1. Early Toxicology: Markets and Approaches
Report Details:
Published:September 2012
No. of Pages: 180
Price: Single User License – US$3995
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

2. •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

3. •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
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Major points covered in Table of Contents of this report include
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

4. 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
Cellular Assays & High-Content Screening (HCS)
HCS Platforms
Cellomics

5. Beckman
GE Biosciences
CompuCyte
Imstar S.A.
Assays
Cellomics
GE Biosciences
Exelixis
Caliper
Promega
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

6. 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?

7. 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

8. 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

9. 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

10. 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

11. 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 Product Area (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 Service Area (In Silico, In
Vitro, In Vivo) 2006-2010
Table 6-3: Leading Competitors in Services for Early Toxicology by Service Area (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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