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India Healthcare Testing

With 1.42 billion inhabitants, India is among the five most populous countries and fast-growing economies in the world with an estimated GDP growth of 7 per cent in FY 2022-‘23. 

The Indian healthcare industry has grown at a rapid and healthy CAGR of more than 17 per cent over the last decade.  The healthcare market was valued at $280 billion in 2020 is expected to reach $370 billion by 2024-‘25.  The impact of the COVID-19 pandemic on India underscores the importance of investing in the healthcare sector.  Industry experts believe there will be a significant increase in healthcare spending in India over the next several years, partially spurred by lessons learned from the pandemic.  Public spending on healthcare in India stands at just 1.2 per cent of GDP, but the Indian government has proposed increasing this to 2.5 per cent by 2025, with a special focus on underprivileged populations.  As expenditures in the Indian healthcare sector increase, corresponding growth in the diagnostic devices sector is anticipated. 

With incredible capital investment in advanced diagnostic facilities, India has become one of the leading destinations for high-end diagnostic services, catering to a much larger population.  Factors such as the high prevalence of infectious diseases in developing countries, the increasing incidence of target diseases, the global preference for home healthcare, and expanding government initiatives to support the adoption of POCT diagnostic products are expected to drive demand in India.  With more than 65 per cent of the Indian population living in rural areas, where quality healthcare delivery remains a major challenge, POCT has become increasingly significant in India.  This industry is expected to have a total market value of $70 million by 2030. Hematology, reagents, molecular diagnostics, and specialty diagnostics are among the key growth products.

The Indian government’s commitment to combating diseases, like HIV and tuberculosis, as well as strong demand for routine diagnostic procedures, like complete blood count, coagulation analysis, and blood glucose tests, are all contributing to the growth of the POCT market and making it very attractive to U.S. exporters.

POCT products in demand:

•  glucose monitoring products
•  infectious disease testing products
•  coagulation testing products
•  cardiometabolic testing products
•  hematology testing products
•  urinalysis testing products
•  cholesterol testing products
•  drugs of abuse testing products
•  tumor/cancer marker testing products
•  pregnancy and fertility testing products
•  fecal occult testing products, and 
•  other POC products (multi-assay testing, liver testing, hepatitis A & B testing, and vitamin assay testing).

The Government of India has an established process to ensure the registration of POCT products.  In India, the authority regulating medical devices is the Central Drug Standard Control Organization (CDSCO) in the Ministry of Health. CDSCO grants product registration either to a distributor or a consultant representing the foreign company.  The usual registration process takes about 6-9 months.  The registration is granted for a period of 3 years.

For entry into the Indian market, it is preferable for U.S. companies to identify quality partners who know this market.  Strategic planning, due diligence, and consistent follow-ups are the prerequisites for doing business successfully in India.

U.S. companies may consider the following upcoming local trade shows to showcase their technologies and meeting Indian companies.
•  Medicall, July 28-30, 2023, Chennai
•  Medical Fair India, April 2024, Mumbai 

U.S. businesses providing technologies and solutions in the sector and interested in India market could reach out to a nearest U.S.  office or the Healthcare and MedTech sector team at the U.S. Commercial Service in India.

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