For six editions, this authoritative resource has defined the market opportunity for companies assisting in the beginning phase of the drug development process.

This Kalorama Information Report, Outsourcing in Drug Discovery, t provides an in depth look into the trends that have shaped the drug discovery outsourcing market today, and details the current and future global market. As part of its coverage, the report provides markets and forecasts for the following segments.

• Chemistry Services Market: Building Blocks, Compound
• Synthesis, Libraries, Process Research, and Other Services,
• Biology Market Revenue by Protein Expression, Structural
• Analysis, Target Validation, Pathways Analysis, and Other Service
• Screening Services Market: Assay Development, Primary
• Screening, Secondary Screening
• Lead Optimization Services Market: Early ADMET/Tox, Create Analogues, Computational Support, and Other Services

The drug discovery process consists of iterative cycles between chemistry and biology that begin with the target finding phase, or selecting a protein (a drug target) leading to the identification of a chemical compound with biological activity (a hit). After confirmation of biological activity and chemical feasibility, the hit becomes a lead structure, which is improved through chemical modifications until it fulfills the criteria for a clinical candidate. A drug candidate then moves into the next stage of drug development, the preclinical phase.

The drug discovery process is long, arduous and costly, which has driven outsourcing in this field. The first phase is discovery of a lead compound, a molecule that affects biological function by binding to a target protein or nucleic acid in a way that is useful for treatment of disease. The process by which molecules are identified for their therapeutic value involves synthesis and analysis of many derivatives of the original leads. There are several steps in the drug discovery process including hit confirmation, lead generation, lead optimization, and other studies. Drug discovery is a high-cost, risky business because only a fraction of the therapeutic targets selected for study will actually yield products that achieve regulatory approval by the Food & Drug Administration (FDA).Since the last edition of Kalorama’s Report on the outsourcing of discovery, major trends that have led to an increase in demand for contract services in drug discovery include:The following companies are profiled in the report:

• Albany Molecular Research, Inc.
• Aptuit, LLC
• Argenta Discovery, Ltd.
• Asclepia MedChem Solutions
• Asinex Ltd.
• AsisChem, Inc.
• Axxam SpA
• BioDuro
• BioFocus DPI
• Caliper Life Sciences
• Charles River Laboratories, Inc.
• ChemBridge Corp.
• Chemical Diversity Inc.
• Covance, Inc.
• CreaGen Biosciences, Inc.
• Crown Bioscience
• Cyprotex PLC
• Domainex
• Emerald Biostructures
• Enamine Ltd.
• Evotec AG
• Exelgen Discovery
• GVK Biosciences Private Limited
• GenScript USA Inc.
• Graffinity Pharmaceuticals GmbH
• Hutchison MediPharma Ltd.
• Jubilant Biosys Ltd
• Nanosyn, Inc.
• Pharmaron Inc.
• Ricerca Biosciences, LLC
• Scynexis, Inc.
• Selcia Limited
• Selvita S.A.
• Shanghai ChemPartner Co., Ltd.
• Shanghai Medicilon Inc.
• Sundia Meditech Company, Ltd.
• Sygnature Discovery Limited
• TCG Lifesciences Limited
• Viva Biotech, Ltd
• WuXI AppTec Co. Ltd.

Table of Contents

One: Executive Summary
Overview
Scope and Methodology
Introduction
Pharmaceutical Industry Challenges
Number of NMEs and BLAs Approved between 1993-2013
Reducing R&D Spending
The Drug Discovery Process
Accelerating the Drug Discovery Process
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
Benefits of Global Outsourcing
Concerns about Global Outsourcing
Outsourcing to China
Chinese Contract Research Organizations
FDA Offices in China
Outsourcing to India
Drug Discovery Services in India
Outsourcing to Eastern Europe
Drug Discovery Outsourcing Market
Global Economic Downturn Has Minimal Affect on Drug Discovery
Current Market and Forecast
Market Analysis by Segment

Two: Introduction To Outsourcing Drug Discovery
Background
Number of NMEs and BLAs Approved between 1993-2013
Reducing R&D Spending
Ramping up the Pipelines
Outsourcing Drug Discovery
The Outsourcing Decision
Developing an Outsourcing Plan
Decision Criteria
Factors to Consider in Offshore Outsourcing
Benefits of Global Outsourcing
Cost advantage
Access to talent and technologies
Compress Timeline
Concerns about Global Outsourcing
Intellectual Property Protection (IP)
Confidential Information and Trade Secrets
Fraud and Corruption
Meeting Regulatory Compliance Demands
Long Distance
Selecting a Contract Research Organization
Introduction
Choosing the Right CRO
Contract Pharma’s Outsourcing Survey
Global Outsourcing

