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Early Toxicology: Markets and Approaches


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Early toxicology testing is emerging as one of the mostsignificant areas of drug discovery. Toxicity is no longer something that can be left to the development stage, or just a small part of ADMET. Toxicity determinations are an integral part of all aspects of drug discovery & development. 

This report, Early Toxicology Markets and Approaches, focuses on markets for early toxicology testing services. The objective of this report is to focus the reader’s attention on the issues and opportunities related to early toxicology testing in drug discovery. It begins with an overview of drug discovery, ADMET, and early toxicology testing. It continues with some of the ways big pharmaceutical developers dealwith early toxicology.  Several areas are covered, including:

For the purposes of reporting market size and growth forecasts, the report segments the market into the following:

  • In Silico Approaches
    • Databases
    • Data Mining Tools
    • Modeling
    In Vitro Assays and Platforms
    • Biochemical Assays
    • Cellular Assays
    • Instruments & Platforms
  • In Vivo Testing
    • Mice & Traditional Animals
    • Zebrafish Models
    • Other Animals
    • Human Microdosing
  • Early Tox Services
    • In Silico Services
    • In Vitro Services
    • In Vivo Services

Market analysis in this report considers primarily the availabilityof products, number and type of clinical trials active, primary endpoints, anddevelopment of new products.  The marketfocuses on the United States region and, where available, discusses the marketglobally. All sales are displayed at the manufacturers’ level in U.S.dollars.  Although the sales figures aredisplayed at the manufacturers’ level, in many instances, this figurerepresents a close comparison to the retail level as many end users arepurchasing directly from the manufacturer.The base year is 2011, with forecasts provided for each year through 2016.  

Early toxicology is done not only to discover problem compounds, but provide directions for compound development. Early toxicology gives more than just a yes/no answer. It provides predictions of how the compound will interactwith cells, tissues, organs, systems, and the whole human. It can also show howa cell responds to a candidate compound.   Various in vivo, in vitro, and in silico approaches have been evolving ever since. The objective of this report is to focus the reader’s attention on the issues and opportunities related to early tox testing in drug discovery, including:

  • Market Size of Segments and Subsegments within Toxicology
  • Forecasts of Expected Future Revenue Growth
  • Review of R&D Spending Trends 
  • Discussion of Various Big Pharma Approaches to Early Toxicology Testing
  • Consideration of Emerging Tools and Techniques
  • Revenues of Top Toxicology Service Companies
  • The Views of Interviewed Experts in the Field 
  • The Key Competitors and their Product and Service Offerings.
At first glance, drug discovery can appear to be a straightforward process of screening compound candidates, optimizing leads, performing pre-clinical evaluations and then, with these steps completed, clinical trials can begin. The reality is not so neat. These activities often overlap, merge, and conflict with each other. So ADME (Absorption, Distribution, Metabolism, Excretion) and Toxicology are not simply a step in lead optimization, they are actually an integral part of an ongoing process.

The report begins with an overview of drug discovery, ADMET, and early tox testing. It continues with some of the ways big pharmas deal with early tox. The next four chapters deal with the markets for in-silico, in-vitro, and in-vivo early tox products, and with the suppliers of early tox services. Product, company and market information are provided in each of these chapters. Opinions of the experts on basic issues are provided in Chapter Seven. The report concludes with profiles of 30 representative suppliers, the products they provide and their approach to the market.

As part of the report's detailed coverage, the following companies are profiled:
  • Accelrys
  • Albany Molecular
  • BD Biosciences
  • Beckman Coulter
  • Bio-Rad
  • Caliper Life Sciences
  • CeeTox
  • Cellectis
  • Cellomics
  • Charles River
  • Covance
  • Entelos
  • GE Biosciences
  • Gene Logic
  • IDBS
  • Ingenuity Systems
  • Life Technologies (Invitrogen)
  • Phylonix
  • Promega
  • Simulations Plus
  • Thermo Fisher
  • Xceleron


