India CRO Market

Globalization of clinical trials is driving the market growth

The primary drivers anticipated to propel the market are the globalisation of clinical trials, adoption of new technologies in clinical research, rising illness diversity and prevalence, and rising research and development encouraging outsourcing. The Indian government is actively pursuing improvements to R&D efforts, which is anticipated to foster market expansion. 

In 2024, the Indian pharmaceutical sector is focused on reducing drug approval times by up to 50%, aiming to accelerate innovation and market entry for new therapies. The Department of Pharmaceuticals, alongside CDSCO, continues enhancing regulatory processes, supporting faster approvals for innovative drugs and biologics. This initiative is part of India's broader push to shift from a generics market to a more innovation-driven economy. 

With increased focus on R&D, local manufacturing, and indigenization, the country is positioning itself as a global leader in pharmaceutical development​.

The digitalization of clinical trials is expected to accelerate market expansion. Digitalization has improved the efficiency of a number of trial procedures, including data collection, regulatory compliance, logistics, and supply management, among others. Additionally, the advent of digital therapies has made it simpler than ever to collect real-time data on safety and toxicity, supporting quick trial design correction and fostering market expansion. 

Clinical trials in India cost about half as much as they do in the United States and Europe. Therefore, it is projected that the county will dominate the market because to its cost effectiveness and big patient pool of untreated patients.

As of 2024, India's clinical research sector has experienced a significant recovery and transformation following the disruptions caused by the COVID-19 pandemic. In the early stages of the pandemic, research and development activities were halted due to supply chain disruptions and the temporary closure of manufacturing facilities.

Additionally, lockdowns resulted in a sharp decline in patient recruitment for clinical studies. However, the urgent need for COVID-19 treatments and vaccines spurred a resurgence in clinical trials by 2021, marking a positive shift in the sector.

India has emerged as a key hub for clinical trials, particularly in the areas of vaccine development, oncology, and emerging therapeutics. This is due to its vast patient population, advancing healthcare infrastructure, and the increasing adoption of digital technologies such as decentralized clinical trials (DCTs). These factors have been pivotal in driving the recovery and continued growth of India's clinical trial market.

Notably, global pharmaceutical companies, as well as domestic firms, are continuing to invest heavily in India's clinical trial ecosystem. Recent reports confirm that the country has maintained a steady pace of trial activities, with many international sponsors choosing India for Phase II and III trials, benefiting from the large, diverse patient base and cost advantages​.

The Global India CRO Market Industry is poised for substantial growth, with projections indicating a rise from 12.5 USD Billion in 2024 to 30 USD Billion by 2035. This trajectory suggests a robust expansion, driven by various factors including increasing clinical trial activities and the growing adoption of CRO services by pharmaceutical companies. The anticipated CAGR of 8.28% from 2025 to 2035 highlights the market's potential for sustained growth. As the industry evolves, stakeholders may need to adapt to changing dynamics and invest in innovative solutions to capitalize on emerging opportunities.

The Global India CRO Market Industry is experiencing a notable increase in demand for clinical trials, driven by the growing need for new therapies and drugs. As pharmaceutical companies seek to expedite the development of innovative treatments, India emerges as a preferred destination due to its diverse patient population and cost-effective services. In 2024, the market is projected to reach 12.5 USD Billion, reflecting the increasing reliance on Contract Research Organizations to conduct clinical trials efficiently. This trend is expected to continue, with the market potentially expanding to 30 USD Billion by 2035, indicating a robust growth trajectory.

Cost-effectiveness remains a pivotal driver in the Global India CRO Market Industry, as organizations seek to optimize their research budgets. India offers competitive pricing for clinical research services, which attracts both domestic and international pharmaceutical companies. This financial advantage allows sponsors to allocate resources more efficiently while maintaining high-quality standards. The anticipated growth from 12.5 USD Billion in 2024 to 30 USD Billion by 2035 underscores the attractiveness of India as a cost-effective hub for clinical trials. The projected CAGR of 8.28% from 2025 to 2035 further emphasizes the increasing reliance on CROs for budget-conscious research initiatives.

The Global India CRO Market Industry benefits significantly from the supportive regulatory environment established by the Indian government. Recent reforms aimed at streamlining the approval process for clinical trials have enhanced the operational landscape for CROs. This regulatory support, coupled with the development of robust infrastructure, facilitates the efficient execution of clinical studies. As the market grows from 12.5 USD Billion in 2024 to an expected 30 USD Billion by 2035, the favorable regulatory framework is likely to attract more global sponsors, thereby reinforcing India's position as a leading destination for clinical research.

