India’s diagnostic industry: Leading battle against Emerging Infectious Diseases

Collaborative efforts and innovation are crucial to strengthening India’s diagnostic landscape for Emerging Infectious Diseases

Emerging infectious diseases (EIDs) are those that have recently appeared in a population or are rapidly increasing in incidence or geographic range. These diseases pose a significant threat due to their unpredictable nature, potential for rapid spread, and the ability to overwhelm healthcare systems. Recent examples, such as the COVID-19 pandemic, have underscored the importance of early detection and containment.

India, with its vast population, high population density, and diverse ecosystems, is particularly vulnerable to the emergence of new infectious diseases. The country has experienced outbreaks of diseases like Nipah virus, Zika virus, and the re-emergence of diseases like dengue and tuberculosis in drug-resistant forms. Therefore, a robust and proactive approach to disease surveillance and diagnostics is essential.

The role of diagnostics in surveillance and early detection is pivotal in mitigating the impact of these diseases. The diagnostics industry’s innovation, collaboration, and technological advancements have played a pivotal role in identifying and managing these diseases before they escalate into public health crises.

As the country continues to invest in this critical area, it can hope to better protect the health and well-being of its population and contribute to global efforts to prevent and manage EIDs.

Explaining about EIDs, Sudhanshu Srivastava, Chief Business Officer, TRUSTlab said, “According to CDC & the National Institute of Allergy and Infectious Diseases, EID can be defined as outbreak of novel infections which has not been reported in last 3 decades viz. HIV, SARS, MERS Lyme disease, E. coli, hantavirus, dengue fever, Ebola, West Nile virus, and the Nipah, Zika virus, & the latest one SARS-CoV2. Though WHO in 2007 warned about the substantial increase in instances as well as unique strains pathogens, and isolated & assorted steps were taken by individual government which not suffice the need.”

Stressing on the landscape of disease detection, Raghavendra Goud Vaggu, Global CEO, Empe Diagnostics said, “The landscape of disease detection and management has witnessed a revolutionary transformation in recent years, largely owing to the rapid progress in technology. From traditional methods of disease diagnosis that took days or even weeks to yield results, we have transitioned to a realm where real-time data analysis can provide insights in a matter of hours. This acceleration has proved invaluable in the early detection of EIDs, as timely information can prevent their escalation into full-blown public health crises.”

Sanjeev Bhatt, Senior Vice President, Meril Life Sciences said, “In the realm of emerging infectious diseases, India’s diagnostic industry takes center stage, providing a critical shield through surveillance and early detection. Fueled by innovation, collaboration, and cutting-edge technology, this sector serves as a guardian, identifying and managing potential health threats before they escalate into crises. Utilising state-of-the-art tools like POCT and IVDs, healthcare professionals are equipped with preemptive insights.”

This endeavor gains further significance against the backdrop of a challenging reality: a resource gap of over 4 million health workers in the country. With nearly 60 per cent of existing personnel situated in urban areas and 70 per cent of our population residing in rural regions, the delivery and maintenance of healthcare facilities become a formidable challenge in resource-limited settings. POC diagnostic devices emerge as a crucial preliminary step in clinical diagnosis, effectively alleviating the strain on our advanced medical ecosystem. As we journey forward, our unwavering commitment to the nation’s health and well-being remains steadfast.”

India’s diagnostic industry: Championing surveillance and early detection of EIDs

Diagnostics form the foundation of disease surveillance and early detection. In the context of EIDs, diagnostics involve the identification of pathogens, characterisation of their genetic makeup, and the development of tests that can rapidly and accurately detect these pathogens in patients or within the environment. Diagnostics also encompass the development of tools for tracking the spread of diseases and monitoring their evolution.

On this, Animesh Roy, Chief of Healthcare Operations, Even Healthcare shares, “India, though rapidly growing, still has a long way to go before being immune to any future EIDs. Diagnostic companies are expanding fast to remote areas to make tests more accessible, but only ~40 per cent of pin codes are currently operational and capable of doing these tests. Making the existing tests available and more accessible to wider regions would be the first win against EIDs. Fair to say we are on the right track. Compared to other developing countries, India is doing far better, evidenced by our commendable efforts during the last pandemic.”

Dr Avinash Phadke, President & Mentor, Agilus Diagnostics said, “India’s diagnostic industry has played a vital role in the surveillance and early detection of EIDs such as H1N1, Zika, and Nipah virus. Through nationwide screening programs, advanced molecular diagnostics, and specialised virology labs, the industry has enabled rapid containment and treatment. Collaborative efforts with global health organisations have further strengthened India’s ability to respond to outbreaks, ensuring adherence to international standards and facilitating the exchange of vital information. The integration of epidemiological data with diagnostic insights has enhanced disease monitoring and containment strategies, contributing to global health security.”

