Outsourcing in Drug Discovery: The Contract Research Organization (CRO) Market, 5th Edition

• Publication date: May 2012
• Report size: 185 pages

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 s...

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 of novel compounds in the pharmaceutical industry, the industry has seen dramatic change. Pharmaceutical companies facing cutbacks in R&D budgets and new demands for novel products need to outsource aspects of their operations. Core functions once kept in-house such as the discovery of potential new drugs are now commonly outsourced. Kalorama Information's Outsourcing in Drug Discovery captures this trend, offering unparalleled coverage 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 in China, India, Russia and Eastern Europe is covered in detail. The report also provides profiles of 23 suppliers, representative of those active in this market.

Segments covered in this report with market size estimates include:

• Chemistry Services
  
  
  
  • Building Blocks
  
  
  • Compound Synthesis
  
  
  • Libraries
  
  
  • Process Research
  
  
  • Other Services
  
  
  
  

   

  
  


• Biology Services
  
  
  
  • Protein Expression
  
  
  • Structural Analysis
  
  
  • Target Validation
  
  
  • Pathways Analysis
  
  
  • Other Services
  
  
  
  

   

  
  


• Screening Services
  
  
  
  • Assay Development
  
  
  • Primary Screening
  
  
  • Secondary Screening
  
  
  
  

   

  
  


• Lead Optimization
  
  
  
  • Early ADMET
  
  
  • Analogues Creation
  
  
  • Computational Support
  
  
  • Other services
  
  
  
  

In addition to market data and forecasts, the report covers issues such as:

• Current outsourcing in drug discovery market size and future forecast


• R&D scale-backs at major companies


• The fastest-growing services for outsourcers


• Logistics, IP, regulatory and other issues in China, India and Eastern Europe


• Common discovery outsourcing pitfalls and how companies overcame them


• What factors should a client consider when deciding whether to do a project in-house or outsource it?


• The choice of a domestic outsourcing partner, or an overseas supplier?


• Best practices when working with a CRO


• Strategic vs. tactical outsourcing models

The information for this report was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, science, medical and business journals. Telephone interviews and email correspondence were the primary method of gathering information. For the purpose of this study Kalorama Information conducted interviews with key industry officials, consultants, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Specific interviews with pharmaceutical, biotechnology and contract research organizations included marketing directors, division managers, and product representatives.

Drug Discovery And Development Industry in India

CHAPTER ONE: EXECUTIVE SUMMARY

• Scope and Methodology


• Introduction
  
  
  
  • Pharmaceutical Industry Challenges
  
  
  • Number of NMEs and BLAs Approved
  
  
  
  


• 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
  
  
  • 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
  
  
  
  


• Outsourcing to india
  
  
  
  • Drug Discovery Services in India
  
  
  
  


• Outsourcing to Eastern Europe


• Drug Discovery Outsourcing Market


• Current Market and Forecast
  
  
  
  • Global Economic Downturn has Minimal Affect on Drug Discovery
  
  
  
  


• Market analysis by Segment

• Background


• Number of NMEs and BLAs Approved between -


• Reducing R&D Spending


• Ramping Up The Pipelines


• Outsourcing Drug Discovery


• The Outsourcing Decision


• Decision Criteria


• 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
  
  
  
  • 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
  
  
  • Experience is Paramount
  
  
  • Facility Standards
  
  
  • Excellent Track Record
  
  
  
  


• Contract Pharma’s Outsourcing Survey


• Global Outsourcing

• 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
  
  
  
  


• Bottlenecks Within the Drug Discovery Process


• Outsourcing To Increase Efficiency


• Outsourcing To Access Novel Technologies


• Bioinformatics


• Lab-on-a-chip: Microfluidics in 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


• Strategic Versus Tactical Outsourcing Model
  
  
  
  • The Tactical Model
  
  
  • The Strategic Model
  
  
  
  


