전임상 CRO(임상시험수탁기관) 시장 예측(-2030년) : 모델 유형별, 서비스별, 동물모델별, 최종 사용자별, 지역별 세계 분석

According to Stratistics MRC, the Global Preclinical Contract Research Organization (CRO) Market is accounted for $4.99 billion in 2023 and is expected to reach $9.42 billion by 2030 growing at a CAGR of 9.5% during the forecast period. A Preclinical Contract Research Organization (CRO) is a specialized service provider in the pharmaceutical and biotechnology industry that conducts research and testing on experimental drugs and therapies before they enter clinical trials. To evaluate the safety, efficacy, and possible dangers associated with novel compounds, preclinical CROs provide a broad range of services. Furthermore, their knowledge and resources aid pharmaceutical businesses in optimizing drug development by offering vital information and regulatory support and by providing adherence to regulatory and industry norms.

According to the IFPMA's 2021 report, the annual R&D spending by the international biopharmaceutical industry is 7.3 times higher than that of the aerospace and defense industries, 6.5 times more than the chemicals industry, and 1.5 times more than the software and computer services industry.

Market Dynamics:

Driver:

Increase in globalization

CROs are international businesses that provide pharmaceutical and biotech firms with access to a wide range of resources, knowledge, and regulatory routes in several jurisdictions. By taking advantage of regulatory benefits, diversified patient populations, and developing markets, corporations can optimize their drug development strategy through globalization. Additionally, it improves healthcare outcomes and public access to cutting-edge therapeutics by encouraging cooperation and innovation and accelerating the time and efficiency of bringing new drugs to market.

Restraint:

High cost

The need to adhere to stringent regulatory regulations and uphold quality standards increases expenditures. To properly undertake preclinical research, CROs must invest a significant amount of money in cutting-edge facilities, machinery, and highly qualified staff. Intense competition is a common occurrence for CROs, which raises the price of marketing and business development initiatives. In addition, smaller or newly established CROs may find it difficult to enter the market due to these exorbitant costs, which thereby hinder market growth.

Opportunity:

Technological advancements

Pharmaceutical and biotech businesses may make well-informed judgments on drug development with the help of their advanced technologies, which enables them to provide reliable and efficient preclinical testing and data analysis. CROs use this specific knowledge to lower development risks, speed up the identification of promising drug candidates, and improve the general quality and safety of novel treatments. Furthermore, because of their specialization and experience, CROs are advantageous collaborators for promoting drug development and innovation in a tough, government-regulated setting thereby driving this market size.

Threat:

Stringent regulatory environment

CROs operating in this space encounter challenges in navigating the intricate regulatory frameworks, leading to increased compliance costs and potential delays in project timelines. The stringent regulatory environment also influences the decision-making process of pharmaceutical and biotechnology companies when selecting CRO partners. Furthermore, the regulatory load results in longer approval processes and more inspection, affects the general effectiveness and pace of preclinical research carried out by CROs. This unfavourable environment inhibits innovation, lowers the availability of preclinical research services, and thereby impedes this market expansion.

COVID-19 Impact

The COVID-19 pandemic has had a notable negative impact on the preclinical contract research organization (CRO) market. The number of preclinical studies that were postponed or cancelled resulted in a decline in the need for CRO services. The pandemic's financial insecurity has resulted in decreased investment in research and development, which has an effect on the money set aside for preclinical study outsourcing. Furthermore, the pandemic-induced economic downturn and uncertainty prompted some clients to postpone or cancel preclinical projects, impacting the revenue and growth prospects of CRO and further impeding this market.

The toxicology testing segment is expected to be the largest during the forecast period

The toxicology testing segment is estimated to hold the largest share. Toxicology-focused CROs offer vital services to biotech and pharmaceutical firms by thoroughly assessing potential drugs in order to satisfy strict regulatory standards. These tests help discover harmful reactions and dosage levels by assessing how chemicals affect different biological systems. Therefore, it protects public health and the success of drug development initiatives by minimizing development risks, expediting regulatory approvals, and guaranteeing the safety of pharmaceutical goods, which thereby boosts this segment's growth.

