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Almost 58 per cent of the contract research organisations (CROs) in the country are of small to medium size and almost 54 per cent of the CROs operating in India are working in the service areas related to patient-based phase I-IV clinical trials conducted at the hospitals, according to a market report.
A Study on CRO Sector in India, conducted by the Department of Pharmaceuticals (DoP) by engaging Biovantis Healthcare Private Limited (Biovantis) to prepare the report, also added that the states of Maharashtra, Tamil Nadu, Gujarat, Delhi and Karnataka account for 65 per cent of sites in India and the presence of these sites is more concentrated in metro and Tier-1 cities.
The study conducted on a sample size of 50 CROs said that for the uniformity and ease of data analysis the revenues of the 50 CROs in the database has been considered irrespective of the specific CRO service area.
The annual revenue of 12 percent of CROs was in the range of US Dollar (USD/$) 0-5 million while those of 22 per cent of the CROs were in the range of $5- 10 million.
"This total segment of around 34 per cent CRO comprised the micro and small segment by revenues," said the study.
There were 24 per cent medium sized CROs whose revenues were in the range of $10-50 million. The large sized CRO segment comprises around 42 per cent (mainly the multinational CROs) whose revenues were more than $50 million.
"The data infers that on the basis of revenues, the majority of CROs (58%) operating in India are of small to medium size and there is a large chunk of CRO market (42%) is dominated by big size global CROs," it said.
On the basis of employee numbers, the majority of CROs (72%) operating in India are of small to medium size and the rest are of big size global CROs.
Almost 40 per cent of the CROs are based in the western region comprising Mumbai, Pune, Ahmedabad, Vadodara, followed by 34 per cent in the Southern region with presence mainly in cities like Bangalore, Chennai and Hyderabad. The northern part of India has around 18 per cent of the contract research organisations which are mainly located in and around Delhi/National Capital Region area. The eastern region of the country stands at 4 per cent with CROs located in.
"The data analysis further elucidates that CRO generally prefer to set up their centres and offices in Metro or Tier 1 cities across the country," it added.
It also noted that despite India being the second most populous country and having one of the highest global disease burdens, India’s global clinical trial participation has been significantly low (2-3%) as compared to countries like the US where participation is as much as 30 per cent.
While the discovery, preclinical and advance stage clinical development CROs primarily work on the new chemical entities and new biological entities, the bioequivalence/bioavailability clinical CROs are primarily on developing the generic drugs through abbreviated new drug applications (ANDAs).
Many CROs operating in India like Syngene, Jubilant, Parexel etc have the capabilities to offer the various combinations of above-mentioned services as well as end to end product development services.
As per the data analysed for 50 CROs in the study 54 per cent of the CROs operating in India are operating in the service areas related to patient-based phase I-IV clinical trials conducted at the hospitals.
This not only include Indian CROs like JSS Medical Research, SiroClinpharm, Navitas, Reliance, Ardent, Ethicare, Novobliss, and Target Research but also include the multinational CROs like IQVIA, Parexel, Syneos, PPD etc. Another 18 per cent of the total CROs primarily offer the clinical bioequivalence/bioavailability service from their inhouse BE centres and normally conduct the pharmacokinetic studies in healthy subjects for ANDA submissions sand generic product marketing authorisations but also have the capabilities to conduct the patient-based studies in hospitals.
India also has a good percentage (20%) of integrated drug discovery and development companies like Syngene, Jubilant, Jai Research Foundation which offer end to end services including chemistry/biology discovery, preclinical and clinical development services. A small percentage (8%) of preclinical CRO like Dabur research foundation and Eurofins Advinus also work in which offer the animal testing services for the pharmaceutical, biotech and medical device companies, said the study.
For the market survey, the secondary data of 50 Indian CROs was collated. The primary survey data was collected from representatives of 24 CROs and 20 users using the questionnaires, telephonic interviews, face to face interviews and focussed group discussions using ICTs. In addition, the agency has also brought in the inputs of the directors of seven NIPERs on the future of the sector.
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