Self-testing kits: A diagnostic revolution?

The market for testing kits is rapidly expanding but awareness building, strategic collaborations and accessibility will be key for sustained growth 

In the dynamic landscape of Indian healthcare, a transformative shift is underway through the widespread adoption of self-testing kits.

These kits are altering the landscape of diagnostics by not just reducing the burden on traditional healthcare systems but are reshaping the entire paradigm of diagnostics.

Emphasising on why in a developing country such as ours there is an increase in the demand for cost-effective testing strategies, Dr Anubhav Pandey, Head of the Department of Laboratory Medicine, Amrita Hospital, Faridabad shares, “The developments in medicine and laboratory techniques have dawned a new age era of self-testing kits which has led to the complete change in the outlook of how illness is detected. The modern advances such as immunochemistry and immunodiffusion has led to creation of numerous testing strategies. It has become so rudimentary that without requirement of any basic training, analytes can be tested at the confines of one’s home. There are numerous benefits for self-testing kits such as such rapid and curate test being performed at a short span of time lending a great advantage in clinical management of illnesses.”

Current market scenario of self-testing kits in India

The outbreak of infectious diseases, such as COVID-19, has heightened the awareness of the importance of infectious disease testing. During pandemics and epidemics, there is an urgent need for accessible and convenient testing methods, which self-testing kits can provide.

Dr Rajesh Bendre, National Technical Head & Chief Pathologist Apollo Diagnostics, Delhi mentions, “As the demand for convenient and discreet healthcare options increases in India, more people are turning to self-testing kits as a viable solution. With the traditional healthcare system often crowded and time-consuming, these self-testing kits offer individuals the opportunity to take their health into their own hands. From diabetes monitoring to fertility testing, these kits provide a level of autonomy that is empowering for users. Furthermore, the privacy and convenience that self-testing kits afford cannot be overstated, especially in a country where discussions about certain health issues may still carry social stigmas. By being able to conduct tests at home and receive accurate results without having to visit a clinic or hospital, individuals can overcome barriers related to privacy concerns or societal taboos surrounding certain medical conditions.”

According to TechSci Research recent report, “India Self-Testing Kits Market has valued at USD 551.41 million in 2023 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 8.56 per cent through 2029.”

Talking about the current market scenario, Dr Nilesh Shah, President & Chief of Science & Innovation, Metropolis Healthcare said, “The current market scenario for self-testing kits in India is marked by a nuanced landscape, shaped by various factors. Point-of-care testing (POCT) in the country can be broadly classified into two categories: Type 1, where patients conduct the tests themselves, and Type 2, where small labs administer the tests.”

Dr Shah also shares, “The prominence of self-testing surged during the COVID-19 pandemic due to limited lab access and extended wait times. However, post-pandemic, widespread adoption of self-testing has yet to take firm root in India. Even established self-testing options, such as urine pregnancy kits, have not gained substantial popularity in the Indian market. Key challenges hindering the growth of self-testing in India include issues of awareness and accessibility. In contrast, countries like the UK offer a diverse range of self-testing options, including blood group, cholesterol, and prostate cancer screenings, readily available in pharmacies.”

Primary health spheres addressed by self-testing kits and prospective growth avenues

Self-testing kits cover a spectrum of health concerns, ranging from infectious diseases, some chronic conditions, and preventive care.

Pregnancy kit, glucose monitoring kits, Troponin I, COVID rapid antigen test, Hepatitis rapid test are some of the major therapeutic areas being covered by self-testing kits. The former two are the most commonly and most widely available kits to monitor and test analytes at a much cost effective and rapid manner.

Dr Vikramjeet Singh- Senior Consultant, Internal Medicine, Aakash Healthcare, New Delhi opines that as technology advances and awareness grows, the potential for growth in additional areas within the self-testing kit domain remains promising, further expanding the scope of at-home diagnostics.

Sharing his views on future of these kits, Dr Shilpa Gupta, Associate Director- Pathology, Asian Hospital Faridabad also believes, “These kits may also be compatible with artificial intelligence technologies, which would further make it easier for people to keep a check on their health from home. These developments, which take into account the changing landscape of at-home diagnostics, could improve healthcare monitoring at home.”

Anticipating on the future growth of self-testing kit, Dr Amardeep Singh Kohli, Chief Executive Officer, PSRI Hospital, New Delhi said, “The future growth of self-testing kits is anticipated to expand into new therapeutic areas, driven by continuous advancements in diagnostic technologies. Emerging areas may include cardiovascular health, respiratory conditions, and infectious diseases.”

