India Rare & Orphan Disease Market

India Rare & Orphan Disease Market size was valued at USD 49,098.2 thousand in 2023 and is projected to reach USD 1,38,357.05 thousand by 2032, growing at a CAGR of 12.2% during the forecast period (2024-2032).

The market growth is fueled by increasing government initiatives, rising healthcare awareness, and technological advancements in diagnostics and treatments for rare diseases. Policies like the National Policy for Rare Diseases (NPRD) 2021, the Production Linked Incentive (PLI) Scheme, and expanded health insurance coverage are facilitating better access to orphan drugs and specialized care. The demand is driven by a large patient pool estimated between 72 to 96 million individuals affected by rare diseases in India, prompting increased domestic manufacturing and innovations in gene therapy, biosimilars, and digital health platforms. Furthermore, strategic partnerships between pharmaceutical companies, research institutions, and patient advocacy groups accelerate R&D and improve patient outcomes.

Top-down and bottom-up approaches were used to estimate and validate the market size. Key players were identified via secondary research, and their market shares determined through primary and secondary sources, including financial reports and industry expert interviews. All data points and segment splits were verified through cross-referencing data sources.

India Rare & Orphan Disease Market Segments Analysis

The market segments include drugs such as Myozyme, Fabrazyme, Cerezyme, Aldurazyme, Naglazyme, Vimizim, Vyvgard, Hemlibra, Takzhyro, and others which cover various rare and orphan diseases. Among these, the "Others" segment, comprising multiple rare disease drugs, dominates with increasing adoption of advanced biologics and novel therapies. Indication segments encompass Pompe Disease, Fabry Disease, Gaucher Disease, Mucopolysaccharidosis, Myasthenia Gravis, Bleeding Disorder, Hereditary Angioedema (HAE), Cystic Fibrosis, Cancer, Cystinosis, and others. Administration routes include intravenous, oral, and subcutaneous, with intravenous being the largest segment. End users are hospitals, specialized clinics, and oncology clinics, where hospitals dominate due to infrastructure and support mechanisms. Distribution channels include hospital pharmacies, drug stores, and others, with hospital pharmacies leading the market.

Driver of the India Rare & Orphan Disease Market

Key drivers include government initiatives providing financial assistance, establishment of specialized Centers of Excellence (CoEs), increasing prevalence of rare diseases, rising patient awareness, domestic drug manufacturing incentives, and advancements in diagnostics and therapies. The National Policy for Rare Diseases 2021, Production Linked Incentive schemes for orphan drugs, and expanding insurance coverage are pivotal in supporting market growth.

Restraints in the India Rare & Orphan Disease Market

Major restraints comprise the high cost of treatment, limited awareness among healthcare providers and patients, regulatory complexities, and insufficient diagnostic and specialized care infrastructure in rural areas. The scarcity of comprehensive patient databases and challenges in local orphan drug manufacturing also impede market penetration.

Market Trends of the India Rare & Orphan Disease Market

Emerging trends include rising adoption of gene therapy and personalized medicine, increased focus on biosimilars, innovative clinical trial designs such as adaptive and basket trials, and deployment of digital health platforms for rare disease management. There is greater collaboration between domestic and global pharmaceutical firms, and an emphasis on patient-centric approaches and patient support programs to improve treatment adherence and outcomes. Show more