Navigating the future – Prospects and policies shaping the MedTech & IVD industry in India

India’s MedTech and IVD (in vitro diagnostics) sector is charting a course for remarkable expansion, with projections indicating growth from a valuation of USD 15 billion to USD 50 billion by 2030. This is growing at a compound annual growth rate (CAGR) of 28 percent, driven by increased government policy, growing infrastructure capabilities, and rising healthcare spending, expected to increase from 3.6 to 6 percent of GDP. This sector’s evolution is further driven by an ageing population, increasing lifestyle-related health issues, and the rising demand for accessible and advanced healthcare solutions. As we explore the intricate web of governmental initiatives, the regulatory landscape, and the standards shaping the industry, we venture into a narrative of strategic development, challenges, and the undoubted potential that the MedTech/IVD industry holds in India.

Government policy
The Government of India is making strategic forays into the MedTech landscape with policies designed to stimulate innovation and growth. The National Medical Device Policy 2017 is a cornerstone of this strategy, offering many incentives to position India as a global manufacturing epicenter. The policy is complemented by the production-linked incentive (PLI) scheme, which propels financial incentives for domestic manufacturing of high-value medical devices. Along with establishing MedTech parks, this scheme aims to foster a conducive environment for MedTech companies by providing access to world-class infrastructure and research facilities, incentivizing innovation, and ensuring a robust supply chain.

Regulatory scenario
The CDSCO is at the helm of India’s regulatory domain, with a mandate to ensure that medical devices entering the market meet stringent safety and efficacy standards. The organization has been instrumental in overhauling the regulatory process to accelerate approvals while maintaining rigorous oversight. India’s regulatory paradigm is expected to continue evolving, focusing on aligning with international best practices and facilitating a faster route to market for innovative products.

Import policy
India’s MedTech import policy strategically encourages domestic manufacturing while maintaining an open market for critical technologies, not yet produced locally. The balance of this policy supports the growth of an indigenous industry while still participating in the global MedTech economy. This nuanced approach helps protect domestic interests while ensuring India’s healthcare system benefits from international advancements and innovations.

Government spend
The Indian government’s role as a significant purchaser in the healthcare sector shapes the MedTech market landscape. Investments in public health infrastructure and procurement policies favoring domestic products suggest a robust demand for locally produced MedTech solutions, bolstering the domestic industry.

Standards
The BIS ensures that Indian MedTech products are on par with global quality standards. As the sector encounters increasingly sophisticated technologies, maintaining and updating these standards becomes crucial for safeguarding patient safety and sustaining industry growth.

Emerging issues and areas of concern
Despite optimistic growth projections, the industry faces challenges that could impede its trajectory. A prevalent concern is the skills gap in the workforce, particularly in specialized manufacturing and R&D roles. The high cost of innovation, especially in a market sensitive to price points, poses another significant challenge. Furthermore, strengthening the intellectual property regime is essential to secure indigenous innovations and encourage further investment in the sector.

Vision for the next couple of years
In the forthcoming years, several key developments are anticipated to shape the Indian MedTech/IVD industry:

• Domestic manufacturing resurgence. The PLI scheme and other incentives will significantly enhance India’s capacity to produce medical devices domestically.
• R&D proliferation. There will be a pronounced emphasis on R&D, with the government’s support likely to lead to significant advancements in medical devices innovation.
• Export market growth. India’s MedTech sector is expected to expand its global footprint, driven by its cost-effective manufacturing and skilled labor force, increasing its share in the international export markets.
• Technological disruption. The integration of AI, machine learning, and big data analytics is set to disrupt the industry, heralding a new era of intelligent healthcare solutions.
• Advances in preventative healthcare. Driven by the growing prevalence of chronic illnesses and the necessity for efficiently controlling healthcare expenses, the industry is preparing to refocus its attention on preventive healthcare.

Outlook
With the assistance of a favorable governmental climate, rising demand for sophisticated healthcare, and a wave of technological innovation, the Indian MedTech/IVD business is at a critical crossroads. The sector is poised for significant growth but must navigate challenges, including workforce development, cost management, and intellectual property protection. With strategic initiatives and sustained government support, the industry is well equipped to meet the growing domestic healthcare demands and establish India as a prominent player in the global MedTech landscape. The sector’s potential is vast, with opportunities for large corporations and agile startups to innovate and thrive. The industry will likely see a stronger focus on collaboration between various stakeholders – government bodies, healthcare providers, and MedTech firms – to ensure the ecosystem operates synergistically. Such collaborations could lead to advancements in telemedicine, home healthcare, and mobile health applications, which have shown significant promise in reaching underserved populations, and creating a more inclusive healthcare system.
In conclusion, while the Indian MedTech/IVD industry faces its share of challenges, its future is undeniably bright. The next couple of years will be formative, potentially transforming healthcare delivery within India and impacting the global stage. With a strategic focus, continuous innovation, and regulatory diligence, the industry is well on its way to realizing its full potential, providing improved healthcare outcomes for millions, and contributing significantly to India’s economic growth.

(Views expressed are personal)