Immunochemistry analyzers are increasingly gaining popularity as theyhaveproven to be an effective tool to diagnose cancer, hepatitis, illegal drugs, fertility problems, sodium levels, endocrine function, and detection of blood clots. The immunochemistry market is heavily impacted by rapid replacement trends, which affect the clinical chemistry market. The market is increasingly seeing the entry of chemiluminescence immunoassay (CLIA) systems, which are replacing older versions. Smaller labs still opt for fluorescent immunoassay (FIA) systems or semi-automated CLIA systems.

Enzyme-linked immunosorbent assay (ELISA) systems and open systems are exhibiting some growth because of their open-platform capabilities, larger test menus, and affordability. FIA and CLIA systems tend to be more expensive, which works in favor of ELISA systems.

immunochemistryELISA systems may eventually experience erosion, given their lack of sensitivity and low specificities, especially as most laboratories are now consolidating and converting to high-throughput systems. As a result, many vendors are using this opportunity to offer immunoassay or standalone clinical chemistry systems at a highly discounted price. Demand for immunochemistry systems seems to work negatively for vendors. Because of this, the retention of the installed base is crucial. Some strategies adopted by vendors include offering large discounts/upgrades, adding automation capabilities to existing modules, and having long-term reagent rental contracts.

Indian Market Dynamics

In 2015-16, the Indian immunochemistry instruments and reagents market was valued at 1000 crore. Reagents accounted for 90 percent of the market. The ELISA kits demand for this segment in 2015-16 is estimated at 325 crore and rapid tests at 250 crore.

Chemiluminescent systems are gaining momentum, especially in Tier-I cities where the installation base and replacement market is increasing. On the other hand, Tier-II and III cites are opting for fluorescent and manual chemiluminescent systems. The purchasing power of the customer has increased. ELISA kits, though a declining segment, continue to have relevance for their large test menus and affordability.

Based on application, test for hepatitis C virus (HCV) dominated the Indian immunoassay market in 2015-16, with its increasing application in the diagnosis of infectious diseases.

immunochemistryIn 2016, on the global front, Abbott has announced a definitive agreement to acquire Alere, significantly advancing Abbott's global diagnostics presence and leadership. Companies are developing solutions that are likely to improve the speed, accuracy, and reliability of lab testing through automation, workflow integration, as well as information management. They are enabling labs to better handle expanding testing and data volumes. Future development will undoubtedly include more micro-scale instrumentation with ultrasensitive detection, rapid and faster turnaround time, as well as increased relevance in clinical laboratories.

Future of Immunodiagnostics

There have been tremendous advances in immunodiagnostics during the last five decades, which have led to the emergence of potential diagnostic technologies, new immunoassay formats, and diagnostic platforms. Radioimmunoassay and ELISA were the predominant techniques during the initial era of immunodiagnostics. The strenuous research efforts during the last three decades have enabled the development of potential antibodies for a wide range of analytes.

There have also been some major advances in lateral flow immunoassays (LFIA), which have been developed for a large number of analytes. Researchers have started looking into the development of quantitative LFIA instead of the conventional qualitative ones.

Moreover, various signal-enhancement strategies have also been developed during the last decade using nanomaterials, nanocomposites, dendrimers, polymers, and nanostructured substrates. They have led to ultrasensitive immunoassays with lower limit of detection and superior analytical performance. The use of magnetic beads/particles in magnetic immunoassays has led to truly remarkable applications that take into account the convenience of handling the magnetic beads/particles.

Dr Neelima Verma, Sr. Consultant, NABL Medical Lead Assessor,Faculty for IS/ISO 15189 IA course (QCI & NITS), SRL Ltd, Fortis Hospital, Delhi
Second Opinion
Market Trends

The rise in the demand for portable point-of-care (POC) testing devices has given a different dimension to immunochemistry market. There is an increasing amount of patient testing being carried out at the bedside. Clinicians are going to opt for integrated analyzers over standalone in the next 2 years. Blood glucose testing accounted for over half of the revenue by POC testing made in 2015 due to the rise in prevalence of diabetes.

Market for immunoassays is gaining popularity with portable immunoassays, novel biomarkers, and innovative technologies for improving sensitivity, cost effectiveness, and rapidness of immunoassays.

There are new range of condition-specific markers and tests with advances in genomics and proteomics. But still for some analytes, low-detection limit and lack of budget to restrict growth are real restraints in immunoassays. Pricing pressure for some tests due to competition for lower cost per test technologies are real threat. Stringent regulatory framework acts as a major challenge.

Future development of immunochemical tests will undoubtedly include more microscale instrumentation with ultra-sensitive detection, faster turnaround time, and increased throughput in clinical laboratories.

Dr Neelima Verma
Sr. Consultant, NABL Medical Lead Assessor,Faculty for IS/ISO 15189 IA course (QCI & NITS),
SRL Ltd, Fortis Hospital, Delhi

Despite tremendous advances, there is a critical need for rapid and cost-effective immunoassay procedures and novel diagnostic platforms in order to increase the outreach of immunodiagnostics to remote settings and developing countries. The most prospective development in this regard is the use of smartphones for immunodiagnostics. Various smartphone-based immunoassays and integrated readers for (LFIAs) have already been developed during the last few years. The current generation of smartphones is equipped with high-resolution camera, advanced processor, GPRS, connectivity, and iCloud computing, which make them the ideal next-generation devices for point-of-care immunodiagnostics, telemedicine, and mobile healthcare. Taking into account ~6.8 billion cellphone users worldwide, there will be a huge market for smartphone-based immunodiagnostics. Moreover, it will lead to tremendous cost-savings due to automated data analysis, highly centralized operations, telemedicine, and personalized healthcare. The integration of smartphones with cheap paper-based immunoassays will be highly useful in developing low-cost immunodiagnostics for the developing world.

Indian Market Dynamics is based on market research conducted by Medical Buyer in March 2016.

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