Early Toxicology: Markets and Approaches
Toxicity is a crucial parameter that is measured throughout the drug development process. Toxic side-effects are one of the most common reasons drug candidates fail. Toxicity can be a factor of dose, the form in which the drug is administered, and the time of exposure before elimination. Patient responses also differ widely, depending on their age and metabolism and other products in the patient’s system may augment the effect of the drug.
Just twenty years ago, toxicology was something that was measured after a drug was developed. Traditional studies were performed in-vivo with animals, and required 20 to 100 grams of the candidate compound for a single set of evaluations. Intake of the compound was measured, and a series of toxicity tests were performed, including LD 50 and histological examinations of target organs. These tox tests were expensive, time-consuming and were only performed on drug candidates that had already passed all other criteria to become successful drugs. These studies were high information, but low throughput estimates of a candidate drug’s toxicology. Failures were common, and expensive. The goal was to find approaches that would predict toxicology at an earlier stage, and with less cost.
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:
- quantification of the current and future markets for various segments and subsegments,
- discussion of various big pharma approaches to early toxicology testing,
- review of the emerging tools and techniques,
- the views of interviewed experts in the field, and
- a landscape of competitors and their product and service offerings.
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.
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
- 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
Table of Contents
Chapter One: Executive Summary
- State of Drug Discovery in 2007
- Toxicology Measurement Issues
- Alternative Approaches to Early Tox
- About This Report
- Market Overview
Chapter Two: Pharma Strategies and Toxicology
- Tactics
- Abbott: Developing Their Own Tools
- Bristol-Myers Squibb: Reducing Drug Attrition
- Eli Lilly: Safety, Toxicity, and the FDA
- Glaxo SmithKline: Promoting Productivity
- Johnson & Johnson: Alliances and Biomarkers
- Novartis: Cheminformatics & Model building
- Pfizer: Multiple approaches
- Wyeth: Hitting Their Targets
Chapter Three: 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
- Fujitsu Biosciences
- Gene Logic
- IDBS
- Inpharmatica
- Simulations Plus
- Predicting Toxicity with QSARs and Expert Modeling Systems
- Government Agency and Public Initiatives
- EPA’s NCCT
- FDA
- ToxCheck
- ChemBench
- In-Silico Markets in Early Tox
Chapter Four: In Vitro Assays & Platforms
- Biochemical Assays & Systems
- Assays
- BD Biosciences
- Promega’s
- Invitrogen
- Systems
- Beckman Coulter
- Tecan
- Molecular Devices
- Hamilton
- NIMBUS Biotechnology
- Assays
- Cellular Assays & High-Content Screening (HCS)
- HCS Platforms
- Cellomics
- Beckman
- GE Biosciences
- CompuCyte
- Imstar S.A.
- Assays
- Cellomics
- GE Biosciences
- Exelixis
- Caliper
- Promega
- HCS Platforms
- Toxicogenomics
- High Throughput Genomics
- Gene Logic
- Gentronix
- Iconix
- New Technologies & Approaches
- ACEA Biosciences
- Amphioxus Cell Technologies
- ACEA Biosciences
- Cellartis AB
- VistaGen Therapeutics
- ESA
- High Throughput Genomics
- Hurel
- InvivoSciences LLC
- Qualyst
- Solidus Biosciences
- Others (Cytomyx Ltd, Cyprotex, CreaCell, Neurion, ChanTest)
- Markets for In Vitro Early Tox Products
- Biochemical Assays
- Cellular Assays
- Instruments and Platforms
Chapter Five: In-Vivo Testing: Animal Models & Human Microdosing
- Animal Models
- Traditional Animal Models
- Zebrafish
- Role in Drug Discovery Testing
- Applications in Toxicology
- Charles River Laboratories
- Daniolabs
- Phylonix
- Zygogen
- Other Animal Models
- Rat Models—Hepaticus, Inc.
