The India biosimilar market has emerged as one of the most promising sectors in the Indian pharmaceutical industry, driven by an increasing prevalence of chronic diseases, growing healthcare costs, and the rising demand for affordable alternatives to biologic treatments. As of 2024, the India biosimilar market was valued at INR 2.20 billion, and it is projected to grow at a CAGR of 25.20% during the forecast period from 2025 to 2034. The market is expected to reach INR 16.6 billion by 2034, reflecting an accelerated expansion driven by both domestic and international factors.
India, with its rapidly expanding healthcare sector, increasing incidence of chronic diseases like cancer, diabetes, and autoimmune disorders, and large-scale investments in biotechnology, presents an enormous opportunity for biosimilar products. The increasing adoption of biosimilars is expected to make biologic treatments more affordable, improving patient access to life-saving therapies. This article delves deep into the India biosimilar market, providing insights into market trends, segmentation, growth drivers, key players, and forecasts for the next decade.
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Market Overview
Biosimilars are highly similar versions of innovator biologic drugs (original brand biologics), which are manufactured after the patent for the innovator biologic expires. They are designed to be as effective and safe as the original biologics, providing an affordable alternative to high-cost treatments. These drugs are typically used for the treatment of diseases such as cancer, rheumatoid arthritis, diabetes, and autoimmune diseases.
The Indian biosimilar market has significant growth potential. This is attributed to factors such as the increasing demand for biologic drugs, the growing burden of chronic diseases, and government support for the development of biosimilars. India has emerged as a key player in the global biosimilars market due to its well-established biotechnology infrastructure, highly skilled workforce, and competitive manufacturing costs.
The rising prevalence of chronic diseases such as diabetes, cardiovascular diseases, and autoimmune conditions is one of the primary reasons for the surge in demand for biologic treatments, and subsequently, biosimilars. This, along with the increasing healthcare spending by the government and private sector, has created a favorable environment for the growth of the biosimilar market.
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Key Market Drivers
1 Rising Prevalence of Chronic Diseases
India is facing a growing burden of chronic diseases, including diabetes, cardiovascular diseases, arthritis, cancer, and neurological disorders. As of 2023, over 77 million people in India were living with diabetes, and the number is expected to rise. Similarly, cancer cases are increasing annually, with over 1 million new cancer cases being diagnosed in India every year.
The increasing demand for biologic drugs to manage these chronic conditions has driven up the cost of treatment. Biosimilars, being more affordable alternatives, are gaining traction as a viable option for both patients and healthcare providers. This trend is expected to continue, propelling the growth of the biosimilar market in India.
2 Cost-effectiveness of Biosimilars
The affordability of biosimilars is a major factor driving their adoption in India. Biologics are often expensive due to the complex manufacturing processes involved. Biosimilars offer an opportunity to reduce treatment costs without compromising on efficacy, which is particularly important in a price-sensitive market like India. This cost-effective nature is making biosimilars the preferred option for patients, especially in government healthcare programs and the public sector.
3 Government Initiatives and Support
The Indian government has implemented several initiatives to support the development and commercialization of biosimilars. The National Biopharma Mission (NBM) and the Make in India initiative have been instrumental in promoting biosimilar research and manufacturing in India. Additionally, the Central Drugs Standard Control Organization (CDSCO) has streamlined the regulatory process for biosimilars, which has facilitated quicker market entry for new biosimilars.
4 Increasing Patient Awareness
As the Indian healthcare system improves and access to healthcare information increases, patients are becoming more aware of their treatment options. This heightened awareness has encouraged patients to explore biosimilars as an alternative to expensive biologic treatments, thereby driving market growth.
5 Expiring Patents of Innovator Biologics
Many blockbuster biologic drugs, such as insulin and monoclonal antibodies, are nearing the expiration of their patents. This provides an opportunity for pharmaceutical companies in India to develop and market biosimilars for these drugs. This trend is expected to contribute to the market expansion, as companies rush to capture market share in the post-patent expiration period.
Market Segmentation
The India biosimilar market can be segmented based on product type, therapy area, distribution channel, and region.
1 By Product Type
Monoclonal Antibodies (mAbs): Monoclonal antibodies are among the most widely used biologic drugs for the treatment of cancer, autoimmune diseases, and infectious diseases. The market for biosimilars of mAbs is one of the largest segments in the Indian biosimilars market.
Insulin: Biosimilar insulin is expected to see significant growth, driven by the rising prevalence of diabetes in India. Biosimilar insulin is an affordable alternative to branded insulin products.
Growth Hormones: Biosimilars for growth hormone therapies are increasingly being adopted in India, particularly for children with growth disorders.
