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The Market for In Vitro Toxicology Testing

Product Type: Market Research Report Publication Date: Mar 29, 2007
 
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SUMMARY

Abstract

INTRODUCTION

Our key objective was to present a comprehensive analysis of the current in vitro toxicity testing market in the United States and its future direction.

SCOPE OF STUDY

This report contains:

  • An overview of the in-vitro toxicology testing market, explaining basic principles and practices, definitions, classes of tests, and the different types of toxicology
  • A technical overview that describes toxicology testing strategies, the various toxicology categories, and alternatives to the standard toxicology methods
  • An in-depth review of the current market status, historical market data, compound annual growth rates, and forecasts to 2011
  • Information on specific technology in the markets, including revenues and developments
  • A thorough analysis of patents and profiles of the major players.

ABOUT THE AUTHOR

Vanita Khetan is a healthcare domain analyst and an entrepreneur. She holds a bachelors degree in Chemistry and a postgraduate degree in Management. During the course of her career, she has analyzed U.S., European and Asian markets in biotechnology, pharmaceuticals, medical devices, wound care, and surgical goods. This is her first publication with BCC Research.

TABLE OF CONTENTS

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)

The Market for In Vitro Toxicology Testing

Publisher: Business Communications Co., Inc.

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