IVD and MedTech – The year ahead

If one is looking for an understanding of any industry these days, one finds a curious section in every online and offline resource, along the lines of impact of Covid-19 on this XYZ industry. Without question, the Covid-19 pandemic has altered the face of healthcare, causing seismic transformations in the in-vitro diagnostic (IVD) business in particular. As the pandemic spread, there has been a growing demand for faster and higher-volume testing, especially the reverse-transcription polymerase chain reaction (RT-PCR), being recognized as the best determiner for prevalence, rate, and cyclicity of the virus.

Much medical equipment has found its way into our homes due to the Covid-19 pandemic. Pulse oximeters, ventilators, respirators, oxygen concentrators, and membrane oxygenators are all medical devices that the general population is now familiar with, much beyond the usual home-use gadgets like a thermometer or a blood pressure monitor. We witnessed a demand for technologies like remote health monitoring and point-of-care (POC) testing, which grew due to on-the-spot screening. In this light, the MedTech Industry, in the context of the IVD industry, and the IVD industry itself, saw tremendous growth during this pandemic, as has been noted by several in academia, members, and veterans of these industries, and business gurus.

There have been developments and technological advancements in the field itself, for example, the increased significance of biomarkers due to improvements in genomics, proteomics, and molecular pathology, which is expected to develop a range of condition-specific tests with the integration of biomarkers and the biomolecular tools. There are socio-economic drivers like growth in the geriatric population, educated population’s skewed interest toward preventive and personalized healthcare, increased preference for home and remote healthcare, etc. These factors give us a good overview of the drivers and opportunities that will boost these industries in the upcoming year, but we should also take note of some bumps in the road. Regulations have got stricter across the globe. In the past, India has had it tough even with a 100-percent FDI allowance under the route for both brownfield and greenfield establishments. IVD test developers and marketers must go through a time-consuming and resource-intensive regulatory process to get their test to market. Furthermore, they must overcome the challenges posed by the US FDA, and acquire payer confidence for a healthy ROI for their products. As a result, many businesses avoid these procedures or abandon their plans to enter this industry altogether.

But the government has geared up and has started addressing these issues. The country is prepared to become a worldwide manufacturing center in medical devices, boosting economic growth and resilience, and reducing our dependence on imports in the diagnostics arena. Large multinationals, as well as small and midsize businesses, make up India’s diagnostics industry. The sector is rapidly expanding, and the government has even designated medical devices as a sunrise sector.

This industry presents a huge potential for Indian manufacturers, ancillary component makers, distributors, and suppliers to participate in the growth story. The sector has the support of various ministries and departments, converging their thoughts, discussing and implementing ways to reduce the burden of regulatory compliance, and identifying outdated regulations to make the sector agile and easier to do business in.

As promising as it looks, we need to work on our internal strengths to keep up with the fantastic collaborative competition we are experiencing. Businesses, especially diagnostics, have depended on each other for outsourced services for a long time. A network helps us cooperate with not just the members at par but also smaller players providing us with the perfect opportunity to serve more and more people with the highest quality, and we do it as an industry together. Not only is each of us upgrading ourselves to the highest standards, but we are also working on models to put our best foot forward as one of the frontline warriors in the country’s fight against this pandemic. As we move into the future, we have uncertainties like Omicron, and Delta, which keep coming up. However, we also have reduced Covid-19 cases to keep us motivated to continue to unburden healthcare.