Early Toxicology: Markets and Approaches

September 2012 | 180 pages | ID: E910C1E504FEN
Kalorama Information

Abstracts

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.

Contents

CHAPTER ONE: EXECUTIVE SUMMARY

Drug Discovery: A Complex Process
  Viox
  Baycol
  Rezulin
  FenPhen
Drug Development Summary
Scope and Methodology
Market Overview
Competitors

CHAPTER TWO: INTRODUCTION TO EARLY TOXICOLOGY

Overview
The Cost of Drug Development
The Role of Contract Research Organizations
Toxicology Measurement Issues
Alternative Approaches to Early Toxicity

CHAPTER THREE: 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: Alliances And Biomarkers
Novartis: Modeling & Simulation
Pfizer: Collaborative Approach

CHAPTER FOUR: 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
Predicting Toxicity With Qsars And Expert Modeling Systems
Government Agency And Public Initiatives
  EPA’s NCCT and CompTox
  FDA
  ToxCheck
  ChemBench
  PubChem
  DSSTox
In-Silico Markets In Early Tox

CHAPTER FIVE: IN-VITRO ASSAYS & PLATFORMS

Overview
Biochemical Assays & Systems
  Assays
  BD Biosciences
  Promega’s
  Life Technologies
  Systems
Cellular Assays &High-Content Screening (Hcs
HCS Platforms
  Thermo Scientific (Cellomics)
  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

CHAPTER SIX: IN-VIVO TESTING: ANIMAL MODELS AND HUMAN MICRODOSING

Overview
Animal Models
  Traditional Animal Models
  Zebrafish
  Role in Drug Discovery Testing
  Applications in Toxicology
  Charles River Laboratories
  Phylonix
  Other Animal Models
Human Microdosing
Markets For In-Vivo Products

CHAPTER SEVEN: TOXICOLOGY SERVICE SUPPLIERS

Overview
Customers For Early Tox Services
Insourcing: A New Approach
Suppliers Of In Silico Services
Suppliers Of In Vitro Testing 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 EIGHT: EXPERT VIEWS ON EARLY TOXICOLOGY

Introduction
General Questions
Questions About In Silico Approaches
Questions About In Vitro Approaches
Questions About In Vivo Approaches

CHAPTER NINE: COMPANY PROFILES

Introduction
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

List Of Exhibits

LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE: DRUG DEVELOPMENT SUMMARY
Table 1-1 Phases of Clinical Drug Development
CHAPTER TWO: INTRODUCTION TO EARLY TOXICOLOGY
Table 2-1: Pharmaceutical/Biopharmaceutical R&D Costs
Figure 2-1: Drug Development Cost Progression
Table 2-2: Total Industry R&D Spending 2004-2010
Figure 2-2: Total Industry R&D Spending 2004-2010
CHAPTER FOUR: IN-SILICO MODELING
Table 4-1: Summary of Pros and Cons of In-Silico Modeling
Table 4-2: Toxicity Software Products and Suppliers
Table 4-3: Market Size of In-Silico Products for Early Toxicology by Product Area (Databases, Data Mining Tools, Modeling) 2011, 2015
Figure 4-1: Distribution of In Silico Products for Early Toxicology by Product Area, 2011
Table 4-4: Average Annual Growth of In-Silico Products for Early Toxicology by Product Area (Databases, Data Mining Tools, Modeling) 2011-2015
Figure 4-2: Growth Trend in Revenues for In Silico Products for Early Toxicology, 2006-2015
Table 4-5: Leading Competitors of In-Silico Products by Product Area (Databases, Data Mining Tools, Modeling) 2011
CHAPTER FIVE: IN-VITRO ASSAYS & PLATFORMS
Table 5-1: Market Size of In Vitro Products for Early Toxicology by Product Area (Biochemical Assays, Cellular Assays, Instruments & Platforms) 2011, 2015
Figure 5-1: Distribution of In Vitro Products for Early Toxicology by Product Area, 2011
Table 5-2: Average Annual Growth of In-Vitro Products for Early Toxicology by Product Area (Biochemical Assays, Cellular Assays, Instruments & Platforms) 2011-2015
Figure 5-2: Growth Trend in Revenues for In Vitro Products for Early Toxicology, 2006-2015
Table 5-3: Leading Competitors of In-Vitro Products by Product Area (Biochemical Assays, Cellular Assays, Instruments & Platforms) 2011
CHAPTER SIX: IN-VIVO TESTING: ANIMAL MODELS AND HUMAN MICRODOSING
Table 6-1: Market Size of In Vivo Products for Early Toxicology by Product Area (Mice & Traditional Animals, Zebrafish Models, Other Animals, Human Microdosing)2011, 2015
Figure 6-1: Distribution of In Vivo Products for Early Toxicology by Product Area(Mice & Traditional Animals, Zebrafish Models, Other Animals, Human Microdosing)
Table 6-2: Average Annual Growth of In-Vivo Products by Product Area (Mice & Traditional Animals, Zebrafish Models, Other Animals, Human Microdosing) 2011-2015
Figure 6-2Growth Trend in Revenues for In Vivo Products for Early Toxicology, 2006-2015
Table 6-3: Leading Competitors of In-Vivo Products by Product Area (Mice & Traditional Animals, Zebrafish Models, Other Animals, Human Microdosing) 2011
CHAPTER SEVEN: TOXICOLOGY SERVICE SUPPLIERS
Table 7-1: Market Size of Services for Early Toxicology by Service Area (In Silico, In Vitro, In Vivo) 2011, 2015
Table 7-1: Distribution of Services for Early Toxicology by Product Area 2011
Table 7-2: Average Annual Growth of Services for Early Toxicology by Service Area (In Silico, In Vitro, In Vivo) 2011-2015
Figure 7-2: Growth Trend of Revenues for Services in Early Toxicology, 2006-2015
Table 7-3: Leading Competitors in Services for Early Toxicology by Service Area In Silico, In Vitro, In Vivo), 2011
CHAPTER NINE: COMPANY PROFILES
Table 9-1: Demographics Of Companies Profiled (Name, Location, Affiliation, Revenues, Product/Service Area)