• Effective Communication is Essential for a Successful Partnership


• Mitigating the Challenges of Protecting IP Rights


• Offshoring Contract Drug Discovery


• Introduction


• Center of Gravity Shifting from West to East


• Evolution of Contract Drug Discovery in Asia


• outsourcing to china
  
  
  
  • Introduction
  
  
  • Multi-National Pharmaceutical Companies Establish Research and Development Facilities in China
  
  
  
  


• Chinese Contract Research Organizations
  
  
  
  • WuXi AppTec China’s Largest CRO
  
  
  
  


• First Chinese CRO Alliance


• FDA Offices in China
  
  
  
  • IP Rights Enforcement System
  
  
  
  


• Outsourcing to india
  
  
  
  • Introduction
  
  
  
  


• 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


• Outsourcing to Eastern Europe


• Introduction


• Russian and Ukraine CROs

• 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
  
  
  
  • Current Market and Forecast
  
  
  
  


• Biology Services Market
  
  
  
  • Current Market and Forecast
  
  
  
  


• High Throughput Screening Services Market
  
  
  
  • Current Market and Forecast
  
  
  
  


• Lead Optimization Services Market
  
  
  
  • Current Market and Forecast
  
  
  
  


• Contract Drug Discovery Competitors


• Emergence of Innovative Drug Discovery Business Models
  
  
  
  • Alliances between Academic Organizations and CROs
  
  
  • Alliances between CROs
  
  
  
  


• MARKET GROWTH EXPANDING GLOBAL REACH AND SCALE OF DRUG DISCOVERY SERVICES

• Albany Molecular Research, Inc.
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Aptuit, LLC
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Argenta Discovery, Ltd. (Galapagos)
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Asclepia MedChem Solutions
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Asinex Ltd.
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• AsisChem, Inc.
  
  
  
  • History and Lines of Buisness
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Bio Duro
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• BioFocus DPI
  
  
  
  • History and Lines of Buisness
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Caliper Life Sciences (Perkin Elmer)
  
  
  
  • History and Lines of Buisness
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Charles River Laboratories, Inc.
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Chembiotek
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• ChemBridge Corp.
  
  
  
  • History and Lines of Buisness
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Chemical Diversity Inc.
  
  
  
  • History and Lines of Buisness
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Covance, Inc.
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• CreaGen Biosciences, Inc.
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Cyprotex PLC
  
  
  
  • History and Lines of Buisness
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Domainex
  
  
  
  • History and Lines of Buisness
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Emerald Biostructures
  
  
  
  • History and Lines of Buisness
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Enamine Ltd.
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Evotec AG
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Exelgen Discovery
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• GVK Biosciences Private Limited
  
  
  
  • History and Lines of Buisness
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• GenScript USA Inc.
  
  
  
  • History and Lines of Buisness
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Griffinity Pharmaceuticals Gmbh
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Hutchison MediPharma Ltd.
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Jubilant Biosys ltd
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Nanosyn, Inc.
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• PHARMARON inc.
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Ricerca Biosciences, LLC
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Scynexis, Inc.
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Selcia Limited
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Selvita S.A.
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Shanghai ChemPartner Co.,Ltd.
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• SHANGHAI Medicilon Inc.
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• Sygnature Discovery Limited
  
  
  
  • History and Lines of Buisness
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  


• WuXI AppTec Co. Ltd.
  
  
  
  • History and Lines of Business
  
  
  • Drug Discovery Services
  
  
  • Financial Information
  
  
  
  

   

  
  LIST OF EXHIBITS
  

  CHAPTER 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 1993-2011
  
  
  • Exhibit 1-3 PhRMA Members R&D Spending, 1995 through 2011 (US billions)
  
  
  • Exhibit 1-4 The Drug Discovery Process
  
  
  • Exhibit 1-5 Drug Discovery Processes Frequently Outsourced
  
  
  • Exhibit 1-6 How important are the following factors in your selection of a Contract Service Provider? (All Respondents)
  
  
  • Exhibit 1-7 Global Drug Discovery Outsourcing Market, 2006-2016 (US billions)
  