Through a combination of cutting-edge technologies, extensive networks, R&D investments, and collaborative efforts, the sector has become a vital component of the country’s public health response. As India continues to face the challenges of EIDs, its diagnostic industry will undoubtedly play a crucial role in protecting the health and well-being of its population.

According to the Indian Brand Equity Foundation (IBEF), the Indian diagnostics market was valued at $8.4 billion in 2020, with an impressive compound annual growth rate (CAGR) of 20.4 per cent over the past decade. Dr Shivani Sharma, Vice-President of Pathology Services & Lab Director, CORE Diagnostics consider this growth as a testament to the industry’s commitment to innovation and its critical role in disease surveillance.

She adds, “The impact of India’s diagnostic industry extends beyond the laboratory doors. Timely and accurate diagnoses empower public health interventions that are both targeted and effective. By identifying the presence of pathogens at an early stage, authorities can implement swift containment measures, preventing the spread of diseases and saving resources. A case in point is the successful containment of the Nipah virus outbreak in Kerala in 2018. Early detection and rapid response, facilitated by diagnostic tests, played a crucial role in preventing a widespread epidemic.”

Role of Point-of-Care Testing (POCT) and In Vitro Diagnostics (IVDs) in combating EIDs

Techniques like POCT and IVDs play pivotal roles in tackling EIDs by enabling rapid and accurate diagnosis, surveillance, and management of these diseases. Their contributions are especially crucial in the context of EIDs, which demand swift and effective responses to prevent their spread and mitigate their impact.

POCT and IVDs are indispensable tools in the battle against EIDs. Their combined capabilities for rapid diagnosis, surveillance, and monitoring are crucial in curbing the spread of EIDs, protecting public health, and guiding effective response strategies. As the field of diagnostics continues to advance, these technologies will play increasingly vital roles in safeguarding global health security.

Srivastava highlights, “POCT directly impacts the overall coverage, convenience, and individual inclination to cooperate for testing, helps to achieve higher success rate of objective to provide security to entire community, Population. IVD is the term used for techniques & methods deployed for early detection by PCR, & Rapid Antigen & surveillance via antibody mapping.”

POCT devices are designed to provide diagnostic results quickly, often within minutes, at or near the patient’s location. This rapid turnaround time is invaluable for EID detection, as it allows healthcare professionals to promptly identify infected individuals and initiate appropriate treatment or isolation measures.

POCT can be deployed in a wide range of settings, including remote or resource-limited areas, where access to central laboratories is limited. This capability is critical for early detection and surveillance of EIDs, as it ensures that even underserved populations can be quickly tested and monitored.

Traditional IVDs, used in centralised laboratories, also offer accurate diagnosis but may have longer turnaround times compared to POCT. However, they remain essential for confirming diagnoses, conducting in-depth analysis, and monitoring disease progression.

Roy shares that POCT is a good weapon against EIDs. He said, “since they require minimal investment and effort. POCT can massively help in segregating cases, thereby reducing loads on medical institutions. However, its availability poses a concern. That said, POCTs are generally developed later than IVDs for an emerging pathogen. Therefore, their role in “reducing an EID” is less preventive and more detective.”

Technological advancements and emerging powerful weapon in surveillance and early detection of EIDs

Technological advancements are playing a significant role in driving the early detection of EIDs in India. These advancements have improved the speed, accuracy, and accessibility of diagnostic tools, allowing for more rapid and effective responses to disease outbreaks.

Experts talks about some key technological advancements and emerging tools that are shaping early detection efforts in India

Phadke shares, “Technological advancements such as Next-Generation Sequencing (NGS) for HIV drug resistance monitoring, AI-driven platforms for TB radiological interpretations, and genomic assays for drug-resistant Typhoid are revolutionising early detection. These technologies provide detailed insights into the nature and behavior of infectious agents, enabling targeted interventions. The integration of these advanced tools ensures a more proactive and precise approach to infectious disease management, contributing to public health resilience.”

