Outsourcing in Drug Discovery: The Contract Research Organization (CRO) Market, 8th Edition
In eight editions, Kalorama Information's report, Outsourcing in Drug Discovery, has kept the industry informed, providing answers to these questions and more. The 8th edition contains 2017 market size estimates and 2022 forecasts for 21 different parts of the process that might be outsourced, including:
Chemistry Services Market, 2017-2022
Building Blocks Outsourcing Market, 2017-2022
Compound Synthesis Market, 2017-2022
Library Construction Market, 2017-2022
Process Research Market, 2017-2022
Biology Services Market, 2017-2022
Protein Expression Market, 2017-2022
Structural Analysis Market, 2017-2022
Target Validation Market, 2017-2022
Pathways Analysis Market, 2017-2022
Screening Services Market, 2017-2022
Assay Development Market, 2017-2022
Primary Screening Market, 2017-2022
Secondary Screening Market, 2017-2022
Lead Optimization Market, 2017-2022
Early ADMET Market, 2017-2022
Analogues Creation Market, 2017-2022
Computational Support Market, 2017-2022
Other Services Market, 2017-2022
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.
Executive Summary
Overview
Table Drug Discovery Timeline: Research to Viable Product to Commercialization
Scope and Methodology
Introduction
Pharmaceutical Industry Challenges
Number of New Molecular Entities (NMEs) and Biologics License Approved (BLAs) Approved
Table Number of New Molecular Entities (NMEs) and Biologics License Approved (BLAs) That the US FDA Center for Drug Evaluation and Research (CDER) Approved between 1993-2016
R&D Spending
Table Domestic R&D and R&D Abroad, PhRMA Member Companies: 1995-2016 ($ billion)
The Drug Discovery Process
Table The Drug Discovery Process
Accelerating the Drug Discovery Process
Bottlenecks within the Drug Discovery Process
Outsourcing to Increase Efficiency
Table Drug Discovery Processes Frequently Outsourced
Outsourcing Drug Discovery
The Outsourcing Decision
Developing an Outsourcing Plan
Contract Research Organizations
Strategic Versus Tactical Outsourcing Model
A New Model Emerging: Insourcing
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
Current Market and Forecast
Table Global Drug Discovery Outsourcing Market, 2012-2022 ($ billion)
Market Analysis by Segment
Table Market Share Drug Discovery Market Segments, 2018 (%; Lead Optimization, Chemistry Services, Biology Services, HTS)
Introduction to Outsourcing Drug Discovery
Background
Number of New Molecular Entities (NMEs) and Biologics License Approved (BLAs) Approved
Table Number of New Molecular Entities (NMEs) and Biologics License Approved (BLAs) That the US FDA Center for Drug Evaluation and Research (CDER) Approved between 1993-2016
R&D Spending
Table Domestic R&D and R&D Abroad, PhRMA Member Companies: 1995-2016 ($ billion)
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
Concerns about Global Outsourcing
Selecting a Contract Research Organization
Introduction
Choosing the Right CRO
Global Outsourcing
Table Selection of Global Drug Discovery Outsourcing Collaborations
The Drug Discovery Process
Introduction
Table The Drug Discovery Process
Discovery Stages
Accelerating the Drug Discovery Process
Technologies Utilized in Drug Discovery
Table Drug Discovery Timeline: Research to Viable Product to Commercialization
Table Bioinformatics/Pharmacogenomics
Table Causes of New Drug Attrition (%; Unsuitable Bioavailability Profile, Toxicity, Commercial Setbacks, Other)
Bottlenecks within the Drug Discovery Process
Outsourcing to Increase Efficiency
Table Drug Discovery Processes Frequently Outsourced
Outsourcing to Access Novel Technologies
Bioinformatics
Lab-on-a-chip: Microfluidics in Drug Discovery
Table Bioinformatics as a Central Hub
Outsourcing Drug Discovery
Overview
The Traditional Drug Discovery Model Is Changing
Table A Selection of R&D Facilities Closed or Reduced in Size between 2010 and 2017
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
Outsourcing Contract Drug Discovery Offshore
Introduction
Robust Growth of Outsourcing Drug Discovery in Asia
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
Table A Selection of Chinese Drug Discovery CROs
WuXi AppTec, China's Largest CRO
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
Table A Selection of Indian Drug Discovery CROs
India's Handling of IP Rights and Laws
FDA Offices in India
Outsourcing to Eastern Europe
Introduction
Eastern European CROs
Table A Selection of Major CROs Operating in Eastern Europe
Drug Discovery Outsourcing Market
Overview
Drug Discovery Outsourcing Market
Current Market and Forecast
Table Global Drug Discovery Outsourcing Market, 2012-2022 ($ billion)
Table Contract Drug Discovery Services, by Market Segment, 2012-2022 ($ billion)
Market Analysis by Segment
Table Market Share Drug Discovery Market Segments, 2018 (%; Lead Optimization, Chemistry Services, Biology Services, HTS)
Chemistry Services Market
Table Chemistry Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market, 2012-2022 ($ billion)
Table Chemistry Market Revenue by: Building Blocks, Compound Synthesis, Libraries, Process Research, and Other Services, 2018 ($ billion)
Biology Services Market
Table Biology Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market, 2012-2022 ($ billion)
Table Biology Market Revenue by: Protein Expression, Structural Analysis, Target Validation, Pathways Analysis, and Other Service, 2018 ($ billion)
High Throughput Screening Services Market
Table HTS Services Market: Revenues, Annual Growth, and Share of Outsourced Drug Discovery Market, 2012-2022 ($ billion)