Increased R&D Spend and Complex Drug Discovery
The pharmaceutical and biotech industries are continually raising investment in R&D, endeavoring to solve unmet medical needs and introduce new therapies to the market. This growth in R&D spending is one of the main drivers for the preclinical CRO market. For example, based on statistics from the National Center for Science and Engineering Statistics (NCSES), U.S. business R&D accomplishment in the pharmaceutical and medicine manufacturing sector was around $98 billion in 2021. At the same time, the drug discovery process has grown more complex, including complex biological targets, novel therapeutic modalities such as cell and gene therapies, and personalized medicine strategies. This level of complexity tends to be beyond the in-house resources of most pharmaceutical firms, and the need is for specialized knowledge and advanced infrastructure provided by preclinical CROs.
Pressure to Shorten Time-to-Market and Cost Savings
The pharma business is under tremendous pressure to shorten drug development timelines and lower the huge costs of taking a new drug from discovery through to market. Preclinical CROs are at the forefront of these issues. By subcontracting preclinical work, pharmaceutical and biotechnology firms can ride on the CROs' established infrastructure, expertise, and regulatory expertise and, in doing so, simplify the drug discovery process and markedly reduce the regulatory submission period. In addition, outsourcing enables firms to transform fixed costs with respect to operating in-house preclinical facilities into variable costs, resulting in substantial cost savings. According to a U.S. Food and Drug Administration (FDA) highlights the significance of effective preclinical development in achieving lower attrition rates in later-stage clinical phases, further illustrating the worth proposition of CROs.
Evolution of Sophisticated Preclinical Models and Technologies
The preclinical CRO industry is confronted with rich opportunities stemming from the ongoing evolution and implementation of sophisticated preclinical models and technologies. These encompass advanced in vitro platforms like organ-on-a-chip and 3D bioprinted tissues, as well as improved in vivo platforms providing higher predictive capacity for human response. For instance, the creation of humanized mouse models has greatly enhanced the translatability of oncology and immunology research. In addition, advances in analytical methods, high-throughput screening, and imaging technologies improve the accuracy and efficiency of preclinical research. CROs that invest in and become experts at these innovative technologies are able to attract a larger client base searching for more precise and accurate preclinical information, thus having an advantage in the marketplace.
Growth into Niche and Highly Specialized Therapeutic Areas
There is a huge potential for growth in preclinical CROs by growing their service offerings in niche and highly specialized therapeutic areas. As drug development continues to shift towards rare diseases, orphan drugs, and personalized medicine, demand is increasing for CROs with expertise in these areas. For example, the number of orphan drug designations approved by the FDA each year has increased steadily, reaching more than 600 in 2023 alone. This requires CROs to perform preclinical studies on diseases that have small patient populations and novel pathological mechanisms. Specialization in such as gene therapy, cell therapy, neurodegenerative disorders, or sophisticated infectious disease areas enables CROs to address a particular client requirement, differentiate themselves from others, and charge premium prices for their very specialized service.
The following Key Market Indicators present a comprehensive overview of the social and economic landscape of the selected region, offering critical insights into market-specific trends and developments. These indicators, combined with data from government statistics, industry associations, and corporate sources, form the analytical foundation of NextGen Intelligence Stats' market models.
| Aspects | Details |
Base Year
|
2024 |
Historic Data
|
2021-2023 |
Forecast Period
|
2025-2035 |
Regions & Countries Covered
|
North America (United States, Canada), Europe (Germany, France, Italy, United Kingdom, Spain, Rest of Europe), Asia Pacific (China, Japan, South Korea, India, Rest of Asia Pacific), Latin America (Brazil, Argentina, Rest of Latin America), Middle East& |
Companies Profiles
|
Celerion Others |
Segmentation Level Customization
|
|
Company Level Customization
|
|
Country level Data Customization
|
Segmental volume analysis Pricing Analysis of Product Company Market Share |
November 2023: Charles River Laboratories had the announcement that they are expanding their gene therapy manufacturing capabilities at their Memphis, Tennessee, site. The expansion will improve their capacity to serve clients working on cell and gene therapies, providing additional capacity for viral vector manufacturing for preclinical and clinical trials.
October 2023: Inotiv, Inc. opened a new vivarium at their West Lafayette, Indiana location. The new addition tremendously boosts their preclinical research capacity, especially in toxicology and DMPK studies, to meet the increasing demand for outsourced preclinical services.
September 2023: Medpace has announced a strategic partnership with a premier biotechnology firm dedicated to rare diseases. The partnership seeks to harness Medpace's knowledge in preclinical & early-phase clinical development to propel forward innovative therapeutics for unmet medical needs across the rare disease arena.
The Preclinical CRO market is marked by a competitive environment where large, established companies coexist with smaller, specialized companies. Leading companies such as Charles River Laboratories, Inotiv, and Medpace have high market shares attributed to their deep service portfolios, international presence, and strong technological capabilities. These firms tend to provide an integrated package of preclinical services, ranging from drug discovery to toxicology and safety testing, to a broad spectrum of pharmaceutical and biotechnology customers. Continuous strategic moves like mergers and acquisitions are observable in the market to extend service products, geographic presence, and technological capabilities. For instance, larger CROs tend to buy specialized smaller companies in order to strengthen their expertise in new therapeutic areas or sophisticated preclinical models. Excellence in methodology of preclinical testing, good customer relationships, and compliance with rigorous regulatory requirements are pivotal for competitive success in this fast-evolving marketplace.
