IVD, being a crucial healthcare component, is quickly expanding in Tier-II and Tier-III cities with the burgeoning healthcare development across India. Many states are making rapid strides with concerted investments to expand testing into rural healthcare development.
Diagnostic testing Visibility is more pronounced when the state govt has established public – private partnerships where private partners are fully responsible for supplying quality diagnostic solutions at affordable prices. Uttar Pradesh and Madhya Pradesh Dx testing schemes have worked well for years and could serve as a model.
Indian IVD business reached USD 2 bn in 2022 and is predicted to reach USD 4 bn by 2028 with double-digit growth. High disease load (diabetes, CVD, cancer, infectious diseases, NCD, and rising mental health/neuro Dx) makes the market attractive. India has 30 percent of the world’s life-threatening diseases. Lifestyle, lack of awareness, low preventive health checkups, and an ageing population create big opportunities for Dx players to focus, explore, and capture business opportunities in cardiac, cancer biomarkers, sepsis, inflammation, ID markers, autoimmunity, self-testing, and home testing, as well as general diagnostic tests.
Core lab Dx. Chemistry is predicted to expand at low double digits while CLIA at high-double digits due to rising disease incidence and biomarker testing needs, specially in cancer biomarkers. Mindray, Sysmex, Autobio, and Agappe are four new CLIA competitors that are challenging the two-decade-old MNC monopoly with advanced systems. Suppliers’ ability to provide dependable systems at low COGS and offer a big menu and competitive test pricing will promote CLIA company success.
Hemat. Currently, market demand is for 3-PDA (~15,000 units per year), but this will slow down, and 5-PDA demand will grow faster and reach 12–15K units by 27. The 5-PDA market is vibrant and enticing because of lower system prices and various Chinese-branded quality items. Make in India analyzers are needed to replace imported 5-PDA systems.
POC. Post-Covid scenarios experienced the surge in POC equipment segment with reliable results. However. Covid has made small hospitals and rural clinics using POC equipments for faster results. Most POC tests can be done remotely with lab-like accuracy. POC diagnostics can pioneer rural Dx with WHO essential diagnostic list (EDL) recommendations for primary, community, and district hospitals.
Supplier issues and challenges. Despite expanding test volumes, IVD vendors will struggle to manage gross margin. Some customer test prices are high enough to make CPTs unprofitable. Many players struggle to grow due to rising resources and operating expenditures. Depreciation expenses are also cutting into the already poor gross margins. Standby systems have made it harder for suppliers to balance investment versus return due to client expectations without quantities.
India also lacks quality standards for labs, thus new labs open and quality suffers. Only 2400 of the projected 100,000 labs have NABL certification, indicating a large gap between labs and hospitals following quality standards to give reliable results. A strong regulatory authority is needed to regulate lab proliferation and set quality standards for current and new labs in the country.
The end-customer pricing (patients) varies significantly from each laboratory, which is a major concern for patients since we in India pay out of pocket. This high pricing is also one reason why physicians do not write the necessary tests for correct diagnosis and tend to write few tests that patients can afford. We really need a regulatory framework or insurance companies setting pricing depending on hospital/lab class and type.
Indian diagnostics may become the third-largest IVD market after US and China in the next decade, making it too enormous to invest in. Only need IVD ecosystems for local manufacturing and sustainable pricing for suppliers to build innovative products and solutions to help patients and healthcare in India.