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Molecular Diagnostics

Increased Acceptance

The steadily growing adoption of molecular diagnostics is enhancing the acceptance level of personalized molecular medicine.

People are facing serious challenges in healthcare from emerging and reemerging diseases. Research in molecular diagnostics has however provided a better understanding of molecular processes affecting human health and diseases, and the tools derived thereof 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.

The practical applications of new molecular technologies are being met by integration of molecular methods with advanced information technology and data analytic methods. The advent of the latest inventions and technologies in accurate detection and quicker screening and the prolific growth in genetic testing have driven the revenues of the Indian molecular diagnostics market in recent years. The increase in number of patients stricken with infectious diseases has further propelled the revenue growth.

Manufacturers are being optimistic about the growth of the diagnostics industry in the country, with the market evolving and concepts of preventive healthcare and monitoring gaining importance. Manufacturers are developing their capabilities and products to ensure that they are playing in all the spaces and keeping in pace with the evolving Indian market. They are trying to create awareness, work on infrastructure, provide tools and working across spectrum of prevention, diagnosis, monitoring, and prognosis. The molecular diagnostics market in India is thus expected to manifest robust growth in the coming years attributing to effective preventive healthcare policies, rapid economic development, and improvement in healthcare infrastructure throughout the country.

Indian Market Dynamics
The Indian molecular diagnostics market is estimated at ₹111 crore in 2016. Reagents contributed ₹100 crore and the balance ₹11 crore is contributed by 4 units of high-throughput extraction analyzers and 8 units of low-throughput extraction analyzers. Additionally 6 units of high-throughput and 4 units of low-throughput extraction analyzers were also placed. Although molecular diagnostics tests are increasingly being preferred and new laboratories and diagnostic centers are being set up, the preference for placements, especially for high-throughput analyzers remains. Roche and Abbott have high-end, closed systems, whereas Qiagen is price competitive and offers open systems.

Reagents continue to be the mainstay and see an increase of about 12–15 percent every year. In India, they are majorly dominated by virology tests, with BBN and HBc reagent packs being the key drivers. Point-of-care is gaining momentum and is expected to be a key driver for next couple of years as the turnaround time for molecular diagnostic tests is critical in detecting infectious agents, in determining a patient’s ability to metabolize a drug or drug class, and in detecting minimal residual disease. These applications would benefit from the development of a point-of-care device for nucleic acid extraction, amplification, and detection.

Global Market
The global molecular diagnostics market is expected to be worth USD 18.9 billion by the end of 2025 as compared to USD 7.1 billion in 2016, reflecting a CAGR of 11.6 percent, predicts Transparency Market Research.

The market is likely to rise against the backdrop of the rising pool of the geriatric population, growing demand for personalized healthcare, and increasing awareness about molecular diagnostics. The market is also expected to grow due to the continuous development in the field of molecular biology. Furthermore, the market will benefit from the increasing investments in R&D of improved molecular diagnostic kits that deliver accurate results.

High prevalence of infectious diseases, such as human papillomavirus and influenza, and various types of cancer are also among the primary driving force for the growth of the market. Prenatal genetic testing, performed for the purpose of early detection of abnormalities that develop in the fetuses of carrier parents, is also expected to widen the client base for the market.

On the other hand, complex regulatory frameworks, budget constraints, the need for high complexity testing centers, and economic turndown are some of the major factors restraining the growth of the molecular diagnostics market.

PCR technology held the largest share in the overall market in 2016. The robust demand for this technology is attributable to its cost-effectiveness in copying or amplification of small segments of DNA or RNA and its high incorporation among researchers and healthcare professionals in the diagnostics space to determine variations that underlie diseases at the genetic level. During the next nine years, the NGS technology is anticipated to showcase rapid growth rate due to its phenomenal throughput, improved speed, and enhanced flexibility, which delivers hundreds of gigabases of data in a single sequencing run. Techniques such as hybridization, microarray, and transcription-mediated amplification are also expected to shine over the years.

