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Preclinical Research Outsourcing Services: Global Markets

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    Report

  • 147 Pages
  • May 2022
  • Region: Global
  • BCC Research
  • ID: 5591419
This report identifies the global preclinical research outsourcing services market, along with all major global preclinical CRO companies. The total preclinical research outsourcing services market is segmented globally and by geographic regions. The service areas provided by preclinical CROs are extensively covered as well. The report offers a detailed examination of preclinical services, analyzes market trends for preclinical research outsourcing services with data from 2020, estimates from 2021, and projections of CAGR through 2026 (forecast period 2021–2026). This report provides a comprehensive analysis of the top preclinical CROs and evolving roles in the preclinical outsourcing services. CRO expertise within certain therapeutic areas and experience with new and adaptive study design protocols can reduce costs and study duration. CROs are expected to continue to play an increasing role in many aspects of the preclinical and clinical trial process. Strong demand for CROs leads to heightened market assessments and many blockbuster mergers and acquisitions (M&As). M&A activity has led to a few companies to develop proficiency across many areas of the clinical trial process. However, niche players still play crucial roles. This report analyzes emerging trends and changing dynamics within the preclinical research outsourcing services industry.



Report Includes

  • 24 data tables and 12 additional tables
  • An up-to-date review and analysis of the global markets for preclinical research outsourcing services
  • Analyses of the global market trends, with historic revenue (sales) data from 2019-2021, estimates for 2022, and projections of compound annual growth rates (CAGRs) through 2026
  • Evaluation and forecast the global market size for preclinical research outsourcing services, projected growth trends, and corresponding market share analysis by functional services and geographic region
  • In-depth information (facts and figures) concerning market drivers, market deterrents and other macroeconomic forces affecting the current and future market demand
  • Identification of companies best positioned to meet this demand owing to their proprietary technologies, mergers and acquisitions, joint ventures and other strategic alliances
  • Regulatory structure for preclinical research studies in the pharmaceuticals industry, marketed and pipeline products, pricing and reimbursement structure, and major developments influencing the progress of this market
  • Detailed analysis on the strength, weakness, and opportunities of the prominent players operating in the global preclinical research outsourcing services market
  • Insight into recent industry structure, current competitive scenario, increasing investments on R&D activities, current pharma/CRO contracts and company value share analysis based on their segmental revenues
  • Company profiles of major players, including Eurofins Scientific, IQVIA, Labcorp, SGS SA, and Thermo Fisher
Frequently Asked Questions about the Global Preclinical Research Outsourcing Services Market

What is the estimated value of the Global Preclinical Research Outsourcing Services Market?

The Global Preclinical Research Outsourcing Services Market was estimated to be valued at $5.6 Billion in 2021.

What is the growth rate of the Global Preclinical Research Outsourcing Services Market?

The growth rate of the Global Preclinical Research Outsourcing Services Market is 8.1%, with an estimated value of $8.3 Billion by 2026.

What is the forecasted size of the Global Preclinical Research Outsourcing Services Market?

The Global Preclinical Research Outsourcing Services Market is estimated to be worth $8.3 Billion by 2026.

Table of Contents

Chapter 1 Introduction
  • Study Goals and Objectives
  • Reasons for Doing this Study
  • Scope of Report
  • Information Sources
  • Methodology
  • Geographic Breakdown
  • Analyst's Credentials
  • Custom Research
  • Related Research Reports

Chapter 2 Summary and Highlights
Chapter 3 Market Dynamics
  • Market Drivers
  • Rising R&D Investment
  • Growth in Outsourcing of Non-Core Function
  • Cros Add Efficiency
  • Market Restraints
  • Challenges in Preclinical Research Outsourcing
  • Lack of Skilled Professionals
  • Market Opportunities
  • Growing Opportunities in Asia-Pacific
  • Inorganic Strategies
  • Emerging Markets

Chapter 4 Impact of Covid-19
  • Overview of Covid-19 Crisis
  • Impact of Covid-19 on the Cro Market
  • Current Outlook

Chapter 5 Global Market Overview
  • Preclinical Process Overview
  • Market for Drug Substance/Active Pharmaceutical Ingredient Manufacturing for Drug Development
  • Manufacturers
  • Market Estimate for Outsourcing Api Manufacturing for Drug Development
  • Formulation and Dosage Design Outsourcing Services
  • Companies
  • Market Overview and Estimates for Outsourcing of Formulation Development
  • Analytical/Bioanalytical Methods Development, Validation and Testing
  • Analytical Methods Development
  • Analytical Methods Validation, Verification and Qualification
  • Analytical Testing Method Development and Validation Market Landscape and Estimates
  • Companies/Providers
  • Metabolism, Pharmacokinetics and Toxicology Outsourcing
  • Companies/Providers
  • Market Estimates: Metabolism, Pharmacokinetics and Toxicology Outsourcing Services
  • Preclinical Stage Outsourcing Services
  • Cros and Preclinical Research Outsourcing
  • Contract Manufacturing
  • Contract Research