The Global India CRO Market Industry is witnessing a shift towards personalized medicine, which is reshaping clinical research paradigms. As the demand for tailored therapies increases, CROs are adapting their services to accommodate this trend. This focus on personalized approaches necessitates more complex trial designs and patient stratification, which CROs in India are well-equipped to handle. The market's growth from 12.5 USD Billion in 2024 to 30 USD Billion by 2035 reflects the increasing importance of personalized medicine in clinical trials. This evolution may lead to a more nuanced understanding of patient responses, ultimately enhancing treatment efficacy.

Technological advancements play a crucial role in shaping the Global India CRO Market Industry. The integration of digital tools, data analytics, and artificial intelligence into clinical research processes enhances efficiency and accuracy. These innovations enable CROs to streamline operations, reduce timelines, and improve patient recruitment strategies. As the market evolves, the anticipated growth from 12.5 USD Billion in 2024 to 30 USD Billion by 2035 suggests that organizations will increasingly adopt these technologies to remain competitive. The projected CAGR of 8.28% from 2025 to 2035 indicates a strong inclination towards leveraging technology in clinical trials.

By region, the study provides the market insights into India. This is due to the accessibility of a sizable patient pool that makes recruitment simple. One of the main factors influencing the industry is the global pandemic. Due to the high quality and speedy turnaround of its studies, India's largest, most experienced biotech CRO, "Novotech," has observed a rise in demand from biotechnology sponsors. 

For COVID-19 studies, an increasing number of biotechnology companies choose India because of the country's vast patient pool and quick processes.

Leading market players are investing heavily in research and development in order to expand their product lines, which will help the CRO market, grow even more. Market participants are also undertaking a variety of strategic activities to expand their global footprint, with important market developments including new product launches, contractual agreements, mergers and acquisitions, higher investments, and collaboration with other organizations. To expand and survive in a more competitive and rising market climate, CRO industry must offer cost-effective items.

Manufacturing locally to minimize operational costs is one of the key business tactics used by manufacturers in the India CRO industry to benefit clients and increase the market sector. In recent years, the CRO industry has offered some of the most significant advantages to medicine. 

Major players in the CRO market, including Quintiles IMS Holdings, Inc., Syngene, Pharmaceutical Product Development, LLC., Siro Clinpharm, Clininvent Research Pvt. Ltd., VIMTA, Bilcare Limited, Aizant Drug Research Solutions Private Limited, Piramal Pharma Solutions, Synapse Labs Pvt Limited, Eurofins Scientific, Laurus Labs., Neuland Laboratories Ltd, and PAREXEL International Corporation, are attempting to increase market demand by investing in research and development End Users.

Operating a life sciences research organisation with the goal of providing clinical research and development services is Aragen Life Sciences. As a result of the company's expertise in drug research, clinical development, contract manufacturing, formulation, and informatics, healthcare organisations are able to provide a wide range of cutting-edge healthcare goods and services. 

In order to broaden its end-to-end comprehensive discovery and development platform for the biotechnology, pharmaceuticals, and other industries, Aragen Life Sciences, an Indian CRO, purchased Intox Pvt. Ltd. in Maharashtra.

Developer of the crystallizable fragment (Fc)-fusion protein platform for the production of novel kinds of biological therapies for the treatment of diabetes is Akston Biosciences. The business produces kilogram-scale batches of medicinal ingredients and provides vaccinations, ultra-long-acting insulins, and treatments for autoimmune diseases, enabling physicians to enhance glucose management, lessen consequences, and completely remove the risk of hypoglycemia for both human and animal health. 

In 2024, Akston Biosciences is continuing its progress with its second-generation COVID-19 vaccine, AKS-452, in India. The vaccine has successfully completed Phase II/III clinical trials, demonstrating a robust safety profile and an impressive 91% seroconversion rate at Day 56.

This vaccine, which is notable for its room-temperature stability, has shown promising results in protecting against variants like Delta and Omicron.

In 2023, Akston took back control over the licensing and commercialization of AKS-452 after ending its partnership with Stelis Biopharma, and is now working with a new contract development and manufacturing organization (CDMO) in India to continue its development​.

This vaccine is especially significant for low- and middle-income countries, as it does not require cold-chain storage, making it easier to distribute in regions with limited infrastructure. Additionally, AKS-452 is being explored as a potential "universal" booster, which has shown to increase neutralizing antibody titers in individuals previously vaccinated with other COVID-19 vaccines​.