- Mouse Models—University of North Carolina
- Caenorhadbitis elegans--Affymetrix
- Caenorhadbitis elegans-- NemaRx
- Drosophila—Indiana University
- Drosophila—Affymetrix
- Human Microdosing
- Markets for In-Vivo Products
Chapter Six: Service Suppliers
- Customers for Early Tox Services
- Suppliers of In Silico Services
- Suppliers of In Vitro Testing Services
- Product Suppliers That Provide In Vitro Services
- Suppliers of Animal Testing Services
- Suppliers of Services Using Traditional Animals
- Suppliers of Services Using Zebrafish
- Suppliers of Services Using Transgenic Rodents
- Service Supplier Markets for Early Tox
Chapter Seven: Expert Views on Early Tox
- General Questions
- ADMET has been treated like a single subject. Is there any merit in considering early tox separately from ADME?
- What are the most important things early tox should tell you?
- Which potential problems and what organ systems should early tox address?
- What are the factors that have made early tox so difficult to deal with?
- In-silico, In-vitro, In-vivo: Which of these three areas hold the most promise?
- If early tox predictions could be made with better than 75% accuracy, how would this impact drug discovery?
- What approach(s) do you use in your early tox work?
- How large is the market for early tox? How fast is it growing?
- Questions About In silico Approaches
- Which in-silico models have been most effective predictors?
- Who are the leading suppliers of models for early tox?
- Which new models should capture our attention?
- Which databases are most useful?
- How important is data sharing between companies (consortiums)?
- Questions About In vitro Approaches
- How important are cellular assays and HCS for early tox work?
- Will they displace traditional biochemical assays for early tox?
- What is the role of toxicogenomics in early tox?
- Will chip assays displace microplate assays as the method of choice?
- What are the hottest new approaches to in-vitro early tox?
- Questions about In Vivo Approaches
- Which animal models are most useful in early tox?
- Will zebrafish assays replace more costly rodent models?
- What are the advantages and limitations of zebrafish models?
- What role do you expect human microdosing to play in drug discovery?
- What impact will microdosing have on early tox?
Chapter Eight: Company Profiles
- Accelrys
- Company Background
- Financials
- Product Lines
- Products and Approach for Early Tox
- Approaches to Market
- ACEA
- Company Background
- Technology & Product Description
- Applications
- Approaches to Market
- Albany Molecular Research Inc. (AMRI)
- Company Focus
- Financials
- Chemistry Services
- ComGenex Acquisition
- Future Opportunities & Challenges
- Amphioxus Cell Technologies (Stem Cell Innovations)
- Company Background
- Technology
- Products and Services
- Approach to Market
- BD Biosciences
- Becton Dickenson
- BD Biosciences
- Products for Early Tox
- Plastic Disposables
- ADME/Tox Products & Services
- BD Bioimaging Systems
- Approach to Market
- Beckman Coulter, Inc.
- Company Overview
- Business Areas
- Financials
- Biomedical Research, Drug Discovery, ADMET Products
- Approach to Market
- Bio-Rad Laboratories
- Company Description
- Financials
- Life Science Research Products
- Informatics / Sadtler Group
- KnowItAll Cheminformatics System
- Caliper Life Sciences (formerly Zymark)
- Background & History
- Financials
- Instrument Systems for Automation
- Caliper Discovery Alliances & Services (CDAS)
- Cambridge Cell Networks
- Background
- Products & Services
- The Buzz on ToxWiz
- CeeTox
- Background & Focus
- Technology and Toxicity Testing Services
- Early Tox Services
- Future
- Cellartis
- Background
- Technology & Products
- Cellomics
- Company History
- HCS Products
- Cellomics Alliances and Future
- Charles River Laboratories
- Overview & Focus
- Financials
- Research Models and Services
- PreClinical Services
- Future Directions
- CompuCyte
- Company Focus
- CompuCyte Products
- LSC Technology and Use in Drug Discovery
- iCyte Applications in Toxicology
- Elsevier MDL
- Company History & Focus
- Drug Discovery Product Lines
