India’s IVD industry has seen rapid changes over the years, and is a critical player in the country’s thriving healthcare marketplace. The spread of COVID-19 caused a massive upheaval in manufacturing and supply chain models. However, it also exposed gaps in care delivery across all sectors, which needs to be addressed. We can now see active participation from public bodies, academic institutes, and research and development organizations to come up with innovative solutions to the healthcare problems prevalent in our country.
India is one of the largest IVD markets in Asia-Pacific, following China and Japan. Reports indicate that the Indian IVD market will grow at a CAGR of 13 percent from 2019 to 2025. Many factors are believed to cause this perfect storm. There has been a rise in chronic, non-communicable and lifestyle diseases, autoimmune conditions, and oncology cases. This is coupled with an increase in the elderly population, which has prompted the patient community to be more aware of preventive health checkups and early diagnosis. The pandemic also shone a light on the threat of infectious diseases and the importance of medical diagnostics, insurance access, and the need for robust healthcare infrastructure.
The Indian government aims to further push this growth by offering production-linked incentive schemes (PLI 2.0). These will enhance the country’s manufacturing strengths by encouraging investment in the IVD sector. The goal is to boost India-based companies that have the potential to grow and scale, using the latest research and technology so that they can break into global supply chains.
Here’s a look at some of the latest trends in medical technology making waves in the IVD industry:
The push toward POCT
COVID-19 was a gamechanger for point-of-care testing (POCT), both in professional and self-testing technologies. By 2025, the global POCT market is expected to display a growth of 11.4 percent.
The idea of new technologies that allow POC devices to produce quality results that can be transferred to information systems or electronic health records from the patient’s bedside is an attractive avenue for diagnostic testing. However, one must keep in mind tests’ costs and data privacy and security when using isolated devices. Indian companies have made headway in the field of POCT medical devices. A recent report published in The Lancet highlighted the invention of the CovidNudge (from TrueLabs), a molecular POCT device used to detect SARS COV-2, through a portable, battery-operated, fully automated quantitative PCR system aptly labelled the laboratory in a suitcase.The move toward molecular testing Molecular diagnostics used to analyze biological markers in genomes and proteomes include microarrays, mass spectroscopy, next-generation sequencing (NGS), polymerase chain reactions (PCRs), and cytogenetics. Globally, the gold standard for COVID-19 testing was identifying the virus particle through RT-PCR tests. However, the increased demand led to the exponential growth of molecular testing, as the applications went beyond just the coronavirus. From infectious diseases (like tuberculosis, hepatitis agents, dengue, malaria, typhoid, and influenza) to testing for cancers and inherited genetic abnormalities, the potential for molecular diagnostics is limitless.
The growth of genomics
With the rise in awareness about congenital and hereditary genetic diseases in urban India, we see more people seeking genetic testing and counselling. This ensures that the gene-based diagnosis will evolve from a niche field to a widely applicable technology to investigate complex diseases, give clues for prevention and guidance for optimized and personalized treatment modalities. Genotype or phenotype correlations and interpretations required the establishment of population-wide sequencing projects for Indian genomes that would help to validate genetic markers for different health conditions. Drawing inspiration from the Human Genome Project, the Indian Department of Biotechnology (DBT) started the Genome India Project in early 2020 to conduct whole genome sequencing and analysis on 10,000 people to develop diagnostic markers for more effective genetic testing.
The smart way to analyze data
In-vitro diagnostics eventually generates a large amount of data from medical devices or analyzers that need to be analyzed and interpreted rapidly and accurately. Digital pathology with whole-slide imaging takes us away from conventional microscopy. The market is expected to expand at a CAGR of over 10 percent by 2026. The adoption of hardware and software solutions has seen faster turnaround times, with good-quality reports delivered through efficient workflows. The possibility of providing expert diagnosis through virtual reporting or telepathology improves accessibility to better care in rural areas.An adjuvant to the IVD industry, but nonetheless an essential factor in its growth, is the use of artificial intelligence (AI) and machine learning. AI-based software has been utilized extensively in the analysis of tissue pathology and is slowly making its way to other lab processes as well. When we envision an AI-enabled program, we look at its ability to formulate a hypothesis based on the patient’s history, clinical findings, as well as the investigations requested to find patterns and arrive at a diagnosis while reducing errors and providing timely therapeutic interventions. There are various factors, excluding capital costs that act as barriers to the implementation of AI-based software. When looking at the flip side of the coin, there is also a valid concern about data security. Recently, this is being addressed with the use of blockchain technology in collecting, analyzing, and storing healthcare data.
These include outdated IT infrastructure, lack of interoperability, network latency or outdated EHRs. The government has also set up an Artificial Intelligence Task Force under the NITI Aayog’s National Strategy for Artificial Intelligence #AIFORALL initiative.
This active promotion of AI-led healthcare initiatives, including those in clinical pathology, may boost the adoption of this technology in the medical industry soon.
The only constant is change…
With new market forces at play, the IVD industry in India is set to grow by leaps and bounds in the near future. However, to attain long-term success, we need to look at some key factors. Will there be a change in global supply chains for reagents? Will the emergence of POCT, home-based tests, and other complementary technologies affect the traditional testing landscape? In these uncertain times, preparation is the name of the game!