Key Details
Building Global Champions: The Asia-Pacific Region’s Next MedTech Wave was released at the 18th CII Global MedTech Summit in New Delhi on 21 August 2026.
India’s manufacturing base: The medical-device Production Linked Incentive scheme has commissioned 24 greenfield plants, with beneficiaries generating exports of ₹6,425 crore.
Trade position: India’s medical-device exports reached $4 billion in FY2025, while imports of high-end electromedical and surgical equipment stood at $5.5 billion.
Regional opportunity: Asia-Pacific currently accounts for approximately $94 billion, or 16%, of the global medical-device market. Demand is projected to reach $132 billion by 2030, growing annually at 6.9% against a global rate of 5.5%.
Innovation gap: Asia-Pacific companies secured around 30% of global US FDA 510(k) clearances during 2021-25, but less than 5% of De Novo authorisations. This indicates greater progress in devices related to existing technologies than in securing pathways for genuinely novel products.
The report covers medical devices, implantable equipment, digital-health platforms and software used as medical devices, but excludes in-vitro diagnostics.
India’s Advantage Lies in Designing for Constrained Settings
The report classifies India’s emerging companies as access-led innovators: businesses that design around high patient volumes, limited infrastructure, workforce shortages and strict affordability constraints.
These conditions can produce technologies with wider global relevance. Portable electrocardiographs and ultrasound systems developed in India for rural or infrastructure-constrained facilities were subsequently introduced in other markets. Indian companies including Poly Medicure and Wipro GE already export to more than 125 and about 70 countries, respectively.
India’s software capabilities provide an additional route to growth. Technology companies support global medical-device manufacturers, while health-AI firms such as Qure.ai earn much of their revenue internationally. Combining these capabilities with domestic component manufacturing could support integrated, software-defined medical devices, rather than continuing to specialise mainly in lower-value production.
Five Gaps Separate Innovation from Global Scale
Gap | Why it matters |
|---|---|
Early and growth-stage capital | Funding is concentrated in mature businesses, leaving clinical validation and translational development underfinanced. |
Regulatory and clinical talent | Companies need professionals experienced in global trials, US and European submissions, and international quality standards. |
Intellectual property | Delayed international patent filings can restrict licensing, acquisitions and market entry even when the underlying technology is strong. |
Commercial infrastructure | Overseas expansion requires physician networks, training, distributors, post-market support and sustained engagement with hospitals. |
Evidence and reimbursement | Regulatory approval permits a product to enter the market; it does not ensure that hospitals or insurers will pay for or adopt it. |
The report argues that these capabilities must be developed before products reach the final approval stage. Retrofitting clinical evidence, quality documentation or patent protection later can add years to market entry.
Indian Companies Can Follow Two Routes Abroad
The evidence-led route starts with clinical trials and documentation designed for demanding markets. Meril Life Sciences followed this approach for its Myval heart valve, combining Indian commercialisation with multinational trials and international expansion.
The local-first route begins with products designed around Indian affordability and infrastructure constraints. These can subsequently enter advanced markets as simpler, portable or more cost-effective alternatives.
Neither route ends with regulatory clearance. Companies must also demonstrate better patient outcomes, clinical productivity or lower total treatment costs—and align their evidence with the reimbursement requirements of each target market.
Policy Relevance
India’s MedTech strategy has successfully expanded production capacity and exports. The next policy layer needs to help companies cross the less visible stages between a working product and repeatable international adoption.
That would mean developing shared multi-site clinical-trial networks, patient registries and regulatory-support centres whose evidence meets international standards. Public funding could be tied to milestones such as trial registration, data quality, peer-reviewed publication and export-ready quality systems—not only factory investment or regulatory filing.
Capital support should address the translational and clinical-development gap, where products are too advanced for research grants but not sufficiently validated for conventional investors. Government-backed funding can be structured to attract private investment rather than replace it.
India will also need deeper pools of specialists in clinical affairs, international regulation, health economics, quality management and global commercialisation. Partnerships with multinational companies can provide training, reference sites and international market access, provided domestic firms retain incentives to build their own technology and intellectual property.
Follow the Full Report Here: Building Global Champions: The Asia-Pacific Region’s Next MedTech Wave