Accessibility and affordability: Penetration in rural healthcare

Self-testing kits have the ability to transcend geographical constraints. By enabling people to conduct diagnostic tests at home, self-testing kits could bridge the gap between urban and rural healthcare, breaking the geographical barriers.

On accessibility and affordability, Sriram Natarajan, Founder and CEO, Molbio Diagnostics said, “The market has grown in urban areas where awareness of the general population is high. In rural areas, the access to such diagnostic modalities can be increased by equipping ASHA workers with such technologies, or collating various of self-kits in a portable box that can be either hand-held or carried in mobile vans. Many such alternatives are now present in India and other geographies. Information dissemination needs to happen in the vernacular and regional languages to reach the most remote parts.”

The average purchasing power of an urban consumer is higher than that in the rural areas. For self-testing kits to truly penetrate the rural market, it has to be extremely affordable. Use of low cost, adequately sensitive testing technologies that contribute to a highly economic bill of materials is of paramount importance. This would make the end product highly affordable”, he added.

Also, the simplicity and ease of use of these kits can empower rural India to take charge of their health without the need for extensive medical infrastructure. This shift towards decentralised diagnostics can be a pivotal step in transforming the healthcare dynamics of rural healthcare.

Dr Geethu Joe, Consultant Microbiologist, Jupiter Hospital, Pune opines that this shift will be especially significant for the elderly, the crippled, and those confined to their homes because it gives them the required lifeline to independently manage their health

She shares, “Self-testing is not only feasible for patients but also cost-effective for medical staff, generally increasing patient satisfaction and yielding positive outcomes in terms of early detection and preventive care. The accessibility and ease of use of self-testing kits is crucial to the global growth of preventive healthcare.”

Dr Bendre emphasises that self-testing kits are heralded as a convenient way to monitor one’s health, but their accessibility in rural areas presents a significant problem.

He said, “The lack of infrastructure and resources in remote regions often means that residents have limited access to these essential kits. This disparity not only hinders individuals from proactive healthcare but also widens the gap in healthcare inequality between urban and rural populations. Moreover, the reliance on self-testing kits in these areas can lead to misinterpretation of results due to limited education and guidance, potentially leading to improper diagnosis and treatment.”

In addition, the expense of self-testing kits poses a substantial barrier for those living in rural communities with lower income levels. Despite their potential benefits, self-testing kits may end up exacerbating disparities rather than alleviating them by further marginalising vulnerable populations. As such, addressing the issue of accessibility and affordability must be at the forefront of any efforts to expand healthcare access in rural areas. Only through innovative solutions and policy changes can we ensure that everyone has equal opportunities for proactive health management regardless of their geographic location.”

Impact of self-testing kits on preventive healthcare?

Using self-testing kits can be a bit tricky. The effectiveness and how much they cost are important things to think about. These tests need to be affordable, especially when putting together health packages. But some people might see them as pricier than other regular tests. Also, most of these tests tell you if something is there or not, rather than giving exact numbers. Some of the tests that do give numbers might not be perfect for what they’re supposed to do.

India’s self-testing boom while promising for decongesting healthcare systems presents a double-edged sword for preventive care.

Dr Sheela Chakravarthy- Director-Internal Medicine, Fortis Hospital, Bannerghatta Road, Bengaluru opines, “India’s self-testing boom while promising for decongesting healthcare systems presents a double-edged sword for preventive care. Accessibility and convenience undoubtedly empower individuals especially in remote areas to take charge of their health. Early detection of chronic conditions like diabetes or STIs, enabled by kits can lead to timely intervention and prevent complications. However, concerns like test accuracy, particularly for complex diseases, and affordability for resource-scarce populations can compromise effectiveness. Misinterpretation of results or lack of follow-up with healthcare professionals can worsen underlying conditions. Moreover, unregulated marketing and over-diagnosis due to user anxieties fueled by readily available tests pose risks.”

To maximise the positive impact on preventive healthcare, comprehensive government measures are crucial. Stringent regulation of test kits coupled with public education on proper usage and interpretation is vital. Integrating self-testing seamlessly into existing healthcare systems with clear pathways for follow-up care, can ensure early detection translates into meaningful prevention. Ultimately, striking a balance between individual empowerment and responsible use, backed by robust public health policies, will determine whether self-testing kits truly revolutionize preventive healthcare in India.”