The patient derived xenograft (PDX) segment is expected to have the highest CAGR during the forecast period

The patient derived xenograft (PDX) segment is anticipated to have highest CAGR during the forecast period due to the tumor tissues from patients being transplanted into immunodeficient mice in PDX models to replicate the tumor environment of the patient. These models show a greater chance of success in human trials when drug candidates are evaluated in a more clinically appropriate setting. Furthermore, customized medicine insights are provided by PDX CROs, enabling treatmentsfor specific patients. The PDX market is essential for further developing efficient and targeted cancer treatments because of the growing significance of precision medicine, thereby driving this segment's expansion.

Region with largest share:

Asia Pacific commanded the largest market share during the extrapolated period due to the growth of integrated platforms that facilitate smooth data exchange and cooperation between pharmaceutical corporations and CROs. Key players such as Covance Inc., Medpace Holdings, Inc., MPI Research, and Eurofins Scientific offer a compelling environment for international collaborations and are establishing themselves in advancing the global pharmaceutical and biotechnology industries. Additionally, growing government support, regulatory harmonization, and technological advancements such as high-throughput screening, machine learning, and artificial intelligence for data processing drive this region's expansion.

Region with highest CAGR:

North America is expected to witness highest CAGR over the projection period, owing to its pivotal role in supporting pharmaceutical and biotechnology companies in the preclinical phase of drug development. The United States, Canada, and Mexico regions are characterized by a robust infrastructure, cutting-edge technology, and a highly skilled workforce. They include pharmacology, toxicology, bioanalysis, and various other preclinical studies essential for regulatory approval. Furthermore, the region's CROs benefit from a favorable regulatory environment and collaboration with academic institutions, fostering innovation and expertise that are propelling this region's growth.

Key players in the market:

Some of the key players in the Preclinical Contract Research Organization (CRO) Market include Crown Bioscience, Eurofins Scientific, Laboratory Corporation of America, Inc., PRA Health Sciences, Inc., Intertek Group Plc (IGP), Wuxi AppTec, SGS SA (SGS), Medpace, Inc., Pharmaceutical Product Development (PPD), LLC, Charles River Laboratories International, Inc., PPD (Thermo Fisher Scientific, Inc.) and WuXi AppTec, Inc. (WAI).

Key Developments:

In November 2023, Intertek, announced the launch of iCare in Turkiye, one of its most successful markets. iCare is an innovative one-stop digital portal providing textile manufacturers with a pioneering solution that enables seamless management and monitoring of their testing processes from start to finish.

In October 2023, SGS is signed an agreement to divest its US powertrain testing operations as part of its strategic portfolio evolution to Columbia River Partners, a private equity firm focused on the industrials, business services and IT services sectors, headquartered in California.

In September 2023, Intertek, proudly announced the integration of advanced PhotonAssay technology into its Minerals laboratory facility in Tarkwa, Ghana. With a legacy of excellence and a commitment to innovation, Intertek Minerals aims to revolutionise gold industry support in West Africa through the implementation of this groundbreaking technology.

Model Types Covered:

• Patient Derived Xenograft (PDX)
• Patient Derived Organoid (PDOs)

Services Covered:

• Safety Pharmacology
• Bioanalysis and Drug Metabolism and Pharmacokinetics (DMPK) Studies
• Toxicology Testing
• Chemistry
• Compound Management
• Other Services

Animal Models Covered:

• Large Animal Model
• Small Animal Model

End Users Covered:

• Government and Academic Institutes
• Medical Device Companies
• Biopharmaceutical Companies

Regions Covered:

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Italy
  • France
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • New Zealand
  • South Korea
  • Rest of Asia Pacific
• South America
  • Argentina
  • Brazil
  • Chile
  • Rest of South America
• Middle East & Africa
  • Saudi Arabia
  • UAE
  • Qatar
  • South Africa
  • Rest of Middle East & Africa

What our report offers:

• Market share assessments for the regional and country-level segments
• Strategic recommendations for the new entrants
• Covers Market data for the years 2021, 2022, 2023, 2026, and 2030
• Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
• Strategic recommendations in key business segments based on the market estimations
• Competitive landscaping mapping the key common trends
• Company profiling with detailed strategies, financials, and recent developments
• Supply chain trends mapping the latest technological advancements

Free Customization Offerings:

All the customers of this report will be entitled to receive one of the following free customization options:

