The India biosimilar market size was valued at INR 2.20 billion in 2024, driven by the rising prevalence of chronic diseases across the region. The market is expected to grow at a CAGR of 25.20% during the forecast period of 2025-2034, with the values likely to rise from INR 2.8 billion in 2025 to INR 16.6 billion by 2034. The rapid increase in chronic conditions such as cancer, diabetes, and autoimmune disorders, combined with the growing affordability and accessibility of biosimilars, is propelling this remarkable growth.

As the demand for biologics surges globally, biosimilars—highly similar versions of original biologic products—are offering more affordable treatment options for patients in India. The biosimilar market in India has gained significant attention from both local and international pharmaceutical companies, offering cost-effective alternatives to patented biologics. This blog post delves into the market overview, dynamics, trends, segmentation, growth, and future outlook of the India biosimilar market, as well as the effects of the COVID-19 pandemic on the industry.

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India Biosimilar Market Overview

The biosimilar market in India is in a rapidly expanding phase, fueled by a growing patient population requiring biologic treatments, the increasing burden of chronic diseases, and favorable government policies promoting the development and adoption of biosimilars. Biosimilars are seen as a cost-effective alternative to expensive branded biologic drugs used to treat a range of complex conditions such as cancer, rheumatoid arthritis, diabetes, and cardiovascular diseases.

India, with its large population and rising healthcare needs, is witnessing a sharp increase in the prevalence of chronic diseases, making biosimilars a key part of the country’s healthcare landscape. The Biosimilars market includes both monoclonal antibodies, which treat cancer and autoimmune diseases, and insulin biosimilars, which are essential for the management of diabetes.

The country’s pharmaceutical sector is one of the largest producers of generic drugs globally, and with the rise of biosimilars, India is now becoming a major hub for biosimilar manufacturing and clinical trials. Several domestic and international pharmaceutical companies are working towards developing and marketing biosimilars in India, creating a competitive and rapidly evolving market.

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Key Market Drivers

1. Rising Prevalence of Chronic Diseases: India has one of the highest incidences of chronic diseases such as cancer, diabetes, cardiovascular disorders, and autoimmune diseases. This has resulted in a substantial increase in the demand for biologic drugs, which has directly fueled the biosimilar market. For example, the growing number of people diagnosed with type 2 diabetes and cancer is driving the demand for biosimilar insulin and monoclonal antibody treatments.

2. Affordable Healthcare Solutions: Biosimilars offer a more affordable alternative to expensive biologics, which is especially important in a price-sensitive market like India. With the rising healthcare costs associated with chronic disease treatments, biosimilars present an opportunity to reduce the overall cost burden for both patients and the healthcare system.

3. Government Initiatives and Support: The Indian government has been actively supporting the biosimilar industry through favorable regulations and policies. The Drug Controller General of India (DCGI) has laid down clear guidelines for the approval and commercialization of biosimilars, encouraging the development of cost-effective biologic alternatives. The National Biopharma Mission and initiatives like Make in India are also facilitating the growth of the biosimilar market.

4. Increasing Patient Access: With the rising number of treatment-naïve patients and improved healthcare infrastructure, biosimilars offer a way to improve access to life-saving biologic therapies. In India, biosimilars can be a game-changer in treating patients who otherwise may not have had access to these therapies due to their high costs.

5. Improved Manufacturing Capabilities: India is home to several pharmaceutical companies that are capable of manufacturing high-quality biosimilars at competitive prices. This has helped position the country as a leader in the global biosimilar production market, making biosimilars more accessible both domestically and in international markets.

Key Market Challenges

1. Regulatory Hurdles: Despite the supportive regulatory environment, the approval and commercialization process for biosimilars in India can be complex and lengthy. Ensuring regulatory compliance, conducting extensive clinical trials, and maintaining transparency in product development remain significant challenges for biosimilar manufacturers.

2. Lack of Awareness: Although awareness of biosimilars is growing, there is still a lack of comprehensive knowledge among healthcare providers and patients. This lack of understanding can lead to hesitancy in prescribing or accepting biosimilars as an alternative to branded biologics.

3. Price Sensitivity: While biosimilars are generally more affordable than branded biologics, the price difference may still be prohibitive for certain segments of the Indian population. The cost of biosimilars, although lower, is still higher than generic medicines, which may limit their accessibility in rural and low-income areas.

4. Quality Concerns: Ensuring that biosimilars meet the same quality, safety, and efficacy standards as their reference biologics is crucial. Any perceived or real differences in quality can create reluctance among healthcare professionals to adopt biosimilars over their original counterparts.

External India Biosimilar Market Trends

1. Technological Advancements in Manufacturing:

The development of new and more advanced biomanufacturing technologies is enabling pharmaceutical companies to produce biosimilars more efficiently. Advances in biotechnology, including cell culture technologies and gene sequencing techniques, are enhancing the production of high-quality biosimilars at a lower cost, which will help drive market growth.

