Report Overview

India's growing number of cancer research studies is the primary factor driving the growth of the CRO market in the country. Furthermore, the growing pharmaceutical and biomedical companies in India, coupled with increasing government support has further fueled the growth of India CRO market.

India CRO Market- Industry Trends & Forecast Report 2027

During the historical period between 2017 and 2020, India CRO Market has grown at a CAGR of 5.51%, in value terms, and is valued at USD 956.8 million in 2020. The market is further expected to reach USD 1,883.0 million by 2027 with a CAGR of 10.75% during the forecast period. Among the factors contributing to the growth of the India CRO market are the rapidly growing oncology studies field, the booming pharmaceutical industry, and efforts from the Indian government. The Indian Council of Medical Research (ICMR) reported that the number of cancer cases among men in India is expected to increase from 6,79,421 in 2020 to 7,63,575 by 2025, propelling oncology trials in the country.

Source: BlueWeave Consulting

India CRO Overview:

A Contract Research Organization or CROis typically hired by another company to oversee the clinical trials, complicated medical validation operations, product development, process development, post-marketing surveillance, and quality monitoring of that company. CRO also provides management services for pharmacovigilance. In simple words, CROs are outsourcing companies hired by a sponsoring company as an independent contractor to lead clinical trials and other research support services on its behalf. Typically, CROs work with pharmaceutical, biotechnology, and medical device companies, government agencies, foundations, and universities. Organizations contract with CROs to offer safe and efficient trials without hiring permanent staff. A CRO can be a large research provider offering extensive study methods or a small niche specialty firm that provides trial services for pharmaceutical manufacturers without the need for staff to manage these trials.

India CRO Forecast and Trend

Growth Drivers

Rising Government Initiatives and Investments

CROs provide research services to pharmaceutical companies, the medical device industry, biotechnology, and others. The CRO assists medical devices companies in conducting trials on medical equipment and analyzes the data they collect. Indian Union Cabinet has approved amendments to Foreign Direct Investment (FDI) policy in the pharmaceutical sector to allow FDI up to 100% under regulations set out by the Indian government for the manufacture of medical devices. According to data supplied by the Department of Industrial Policy and Promotion (DIPP), between April 2000 and March 2019, the medications and pharmaceuticals sector attracted USD 15.98 billion in FDI inflows,

These initiatives by the government and rising investment in the medical devices segment have propelled the growth of the Indian CRO market.The state government of Uttar Pradesh, India, announced plans to establish six pharmaceutical parks in the state and has committed more than USD 712-855 million for new medical research and development. Under Union Budget 2021-22, the Ministry of Health and Family Welfare has allocated USD 10.35 billion, and the Department of Health Research has allocated USD 365.68 billion.

Change in Regulatory Laws by the Government

In order to facilitate drug development and innovation, clinical trials are an important component, and the Indian government is making strides in streamlining the rules and regulations. The clinical trial structure has changed significantly in India in the last few decades.Several new drugs and clinical trials regulations have led to an increase in clinical research in the country. Moreover, the Central Drugs Standard Control Organization (CDSCO) removed the restriction prohibiting investigators from conducting more than three clinical trials, enabling the India CRO market to grow.

Drugs Controller General of India (DCGI) has relaxed the requirements for clinical trials and granted permission for trials based on the nature of the clinical trials.According to the new regulatory framework, hospitals that have more than 50 beds may be able to conduct clinical trials. The ethics committee has full authority over deciding whether a clinical trial site is suitable for conducting the clinical trial. The government has also mandated that trial sites maintain the emergency medical care and rescue arrangements required for clinical trials. This has significantly boosted the number of experienced investigators and key opinion leaders who leverage their expertise and drive the growth of CROs in India.

Restrain

Data breach and Patient Security

Securing data in the healthcare industry is not an easy task. The Health Insurance Portability and Accountability Act (HIPAA) requires strict regulations to protect the privacy of patients. According to HIPAA regulations, it is the fundamental responsibility of healthcare providers and their business associates to protect patient privacy while delivering patient data for clinical trials. The growing security concern, particularly data security and patient security, has stifled the growth of the India CRO market.  Additionally, the compromises made by some Indian CROs on ethical and technical standards that lead to leakage of patients' data and research data are considered crimes, which restricts the growth of the India CRO market.

