Oct 04, 2019:
The bio-services sector has shown an impressive growth trajectory, due to confident strides in clinical research, contract manufacturing, and contract research. The growth trend in this industry can be envisioned by looking at the number of clinical trials that were contracted to India a few years back-120 clinical trials in all. Currently, there are nearly 600 trials that include drugs, surgical procedures, devices and treatments that are carried out in India.
Escalating costs of production and stringent regulations have been easing pharmaceutical companies in developed countries to assent to using the services of contract manufacturing and research services (CRAMS) in emerging countries. This helps in lowering costs and increasing production rates, which also helps such pharmaceutical companies concentrate on their core competency, which could be either marketing or even drug discovery rather than manufacturing.
In 2017, the Indian clinical trials market was estimated to be USD 1.6 billion, with a promising CAGR of 8.7%. The major market drivers for this sector has been the increasing variation in disease and the globalization of clinical trials. Other factors which could spearhead further growth are the inclusion of improved technology and an increase in R&D.
Here are some compelling statistics that make India a natural destination for clinical trials, 16% of the global population lives in India, with 20% of the global disease burden. Nevertheless, only about 1.4% of global clinical trials are carried out here, though the vast and diverse patient and genetic pool make India the perfect hotbed for clinical trials.
An important point to note is that emerging markets are subject to International standards of conducting clinical trials, as put forward by markets such as the U.S. The FDA has dictated a set of regulations that studies, which involve a medical device or drug, should adhere to, called the good clinical practice guidelines (GCP). An important criterion included in these guidelines is a review by an independent ethical committee (IEC), which helps allay fears about poor quality research or the use of unethical practices.
The Indian clinical trial industry has not been altogether free of challenges, though, with the 2011 litigation being a case in point. The litigation challenged the regulatory framework and guidelines for patient safety. This resulted in a three-phase clinical trial process, which increased the time of approval, resulting in India losing out to the other emerging markets.
These guidelines were revisited in 2014, with strengthened protocols for consent, reimbursement and for adverse outcomes. Another significant decree was that these clinical trials could only be carried out in centers which were accredited. Additional regulatory measures put forth included restricting the number of clinical trials that could be carried out by a principal investigator with added stringency for ethics committee and site certifications. This has greatly improved the quality of the trials conducted and the results obtained.
In terms of the manufacture of drugs and medical products, India enjoys an advantage over nations like Vietnam, China and Ireland owing to better and a greater number of the technically well-informed talent pool, manpower and production houses that are WHO-GMP approved. This reduces the production and operation costs of pharma companies in developed countries by 40%, flagging the interest of multinationals to make a beeline to India for their outsourcing requirements.
The success of the generic manufacturing industry is evident in the fact that nearly half of India’s total pharmaceutical production is exported to nearly 200 countries across the world. The high quality of production and lower cost have helped build international markets. India being the hub for IT services can further accentuate the progress of global bio-services industry through IT-enabled clinical data management.
Bio-services industry aids in bringing together world-class investigators and large patient groups, resulting in high-quality data, faster completion of studies due to efficient study enrolments, with reduced costs. Bio-service industries benefit sponsoring pharmaceutical industries while improving the financial growth and healthcare of emerging countries.
|Dr Ayaaz Hussain Khan
Global Head, Generics,
Navitas Life Sciences