전임상 CRO 시장 : 서비스, 용도, 최종 사용자별 - 세계 예측(2025-2030년)

The Preclinical CRO Market was valued at USD 6.25 billion in 2023, expected to reach USD 6.85 billion in 2024, and is projected to grow at a CAGR of 9.68%, to USD 11.95 billion by 2030.

Preclinical Contract Research Organizations (CROs) play a crucial role in drug development by providing outsourced research services that range from target identification to preclinical testing. The scope of preclinical CROs encompasses a wide array of services, including in vitro and in vivo models, pharmacokinetics, toxicology, and bioanalytical testing. As pharmaceutical companies aim to accelerate their drug development processes while managing costs and navigating complex regulatory landscapes, the necessity and application of preclinical CROs have become more pronounced. The end-use scope predominantly covers pharmaceutical and biotechnology firms, academic research institutes, and government bodies seeking expert guidance and facilities for drug discovery and validation.

Market growth for preclinical CROs is driven by factors such as increasing R&D investments, technological advancements in drug discovery methods, and an escalating demand for personalized medicine. Emerging opportunities, such as the adoption of AI and machine learning in preclinical studies, present avenues for significant operational efficiencies and improved predictability of clinical outcomes. Another potential growth area lies in expanding services related to biologics and biosimilars, given the rising interest in biologically-derived drugs. However, the market also faces limitations and challenges, including high competition, evolving regulatory requirements, and ethical concerns around animal testing.

One major area of innovation lies in the development of alternative testing models like organ-on-chip technologies, which promise a more ethical and precise approach to drug testing. Additionally, further integration of digital platforms to improve data management and increase collaboration between CROs and sponsors can also propel growth. The nature of the market is dynamic and competitive, with an increased focus on strategic partnerships, mergers, and acquisitions to enhance service portfolios and global reach. To thrive amidst these dynamics, CRO businesses should focus on offering flexible, customizable services and investing in cutting-edge technologies to meet the evolving needs of their clientele while staying ahead of regulatory changes.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Preclinical CRO Market

The Preclinical CRO Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • Increasing R&D activities by pharmaceutical and biopharmaceutical companies to develop new drugs & therapies
  • Rising trend of outsourcing drug development activities to CROs by pharmaceutical companies
  • Growing focus on the development of personalized medicines
• Market Restraints
  • High cost and time-consuming constraints associated with preclinical CRO services
• Market Opportunities
  • Growing advances in technologies to enable more efficient and cost-effective preclinical research
  • High potential for preclinical research for biologics, including monoclonal antibodies, vaccines, and cell therapies
• Market Challenges
  • Stringent regulations and guidelines set by international regulatory authorities

Porter's Five Forces: A Strategic Tool for Navigating the Preclinical CRO Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Preclinical CRO Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Preclinical CRO Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Preclinical CRO Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Preclinical CRO Market

A detailed market share analysis in the Preclinical CRO Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Preclinical CRO Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Preclinical CRO Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Key Company Profiles

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

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:

• Based on Services, market is studied across Bioanalysis & DMPK Studies and Toxicology Testing.
• Based on Application, market is studied across Cardiovascular Disease, Dermatology, Gastrointestinal, Genitourinary & Women's Health, Hematology, Immunological Disorders, Infectious Diseases, Metabolic Disorders, Neurology, Oncology, Ophthalmology, and Respiratory Disorders.
• Based on End-User, market is studied across Biopharmaceutical Companies, Government & Academic Institutes, and Medical Device Companies.
• Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

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. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental
• 5.5. 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

Companies Mentioned

• 1. Phenos GmbH
• 2. Syneos Health, Inc.
• 3. Eurofins Scientific SE
• 4. Jubilant Biosys Ltd. byJubilant Pharmova Limited Company
• 5. Parexel International Corporation.
• 6. CTI Clinical Trial and Consulting, Inc.
• 7. Shanghai Medicilon Inc.
• 8. ICON PLC
• 9. Atuka Inc.
• 10. Gubra
• 11. MCI Group Holding SA
• 12. SGS SA
• 13. Immusmol SAS
• 14. PsychoGenics Inc.
• 15. Laboratory Corporation of America Holding
• 16. Hera Biolabs
• 17. IQVIA Inc.
• 18. Biotrofix, Inc.
• 19. Medpace Holdings, Inc.
• 20. Veristat, LLC
• 21. Crown Bioscience, Inc.
• 22. PharmaCircle LLC
• 23. PPD by Thermo Fisher Scientific Inc.
• 24. Sanofi S.A.
• 25. Celerion
• 26. BenchSci
• 27. SCiAN Services Inc.
• 28. Vimta Labs Limited
• 29. Transpharmation
• 30. Diag2Tec SAS
• 31. MD Biosciences
• 32. ImQuest BioSciences
• 33. QPS Holdings, LLC
• 34. Invivotek by Genesis Biotechnology Group, LLC
• 35. Intertek Group PLC
• 36. WuXi AppTec Co., Ltd.
• 37. 10x Genomics, Inc.
• 38. Novartis AG
• 39. AmplifyBio
• 40. Charles River Laboratories International, Inc.
• 41. F. Hoffmann-La Roche Ltd.
• 42. Inotiv, Inc.
• 43. Bioserve Biotechnologies (India) PVT Ltd. by REPROCELL Inc.