Three: The Drug Discovery Process
Introduction
Drug Discovery Stages
Accelerating the Drug Discovery Process
Technologies Utilized in Drug Discovery
Bottlenecks Within the Drug Discovery Process
Outsourcing to Increase Efficiency
Outsourcing to Access Novel Technologies
Bioinformatics
Lab-on-a-Chip: Microfluidics in Drug Discovery

Four: Outsourcing Drug Discovery
Overview
Is the Traditional Drug Discovery Model Changing?
Outsourcing Drug Discovery Useful Core Management Tool
Contract Research Organizations
Introduction
Role of a CRO
Outsourcing Models
Effective Communication Is Essential for a Successful Partnership
Mitigating the Challenges of Protecting IP Rights
Offshoring Contract Drug Discovery
Introduction
Robust Growth of Outsourcing Drug Discovery in Asia
Outsourcing to China
Introduction
Multi-National Pharmaceutical Companies Establish Research and
Development Facilities in China
Chinese Contract Research Organizations
First Chinese CRO Alliance
FDA Offices in China
China's Management of Counterfeit Pharmaceuticals, IP Rights and Laws
Outsourcing to India
Introduction
Drug Discovery Services in India
India’s Handling of IP Rights and Laws
FDA Offices in India
Outsourcing to Eastern Europe
Introduction
Russian and Ukraine CROs

Five: Drug Discovery Outsourcing Market
Overview
Drug Discovery Outsourcing Market
Global Economic Downturn Has Minimal Affect on Drug Discovery
Current Market and Forecast
Market Analysis by Segment
Chemistry Services Market
Market Estimate
Forecast
Biology Services Market
Market Estimate
Forecast
High Throughput Screening Services Market
Market Estimate
Forecast
Lead Optimization Services Market
Market Estimate
Forecast
Contract Drug Discovery Competitors
The Evolving Open-Innovation Model Gaining Traction in Drug Discovery
Alliances between Academic Organizations and CROs
Academic CROs
Alliances between CROs
Market Growth Expanding Global Reach and Scale of Drug Discovery Services

Six: Competitor Profiles
Albany Molecular Research, Inc.
History and Lines of Business
Drug Discovery Services
Financial Information
Aptuit, LLC
History and Lines of Business
Drug Discovery Services
Argenta Discovery, Ltd
History and Lines Business
Drug Discovery Services
Asclepia MedChem Solutions
History and Lines of Business
Drug Discovery Services
Asinex Ltd.
History and Lines of Business
Drug Discovery Services
AsisChem, Inc.
History and Lines of Business
Drug Discovery Services
Axxam SpA
History and Lines of Business
Drug Discovery Services
BioDuro
History and Lines of Business
Drug Discovery Services
BioFocus DPI
History and Lines of Business
Drug Discovery Services
Caliper Life Sciences
History and Lines of Business
Drug Discovery Services
Charles River Laboratories, Inc.
History and Lines of Business
Drug Discovery Services
Financial Information
ChemBridge Corp.
History and Background
Drug Discovery Services
Chemical Diversity Inc.
History and Lines of Business
Drug Discovery Services
Covance, Inc.
History and Lines of Business
Drug Discovery Services
Financial Information
CreaGen Biosciences, Inc.
History and Lines of Business
Drug Discovery Services
Crown Bioscience
History and Lines of Business
Drug Discovery Services
Cyprotex PLC
History and Lines of Business
Drug Discovery Services
Domainex
History and Lines of Business
Drug Discovery Services
Emerald Biostructures
History and Lines of Business
Drug Discovery Services
Enamine Ltd.
History and Lines of Business
Drug Discovery Services
Evotec AG
History and Lines of Business
Drug Discovery Services
Financial Information
Exelgen Discovery
History and Lines of Business
Drug Discovery Services
GVK Biosciences Private Limited
History and Lines of Business
Drug Discovery Services
GenScript USA Inc.
History and Lines of Business
Drug Delivery Services
Graffinity Pharmaceuticals GmbH
History and Lines of Business
Drug Discovery Services
Hutchison MediPharma Ltd.
History and Lines of Business
Drug Discovery Services
Jubilant Biosys Ltd
History and Lines of Business
Drug Discovery Services
Nanosyn, Inc.
History and Lines of Business
Drug Delivery Services
Pharmaron Inc.
History and Lines of Business
Drug Discovery Services
Ricerca Biosciences, LLC
History and Lines of Business
Drug Discovery Services
Scynexis, Inc.
History and Lines Business
Drug Discovery Services
Selcia Limited
History and Lines of Business
Drug Delivery Services
Selvita S.A.
History and Lines of Business
Drug Discovery Services
Shanghai ChemPartner Co., Ltd.
History and Lines of Business
Drug Discovery Services
Shanghai Medicilon Inc.
History and Lines of Business
Drug Discovery Services
Sundia Meditech Company, Ltd.
History and Lines of Business
Drug Discovery Services
Sygnature Discovery Limited
History and Lines of Business
Drug Discovery Services
TCG Lifesciences Limited
History and Lines of Business
Drug Discovery Services
Viva Biotech, Ltd
History and Lines of Business
Drug Delivery Services
WuXI AppTec Co. Ltd.
History and Lines of Buisness
Drug Discovery Services
Financial Information

