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R&D and innovation in molecular diagnostics: Challenges & opportunities

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Technology & innovation are two important catalyst in the development of any diagnostic product. While, India is still harnessing the molecular diagnostic sector and coming out with ways to accelerate the need for it, R&D and innovation could be the game changer in this direction and a major learning as well

 The Indian molecular diagnostics industry has been playing a crucial role in the screening, detection and monitoring of various life-threatening diseases. This sector is rapidly evolving and emerged to be a key component of the healthcare segment. Molecular diagnostic tools ranging from polymerase chain reaction (PCR), sequencing, hybridisation, to microarray have benefited the clinicians by providing rapid and sensitive approaches for the screening, detection and monitoring of innumerable genetic disorders, cancers, infectious, and chronic diseases. The pandemic has pushed the sector even more to meet the challenges posed.

Testing & COVID-19

The COVID-19 pandemic has tested the healthcare ecosystem of even the most developed countries. Since the onset of the pandemic, India has been strengthening and expanding its testing strategy as per the changing paradigm which is in line with the scope, need and capacity to rapidly scale-up tests that needs to be performed. The government’s 3Ts strategy of testing, tracking and tracing has played a major role in containment of the virus till now.

The testing rate has been ramped up significantly over the last few months with the introduction of the rapid antigen detection test in addition to the molecular tests, which remain the mainstay of diagnosis. This has accelerated the need, demand and responsibility of the diagnostic sector in India, especially the molecular diagnostic sector which proved to be the backbone, supporting containment efforts to mitigate the outbreak with government’s higher focus on testing.

Highlighting the role of diagnostic sector during COVID-19, Amit Chopra, Managing Director, India and South Asia, Thermo Fisher Scientific said, “COVID-19 has significantly accelerated the need for reliable diagnostic testing, and the adoption of new approaches that are redefining the industry landscape. A more intense second wave and rising concerns related to the mutations are further driving the need for a multi-pronged strategy to strengthen healthcare systems”.

The severity of this crisis and increasing capacity issues associated with polymerase chain reaction (PCR)-based testing, accelerated the development of diagnostic solutions to meet demands for mass testing.

Talking about the acceleration of molecular diagnostic solutions during the pandemic, Hasmukh Rawal, MD & Co-founder, Mylab Discovery Solutions said, “As the COVID pandemic escalated, Indian companies like us indigenised the development of molecular diagnostic solutions, which played an essential role in scaling up the testing capacity in the country”.

Market Watch

As per the report by Markets & Research, “The Indian Molecular Diagnostics Market stood at an estimated 920 million in FY 2020 and is projected to grow at a CAGR of around 10% until FY 2026, predominantly on account of rising cases of fatal and chronic diseases. Moreover, spread of COVID-19 pandemic is expected to create more opportunities, which is anticipated to drive the market growth during the forecast period. Furthermore, government initiatives of raising funds for the country’s molecular department is also expected to positively influence the market in the coming years”.

The report also says, “However, since the department requires high competence and professional skillset, absence of the same can pose a hurdle. Also, with over 25% of the country’s population being below poverty line and the rest of the population is either middle-class or lower middle-class, lack of funds and high cost of molecular diagnostics is also expected to hinder the growth of the market during the forecast period”.

Giving insights on the molecular diagnostic market, Dr Sunita Polampalli, Head-Research & Development and Molecular Genomics, SRL Diagnostics says, “The technological advancements in molecular diagnostics has considerably boosted market growth due to improved accuracy, cost-effectiveness, and portability. Due to these reasons, the molecular diagnostics market has gained prominence and become more profitable lately, and especially so during the COVID-19 pandemic”.

Talking about the molecular diagnostic market, Dr Shantikumar Nair, Director, Center for Nanosciences and Molecular Medicine, Dean Research, Amrita Vishwa Vidyapeetham added, “India’s growth rate in the molecular diagnostics sector is expected to be between 20 and 30 percent compared to about 10% globally.  This is because of the large disease burden in areas such as infectious diseases, diabetes, cancer and aging-related disorders such as Alzheimer’s and Parkinson’s.  The market size that was $ 5 billion USD in 2015 reached about $ 10 billion in 2020 and is expected to be between $ 20 billion USD and $ 30 billion USD in 2030”.