2. Increased Collaboration Between Biopharma Companies:

Several partnerships and collaborations between global biopharma giants and Indian pharmaceutical companies have resulted in the development and commercialization of biosimilars. These collaborations are helping bring more innovative biosimilars to the Indian market, and expanding the country's presence in the global biosimilar market.

3. Rising Export Potential:

As India strengthens its position as a leading biosimilar manufacturing hub, the export potential for Indian biosimilars is growing. Indian biosimilars are increasingly being exported to developed markets such as the US, Europe, and Australia, where demand for affordable biologics is growing due to the high costs of reference products.

4. Policy Support from Global Bodies:

International regulatory bodies like the World Health Organization (WHO) and the European Medicines Agency (EMA) are providing clearer guidelines for the approval of biosimilars. This is helping to reduce uncertainty in the market, making it easier for Indian biosimilar companies to navigate regulatory processes and bring products to market.

5. Focus on Biosimilar Insulin:

Biosimilar insulin products are a major growth driver in India due to the rising incidence of diabetes. Biosimilar insulin offers a more affordable treatment option for millions of people with diabetes, and Indian companies are increasingly focusing on developing and commercializing insulin biosimilars.

India Biosimilar Market Segmentation

The India biosimilar market can be segmented based on product type, therapeutic area, distribution channel, and region.

By Product Type:

1. Monoclonal Antibodies: Monoclonal antibodies (mAbs) are the most widely used type of biologic drug in the treatment of cancer, rheumatoid arthritis, and other immune system disorders. Biosimilar versions of mAbs are expected to gain significant traction in India as they provide affordable alternatives to blockbuster drugs such as Rituximab, Trastuzumab, and Bevacizumab.

2. Insulin Biosimilars: Insulin biosimilars are one of the fastest-growing segments in India. With the increasing prevalence of type 2 diabetes, the demand for insulin is rising. Biosimilar insulin offers a more affordable solution for people with diabetes, making it a significant contributor to the market.

3. Erythropoiesis-Stimulating Agents (ESAs): ESAs are used to treat anemia caused by chronic kidney disease and cancer treatments. The increasing number of patients with kidney-related conditions and cancer is driving the demand for biosimilars in this category.

4. Growth Hormones: Biosimilar growth hormones are used to treat conditions like growth hormone deficiency and short stature. The market for biosimilar growth hormones in India is expected to grow, especially with the rise in pediatric conditions related to growth disorders.

5. Other Biosimilars: Other biosimilars include filgrastim (used for neutropenia), interferons (for hepatitis), and vaccines. These products are expected to witness growing demand as the scope of biosimilar treatments broadens.

By Therapeutic Area:

1. Oncology: Cancer treatment is one of the largest therapeutic areas for biosimilars, with monoclonal antibodies being widely used to treat various cancers. This segment is expected to see substantial growth in India as the incidence of cancer continues to rise.

2. Diabetes: The increasing prevalence of diabetes is leading to a surge in demand for biosimilar insulins and other diabetes-related therapies, making this a high-growth area for the biosimilar market.

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3. Rheumatology: Rheumatoid arthritis (RA) and other autoimmune diseases are common in India, and the demand for biosimilars such as adalimumab and infliximab for treating these conditions is growing. As biosimilars of TNF inhibitors and other biologics are approved, they are expected to become increasingly popular in managing chronic autoimmune conditions due to their affordability.

4. Nephrology: Patients with chronic kidney disease (CKD) or those undergoing dialysis often require erythropoiesis-stimulating agents (ESAs) and other supportive therapies. The adoption of biosimilar ESAs is on the rise as these biologics are more affordable, thus increasing their accessibility to patients in India.

5. Endocrinology: In the field of endocrinology, growth hormones and other biologic therapies have seen growing demand. The increasing number of patients requiring growth hormone therapy, along with the availability of cost-effective biosimilars, has made this a key therapeutic segment.

By Distribution Channel:

1. Hospital Pharmacies: Hospital pharmacies are significant distribution channels for biosimilars, especially in the treatment of oncology, diabetes, and rheumatology. Hospitals, being the primary treatment centers for chronic diseases, play a vital role in the availability and prescription of biosimilars.

2. Retail Pharmacies: Retail pharmacies are also seeing an increase in demand for biosimilars, particularly biosimilar insulin and growth hormones. These drugs are more affordable than branded alternatives, and patients are increasingly seeking them in retail pharmacies.

3. Online Pharmacies: With the growing popularity of online pharmacies in India, biosimilars are also becoming more accessible to a broader population. The convenience of home delivery and easy access to affordable drugs is contributing to the growth of biosimilars through this channel.

India Biosimilar Market Growth

The India biosimilar market is set to experience robust growth in the coming years due to the following factors:

1. Strong Domestic Manufacturing Capabilities:

India has become a global hub for generic drug production, and this extends to biosimilars. Domestic pharmaceutical companies, such as Biocon, Dr. Reddy's Laboratories, and Cipla, are investing heavily in biosimilar development and manufacturing. This growth in local production is helping to reduce the overall cost of biosimilars and improve their availability in the country.