  • Executive Summary
    • DRUG DISCOVERY:ACOMPLEX PROCESS
      • Vioxx
      • Baycol
      • Rezulin
      • FenPhen
    • DRUG DEVELOPMENT SUMMARY
      • Table Phases of Clinical Drug Development
    • SCOPE AND METHODOLOGY
    • MARKET OVERVIEW
    • COMPETITORS
  • Introduction to Early Toxicology
    • OVERVIEW
    • THE COST OF DRUG DEVELOPMENT
      • Table Pharmaceutical/Biopharmaceutical R&D Costs
      • Table Total Industry R&D Spending 2004-2010 ($Millions)
    • THE ROLE OF CONTRACT RESEARCH ORGANIZATIONS
    • TOXICOLOGY MEASUREMENT ISSUES
    • ALTERNATIVE APPROACHES TO EARLY TOXICITY
  • Pharma Strategies and Toxicology Tactics
    • OVERVIEW
    • ABBOTT: DEVELOPING THEIR OWN TOOLS
    • BRISTOL-MYERS SQUIBB: REDUCING DRUG ATTRITION
    • ELI LILLY &COMPANY: IN SILICO AND IN VITRO METHODS
    • GLAXO SMITHKLINE: GLOBAL SAFETY BOARD
    • JOHNSON &JOHNSON: ALLIANCESAND BIOMARKERS
    • NOVARTIS: MODELING &SIMULATION
    • PFIZER: COLLABORATIVE APPROACH
  • In Silico Approaches: Databases and Modeling
    • BACKGROUND
    • DATABASES
    • DATA MINING AND ANALYSIS
    • IN-SILICO MODELING
      • Standard Tests
      • Commercial Modeling Products
      • Advanced Chemistry Development (ACD)
      • Bio-Rad
      • GeneGo
      • Gene Logic
      • IDBS
      • Ingenuity Systems
      • KNIME
      • Simulations Plus
        • Table Summary of Pros and Cons of In-Silico Modeling
    • PREDICTING TOXICITY WITH QSARSAND EXPERT MODELING SYSTEMS
    • GOVERNMENT AGENCY AND PUBLIC INITIATIVES
      • EPA's NCCT and CompTox
      • FDA
      • ToxCheck
      • ChemBench
      • PubChem
      • DSSTox
        • Table Toxicity Software Products and Suppliers
    • IN-SILICO MARKETS IN EARLY TOX
      • Table Market Size of In-Silico Products for Early Toxicology by Product Area (Databases, Data Mining Tools, Modeling) 2011, 2015
      • Table Average Annual Growth of In-Silico Products for Early Toxicology by Product Area (Databases, Data Mining Tools, Modeling) 2011-2015
      • Table Leading Competitors of In-Silico Products by Product Area (Databases, Data Mining Tools, Modeling) 2011
  • In-Vitro Assays & Platforms
    • OVERVIEW
    • BIOCHEMICAL ASSAYS &SYSTEMS
      • Assays
      • BD Biosciences
      • Promega's
      • Life Technologies
      • Systems
    • CELLULAR ASSAYS &HIGH-CONTENT SCREENING (HCS)
      • HCS Platforms
      • GE Biosciences
      • CompuCyte
      • Imstar S.A.
      • PerkinElmer Company
      • TTP Labtech
      • Assays
      • Thermo Scientific
      • GE Biosciences
      • Caliper, a PerkinElmer Company
      • Promega
    • TOXICOGENOMICS
      • Gene Logic
      • Gentronix
      • High Throughput Genomics
    • NEW TECHNOLOGIES &APPROACHES
      • ACEA Biosciences
      • Cellartis AB
      • ChanTest
      • CreaCell
      • Cyprotex
      • Hurel
      • InvivoSciences LLC
      • Qualyst
      • Solidus Biosciences
      • VistaGen Therapeutics
    • MARKETS FOR IN VITRO EARLY TOX PRODUCTS
      • Biochemical Assays
      • Cellular Assays
      • Instruments and Platforms
        • Table Market Size of In Vitro Products for Early Toxicology by Product Area (Biochemical Assays, Cellular Assays, Instruments & Platforms) 2011, 2015
        • Table Average Annual Growth of In-Vitro Products for Early Toxicology by Product Area (Biochemical Assays, Cellular Assays, Instruments & Platforms) 2011-2015
        • Table Leading Competitors of In-Vitro Products by Product Area (Biochemical Assays, Cellular Assays, Instruments & Platforms) 2011
  • In-Vivo Testing: Animal Models and Human Microdosing
    • OVERVIEW
    • ANIMAL MODELS
      • Traditional Animal Models
      • Zebrafish
      • Applications in Toxicology
      • Charles River Laboratories
      • Phylonix
      • Other Animal Models
    • HUMAN MICRODOSING
