Natural and Organic Foods and Beverages in the U.S., 4th Edition
Outsourcing in Drug Discovery: The Contract Research Organization (CRO) Market, 4th Edition
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Outsourcing in Drug Discovery: The Contract Research Organization (CRO)
Market, 4th Edition
June 1, 2010
Kalorama Information's Outsourcing in Drug Discovery offers unparalleled discussion of
the drug discovery outsourcing market. It presents viewpoints from both customers and
suppliers. Segments, size, and growth of the market are presented. The trend toward
the increased use of offshore suppliers is covered in detail. The report also provides
profiles of 22 suppliers, representative of those active in this market.
Segments covered in this report include:
• Chemistry Services
o Building Blocks
o Compound Synthesis
o Libraries
o Process Research
o Other Services
• Biology Services
o Protein Expression
o Structural Analysis
o Target Validation
o Pathways Analysis
o Other Services
• Screening Services
o Assay Development
o Primary Screening
o Secondary Screening
• Lead Optimization
o Early ADMET
o Analogues Creation
o Computational Support
o Other services
In addition to market data and forecasts, the report covers issues such as:
• What factors should a client consider when deciding whether to do a project in-
2. house or outsource it?
• Is it in the client's best interest to seek a domestic outsourcing partner, or go with
an overseas supplier?
• How does the client select the CRO that is best for him?
• What are the best practices when working with a CRO?
• How do you measure his effectiveness?
• How do you avoid problems with your CRO?
• How do you maximize benefits?
This report looks offshore at outsourcing suppliers based in three major areas: India,
China, and Eastern Europe. The relative advantages each country provides are
contrasted with some of their limitations. The report asses which projects are moving to
which suppliers and why.
Table of Contents
CHAPTER ONE: EXECUTIVE SUMMARY
• Overview
• Scope and Methodology
• Introduction
o Pharmaceutical Industry Challenges
• The Drug Discovery Process
o Accelerating the Drug Discovery Process
o Bottlenecks Within the Drug Discovery Process
• Outsourcing to Increase Efficiency
• Outsourcing Drug Discovery
• The Outsourcing Decision
• Developing an Outsourcing Plan
• Contract Research Organizations
• Strategic Versus Tactical Outsourcing Model
• Effective Communication is Essential
• Mitigating the Challenges of Protecting IP Rights
• Offshoring Contract Drug Discovery
• Factors to Consider in Offshore Outsourcing
o Benefits of Global Outsourcing
o Cost Advantage
o Concerns about Global Outsourcing
• Outsourcing to China
o Chinese Contract Research Organizations
o FDA Offices in China
• Outsourcing to India
o Indian Contract Research Orgnizations
3. o FDA Offices in India
• Outsourcing to Eastern Europe
• Drug Discovery Outsourcing Market
• Current Market and Forecast
• Market Analysis by Segment
CHAPTER TWO: INTRODUCTION
• Introduction To Outsourcing Drug Discovery
• Number of NME Approved in Decline While R&D Spending Rising
• Ramping up the Pipelines
• Factors to Consider in offshore Outsourcing
• Benefits of Global Outsourcing
• Cost Advantage
• Access to talent and technologies
• Compress Timeline
• Increase Production
• Concerns about Global Outsourcing
o Intellectual property Protection (IP)
o Confidential Information and Trade Secrets
o Fraud and Corruption
o Meeting Regulatory Compliance Demands
o Long distance
• Introduction
• Choosing the Right CRO
• Experience is Paramount
• Facility Standards
• Excellent Track Record
• Contract Pharma’s Outsourcing Survey
• Global Outsourcing
CHAPTER THREE: THE DRUG DISCOVERY PROCESS
• Introduction
• Drug Discovery Stages
• Target Identification
• Target Validation
• High Throughput Screening
• Lead Optimization
• Accelerating the Drug Discovery Process
• Technologies Utilized in Drug Discovery
• Combinatorial Chemistry
• Bioinformatics/Pharmacogenomics
• ADME/Tox Screening
• High Throughput Screening
• Computational Modeling and Bioinformatics
4. • Outsourcing to increase efficiency
• Outsourcing to access novel technologies
• Bioinformatics
• Lab-on-a-chip: Microfluidics in Drug Discovery
CHAPTER FOUR: OUTSOURCING TRENDS
• Overview
• Contract research Organizations
o Introduction
o Role of a CRO
• Strategic Versus Tactical Outsourcing Model
o The Tactical Model
o The Strategic Model
• Mitigating the Challenges of Protecting IP Rights
• Offshoring Contract Drug Discovery
o Introduction
o Center of Gravity for the Pharmaceutical Industry Shifting from West to
East
o Evolution of Contract Drug Discovery in Asia
o Outsourcing to China
Introduction
Multi-National Pharmaceutical Companies Establish Drug
Discovery Facilities in China
Chinese Contract Research Organizations
WuXi AppTec China’s Largest CRO
First Chinese CRO Alliance
FDA Offices in China
China's Management of Counterfeit Pharmaceuticals and IP Rights
and Laws
IP Rights Enforcement System
o Outsourcing to India
Introduction
AstraZeneca Sets up Drug Discovery Facility in Bangalore
Drug Discovery Services in India
India’s Handling of IP Rights and Laws
Patent Filing Considerations
Limitations on Patentability
Compulsory Licenses
FDA Offices in India
o Outsourcing to Eastern Europe
Introduction
Russian and Ukraine CROs
CHAPTER FIVE: MARKET ANALYSIS
5. • Drug Discovery Outsourcing Market
• Unfavorable Global Economic Market Conditions
• Current Market and Forecast
• Contract Drug Discovery Competitors
• Market Analysis by Segment
o Chemistry Services Market
o Current Market and Forecast
o Biology Services Market
• Current Market and Forecast
• High Throughput Screening Services Market
• Current Market and Forecast
• Lead Optimization Services Market
• Current Market and Forecast
CHAPTER SIX: COMPETITOR PROFILES
• Competitor Profiles
• Albany Molecular Research, Inc.
