Preclinical CRO Market by Services, Application, End-User

List of Tables

[195 Pages Report] The Preclinical CRO Market size was estimated at USD 6.25 billion in 2023 and expected to reach USD 6.85 billion in 2024, at a CAGR 9.68% to reach USD 11.95 billion by 2030.

A preclinical CRO is a support center providing expertise in research and development activities (R&D) essential for navigating a drug candidate through animal testing and forwarding it into the clinical phase. Preclinical research services encompass several studies critical to assessing drug efficacy & safety in animal models and complete Investigational New Drug (IND) filing studies. In a preclinical trial, CROs are hired by sponsors such as biopharma companies to perform a set of tasks, taking various technical and administrative responsibilities on the sponsor's behalf. A surge in the number of drugs in the preclinical phase and an increased research & development (R&D) budget for drug development are driving the usage of preclinical CRO services. The high cost and time-consuming process of preclinical CROS services hamper the market growth. Advances in technology, which include high-throughput screening and in silico modeling, enable more efficient and cost-effective preclinical research and are expected to create opportunities for market growth.

KEY MARKET STATISTICS
Base Year [2023]	USD 6.25 billion
Estimated Year [2024]	USD 6.85 billion
Forecast Year [2030]	USD 11.95 billion
CAGR (%)	9.68%

Services: Burgeoning usage of Toxicology testing services focusing on the safety and regulatory compliance aspects

Bioanalysis and DMPK studies are crucial for understanding potential therapeutic agents' absorption, distribution, metabolism, and excretion (ADME) properties. This segment provides vital information on the drug's behavior in a biological system, which is paramount for dosage determination and safety assessment. These studies are preferred in the early stages of drug development when detailed insight into the drug's pharmacokinetic profile is required. Pharmaceutical companies and biotechnology firms often rely on external CROs with specialized expertise in bioanalytical methodologies and state-of-the-art technologies. Toxicology testing services are vital for evaluating the safety profile of drug candidates, ensuring they are safe for further development and human consumption. This segment encompasses a range of studies to assess the potential adverse effects of compounds on living organisms. These tests are critical before advancing to clinical trials, catering mainly to regulatory requirements that drugs must pass for approval. They are indispensable for all pharmaceutical and biotechnological companies needing to demonstrate the non-toxic nature of their products.

End-User: Evolving usage of preclinical CRO by biopharmaceutical companies

Biopharmaceutical companies are primary clients of preclinical CROs, leveraging their services for the development and testing of biologic drugs. These companies seek CRO partnerships to access specialized expertise in pharmacology, toxicology, and molecular biology. Services offered to biopharmaceutical companies often include drug efficacy and safety assessments, absorption, distribution, metabolism, excretion (ADME) studies, and regulatory support. Collaborating with preclinical CROs enables biopharmaceutical companies to accelerate their drug development process, manage costs effectively, and navigate complex regulatory requirements efficiently. Government and academic institutes often engage with preclinical CROs for research and development initiatives fundamental to public health objectives. These partnerships support projects, including new drug discoveries, vaccine development, and innovative medical treatments. Preclinical CROs provide these institutions with access to specialized resources and expertise that may not be available in-house. Additionally, CROs assist in conducting high-quality, regulatory-compliant research studies that can lead to groundbreaking medical advancements. Collaborations between government / academic institutes and CROs are pivotal in bridging the gap between basic research and clinical application. Medical device companies utilize preclinical CRO services to validate the security and efficacy of their products before proceeding to clinical trials. These companies benefit from CROs' technical and regulatory expertise to conduct comprehensive biomedical testing, biomechanical evaluation, and risk assessment. Services tailored to medical device companies often encompass preclinical study design, prototype testing, and support in complying with international standards and regulations. By partnering with CROs, medical device companies can assure their products meet the highest quality and safety standards, facilitating smoother transitions into clinical phases.

