The India Orphan Drugs Market was valued at USD 7.80 Billion in 2024 and is projected to reach USD 18.29 Billion by 2033, growing at a CAGR of 10.00% during 2025-2033. This growth is driven by increased rare disease awareness, government incentives, enhanced diagnostics, and patient advocacy. Biotechnology progress and pharmaceutical partnerships further fuel development, addressing unmet medical needs in India. The report presents a thorough review featuring the India Orphan Drugs Market Analysis, share, trends, and research of the industry.

STUDY ASSUMPTION YEARS

• Base Year: 2024
• Historical Year/Period: 2019-2024
• Forecast Year/Period: 2025-2033

INDIA ORPHAN DRUGS MARKET KEY TAKEAWAYS

• Current Market Size: USD 7.80 Billion in 2024
• CAGR: 10.00%
• Forecast Period: 2025-2033
• Regulatory reforms like the National Policy for Rare Diseases and incentives such as fast-track approvals and fee exemptions boost pharmaceutical investments.
• India’s rare disease patient population is estimated between 70 to 96 million, increasing orphan drug demand.
• Public-private partnerships and global alliances are accelerating orphan drug development and market entry.
• Advancements in genomic research and personalized medicine, including the Genome India Project, enhance early diagnosis and targeted therapies.
• The Indian Council of Medical Research’s National Registry supports tracking and research on over 15,000 rare disease cases.

MARKET TRENDS

India’s orphan drugs market growth is bolstered by significant government support and regulatory reforms. Policies such as the National Policy for Rare Diseases (NPRD) and recognition of rare diseases by health authorities create a conducive environment. Incentives include fast-track approvals, fee exemptions, and market exclusivity, stimulating pharmaceutical sector investments. The Central Drugs Standard Control Organization (CDSCO) streamlines clinical trials and drug approvals, facilitating quicker market entry. With an estimated 70 to 96 million rare disease patients, need-driven demand is intensifying, attracting international firms and fostering innovation to meet unmet medical needs.

A key trend is the rise of public-private collaborations and international partnerships. Indian pharmaceutical companies collaborate with overseas firms for technology transfer, co-development, and marketing of orphan drugs. These alliances bridge infrastructure, knowledge, and financing gaps, accelerating development and approval processes. Additionally, collaborations with academic and healthcare organizations promote research innovation in rare disease therapies. These shared efforts are crucial in overcoming development challenges and delivering advanced treatment options adapted for Indian patients via global best practices.

Advances in genomic research and personalized medicine notably strengthen the market landscape. The Genome India Project (GIP), launched in 2020, has sequenced 10,000 genomes from diverse ethnic groups, pushing rare disease research forward. Investment in genetic diagnostics, bioinformatics, and molecular profiling fosters targeted therapies and personalized care solutions. Startups and research institutions produce gene-based and biomarker-driven treatments for rare diseases. As genetic sequencing costs decrease and diagnosis awareness rises, early diagnosis improves, boosting orphan drug demand. The National Registry for Rare Diseases supports this transition, enabling precision medicine and expanded orphan drug accessibility.

MARKET GROWTH FACTORS

Government incentives and regulatory reforms play a pivotal role in market expansion. Measures like the NPRD encourage pharmaceutical investments by offering accelerated approvals, fee waivers, and extended market exclusivity. The CDSCO’s efforts in streamlining clinical trials and approvals reduce entry barriers. This regulatory backing drives innovation, increases treatment accessibility, and boosts international company presence in India, fulfilling the unmet needs of millions affected by rare diseases.

The market benefits from growing public-private and international partnerships. Strategic alliances between Indian pharmaceutical companies and global biotech firms facilitate knowledge exchange, technology transfer, and joint marketing initiatives. These collaborations mitigate financial and infrastructural shortcomings, expediting orphan drug development and commercialization. Partnerships with academic institutions foster research and novel therapy development, enhancing treatment availability for rare disease patients across India.

Progress in genomic research and personalized medicine further propels growth. The Genome India Project’s extensive genome sequencing aids in understanding genetic disorders, enabling precise diagnosis and targeted therapies. Increased investment in molecular profiling and bioinformatics supports personalized medicine approaches. Declining costs of genetic testing and growing awareness lead to earlier and more accurate diagnosis, increasing orphan drug demand. Supportive national registries aid research and treatment optimization, expanding market potential.

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MARKET SEGMENTATION

Drug Type Insights:

• Biological: Analysis includes biopharmaceuticals used for treating rare diseases.
• Non-Biological: Covers chemically synthesized orphan drugs used across disease categories.

Disease Type Insights:

• Oncology: Focuses on rare cancers and associated orphan drug therapies.
• Hematology: Includes treatments related to rare blood disorders.
• Neurology: Covers neurological rare diseases and their drug treatments.
• Cardiovascular: Addresses rare cardiovascular conditions with specialized drugs.
• Others: Encompasses other rare disease categories treated with orphan drugs.

Phase Insights:

• Phase I: Initial clinical trials focusing on safety and dosage assessment.
• Phase II: Trials evaluating efficacy and side effects.
• Phase III: Large-scale testing for confirming effectiveness and monitoring adverse reactions.
• Phase IV: Post-marketing studies for long-term effects and additional indications.

Top Selling Drugs Insights:

• Revlimid, Rituxan, Copaxone, Opdivo, Keytruda, Imbruvica, Avonex, Sensipar, Soliris, Others: The report analyzes market shares and trends of leading orphan drugs by sales.

Distribution Channel Insights:

• Hospital Pharmacies: Distribution through institutional healthcare facilities.
• Retail Pharmacies: Availability via retail drugstores.
• Online Stores: Growing sales through e-commerce platforms.
• Others: Includes alternative distribution channels.

REGIONAL INSIGHTS

The report covers all major Indian regions: North India, South India, East India, and West India. Among these, no specific dominant region is explicitly stated nor are exact regional market shares or CAGRs provided. The report provides comprehensive regional analysis without pinpointing a lead market.

RECENT DEVELOPMENTS & NEWS

In May 2024, Zydus Lifesciences’ US-based subsidiary, Sentynl Therapeutics Inc, acquired global proprietary rights for Zokinvy, the only USFDA-approved treatment for progeria. Zokinvy addresses symptoms and causes of this rare genetic disorder in patients over 12 months old. This strategic acquisition strengthens Zydus’s rare disease portfolio and enhances global access to advanced progeria treatments, marking significant industry progress.

KEY PLAYERS

• Zydus Lifesciences
• Sentynl Therapeutics Inc

CUSTOMIZATION NOTE

If you require any specific information that is not covered currently within the scope of the report, we will provide the same as a part of the customization.

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