IVD, playing a significant role in care continuum

In-vitro diagnostics (IVD) refers to a wide range of medical and veterinary laboratory tests that are used to diagnose diseases, and monitor the clinical status of patients, using samples of blood, cells, or other tissues obtained from a patient. IVDs are a crucial part of modern medicine – laboratory-based tests performed on biological samples provide information that is key for the prevention, treatment, and management of disease. With the increasing focus from cure to prevention, diagnostics is becoming a center point, and is increasingly performed in wellness and disease prevention.

The domestic IVD industry is still at a nascent stage. Estimated at USD 9 billion, it is expected to grow at a CAGR of ~15 percent in the next 5 years. As a result, there have been several positive trends in the Indian IVD industry.

With increasing demand for testing volumes, IVD devices manufacturers are keeping up with the pace, along with focusing on innovative diagnostic solutions. Manufacturers, like Transasia, are investing in research for the development of infectious diseases like HIV, TB, hepatitis, etc. Transasia offers rapid test kits for dengue and malaria with a unique dual-color advantage for easy interpretation. Besides this, Transasia has also recently introduced rapid tests for critical infections, such as hepatitis, HIV, HBSAg and syphilis, and Covid-19.

Growth of this industry will primarily be driven by increase in diseases due to the adoption of Western lifestyle, change in demographics, higher income levels among different sections of society, along with rise in preventive testing and expansion of insurance industry. With proposal of around 41 percent to be spent in primary healthcare on diagnostics, the Indian medical diagnostics will play a vital role in prevention and wellness space, which lays the foundation of Ayushman Bharat. Wellness centers, being an important pillar for Ayushman Bharat, the government aims to setup 1.5 lakh such centers across the country.

NITI Ayog has called for making these centers operational by 2022-23 to ensure sufficient coverage and to lower the burden on secondary and tertiary care. The diagnostic industry will play a critical role in making this a reality, while working closely with the government. NITI Aayog, in its recent report, has stated that diagnostic and pathology centers will expand in the times to come and the sector has a promising future. More and more people are opting for preventive diagnosis. Moreover, with people being aware of health concerns and importance of early detection of diseases, the onus is on manufacturers to provide techno­logically advanced systems for labs and home-testing.

The Indian diagnostic industry with over 1 lakh labs is broadly segregated into pathology services and imaging diagnostic services. Pathology testing (in-vitro diagnosis) includes sample collection in the form of blood, urine, and stool. This is followed by sample analysis, using laboratory equipment and technology, to drive useful clinical information for assisting in the patient’s treatment. The imaging diagnosis segment consists of more complex tests like CT scans and MRI and other specialized tests like positron emission tomography (PET) CT Scans.

There are around 2500+ National Accreditation Board of Laboratories (NABL) and/or College of American Pathologists (CAP) accredited labs, which is ~1 percent of total labs in India. However, the number of accredited labs is increasing rapidly, which results in improvement in quality over the years, with more automation. The industry is increasingly opting for accreditation, and deploys some of the best standards like CAP accreditation, NABL, and ISO certifications.

Overall, lab diagnostic industry plays a significant role in care continuum. Along with core objective of diagnosis, the industry offers additional benefits, be it employment generation, availability of specialized tests, improved access, or technological advancement.