The India biosimilar market was valued at INR 2.20 billion in 2024, driven by the rising prevalence of chronic diseases, the increasing demand for cost-effective biologic therapies, and the growing adoption of biosimilars across the region. India’s healthcare system is undergoing rapid transformation, with an increasing focus on affordable healthcare solutions, and biosimilars have emerged as a key component in addressing the rising burden of diseases like cancer, autoimmune disorders, diabetes, and infectious diseases.

The market is expected to grow at an impressive CAGR of 25.20% during the forecast period of 2025-2034, with values likely to rise from INR 2.8 billion in 2025 to INR 16.6 billion by 2034. This significant growth is attributed to factors such as the growing adoption of biosimilar drugs, increased government support, expanding healthcare access, and advancements in biosimilar manufacturing processes.

The India biosimilar market, its dynamics, trends, and segmentation. We will also discuss the growth prospects, recent developments, and market scope, along with insights into the impact of the COVID-19 pandemic on the biosimilar sector.

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India Biosimilar Market Overview

What are Biosimilars?

Biosimilars are biologic medical products that are highly similar to an already approved reference biologic drug, with no clinically meaningful differences in terms of safety, efficacy, and quality. These products are developed to mimic the original drug but are typically more affordable due to the lower development and production costs. Biosimilars are essential in offering cost-effective alternatives to expensive biologic drugs, which are often out of reach for many patients in countries with limited healthcare budgets.

In India, the increasing burden of chronic diseases, including cancer, rheumatoid arthritis, diabetes, and autoimmune disorders, has fueled the demand for biologic therapies. As the patents for some of the world's top biologic drugs expire, biosimilars have gained significant traction as viable alternatives. This has led to a surge in the development, manufacturing, and marketing of biosimilars in India, further boosting the market.

Regulatory Landscape

The Indian government has been proactive in creating a conducive environment for the biosimilars market, with agencies like the Central Drugs Standard Control Organization (CDSCO) overseeing regulatory processes. India has introduced guidelines for the approval and monitoring of biosimilars, ensuring that these products meet the necessary standards for safety and efficacy.

In 2012, India became one of the first countries to approve a biosimilar version of etanercept, a widely used biologic drug. Since then, the approval process for biosimilars has gained momentum, and the market for these products is expanding rapidly. The National Biopharma Mission and other government initiatives have played a key role in encouraging the development of biosimilars.

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India Biosimilar Market Dynamics

Market Drivers

1. High Prevalence of Chronic Diseases: The increasing prevalence of chronic conditions such as cancer, rheumatoid arthritis, diabetes, and autoimmune disorders has significantly driven the demand for biologic therapies in India. As the cost of innovator biologics remains high, biosimilars offer a more affordable and accessible option to patients, thereby expanding market adoption.

2. Cost-Effectiveness of Biosimilars: The cost of biologic drugs remains prohibitively high for many patients in India, especially those in lower-income segments. Biosimilars provide a more affordable alternative without compromising on safety and efficacy, making them attractive to healthcare providers, insurers, and patients.

3. Patent Expiry of Biologic Drugs: The expiration of patents for several blockbuster biologic drugs, such as Humira, Rituxan, and Herceptin, has paved the way for the introduction of biosimilar drugs. The availability of affordable alternatives has significantly impacted the treatment landscape in India, increasing the accessibility of biologic therapies to a broader population.

4. Government Initiatives and Policies: The Indian government has made efforts to promote the development and use of biosimilars through initiatives such as the National Biopharma Mission and financial incentives for domestic biosimilar manufacturers. Additionally, the government's efforts to strengthen healthcare infrastructure and expand access to affordable drugs have further supported market growth.

5. Growing Healthcare Access: As India’s healthcare infrastructure improves and access to medicines becomes more widespread, the adoption of biosimilars is expected to increase. The expansion of healthcare facilities and the growing focus on universal health coverage are key factors contributing to the biosimilars market’s expansion.

6. Favorable Regulatory Framework: The CDSCO's regulatory framework for biosimilars provides a clear path for product approval. This encourages the development of biosimilars by both domestic and international manufacturers. The increasing number of biosimilars receiving approval in India is a positive indicator for the market's growth.

7. Increasing Awareness Among Healthcare Providers and Patients: Awareness about biosimilars has increased over the years, especially among healthcare professionals. The growing adoption of biosimilars by oncologists, rheumatologists, and other specialists is helping improve access to affordable biologics for patients in India.

