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Diagnostics

The Market for In Vitro Toxicology Testing


Publication Date   March 2007
Publisher   Business Communications Company
Product Type   Report
Pages   177
ISBN Number   not applicable
Product Code   BCC062
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Summary


BCC's goal in conducting this study was to determine the current status of the U.S. in vitro toxicity testing market and assess its growth potential over the 5-year period from 2006 to 2011. We were particularly interested in understanding the current market scenario for alternative measures to animal testing. Predictive toxicology is often cross-referenced with in vitro methods. This report assesses the growth and market potential for these methods. In addition, we were interested in understanding the impact of these methods on different industry sectors.

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.

Report Highlights

  • The U.S. in vitro toxicity (predictive toxicity) testing market has been valued at $765 million in 2006. At a compound annual growth rate (CAGR) of 14.4%, the total U.S. market will grow to reach $1.5 billion by 2011.
  • Mechanistic toxicology testing had the highest growth through the forecast period, with an estimated CAGR of 21.8%. This sector of the market will be worth $720 million by 2011.
  • Non-mechanistic toxicology testing was the larger of the two sectors in 2006. Even with a CAGR of 9.4%, it will still maintain the majority of the market at $780 million in 2011.

Content


  • 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
    • BCC Online Services
    • 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
      • Factors Influencing Toxicity Of A Substance
        • Means Of Exposure
        • Dose Expressions And Dose Response Functions
        • Disposition Of Toxicants
      • Development Of Toxicology
    • 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
        • Acute Toxicity Testing
        • Ld50
        • Chronic Toxicity Testing
        • Sub-Chronic Or Repeated-Dose Toxicity Testing
        • Subacute Testing
    • Types Of Toxicology
    • Technical Overview
      • Toxicity Testing Strategies
      • Types Of Toxicity-Testing Strategies
      • Alternative Toxicology Methods For Different Toxicity Categories
        • Cytotoxicity
        • In Vitro Tests For Cellular Toxicity And Other End Points
        • Specific Target End Point Toxicity
        • Ocular Toxicity
        • In Vitro Methods For Ocular Irritation
        • Bcop
        • Het-Cam
        • Ice Test
        • The Ire Test
        • 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
    • 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
  • Company Profiles
    • Accelrys Software, Inc.
    • Bio-Rad Laboratories
    • Bioreliance Invitrogen Bioservices
    • Ceetox, Inc.
    • Covance, Inc.
    • Genego, Inc.
    • Gene Logic, Inc.
    • Htg, Arizona
    • Iconix Biosciences, Inc.
    • In Vitro International
    • In Vitro Technologies
    • Mattek Corporation
    • Molecular Toxicology, Inc.
    • Tecan Group Ag
    • Xenobiotic Detection Systems (XDS)
    • Xenometrix
  • Markets By Technology
    • Markets By Technology
    • Significant Technology Developments
      • Alternatives Methods In Toxicology Testing
        • 3r Approach
        • Reduction Alternative
        • Replacement Alternative
        • Refinement
        • Use Of Alternative Species
      • Overview Of High Enabling Technologies
        • Toxicogenomics
        • Microarrays
        • Proteomics
        • Metabolomics
        • Bioinformatics
        • Computational Toxicology
        • Structure-Activity Relationships
        • Physiologically Based Pharmacokinetic Models (PBPK)
        • Biologically Based Dose-Response (BBDR) Models
        • Computational Approaches To Predicting Metabolic Fate
        • 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
      • Roadmap For The Future
  • Revenue Forecasts By Technology
    • Revenue Forecasts By Technology
    • Observations
  • Patent Analysis
    • 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
        • Segmentation
      • Industry Structure
      • Competitive Framework
        • Pricing Trends
        • International Scenario
  • Market Trends By Industry Sector For In Vitro Toxicity Testing
    • Cosmetics And Household Products
    • Pharmaceutical Industry Outlook
      • Drug Discovery And Development Overview
      • New Product Developments And Its Significance In The Biopharmaceutical Sector
        • The Need For Predictive Toxicity
        • Adverse Drug Reactions Fueling The Need For Predictive Toxicity
        • Typical Reasons For Drug Attrition
    • Food Industry
      • Toxicity Testing Strategies
        • Federal Insecticide, Fungicide, And Rodenticide Act Testing Program
        • Microbial Pest-Control Agents Testing Program
        • Fda Testing Strategies For 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
      • Toxicity-Testing Strategies For Screening Of Industrial Chemicals
        • The Toxic Substances Control Act And The High-Production-Volume Chemical Testing Program
      • Testing Strategies For Screening Chemicals Addressing Specific System End Points
        • Epa Endocrine-Disruptor Testing Strategy
        • Oecd Endocrine-Disruptor Testing Strategy
        • Developmental-Toxicity Testing
        • Conclusion
  • Markets By Industry Applications: Revenue Forecasts
    • Markets By Industry Applications: Revenue Forecasts
      • 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
  • Regulatory Overview
    • Regulatory Overview
    • Principal Challenges
    • Future Opportunities
    • Institutions That Impact Toxicity Testing Measures
      • 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
      • Consumer Products Safety Commission
        • Overview
        • Cpsc And Toxicology
      • Environmental Protection Agency
        • Overview
        • Epa And Toxicology
      • 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
        • Alternative Testing Approaches
        • Nanotechnology Initiative
        • Toxicogenomics
        • Phototoxicity
        • Endocrine Disruptors
      • Iccvam And Nicetam
        • Overview
      • 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
  • List Of Figures
    • 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)