The reagents and kits accounted for the largest share of the market in 2016. The accessibility of a wide range of reagents and need for reliable, specific, and faster detection of chronic diseases and genetic disorders at early stages are expected to drive this segment in the future. Moreover, instruments are also being widely preferred by central laboratories and diagnostic institutes due to the nature of these tests that helps in delivering quick and reliable results and the high volume of diagnostic procedures in this segment. Thus, this segment is expected to maintain a constant growth at a CAGR of around 9 percent from 2016 to 2025.

In 2016, North America held the leading share of 39.1 percent in the global market. Presence of a well-established laboratory accreditation system, favorable awareness programs educating patients about early diagnosis, high technology adoption, and the rising healthcare expenditure are the major factors reinforcing the dominance of this region.

Asia-Pacific is also expected to offer several lucrative opportunities to the global market during the next nine years. The demand for molecular diagnostics in the region is expected to be propelled by the rising disposable income among the population, growing concerns about health, rising demand for improved diagnostic technologies employed for the prevention of epidemics, unaddressed clinical needs, and various activities of key players targeting expansion in the region.

The market is highly competitive owing to extensive R&D endeavors undertaken by established players to develop novel, biomarker-based companion diagnostic tests. Unmet needs and the rising geriatric population are estimated to be the key focus areas of the major players in this vertical. They are advancing strategic collaborations with major technology-based companies and diagnostic centers and expanding into the developing regions in an attempt to increase their market share and attain stability. New product developments, venture capital investments, and M&As are other strategic initiatives undertaken by the players. For instance, Danaher Corporation acquired the medical diagnostics company Cepheid in November 2016.

Globally, the key players operating in the global molecular diagnostic market are F. Hoffmann-La Roche, Abbott Laboratories, bioMrieux, Becton, Dickinson and Company, Bio-Rad Laboratories, Danaher Corporation, Siemens, Thermo Fisher Scientific, and Qiagen. As of 2016, F. Hoffmann-La Roche Ltd. dominated the global competitive landscape due to its wide product portfolio and its sprawling presence. Roche was closely followed by Abbott Laboratories and Danaher Corporation in the global market.

Technology Trends
Molecular diagnostics is an integral part of the in vitro diagnostics (IVD) industry and has gained an accelerated momentum in recent years. It represents more than one-tenth of the global IVD market with a growth trajectory secured through platform innovation in lower-cost nucleic acid amplification tests (NAATs) and clinical next-generation sequencing (NGS).

As healthcare becomes more dependent on molecular diagnostic testing, suppliers are continually developing new molecular methods. These include improvements in PCR (polymerase chain reaction), as well as newer amplification methodologies. The rapid improvement in workflow and turnaround time for most molecular tests has thus provided promising results. The newly developed assays are more accurate than before and have the potential to replace many conventional assays. Advancements in technology have also resulted in more user-friendly testing platforms that are automated, have lower risks for contamination, and have the ability to deliver faster results.

Microfluidics. The emergence of microfluidics and nanotechnologies has enabled both new capabilities and instrument sizes practical for point-of-care (POC). They have introduced new functionality, enhanced the sensitivity, and reduced the time and cost involved in conventional molecular diagnostic techniques. Overall, microfluidic approaches to a wide variety of molecular diagnostics applications are developing rapidly. Because of its advantages, microfluidics technology holds the promise for developing molecular diagnostic tests with improved sensitivities, accuracy, turnaround time, and affordability.

NGS. The principle of NGS has remained virtually the same since its introduction, but recent improvements and automation have dramatically increased the speed and accuracy in delivering maximum volume of data. NGS technologies have now far exceeded previous DNA sequencing technologies, both in the breadth of genomic real estate that can be sequenced in a single experiment and in the depth of coverage for each genomic region sequenced, which allows for a superior limit of detection for low-level sequence variants. Labs are moving many molecular assays over to NGS – especially those involving large numbers of variants, whether for a single gene or multiple genes. Pyrosequencing is currently the variant of choice within NGS systems.

NAATs. NAATs are now considered as the gold standard method for diagnostic practices such as screening donated blood for transfusion-transmitted viruses. With recent NAATs, the turnaround time is reduced to 1–2.5 hours, resulting in improved clinical outcomes and reduced hospital cost. Multiplexed NAATs have been designed to detect multiple viruses or subtypes in a single run. Their detection platforms can comprise up to 20 viruses using diversified panels, for example, concurrent detection of HAV, HBV, and HCV infections, as well as co-infections.

