR THE FUTURE
      • Roadmap for the Future (Continued)
• REVENUE FORECASTS BY TECHNOLOGY
  • REVENUE FORECASTS BY TECHNOLOGY
    • REVENUE FORECASTS BY ... (CONTINUED)
      • OBSERVATIONS
  • Table 22 U.S. IN VITRO TOXICITY TESTING MARKETS: CONTRIBUTION BY TECHNOLOGY
  • Table 23 U.S. MARKET FORECAST FOR IN VITRO TOXICITY TESTING BY TECHNOLOGY, THROUGH 2011 ($ MILLIONS)
  • Figure 4 U.S. IN VITRO TOXICITY TESTING MARKET FORECAST, NON-MECHANISTIC VS. MECHANISTIC APPROACH, 2006 AND 2011 ($ MILLIONS)
  • Figure 5 ESTIMATED CONTRIBUTION OF TECHNOLOGY SEGMENTS FOR THE U.S. IN VITRO TOXICITY TESTING MARKETS (%)
• PATENT ANALYSIS
  • Table 24 U.S. PATENTS ISSUED FOR IN VITRO TOXICITY RESEARCH
  • Table 24 (CONTINUED)
  • Table 24 (CONTINUED)
  • Table 25 SEGMENTATION OF PATENTS BY ORGANIZATIONS
  • Table 26 SEGMENTATION OF PATENTS BY TECHNOLOGIES
    • PATENT ABSTRACTS PERTAINING TO TOXICOLOGY SCREENING
      • UNIVERSITEIT GENT (U.S. PATENT NUMBER: 6,436,630)
      • ANTI-CANCER, INC. (U.S. PATENT NUMBER: 6,399,380)
      • WISCONSIN ALUMNI RESEARCH FOUNDATION (U.S. PATENT NUMBER: 6,150,126)
      • PHARMACIA & UPJOHN COMPANY (U.S. PATENT NUMBER: 6,998,249)
      • LYNX THERAPEUTICS, INC. (U.S. PATENT NUMBER: 6,228,589)
      • THE PROCTER & GAMBLE COMPANY (U.S. PATENT NUMBER: 6,020,148)
      • LION BIOSCIENCE AG (U.S. PATENT NUMBER: 6,996,473)
      • U.S. Patent Number: 6,542,858
      • TRELLIS BIOSCIENCE, INC. (U.S. PATENT NUMBER: 7,060,447)
      • PHYLONIX PHARMACEUTICALS, INC. (U.S. PATENT NUMBER: 6,299,858)
      • BRISTOL-MYERS SQUIBB COMPANY (U.S. PATENT NUMBER: 7,041,501)
      • OTSUKA PHARMACEUTICAL CO., LTD. (U.S. PATENT NUMBER: 7,018,806)
      • EXONHIT THERAPEUTICS S.A. (U.S. PATENT NUMBER: 6,881,571)
• INDUSTRY COMPETITIVENESS
  • INDUSTRY TRENDS FOR IN VITRO TOXICITY TESTING
    • INTRODUCTION
    • MARKET OVERVIEW
      • Market Lifecycle
  • Figure 6 U.S. IN VITRO TOXICITY TESTING MARKETS: MARKET LIFECYCLE, 2006
    • Segmentation
      • INDUSTRY STRUCTURE
      • INDUSTRY STRUCTURE (CONTINUED)
  • Table 27 COMPANIES PROVIDING TOXICITY TESTING SERVICES
  • Table 28 IN VITRO TOXICITY TESTING SUPPLIERS (DEDICATED/NON-DEDICATED)
  • Table 28 (CONTINUED)
  • Table 29 U.S. IN VITRO TOXICITY TESTING MARKET FORECASTS, THROUGH 2011 ($ MILLION)
    • COMPETITIVE FRAMEWORK
  • Figure 7 COMPETITIVE FRAMEWORK
    • Pricing Trends
    • International Scenario
  • Table 30 GLOBAL MARKET FORECASTS AND SHARES OF IN VITRO TOXICITY TESTING, THROUGH 2011 ($ MILLION)
  • Table 31 EUROPEAN IN VITRO TOXICITY TESTING MARKET FORECASTS AND SHARES, THROUGH 2011 ($ MILLION)