Although these kits have the capability of putting more control of the health in the hands of individuals and proactively monitor their health, the effectiveness of these kits can vary, and factors such as cost and the type of tests performed play a crucial role.

While they enhance accessibility, concerns about accuracy and the need for proper follow-up remain, highlighting the importance of informed and responsible use in achieving the full potential of self-testing kits in preventive healthcare.

Stressing on the positive side, Natarajan said, “It would help reduce healthcare costs. It greatly increases the pool of patients opting for active triaging and screening, thereby reducing overall burden on the healthcare system. It will have huge impact on India’s health indices and overall economic productivity.”

Technology integration

The integration of technology in self-testing kits can play a pivotal role in shaping a healthier and more connected future for healthcare in India.

Dr Singh believes that striking a balance between technological innovation and regulatory oversight is essential to harness the full potential of self-testing kits in India’s evolving healthcare landscape and says, “technology integration in self testing kits is an important aspect to enhance their accuracy and make them more reliable for users. Additionally, technological innovations can improve accessibility by ensuring that these kits are user-friendly and easily understandable for individuals with varying levels of health literacy. Moreover, leveraging technology can contribute to affordability by streamlining manufacturing processes and reducing production costs. This, in turn, makes the self-testing kits more economically accessible to a broader population.

While technology integration enhances the overall effectiveness of self-testing kits, it also brings about the need for robust regulatory measures to prevent potential misuse.”

Dr Kohli also said, Technology integration is a key factor in addressing many of the challenges associated with self-testing kits. Advanced technologies, such as artificial intelligence and digital health platforms, can enhance the accuracy of results and improve the overall user experience. Regulatory frameworks should encourage and guide the integration of such technologies, ensuring that they contribute to the effectiveness and reliability of self-testing kits.”

As technology continues to advance, this fusion is also capable of creating a promising chapter in the evolution of healthcare by making diagnostics more accessible but also empowering people.

Dr Mahendra Dadke, HoD-Internal Medicine, Jupiter Hospital, Pune opines, The rapid uptake of self-testing kits in India represents a paradigm shift in healthcare dynamics that releases pressure on established systems. But issues with precision, price, accessibility, and possible abuse highlight the importance of giving it considerable thought. Integrating technology is essential to resolving these issues.”

These kits’ integration of cutting-edge technology can improve accuracy and guarantee consistent outcomes. Technology also helps to increase accessibility, which makes the kits easy to use for a variety of users. By simplifying production procedures, innovations also help to make products more affordable. Harnessing the full potential of self-testing kits in India’s changing healthcare scene requires striking a balance between solid regulatory measures and technical improvements.”

Challenges and regulatory landscape: In need of collaborative approach

One of the primary challenges faced by self-testing kits in India revolves around ensuring accuracy and reliability.

On this, Dr Bendre said, “One of the key hurdles is the lack of clear guidelines and standards for these kits, leading to concerns about their accuracy and reliability. As a result, many consumers are hesitant to trust the results obtained from self-testing kits, hindering their widespread adoption.”

Striking a balance between using digital capabilities for enhanced user experience and ensuring the confidentiality of health data is a complex process which poses another challenge.

Dr Pandey stresses, “There is always a bittersweet aspect of any technology or innovation we humans have come across. In the current fast paced life of ours growth for the sake of growth must not be the lay of the land. Innovation without oversight is a recipe for disaster as it is as same as playing with fire. The proper regulation and proper quality control of every innovation is mandatory as it is going to gravely influence the outcome in their absence. Self-testing kits cannot shy away from these regulations as they must be carefully studied and relevant studies backed by a solid principle is always a must.”

Another significant challenge lies in fostering public awareness and education regarding self-testing kits.

Dr Mohan also believes that lack of trained professionals available to provide counselling and support after using self-testing kits is a challenge. Proper guidance is essential when interpreting test results or understanding further steps that need to be taken based on the results.

Addressing the challenges and navigating the regulatory landscape of self-testing kits in India requires a collaborative approach. All the concerned stakeholders must work together to establish guidelines, foster innovation, and ensure that these kits contribute positively to the broader healthcare ecosystem.

Way forward

While self-testing kits bring transformative potential to healthcare in India, addressing challenges and establishing robust regulatory frameworks is essential. The market for testing kits is rapidly expanding but awareness building, strategic collaborations and accessibility will be key for sustained growth.

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