PCR. The most widely used variants of conventional amplification are real-time PCR (quantitative PCR) and reverse transcription-PCR (RT-PCR). Both are nowadays becoming benchmarks in assessing the viral load. Among the latest enhancements in PCR systems, extraction, amplification, and detection steps have been combined within one unit. Today, new advances in PCR technology, including more sensitive assays and high-throughput instruments, may further revolutionize healthcare. Digital PCR (dPCR) is an increasingly popular manifestation of PCR that offers a number of unique advantages and is a robust and reproducible approach that could lend itself to supporting accurate diagnostics in the future.

The current state of science is all about customized and evidence-based medicines and as such, the coming years will witness a transformation in the healthcare industry. The diagnostic business in India is all set to witness a movement toward molecular diagnostics. The molecular diagnostics products market is expanding rapidly as they possess higher precision and allow for speedy detection of infectious diseases and genetic disorders at an early stage of development. The Indian appetite for some of the high-tech products is also increasing. The accuracy of molecular diagnostics as well as its high sensitivity, its fast turnaround time, and increasingly easy workflow, as well as recent improvements in the cost-effectiveness of molecular testing are the key benefits that will drive growth in the coming years.

In today’s fast-paced lifestyle people believe that maintaining a healthy lifestyle is important and are now increasingly asserting toward preventive healthcare measures well ahead of time, when the illness has not even manifested. Due to the expensive nature of healthcare, more and more people aim for preventive healthcare to save themselves from heavy financial losses. There are lot of opportunities in preventive healthcare and screening space in the country. And this is going to turn around both diagnostics and healthcare business in India.

Industry Speak

Fluorescence Detection Based POC Diagnostics

Harshad Bhanushali
Product Manager – Instruments
DiaSys Diagnostic India Pvt. Ltd.

The point-of-care testing (POCT) market, first devised more than two decades ago has steadily increased over the last few years since its widespread introduction. These have undoubtedly been refined and improved to deliver easy-to-use devices with incremental improvements in analytical performance. POCT devices can be divided as:

Small handheld devices, providing qualitative or quantitative determination of an increasing range of analytes. These use biosensor strips and lateral flow strips with immobilized antibodies that bind to the analyte detected by reflectance or fluorescence spectrophotometry.
The larger bench-top devices (essentially the laboratory instruments) reduced in both size and complexity. These include critical care analyzers and more recently, small hematology and immunology analyzers.
New emerging POCT devices, which include those that utilize molecular techniques such as PCR to provide infectious disease testing in a sufficiently small device.

This area is likely to grow with many devices being developed and reaching the commercial market in the next few years. Data on the growth of molecular testing market in POCT is interesting in the context of the increase in infectious disease testing. With the emergence of new devices to perform molecular testing at the point of care and the well-documented needs for more infectious disease testing in the developing world, it will be interesting to see the growth that takes place in the POCT market.

Yet there are clearly areas where new technologies are needed in order to deliver the required analytical performance. POCT devices that use PCR to detect a number of different pathogens are just starting to appear and in the next few years we are likely to see a number of these reach commercialization and be used in healthcare markets. Given that the analytical performance of these devices is well-proven, the remaining challenge will be to see if they can be produced at a price which will enable them to have an impact on dealing with infectious disease in developing countries.

QDx Instacheck, marketed by DiaSys Diagnostics India Pvt. Ltd. is a table-top POCT device based on the sandwich immune-detection method used for analysis of various analytes such as hormones, sepsis (PCT), CRP, micro albumin, cancer markers, and cardiac markers. Quantitative results, convenient to use, very low maintenance, and use of universal sampling are some of the attributes that make QDx Instacheck a powerful and superior POCT analyzer.

Industry Speak

Dengue Diagnosis

Jatin Mahajan
Managing Director,
J. Mitra & Co. Pvt. Ltd.

The incidence of dengue has grown dramatically around the world in recent decades. With the monsoon season weaning away from India, dengue cases are likely to increase as the environment becomes more conducive for mosquito-borne diseases. Dengue is a viral disease spread by female mosquito of species Aedes aegypti and, to a lesser extent, Aedes albopictus. Dengue generally presents with flu-like symptoms including fever, headache, body ache, pain behind the eyeballs, petechial rashes, pain in joints etc. Occasionally, the symptoms may develop into potentially lethal symptoms called severe dengue. There is no specific treatment of dengue/severe dengue but early diagnosis and treatment under proper medical care lowers the fatality rate to below one percent.