2. Global Market Expansion:

As India strengthens its position as a biosimilar manufacturing powerhouse, the country’s exports of biosimilars are expected to grow significantly. Indian biosimilar companies are increasingly entering high-value markets like the US and Europe, where demand for cost-effective alternatives to expensive biologics is rising. These exports contribute to the overall market growth and raise India’s profile on the global stage.

3. Regulatory Framework Improvements:

The Indian government has been actively improving the regulatory framework for biosimilars, with clearer guidelines from the Central Drugs Standard Control Organization (CDSCO) and the DCGI. This has simplified the approval process for biosimilars, boosting market confidence and allowing more companies to bring their products to market.

4. Rising Patient Population:

With India’s large and growing population, the prevalence of chronic diseases such as diabetes, cancer, and autoimmune disorders is on the rise. This is directly increasing the demand for biologic treatments, and as biosimilars offer an affordable alternative, their demand is expected to grow exponentially.

5. Government Initiatives for Healthcare Access:

Initiatives like Ayushman Bharat and the Pradhan Mantri Jan Arogya Yojana (PMJAY) aim to improve healthcare access and affordability in India. By promoting affordable biosimilars, these initiatives are expected to make biologic treatments more accessible to a wider population.

Recent Developments in the India Biosimilar Market

1. Regulatory Approvals: In recent years, several biosimilars have received regulatory approvals in India. Companies like Biocon and Dr. Reddy’s have received approvals for biosimilar versions of Herceptin, Rituxan, and Humira—leading to greater accessibility for patients and increased competition in the market.

2. Partnerships and Collaborations: Leading global pharmaceutical companies like Pfizer, Eli Lilly, and Celltrion are forging partnerships with Indian pharmaceutical firms to tap into the growing biosimilars market. These collaborations are enhancing the development and distribution of biosimilars, improving market penetration.

3. Investment in Research & Development: Companies in India are increasingly investing in R&D to develop innovative biosimilars. The Indian biosimilar market is likely to witness further innovations, especially in complex biosimilars such as monoclonal antibodies and fusion proteins.

COVID-19 Impact Analysis

The COVID-19 pandemic had significant effects on the India biosimilar market. The pandemic caused disruptions in the global supply chain, leading to shortages and delays in the production and distribution of some biosimilars. Hospitals and healthcare providers were also overwhelmed, leading to a temporary slowdown in the uptake of non-COVID-related treatments.

However, the pandemic also had positive impacts in some areas:

1. Increased Focus on Healthcare: COVID-19 highlighted the importance of affordable healthcare solutions. As a result, the demand for affordable biologic treatments, including biosimilars, has surged. The pandemic has driven the adoption of telemedicine and online consultations, facilitating greater access to biosimilars.

2. Biosimilar Insulin Demand: The pandemic has increased the demand for diabetes care as many patients with pre-existing conditions, including diabetes, faced complications during COVID-19. The rising awareness about insulin biosimilars has led to their increased adoption, especially among price-sensitive populations.

Key Players in the India Biosimilar Market

1. Pfizer Inc.: Pfizer, a global leader in biologics, is actively expanding its biosimilar portfolio in India. The company has launched several biosimilars, including versions of Infliximab and Trastuzumab, providing patients with affordable treatment options.

2. Eli Lilly and Company: Eli Lilly is a key player in the Indian biosimilar market, especially in the insulin segment. Lilly has launched biosimilar insulins such as Insulin Glargine, which has gained traction due to the high prevalence of diabetes in India.

3. Celltrion Healthcare: Celltrion, a South Korean biopharmaceutical company, is expanding its biosimilar portfolio in India. With products like Trastuzumab, Rituximab, and Infliximab, Celltrion is making affordable biologics more accessible to Indian patients.

FAQ

1. What is the current market size of the India biosimilar market?

The India biosimilar market was valued at INR 2.20 billion in 2024 and is expected to grow at a CAGR of 25.20% during the forecast period from 2025 to 2034, reaching INR 16.6 billion by 2034.

2. What are the key drivers of the India biosimilar market?

The key drivers include the rising prevalence of chronic diseases, affordable healthcare solutions, government initiatives, strong domestic manufacturing capabilities, and global market expansion.

3. Which biosimilar segments are expected to grow the most in India?

The monoclonal antibody and insulin biosimilar segments are expected to witness the highest growth due to the increasing prevalence of cancer and diabetes in India.

4. What are the major challenges faced by the India biosimilar market?

The key challenges include regulatory hurdles, lack of awareness, price sensitivity, and quality concerns regarding the efficacy and safety of biosimilars.

5. Who are the key players in the India biosimilar market?

Key players include Pfizer Inc., Eli Lilly and Company, Celltrion Healthcare, Biocon Ltd., and Dr. Reddy’s Laboratories.