Impact of COVID-19 in the industry

The World Health Organization (WHO)declared the novel coronavirus (COVID-19) to be a pandemic. Developments in developing countries are particularly at risk as a result of the COVID-19 with a reduction in the labor force, affecting economies and livelihoods as well as reducing production-related operations. On 25th March 2020, the Indian government announced a national wide lockdown to prevent the spread of the virus. Moreover, the lockdown was extended until 31st May 2020 due to high infection rates across India.

The COVID-19 pandemicimpacted almost every business. As a result of lockdown restrictions and distancing norms, the manufacturing units were temporarily suspended.Moreover, the suspension of operation created an imbalance between supply and demand. Additionally, there was a disruption in the supply chain due to nationwide lockdown. CROs in India hasbeen growing due to the shift from COVID-19-based drugs and medical devices to COVID-19-based diagnosis and treatment.

India CRO Market: Service Type

Based on service types, the India CRO Market is segmented into clinical trials, product development, process development, post-marketing surveillance, quality monitoring, and others. Among these, the process developmentsegment accounts for the largest share in the India CRO market. However, the increasing complexity of clinical trials and growing focus on the quality of drugs and integration of new and advanced technology supports the growth of the clinical trials segment in the India CRO market.Nevertheless, pharmaceutical companies are increasingly looking to collaborate with CROs for various other purposes, including product development, process development, and quality monitoring, which in turn is contributing to the growth of the India CRO market.

India CRO Market: End-User

Based on end-users, the India CRO market is fragmented into pharmaceutical/biopharmaceutical companies, medical devices companies, and academic institutes.Among these segments, the pharmaceutical/biopharmaceutical companies dominate the market due to the outsourcing of product development, process development, quality monitoring, and other activities due to a lack of in-house expertise and infrastructure. For example, Aragen Life Sciences, a leading Indian CRO, announced in July 2021 that Skyhawk Therapeutics, a global leader in the development of small molecule therapeutics for correction in RNA expression, has chosen the company as its partner in India. Skyhawk will be provided with discovery chemistry and biology services through this collaboration with Aragen.

Source: BlueWeave Consulting

India CRO Market: Regional Insights

Based on regions, the India CRO Market is grouped into East India, North India, South India, and West India. Among all the regions, South India accounts for the highest share in the India CRO market. However, the market is shifting towards West India, as the Western region has a number of high-profile pharmaceutical companies operating with better availability of infrastructure and support from the regional governments. Additionally, the North Indian region is slated to grow significantly due to the presence of different regulatory agencies and the growing pharmaceutical industry, which is driving the development of the India CRO market.

Competitive landscapes

India's CRO market is moderately consolidated, with a small number of players covering a large portion of the market. As a result of this consolidation, the newer entrants find it difficult for establishing themselves in the market to offer exclusive services to their customers in India. The major companies in the India CRO market are IQVIA Consulting and Information Services India Private Limited (Quintiles IMS Holdings, Inc.), PAREXEL International (India) Pvt Ltd., Syngene International Ltd., Pharmaceutical Product Development LLC, Siro Clinpharm Pvt. Ltd., Clininvent Research Pvt. Ltd., VIMTA Labs Ltd., Bilcare Limited, Aizant Drug Research Solutions Private Limited, Piramal Pharma Solutions, Synapse Labs Pvt. Ltd., Eurofins Scientific, Covance India Pharmaceutical Services Pvt. Ltd., Abiogenesis Clinpharm Pvt. Ltd., Laurus Labs, Neuland Laboratories Ltd., Accustest Research Laboratories Pvt Ltd., and other prominent players.

Recent Development

• In July 2021,  Parexel has announced a formal merger agreement under which it will be acquired by EQT IX fund ("EQT Private Equity") and Goldman Sachs Asset Management ("Goldman Sachs") for USD8.5 billion.

• In April 2021, PPD, Inc. and Science 37, the creator of the Decentralized Clinical Trial Operating System, have announced a groundbreaking partnership in which PPD would be able to fully design, build, test, implement, and execute digital trials using Science 37's DCT SaaS-based technology platform.

Scope of the Report

By Service Type

• Clinical trials
• Product Development
• Process Development
• Post-Marketing Surveillance
• Quality Monitoring
• Others  

By Therapeutic Application

• Oncology
• Cardiovascular
• Neurology
• Nephrology and Urology
• Others

By End-User Industry

• Pharmaceutical/Biopharmaceutical Companies
• Medical Devices Companies
• Academic Institutes

By Region

• East India
• North India
• South India
• West India