- Collaborations
- GE Healthcare Bio-Sciences (formerly Amersham Biosciences)
- About GE Healthcare
- About GE Healthcare Bio-Sciences
- Products for Early Tox
- LEADseeker
- IN Cell Platforms
- Reagents & Early Tox Applications
- Approach to Market
- Gene Logic
- Background & History
- Gene Logic Re-Invented
- Financials
- Genomics & Toxicogenomics Products & Services
- Future
- High Throughput Genomics
- Company Focus
- Technology
- Products & Services
- Applications
- Hurel Corporation
- Company Focus
- Technology and Applications
- Iconix Biosciences
- Company History & Focus
- Technology & Products
- Partnerships & Alliances
- Future Opportunities
- ID Business Solutions Ltd. (IDBS)
- Background & History
- Areas of Focus
- Drug Discovery Products
- Approach to the Market
- Invitrogen
- Background & History
- Areas of Focus
- Financials
- Invitrogen Contract Services & BioReliance
- Assays & Reagents for Drug Discovery
- Approach to the Market
- Phylonix
- Company Background
- Phylonix Services
- PreClinOmics
- Company History & Focus
- Technology, Products & Services
- Benefits & Collaborations
- Promega
- Company Focus
- Product Lines and Early Tox
- Applications Support
- Approach to Market
- Qualyst
- Background & History
- B-Clear System Technology
- Commercial Products & Services
- Simulations Plus
- Background & History
- Financials
- ADME Prediction Software
- Solidus Biosciences
- Background
- Technology
- Future Plans
- Xceleron
- Background
- Technology & Rationale
- Applications & Services
- Marketing & Future
- Zygogen
- Company Background
- Technology
- Applications, Advantages & Products
- Affililiations & Expansion
List of Exhibits
Chapter One: Executive SummarY
- Figure 1-1: Market Summary: Early Toxicology Market 2006-2010
- Figure 1-2: Distribution of Early Tox Market by Area (In Silico Products, In Vitro Products, In VivoProducts, Early Tox Services) 2006
- Table 1-1: Leading Competitors by Market Area 2006
Chapter Three: In Silico Approaches: Databases and Modeling
- Table 3-1: Summary of Pros and Cons of In-Silico Modeling
- Table 3-2: Toxicity Software Products and Suppliers
- Table 3-3: Market Size of In-Silico Products for Early Toxicology by Product Area (Databases, Data Mining Tools, Modeling) 2006, 2010
- Table 3-4: Average Annual Growth of In-Silico Products by Product Area (Databases, Data Mining Tools, Modeling) 2006-2010
- Table 3-5: Leading Competitors of In-Silico Products by Product Area(Databases, Data Mining Tools, Modeling) 2006
Chapter Four: In Vitro Assays & Platforms
- Table 4-1: Market Size of In Vitro Products for Early Toxicology by Product Area (Biochemical Assays, Cellular Assays, Instruments & Platforms) 2006, 2010
- Table 4-2: Average Annual Growth of In Vitro Products by Product Area (Biochemical Assays, Cellular Assays, Instruments & Platforms) 2006-2010
- Table 4-3: Leading Competitors of In Vitro Products by Product Area (Biochemical Assays, Cellular Assays, Instruments & Platforms) 2006
Chapter Five: In-Vivo Testing: Animal Models & Human Microdosing
- Table 5-1: Market Size of In Vivo Products for Early Toxicology by ProductArea (Mice & Traditional Animals, Zebrafish Models, Other Animals, Human Microdosing) 2006, 2010
- Table 5-2: Average Annual Growth of In Vitro Products by Product Area (Mice & Traditional Animals, Zebrafish Models, Other Animals,Human Microdosing) 2006-2010
- Table 5-3: Leading Competitors of In Vitro Products by Product Area (Mice & Traditional Animals, Zebrafish Models, Other Animals, Human Microdosing) 2006
Chapter Six: Service Suppliers
- Table 6-1: Market Size of Services for Early Toxicology by Service Area (In Silico,In Vitro, In Vivo) 2006, 2010
- Table 6-2: Average Annual Growth of Services for Early Toxicology by ServiceArea (In Silico, In Vitro, In Vivo) 2006-2010
- Table 6-3: Leading Competitors in Services for Early Toxicology by ServiceArea (In Silico, In Vitro, In Vivo) 2006
Chapter Eight: Company Profiles
- Figure 8-1: Demographics of Companies Profiled (Name, Location, Affiliation, Revenues, Product/Service Area)
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