POC diagnostics hold immense potential in transforming healthcare accessibility in India, provided there are clear regulatory pathways, optimal infrastructure investment, and stringent quality control measures
In recent years, the healthcare landscape in India has witnessed a paradigm shift towards more accessible, efficient, and patient-centric diagnostic solutions. Among these advancements, Point-of-Care (POC) diagnostics stands out as a transformative technology with the potential to revolutionise healthcare delivery across the country.
Current state of POC diagnostics in India
Markets and Markets report says, “The size of global point of care diagnostics market in terms of revenue was estimated to be worth $49.7 billion in 2023 and is pois to reach $77.8 billion by 2028, granting at a CAGR of 9.4 per cent from 2023 to 2028. The key factors driving market growth include the rising incidence of infectious diseases such as influenza, HIV, tuberculosis, moreover, favourable government policies promoting the adoption of POC testing, rising CLIA-waived point of care tests, and shift towards healthcare decentralisation are some of the major factors contributing towards the growth of market during the forecast period.”
“However, the rising pricing pressure on these devices due to reimbursement cuts, and the stringent regulatory approval processes for commercialising POC products is expected to restrain market growth during the forecast period. Point of Care Diagnostics Market.”
Talking about the current state of POC diagnostic market, Pritam Kumawat, Founder and CEO, Sanskritech Smart Solutions said, “The current state POC diagnostics in India reflects a promising landscape marked by increasing adoption of new technologies. There is a noticeable shift towards POC testing, especially in remote and underserved areas. The demand for rapid and on-the-spot diagnostics is driving the increased adoption of POCT.”
Venkata Suman Cherukuri, MD and Chairman, TRUSTlab Diagnostics also shares, “The current state of POC diagnostics in India reflects a growing adoption of this technology, particularly in addressing the challenges of accessibility and timely healthcare delivery. POC diagnostics have gained traction due to their ability to provide rapid, accurate test results at or near the site of patient care. This is particularly crucial in India, where remote and underserved communities often face barriers to accessing centralised healthcare facilities. While progress has been made in deploying POC tests for diseases like HIV, malaria, and tuberculosis, challenges such as infrastructure limitations, regulatory hurdles, and ensuring quality assurance remain areas of focus for further development and expansion of POC diagnostics in India.”
Dr Nilesh Shah, President & Chief of Science & Innovation, Metropolis Healthcare opines that one of the remarkable aspects of POC diagnostics is its ability to transcend geographical barriers. It enables testing in locations where traditional lab setups are impractical or unavailable, ensuring broader access to diagnostic services. This ease of adoption has fueled a surge in demand for POC testing within the diagnostic industry, making it an increasingly pivotal field today. In this transformation, POC diagnostics play a crucial role as key facilitators. By bringing testing closer to patients, they reduce turnaround times and enhance patient outcomes, thus reshaping the landscape of healthcare delivery.
Sharing some stats, Dr Sohini Sengupta, Medical Laboratory Director, Redcliffe Labs and member of POCT Committee of the International Federation of Clinical Chemistry & Laboratory Medicine (IFCC) emphasises, “With its huge population, India has a resource gap of over 4 million health workers. About 60 per cent of the existing personnel work in urban areas, whereas 70 per cent of the Indian population lives in rural areas. This scenario makes accessibility of diagnostics challenging in resource-limited rural areas. This is where POCT can help India by reducing the burden on the medical ecosystem. With a rapid increase, the POC diagnostics market was estimated to advance at a compound annual growth rate (CAGR) of 9.3 per cent from 2013 to 2018 and is expected to grow at 11.9 per cent CAGR during 2018–2023 worldwide. While the use of POCs has gained momentum in India, the country provides a huge market potential for POC diagnostic devices, particularly in the future, particularly in the case of non-communicable and infectious diseases.”
“If we talk about sales, the fiscal year 2020-21 has been a boom so far. People now have increased awareness, and the market is expected to grow by a CAGR of 17.3 per cent between 2022 and 2027, which will bring the evaluation of the POCT market in India closer to approximately 11,000 crores.”
Significance of POC diagnostics in improving healthcare access
The significance of POC diagnostics can be understood through various dimensions including accessibility and convenience, rapid results and early intervention, cost-effectiveness, empowerment of healthcare providers, support for national health initiatives and integration with digital health solutions.
Through POC diagnostics, testing is done at the patient’s location such as a remote village, community health center or even a patient’s home. By reducing the distance that patients have to travel for medical assistance, POC diagnostics can greatly improve access to healthcare.
Minimising expensive laboratory infrastructure and reducing the number of hospital visits are the ways through which POC diagnostics help to cut down healthcare costs. This is very useful for low-income populations who may refuse to go for necessary tests due to financial problems. Furthermore, early detection and treatment of diseases can avert complications hence decreasing long term health care expenses.
