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 growing burden of diseases such as cancer, diabetes, autoimmune conditions, and others is driving the demand for biologic treatments. As patents for several blockbuster biologic drugs expire, biosimilars are becoming more accessible, affordable, and a preferred option for many healthcare providers and patients. This blog post will explore the India biosimilar market, its dynamics, growth drivers, trends, key players, and the impact of the COVID-19 pandemic.
Get a Free Sample Report with a Table of Contents: https://www.expertmarketresearch.com/reports/india-biosimilar-market/requestsample
India Biosimilar Market Overview
Biosimilars are biologic medical products highly similar to an already approved reference biologic product, with no significant differences in safety, purity, and potency. The demand for biosimilars is driven by the growing need for affordable alternatives to expensive biologic drugs, which are used to treat various chronic diseases such as cancer, rheumatoid arthritis, and diabetes. India, with its large population and increasing healthcare needs, presents a significant market opportunity for biosimilar manufacturers.
The Indian biosimilar market is supported by favorable government policies, increasing investment in healthcare infrastructure, and the availability of high-quality manufacturing facilities. As the market for biologics continues to grow, especially in therapeutic areas such as oncology, immunology, and diabetes, the market for biosimilars is also expanding. Indian pharmaceutical companies have become global leaders in the production of biosimilars, benefiting from cost-effective production capabilities, skilled workforce, and regulatory expertise.
Read Full Report with Table of Contents: https://www.expertmarketresearch.com/reports/india-biosimilar-market
India Biosimilar Market Dynamics
Market Drivers
Rising Prevalence of Chronic Diseases: India faces a growing burden of chronic diseases such as cancer, diabetes, cardiovascular diseases, and autoimmune disorders. This has led to an increased demand for biologic treatments. As biologic drugs often come with high costs, biosimilars offer a more affordable alternative, driving their adoption.
Expiring Patents of Biologics: Many high-value biologic drugs, including monoclonal antibodies, insulin, and growth hormones, have patents that are expiring. Once patents expire, biosimilar manufacturers can produce versions of these biologics at a lower cost, thus making these treatments more accessible to patients and healthcare providers.
Government Initiatives and Support: The Indian government has been actively promoting the use of biosimilars through various initiatives. The approval process for biosimilars in India has been streamlined, and the government has introduced favorable policies to encourage the production and use of biosimilars in the country. Programs aimed at improving healthcare access and affordability also support the growth of the biosimilar market.
Affordability of Biosimilars: Biosimilars are generally priced lower than the original biologics, making them more affordable for both patients and healthcare systems. In India, where a large portion of the population lacks adequate health insurance coverage, the cost-effectiveness of biosimilars is a key factor in their adoption.
Technological Advancements in Biomanufacturing: Advances in biomanufacturing technologies, such as cell line development and process optimization, have helped reduce the cost of biosimilar production. These improvements are expected to drive the availability of high-quality, low-cost biosimilars in India.
Expanding Healthcare Access: As India’s healthcare infrastructure continues to improve, there is greater access to healthcare services, including biologic treatments. The introduction of biosimilars is helping to bridge the treatment gap, particularly in underserved areas.
Market Restraints
Regulatory Challenges: The approval process for biosimilars, while more streamlined in India than in many other regions, still faces challenges. Regulatory guidelines for biosimilars are constantly evolving, and some biosimilars may face delays in approval due to regulatory scrutiny and clinical trial requirements.
Competition from Generic Drugs: Generic drugs, which are chemically identical to branded drugs, remain a strong competitor to biosimilars in India. While biosimilars are biologically similar to reference biologics, they are not exact copies, which can lead to hesitancy among healthcare providers and patients who are familiar with generics.
Lack of Awareness: Despite increasing awareness about biosimilars, many patients and healthcare providers in India are still unaware of their benefits and differences from original biologic drugs. This can lead to slower adoption of biosimilars, particularly in rural areas where education and healthcare access are limited.
Manufacturing Costs: Although biosimilars are more affordable than reference biologics, the cost of manufacturing them can still be high due to complex production processes and the need for regulatory compliance. This could limit the ability of some companies, particularly smaller firms, to compete effectively in the market.
External India Biosimilar Market Trends
1. Growth in Global Biosimilar Market
The global biosimilar market is expanding rapidly as governments and healthcare systems around the world seek cost-effective alternatives to expensive biologics. This global growth is driving the Indian biosimilar market, as Indian manufacturers capitalize on their strong biosimilar production capabilities to supply both domestic and international markets.
2. Collaborations with Global Biopharmaceutical Companies
Many Indian biosimilar manufacturers are forming strategic partnerships with global biopharmaceutical companies to develop and market biosimilars. These collaborations help Indian companies gain access to advanced technologies, improve product offerings, and enter international markets more easily.
3. Increase in Biosimilar Approvals
The approval process for biosimilars has become more streamlined globally, with regulatory agencies such as the FDA and EMA setting clear guidelines for their approval. In India, the Central Drugs Standard Control Organization (CDSCO) has also worked to create an efficient regulatory pathway for biosimilars, resulting in increased approvals and availability of biosimilars in the market.
