MedTech and IVD in India – 2024 in review

At the start of 2024, India’s MedTech and in-vitro diagnostics (IVD) sector set ambitious goals, aiming for innovation-driven growth, deeper market penetration, and greater accessibility across urban and rural regions. As the year draws to a close, it is time to reflect on the progress, milestones, and gaps that still need to be addressed.

What we wanted in 2024

• Increased adoption of point-of-care testing (POCT).
• Vision of AI-driven diagnostics and automation.
• Bridging the urban-rural gap.
• Regulatory streamlining and incentives.
• Public-private collaboration:

What we have achieved so far
Point-of-care testing (POCT). Mobile diagnostics and POCT are expanding in rural areas, offering real-time glucose monitors, portable ECGs, and infectious disease tests. However, scaling nationwide faces challenges like unreliable infrastructure, last-mile delivery issues, and inconsistent quality control. Workforce gaps, integration difficulties with healthcare systems, and high costs hinder adoption. Limited patient awareness and skepticism also reduce utilization. To unlock POCT’s full potential, India needs strategic investments in infrastructure, workforce training, supportive policies, and public awareness initiatives. Good work has been done, but a lot needs to be done!

Advances in AI-integrated solutions. AI-driven diagnostics are fast transforming healthcare in India, bridging the urban-rural divide with faster, more accurate diagnoses and better patient outcomes. Integrating AI with cloud-based reporting boosts lab efficiency, while AI-powered tools and POCT devices improve access to remote areas. India’s AI healthcare market is projected to grow at a CAGR of 37.86 percent, reaching USD 6.8 billion by 2032. The year has seen some phenomenal growth and support from industry and policymakers. However, challenges like data security, regulatory compliance, and workforce upskilling remain. Strategic investments, implementation of policy reforms, continued investments to create robust infrastructure, and workforce upskilling are crucial to harness AI’s potential and create an inclusive healthcare ecosystem.

Expansion of diagnostic services in rural areas. Mobile testing units and telemedicine have now expanded diagnostics to remote areas. However, urban areas still dominate 74 percent of the diagnostic market, with limited rural access to advanced technologies. India’s USD 10-billion diagnostic industry is set to grow at a 14-percent CAGR, reaching USD 20 billion by FY26, but fragmentation across 100,000 labs and poor rural infrastructure hinder scaling. Testing volumes also lag behind global benchmarks. We must strictly monitor our targets in underserved markets with bundled packages and digital platforms to bridge these gaps. While technology offers promising solutions, policy support, improved infrastructure, and quality regulation will be crucial to ensure equitable access and sustainable growth.

Boost in local manufacturing and innovation. In 2024, India’s IVD sector advanced in local manufacturing and innovation, supported by the PLI scheme and a push for self-reliance, with growth in POCT and companion diagnostics. However, regulatory challenges and supply chain disruptions persist. Post-pandemic, demand for molecular testing and digital solutions surged, with the global IVD market expected to reach USD 96 billion by 2025. Companies must focus on automation, strategic collaborations, R&D, and scaling domestic production to sustain momentum. Public-private partnerships will be crucial for continued growth into 2025.

Evolving regulatory landscape. India’s regulatory framework has improved with faster approvals, with reforms like the updated Drugs and Clinical Trials Rules (DCTR) accelerating product clearances by 30–40 percent. However, 72 percent of companies face challenges aligning with international standards like the US FDA and EMA. The National Medical Devices Policy 2023 aims to reduce import dependency by boosting domestic manufacturing, and the single-window clearance system has cut approval times from 180 to 90 days. Yet, only 23 percent of labs and 10 percent of manufacturers hold international certifications, limiting global reach. Stakeholders urge alignment with ISO 13485 and global regulators to streamline processes, ensuring India’s position as a healthcare innovation hub.

Collaborations for better health outcomes. Notable partnerships among private diagnostic players, technology firms, and the government have helped drive pilot programs and population screening initiatives, particularly in combating non-communicable diseases.

Gaps and areas to focus on in 2025
Scaling POCT to reach the last mile. Despite progress, the infrastructure for reliable testing in the most remote regions needs to be further enhanced.

Addressing workforce gaps. Upskilling technicians and healthcare workers handling advanced IVD technologies remains crucial for sustainable growth.

Improving data management and interoperability. Seamless data exchange between diagnostic systems and healthcare providers is essential for holistic patient care.

Affordability and accessibility. While innovation has grown, ensuring affordability across diverse socioeconomic segments will be a crucial challenge.

As 2024 draws to a close, India’s MedTech and IVD sectors have made significant progress, but much remains to be done to build an inclusive, sustainable healthcare ecosystem. Our mission cannot slow down – healthcare is a lifeline, especially for the most vulnerable. As we look to 2025, our efforts must gain new momentum. Through technology, compassion, and collaboration, we can create a future where healthcare is not just about treatment but ensuring that no one is left behind.