• Biorasi
• Inotiv
• Charles River Laboratories
• Medpace
• KCR
• Synlogic
• Boehringer Ingelheim
• PRA Health Sciences
• Parexel International
• Celerion
• Others
The global Preclinical CRO market size accounted for USD 10.02 Bn in 2024 and it is expected to reach around USD 28.06 Bn by 2035.
The Preclinical CRO market is poised to grow at a CAGR of 9.2% from 2025 to 2035.
Increased R&D Spend and Complex Drug Discovery, Pressure to Shorten Time-to-Market and Cost Savings, Evolution of Sophisticated Preclinical Models and Technologies, Growth into Niche and Highly Specialized Therapeutic Areas
Asia Pacific held largest share accounting for approximately 6.8% of the revenues in 2024
Biorasi, Inotiv, Charles River Laboratories, Medpace, KCR, Synlogic, Boehringer Ingelheim, PRA Health Sciences, Parexel International, Celerion
North America is expected to dominate as the largest market in the market, accounting for 46.50%.
1.1. Introduction
1.2. Report Description & Objective
1.3. Assumption And Limitation
2.1. Data Collection
2.2. Primary Research & Secondary Research
2.3. Bottom-Up Approach & Top-Down Approach
2.4. Market Analysis & Size Estimation
2.5. Quality Check & Final Review
3.1. Report Scope
3.2. Executive Summary
4.1. Top Trends To Watch
4.2. Top Strategies Followed By Key Players
4.3. Top Investment Pockets
4.4. Strategic Recommendations
5.1. Market Definition
5.2. Market Drivers
5.3. Market Restraints & Challenges
5.4. Market Opportunities
6.1. Porter’s Five Forces’ Analysis
6.2. Value Chain Analysis / Supply Chain Analysis
6.3. PESTLE Analysis
6.4. Regulatory Landscape
6.5. Pricing Analysis
6.6. Go to Market Strategy
7.1. Global Preclinical CRO Market, By Service Type
7.2. Global Preclinical CRO Market Attractiveness, By Service Type
7.2.1. Biologics Testing
7.2.2. Small Molecule Testing
7.2.3. Toxicology Testing
7.2.4. Pharmacology Testing
8.1. Global Preclinical CRO Market, By Therapeutic Area
8.2. Global Preclinical CRO Market Attractiveness, By Therapeutic Area
8.2.1. Oncology
8.2.2. Neurology
8.2.3. Cardiology
8.2.4. Infectious Diseases
9.1. Global Preclinical CRO Market, By Validation Type
9.2. Global Preclinical CRO Market Attractiveness, By Validation Type
9.2.1. In Vivo Studies
9.2.2. In Vitro Studies
9.2.3. Comparative Studies
9.2.4. Regulatory Studies
10.1. Global Preclinical CRO Market, By End User
10.2. Global Preclinical CRO Market Attractiveness, By End User
10.2.1. Pharmaceutical Companies
10.2.2. Biotechnology Companies
10.2.3. Academic Institutions
10.2.4. Research Organizations
11.1. Global Preclinical CRO Market, By Geography
11.2. Global Preclinical CRO Market Attractiveness, By Geography
11.2.1. North America
11.2.2. Europe
11.2.3. Asia Pacific
11.2.4. Middle East & Africa
11.2.5. Latin America
12.1. North America Market Overview, By Countries
12.2. Market Overview, By Type
12.3. Market Overview, By Service Type
12.3.1. United States
12.3.2. Canada
13.1. Europe Market Overview, By Countries
13.2. Market Overview, By Type
13.3. Market Overview, By Service Type
13.3.1. Germany
13.3.2. France
13.3.3. UK
13.3.4. Italy
13.3.5. Spain
13.3.6. Rest of Europe
14.1. Asia Pacific Market Overview, By Countries
14.2. Market Overview, By Type
14.3. Market Overview, By Service Type
14.3.1. India
14.3.2. China
14.3.3. Japan
14.3.4. South Korea
14.3.5. Rest of Asia Pacific
15.1. Middle East & Africa Market Overview, By Countries
15.2. Market Overview, By Type
15.3. Market Overview, By Service Type
15.3.1. GCC
15.3.2. South Africa
15.3.3. Rest of Middle East & Africa
16.1. South America Market Overview, By Countries
16.2. Market Overview, By Type
16.3. Market Overview, By Service Type
16.3.1. Brazil
16.3.2. Argentina
16.3.3. Rest of South America
17.1. Key Developments
17.1.1. Partnerships, Collaborations, Agreements
17.1.2. Mergers & Acquisitions
17.1.3. New Product Developments
17.1.4. Other Developments
17.2. Company Share Analysis
17.3. Company Profiles
17.3.1. Biorasi
17.3.1.1. Company Overview
17.3.1.2. Product Overview
17.3.1.3. Financial Insights
17.3.1.4. Recent Developments
17.3.1.5. SWOT Analysis
17.3.2. Inotiv
17.3.3. Charles River Laboratories
17.3.4. Medpace
17.3.5. KCR
17.3.6. Synlogic
17.3.7. Boehringer Ingelheim
17.3.8. PRA Health Sciences
17.3.9. PAREXEL International
17.3.10. Celerion
Data Collection
Primary Research & Secondary Research
Bottom-Up Approach & Top-Down Approach
Market Analysis & Size Estimation
Quality Check & Final Review
By Service Type
• Biologics Testing
• Small Molecule Testing
• Toxicology Testing
• Pharmacology Testing
By Therapeutic Area
• Oncology
• Neurology
• Cardiology
• Infectious Diseases
By Validation Type
• In Vivo Studies
• In Vitro Studies
• Comparative Studies
• Regulatory Studies
By End User
• Pharmaceutical Companies
• Biotechnology Companies
• Academic Institutions
• Research Organizations
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