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
- 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
- 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
- In Vitro Tests for Dermal Corrosivity
- 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
- 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)
- 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
- 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)
- 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)
- 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
- Table 63 FEDERAL AGENCIES PARTICIPATING IN ICCVAM
- Table 63 (CONTINUED)
- Table 64 ICCVAM STRATEGIC PRIORITIES
- INTERNATIONAL AGENCY FOR RESEARCH ON CANCER (IARC)
- 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)
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