Dengue fever may mimic other prevalent diseases like Chikungunya, malaria, viral infections, urinary tract infection, leptospirosis, typhoid among others. The emphasis for dengue diagnosis in the recent decade has been on the early diagnosis of the disease so that the patients can be treated accordingly. Detection of dengue NS1 antigen, which is a highly conserved glycoprotein is good marker for detecting the disease on day one of the fever. Detecting dengue on day one is made possible through detection of NS1 antigen in the serum, as antibodies (IgM) develop later during the illness, mostly when the critical phase of the disease has already started. Bleeding and shock occur during the critical phase of the disease, usually when the fever subsides.

WHO recommends dengue NS1 antigen in rapid test format as diagnostic tools for primary, district, and reference centers and dengue NS1 antigen, ELISA test for district and reference centers. Detection of NS1 antigen in the serum from 1 to 5 days of fever has been considered as a confirmatory test by WHO. Serologic testing is the most-prevalent diagnostic method in dengue-affected countries as other techniques require sophisticated equipment and highly skilled technicians. Some companies are contemplating newer techniques like fluorescent immunoassays which will offer higher sensitivities and specificities for dengue NS1 antigen detection. Currently, the availability of tests which detect dengue on day one give an advantage of diagnosing the disease before the patient enters into the critical phase of the disease where platelets and other vital parameters require careful monitoring. Therefore, an early detection of the disease will go a long way in preventing complications in dengue-affected patients.

Sudip Banerjee
National Sales Manager,

The current trend in the IVD market is showing a slowdown in certain segments, however, molecular testing continues to grow in double digits clearly indicating the fact that this is the future.

Organizations now need to focus on the tier II and tier III cities because this is where the major population of the country resides. This is the era to take specialized testing to the common man of India and this will be possible only through awareness and partnerships.

Newer technologies, like short sequencing, are emerging and clearly seem to have a future. It is evident that with healthcare gaining prominence, we can clearly see the need for specialized testing emerging across the country.”


Industry Speak

POCT: The First Line Diagnosis

Pragya Jain
Product Manager
Alere Medical Pvt. Ltd.

The long-term social and economic stability of a country is highly dependent on improved health. In spite of technological advancements, developing countries still struggle with numerous health challenges. Though the burden of diseases is highest in the developing countries, laboratory or medical testing facilities are often limited and inaccessible to most patients, resulting in high mortality rates. The fundamental basis of evidence-based treatment is to find the cause of a patient’s illness. Reliable and accurate diagnostic investigations play a vital role in healthcare decisions, choice of treatment, and achievable survival. Unfortunately, a major aspect in developing countries is that they often lack modern laboratories, fully automated instruments that provide highly reproducible, quantitative, and hence sensitive and accurate diagnostic results. Rural areas often lack access to even basic diagnostic devices and trained personal. The scarcity of running water and reliable electrical services are additional challenges for delivering healthcare in these areas. In order to circumvent these issues the emergence of rapid and easy-to-use point-of-care tests (POCT) can dramatically enhance a physician’s ability to diagnose patients’ diseases rapidly and accurately.

Alere is one of the global leaders in POCT tests for different infectious diseases. Alere Trueline rapid test kit for HBsAg is one of the best offering for detection of hepatitis B surface antigen in human serum or plasma. It is an in vitro immunochromatographic, one step assay designed for qualitative determination of HBsAg. It produces high precision, accurate results within 20 minutes. It is the best screening tool for first line diagnosis of infection in patients with symptoms of hepatitis or for general blood screening. Use of mouse monoclonal antibodies (anti-HBs) to capture human HBsAg makes it more reliable and accurate test. The Trueline rapid test kit for HBsAg can detect HBsAg in human plasma or serum with a high degree of sensitivity. This is only a screening test. All reactive samples should be confirmed by confirmatory test. Therefore for a definitive diagnosis, the patient’s clinical history, symptomatology as well as serological data should be considered.


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