Global Preclinical CRO Market Grows at a Staggering CAGR of 14.4%

Introduction

The preclinical Contract Research Organization (CRO) market refers to the industry segment that provides outsourced research services for the early stages of drug development, including testing new compounds' safety, efficacy, and toxicity before clinical trials in humans. Preclinical CROs offer a wide range of services, including in vitro (laboratory) and in vivo (animal) studies and regulatory support, bioanalysis, pharmacokinetics, and toxicology studies. These services allow pharmaceutical, biotechnology, and medical device companies to streamline their research and development processes, reduce costs, and accelerate the timeline for bringing new drugs and therapies to market. Substantial public and private funding is a crucial driver of growth in the preclinical Contract Research Organization (CRO) market.

Market Dynamics

Increased Prevalence of Chronic Diseases Drives the Global Market

The demand for new therapies and preclinical trial activities is being substantially driven by the increasing prevalence of chronic diseases, including cancer, cardiovascular diseases, and neurological disorders. The urgency for innovative treatments and interventions is heightened as these diseases become more prevalent, resulting in a heightened emphasis on preclinical research.
For example, the Pan American Health Organization reported in 2023 that approximately 20 million new cancer cases and 10 million cancer-related fatalities occur globally each year.

Additionally, it is anticipated that the cancer burden will rise by approximately 60% in the next two decades. Pharmaceutical and biotechnological companies are investing significantly in preclinical studies to develop new medications and treatments, as this alarming trend underscores the critical need for effective therapeutic solutions.

Consequently, the demand for preclinical CRO services is anticipated to continue to increase, indicative of the broader need for innovative healthcare solutions in response to the escalating prevalence of chronic diseases.

Increased R&D Investments Create Tremendous Opportunities

The global preclinical CRO market has a substantial opportunity due to the increased R&D investments. Many pharmaceutical companies are designating larger budgets for research and development in response to the necessity to innovate and the intense competition they are encountering. For example, in 2023, a significant pharmaceutical company increased its research and development budget by 15% to facilitate the development of new oncology drugs.
This increased investment has increased demand for preclinical CROs offering critical services, including toxicology testing, pharmacology studies, and bioanalytical support. These companies can improve their odds of regulatory approval and accelerate their drug development timelines by partnering with preclinical CROs.

Additionally, CROs specializing in niche areas, such as gene therapy or rare diseases, will be well-positioned to capitalize on this trend as the complexity of drug development increases. This will enable clients to navigate the complex preclinical landscape and optimize their R&D returns.

North America is the most significant global market shareholder, with 47.2% market share during the forecast period. Several critical factors have contributed to North America's dominant position in the global preclinical CRO market. The high costs of in-house drug development, ranging from USD 43.4 million to USD 4.2 billion per new drug, have compelled pharmaceutical companies to outsource preclinical trials to manage expenses. The demand for preclinical research is further fueled by the increasing prevalence of chronic diseases, including cardiovascular conditions, diabetes, cancer, and neurological disorders.

For example, the number of lung cancer cases in the United States increased from 236,740 in 2022 to 238,340 in 2023, with further growth anticipated. Furthermore, the region's market is expected to expand due to the increasing complexity of clinical trials and the high number of investigational candidates.

The Asia Pacific region is experiencing a rapid growth rate in the preclinical CRO market. The rise in R&D costs and the transformation of MNC outsourcing models resulted in increased preclinical outsourcing to the Asia Pacific. CROs in countries such as China and India can provide cost-effective services.

Furthermore, companies from the United States and Western Europe are progressively utilizing the region for clinical activities, site research development, and analytical services to reduce research costs. For instance, the aggregate R&D expenditure of the largest pharmaceutical companies in India increased by 1.7% from 2021 to exceed USD 138 billion in 2022, as indicated by a report from India's Department of Pharmaceuticals in August 2023.

• The global preclinical CRO market size was valued at USD 8,621.68 million in 2024. It is projected to reach USD 21,482.25 million by 2033, growing at a CAGR of 14.12% during the forecast period (2025-2033).
• By service, the global preclinical CRO market is bifurcated into bioanalysis and DMPK studies, toxicology testing, compound management, chemistry, safety pharmacology, and others. The toxicology testing segment is the dominant force in the preclinical CRO market.
• By model, the global preclinical CRO market is bifurcated into patient-derived organoid (PDO) model and patient-derived xenograft model. The patient-derived organoid (PDOs) segment dominates the preclinical CRO market.
• By application, the global preclinical CRO market is bifurcated into oncology, neurology, cardiology, infectious diseases, metabolic disorders, and others. The oncology segment leads the preclinical CRO market.
• By end-user, the global preclinical CRO market is divided into pharmaceutical and biotechnological companies, government and academic institutes, medical device companies, and others. The pharmaceutical and biotechnological companies segment is the dominant player in the preclinical CRO market.
• North America is the most significant global market shareholder, with 47.2% market share during the forecast period.

Competitive Players

1. Charles River Laboratories International, Inc.
2. Covance Inc.
3. ICON plc
4. Medpace, Inc.
5. WuXi AppTec
6. Envigo
7. PRA Health Sciences
8. Syngene International Limited
9. Eurofins Scientific
10. Parexel International Corporation
11. SGS SA
12. MPI Research
13. Crown Bioscience, Inc.
14. Toxikon Corporation
15. Pharmaron

Recent Developments

Recent Developments

• September 2024 - PharmaLegacy Laboratories acquired BTS Research, a San Diego-based preclinical CRO, to enhance its preclinical services and expand operations into North America. This acquisition allows PharmaLegacy to strengthen its global research capabilities and better serve clients in the U.S. The combined expertise aims to provide rapid and reliable pharmacology data, adding GLP toxicology services to their offerings. 

Segmentation

Preclinical CRO Market Segmentation

1. By Service
   1. Bioanalysis and DMPK studies
      1. In vitro ADME
      2. In-vivo PK
   2. Toxicology Testing
      1. GLP
      2. Non-GLP
   3. Compound Management
      1. Process R&D
      2. Custom Synthesis
      3. Others
   4. Chemistry
      1. Medicinal Chemistry
      2. Computation Chemistry
   5. Safety Pharmacology
   6. Others
2. By Model
   1. Patient-Derived Organoid (PDO) Model
   2. Patient-Derived Xenograft Model
3. By Applications
   1. Oncology
   2. Neurology
   3. Cardiology
   4. Infectious Diseases
   5. Metabolic Disorders
   6. Others
4. By End-User
   1. Pharmaceutical and Biotechnological Companies
   2. Government and Academic Institutes
   3. Medical Device Companies
   4. Others