Propelled by encouraging regulatory reforms since 2014, India is fast emerging as a much sought-after destination for global clinical trials. Streamlined approval timelines, clearer ethical guidelines, and stronger patient protection frameworks have improved sponsor confidence and operational predictability.
The clinical research market estimated to be valued at US$ 73.4 billion in 2025, is projected to reach US$ 164.3 billion by 2035, registering a compound annual growth rate (CAGR) of 8.4 per cent over the forecast period.
The geopolitical uncertainties and regulatory challenges in traditional trial destinations of Russia and China have prompted pharma companies to diversify trial locations. Supported by an extensive network of tertiary care hospitals, a large and treatment-naïve patient pool, and comparatively low clinical trial operating costs, India is well positioned as a global hub for clinical research, said industry experts.
Amongst the top 20 pharma, AstraZeneca, Novartis, Eli Lilly, Pfizer, and J&J are the top sponsors of clinical trials in India with growth opportunities across pain, epilepsy, cervical cancer and orphan diseases like thalassemia, Duchenne Muscular Dystrophy.
The leading clinical trial companies are IQVIA, ICON Plc, Syngene International Aragen Life Sciences former GVK Biosciences, Sai Life Sciences, Lambda Therapeutic Research, Vimta Labs, Syneos Health, PPD a Thermo Fisher company, Parexel, Accutest Research Laboratories, Catalyst Clinical Services, APCER Life Sciences to name a few. Accenture, Cognizant, Wipro, TCS are the information technology majors with large clinical research divisions.
Clinical research becoming more global
Sanjay Vyas, Managing Director, Parexel and President, Global Head-Clinical Logistics and Patient Safety & Pharmacovigilence said “Clinical research is becoming more global and evenly distributed, with India playing a steadily larger role. This is driven by a diverse patient population, improving regulatory clarity, and stronger site and investigator capabilities. While the US and Europe continue to serve as major hubs for clinical trials, sponsors are increasingly diversifying trial footprints, with China and parts of Asia-Pacific gaining share.”
Globally, clinical research is being shaped by more patient-focused approaches, the rise of hybrid and decentralized trial models, and greater use of real-world data. Technology adoption has played a central role in this shift, enabling faster site and patient identification, remote monitoring, and digital data capture. Together, these changes are improving trial efficiency, study oversight, and access for patients, while helping sponsors move with greater speed and confidence, said Vyas.
Despite India being the second most populous country and having one of the highest global disease burdens, its global clinical trial participation has been significantly low at 2- 3 per cent as compared to the US where is participation is 30 per cent. In India, Maharashtra, Tamil Nadu, Gujarat, Delhi, Karnataka account for 65 per cent. The presence of these sites is concentrated in metro and Tier 1 cities.
The industry’s most notable achievement lies in clinical trial infrastructure. India registered approximately 18,000 new clinical trials in 2024, a 50 per cent year-over-year increase, making it the preferred global destination for multinational pharma companies.
In addition, the New Drugs and Clinical Trial Rules of 2019 have streamlined the approval processes, reduced the timelines by 30-40 per cent, and introduced several exemptions and provisions to improve the overall efficiency of conducting clinical trials. Several relaxations and exemptions to conduct clinical trials for rare diseases, including exemptions from phase III and phase IV trials initiatives like audio visual consenting of patients, ethics committee registration, new compensation law and robust scrutiny system for the clinical trial applications have been implemented.
In the metro cities which has the largest concentration of advanced medical infrastructure, increase in the number of investigators has a population with a high disease burden, diverse, treatment-naive patients. But in recent times, there is a visible change on the clinical trial landscape with a huge scope to move towards Tier II and Tier III cities. It is noted that targeting tier-2 and tier-3 cities as sites for clinical trials can result in higher access to patients and investigators. This is because it manifests an unmet need with high burden and low trial activity, according to Dr Sujay Shetty, Global Health Industries Advisory, PwC along with Anup Kharode Partner, Global R&D / Clinical Transformation Geneva, Switzerland and Karun Rishi President USAIC, the faces behind the report ‘Clinical Trial Opportunities in India.’
Technology takes centre stage
The adoption and acceptance of virtual and decentralized clinical trials by pharmaceutical companies and regulatory agencies have gained momentum in recent years and this trend has been accelerated by the Covid-19 pandemic in 2020. Virtual trials maximise use of technologies like telemedicine, wearable devices, and remote clinical trial monitoring to reduce the burden on patients, reduce the cost, enhance recruitment rates, and increase geographical diversity.
