The Indian bio-services sector is the second largest sector of the biotechnology industry, with about 33% market share.
The industry consists of contract and clinical research organizations (CROs), as well as contract manufacturers (CMOs) and is often referred to as Contract Research and Manufacturing Services (CRAMS). The CRAMS industry, especially biotechnological contract services and manufacturing in India barely existed in the middle of the 1990s, but has grown today to be an important contributor to India’s bio-economy.
ABLE-BioSpectrum estimates that there are 30 CROs that conduct Bio-availability (BA) / Bio-equivalence (BE) trials, and around 50 CROs that are involved in Phase I-IV trials. Leading Indian CROs like Jubilant Bio-sys provide an integrated platform for drug discovery right from target validation to clinical trials and data management. GVK BIO is another company that provides an equally wide range of competency. Advinus (a TATA enterprise) is an end-to-end bio-services company and is strategizing to be a drug discovery company.
The Indian bio-services industry has been steadily rising over the past few years, clocking total revenues of US$ 738.4 million in 2010-11 and registering a growth of 23 % over last year’s (2009-10) total segment revenue of US$ 600.2 million. This constitutes about 19 % of the total biotech industry revenue for the fiscal year.
According to the Biospectrum- ABLE survey of 2011, India has the opportunity to become a leading hub for clinical trials, with 1584 ongoing clinical trials in 2011. Furthermore, the DCGI has introduced a compulsory registration process with CTRI for all clinical trials being conducted in India.
Looking into the future, the CRO industry will continue to grow at a rate of 20-30 % over the next three years, and the segment will also see the entry of a number of small-sized home-grown CROs into the market looking at BA/BE studies. Also, being on the growth mode, Indian CROs will look at outbound acquisitions both big and small. Mandatory registration of all clinical trials in India has brought about the much-needed transparency into the system and this in turn will lead to a rise in the number of global companies outsourcing clinical trials to India.
The country offers a suitable population for clinical trials because of its diverse gene pools, which cover a large number of diseases. Cost effectiveness, competition, and increased confidence on capabilities and skill sets have propelled many global pharmaceutical companies to expand their own clinical research investment in the nation.
The market has companies doing clinical research and trials for molecules developed in-house (captive CRO) such as Eli Lilly, as well as organizations doing contract research and trials for other companies (independent CRO) which include Quintiles; Syngene International; SIRO Clinpharm and Ecron Acunova; Lambda Therapeutic; Advinus; Aurigene; Jubilant; Sai Advantum, and Suven Lifesciences among many others. Set up in 1994, Syngene International is a Biocon Group company which was India’s first integrated CRO in the area of drug discovery. It is presently serving over a dozen pharmaceutical R&D units in Europe and the US, with diverse competencies in the Indian CRO industry.