List of Exhibits

One: Executive Summary
Exhibit 1-1: Drug Discovery Timeline: Research to Viable Product to Commercialization
Exhibit 1-2: Number of NME and BLA License Applications Approved between 1993-2013
Exhibit 1-3: PhRMA Members R&D Spending, 1995 through 2012
Exhibit 1-4: The Drug Discovery Process
Exhibit 1-5: Drug Discovery Processes Frequently Outsourced
Exhibit 1-6: Global Drug Discovery Outsourcing Market, 2008-2018
Exhibit 1-7: Market Share of Segments of Drug Discovery Market, 2014
Two: Introduction To Outsourcing Drug Discovery
Exhibit 2-1: Number of NME and BLA License Applications Approved between 1993-2013
Exhibit 2-2: PhRMA Members R&D Spending, 1995 through 2012
Exhibit 2-3: Selection of Global Drug Discovery Outsourcing Collaborations
Three: The Drug Discovery Process
Exhibit 3-1: The Drug Discovery Process
Exhibit 3-2: Drug Discovery Timeline: Research to Viable Product to Commercialization
Exhibit 3-3: Bioinformatics/Pharmacogenomics
Exhibit 3-4: Causes of New Drug Attrition
Exhibit 3-5: Drug Discovery Processes Frequently Outsourced
Exhibit 3-6: Bioinformatics as a Central Hub
Four: Outsourcing Drug Discovery
Exhibit 4-1: A Selection of R&D Facilities Closed or Reduced in Size between 2010 and 2014
Exhibit 4-2: A Selection of Chinese Drug Discovery CROs
Exhibit 4-3: A Selection Indian Drug Discovery CROs
Exhibit 4-4: A Selection of Major CROs Operating in Eastern Europe
FIVE: DRUG DISCOVERY OUTSOURCING MARKET
Exhibit 5-1: Global Drug Discovery Outsourcing Market, 2008-2018
Exhibit 5-2:Contract Drug Discovery Services, by Market Segment, 2008-2018
Exhibit 5-3: Market Share Drug Discovery Market Segments, 2014
Exhibit 5-4: Chemistry Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market, 2008-2018
Exhibit 5-5: Chemistry Market Revenue by: Building Blocks, Compound Synthesis, Libraries, Process Research, and Other Services, 2014
Exhibit 5-6: Biology Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market, 2008-2018
Exhibit 5-7: Biology Market Revenue by: Protein Expression, Structural Analysis, Target Validation, Pathways Analysis, and Other Service, 2014
Exhibit 5-8: Screening Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market, 2008-2018
Exhibit 5-9: Screening Services Market: Assay Development, Primary Screening, Secondary Screening, 2014
Exhibit 5-10: Lead Optimization Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market, 2008-2018
Exhibit 5-11: Lead Optimization Services Market: Early ADMET/Tox, Create Analogues, Computational Support, and Other Services, 2014
Exhibit 5-12: A Selection of Drug Discovery Contractors, by Market Segment
Exhibit 5-13: A Selection of Collaborations between Academic Organizations and CROs
Exhibit 5-14: Partnerships between Pharma and Academia
Exhibit 5-15: A Selection of Alliances between CROs
Exhibit 5-15: Global Expansion of Contract Drug Discovery Services, East and West