India Medication Access Programs Market Analysis

India Medication Access Programs Market Executive Summary

The India Medication Access Programs Market was valued at $99.8 Mn in 2023 and is predicted to grow at a CAGR of 17.6% from 2023 to 2030, to $310.5 Mn by 2030.

Patient Support Programs (PSPs) are initiatives organized by pharmaceutical companies to enhance access, usage, and adherence to prescription drugs. These programs encompass financial assistance, clinical support, educational efforts, or a blend of these elements. A Medication Access Program (MAP) is a part of PSP that serves as a crucial connection between patients and the medications they need. Managed Access Programs are initiatives that enable patients with serious or life-threatening illnesses to obtain investigational medicines or treatments not yet commercially available. These programs aim to provide early access to therapies for patients who have exhausted all other options and are ineligible for clinical trials. Offered by pharmaceutical companies, MAPs help patients overcome financial barriers to access essential medications. A centralized, pharmacy-driven MAP can enhance patient outcomes, reduce unnecessary healthcare costs, improve patient and provider satisfaction, streamline patient flow, and boost revenue through increased prescription capture.

An estimate suggests that access to essential medicines in India is less than 35%. Approximately 65% of India's rural population has access to only 30% of the total healthcare infrastructure available in the country. The market is driven by significant factors like disease burden, government initiatives, and healthcare expenditure. However, lack of awareness, supply chain issues, and administrative burdens restrict the growth and potential of the market.

Prominent players in this field include Gilead Sciences and Takeda Pharmaceuticals which provides Medicine Access or Access to Medicine Program. Pfizer, Novartis, Merck, and AstraZeneca among others are some of the pharmaceutical companies providing patient support programs and are potential players for the Medication Access Program in India.

Market Dynamics

Market Growth Drivers

Disease Burden: Around 21% of India's elderly population aged 60 and above suffer from at least one chronic disease, with urban areas showing a higher prevalence at 29% compared to 17% in rural areas. This highlights the demand for medication access programs in India to address chronic diseases among the elderly, driving the market for accessible medications and better health outcomes.

Government Initiatives: Initiatives such as the National Health Mission (NHM) and Ayushman Bharat are aimed at enhancing healthcare access and affordability, including medications. This serves as a market driver for medication access programs in India by increasing demand for comprehensive healthcare services and ensuring wider availability of essential medications across the population.

Healthcare Expenditure: The National Health Policy proposed doubling the government's healthcare expenditure from 1.2% to 2.5% of GDP by 2025. This commitment acts as a market driver for medication access programs in India by significantly boosting investment in healthcare infrastructure, including the availability and affordability of medications.

Market Restraints

Lack of Awareness: Limited awareness among the population about existing medication access programs can restrain the market by reducing their utilization and effectiveness. This obstacle prevents many individuals from accessing and benefiting from these programs, thereby limiting their impact on improving healthcare outcomes in India.

Supply Chain Issues: Challenges in logistics and distribution, such as medication shortages and stockouts, pose a market restraint for medication access programs in India by disrupting the reliable availability of medicines. These issues hinder the consistent supply of medications, impacting the effectiveness and continuity of healthcare services provided through such programs.

Administrative Burden: The administrative complexities and substantial paperwork involved in enrolling and managing patients in Medication Access Programs (MAPs) can present a market restraint in India. This challenge burdens both healthcare providers and patients, potentially discouraging participation and hindering the efficient delivery of medication access services across the country.

Regulatory Landscape and Reimbursement Scenario

The Ministry of Health and Family Welfare (MoHFW) is India's primary legislative body responsible for health policy formulation. Under the MoHFW, the Central Drugs Standard Control Organization (CDSCO) serves as the national authority overseeing the safety, efficacy, and quality of pharmaceuticals and cosmetics in India. Managed Access Programs (MAPs), also known as Compassionate Use or Expanded Access programs, provide patients with serious or life-threatening conditions access to investigational or unapproved medicines when standard treatments are not available. According to Rule 36, individual patients can request the Drug Controller General of India (DCGI) to import unapproved drugs for personal use with a prescription from their physician using Form 12-A. Proposed amendments in the New Drugs and Clinical Trials Rules aim to simplify this process by potentially allowing hospitals and medical institutions to provide unapproved drugs under compassionate use programs, provided the drug is in Phase III clinical trials in India or abroad. On the reimbursement side, the government-sponsored Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY) health insurance program aims to provide coverage for specified medical procedures to low-income families.

Competitive Landscape

Key Players

Here are some of the major key players in the India Medication Access Programs Market:

• Gilead Sciences
• Takeda Pharmaceuticals
• Pfizer
• Novartis
• Merck
• AstraZeneca
• Bristol-Myers Squibb
• Sanofi
• Eli Lilly and Company
• Roche