Medical devices are two kinds- sutures, implants etc. and In vitro Diagnostic kits, Reagents and Instruments. In this article I will be discussing the later part. The Medical Devices Industry includes Rapid tests, Clinical reagents, Haematology, Microbiology, Immunology, Coagulation Reagents, Molecular Diagnostics kits and ELISA Kits. In addition we are dealing with the instruments used for analysing the reagents and kits.

Current market size

It is very difficult to gauge the correct market size of the industry as no proper survey is available. Many available reports are not complete as many markets are still not documented. Many government supplies are seasonal and may not be available for estimation. The Indian IVD Industry market size is estimated to be at Rs. 6000 Crores and may reach Rs. 10000 Rs. Crores by 2020 with a CAGR of 15-20%.

Latest trends

Latest trends in Diagnostics are mainly in the areas of sensor based products. These may be independent with readers or many of them are based on smart phones. Bhat Biotech is working with several projects independently and with other collaborators based in UK and USA. We are working on thyroid hormone estimations based on Smart phone readers (USA) and based on molecular semiconductors (UK). We are also working on Real time PCR based on Impedance and Capacitance.

Major bulky and expensive diagnostic equipment are being replaced with tiny (nano) electronics machineries. With the easy excess for internet tele- diagnostics is taking shape. People can perform the test at home or at POC and consult the doctors for treatment worldwide.

Key players

We can divide the key players in to two sections- one who are real manufacturers and others are mainly marketing companies. Major Multinational companies are Roche Diagnostics, Beckman Coulter, Abbott Diagnostics, Siemens Healthcare, Becton and Dickenson, Qiagen, Sigma Aldrich, Perkin Elmer, Accurex, Bayer Healthcare, Johnson and Johnson, Hitachi, Bio-Rad, BioMerieux Etc. Major Indian companies are, Tulip group of companies (Now a Perkin Elmer Company), J. Mitra and company, Span Diagnostics, Bhat Biotech India (P) Ltd., Trans Asia, Agappe Diagnostics etc. Please see the list in http:// admi-india.org/ for more details. In addition, there are several startup companies ventured into the POC sector, which includes, Neurosynaptic, and Achira Labs.

Products developed and manufactured

Today almost all kind of diagnostic products are being manufactured and sold in India. They may be kits for infectious diseases such as HIV, HCV, HBV, Malaria, Dengue, Chikungunya, etc. or Clinical chemistry reagents and instruments, Haematology reagents and instruments, Immunology Reagents and instruments, Urine chemistry reagents and instruments, ELISA reagents and instruments for a variety of infectious and other conditions, Blood Glucose strips and meters.

Companies who are into exports

Almost all major manufacturing and marketing companies are into export. Our major bottle necks in exporting to developed countries are the regulatory approvals and registrations. The stringent regulations and the regulatory approvals are some of the areas of concern. Even the developing countries in Africa also need the WHO or CE approvals. Another problem in the export to the African countries is due to the competition from China and Korea, who many times sell their products at below cost.

Opportunities

The growth drivers of the Indian IVD market is by the increase in healthcare awareness and demand for quality healthcare and increase in corporate hospitals, and laboratory services, and expansion of diagnostic services to the rural areas.

In a nutshell the outlook is good, in spite of some of the problems which can be solved easily if the government applies its mind.