Erythropoiesis-Stimulating Agents (ESAs): Biosimilars of ESAs are used in the treatment of anemia associated with chronic kidney disease and cancer chemotherapy.
Other Biosimilars: This includes biosimilars of interferons, filgrastim, and rituximab, which are used for various medical conditions such as autoimmune diseases, cancer, and blood disorders.
2 By Therapy Area
Oncology: The oncology segment holds a significant share of the India biosimilar market, driven by the increasing incidence of cancer and the high cost of cancer treatments. Biosimilars for drugs like rituximab, trastuzumab, and bevacizumab are gaining traction in India.
Diabetes: Biosimilar insulins are a major area of focus in the Indian market due to the growing diabetic population. These products offer an affordable alternative to expensive branded insulin products.
Autoimmune Diseases: Biosimilars for autoimmune diseases, including rheumatoid arthritis and psoriasis, are expected to drive market growth in the coming years. Biosimilars of etanercept and infliximab are widely used in these treatments.
Chronic Kidney Disease: With a rising number of patients suffering from chronic kidney disease (CKD), biosimilars for erythropoiesis-stimulating agents (ESAs) are gaining popularity.
3 By Distribution Channel
Hospital Pharmacies: Hospital pharmacies are a major distribution channel for biosimilars, especially for high-cost products such as monoclonal antibodies and insulin.
Retail Pharmacies: Retail pharmacies are also crucial in the distribution of biosimilars, particularly for products like insulin and growth hormone biosimilars.
Online Pharmacies: The rise of e-commerce and online pharmacies in India is contributing to the accessibility of biosimilars, particularly in urban areas.
Market Dynamics
1 Opportunities
Export Potential: India is already a global leader in the production of generic drugs. The country’s biosimilar manufacturers are also increasingly focusing on expanding their presence in international markets, especially in developing regions where biosimilars are gaining momentum.
Research and Development: The growing investment in biotechnology research and the focus on developing innovative biosimilars will open new opportunities in the market.
Partnerships and Collaborations: Collaborations between Indian companies and multinational corporations for biosimilar development will provide both technological expertise and access to international markets.
2 Challenges
Regulatory Hurdles: The regulatory landscape for biosimilars in India is evolving, and companies may face challenges in ensuring compliance with changing regulations. Although the CDSCO has streamlined the approval process, navigating the regulatory framework can still be complex.
Market Penetration: While the biosimilar market is growing, the penetration rate of biosimilars is still relatively low compared to biologics. Overcoming resistance from healthcare professionals and patients, who may be wary of the safety and efficacy of biosimilars, remains a challenge.
Intellectual Property Rights: Intellectual property concerns related to patents and patent infringements are common issues in the biosimilar sector, which could impede the growth of certain biosimilar products.
Key Players in the India Biosimilar Market
1 Biocon Limited
Biocon is one of India’s leading biotechnology companies and a pioneer in the development of biosimilars. The company’s Insulin Glargine (Basalog) and Trastuzumab (Canmab) have been successfully launched in India and other international markets.
2 Dr. Reddy’s Laboratories
Dr. Reddy's Laboratories has a strong presence in the biosimilar market with its portfolio of biosimilars, including filgrastim and rituximab. The company is focusing on expanding its biosimilar pipeline for oncology and autoimmune diseases.
3 Sandoz (Novartis)
Sandoz, a division of Novartis, is a major player in the biosimilars market. The company offers biosimilar infliximab and etanercept, which have gained significant market acceptance.
4 Mylan
Mylan has a growing presence in India’s biosimilar market, with a focus on biosimilars for oncology, diabetes, and autoimmune diseases. The company’s Herzuma and Renflexis are popular biosimilars.
FAQs
Q1: What is the current size of the India biosimilar market?
The India biosimilar market was valued at INR 2.20 billion in 2024 and is projected to grow at a CAGR of 25.20%, reaching INR 16.6 billion by 2034.
Q2: What are the key drivers for the growth of the biosimilar market in India?
The growth drivers include the rising prevalence of chronic diseases, the increasing cost of biologic drugs, government support, and the affordability of biosimilars.
Q3: Who are the major players in the India biosimilar market?
Key players in the India biosimilar market include Biocon Limited, Dr. Reddy’s Laboratories, Sandoz (Novartis), and Mylan.
Q4: What are the most common types of biosimilars used in India?
The most common types of biosimilars in India include insulin, monoclonal antibodies, and erythropoiesis-stimulating agents.
Q5: How does India compare to other countries in the biosimilar market?
India is one of the largest producers of biosimilars globally due to its strong pharmaceutical manufacturing capabilities, skilled workforce, and cost advantage.