    • International Scenario (Continued)
      • International ... (Continued)
  • Table 32 EUROPEAN IN VITRO TOXICITY TESTING MARKET FORECASTS BY INDUSTRY, THROUGH 2011 ($ MILLIONS)
• MARKET TRENDS BY INDUSTRY SECTOR FOR IN VITRO TOXICITY TESTING
  • COSMETICS AND HOUSEHOLD PRODUCTS
    • COSMETICS AND ... (CONTINUED)
  • Table 33 COSMETIC MANUFACTURERS ADOPTING IN VITRO TESTING MEASURES
  • Table 33 (CONTINUED)
    • PHARMACEUTICAL INDUSTRY OUTLOOK
  • Table 34 PHARMACEUTICAL COMPANIES INVOLVED IN TOXICOGENOMICS RESEARCH
    • DRUG DISCOVERY AND DEVELOPMENT OVERVIEW
    • NEW PRODUCT DEVELOPMENTS AND ITS SIGNIFICANCE IN THE BIOPHARMACEUTICAL SECTOR
  • Figure 8 U.S. PHARMACEUTICAL R&D EXPENDITURE, 1970-2005
  • Figure 9 R&D EXPENDITURES, TOTAL AND AS A PERCENTAGE OF REVENUE, 1965-2003
    • The Need for Predictive Toxicity
      • Adverse Drug Reactions Fueling the Need for Predictive Toxicity
    • Typical Reasons for Drug Attrition
  • Table 35 MAJOR CAUSES OF DRUG ATTRITION (%)
  • Figure 10 DRUG R&D PROCESS
  • Table 36 STAGES OF DRUG DEVELOPMENT AND PERCENTAGE SHARES OF R&D EXPENDITURE (%)
  • Figure 11 REASONS FOR DRUG ATTRITION AT THE LEAD OPTIMIZATION PHASE
    • Typical Reasons for Drug Attrition (Continued)
  • Table 37 KEY FEATURES TO GENERATE LEAD COMPOUNDS
  • Table 38 SWOT ANALYSIS FOR THE IN VITRO TOXICITY TESTING MARKET IN THE PHARMACEUTICAL INDUSTRY, 2006
  • Table 39 TOP PHARMACEUTICAL MANUFACTURERS' CHALLENGES AND THEIR IMPACT, 2006-2011
  • Table 40 IMPACT OF END USER CHALLENGES, 2006-2011
    • FOOD INDUSTRY
      • FOOD INDUSTRY (CONTINUED)
  • Table 41 DISADVANTAGES OF IN VITRO SYSTEMS SUCH AS INTACT CELLS, TISSUE SLICES, AND ORGAN CULTURES
    • TOXICITY TESTING STRATEGIES
      • Federal Insecticide, Fungicide, and Rodenticide Act Testing Program
  • Table 42 BATTERY OF TESTS REQUIRED BY EPA FOR NEW PESTICIDE CHEMICALS
    • Microbial Pest-Control Agents Testing Program
    • FDA Testing Strategies for Food Additives
  • Table 43 TOXICITY TESTS FOR MICROBIAL PEST-CONTROL AGENTS
  • Table 44 CONCERN LEVELS FOR DIRECT FOOD ADDITIVES
  • Table 45 TESTING REQUIREMENTS FOR DIRECT AND INDIRECT FOOD ADDITIVES
    • CHEMICALS INDUSTRY
      • THE HIGH PRODUCTION VOLUME CHALLENGE PROGRAM (HPV)
        • Shortcomings of the HPV Implementation
        • Conclusion
      • REACH PROGRAM
        • Toxicogenomics and Its Potential to Assess Environmental Carcinogens
  • Table 46 POTENTIAL OF TOXICOGENOMICS FOR ENVIRONMENTAL CARCINOGENS
    • TOXICITY-TESTING STRATEGIES FOR SCREENING OF INDUSTRIAL CHEMICALS
      • The Toxic Substances Control Act and the High-Production-Volume Chemical Testing Program
