IVD industry in India

The role of diagnostics services is very crucial in assessing the ailments, deciding on suitable treatment, decision on surgeries, and so on. Diagnostics services are widely used by all systems of medicine of our country. Hence, this industry is growing steadily with an average annual growth rate of 15–20 percent.

The private players of this industry, both organized and unorganized, are inevitable and dominating. Private players include standalone laboratories, national and international chains of laboratories, hospital-attached labs, lab facilities at clinics and at nursing homes, online aggregators of lab services, and many other forms of diagnostics services.

With an introduction of our National Essential Diagnostics list in 2019 based on WHO list, all public healthcare facilities realized the need for having well equipped diagnostics testing facilities to treat the patients effectively for all kinds of diseases. This trend will boost better coverage of diagnostics services even in rural areas, where it is far behind compared with other healthcare delivery services.

Another prospective growth potential for the IVD industry is the shift from curative to preventive and promotive care mindset, which will boost diagnostic services. The demand for door-step and home diagnostic services has tremendously increased during the past few years. Growth of point-of-care diagnostic solutions is an added advantage to record higher growth rate of this industry.

Further, diagnostic services have drawn wider attention among all segments of the population due to the pandemic of COVID-19. The importance of diagnostics in healthcare services is now appreciated by the general public, public health administrators of central and state governments, healthcare planners, and policy makers. This has led to increase in healthcare infrastructure, focus on regulation to establish robust diagnostic delivery system, encouraging the accreditation and certification to maintain the quality standards in providing diagnostics services, private competition, and policy level thrust for affordable pricing for diagnostic services to cover all economic classes of our population, and finally the thrust on patient service effectiveness in the diagnostics arena.

This industry needs much better regulation in order to provide effective clinical outcomes since still major part of this industry is under-organized, which means not covered by many statutory norms of central and state level Clinical Establishment Act, and norms of accreditation bodies of quality regulation like NABL, NABH, and CAP.

Digital technology, digitalization, Artificial Intelligence, data analytics, Big Data, machine learning, and public awareness in diagnostic arena gained huge momentum during the past few years. This trend attracted many companies and entrepreneurs to focus on diagnostic services to offer cost-effective and quality services. Technological backup is expected to influence to a larger extent in the area of patient care management like patient data analytics, disease pattern and prediction analysis, analysis of variations in values of test parameters, effective image analysis, clinical prediction analysis, establishing strong link between service provider and patients, and it is obvious that many pharma companies have ventured into diagnostics industry in the area of diagnostic equipment and devices, reagents, consumables, and diagnostics services. It is due to expectation of exponential future growth potential since the diagnostic segment of our rural healthcare system is not explored fully.

At the same time, there is need to tackle the challenges like lack of public awareness on the importance of diagnostics, consumer education on the importance of diagnostic services, regulation, quality, accreditation, certification, ethical values, responsibility for healthcare consumers, acquiring and managing task of qualified, trained, well equipped medical and clinical manpower, lack of public confidence on diagnostic service delivery system due to evidence of sporadic unethical practices.

Recent government policies and incentives encouraged many domestic companies, who have entered into this industry and are competing with many multinational corporations in the areas of IVD infrastructure, IVD reagents, consumables, devices and equipments, clinical trials, and research and development.