Outsourcing in Drug Discovery: The Contract Research Organization (CRO) Market, 5th Edition
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:
In addition to market data and forecasts, the report covers issues such as:
This report 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.
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.
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
This report 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.
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.
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
CHAPTER TWO: INTRODUCTION
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
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
Bottlenecks Within the Drug Discovery Process
Outsourcing To Increase Efficiency
Outsourcing To Access Novel Technologies
Bioinformatics
Lab-on-a-chip: Microfluidics in Drug Discovery
CHAPTER FOUR: OUTSOURCING TRENDS
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
CHAPTER FIVE: DRUG DISCOVERY MARKET ANALYSIS
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
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
CHAPTER TWO: INTRODUCTION
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
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
Bottlenecks Within the Drug Discovery Process
Outsourcing To Increase Efficiency
Outsourcing To Access Novel Technologies
Bioinformatics
Lab-on-a-chip: Microfluidics in Drug Discovery
CHAPTER FOUR: OUTSOURCING TRENDS
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
CHAPTER FIVE: DRUG DISCOVERY MARKET ANALYSIS
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