  • Table 47 BASIC SCREENING INFORMATION DATA SET TESTING BATTERY
    • TESTING STRATEGIES FOR SCREENING CHEMICALS ADDRESSING SPECIFIC SYSTEM END POINTS
      • EPA Endocrine-Disruptor Testing Strategy
  • Table 48 DIFFERENT CATEGORIES OF CHEMICALS TO PRIORITIZE TESTING METHODS
  • Table 49 ENDOCRINE-DISRUPTOR SCREENING TESTS
    • OECD Endocrine-Disruptor Testing Strategy
    • Developmental-Toxicity Testing
  • Table 50 OECD CONCEPTUAL FRAMEWORK FOR TESTING ENDOCRINE DISRUPTORS
    • Developmental-Toxicity ... (Continued)
    • Developmental-Toxicity ... (Continued)
  • Conclusion
• MARKETS BY INDUSTRY APPLICATIONS: REVENUE FORECASTS
  • MARKETS BY INDUSTRY APPLICATIONS: REVENUE FORECASTS
    • MARKETS BY INDUSTRY: ... (CONTINUED)
  • Table 51 U.S. MARKETS FOR IN VITRO TOXICITY TESTING INDUSTRY BY SEGMENT, THROUGH 2011 ($ MILLION)
  • Table 52 U.S. MARKET FORECAST FOR IN VITRO ADME/TOX REVENUE SHARE BY SEGMENT, THROUGH 2011 ($ MILLIONS)
  • Table 53 U.S. IN VITRO TOXICITY TESTING MARKET FORECAST BY TEST CATEGORY IN COSMETICS, THROUGH 2011($ MILLION)
  • Table 54 SEGMENTATION OF EXPECTED SHARE IN THE IN VITRO TOXICITY MARKETS BY INDUSTRY, 2006 AND 2011 (%)
  • Figure 12 SEGMENTATION REVENUE ANALYSIS FOR THE IN VITRO TOXICITY TESTING IN THE PHARMACEUTICAL INDUSTRY, 2006 (%)
  • Figure 13 U.S. IN VITRO TESTING MARKET, BY INDUSTRY, 2006 ($ MILLIONS)
    • GROWTH FACTORS
      • Safety Concerns Are Impelling the Need for Better Modes of Toxicity Testing Measures
      • Paucity of Information on the Dose-Response Relationship
      • Guidance from FDA and Other Federal Institutions Further the Adoption Rate
      • Faster Turn Around Time Hopes to Improve Adoption Rate of These Enabling Technologies
      • Biomarkers Show Potential for Toxicity Tests
    • INHIBITORS
      • Disincentive toward Sharing Data
      • Limited Data Availability and Experimental Facts Might Slow Market Growth
      • Limited Funding for Validation of Alternative Approaches
      • Attitude of Regulatory Authorities Impedes Growth
  • Table 55 CRITICAL BARRIERS IMPEDING THE USE OF ALTERNATIVE METHODS
  • Table 56 TECHNICAL BARRIERS AND RECOMMENDATIONS
  • Table 56 (CONTINUED)
  • Table 57 REGULATORY BARRIERS AND RECOMMENDATIONS
• REGULATORY OVERVIEW
  • REGULATORY OVERVIEW
  • PRINCIPAL CHALLENGES
  • FUTURE OPPORTUNITIES
  • INSTITUTIONS THAT IMPACT TOXICITY TESTING MEASURES
  • Table 58 SOME MAJOR U.S. REGULATORY AGENCIES, PUBLIC-HEALTH GOALS, AND RISK-MANAGEMENT APPROACHES
    • AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY
      • Overview
      • ATSDR and Toxicology