Dr Kirti Chadha, Chief Scientific Officer, Metropolis Healthcare also believes that NGS and Polymerase Chain Reaction (PCR) are emerging as powerful technologies in the surveillance and early identification of EIDs. NGS enables rapid and thorough genetic sequencing of pathogens, allowing for the identification and characterisation of new bacteria. PCR, on the other hand, allows for the highly sensitive detection of specific DNA or RNA sequences, which aids in quick pathogen identification. These techniques enable scientists to quickly identify and track EIDs, allowing them to take proactive efforts to limit their spread. Furthermore, serological techniques that detect antibodies in blood samples help to monitor immunity and estimate the incidence of EIDs. By enabling precise and prompt reactions, the integration of these new diagnostic technologies improves worldwide readiness against the threat of EIDs.

Dr Sharma considers Rapid antigen tests and multiplex PCR panels as the emerging powerful tools for EID surveillance and early detection. She added, “Rapid antigen tests offer quick results and are suitable for mass screening, while multiplex PCR panels allow simultaneous detection of multiple pathogens, saving time and resources during outbreaks.”

Talking about Cutting-edge tools, Dr Chadha said, “The substantial developments in surveillance and diagnostics that have been achieved demonstrate that the incidence of EIDs and REIDs has increased considerably over the last few decades. These developments improve the detection of outbreaks and facilitate the early implementation of response measures. Certain geographic areas such as Asia, tropical Africa, and Latin America are more likely to experience EID and REID events. EID and REID events have diverse potential to give rise to epidemics and pandemics, and their association with critical illness, adverse health outcomes, and the need for isolation measures is variable.”

Chander Shekhar Sibal – Senior Vice President & Head of Healthcare Division, FUJIFILM India opines that by harnessing modern technologies to create sophisticated surveillance systems, India’s diagnostic industry has laid a solid foundation for a robust response to emerging infectious diseases. He added, “effective disease surveillance forms the bedrock of robust public health responses. India’s diagnostic sector acknowledges this imperative and is investing in the enhancement and expansion of surveillance systems so that potential outbreaks can be swiftly identified and addressed, thereby preventing their escalation. Advancements in current technologies have given rise to novel applications like point-of-care, direct-to-consumer testing, and over-the-counter testing. This fusion of cutting-edge technology, collaborative partnerships, and pioneering research positions India’s diagnostic sector at the forefront of the global fight against impending challenges.”

Vaggu opines, “India has recognised the potential of technological advancements in disease surveillance and the diagnostics industry in India has responded to this challenge with remarkable innovation and collaboration. Advanced molecular techniques, like PCR and gene sequencing, have revolutionised the identification of pathogens. These techniques allow scientists to quickly analyse genetic material, enabling the accurate detection and classification of infectious agents. Moreover, the integration of data science and Artificial Intelligence (AI) into disease surveillance has been a game-changer. Through the analysis of vast datasets, these technologies can identify patterns and anomalies that might not be evident to the human eye. This not only expedites the identification of potential outbreaks but also aids in predicting disease spread and severity, enabling proactive measures.”

Dr Gunisha Pasricha, Principal Scientist, Infectious Disease Expert, MedGenome also shares, “Many innovative technologies, ranging from liquid biopsies and single-cell sequencing to AI-driven diagnostics and CRISPR-based tests, offer unprecedented insights into disease detection, biomarker discovery, and personalised treatment. Leveraging the capabilities of mass spectrometry imaging, metagenomics analysis, and advanced biomarker platforms, these tools are advancing our understanding of diseases, enabling early interventions, and guiding the development of targeted therapies.”

One of these important diagnostic tool Liquid biopsies involves the analysis of circulating biomolecules such as DNA, RNA, and proteins found in bodily fluids like blood. They offer a minimally invasive way to detect and monitor diseases, including cancer, by identifying genetic mutations, tumour markers, and other relevant biomarkers.”

Challenges and journey ahead

The diagnostic landscape for EIDs in India faces several significant challenges that impact the early detection, monitoring, and management of these diseases. Addressing these challenges is crucial to strengthening the country’s preparedness and response to EIDs.

Limited access to advanced diagnostics, resource constraints, including shortages of skilled personnel, laboratory infrastructure, and funding, pose significant challenges. Many healthcare facilities in India lack the necessary resources to establish and maintain advanced diagnostic capabilities.

Dr Sharma opines that despite advancements, challenges persist. She added, “limited access to advanced diagnostics in rural areas, regulatory hurdles, and the need for continuous innovation are among the challenges faced by the diagnostic industry. Looking ahead, investments in research and development, strengthening healthcare infrastructure, and promoting public-private partnerships will be crucial in enhancing India’s diagnostic capabilities for EID surveillance and early detection.”