Sharing his views on this, Dr Shah said, “The significant increase or improvement in access is most noticeable in tier 3, tier 4, or rural areas when utilising POC diagnostics. By conducting prompt and accurate diagnostic procedures at the point of care, POC diagnostics eliminate the need for patients to travel from remote locations to centralised facilities, thus enhancing healthcare accessibility, particularly in rural and underserved areas.
For instance, in Gujarat, where numerous pockets exhibit a high prevalence of sickle cell anemia, POC diagnostics have facilitated the screening of over a crore population. This achievement, which would have been unfeasible with traditional lab tests, underscores the reliability and utility of POC diagnostics for mass screening initiatives.”
Rapid result delivery by POC diagnostics hastens decision-making and early intervention. This is crucial for acute ailments and communicable diseases where prompt diagnosis can remarkably improve patient outcomes, as well as halt disease propagation. For instance, rapid testing for diseases like malaria, tuberculosis, leprosy, and COVID-19 has been instrumental in managing outbreaks and giving instant care to the concerned populations.
Also, POC diagnostic tools put right into the hands of local health care providers, such as community health workers and nurses, the ability to carry out fundamental diagnostic tests. This decentralisation of diagnostic services strengthens the primary healthcare systems for wider coverage and better resource utilisation in public health programmes
On this, Deepak Sahni, Founder, Healthians shares, “Given the scarcity of healthcare professionals relative to the growing population, the development of POCT devices is paramount. These devices empower non-specialised personnel and individuals to conduct essential diagnostic tests swiftly, easing the burden on healthcare professionals and infrastructure.”
Latest technological innovations driving the evolution of POC diagnostics in India
Technology integration enable collecting data in real-time, remote monitoring, telemedicine consultations, extending healthcare services and enabling continuous patient management. These types of innovations have great potential to improve rural healthcare delivery (e.g., portable diagnostic devices, telemedicine systems).
Dr Nanda Kachare, Head of Department of Pathology & Laboratory Medicine, Jupiter Hospital, Pune stresses, “POCT devices are becoming smaller and more precise thanks to technological advancements including better instrumentation and the downsising of electronics. To increase comfort, speed, and accuracy, some examples of state-of-the-art POCT techniques include blood gas analysis, microneedles, urine strip tests, and microfluidics. “
“There are several recommendations available for different subsets of POCT, such as the World Health Organization’s (WHO) ASSURED recommendations. WHO has suggested that affordable, sensitive, specific, user-friendly, robust, equipment-free, and delivered (to the end user) referred to by the abbreviation ASSURED are the essential elements of an effective POCT.”
Dr Divya Kant, Consultant –Radiologist, Asian Hospital Faridabad, “Advancements in biosensors and bioanalytical techniques are revolutionising point-of-care testing (POCT) devices, promising improved accuracy, and reliability in diagnostics. These novel biosensors, offer highly sensitive and specific detection of analytes, facilitating rapid and precise diagnostics at the point of care.”
Kumawat shares that the integration of biosensors and nanotechnology has further enhanced the capabilities of POCT devices, enabling rapid and sensitive detection of biomarkers associated with various diseases. Biosensors utilise biological molecules or synthetic receptors to detect specific analytes in biological samples, offering high sensitivity and specificity. Nanotechnology-based assays leverage nanoparticles’ unique properties to enhance diagnostic test performance, such as amplifying signal detection or enabling multiplexed analysis of multiple targets simultaneously. Recent advancements in the field of biosensing technology, microfluidics, and paper-based diagnostics will improve the quality and efficiency of diagnostics.
Challenges hindering the widespread adoption of POC diagnostics in India
While POC diagnostics hold great potential for improving healthcare access in India, several challenges hinder their widespread adoption.
The regulatory landscape for medical devices and diagnostics continues to change in India. Also, complicated regulatory requirements can prevent new POC diagnostics tools from getting their approval and entry into the market.
Dr Harpreet Kaur, Senior Consultant & HOD-Lab Services & Blood Centre, Aakash Healthcare, New Delhi explains, “The regulatory framework is a little complex and can cause delays in approvals. However, with the rise in the demand and more awareness processes are getting established. Streamlining regulatory processes, investing in healthcare infrastructure, and training programs, promoting quality assurance mechanisms, and exploring innovative financing mechanisms to improve affordability and access to POC testing services is the need of the hour.”
Dr Shah believes that maintaining quality assurance standards in POC diagnostics poses a significant challenge.