    • CASE STUDIES IN ENVIRONMENTAL MEDICINE (CSEM)
      • Introduction
      • ToxFAQs
    • FOOD AND DRUG ADMINISTRATION
      • Overview
      • FDA and Toxicology
    • CIIT CENTERS FOR HEALTH RESEARCH (CIIT)
      • Overview
      • CIIT Centers for Health Research and Toxicology
  • Table 59 CIIT MEMBER COMPANIES
  • Table 59 (CONTINUED)
  • Table 60 CIIT SPONSORS 2005
  • Table 60 (CONTINUED)
    • CONSUMER PRODUCTS SAFETY COMMISSION
      • Overview
      • CPSC and Toxicology
    • ENVIRONMENTAL PROTECTION AGENCY
      • Overview
      • EPA and Toxicology
  • Table 61 EPA' S PROGRAMS, PUBLIC HEALTH OBJECTIVES, AND EXECUTION FRAMEWORKS
    • ILSI HEALTH AND ENVIRONMENTAL SCIENCES INSTITUTE (HESI)
      • Overview
      • HESI and Toxicology
      • Development of Biomarkers of Toxicity
    • NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS)
      • Overview
      • National Toxicology Program
  • Table 62 NOMINATION RATIONALE FOR NTP STUDIES
    • Alternative Testing Approaches
    • Nanotechnology Initiative
      • Toxicogenomics
      • Phototoxicity
      • Endocrine Disruptors
    • ICCVAM AND NICETAM
      • Overview
  • Table 63 FEDERAL AGENCIES PARTICIPATING IN ICCVAM
  • Table 63 (CONTINUED)
  • Table 64 ICCVAM STRATEGIC PRIORITIES
    • INTERNATIONAL AGENCY FOR RESEARCH ON CANCER (IARC)
      • Overview
    • SCIENTIFIC GROUP ON METHODOLOGIES FOR THE SAFETY EVALUATION OF CHEMICALS (SGOMSEC)
    • TOXICOLOGY DATABASES
      • Extoxnet
      • HSDB (Hazardous Substances Databank)
      • TOXLINE
      • IRIS (Integrated Risk Information System)
      • CCRIS (Chemical Carcinogenesis Research Information System)
      • Gene-Tox (Genetic Toxicology Data Bank)
      • ITER (International Toxicity Estimates for Risk)
      • ChemIDplus (Chemical Identification Plus)
      • DART/ETIC (Developmental and Reproductive Toxicology/ Environmental Teratology Information Center
      • TRI (Toxics Release Inventory)
      • Haz-Map
      • Household Product Database
      • Toxmap
      • DSSTOX (Distributed Structure-Searchable Toxicity Database Network)
      • CPDB (Carcinogenic Potency Database)
      • TETRATOX
      • Acute Toxicity Database
  • Table 65 TOXICITY DATABASES
• LIST OF TABLES
  • Summary Table:
  • U.S. MARKET FORECAST FOR IN VITRO TOXICITY TESTING BY TECHNOLOGY, THROUGH 2011 ($ MILLIONS)
  • Table 1 TYPES OF SYSTEMIC TOXICITY
  • Table 2 TYPE OF DOSES
  • Table 3 IN VITRO TESTS FOR DIFFERENT TOXICITY END POINTS
  • Table 4 EPA ACUTE-TOXICITY CATEGORIES
  • Table 5 CLINICAL TOXICOLOGY IN THE HOSPITAL SETTING
  • Table 6 FORENSIC TOXICOLOGY, APPLICATION IN THE MEDICAL EXAMINERS OFFICE