Talking about the journey ahead, she said, “As the world grapples with the ever-present threat of EIDs, India’s diagnostic industry stands as a beacon of hope and progress. The sector’s ability to harness technology, leverage data, and drive targeted interventions has positioned it as a global leader in disease surveillance and early detection. The remarkable growth trajectory, coupled with the tangible impact on public health outcomes, underscores the industry’s indispensable role in safeguarding communities, both in India and beyond.”

Phadke shares, “Challenges in the diagnostic landscape include disparities in rural healthcare infrastructure affecting diseases like tuberculosis, regulatory complexities in diagnostic approvals for emerging infections, and skilled workforce shortages in specialised areas like virology. However, national initiatives and public-private partnerships are fostering innovation and collaboration to overcome these challenges. The journey ahead is promising, with continued technological advancement, collaboration, and a focus on quality and patient-centric care. The diagnostic industry’s commitment to these principles ensures that we are well-positioned to face future challenges and continue to make significant contributions to global health.”

Effective data management and reporting systems are essential for monitoring disease trends and outbreaks. However, India faces challenges in data integration, real-time reporting, and data sharing among healthcare facilities and public health authorities.

Emphasising on the management of vast data, Dr Pasricha said, “Challenges encompass the management of vast data that is generated, requires robust storage capacity, and skilled resources and finances to extract meaningful insights while ensuring data protection. However, looking forward, the journey entails advancing precision medicine, leveraging population genomics for public health, harnessing AI and data science, enhancing early detection and prevention, innovating in therapeutics, and empowering patients with their genetic information. By seizing these opportunities, we can reshape healthcare with a profound understanding of genetics on health through cutting-edge diagnostics, thus charting a transformative path forward.”

Public awareness of the importance of early diagnosis and the existence of diagnostic facilities is often low, particularly in rural areas. Additionally, stigma associated with certain EIDs can deter individuals from seeking testing and treatment, hindering early detection efforts.

Collaboration between various stakeholders, including government agencies, research institutions, private diagnostic companies, and international organisations, is essential for a comprehensive response to EIDs. Ensuring effective coordination can be challenging due to bureaucratic hurdles and differing priorities.

Dr Chadha mentions, “EIDs pose ongoing challenges that demand a strategic approach to manage spread of such diseases. The response should be based on a multifaceted approach, which integrates different disciplines and sectors, including veterinary medicine, biology, epidemiology, immunology, human medicine, public health, behavioral and communication science, anthropology, sociology, psychology, education, and others. Focusing on preventive strategies and policies, especially in developing countries where resources are limited, along with strengthening surveillance, rapid risk assessment, and risk communication are of paramount importance.”

Newer epidemiological surveillance tools, such as artificial intelligence and wastewater surveillance, the evolution of rapid, multiplex, and easy to use diagnostics, and the prompt development and evaluation of novel therapeutics will help. In addition, speed in producing safe and effective vaccines against as during recent pandemic for the novel virus can save more lives.”

The rapid evolution of pathogens and the emergence of new variants, as seen with COVID-19, can pose challenges for diagnostics. Ensuring that existing diagnostic tests remain effective against new strains requires ongoing research and development.

Also, deciding where and how to allocate limited resources for diagnostics during an EID outbreak can be a complex task. Balancing the need for widespread testing with resource constraints is a continuous challenge.

Talking about the collaborative nature of modern diagnostics, Vaggu said, “Public health agencies, research institutions, and private sector entities are joining forces to pool their expertise and resources. This interdisciplinary approach has facilitated the quick development of diagnostic tools, such as rapid antigen tests and point-of-care devices, which can provide results within minutes. Such tools are particularly vital in resource-limited settings, where timely detection can make a substantial difference.”

Furthermore, the diagnostics industry’s commitment to continuous research and development has led to the creation of innovative surveillance systems. These systems amalgamate data from various sources, including clinical laboratories, hospitals, and even social media, to detect early signs of disease outbreaks. By identifying unusual spikes in cases or symptoms, these systems offer an invaluable tool for early intervention. As the world grapples with the complexities of global health security, the strides made by the Indian diagnostics sector stand as a beacon of hope, ushering in an era where data-driven early detection is a formidable shield against the threat of EIDs”

Addressing these challenges requires a multi-pronged approach that involves investment in healthcare infrastructure, workforce training, quality control measures, and public health education. Collaborative efforts among government agencies, healthcare institutions, researchers, and international partners are crucial to strengthening India’s diagnostic landscape for EIDs.

diagnosticsdisease outbreakEmerging infectious diseasesScreening
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