  
  • Exhibit 1-8 Market Share of Segments of Drug Discovery Market, 2011
  
  
  
  CHAPTER TWO: INTRODUCTION TO OUTSOURCING DRUG DISCOVERY
  
  
  
  • Exhibit 2-1 Number of NME and BLA License Applications Approved Between 1993-2011
  
  
  • Exhibit 2-2 PhRMA Members R&D Spending, 1995 through 2011 (US billions)
  
  
  • Exhibit 2-3 How important are the following factors in your selection of a Contract Service Provider? (All Respondents)
  
  
  • Exhibit 2-4 Selection of Global Drug Discovery Outsourcing Collaborations
  
  
  
  CHAPTER 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 Process Frequently Outsourced
  
  
  • Exhibit 3-6 Bioinformatics as a Central Hub
  
  
  
  CHAPTER FOUR: OUTSOURCING TRENDS
  
  
  
  • Exhibit 4-1 A Selection of R&D Facilities closed or reduced in Size between 2010 and 2011
  
  
  • 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
  
  
  
  CHAPTER FIVE: MARKET ANALYSIS
  
  
  
  • Exhibit 5-1 Global Drug Discovery Outsourcing Market, 2006-2016
  
  
  • Exhibit 5-2 Contract Drug Discovery Services, by Market Segment, 2006-2016
  
  
  • Exhibit 5-3 Market Share Drug Discovery Market Segments, 2011
  
  
  • Exhibit 5-4 Chemistry Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market, 2006-2016
  
  
  • Exhibit 5-5 Chemistry Market Revenue by: Building Blocks, Compound Synthesis, Libraries, Process Research, and Other Services, 2011
  
  
  • Exhibit 5-6Biology Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market, 2006-2016
  
  
  • Exhibit 5-7 Biology Market Revenue by: Protein Expression, Structural Analysis, Target Validation, Pathways Analysis, and Other Service, 2011
  
  
  • Exhibit 5-8 Screening Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market, 2006-2016
  
  
  • Exhibit 5-9 Screening Services Market: Assay Development, Primary Screening, Secondary Screening, 2011
  
  
  • Exhibit 5-10 Lead Optimization Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market, 2006-2016
  
  
  • Exhibit 5-11 Lead Optimization Services Market: Early ADMET/Tox, Create Analogues,Computational Support, and Other Services, 2011
  
  
  • 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 A Selection of Alliances between CROs
  
  
  • Exhibit 5-15 Global Expansion of Drug Discovery Services East and West
  
  
  
  

Clinical Trial in India

India Phase I Clinical Trials

• $ 250
• Industry data
• January 2013

Yearly, From 2006 To 2010
By Business Monitor International
Source: ClinicalTrials.gov, BMI. N.B. Sourced by date of initial registration.

• Industries : Drug Discovery and Development
• Countries : India

India Phase Ii Clinical Trials

• $ 250
• Industry data
• January 2013

Yearly, From 2006 To 2010
By Business Monitor International
Source: ClinicalTrials.gov, BMI. N.B. Sourced by date of initial registration.

• Industries : Drug Discovery and Development
• Countries : India

India Total Clinical Trials

• $ 250
• Industry data
• January 2013

Yearly, From 2006 To 2010
By Business Monitor International
Source: ClinicalTrials.gov, BMI. N.B. Sourced by date of initial registration.

• Industries : Drug Discovery and Development
• Countries : India

India Phase Iii Clinical Trials

• $ 250
• Industry data
• January 2013

Yearly, From 2006 To 2010
By Business Monitor International
Source: ClinicalTrials.gov, BMI. N.B. Sourced by date of initial registration.

• Industries : Drug Discovery and Development
• Countries : India

India Phase Iv Clinical Trials

• $ 250
• Industry data
• January 2013

Yearly, From 2006 To 2010
By Business Monitor International
Source: ClinicalTrials.gov, BMI. N.B. Sourced by date of initial registration.

• Industries : Drug Discovery and Development
• Countries : India