IVD in India will Ride on CLIA and ELISA

New Delhi: The Indian in-vitro diagnostics (IVD) industry has been increasing at an incremental rate, owing to numerous innovative technologies that have been its primary support. ELISA (Enzyme-Linked Immunosorbent Assay) has been the mainstay of diagnostic test, not only in India, but also in the rest of the world over the last fifty-odd years. The ELISA plate was associated with low cost, availability, and reliability. No overstatement is made describing how ELISA influenced the diagnostic scene in the field of infectious disease, autoimmune disease and regular screenings in economically constrained contexts.
The current trends, however, are different with demands on laboratories. Increased patient numbers, burden of chronic diseases and the increasing demand of quick turnaround have challenged diagnostics to a new dimension. CLIA (Chemiluminescence Immunoassay) has been found to be the new technology of tomorrow that supplements the role played by ELISA. Forms CLIA offers automation, increased sensitivity as well as throughput yet ELISA still has its uses in specific, cost sensitive applications.
Direct comparisons between CLIA and ELISA show that both technologies produce strong results. However, CLIA frequently edges ahead in terms of sensitivity and specificity, particularly in complex assays. CLIA minimizes reruns and assists laboratories in creating more consistent reports in high-stakes scenarios, such as blood safety and infectious disease screening, by providing a broader dynamic range and reduced background noise.
A significant portion of ELISA solutions are either manual or semi-automatic, requiring stackable solutions for Automated processes, while CLIA fits in effortlessly into automated workflows, thereby providing greater comfort, ease of use, and better suited for high-volume testing. CLIA analyzers are a good example of technology providing both reliability and efficiency. Features like refrigerated onboard reagents and continuous sample loading are common in compact systems that have an output of 100–200 assays per hour. Larger integrated tracks merge chemistry and immunoassay, allowing labs to run panels around the clock with minimal intervention.
This automation not only reduces human error but also stabilizes turnaround time, critical in emergency departments and high-volume diagnostic centers.
While ELISA remains ideally suited for many low and mid-volume scenarios, CLIA’s advantages are most visible in:
    • Infection Serology: like HBV, HCV, HIV, and dengue panels that require early detection and low false-negative rates
    • Endocrinology, including Thyroid and fertility panels like TSH, AMH, and LH, that enable accurate quantification to facilitate long-term patient management.
    • Cardiology - Emergency cardiac care necessitates the use of high-sensitivity troponin and NT-proBNP assays.
    • Oncology & Autoimmune Testing: (PSA, CEA, and ANA markers), where reproducibility and linearity matter for clinical confidence.
The greater utilization of CLIA in India is not by chance or accident. It is quite a strategic action considering the social-economic factors as well as the Indian diverse and far distant rural population. It is a product of the healthcare reforms that are contributing to market consolidation. Initiatives like Ayushman Bharat are leading to more people having access to sophisticated diagnostics. The PM-ABHIM project is establishing a national system of surveillance laboratories and this leads to the need to have standardized, automated platforms.
In the meantime, the spread of NABL accreditation is ongoing in the country, and laboratories are forced to implement systems that are capable of providing reproducibility and traceability at scale. Partnership consolidation is also happening through diagnostic chains to push the initiative towards the integrated chemistry-immunoassay platforms in which the default backbone is CLIA.
The immuno assay market of India is expected to grow by 2024 to USD 900 million and by 2030 to USD 1.31 billion, whereas the immuno assay analyzers will grow by 2024 to USD 241 million and by 2030 to USD 342 million. In this segment, a chemiluminescense analyzers are expected to experience a growth rate of approximately 6 percent CAGR by the year 2033.
ELISA will not be completely pushed out of this growth. In its place, ELISA will continue to be concentrated in the lower volume, decentralized facilities and certain public health programs. Meanwhile, core laboratories, tertiary hospitals, and multi-site providers with the need to be fast, automated, and precise are dominated by CLIA.
For clinicians and laboratory managers, the lesson is clear: this is not a fruitless choice. ELISA and CLIA fulfill diverse but complementary requirements. In comparison, ELISA is the ideal choice for cost-sensitive, smaller volumes and specific programmatic testing, while CLIA is critical when sensitivity, scalability, and turnover are of the utmost importance. A hybrid approach, which employs CLIA for routine high-throughput menus and ELISA for select assays, frequently results in the most optimal patient outcomes and the most equitable economics.
ELISA and CLIA are the partners in progress at J Mitra and Company. On the one hand, achieving a stronger ELISA portfolio that includes the tests of more than 27 parameters to be used by the laboratories in India, we are investing in CLIA based on the Indian loads. We have a product line of 44+ parameters in CLIA (infectious disease serology, thyroid and fertility panels and cardiac markers). Our analysers are designed in terms of uptime and cost management, making them affordable but not sacrificing on accuracy.
We are not trying to steal ELISA out of all locations, but we want to make sure that each lab has the appropriate technology in its environment, be it community-based ELISA test or a high-volume CLIA panel in a core lab.