The India preclinical Contract Research Organization (CRO) market was valued at USD 183.3 million in 2023 and is expected to expand at a compound annual growth rate (CAGR) of 11.4% from 2024 to 2030. This growth is primarily driven by the increasing global trend of outsourcing RD for clinical trials, rapid technological advancements, and India’s unique advantages—such as a vast patient population, numerous hospitals, and relatively low operational costs thanks to a skilled and cost-effective workforce. As reported by the World Health Organization, India hosted 9,954 clinical trials in 2022.

Global pharmaceutical, biotechnology, medical device, and agrochemical companies are increasingly outsourcing preclinical research activities to CROs in India. This enables these firms to streamline operations by focusing on core functions while relying on the specialized capabilities of CROs. India stands out as an attractive destination for such outsourcing due to its cost efficiencies, regulatory support, and scientific talent pool.

Moreover, rising global RD spending is fueling further growth in India’s preclinical CRO market. Multinational companies continue to leverage India’s capabilities to strengthen their drug development pipelines. According to an August 2023 report by the Department of Pharmaceuticals, Ministry of Chemicals Fertilizers, Government of India, the combined RD expenditure of the top pharmaceutical firms globally surpassed USD 138 billion in 2022, reflecting a 1.7% increase from 2021—further emphasizing the expanding scope for CROs in India.

Key Market Trends Insights:

• Based on service type, the toxicology testing segment emerged as the market leader in 2023, holding the highest revenue share at 22.5%. This dominance can be attributed to the critical role toxicology testing plays in evaluating the safety profile of drug candidates during the early stages of development, ensuring regulatory compliance and minimizing potential risks in later phases.

• By model type, the patient-derived organoids (PDOs) segment accounted for the largest revenue share in 2023. The growing adoption of PDOs is due to their ability to closely mimic human tissue biology, offering more accurate and personalized models for drug testing and disease modeling, which enhances the predictability of preclinical studies.

• In terms of end-use, biopharmaceutical companies led the market in 2023, contributing the largest share. Their dominance is driven by increased investments in drug discovery and development, as well as a greater reliance on outsourcing preclinical research to CROs in order to optimize costs and accelerate time-to-market for new therapies.

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Market Size Forecast:

• 2023 Market Size: USD 183.3 Million

• 2030 Projected Market Size: USD 393.6 Million

• CAGR (2024-2030): 11.4% 

Key Companies Market Share Insights:

Some of the prominent companies actively operating in the Indian preclinical CRO market include Syngene International Limited, Dabur Research Foundation, JSS Medical Research, and Jubilant Biosys Ltd. These organizations play a significant role in supporting the drug discovery and development ecosystem through their specialized preclinical service offerings.

• Syngene International Limited, headquartered in Bangalore, is a leading contract research organization that provides an extensive portfolio of services, including medicinal chemistry, in vitro and in vivo biology, toxicology studies, and other preclinical research support. With cutting-edge infrastructure and high-end laboratory facilities, Syngene has established a strong reputation for delivering quality research services and has formed strategic collaborations with numerous global pharmaceutical and biotechnology companies.

• Dabur Research Foundation is an Indian CRO known for offering comprehensive preclinical drug development services, starting from early-stage molecule identification to IND-enabling studies. It serves a wide spectrum of industries, including biotechnology, medicine, phytopharmaceuticals, cosmetics, and basic sciences. Dabur’s capabilities span multiple functional areas such as in vitro, ex vivo, and in vivo pharmacology, GLP-compliant toxicology, and drug metabolism and pharmacokinetics (DMPK) studies, positioning it as a full-service preclinical CRO for global clients.

Other key market participants include Sugen Life Sciences, Eurofins Advinus, GVRP, and Veeda Clinical Research Limited, all of which contribute significantly to the growing preclinical CRO sector in India.

• Sugen Life Sciences is a CRO specializing in toxicology, efficacy, preclinical safety evaluation, and clinical research services. The company adheres to international and national regulatory standards, such as those outlined by the FDA, EPA, Schedule Y, and ICH-GCP, ensuring its services meet global compliance requirements.

• Eurofins Advinus is another major player offering a full spectrum of preclinical and early development contract research services. The company’s portfolio includes analytical research and development (RD), chemistry manufacturing and controls (CMC) services, regulatory toxicology, drug discovery support, and DMPK studies. Eurofins Advinus also engages in the manufacturing of medicinal products used to support both clinical and toxicological research.

Key Players

• Syngene International Limited

• Dabur Research

• JSS Medical Research

• Jubilant Biosys Ltd.

• Sugen Life Sciences

• Eurofins Advinus

• GVRP

• Veeda Clinical Research Limited

• Axis Clinicals

• Syneos Health

• Ethicare-cro

• Liveon Biolabs Pvt.Ltd.

• IQVIA Inc

• Bioneeds

• TheraIndx Lifesciences Pvt. Ltd.

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Conclusion:

The India preclinical CRO market is advancing rapidly, driven by its cost-efficiencies, skilled workforce, and growing global outsourcing of RD activities. The infrastructure—bolstered by advanced technologies like high-throughput screening, in silico modeling, and automation—has elevated the country's role in accelerating drug discovery and development processes. As pharmaceutical and biopharma firms increasingly delegate preclinical operations, India’s comprehensive capabilities—from toxicology testing to patient-derived organoid models—position it as a pivotal destination. This upward momentum underscores India’s expanding relevance in the global drug development landscape, with continued innovation and strategic partnerships fueling future growth.