Chapter 6 Regulatory Landscape
  • Fda Regulation and Impact
  • Regulations on Sponsor Activities
  • The Declaration of Helsinki
  • Cdisc Standards
  • Regulations for Contract Manufacturing Services
  • Regulations for Contract Pharmaceutical Clinical Research in Each Stage of Drug Discovery and Development Process
  • Current Market Trends
  • Existing Drugs for New Indications
  • Increased Competition

Chapter 7 Market Analysis by Functional Service
  • Discovery Services
  • Chemistry
  • Bioanalysis
  • Toxicology

Chapter 8 Market Analysis by Region
  • Overview
  • North America
  • U.S.
  • Canada
  • Europe
  • Germany
  • U.K.
  • France
  • Italy
  • Spain
  • Rest of Europe
  • Asia-Pacific
  • China
  • Japan
  • India
  • South Korea
  • Rest of Asia-Pacific
  • Rest of the World
  • South America
  • Middle East & Africa

Chapter 9 Competitive Landscape
  • Market Share Analysis
  • Current Pharma/Cro Contracts
  • Mergers and Acquisitions

Chapter 10 Analysis of Market Opportunities
  • Porter's Five Forces Analysis
  • Threat of New Entrants
  • Threat of Substitutes
  • Bargaining Power of Suppliers
  • Bargaining Power of Buyers
  • Competitive Rivalry/Degree of Competition
  • Swot Analysis
  • Strengths of the Global Market for Preclinical Research Outsourcing Services
  • Challenges Within the Global Market for Preclinical Research Outsourcing Services
  • Opportunities in the Global Market for Preclinical Research Outsourcing Services
  • Threats to the Global Market for Preclinical Research Outsourcing Services

Chapter 11 Company Profiles
  • Top 11 Cros
  • Charles River Laboratories
  • Eurofins Scientific
  • Evotec
  • Frontage Labs
  • Icon plc
  • Iqvia
  • Laboratory Corporation of America Holdings
  • Medpace
  • Sgs Sa
  • Thermo Fisher Scientific Inc.
  • Wuxi Apptec

Chapter 12 Appendix: Abbreviations and Acronyms
List of Tables
Summary Table: Global Market for Preclinical Research Outsourcing Services, by Preclinical Services, Through 2026
Table 1: R&D Investment, by Major Companies, 2019-2020
Table 2: Leading CROs in India
Table 3: Companies in the API Manufacturing Sector/Average Annual Revenues
Table 4: Companies Providing Formulation and Dosage Design Services for Drug Development (Examples)
Table 5: Distribution of Company Shares of the CDMO Sector by Revenue Range
Table 6: Companies Providing Analytical Testing Method Development and Validation Services for Drug Development (Examples)
Table 7: Companies Providing Drug Metabolism and Toxicology Services for Preclinical Drug Development (Examples)
Table 8: New Drug Approvals in the Global Biopharmaceuticals Market, 2006-2021
Table 9: Approved Drugs Repurposed for Infectious Diseases
Table 10: Global Market for Preclinical Research Outsourcing Services, by Functional Service, Through 2026
Table 11: Global Market for Discovery Services, by Region, Through 2026
Table 12: Global Market for Chemistry Services, by Region, Through 2026
Table 13: Global Market for Bioanalysis Services, by Region, Through 2026
Table 14: Global Market for Toxicology Services, by Region, Through 2026
Table 15: Global Market for Preclinical Research Outsourcing Services, by Region, Through 2026
Table 16: North American Market for Preclinical Research Outsourcing Services, by Functional Service, Through 2026
Table 17: European Market for Preclinical Research Outsourcing Services, by Functional Service, Through 2026
Table 18: Asia-Pacific Clinical Trial Regulatory Bodies
Table 19: Asia-Pacific Market for Preclinical Research Outsourcing Services, by Functional Service, Through 2026
Table 20: RoW Market for Preclinical Research Outsourcing Services, by Functional Service, Through 2026
Table 21: Pharma and CRO Partnership Alliances for Preclinical Research Services
Table 22: Recent M&As in CROs and Pharma Outsourcing Sector, 2016-2021
Table 23: Porter’s Five Forces Analysis
Table 24: Service Offerings, Major CROs
Table 25: Charles River Laboratories: Revenues, 2018-2020
Table 26: Eurofins Scientific: Revenue, 2018-2020
Table 27: Evotec: Revenues, 2018-2020
Table 28: Frontage Labs: Revenue, 2018-2020
Table 29: ICON plc: Revenue, 2018-2020
Table 30: IQVIA: Revenues, 2018-2020
Table 31: LabCorp: Revenue, 2018-2020
Table 32: Medpace: Revenues, 2018-2020
Table 33: SGS SA: Revenue, 2018-2020
Table 34: Thermo Fisher Scientific Inc.: Revenue, 2018-2020
Table 35: WuXi AppTec: Revenue, 2018-2020
Table 36: Abbreviations and Acronyms
List of Figures
Summary Figure: Global Market for Preclinical Research Outsourcing Services, by Preclinical Services, 2020–2026
Figure 1: Drug Approval Timeline
Figure 2: FDA cGMP Manufacturing Guidance Documents
Figure 3: FDA Site Inspections
Figure 4: European cGMP Guideline Documentation
Figure 5: European Site Inspection Outcomes
Figure 6: Global Market Size and Growth of Preclinical Research Outsourcing Services, 2019-2026
Figure 7: Pharma R&D Spending, 2016-2026
Figure 8: Global Prescription Drug Sales, 2016-2026
Figure 9: Global Market Shares of Preclinical Research Outsourcing Services, by Functional Service, 2020
Figure 10: Global Market for Discovery Services, 2019-2026
Figure 11: Global Market for Discovery Services, by Region, 2019-2026
Figure 12: Global Market for Chemistry Services, 2019-2026
Figure 13: Global Market for Bioanalysis Services, 2019-2026
Figure 14: Global Market for Bioanalysis Services, by Region, 2019-2026
Figure 15: Global Market for Toxicology Services, 2019-2026
Figure 16: Global Market for Toxicology Services, by Region, 2019-2026
Figure 17: Global Market for Preclinical Research Outsourcing Services, by Region, 2020–2026
Figure 18: Global Market Shares of Preclinical Research Outsourcing Services, by Region, 2020
Figure 19: North American Market for Preclinical Research Outsourcing Services, 2020–2026
Figure 20: European Market for Preclinical Research Outsourcing Services, 2020–2026
Figure 21: Asia-Pacific Market for Preclinical Research Outsourcing Services, 2020–2026
Figure 22: Asia-Pacific Market for Preclinical Research Outsourcing Services, 2020–2026
Figure 23: Global Market Shares of Leading Preclinical Research Outsourcing Service Providers, 2020
Figure 24: Expanding Value, Outsourcing Deals Involving CROs, 2007-2017
Figure 25: SWOT Analysis of the DTC Testing Market
Figure 26: Charles River Laboratories: Revenue Share, by Segment, 2020
Figure 27: Eurofins Scientific: Revenue Share, by Segment, 2020
Figure 28: Evotec: Revenue Share, by Segment, 2020
Figure 29: Frontage Labs: Revenue Share, by Segment, 2020
Figure 30: IQVIA: Revenue Share, by Segment, 2020
Figure 31: LabCorp: Revenue Share, by Segment, 2020
Figure 32: SGS SA: Revenue Share, by Segment, 2020
Figure 33: Thermo Fisher Scientific Inc.: Revenue Share, by Segment, 2020
Figure 34: WuXi AppTec: Revenue Share, by Segment, 2020

