Pathways for need-based development of IVD industry in India

Over the period of last one decade, IVD has emerged to be an area of significant innovations, translating the practice of medicine into process, throughout the world and promoting the evidence-based treatment approach.

The structure of the growth of IVD sector in India is strongly characterized by two features, firstly an accelerating demand due to increasing incidences of both lifestyle and infectious diseases, and secondly the technological advancements that are rapidly moving toward molecular level for the detection of causative agents of the disease and for determining the health conditions. The market has been historically led by revenues from immunochemistry market, with biochemistry and hematology being the second and the third largest segments respectively. Each of the aforementioned segments is governed by a gamut of different factors, with two important factors being the technology used and the nature of diseases.

As far as the pathways for the growth of India’s IVD industry is concerned for the coming years, when the sector as emerged as crucial component of healthcare system during the recent pandemic of Covid-19, it becomes very important to looking into the nature of the ecosystem within which the sector is evolving. Having said that, the current ecosystem within which the IVD sector is developing is characterized by the country’s various specific concerns like: 1) high dependence on imports – there has been a prevalence of imported products from other countries, both as original equipment manufacturer and in finished form. This makes the diagnosis high-priced and inaccessible due to unsuitability of imported technologies for resource-poor healthcare settings; 2) emphasis on indigenous research has been notably lacking amongst the local players due to limited resources and funding options; 3) the sector is highly technology-intensive that requires continuous efforts toward capability building, especially in molecular or synthetic biology disciplines, to catch up with the technological advancement worldwide; 4) emerging diagnostics challenges associated with mutations of pathogenic strains for highly burdened infectious diseases and emerging incidences of lifestyle diseases; 5) at present, less than 10 percent of clinical laboratories have been found to participate in external quality-assurance programs; 6) lack of instruments and mechanisms to facilitate translational research; 7) adoption of strong IPR polices over the period has put barrier on innovation making due to patents’ monopolies; 8) in the past few years, however, many young start-ups have emerged, which have been playing a significant role by focusing on the development of IVD technologies relevant to local priorities but these firms face severe market competition from large firms and prevalence of imported products; 9) lack of collaboration between national R&D institutions, academia, industry, and hospitals/medical colleges continues to be the defining feature of the national innovation system in the case of IVD.

A special focus on the development of policy instruments and institution-building practices, capable of promoting innovations for local needs, is a priority of Indian policymakers. There is a need to align the instruments and mechanisms in such a manner as to promote the integration of non-market calculations based on social criteria to address the country’s specific issues. This will help in getting the industry, research institutions, academia, and healthcare organizations to sustain their investment in the system-building activities for the development and diffusion of technologies. We are a technology-follower country; therefore, the technological catch-up process needs government policies that can help the country through knowledge production, emerging from relationships building between industry-research institute-university-clinical settings. It is necessary to retain the strategic control of domestic structures of knowledge creation for innovation. Also, it is necessary for the policy regime to make researchers, entrepreneurs, and healthcare personnel prioritize appropriate social calculation-based developmental activities to deal with the challenges of indigenization and the development of diagnostics suitable for the country’s needs. To sum up, the growth of the sector in the coming years would require policies that encourage the actors to work toward the need-based innovations, while focusing on current institutional voids.