With 1,00,000 laboratories and a vast number of hospitals constituting a bulk of the Indian IVD industry, India broadly accounts for one percent of the global diagnostic industry, hardly a fact to be proud of. By 2022, the Indian IVD industry is anticipated to show an exponential growth of 20 percent and clock figures of USD 32 billion by augmenting infrastructural strengths and rolling out key policy initiatives to fast-pace production efforts and derive quick results. The Indian medical diagnostics industry chiefly comprises of In-vitro diagnostics (IVD) and in-vivo diagnostics which are witnessing tremendous growth and changing the paradigms of the business. The growth in key market segments like biochemistry, immunoassays, hematology, reagents, molecular diagnostics, and microbiology or tissue diagnostics is likely to position the Indian medical diagnostics market in the 15-20 percent growth rate range in the near term and earn revenues of around USD 1.7 billion

The IVD sector in the country is chiefly characterized by 70 percent laboratories offering pathology services and 30 percent entities doling out radiology and imaging services. Though domestic players are flexing their muscles and are gearing to provide new-age diagnostic services with path-breaking innovations and strategic investments, multinational companies continue to hold sway over 60% of the domestic IVD market which is expected to grow by leaps and bounds in coming times.

An investor-friendly policy initiative and market-friendly environment to foster sector growth is the immediate need of the hour. The domestic industry is in need of product innovations and adherence to global service delivery standards to give it a sharp edge in a global competitive milieu. Clear cut regulations to ensure operational transparency and strict quality control with periodical checks, improved infrastructure for new-age manufacturing capacities, incentivizing producers through initiatives like tax breaks, building research and development capabilities to audit equipment performances are key pathways to boost the competencies of the Indian medical devices industry.

A rise in healthcare costs, a population becoming sensitized and aware of new-age healthcare products and facility and the escalation of minimally invasive and non-invasive diagnostic practices in determining treatment accuracies have come up as a main reason for the growth of the medical devices industry in India. Hospital laboratories are demanding advanced IVD products which facilitate expansive emergency services and testing innovations to drive the competencies of post-surgical testing. With lifestyle diseases like diabetes on the rise, home healthcare has also emerged as a core consumer of IVD products. The demand for high-end testing capabilities and innovative diagnostic procedures has also made independent clinical laboratories frontline customers of products coming from IVD product manufacturing companies.  

The demand for molecular diagnostic products is likely to witness an upswing with awareness rising among the medical fraternity for the need of accurate screening methodologies and the diagnosis of tumors and complex genetic disorders which are speedily on the rise. The expansive need for point of care (POC) diagnostic technologies has been triggered by urban lifestyles which are a mixture of sedentary habits, chronic diseases which are emerging as dangerous health patterns, poor dietary choices in the form of junk food and the unhindered aping of unhealthy habits seeping into our daily routines. The Indian healthcare market has been growing aggressively as the molecular diagnostics markets witnesses and marked growth and POC products playing a key role in the first line of effective diagnosis.

The increasing choice of point-of-care and the mount in use of diabetes self-monitoring devices will largely drive the market fortunes of home IVD products. Rising important on detection of infectious diseases and therapeutic drug monitoring, cancer testing and cardiovascular diagnosis will pave the path for specifically tailored immunoassay solutions. Speedily increasing cases of ovarian and breast cancer will trigger the demand for particularly outlined cellular analysis reagents and instruments. 

Operational constraints and policy bottlenecks continue to spoil the efficacies of the Indian IVD sector, which continues to display nascent characteristics. Qualified manpower and trained personnel are in alarming paucity in the country at a time when there is a dire needed to roll out innovatively developed histological and molecular tests.  The country faces a startling paucity of trained workforce equipped to operate a host of advanced histological and molecular tests. With a view to approach the technological competence of laboratory resources, new automation tools have been launched, to obliterate human error in critical diagnostic procedure and higher precision levels. Automation is rising as a pivot along which sample analysis and testing will be handled in histology, microbiology, hematology and blood banks. Widen aims for automation will lead to reinforcement in the sector with the setting up of huge amplitude laboratories will enable large-scale testing procedures.  Analytical procedure across the diagnostic range comprising diabetes, infectious diseases and HPV will be increasingly automated. 

There is a robust need to create a sustained technology policy framework through propelling of innovation and allocation of resources for fast-pacing the development of the IVD sector. The advanced diagnosis technology model needs to be planned which will ensure that advance healthcare is available to the population. A quality system check and balances need to be instituted for regulating the quality of diagnostic exam with the setup of a strong regulator. The government also needs to incentivize public-private partnership to encourage R&D in the IVD sector and fund the setting up of IVD start-ups which can expedite product innovation.

Find the below statistic and healthcare market details on India, specific details on the medical device and industries.

Overview of medical device industry: The Indian medical device market has been marking steady commercial growth. Valued at approximately USD3.5 billion in 2015, it could scale the expansionary curve to record growth figures of USD 4.8 billion by 2019. India's economic, healthcare, and social landscapes evolve, its medical device industry rising as a promising opportunity for foreign manufacturers.

Opportunities in the Indian market: India mostly depends on imports to supply its healthcare system with medical technology. Demand for advanced, high-tech medical equipment and devices has been the marked apex of the medical tourism and luxury healthcare segments which are among India's fastest-growing industries. There is regular demand for surgical instruments, orthopedic and prosthetic equipment, cancer diagnostics, imaging, orthodontic and dental implants, and electro-medical equipment.

Industry challenges in India: Only certain product categories come under the purview of the medical device regulation mechanism in India. A significant business obstacle presents itself for foreign manufacturers of regulated device types in the form of an underdeveloped regulatory framework. The pressure for manufacturers competing with low-cost Chinese products is severe especially with a weak rupee making it difficult for some medical device companies to remain profitable in the market. Also, international manufacturers will also encounter significant competition from American, European, and Japanese companies.

A report by Deloitte has stated that the Indian medical devices industry is expected to record a growth rate of USD 25-30 billion by 2025.

Indian companies are expected to exhibit a more credible business outlook on the global platform with the introduction of the New Medical Devices Bill and the maturity and process driven DNA of some of the companies. 

The manufacturing space in the medical devices sector is still in extremely primary stages and Indian companies could scale the curve with a firm push from the government.  Apart from the cost, the government plans to separate manufacturing of medical devices from drugs from the regulatory perspective could lead to better transparency and a level playing field for medical devices makers. This can raise robust standards ecosystem for the industry, boost national production as well as boost exports, lead to greater foreign investment in the sector and bring in more investments into infrastructure and processes.

Similarly, technology will continue to be the core medium for disruptive innovation, wherein the capacity of the wearables and diagnostic framework to leverage technology can be the basis to provide out-of-the-box, innovative and cost-effective mass healthcare solutions.

These two model will continue to progress parallel to each other with the Medical devices Industry providing fantastic opportunities for convergence in the coming future, both for high-tech and traditional manufacturing, to create innovative solutions for both India and the world.

Emerging start-ups and new-age SMEs have been changing their product portfolios by increasingly marketing specialty surgical devices such as stents, catheters and manufacturing high-end devices and specialized equipment to cater to advanced medical disciplines like Interventional Radiology.  The “Make In India” program is expected to spur the growth of the Indian private sector and is expected to reduce demand burden on imported medical devices products.

Even though manufacturing in the past were limited to producing technology products at the low end of the product chain, the value chain is being speedily scaled by a few Indian domestic companies. These companies are leading the fortunes of the Indian medical devices industry by clinging to a lower cost model of manufacturing specialty device offering superior impact and economies of scale and having the capacity to drive sales by being globally competitive and offering superior market quality.