Executive Summary

Outsourcing preclinical services of the drug discovery and development process offers the pharmaceutical industry a wide range of opportunities to develop and commercialize, innovative methods and technologies. Outsourcing is an attractive approach for investigations that are too complex, too expensive, and too lengthy otherwise to be conducted in-house. In previous times, outsourcing was seen as a short-term strategy for demand realization. Now, it is considered as the key lever for the core competencies to increase performance in pharmaceutical research. Outsourcing can positively impact research performance because it lowers the cost and time associated with new innovations.

There are two ways to outsource services:

  • Full vertical integration, which maximizes operations conducted in-house.
  • Virtual operations, which relates to full outsourcing and where all operations are methodically outsourced to third parties.

The outsourcing service providers/CROs market continues to exhibit significant growth, largely attributed to increased demand for services in clinical trials including preclinical research. The proliferation of therapies for orphan drugs and precision-based medicines, preclinical and clinical trials are becoming increasingly complex, which is driving demand for sophisticated outsourcing partners with expertise in preclinical services, disease registries, real world evidence, medical affairs and risk-based monitoring. Expanding service offerings and capabilities remain a predominant strategy among CROs.

The geographic distribution of clinical research is slowly shifting from developed nations to emerging countries in regions such as Central and Eastern Europe, Asia-Pacific and Latin America. Also, the greater disease difference among developing countries offers more diverse population samples, particularly for rare disease studies.

IQVIA Inc. , Labcorp PPD Inc. , Syneos Health, Charles River Laboratories International Inc. and Medpace are the CRO industry’s dominant players. Mergers and acquisitions among these and other large companies in the preclinical research outsourcing continues at an extraordinary pace, driven by high valuations and the increasing need to become complete service providers. Current pharmaceutical R&D spending is driven by precision-based medicines and immunotherapies for smaller populations, genetic therapies for oncology, rare disease treatment and generally more demanding and complex protocols for drug development.

The preclinical research environment continues to be tied to exorbitant costs as complex therapies requiring larger and more diverse samples increases the time required and geographies involved in conducting a typical trials. To rein in costs and shorten development timelines, pharmaceutical and biopharma firms are increasingly outsourcing services to CROs. In addition to complex therapies, combination regimens increase timelines and difficulties. Today, CROs operate more efficiently and improve quality and timeliness for sponsors despite the increasing complexities of studies. This is bolstering CRO penetration in all stages of development.