  • Table 7 INDUSTRIAL TOXICOLOGY
  • Table 8 PRODUCT DEVELOPMENT TOXICOLOGY, IN THE BUSINESS/CORPORATE ARENA
  • Table 9 REGULATORY TOXICOLOGY IN INDUSTRY AND GOVERNMENT SETTINGS
  • Table 10 FOCAL POINTS FOR ALTERNATIVE APPROACHES IN TOXICITY TESTING
  • Table 11 DIFFERENT APPROACHES TO IN VITRO TESTS
  • Table 12 VALIDATED ASSAYS FOR CYTOTOXICITY EVALUATION
  • Table 13 COMPARISON OF IN VITRO SYSTEMS FOR HEPATOTOXICITY STUDIES
  • Table 14 COMPARISON OF ALTERNATIVE IN VITRO APPROACHES TO THE CONVENTIONAL MODEL
  • Table 15 SEGMENTATION FOR ALTERNATIVE APPROACHES TO TOXICITY (PREDICTIVE TOXICITY TESTING)
  • Table 16 ADVANTAGES AND LIMITATIONS OF IN VITRO ORGANOTYPIC CONSTRUCTS
  • Table 17 MAJOR COMPANIES IN TOXICOGENOMICS RESEARCH
  • Table 18 APPLICATIONS OF PBPK MODELS
  • Table 19 COMMERCIALLY AVAILABLE SYSTEMS FOR METABOLIC FATE PREDICTION
  • Table 20 CHALLENGES FACED BY TOXICOGENOMICS
  • Table 21 STRENGTHS, WEAKNESSES, OPPORTUNITIES, AND THREATS (SWOT) TO OMICS TECHNOLOGIES
  • Table 22 U.S. IN VITRO TOXICITY TESTING MARKETS: CONTRIBUTION BY TECHNOLOGY
  • Table 23 U.S. MARKET FORECAST FOR IN VITRO TOXICITY TESTING BY TECHNOLOGY, THROUGH 2011 ($ MILLIONS)
  • Table 24 U.S. PATENTS ISSUED FOR IN VITRO TOXICITY RESEARCH
  • Table 25 SEGMENTATION OF PATENTS BY ORGANIZATIONS
  • Table 26 SEGMENTATION OF PATENTS BY TECHNOLOGIES
  • Table 27 COMPANIES PROVIDING TOXICITY TESTING SERVICES
  • Table 28 IN VITRO TOXICITY TESTING SUPPLIERS (DEDICATED/NON-DEDICATED)
  • Table 29 U.S. IN VITRO TOXICITY TESTING MARKET FORECASTS, THROUGH 2011 ($ MILLION)
  • Table 30 GLOBAL MARKET FORECASTS AND SHARES OF IN VITRO TOXICITY TESTING, THROUGH 2011 ($ MILLION)
  • Table 31 EUROPEAN IN VITRO TOXICITY TESTING MARKET FORECASTS AND SHARES, THROUGH 2011 ($ MILLION)
  • Table 32 EUROPEAN IN VITRO TOXICITY TESTING MARKET FORECASTS BY INDUSTRY, THROUGH 2011 ($ MILLIONS)
  • Table 33 COSMETIC MANUFACTURERS ADOPTING IN VITRO TESTING MEASURES
  • Table 34 PHARMACEUTICAL COMPANIES INVOLVED IN TOXICOGENOMICS RESEARCH
  • Table 35 MAJOR CAUSES OF DRUG ATTRITION (%)
  • Table 36 STAGES OF DRUG DEVELOPMENT AND PERCENTAGE SHARES OF R&D EXPENDITURE (%)
  • Table 37 KEY FEATURES TO GENERATE LEAD COMPOUNDS
  • Table 38 SWOT ANALYSIS FOR THE IN VITRO TOXICITY TESTING MARKET IN THE PHARMACEUTICAL INDUSTRY, 2006
  • Table 39 TOP PHARMACEUTICAL MANUFACTURERS' CHALLENGES AND THEIR IMPACT, 2006-2011
  • Table 40 IMPACT OF END USER CHALLENGES, 2006-2011
  • Table 41 DISADVANTAGES OF IN VITRO SYSTEMS SUCH AS INTACT CELLS, TISSUE SLICES, AND ORGAN CULTURES