Regional Insights

The unprecedented rise in non-communicable diseases among the geriatric population and communicable diseases caused by changing environmental conditions, such as pollution, and insect infestation, create a demand for effective drug development in the healthcare sector, subsequently increasing the need for preclinical CRO services across the Americas, Asia-Pacific, and EMEA. The investments made by the governments of Asia-Pacific to push research and development (R&D) activities of medical devices and drug development are estimated to provide growth opportunities for the preclinical CRO market players. In August 2021, the Australian government invested USD 79 million in medical innovation and research projects. The developed economies in the European Union have established a supportive government framework to boost technological advancements by prioritizing research and innovation of new technologies and drug development. The government introduces several stringent regulations and standards to ensure that the medicines and devices developed are safe, reliable, and of high quality. In January 2022, the Clinical Trials Regulation (Regulation (EU) No 536/2014) was set to launch in the EU to modify the clinical trial processes. The government introduced a Clinical Trials Information System (CTIS) to harmonize the supervision and assessment processes. Thus, the ongoing government support for clinical trials for medical devices and drug development is expected to fuel the growth of the preclinical CRO market in EMEA.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Preclinical CRO Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Preclinical CRO Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the Preclinical CRO Market, highlighting leading vendors and their innovative profiles. These include 10x Genomics, Inc., AmplifyBio, Atuka Inc., BenchSci, Bioserve Biotechnologies (India) PVT Ltd. by REPROCELL Inc., Biotrofix, Inc., Celerion, Charles River Laboratories International, Inc., Crown Bioscience, Inc., CTI Clinical Trial and Consulting, Inc., Diag2Tec SAS, Eurofins Scientific SE, F. Hoffmann-La Roche Ltd., Gubra, Hera Biolabs, ICON PLC, Immusmol SAS, ImQuest BioSciences, Inotiv, Inc., Intertek Group PLC, Invivotek by Genesis Biotechnology Group, LLC, IQVIA Inc., Jubilant Biosys Ltd. byJubilant Pharmova Limited Company, Laboratory Corporation of America Holding, MCI Group Holding SA, MD Biosciences, Medpace Holdings, Inc., Novartis AG, Parexel International Corporation., PharmaCircle LLC, Phenos GmbH, PPD by Thermo Fisher Scientific Inc., PsychoGenics Inc., QPS Holdings, LLC, Sanofi S.A., SCiAN Services Inc., SGS SA, Shanghai Medicilon Inc., Syneos Health, Inc., Transpharmation, Veristat, LLC, Vimta Labs Limited, and WuXi AppTec Co., Ltd..

Market Segmentation & Coverage

This research report categorizes the Preclinical CRO Market to forecast the revenues and analyze trends in each of the following sub-markets:

Services
- Bioanalysis & DMPK Studies
- Toxicology Testing

Application
- Cardiovascular Disease
- Dermatology
- Gastrointestinal
- Genitourinary & Women's Health
- Hematology
- Immunological Disorders
- Infectious Diseases
- Metabolic Disorders
- Neurology
- Oncology
- Ophthalmology
- Respiratory Disorders

End-User
- Biopharmaceutical Companies
- Government & Academic Institutes
- Medical Device Companies

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Preclinical CRO Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Preclinical CRO Market?

3. What are the technology trends and regulatory frameworks in the Preclinical CRO Market?

4. What is the market share of the leading vendors in the Preclinical CRO Market?

5. Which modes and strategic moves are suitable for entering the Preclinical CRO Market?

Product Code: MRR-A339DAEFA51A

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Increasing R&D activities by pharmaceutical and biopharmaceutical companies to develop new drugs & therapies
  - 5.1.1.2. Rising trend of outsourcing drug development activities to CROs by pharmaceutical companies
  - 5.1.1.3. Growing focus on the development of personalized medicines
- 5.1.2. Restraints
  - 5.1.2.1. High cost and time-consuming constraints associated with preclinical CRO services
- 5.1.3. Opportunities
  - 5.1.3.1. Growing advances in technologies to enable more efficient and cost-effective preclinical research
  - 5.1.3.2. High potential for preclinical research for biologics, including monoclonal antibodies, vaccines, and cell therapies
- 5.1.4. Challenges
  - 5.1.4.1. Stringent regulations and guidelines set by international regulatory authorities
5.2. Market Segmentation Analysis
- 5.2.1. Services: Burgeoning usage of Toxicology testing services focusing on the safety and regulatory compliance aspects
- 5.2.2. End-User: Evolving usage of preclinical CRO by biopharmaceutical companies
5.3. Market Trend Analysis
- 5.3.1. Presence of well-established pharmaceutical & biopharmaceutical companies and the rising introduction of advanced preclinical CRO platforms in the Americas
- 5.3.2. Rising government support for expanding research & development activities into developing new drugs and medical devices in the Asia-Pacific region
- 5.3.3. Potential government funding in drug development activities expands the preclinical CRO business in the EMEA region.
5.4. Cumulative Impact of High Inflation
5.5. Porter's Five Forces Analysis
- 5.5.1. Threat of New Entrants
- 5.5.2. Threat of Substitutes
- 5.5.3. Bargaining Power of Customers
- 5.5.4. Bargaining Power of Suppliers
- 5.5.5. Industry Rivalry
5.6. Value Chain & Critical Path Analysis
5.7. Regulatory Framework Analysis
5.8. Client Customization

