Patients are facing serious challenges in healthcare from emerging and reemerging diseases. Research in molecular diagnostics has provided a better understanding of molecular processes affecting human health and diseases, and the tools derived therefrom are becoming the standard of care for treatment of several diseases. The availability of new sequencing methods, microarrays, microfluidics, biosensors, and biomarker assays has made a shift toward developing diagnostic platforms, which stimulates growth in the field by providing answers to questions regarding diagnosis, prognosis, and best course of treatment, leading to improved outcomes and greater cost savings.

Indian Market Dynamics

molecular diagnosticsThe Indian molecular diagnostics market is estimated at 104 crore, with reagents contributing 100 percent to sales. Analyzers are totally being placed. The revenue generation takes place from the reagents procured for the closed systems supplied by the vendors or some plastic consumables.

Automation is the foundation of clinical molecular laboratory to report patient results with confidence. We have confined our study to extraction analyzers used for clinical applications. In many areas of infectious diseases, classical detection methods have been replaced or supplemented by PCR. Large buyers continue to be premium laboratories as SRL Diagnostics, Dr Lal PathLabs, Metropolis India, Suburban Diagnostics, PGI-Chandigarh, and Institute of Liver and Biliary Sciences (ILBS) New Delhi.

Roche and Qiagen offer extraction analyzers, real-time PCRs and a combination of both. Abbot's m2000 real-time system automates steps to perform nucleic acid amplification assays from sample processing through amplification, detection, and data reduction.

The year 2015-16 saw increasing reliance on Cepheid, for its Xpert MTB/RIF test, which detects mycobacterium tuberculosis complex DNA and, in positive specimens, provides simultaneous identification of rifampin-resistance associated mutations of the rpoB gene. Bio Rad's real-time PCRs and droplet digital PCR systems are also increasingly being used for molecular diagnostics by smaller laboratories; it no longer being the exclusive prerogative of large labs, smaller laboratories are also now conducting these tests.

Last year, Tulip Group entered the world of molecular diagnostics with the launch of its portable Truela real-time micro PCR system. It expects this portable system, which gives results in less than 30 minutes, to be a game changer in the diagnostics field. In 2015, it had success in the Indian market. Danaher India is planning an aggressive entry in this segment this year. bioMrieux India has some presence with its molecular biology solutions covering extraction, amplification, and detection. Beckman Coulter too is moving medicine forward by bringing
75 years of automation and innovation history in the clinical diagnostics lab to the molecular diagnostics arena.

A Paradigm Shift

Previously, laboratory technicians relied on a combination of manual preparation steps with a thermal cycler and crude data capture systems to generate a usable result. The changing need led to the emergence of two kinds of instrumentation.

Automated liquid handler platforms, which can be integrated onto a singular automated platform that can automate most of the manual preparation steps and thermal cycling. By adding a data analysis platform to the back end, the system is able to achieve a high degree of semi-automation for a completely manual lab testing process. The automated liquid handlers, with their open architecture, help to automate the entire test process, no matter what the test process is, as long as it can be split into logical steps.

Commercial analyzers, which use manufacturer-specific reagents, mostly on a closed mechanical analytics system. These resemble the analyzers for other areas of the clinical lab but with a key, distinct feature. Rather than improving upon speed or throughput, the core enhancement made was with regard to ease-of-use – how much the system can automate in order to minimize user intervention.

With the arrival of automated molecular diagnostic analyzers, the molecular laboratory underwent rapid growth and expansion. Automated analyzers provided a number of benefits – ability to process a large number of samples simultaneously; elimination of human error to increase accuracy and reliability of results; reduction in labor costs to enable the performance of complex genetic testing.

What's Next?

So, now market has four distinct types of analyzers that can populate a modern molecular diagnostic clinical laboratory to meet the needs of multiple forms of
testing – automated liquid handlers, ease-of-use commercial analyzers; sample-to-result analyzers; and high-throughput systems. Currently, laboratories are observing two new trends:

Consolidation of testing. As many smaller labs are joining forces, and large labs are looking to absorb smaller regional players, there is a need for analyzers to not only be high-throughput but to have sufficient automation to handle the more complex panels and the ability to perform different kinds of tests in the same system.

Rapid point-of-care testing. Many physician offices and small clinics are gearing up to provide rapid genetic testing to their patients. They require analyzers that are fast, easy-to-use, and have small footprints.

However, these new trends reflect the increased rate of adoption of molecular medicine in the clinical lab. Molecular diagnostics is transforming healthcare, and analyzers with novel technologies may soon emerge to push the molecular diagnostics laboratory into yet another stage of evolution.

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


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