4. Focus on Oncology and Autoimmune Diseases
Biosimilars are gaining particular traction in the oncology and autoimmune disease segments. With the growing burden of cancer and autoimmune diseases in India, the market for oncology and immunology biosimilars is expected to grow significantly, with treatments for diseases like rheumatoid arthritis and inflammatory bowel disease becoming more accessible.
India Biosimilar Market Segmentation
The India biosimilar market can be segmented based on type, application, and distribution channel.
1. By Type
- Monoclonal Antibodies: These are one of the largest segments in the biosimilar market. Monoclonal antibody biosimilars are used in the treatment of cancer, autoimmune diseases, and other conditions.
- Insulin: Insulin biosimilars are used for diabetes management and are expected to witness significant growth due to the increasing diabetes prevalence in India.
- Growth Hormones: Recombinant growth hormone biosimilars are used to treat conditions such as dwarfism and growth disorders. This segment is expected to grow as awareness increases and treatment options become more affordable.
- Other Biosimilars: These include biosimilars for diseases such as rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease.
2. By Application
Oncology: Biosimilars are increasingly being used in oncology to treat various types of cancers. The market for oncology biosimilars in India is expected to expand rapidly, driven by the rising incidence of cancer and the cost-effectiveness of biosimilars compared to original biologics.
Autoimmune Diseases: Biosimilars used in the treatment of autoimmune diseases, such as rheumatoid arthritis and Crohn’s disease, are also gaining traction in the Indian market.
Diabetes: Insulin biosimilars are becoming a popular treatment option in India, where diabetes is a growing health concern. The demand for insulin and insulin biosimilars is expected to rise significantly.
3. By Distribution Channel
Hospitals and Clinics: Hospitals and clinics remain the primary distribution channels for biosimilars, as they are the major point of care for patients requiring these medications.
Pharmacies and Retail: Pharmacies are also important distribution channels for biosimilars, particularly for insulin and growth hormone biosimilars.
Online Pharmacies: The rise of online pharmacies and e-commerce platforms in India is making biosimilars more accessible to consumers across the country.
India Biosimilar Market Growth
The India biosimilar market is poised for significant growth over the forecast period. The rising incidence of chronic diseases, the demand for affordable healthcare solutions, and the increasing approval of biosimilars by regulatory agencies will fuel the growth of the market. Additionally, technological advancements in biosimilar production and strategic collaborations with international pharmaceutical companies will provide new opportunities for market expansion.
Recent India Biosimilar Market Developments
India has seen numerous advancements in biosimilar production in recent years. Many Indian pharmaceutical companies, including Sun Pharmaceutical Industries, Biocon, and Dr. Reddy’s Laboratories, are at the forefront of developing and manufacturing biosimilars. The Indian government has also supported biosimilar initiatives by simplifying regulatory processes and promoting research in this area.
India Biosimilar Market Scope
The India biosimilar market has a broad scope, with opportunities in various therapeutic areas such as oncology, autoimmune diseases, diabetes, and growth hormone deficiency. As the Indian healthcare system improves and the demand for affordable medications increases, the biosimilar market will continue to expand. India is well-positioned to become a global leader in the biosimilar space, with its strong manufacturing capabilities and skilled workforce.
India Biosimilar Market Analysis
The India biosimilar market is set to experience robust growth, driven by favorable government policies, an increasing burden of chronic diseases, and the rising adoption of biosimilars as affordable alternatives to original biologic drugs. With key players investing in research and development, India is poised to become a major player in the global biosimilar market.
COVID-19 Impact Analysis
The COVID-19 pandemic had a significant impact on the biosimilar market in India. While the healthcare sector faced numerous challenges, the importance of affordable and accessible treatments became more evident. Biosimilars were essential in ensuring continued access to critical medications during the pandemic, which led to an increase in their adoption. Additionally, the pandemic highlighted the need for robust healthcare infrastructure, further driving investments in biosimilar production and distribution.
Key Players in the India Biosimilar Market
Pfizer Inc. (Headquarters: United States) Pfizer is a major player in the biosimilar market, offering a range of biosimilars for oncology, autoimmune diseases, and other therapeutic areas. The company is expanding its footprint in India through partnerships and local manufacturing initiatives.
Eli Lilly and Company (Headquarters: United States) Eli Lilly is a leading biopharmaceutical company involved in the development and production of biosimilars, particularly insulin. The company is well-positioned in India’s growing diabetes care market.
Celltrion Healthcare (Headquarters: South Korea) Celltrion is a leading manufacturer of biosimilars, with a focus on oncology and autoimmune diseases. The company has been expanding its presence in India, offering high-quality and affordable biosimilars.
(FAQ)
1. What are biosimilars?
Biosimilars are biologic medical products that are highly similar to an approved reference product, with no clinically meaningful differences in terms of safety, purity, and potency.
2. Why are biosimilars important in India?
Biosimilars provide an affordable alternative to expensive biologics, improving access to life-saving treatments for patients suffering from chronic diseases like cancer, diabetes, and autoimmune disorders.
3. Who are the major players in the India biosimilar market?
Key players in the India biosimilar market include Pfizer Inc., Eli Lilly and Company, and Celltrion Healthcare, which are involved in the development and distribution of biosimilars across various therapeutic areas.
