Advances in sampling technology and data analysis are helping make molecular diagnostics more acceptable to clinicians and more easily adopted into their workflow. The field of clinical microbiology is undergoing quick transformation with novel molecular technologies cutting the time needed to diagnose infections, enabling more precise and appropriate individualized therapies, improving patient care and optimizing clinical outcome. This field is on the cusp of the largest change in its history.

Indian Market Dynamics

Buying seems to be passé. The molecular diagnostics industry is a case in point, where in 2014, only one system was purchased, and in spite of a growing market, all others had to be placed. And yet we see new players enter the Indian market.

The Indian molecular diagnostics market is estimated at Rs.91 crore (does not include placed systems) in 2014. Reagents contributed Rs.90 crore and the analyzers a mere Rs.1 crore, which came from five numbers of standalone, real-time PCRs. All other systems were placed. There were placements of 4 numbers of extraction analyzers and 12 numbers of standalone PCRs. This is gradually emerging as an acceptable trend in the Indian medical ecosystem.

Installations included two numbers at NACO, 1 system at Metropolis Hospital, Mumbai; 1 unit at Dr Lal Pathlabs, Delhi; and 1 system at Shah Satnam Ji Speciality Hospital, Sirsa, Haryana.

Abbott Diagnostics, Roche Diagnostics India, and Qiagen India Private Limited are the leading players in the Indian market. LabIndia Healthcare, Bio-Rad Laboratories Inc., and some Chinese brands also have aggressive presence.

2014 saw the entry of Cepheid, with its expanded claims on 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.

Technology Expansion

Molecular diagnostics combines laboratory medicine with the technology and knowledge of molecular genetics and has been enormously revolutionized over the past decades, benefiting from the discoveries in the field of molecular biology. Select key technologies, including polymerase chain reaction and next-generation sequencing, are helping to transform the ability to analyze cancer specimens. As these technological advances become more and more incorporated into routine diagnostic testing, the classification systems are likely to be impacted and the approach to treatment transformed. The routine use of such technology also brings challenges for analysis and reimbursement.

Recombinase polymerase amplification. Isothermal molecular diagnostics are bridging the technology gap between traditional diagnostics and polymerase chain reaction-based methods. These new techniques enable timely and accurate testing, especially in settings where there is a lack of infrastructure to support polymerase chain reaction facilities. Despite this, there is a significant lack of uptake of these technologies in developing countries where they are highly needed. Among these novel isothermal technologies, recombinase polymerase amplification (RPA) holds particular potential for use in developing countries. This rapid nucleic acid amplification approach is fast, highly sensitive and specific, and amenable to countries with a high burden of infectious diseases. Implementation of RPA technology in developing countries is required to critically assess limitations and potentials of the diagnosis of infectious disease, and may help identify impediments that prevent adoption of new molecular technologies in low-resource and low-skill settings.

Next-generation sequencing. Demand has never been greater for revolutionary technologies that deliver fast, inexpensive, and accurate genome information. This challenge has catalyzed the development of next-generation sequencing (NGS) technologies. The inexpensive production of large volumes of sequence data is the primary advantage over conventional methods. Cataloguing all mutations, copy number aberrations, and somatic rearrangements in an entire cancer genome at base pair resolution can now be performed in a matter of weeks. Furthermore, massively parallel sequencing can be used as a means for unbiased transcriptomic analysis of mRNAs, small RNAs and noncoding RNAs, genome-wide methylation assays, and high-throughput chromatin immunoprecipitation assays.

Point-of-care technology. While historically focused on infectious diseases that affect developing nations, molecular point-of-care (POC) has rapidly advanced into other clinical areas. Advances in microfluidics and other instrumentation technologies that can enable development of relatively low-cost platforms and tests that meet the needs of a true POC system are the key technologic factors contributing to the favorable funding climate and interest in developing molecular POCs. Investigators and clinicians anticipate that the current demand in specific markets, most notably infectious diseases, hand-held, inexpensive POC devices, equivalent to currently offered full-size molecular analytical systems, will become available.

"Molecular diagnostics is one of the fastest growing segments of IVD industry. Out of all the current molecular technologies available, nucleic acid amplification technique, more commonly referred to as PCR, is maximally used in Indian IVD industry. Technology-wise, next-generation sequencing (NGS) may revolutionize the IVD replacing the currently used PCR methods. The advantage of molecular-based tests over others is the turn-around time in getting results, apart from high sensitivity and specificity of the tests. A lot of research is on for developing instruments for point-of-care testing, especially in infections and pharmacogenetics. Oncology and prenatal testing of circulating fetal cells in maternal blood are other areas of potential growth of use of molecular diagnostics."

Dr Charu Aggarwal,
Head of Department, Microbiology, Serology, and Molecular Lab,
City X-Ray & Scan Clinic Private Limited, New Delhi

Way Forward

Technological advancements are coming hard and fast in the molecular diagnostics market. The integration of diagnostic methods with advanced IT and data analytics is minimizing the complexity of assays and further analysis. Moreover, the use of nanotechnology for developing molecular diagnostic products will help increase the efficiency of diagnostic methods and results.

In the near future, molecular diagnostics is likely to undergo some developments that will lead to greater adoption in the clinic. The first of these will be the increased use, and mandate by the FDA, of companion diagnostics. The second improvement will be the simplification of the workflow to allow a decentralization or democratization of molecular diagnostics. Within the next 10 years, high-end testing will be adopted for use in many smaller community labs.

The fast pace of such change and the use of smaller, noninvasive samples is helping to move molecular diagnostics forward into the clinic, expanding its diagnostic role into prognosis and treatment. Future progress will be facilitated by developing more actionable readouts for clinicians.

Indian Market Dynamics is based on market research conducted by Medical Buyer in September 2015.

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