6. Preclinical CRO Market, by Services

6.1. Introduction
6.2. Bioanalysis & DMPK Studies
6.3. Toxicology Testing

7. Preclinical CRO Market, by Application

7.1. Introduction
7.2. Cardiovascular Disease
7.3. Dermatology
7.4. Gastrointestinal
7.5. Genitourinary & Women's Health
7.6. Hematology
7.7. Immunological Disorders
7.8. Infectious Diseases
7.9. Metabolic Disorders
7.10. Neurology
7.11. Oncology
7.12. Ophthalmology
7.13. Respiratory Disorders

8. Preclinical CRO Market, by End-User

8.1. Introduction
8.2. Biopharmaceutical Companies
8.3. Government & Academic Institutes
8.4. Medical Device Companies

9. Americas Preclinical CRO Market

9.1. Introduction
9.2. Argentina
9.3. Brazil
9.4. Canada
9.5. Mexico
9.6. United States

10. Asia-Pacific Preclinical CRO Market

10.1. Introduction
10.2. Australia
10.3. China
10.4. India
10.5. Indonesia
10.6. Japan
10.7. Malaysia
10.8. Philippines
10.9. Singapore
10.10. South Korea
10.11. Taiwan
10.12. Thailand
10.13. Vietnam

11. Europe, Middle East & Africa Preclinical CRO Market

11.1. Introduction
11.2. Denmark
11.3. Egypt
11.4. Finland
11.5. France
11.6. Germany
11.7. Israel
11.8. Italy
11.9. Netherlands
11.10. Nigeria
11.11. Norway
11.12. Poland
11.13. Qatar
11.14. Russia
11.15. Saudi Arabia
11.16. South Africa
11.17. Spain
11.18. Sweden
11.19. Switzerland
11.20. Turkey
11.21. United Arab Emirates
11.22. United Kingdom

12. Competitive Landscape

12.1. Market Share Analysis, 2023
12.2. FPNV Positioning Matrix, 2023
12.3. Competitive Scenario Analysis
- 12.3.1. CRO Company TriApex Completes Series C Financing Round Led by Legend Capital
- 12.3.2. PsychoGenics Launches eCube, a New AI-Enabled Platform for Drug Discovery
- 12.3.3. Proscia Announces Major Expansion in Preclinical R&D to Drive Faster Drug Safety Decisions
- 12.3.4. AmplifyBio Expands Cell Therapy Characterization, Fills Gap in Preclinical Development
- 12.3.5. Clinchoice Continues Expansion with CRO Acquisition
- 12.3.6. QPS opens an additional preclinical research facility in Taiwan
- 12.3.7. CRO Avania Acquires MAXIS
- 12.3.8. Apax Acquires a Majority Stake in Porsolt to Support its Growth Strategy and Become a Global Leader in Preclinical Services
- 12.3.9. Cryoport Announces Strategic Partnership with Syneos Health to Advance Cell & Gene Therapies
- 12.3.10. Crown Bioscience and ERS Genomics Announce Global CRISPR/Cas9 Licensing Agreement for Genome Editing Patents
- 12.3.11. Domain Therapeutics and Explicyte Enter Partnership Agreement in Immuno-Oncology
- 12.3.12. Celerion Expands Early Phase Clinical Pharmacology Units
- 12.3.13. ClinChoice Raises USD 150 Million in Series E Round
- 12.3.14. Hera BioLabs Announces Exclusive Global License With Charles River
- 12.3.15. IonsGate Preclinical Services and InSilicoTrials Form Partnership

13. Competitive Portfolio

13.1. Key Company Profiles
13.2. Key Product Portfolio