The future of in-vitro diagnostics in India – Trends and transformations toward 2025 and beyond

The in-vitro diagnostics (IVD) industry plays a foundational role in modern healthcare, enabling accurate disease diagnosis, monitoring, and treatment planning. Globally, the IVD market has been experiencing robust growth, fuelled by advancements in technology and the increasing prevalence of chronic and infectious diseases. With approximately 70 percent of clinical decisions relying on diagnostic results, the IVD sector is indispensable to global healthcare. By 2023, the global market was valued at USD 98 billion and is projected to grow at a CAGR of 4 percent to 5 percent to reach USD 120 billion by 2028. In this context, India is emerging as a critical player, poised for transformative growth in the coming years.

India’s IVD market, valued at USD 2.3 billion in 2024, is expected to grow at a robust CAGR of 12 percent to 13 percent to reach USD 3.98 billion by 2028. This outpaces global growth trends, reflecting India’s increasing healthcare demand and domestic manufacturing capacity. Currently contributing 1 percent to 2 percent to the global IVD market, India’s share is set to grow as local production rises, supported by initiatives like Make in India. Domestic manufacturing accounts for 60 percent to 70 percent of the Indian market, reducing dependency on imports and boosting exports, which currently stand at USD 300 million. Key export markets include Asia, Africa, and Latin America, with opportunities expanding in developed regions.

The Indian IVD market is highly diverse, with several segments contributing uniquely to its growth trajectory. Immunology holds the largest market share at 22.5 percent, playing a vital role in disease diagnosis and monitoring, and is projected to grow at a robust rate of 16 percent. Clinical chemistry and immunochemistry, accounting for 18.5 percent of the market, are expected to expand at a CAGR of 12 percent, while point-of-care (POC) diagnostics represents 18 percent of the market and is growing at 13 percent, driven by its decentralized and immediate diagnostic applications.

Other segments include hematology, which holds a 9.9 percent share with a projected growth of 14 percent, and molecular diagnostics, a pivotal segment at 7.5 percent, growing at 15 percent. Smaller yet crucial segments like microbiology (5 percent) and coagulation (3.7 percent) are forecasted to grow at 15 percent, while urine analysis, though accounting for only 3 percent, is poised for remarkable growth at 17 percent, reflecting the growing interest of automation from Indian customers.

India’s significant disease burden highlights the critical need for advanced diagnostic solutions. The prevalence of lifestyle and chronic diseases is rising sharply. Diabetes affects over 100 million people, a figure projected to reach 134 million by 2045, with complications, such as heart and kidney diseases becoming increasingly common. Cardiovascular diseases (CVDs) account for 30 percent of the global burden, with rising incidence among younger populations due to unhealthy eating habits and sedentary lifestyles. Cancer, affecting 2.7 million people, sees 1.4 million new cases annually and nearly 900,000 deaths, with lung, breast, esophageal, mouth, stomach, and cervical cancers comprising 42 percent of cases. Infectious diseases, such as malaria, dengue, hepatitis, and tuberculosis continue to challenge lower socioeconomic groups.

Deliberating other miscellaneous factors influencing the IVD future trends, technological innovations are the most important ones afront. Technological innovations enable transformative healthcare solutions. AI and machine learning enhance diagnostic accuracy, automate workflows, and enable predictive analytics for faster decision-making. Moving forward, molecular tests for oncology, such as lung and breast cancer will be in vogue. The molecular diagnostics market in India, which stood at USD 920.05 million in 2023, is steadily growing at a double-digit rate after Covid.

Point-of-care testing (POCT) extends diagnostic capabilities to rural and underserved areas, improving access and early detection. Devices for diabetes, electrolyte imbalances, and cardiac markers, especially in rural and underserved areas gain more momentum. The Indian POCT market is valued at USD 1.41 billion in FY 2024, and expected to reach USD 2.71 billion by FY 2032 at 8.47-percent CAGR from 2025 to 2029. POCT devices are projected to be widely deployed in primary healthcare settings by 2025.

Modular laboratory automation system will streamline diagnostic workflows, optimizing turnaround times and resource utilization. This efficiency will be vital as India’s diagnostic sector grows, meeting increasing patient volumes without compromising quality. High-end automated analyzers will streamline laboratory workflows by running multiple tests simultaneously in clinical chemistry, immunology, and molecular testing.

The focus on companion diagnostics will strengthen personalized medicine in India, aligning treatments with individual patient profiles. This approach ensures higher efficacy of therapies in managing complex diseases like cancer and autoimmune disorders. NGS-based testing will be the key for cancer detection and treatment as in herceptin testing for HER2-positive breast cancer patients for personalized therapies. The global companion diagnostics market size was valued at USD 8.51 billion in 2023. The global market is projected to grow from USD 9.38 billion in 2024 to USD 22.37 billion by 2032, exhibiting a CAGR of 11.5 percent during the forecast period.