A Contract Research Organization
(CRO) provides support to the pharmaceutical, biotechnology, and medical device
industries for specific services on a contract basis. The services may be clinical research
, product development such as drug development or process development such as bio analytical assay development. A CRO may also provide management services such as clinical trials management, and pharmacovigilance.
The CRO market is being driven by the biopharmaceutical industry’s improving fundamentals. Most biopharma companies, the CRO industry’s most important customers, are now at the tail end of multiyear patent cliffs and are stepping up investments in their late-stage pipelines. This is expected to drive modest growth in biopharma Research & Development expenditure in the foreseeable future.
The global biologics (biopharmaceutical drugs) market is expected to grow to $428 billion by 2022 at an annual rate of more than 10 per cent. This rapid growth is expected to accelerate the development of biologics. In tandem, biopharmaceutical sponsors are expected to increase their outsourcing activities, supporting the growth of the CRO market.
Globalization of clinical trials
The Indian clinical trials market size is expected to reach USD 3.15 billion by 2025. It is projected to register a CAGR of 8.7% over the forecast period. Globalization of clinical trials, adoption of new technology in clinical research, growing disease variation and prevalence, and increasing Research & Development promoting outsourcing are the key factors driving the market.
India is a country of nearly 1.3 billion individuals with varying genetic background and thus offers a large treatment patient pool for development of therapeutics on a range of disease conditions. Furthermore, the economic, environmental, and ecological variations in the 29 states and 7 union territories in the country present the most diverse disease profiles. For instance, Rajasthan, Bihar, Jharkhand, and Uttar Pradesh have less dominance of non-communicable diseases as compared to Kerala, Tamil Nadu, and Goa.
Favourable destination for clinical trials
Streamlining of the regulations has led to increase in harmonization and reduction in approval time, thus making India a favourable destination for clinical trials. Furthermore, the cost of carrying out clinical trials in India is nearly 40-70% less than that in Europe or United States. Thus, the cost efficiency, along with availability of skilled professionals, and ease of doing business, is accelerating the market growth.
Contract Research Organizations are increasingly incorporating real world evidence in their clinical studies.