HEOR & RWE: Ushering a New Era in Indian Healthcare and Pharma

With India’s pharmaceutical market projected to reach $130 billion by 2030 and the healthcare sector undergoing rapid modernization, Health Economics and Outcomes Research (HEOR) and Real-World Evidence (RWE) are becoming crucial pillars in decision-making for drug development, market access, and patient care.

Globally, the HEOR market is expected to grow at a CAGR of 12.3%, reaching $5.8 billion by 2028. India, with its unique healthcare challenges, is seeing increased adoption of HEOR and RWE-driven insights to improve drug affordability, optimize clinical outcomes, and shape public health policies.

Understanding HEOR & RWE in the Indian Context

Health Economics and Outcomes Research (HEOR)

HEOR assesses the economic value, clinical effectiveness, and quality-of-life impact of healthcare interventions using:
✔ Cost-effectiveness analysis (CEA) – Evaluates value-for-money in drug pricing.
✔ Budget impact analysis (BIA) – Helps policymakers optimize healthcare spending.
✔ Quality-adjusted life years (QALYs) and disability-adjusted life years (DALYs) – Measures patient outcomes and treatment impact.

Real-World Evidence (RWE)

RWE involves analyzing clinical data from real-world settings, including:
✔ Electronic health records (EHRs)
✔ Prescription databases
✔ Wearable health devices & mobile health applications

🔹 Industry Forecast: By 2027, India’s RWE market is expected to grow at 15-20% CAGR, driven by digital health adoption and regulatory advancements.

Why HEOR & RWE Matter in India

1. Bridging the Drug Accessibility Gap (Impacting Over 65 Million Indians)

• In India, over 65 million people suffer from chronic diseases like diabetes and cardiovascular conditions.
• Affordability is a challenge, with 55% of healthcare expenses being out-of-pocket.
• HEOR helps in designing policies for generic drug usage, ensuring wider patient access at lower costs.

🔹 Example: Government Jan Aushadhi Kendras use HEOR insights to optimize pricing for essential medicines.

2. Regulatory Decision-Making & Faster Drug Approvals

• The Central Drugs Standard Control Organization (CDSCO) now mandates RWE insights for drug pricing and reimbursement decisions.
• Inclusion of RWE in clinical trials is speeding up drug approvals for rare diseases.
• A 2023 study revealed that 35% of new drugs launched in India leveraged RWE for market entry.

🔹 Example: RWE data helped justify the launch of new biosimilars and gene therapies in India.

3. Improving Public Health and Public Policy

• India has 1.4 billion people, with only 37% covered under health insurance.
• HEOR helps governments allocate resources for initiatives like Ayushman Bharat.
• Big data models in RWE predict disease outbreaks and optimize vaccination programs.

🔹 Success Story: COVID-19 vaccine distribution in India was enhanced using RWE-driven epidemiological insights.

4. Pharma Market Expansion & Competitive Advantage ($130B Market by 2030)

• Indian pharma companies like Sun Pharma, Dr. Reddy’s, and Biocon now use RWE to:
  ✔ Identify high-growth therapeutic areas
  ✔ Optimize Phase IV post-marketing surveillance
  ✔ Improve patient-centric drug design

🔹 Outcome: Businesses using advanced HEOR analysis see 20-30% more efficient resource allocation in R&D.

5. Digital Health & AI-Driven RWE Analytics (A $12B+ Market by 2025)

• The Indian digital health market is poised to reach $12 billion by 2025.
• Wearables, mobile health apps, and AI-driven predictive modelling enhance RWE data collection in real-time.
• AI-driven HEOR models now reduce drug pricing errors by 30%.

🔹 Example: Apollo Hospitals uses AI-based HEOR models for effective disease management in multi-specialty care.

Challenges in HEOR & RWE Adoption in India

1. Lack of Standardized RWE Data – India’s fragmented healthcare system lacks a unified data repository.
2. Regulatory Barriers – Indian HEOR guidelines are still evolving, leading to inconsistency in adoption.
3. Limited Analytics Expertise – Only 5-7% of pharma professionals in India are skilled in HEOR/RWE analytics.

🔹 Solution: Expanding AI-driven analytics, regulatory clarity, and government collaborations can accelerate HEOR integration in India.

Future Outlook: The HEOR & RWE Landscape in India (2024-2030)

🚀 By 2030, India’s HEOR-driven pharma market could see:
✔ A 40% reduction in clinical trial costs through AI-driven RWE insights.
✔ Increased drug accessibility to 70% of India’s population via cost-effective reimbursement models.
✔ Over 75% of new drug approvals leverage RWE in regulatory decision-making.

🔹 Government Push: With initiatives like Ayushman Bharat Digital Mission (ABDM), India aims to integrate nationwide health databases, further propelling HEOR and RWE adoption.

Conclusion

The rise of HEOR and RWE in India marks a transformative shift—enhancing drug affordability, ensuring better patient outcomes, and improving healthcare policy-making. As India strengthens its pharma and healthcare ecosystem, investing in data-driven HEOR/RWE strategies will be key to sustaining long-term growth and making healthcare truly patient-centric.