  • Table 42 BATTERY OF TESTS REQUIRED BY EPA FOR NEW PESTICIDE CHEMICALS
  • Table 43 TOXICITY TESTS FOR MICROBIAL PEST-CONTROL AGENTS
  • Table 44 CONCERN LEVELS FOR DIRECT FOOD ADDITIVES
  • Table 45 TESTING REQUIREMENTS FOR DIRECT AND INDIRECT FOOD ADDITIVES
  • Table 46 POTENTIAL OF TOXICOGENOMICS FOR ENVIRONMENTAL CARCINOGENS
  • Table 47 BASIC SCREENING INFORMATION DATA SET TESTING BATTERY
  • Table 48 DIFFERENT CATEGORIES OF CHEMICALS TO PRIORITIZE TESTING METHODS
  • Table 49 ENDOCRINE-DISRUPTOR SCREENING TESTS
  • Table 50 OECD CONCEPTUAL FRAMEWORK FOR TESTING ENDOCRINE DISRUPTORS
  • Table 51 U.S. MARKETS FOR IN VITRO TOXICITY TESTING INDUSTRY BY SEGMENT, THROUGH 2011 ($ MILLIONS)
  • Table 52 U.S. MARKET FORECAST FOR IN VITRO ADME/TOX REVENUE SHARE BY SEGMENT, THROUGH 2011 ($ MILLIONS)
  • Table 53 U.S. IN VITRO TOXICITY TESTING MARKET FORECASTS BY TEST CATEGORY IN COSMETICS, THROUGH 2011
  • Table 54 SEGMENTATION OF EXPECTED SHARE IN THE IN VITRO TOXICITY MARKETS BY INDUSTRY, 2006 AND 2011 (%)
  • Table 55 CRITICAL BARRIERS IMPEDING THE USE OF ALTERNATIVE METHODS
  • Table 56 TECHNICAL BARRIERS AND RECOMMENDATIONS
  • Table 57 REGULATORY BARRIERS AND RECOMMENDATIONS
  • Table 58 SOME MAJOR U.S. REGULATORY AGENCIES, PUBLIC-HEALTH GOALS, AND RISK-MANAGEMENT APPROACHES
  • Table 59 CIIT MEMBER COMPANIES
  • Table 60 CIIT SPONSORS 2005
  • Table 61 EPA' S PROGRAMS, PUBLIC HEALTH OBJECTIVES, AND EXECUTION FRAMEWORKS
  • Table 62 NOMINATION RATIONALE FOR NTP STUDIES
  • Table 63 FEDERAL AGENCIES PARTICIPATING IN ICCVAM
  • Table 64 ICCVAM STRATEGIC PRIORITIES
  • Table 65 TOXICITY DATABASES
• LIST OF FIGURES
  • Summary Figure:
  • SEGMENTATION BY TECHNOLOGY APPROACH, 2004-2011 ($ MILLIONS)
  • Figure 1 CLASSICAL APPROACH
  • Figure 2 ALTERNATIVE APPROACH
  • Figure 3 FLOWCHART ILLUSTRATING THE IMPORTANCE OF VALIDATION
  • Figure 4 U.S. IN VITRO TOXICITY TESTING MARKET FORECAST, NON-MECHANISTIC VS. MECHANISTIC APPROACH, 2006 AND 2011 ($ MILLIONS)
  • Figure 5 ESTIMATED CONTRIBUTION OF TECHNOLOGY SEGMENTS FOR THE U.S. IN VITRO TOXICITY TESTING MARKETS (%)
  • Figure 6 U.S. IN VITRO TOXICITY TESTING MARKETS: MARKET LIFECYCLE, 2006
  • Figure 7 COMPETITIVE FRAMEWORK
  • Figure 8 U.S. PHARMACEUTICAL R&D EXPENDITURE, 1970-2005
  • Figure 9 R&D EXPENDITURES, TOTAL AND AS A PERCENTAGE OF REVENUE, 1965-2003
  • Figure 10 DRUG R&D PROCESS
  • Figure 11 REASONS FOR DRUG ATTRITION AT THE LEAD OPTIMIZATION PHASE
  • Figure 12 SEGMENTATION REVENUE ANALYSIS FOR THE IN VITRO TOXICITY TESTING IN THE PHARMACEUTICAL INDUSTRY, 2006 (%)
  • Figure 13 U.S. IN VITRO TESTING MARKET, REVENUE BY INDUSTRY, 2006 ($ MILLIONS)