He said, “Variations in testing conditions and operator skills can compromise the reliability of results. However, depending on the adopted tool, the reliability level of POCT is notably high. While using POCT solely as a screening tool, concerns arise regarding false negatives, but false positives are deemed acceptable as they can be confirmed through further testing. This quality concern is one of the primary challenges faced.”
In many parts of India, especially rural and remote areas, there is inadequate infrastructure to support the use of advanced POC diagnostic tools. Issues such as unreliable electricity supply, lack of internet connectivity, and insufficient healthcare facilities can impede the effective deployment and use of these technologies.
According to Dr Aakaar Kapoor, CEO and Lead Medical Advisor, City X- Ray & Scan Clinic, While POC diagnostics have positively impacted healthcare, issues related to equitable access, energy sustainability, and scalability across diverse populations and geographies need to be addressed. For POC diagnostics to be widely and successfully adopted in the medical system of India, efforts in the areas of setting up the infrastructure, designing policies, and technology are necessary.
Dr Rajesh Bendre, National Technical Head & Chief Pathologist Apollo Diagnostics, Mumbai also shares, “The challenges hindering the widespread adoption of POC diagnostics in India are multifaceted and deeply rooted. Regulatory hurdles, such as lengthy approval processes and complex compliance requirements, often act as a barrier for manufacturers looking to introduce new technologies into the market. Infrastructural constraints, including inadequate healthcare facilities, limited access to electricity, and a lack of trained personnel to operate POC devices cause further issues. There should be norms for test validation and compatibility with existing lab-based technologies. Aligning and establishing the medical decision limits on POC requires larger comparative studies with already established lab based technologies.”
Effective use of POC diagnostics requires trained personnel who can operate the devices, interpret results accurately, and maintain the equipment. There is a significant gap in training and skill development among healthcare workers, particularly in rural areas. Continuous education and training programs are necessary to ensure that healthcare providers can effectively utilise POC diagnostics.
Collaborative efforts at each level of the ecosystem is crucial to overcome the current challenges.
Highlighting the role of collaboration for better quality assurance and standardisation, Dinesh Chauhan, CEO, CORE Diagnostics said, “Collaboration among accreditation bodies, manufacturers, and healthcare professionals is essential. Robust quality control mechanisms for POC devices, along with standardised protocols for calibration, maintenance, and performance evaluation, ensure accurate and reliable results. Trust in POC diagnostics builds confidence among patients and clinicians.”
He added, “NGOs, community health workers, and educational institutions can collaborate to raise awareness about POC benefits. Emphasising early diagnosis and timely treatment through POC devices is crucial. Proper training of healthcare workers ensures effective utilisation of these technologies.”
Sahni also believes that, “Quality assurance concerns outlined by ISO 22870 underscore the necessity for rigorous standards in method performance verification, staff competency, and continuous improvement. Addressing these barriers requires collaborative efforts from policymakers, healthcare professionals, and technology providers to ensure effective integration and utilisation of POC diagnostics in India’s healthcare ecosystem. Overcoming these challenges is essential to realise the potential benefits of POC diagnostics in improving healthcare access and outcomes nationwide.”
According to Cherukuri, “Government-industry partnerships can streamline regulatory processes and incentivise innovation. Healthcare provider involvement is crucial for integrating POC technologies into existing workflows and ensuring quality assurance. Collaboration with academic institutions can drive research and development of affordable and accurate POC devices tailored to India’s needs. Additionally, partnerships with non-governmental organisations can extend POC testing to underserved communities. To capitalise on opportunities, stakeholders must invest in infrastructure, training, and public awareness campaigns. Leveraging digital platforms for telemedicine and data management can enhance accessibility and efficiency. “
Future outlook of POC diagnostics in India
Experts believes that the future outlook for POC diagnostics in India is promising
According to Manav Teli, Executive Director, Lord’s Mark Industries, the possibilities for POC diagnostics in India are good. As healthcare costs and life expectancy increases, there will be a greater demand for accessible and affordable diagnostic options. Rising income levels and knowledge of preventative testing are likely to drive up demand, especially in underprivileged areas. Furthermore, technological breakthroughs like as AI and IoT will drive industry innovation, making POC diagnostics more precise and efficient than ever before.
Finally, POC diagnostics have the potential to transform healthcare in India by providing a path to increased access, cost, and treatment quality. By solving implementation issues and impediments and leveraging technology breakthroughs, we may realise the full promise of POC diagnostics, altering the healthcare landscape for future generations. As we welcome these advancements, let us maintain our commitment to guaranteeing fair access to healthcare for all, regardless of geography or socioeconomic background.”
POC diagnostic hold immense potential in transforming healthcare landscape in India, provided there are clear regulatory pathways, optimal infrastructure investment, and stringent quality control measures.
Kalyani Sharma
kalyani.sharma@expressindia.com