o History and Lines of Business
o Drug Discovery Services
o Financial Information
• Argenta Discovery, Ltd.
o History and Lines Business
o Drug Discovery Services
o Biology
o Chemistry
• Asinex Ltd.
o History and Lines of Business
o Drug Discovery Services
• BioDuro, Inc.
o History and Lines of Business
o Drug Discovery Services
o Chemistry Services
o Biology Services
• BioFocus DPI
o History and Lines of Business
o Drug Discovery Services
o Integrated drug discovery
o ADME/PK
o Target discovery
o Assay development & screening
o Additional drug discovery services include:
• Caliper Life Sciences
o History and Lines of Business
o Drug Discovery Services
o Financial Information
6. • Charles River Laboratories, Inc.
o History and Lines of Business
o Drug Discovery Services
o Financial Information
• ChemBridge Corp.
o History and Background
o Drug Discovery Services
o Chemical Diversity Inc.
o History and Lines of Business
o Drug Discovery Services
o Lead Optimization Services
o High throughput Services
o Biologically Annotated Libraries
o Focused Diversity
• Emerald Biostructures
o History and Lines of Business
o Drug Discovery Services
o Gene to Structure
o Fragment Screening
• Enamine Ltd.
o History and Lines of Business
o Drug Discovery Services
o Screening Compounds
o Screening Compounds From REAL Database®
o Lead Optimization
o Discovery Chemistry and Custom Synthesis
o Research
• Evotec OAI
o History and Lines of Business
o Drug Discovery Services
o Assay Development Services
o High throughput Screening
o Medicinal Chemistry Services
o Compound Library Services
o Financial Information
o History and Lines of Business
o Drug Discovery Services
o Bioinformatics
o Chemoinformatics
o Structural Biology
o Biology Services
• GenScript USA Inc.
o History and Lines of Business
o Drug Delivery Services
o Bio-Reagent Center
o Molecular Biology Services
7. o Peptide Services
o Protein Services
o Antibody Services
o Cell Line Services
o Bio-Assay Center
o Lead Optimization Center
o Antibody Drug Development
o hERG testing for drug candidates
o Bioprocess Services
• Hutchison MediPharma Ltd.
o History and Lines of Business
o Drug Discovery Services
o Discovery Chemistry
o Discovery Biology
o Discovery Pharmacology
o Drug Metabolism and Pharmacokinetics (DMPK)
• Jubilant Biosys Ltd.
o History and Lines of Business
o Drug Discovery Services
o Discovery Informatics
o Discovery Research
o Drug Development
o IT Services
• Ligand Pharmaceuticals, Inc.
o History and Lines of Business
o Drug Discovery Services
• Pharmaron inc.
o History and Lines of Business
o Drug Discovery Services
• Ricerca Biosciences, LLC
o History and Lines of Business
o Drug Discovery Services
• Scynexis, Inc.
o History and Lines Business
o Drug Discovery Services
o Medicinal Chemistry
o Custom Synthesis
o High Throughput Purification & Analysis
o ADMET & Bioanalytical Services
o Bioanalytical Capabilities
o Data Management And Collaboration
• Shanghai ChemPartner Co.,Ltd.
o History and Lines of Business
o Drug Discovery Services
o Discovery Chemistry
o Library Generation
8. o Analytical Chemistry
o Medicinal Chemistry
o ADME Studies
o Natural Product Chemistry
o Computational Chemistry And Drug Design
• Shanghai Medicilon Inc.
o History and Lines of Business
o Drug Discovery Services
o Custom Chemical Synthesis
o Pharmacokinetics
o Metabolism Services
o Bioanalytical Services
o Structural Biology Services
o Other Biological Services
• TCG Lifesciences Ltd.
o History and Lines of Business
o Drug Development Services
• WuXI AppTec Co. Ltd.
o History and Lines of Buisness
o Drug Discovery Services
o Discovery Chemistry Services
o Analytical Services
o Biological Services
o Financial Information
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