As far as point-of-care testing (POCT) market in India is concerned, it is still at a nascent stage. However, its acceptance is gradually increasing due to greater efficiency as compared to other testing options.

Stressing on the acceptance of point-of-care testing in India, Chopra added,Fast, accurate, and cost-effective point-of-care (POC) COVID-19 tests are set to revolutionise the testing market. Point of care tests are based on a variety of technologies and formats both old and new, like the conventional antigen-based tests for detecting viral proteins; nucleic acid amplification tests (NAAT) and loop-mediated isothermal amplification (LAMP) for the detection of viral genetic material. The volume of point-of-care (POC) testing has risen during the COVID-19 pandemic and there is sustained focus on testing leading to adoption of new and advanced technologies that offer reliable yet faster results”.

The Ken Research report predicts the POCT market to register a positive CAGR of 11.9% in terms of revenue during the forecast period FY’2018-FY’2023.

R&D and innovation in the molecular diagnostics sector in India

Technology & innovation are two important catalyst in the development of any diagnostic product. While, India is still harnessing the molecular diagnostic sector and coming out with ways to accelerate the need for it, R&D and innovation could be the game changer in this direction and a major learning as well. Moreover, the ability to engage in academic research that benefits both society and the sector overall is the greatest benefit for both industry and the research communities.

Talking about the importance of Industry-Academia collaboration in the advancement of the molecular diagnostics sector in India, Neeraj Gupta, Founder and CEO, Genes2me says, “Molecular diagnostics is a growing and challenging niche in health care services. Industry-academia collaborations provide a mechanism to bring disparate sectors together to alleviate the molecular diagnostics challenges of innovations, fundings, reach, engagements, dissemination, and equity.

“With the help of industry-academia collaboration in molecular diagnostics, India has the potential to unleash a new era of innovation in R&D that brings new solutions and develops the institutional capacity of both faculty and students”, he added.

Sharing his opinions on the same, Dr Sam Balu, Head of Genomics, Lilac Insights said, “The connection between academia and industry is very important for the development of the next generation diagnostics methods, especially molecular methods. This includes newer methods of diagnostics whether it is lab based molecular tests such as quantitative fluorescence (QF) PCR based tests or droplet digital PCR in Oncology for analysis of Minimal Residual Disease up to Liquid Biopsy analysis by Next Generation Sequencing (NGS)”.

“This type of collaboration can also lead to development of diagnostic kits as well field-based testing devices for rapid testing and screening; known as point of care devices. Most of these technologies are currently developed in Industrial R&D setup. However, in recent times there have been many devices and tests that have been developed in the academic setting which has been adopted by industry especially in view of the Covid pandemic and its testing”, he added.

Way forward

The pandemic without a doubt has highlighted the role of many aspects of diagnostic sector including strengthening of testing infrastructure in the country and greater focus and push to the industry-academia collaboration and R&D and innovation. While, India is already comparatively active in this direction, there is still a long way to go.

Sharing her views on this, Dr Angeli Misra, Founder and Director, Lifeline Laboratory said, “The lessons leant from the covid pandemic in the field of Molecular Medicine has shown that the diagnostic tests and reagents can be fabricated in a short time. Not only that, we have seen that the instrumentation can be simpler, easily available and user and lab-friendly. Many such equipments do not now require the stringent structural changes needed in the laboratory. Hence, using the technique of molecular diagnostics is possible in smaller and mid-size laboratories, bringing this technology closer to the common man.”

Sharing his opinions on this, Chopra said, “Mitigating the effects of the pandemic is not just the responsibility of the government or healthcare facilities. A collaborative effort between Industry and academia will help in implementing strategies that can improve efficiencies, enhance customer experience, and propel scientific advancements to be prepared for future outbreaks.”

Talking about the way forward, Dheeraj Jain, Founder, Redcliffe Life Diagnotics said, “The country needs to expand its information capability in a way that is encompassing as well as globally competitive. In the light of a developing country like India, innovation can offer a channel to both mount growth and decrease poverty. By applying knowledge in new ways to production processes, more, better, or formerly unavailable products can be produced at prices that all Indians can afford”.

In the process of revolutionising the sector, adoption and invention of advanced technologies will play a crucial role.

Kalyani Sharma

[email protected]

[email protected]

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