Prospect for medical devices and in-vitro diagnostics in India

Amid COVID-19 pandemic, and unprecedented changes the world is going through, the healthcare industry is also experiencing rapid transformations. It is not that hard to evaluate that medical devices (MD) and in-vitro diagnostics (IVD) sector is growing significantly, and is expected to expand in future. This is due to the increasing population, prevailing chronic diseases, communicable and non-communicable diseases; also, people are more aware than before about health issues, insurance, and personalized medical care. In addition, COVID-19 pandemic has widened the gap further between demand and supply of medical devices and IVD. There is a potential growth opportunity in this sector as Indian government’s initiative and schemes (100% FDI, eased rules) for these sectors are supportive with the intent to become a global MD/IVD manufacturing power.

Government policy and incentives are encouraging as there is 100 percent FDI in greenfield and brownfield projects, and import regulations for critical devices have been eased. Recently, Indian government launched production-linked incentives (PLI 2.0) to increase India’s manufacturing at lower cost. Six medical devices parks in India are upcoming, which will establish India as a manufacturing power with export capabilities.

Limiting factors

• Regulatory policies are stringent.
• Insufficient insurance policies.
• Uncertain reimbursement of expensive tests and procedures may adversely affect this sector’s growth.

Impact of COVID-19
COVID-19 pandemic has left a massive impact. It has increased the demand not only for accurate and faster testing but many-fold higher volume of samples, particularly for RT-PCR. In various countries, research institutes and many companies at global level are focusing on the launch of new products of utility. The companies have started introducing rapid diagnostic tests. In June 2020, Roche introduced highly efficient and useful SARS-CoV-2 antibody test with wide acceptance internationally. SD Biosensor, Sysmex launched rapid antigen detecting test for COVID-19 virus. Introducing such superior-quality reagents in such a short period of time has proved to be useful for public in pandemic crisis and has positively impacted the company’s growth.

Impact of innovations in the same line, Mylab, which is a Pune-based company, launched first compact XL equipment to automate the manual processes of molecular diagnostic tests, which is simpler and less space-occupying with better control of contamination to ensure quality results. They also launched the first diagnostic kit for COVID-19 RT-PCR in India. In addition, Coviself is India’s first ICMR-approved rapid antigen self-test kit for COVID-19 for use at individual level at home. Recent advancement of technology in this segment and competition has significantly reduced the cost (e.g., RT-PCR from ₹5000 to ₹500) of molecular diagnostic tests, which is affordable and accessible to more patients of genetic diseases and other infectious diseases.

Changing preferences
During lockdown period of the pandemic, tests/screenings were conducted efficiently from home, and pulse oximeter became a household article for monitoring of disease like glucometer. Time has come for discussion of point-of-care testing (POCT)/near-patient testing. POCT is usually performed outside the central laboratory in a near-patient setting, e.g., at the patient’s bedside in emergency, ICUs, operation theaters, clinicians’ chambers, and at home. It provides real-time, lab-quality results in minutes rather than hours, and enables the medical team to optimize rapid triage and treatment decision, which ensures effective and efficient care near the patient.

Conclusion
Emerging innovative technology has ensured delivery of highly efficient superior-quality products to overcome the challenges and meet the need. Economical and efficient products have better adoption possibilities. India is going to be a heavenly destination for MD/IVD manufacturing sector owing to increasing demand and government initiative.