Bioprinting is emerging to replace where procedures comparable to 3D printing, may manufacture human organs and tissue replicas. In clinical studies, these organs can be used to substitute living participants to offset the lengthy and tedious process.
The use of biomarkers and companion diagnostics has gained prominence in personalized medicine and targeted therapies. Clinical Research Organisations (CROs) are expanding their capabilities in biomarker identification, validation and offering services related to companion diagnostic development and testing. These services enable pharmaceutical companies to better stratify patient populations, improve clinical trial outcomes, and develop precision therapies.
DNA sequencing and array-based technologies are gaining ground. For instance, AstraZeneca announced a strategic research collaboration with Illumina, aimed to expedite drug target discovery by melding their respective competencies in AI-based genome interpretation and genomic analysis. The initiative will examine if a unified approach utilizing these technologies can bolster the efficiency and certainty of target discovery in pursuit of promising drugs built upon human omics insights.
There is a visible increase utilizing data analytics to improve clinical trial design, patient recruitment, site selection, and overall regulatory compliance. The CROs are using complex algorithms to analyse large volumes of patient data, including electronic health records (EHRs), to identify eligible candidates for clinical trials. Additionally, real-world data and evidence are being integrated into the drug development process of global to provide robust insights into drug safety and efficacy.
CROs are looking at artificial intelligence (AI) along with supercomputing to offer specialized services that support various stages of the drug development process. Advanced research tools like high-throughput screening, molecular profiling, next-generation sequencing, bioinformatics analysis, and advanced imaging technologies are a driver of the early discovery CRO market. Expertise in biomarker identification, validation, and companion diagnostic development are playing a crucial role in supporting personalized medicine initiatives. Efforts to strengthen regulatory expertise and ensure compliance with regulations across multiple jurisdictions will help in successful contract research partnerships.
On the animal testing front preclinical CROs using rats, mice, guinea-pigs, rabbits, canines, bovines or non-human primates for checking the safety profiles are facing problems. In 2022, 42 countries globally banned or restricted cosmetic animal testing, including all 27 countries in the EU, Australia, Colombia, Guatemala, Iceland, India, Israel, Mexico, New Zealand, Norway, South Korea, Switzerland, Taiwan, Turkey, and the United Kingdom.
In India too, the amendment to the New Drugs and Clinical Trial Rules (2023), looks to replace animals. It authorises researchers to use non-animal and human-relevant methods, including technologies like 3D organoids, organ-on-chip, and advanced computational methods, to test the safety and efficacy of new drugs.
In terms of workforce building, there is a huge requirement for scientific writing and regulatory capabilities. Companies in this space are expanding their high-quality medical writing, documentation and regulatory capabilities to assist pharmaceutical companies in specific complex regulatory requirements, ensuring compliance, and expediting the approval process.
Drivers of clinical trials
The big drivers of clinical trials for new drugs and repurposing existing medicines are in oncology, antimicrobial resistance, vaccines, infectious diseases, Central Nervous System Disorders like Alzheimer’s disease, Parkinson’s disease, and mental health disorders. Another is Immunology and Autoimmune Diseases where drugs for rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease are much-desired. Cardiovascular conditions, including heart disease and stroke, remain leading causes of mortality which require newer drugs.
The BA/BE CROs with adequate regulatory experience with the clinical trial audits and inspections from international regulatory bodies like USFDA, EMEA, TGA, ANVISA are in demand. Compliance to ICH-GCP, HIPAA, HITECH, the Privacy Rule, GDPR (General Data Protection Regulation), are important factors to be considered for the sponsors while selecting the CROs.
The growing number of clinical trials is a major market driver for the global contract research organization (CRO) market as expertise in data management, regulatory support, and post-marketing surveillance are in demand. Pharmaceutical companies leverage the knowledge and experience of such CROs to increase their research capabilities and overcome challenges in specific therapeutic research domains.
Therefore, regulatory reforms that streamline approvals, strengthen ethical oversight, and align India with global standards combined with shifting geopolitical priorities that are prompting sponsors to diversify trial locations are creating a timely opportunity for the country.
With its large and diverse patient pool, growing research infrastructure, and cost efficiencies, India is well placed as a preferred destination for global clinical trials. Sustaining this momentum, however, will require continued policy consistency, investment in investigator training and site quality, and a strong focus on transparency and patient trust. If these elements align, India can move beyond being a cost-effective alternative to becoming a globally competitive and innovation-driven clinical research hub, opine industry experts. |