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INCREASING R&D EXPENDITURE The Contract Research Organization (CRO) market in India has witnessed significant growth in recent years, primarily driven by the substantial increase in research and development (R&D) expenditure within the country. One of the key factors contributing to this growth is the Indian government's commitment to bolstering the country's R&D infrastructure. Various initiatives and policies have been introduced by government (such as incentives, tax benefits, and regulatory support) to promote innovation and scientific research which has made India an attractive destination for pharmaceutical and biotech companies looking to outsource their R&D activities. For instance, Section 35(2AA) of the Income Tax Act provides weighted deductions for companies engaged in scientific research. This incentive encourages pharmaceutical companies to invest in research and innovation. Furthermore, in 2017, India government had launched National Biopharma Mission to accelerate the early development of biopharmaceuticals, vaccines, and diagnostics. It includes initiatives to support biotechnology startups and encourage innovation. Furthermore, India's favorable regulatory landscape, large and diverse patient population, and availability of world-class research facilities make it a magnet for clinical trials and other research endeavors. In addition, rise in government spending on research and development (R&D) activities for drug development further drives the growth of the India Contract Research Organization (CRO) market. For instance, According to Department of Science and technology, India’s per capita R&D expenditure has increased to current Public-private partnerships for innovation (PPP)$ 42.0 in 2020–21 from current Public-private partnerships for innovation (PPP) $ 29.2 in 2007–08. Furthermore, according to same source, India has spent 0.7% of GDP on research and development activities. Thus, rise in government spending on research and development (R&D) activities for drug development further drives the growth of the India Contract Research Organization (CRO) market. RISING NUMBER OF CLINICAL TRIALS The India CRO market has experienced remarkable growth, largely propelled by the surge in the number of clinical trials conducted in the country. For instance, in 2023, Sun Pharmaceutical Industries Limited had announced positive results of Nidlegy™ drug from the Phase III PIVOTAL trial for the patients suffering from locally advanced fully resectable melanoma. In addition, according to drug control organization (India's largest clinical trial firm) India has emerged as a key destination for clinical trials in the aftermath of the pandemic, with numbers increasing tenfold in the last three years. Thus, increase in clinical trial activity for drug development is a significant driver for the Indian CRO market, reflecting India's growing importance as an India hub for pharmaceutical and biotechnology research and development. Moreover, one of the primary catalysts for this surge is the cost-effectiveness of clinical trials in India, which offers substantial savings to pharmaceutical and biotech companies compared to trials conducted in more developed economies. Additionally, India's well-established infrastructure for clinical trials, including state-of-the-art research facilities and a robust regulatory framework, has further cemented its status as a preferred location for conducting a wide range of clinical trials. As the demand for innovative drugs and therapies continues to grow, the Indian CRO market is well-positioned to play an integral role in the advancement of medical research and pharmaceutical development on an India scale, making it a pivotal player in the ever-evolving landscape of healthcare and life sciences. For instance, according to clinical trials arena in 2021, about 40.6% industry sponsored clinical trials held in India and non-industry sponsored trials accounted for a 59.4% share in 2021 as against the average of 62.8% in the last ten years. GROWING CRO OUTSOURCING IN DRUG DEVELOPMENT The India CRO market has emerged as a dynamic and influential player in the India pharmaceutical and biotechnology industries. Several drivers fuel the rapid growth of CRO outsourcing in drug development in India, transforming it into a powerhouse of research and development activities. One of the primary drivers is the significant cost advantage offered by Indian CROs, which can offer high-quality services at a fraction of the cost compared to their Western counterparts, making it an attractive option for companies looking to optimize their R&D budgets. For instance, Syngene (India) signed a 5-year agreement in August 2021 with the drug discovery and development subsidiary of Deerfield Management (US). Additionally, in 2022, Aurigene has collaborated with EQRx company for drug discovery, pre-clinical and clinical development and commercialization. In this Collaboration, Aurigene will lead drug discovery and pre-clinical development efforts, and EQRx will assume responsibility for clinical development, manufacturing, regulatory and commercialization efforts. The parties would share both funding for the discovery and development of the programs and financial results resulting from the commercialization of any eventual drug candidates. Furthermore, India's diverse patient population along with high genetic & rare disease prevalence rates increasing clinical trials development, especially for diseases endemic to the region. This diversity allows for more comprehensive and diverse data collection, critical for the success of drug development projects. The Indian government's supportive policies and initiatives to promote the pharmaceutical and biotechnology sectors, including the 'Make in India' campaign, have also encouraged the growth of CRO services, fostering a business-friendly environment. Moreover, the COVID-19 pandemic accelerated the adoption of digital technologies and telemedicine, providing an impetus for Indian CROs to offer innovative solutions and leverage cutting-edge technologies for drug discovery and clinical research. As a result of these multifaceted drivers, India's CRO market has experienced remarkable growth, establishing itself as a pivotal player in the India drug development landscape, with a promising future ahead.
