Dublin, Feb. 16, 2026 (GLOBE NEWSWIRE) — The “India Biosimilars Market: Industry Trends and Global Forecasts – Distribution by Drug Class, Therapeutic Area, Type of Manufacturer, Distribution Channel, Geographical Regions and Leading Players” report has been added to ResearchAndMarkets.com’s offering.
The India biosimilars market is estimated to grow from USD 184 million in the current year to USD 1.02 billion by 2035 at a CAGR of 21% during the forecast period, Till 2035.
The growth of the biosimilars market in the coming decade is projected to be fueled by the expiration of biologics patents, resulting in the development of alternative biosimilars that closely resemble their reference biologics.
In recent times, the biologics sector has experienced significant growth, largely attributed to its improved efficacy in managing chronic illnesses. Nonetheless, the elevated expenses linked to biologics present considerable financial and healthcare challenges. With the increasing demand for biologics, developers are exploring innovative approaches to create more cost-effective biologic products that maintain comparable safety and efficacy profiles to optimize their investment returns.
Over the past few years, the field has seen a rise in investments and cooperative initiatives from the biosimilar developers. Additionally, regulatory progress, more efficient approval processes, and increased research have bolstered the development of biosimilars, including those for oncology.
In 2026, India’s biosimilars market demonstrates strong activity characterized by strategic acquisitions, pipeline growth, regulatory changes, and international partnerships, with expected double-digit growth
With the expanding market for biosimilars as a cost-effective option, the operations for in-house development and outsourcing services are anticipated to rise in India. This trend is set to offer appealing growth prospects for developers of biosimilars.
Growth Drivers: Strategic Enablers of Market Expansion
The India biosimilars market experiences robust growth driven by several key factors, including rising prevalence of chronic diseases like cancer, diabetes, and autoimmune disorders and increased demand for affordable biologic alternatives. In addition, government initiatives such as streamlined regulatory pathways via the Central Drugs Standard Control Organization (CDSCO) and incentives under the PLI (Production Linked Incentive) Scheme for biologics also propel market growth.
Further, patent expiries of major drugs like Herceptin and Rituxan, enable local manufacturers to expand portfolios rapidly. Strategic partnerships with global firms, low-cost manufacturing capabilities, and a skilled workforce further position India as a leading exporter.
Market Challenges: Critical Barriers Impeding Progress
Challenges persist in the India biosimilars market despite the ongoing market growth, hindering faster adoption. High development costs, complex manufacturing processes requiring stringent quality controls, and risks of immunogenicity or structural variability raise entry barriers for smaller players in this market space. Further, regulatory hurdles, including evolving guidelines and the need for comparative clinical trials, result in delayed approvals. Market access issues, such as competition from branded generics, pricing pressures, and patent litigations from originator companies, also constrain growth.
Monoclonal Antibodies: Leading Market Segment
Currently, monoclonal antibodies segment captures nearly 55% of the overall market share in India. This dominance can be primarily attributed to their extensive use in treating chronic conditions like cancer, rheumatoid arthritis, and other autoimmune disorders. However, the peptide segment is likely to grow at a higher CAGR during the forecast period.
Oncological Disorders: Dominating Market Segment
At present, majority (~40%) of the market share of biosimilars in India is held by oncological disorders, due to the increasing cancer burden. This is further fueled by rising aging population, lifestyle changes, and enhanced diagnostic methods, which need cost-effective treatments, especially for expensive monoclonal antibody therapies. This is likely to offer appealing growth prospects for developers of biosimilars. Further, the hematological disorders segment is likely to grow at a higher CAGR during the forecast period.
Key Questions Answered in this Report
- How many India biosimilars providers are currently engaged in this market?
- Which are the leading companies in this market?
- Which country dominates the India biosimilars market?
- What are the key trends observed in the India biosimilars market?
- What factors are likely to influence the evolution of this market?
- What are the primary challenges faced by biosimilars providers in India?
- What is the current and future India biosimilars market size?
- What is the CAGR of India biosimilars market?
- How is the current and future market opportunity likely to be distributed across key market segments?
Key Attributes:
| Report Attribute | Details |
| No. of Pages | 100 |
| Forecast Period | 2026 – 2035 |
| Estimated Market Value (USD) in 2026 | $184 Million |
| Forecasted Market Value (USD) by 2035 | $1020 Million |
| Compound Annual Growth Rate | 21.0% |
| Regions Covered | Global, India |
INTRODUCTION
- Overview of Biologics
- Overview of Biosimilars and Biobetters
- Difference between Innovator Biologics, Biosimilars and Generics
- Advantages of Biosimilars
- Manufacturing of Biosimilars
- Development Timeline of Biosimilars
- Future Perspectives
MARKET LANDSCAPE
- Biosimilars: Developers Landscape
- Analysis by Year of Establishment
- Analysis by Company Size
- Analysis by Location of Headquarters (Region)
- Analysis by Location of Headquarters (Country)
- Biosimilars: Overall Market Landscape
- Analysis by Stage of Development
- Analysis by Therapeutic Area
- Analysis by Drug Class
COMPANY COMPETITIVENESS ANALYSIS
- Chapter Overview
- Assumptions and Key Parameters
- Methodology
- Biosimilars Providers in Japan: Company Competitiveness Analysis
- Small Biosimilar Developers (Peer Group I)
- Mid-sized Biosimilar Developers (Peer Group II)
- Large Biosimilar Developers (Peer Group III)
- Capability Benchmarking of top Biosimilar Developers
COST PRICE ANALYSIS
- Factors Contributing to High Price of Novel Biologics
- Pricing of Biosimilars
- Price Comparison of Different Biosimilars with its Reference Biologic
- Concluding Remarks
DEMAND ANALYSIS
- Key Assumptions and Methodology
- Global Annual Demand for Biosimilars
- Analysis by Drug Class
- Analysis by Therapeutic Area
- Analysis by Type of Manufacturer
- Analysis by Distribution Channel
- Analysis by Geographical Regions
Key Players in India Biosimilars Market
- Avesthagen
- Biocon Biologics
- Biosimilar Sciences India
- Cipla
- Clonz Biotech
- CuraTeQ Biologics (Subsidiary of Aurobindo Pharma)
- Enzene Biosciences
- GeneSys
- Glenmark Pharmaceuticals
- Intas Pharmaceuticals
- Jodas Expoim
- Levim Lifetech
- Lupin
- Sayre Therapeutics
- Shilpa Biologicals
- Stelis Biopharma
- VITANE Biologics
- Zydus Cadila
KEY SEGMENTS
By Drug Class
- Monoclonal Antibodies
- Proteins
- Peptides
- Others
By Therapeutic Area
- Oncological Disorders
- Autoimmune and Inflammatory Disorders
- Hematological Disorders
- Metabolic Disorders
- Other Disorders
By Type of Manufacturer
- Contract Manufacturers
- In-house Developers
By Distribution Channel
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
Complementary Benefits
- Complimentary PPT Insights Packs
- Complimentary Excel Data Packs Covering All Analytical Modules
- Up to 15% Complimentary Content Customization
- In-Depth Report Walkthrough with the Research Team
- Complimentary Report Update if the Report is 6+ Months Old
For more information about this report visit https://www.researchandmarkets.com/r/7nkhf1
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- Indian Biosimilars Market