• Company Profiling
  • Comprehensive profiling of additional market players (up to 3)
  • SWOT Analysis of key players (up to 3)
• Regional Segmentation
  • Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
  • Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface

• 2.1 Abstract
• 2.2 Stake Holders
• 2.3 Research Scope
• 2.4 Research Methodology
  • 2.4.1 Data Mining
  • 2.4.2 Data Analysis
  • 2.4.3 Data Validation
  • 2.4.4 Research Approach
• 2.5 Research Sources
  • 2.5.1 Primary Research Sources
  • 2.5.2 Secondary Research Sources
  • 2.5.3 Assumptions

3 Market Trend Analysis

• 3.1 Introduction
• 3.2 Drivers
• 3.3 Restraints
• 3.4 Opportunities
• 3.5 Threats
• 3.6 End User Analysis
• 3.7 Emerging Markets
• 3.8 Impact of Covid-19

4 Porters Five Force Analysis

• 4.1 Bargaining power of suppliers
• 4.2 Bargaining power of buyers
• 4.3 Threat of substitutes
• 4.4 Threat of new entrants
• 4.5 Competitive rivalry

5 Global Preclinical Contract Research Organization (CRO) Market, By Model Type

• 5.1 Introduction
• 5.2 Patient Derived Xenograft (PDX)
• 5.3 Patient Derived Organoid (PDOs)

6 Global Preclinical Contract Research Organization (CRO) Market, By Service

• 6.1 Introduction
• 6.2 Safety Pharmacology
• 6.3 Bioanalysis and Drug Metabolism and Pharmacokinetics (DMPK) Studies
  • 6.3.1 In vitro Pharmacokinetics (PK)
  • 6.3.2 In-vivo Pharmacokinetics (PK)
• 6.4 Toxicology Testing
• 6.5 Chemistry
  • 6.5.1 Computation Chemistry
  • 6.5.2 Medicinal Chemistry
• 6.6 Compound Management
  • 6.6.1 Process R&D
  • 6.6.2 Custom Synthesis
  • 6.6.3 Other Compound Managements
• 6.7 Other Services

7 Global Preclinical Contract Research Organization (CRO) Market, By Animal Model

• 7.1 Introduction
• 7.2 Large Animal Model
• 7.3 Small Animal Model

8 Global Preclinical Contract Research Organization (CRO) Market, By End User

• 8.1 Introduction
• 8.2 Government and Academic Institutes
• 8.3 Medical Device Companies
• 8.4 Biopharmaceutical Companies
• 8.5 Other End Users

9 Global Preclinical Contract Research Organization (CRO) Market, By Geography

• 9.1 Introduction
• 9.2 North America
  • 9.2.1 US
  • 9.2.2 Canada
  • 9.2.3 Mexico
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 Italy
  • 9.3.4 France
  • 9.3.5 Spain
  • 9.3.6 Rest of Europe
• 9.4 Asia Pacific
  • 9.4.1 Japan
  • 9.4.2 China
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 New Zealand
  • 9.4.6 South Korea
  • 9.4.7 Rest of Asia Pacific
• 9.5 South America
  • 9.5.1 Argentina
  • 9.5.2 Brazil
  • 9.5.3 Chile
  • 9.5.4 Rest of South America
• 9.6 Middle East & Africa
  • 9.6.1 Saudi Arabia
  • 9.6.2 UAE
  • 9.6.3 Qatar
  • 9.6.4 South Africa
  • 9.6.5 Rest of Middle East & Africa

10 Key Developments

• 10.1 Agreements, Partnerships, Collaborations and Joint Ventures
• 10.2 Acquisitions & Mergers
• 10.3 New Product Launch
• 10.4 Expansions
• 10.5 Other Key Strategies

11 Company Profiling

• 11.1 Crown Bioscience
• 11.2 Eurofins Scientific
• 11.3 Laboratory Corporation of America, Inc.
• 11.4 PRA Health Sciences, Inc.
• 11.5 Intertek Group Plc (IGP)
• 11.6 Wuxi AppTec
• 11.7 SGS SA (SGS)
• 11.8 Medpace, Inc.
• 11.9 Pharmaceutical Product Development (PPD), LLC
• 11.10 Charles River Laboratories International, Inc.
• 11.11 PPD (Thermo Fisher Scientific, Inc.)
• 11.12 WuXi AppTec, Inc. (WAI)