Covered Aspects:
| Report Attribute/Metric | Details |
|---|---|
| Market Opportunities | Adoption of artificial intelligence-based tools for drug discovery |
| Market Dynamics | The globalization of clinical trials, adoption of new technology in clinical research, growing disease variation and prevalence, and increasing research and development promoting outsourcing |
India CRO Market Overview
India CRO Market size was valued at USD 0.69 Billion in 2023. The CRO market industry is projected to grow from USD 0.73 Billion in 2024 to USD 1.32 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 7.23% during the forecast period (2024 - 2032).
Clinical trials' globalization, the use of new technologies in clinical research, the rise in illness diversity and prevalence, and the expansion of R&D all support outsourcing, are the key market drivers enhancing the market growth.
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
India CRO Market Trends
- 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​.
India CRO Market Segment Insights
India CRO Service Type Insights
The India CRO market segmentation, based on service type, includes clinical trials, product development, process development, post-marketing surveillance, and quality monitoring others. Clinical trials segment dominated the market in 2022. This is explained by the segment's high cost structure. One of the main factors contributing to the high cost of this experiment is the requirement for a big patient group in phase clinical studies.
Additionally, the investigations in clinical trials are conducted for a longer period of time, which lowers the trial's cost and raises its market segment share.
India CRO Therapeutic Application Insights
The India CRO market segmentation, based on application, includes oncology, cardiovascular, neurology, nephrology and urology, and others. Oncology segment dominated the market in 2022. This is due to the rising incidence of cancer in the nation and the rising demand for cutting-edge medical technology and cancer therapies.
The Cancer Tomorrow projects that by 2040, 2 million people in India will be affected by cancer, which is one of the leading causes of death in the world. The majority of cancer treatments are ineffective when the disease is advanced, which is a major factor in the nation's rising demand for novel cancer therapy choices.
India CRO End User Insights
The India CRO market segmentation, based on end user, includes pharmaceutical/biopharmaceutical companies, medical devices companies, and academic institutes. Pharmaceutical/biopharmaceutical companies segment dominated the India CRO market in 2022.This is due to India's expanding CRO adoption.
Figure 1: India CRO Market, by End User, 2023 & 2032 (USD Billion)
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
India CRO Regional Insights
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.
India CRO Key Market Players & Competitive Insights
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​.
Key Companies in the India CRO market include
- Quintiles IMS Holdings, Inc.
- Syngene
- 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
- PAREXEL International Corporation
India CRO Industry Developments
IQVIA (Quintiles IMS Holdings) remains a frontrunner in India's CRO industry by leveraging big data analytics and advanced clinical trial solutions. Their platform enhances real-time insights and optimizes clinical trials, significantly reducing time-to-market for pharmaceuticals. Their innovation in Clinical Trial Data Management continues to push the boundaries of efficiency and precision in drug development​.
Syngene International has strengthened its position as a leader in drug discovery, development, and manufacturing services. The company expanded its research and development capacity in 2023 by opening a state-of-the-art biotechnology facility in Bangalore.
Syngene's collaboration with Bristol Myers Squibb focuses on advanced research in oncology and immuno-oncology, driving the development of next-generation therapies​.
Siro Clinpharm has been making notable strides in clinical pharmacology services, particularly with the launch of an enhanced Clinical Trials Management System (CTMS). Their efforts in pharmacovigilance and safety monitoring are helping to ensure higher standards for patient safety during clinical trials, positioning them as a reliable partner for global pharmaceutical companies​.
Clininvent Research Pvt. Ltd., part of TCG Lifesciences, continues to offer end-to-end solutions for drug discovery, development, and commercialization. The company's focus on custom manufacturing and regulatory compliance, particularly through FDA-approved facilities, ensures that they meet the stringent quality requirements of the pharmaceutical industry.
Their expertise in GMP (Good Manufacturing Practice) compliance and clinical trial management further solidifies their role in India's growing CRO ecosystem​
India CRO Market Segmentation
India CRO Service Type Outlook
- Clinical Trials
- Product Development
- Process Development
- Post-Marketing Surveillance
- Quality Monitoring Others
India CRO Therapeutic Application Outlook
- Oncology
- Cardiovascular
- Neurology
- Nephrology and Urology
- Others
India CRO End User Outlook
- Pharmaceutical/Biopharmaceutical Companies
- Medical Devices Companies
- Academic Institutes
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