    • MARKETS FOR IN-VIVO PRODUCTS
      • Table Market Size of In Vivo Products for Early Toxicology by Product Area (Mice & Traditional Animals, Zebrafish Models, Other Animals, Human Microdosing) 2011, 2015
      • Table Average Annual Growth of In-Vivo Products by Product Area (Mice & Traditional Animals, Zebrafish Models, Other Animals, Human Microdosing) 2011-2015
      • Table Leading Competitors of In-Vivo Products by Product Area (Mice & Traditional Animals, Zebrafish Models, Other Animals, Human Microdosing) 2011
  • Toxicology Service Suppliers
    • OVERVIEW
    • CUSTOMERS FOR EARLY TOX SERVICES
    • INSOURCING:ANEW APPROACH
    • SUPPLIERS OF IN SILICO SERVICES
    • SUPPLIERS OF IN VITRO TESTING SERVICES
    • SUPPLIERS OFANIMAL TESTING SERVICES
      • Suppliers of Services Using Traditional Animals
      • Suppliers of Services Using Zebrafish
      • Suppliers of Services Using Transgenic Rodents
    • SERVICE SUPPLIERMARKETS FOR EARLY TOX
      • Table Market Size of Services for Early Toxicology by Service Area (In Silico, In Vitro, In Vivo) 2011, 2015
      • Table Distribution of Services for Early Toxicology by Product Area 2011
      • Table Average Annual Growth of Services for Early Toxicology by Service Area (In Silico, In Vitro, In Vivo) 2011-2015
      • Table Leading Competitors in Services for Early Toxicology by Service Area (In Silico, In Vitro, In Vivo) 2011
  • Expert Views on Early Toxicology
    • INTRODUCTION
    • GENERAL QUESTIONS
    • QUESTIONS ABOUT IN SILICO APPROACHES
    • QUESTIONS ABOUT IN VITRO APPROACHES
    • QUESTIONS ABOUT IN VIVO APPROACHES
  • Company Profiles
    • INTRODUCTION
      • Table Demographics of Companies Profiled (Name, Location, Affiliation, Revenues, Product/Service Area)
    • ACCELRYS
      • Background
      • Financials
      • Product Lines
      • Approaches to Market
    • ALBANY MOLECULAR RESEARCH INC. (AMRI)
      • Background
      • Financials
      • Future Opportunities & Challenges
    • BD BIOSCIENCES
      • Becton Dickenson
      • BD Biosciences
      • Approach to Market and Strategy
    • BECKMAN COULTER, INC.
      • Background
      • Products
      • Financials
      • Approach to Market
    • BIO-RAD LABORATORIES
      • Background
      • Products & Technologies
      • Financials
    • CALIPER LIFE SCIENCES
      • Background
      • Acquisitions and Business Development
      • Financials
    • CEETOX
      • Background
      • Technology and Toxicity Testing Services
      • CeeTox's Alliance
    • CELLECTIS
      • Background
      • Technology
      • Financials
    • CHARLES RIVER LABORATORIES
      • Background
      • Financials
      • Products and Services
      • Future Directions
    • COVANCE
      • Background
      • Financials
    • ENTELOS
      • Background
      • Technology and Services
    • GE HEALTHCARE LIFE SCIENCES/BIO SCIENCES
      • About GE Healthcare
      • IN Cell Platforms
    • GENE LOGIC
      • Background
      • Genomics & Toxicogenomics Products & Services
    • ID BUSINESS SOLUTIONS LTD. (IDBS)
      • Background
      • Approach to the Market
    • INGENUITY SYSTEMS
      • Background
      • Technology & Products
      • Partnerships & Alliances
    • LIFE TECHNOLOGIES
      • Background
      • Areas of Focus
      • Financials
      • Future
    • PHYLONIX
      • Background
    • PROMEGA
      • Background
      • Financials
      • Product Lines
      • Approach to Market
    • SIMULATIONS PLUS
      • Background
      • Financials
      • ADME Prediction Software
    • THERMO FISHER
      • Background
      • Financials
    • XCELERON
      • Background
      • Technology & Rationale
      • Applications & Services
  • Relevant Toxicology Service and Product Suppliers

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