Market Restraints

1. Intellectual Property Challenges: Despite the expiration of patents for some biologics, intellectual property issues remain a challenge in the biosimilar market. There is ongoing litigation over patent rights between innovators and biosimilar manufacturers, which can delay the availability of biosimilars in India.

2. Regulatory Hurdles and Approval Delays: Although the regulatory framework for biosimilars in India is improving, the approval process can still be complex and time-consuming. Delays in approval can impact the availability and adoption of biosimilars in the market.

3. Perception and Acceptance Issues: While biosimilars have been proven to be safe and effective, some patients and healthcare providers are still hesitant to switch from originator biologics to biosimilars due to concerns about efficacy, safety, and regulatory standards. Educating the public and healthcare professionals about the benefits of biosimilars remains a key challenge.

4. Limited Distribution and Access in Rural Areas: In India, access to biosimilars is often limited to urban areas, with rural regions facing challenges in terms of distribution and availability. This geographic disparity limits the market potential of biosimilars in the country.

External India Biosimilar Market Trends

1. Global Expansion of Indian Biosimilar Manufacturers: Indian companies such as Biocon, Cipla, and Dr. Reddy’s Laboratories are making significant strides in the global biosimilars market. By leveraging India’s cost-effective manufacturing capabilities, Indian companies are able to produce affordable biosimilars and expand into international markets. This trend is likely to continue as India becomes a hub for biosimilar production.

2. Technological Advancements in Biosimilar Development: Continuous advancements in biotechnology and bioprocessing technologies have enhanced the development of biosimilars. These technological improvements help reduce production costs, improve product quality, and shorten development timelines, further driving the market growth.

3. Increasing Collaboration Between Domestic and International Players: Collaborative partnerships between domestic biosimilar manufacturers and global pharmaceutical companies are increasing in India. These partnerships facilitate the development, manufacturing, and commercialization of high-quality biosimilars in India and other emerging markets.

4. Expanding Application Areas: Initially, biosimilars were primarily used in the treatment of oncology and rheumatology conditions. However, there is a growing trend of expanding biosimilar applications to other therapeutic areas, such as autoimmune diseases, diabetes, and neurological disorders. This expansion is expected to drive the growth of the market across a broader range of therapeutic categories.

India Biosimilar Market Segmentation

By Product Type

1. Monoclonal Antibodies (mAbs): The largest segment of the biosimilars market, mAbs are widely used in the treatment of cancer, autoimmune diseases, and chronic inflammatory diseases. Some of the leading biosimilars in this category include rituximab (biosimilar to Rituxan) and trastuzumab (biosimilar to Herceptin).

2. Insulin: Insulin biosimilars are in demand due to the high prevalence of diabetes in India. Biosimilar insulins, such as biosimilar insulin glargine (biosimilar to Lantus), offer more affordable alternatives to expensive branded insulin products.

3. Erythropoiesis-Stimulating Agents (ESAs): ESAs, used to treat anemia in cancer and chronic kidney disease patients, are another important segment of the biosimilars market.

4. Growth Hormones: Growth hormone biosimilars, such as somatropin, are used to treat growth disorders in children and adults. The market for growth hormone biosimilars is expanding in India.

5. Other Biosimilars: This includes filgrastim and interferons, used in a range of diseases including cancer, multiple sclerosis, and infections.

By End-User

1. Hospitals: Hospitals are the largest end-users of biosimilars, particularly in therapeutic areas like oncology and rheumatology.

2. Clinics: Biosimilars are also increasingly being used in clinics, particularly for outpatient care in chronic conditions.

3. Research and Academic Institutions: These institutions contribute to biosimilar development and are key users of biosimilars for clinical trials and research purposes.

India Biosimilar Market Growth

India's biosimilar market is poised for rapid growth, with major drivers including high unmet medical needs, the growing burden of chronic diseases, and the increasing adoption of biosimilars due to their affordability. Furthermore, the presence of well-established pharmaceutical companies in India, such as Biocon and Dr. Reddy's, will continue to drive market expansion.

Recent Developments

• Biocon's launch of the biosimilar insulin glargine (Basaglar) in India in collaboration with Mylan is a major milestone in the market.
• Celltrion Healthcare has made inroads into the Indian market with its biosimilar infliximab (Inflectra), targeting rheumatology and oncology indications.

COVID-19 Impact Analysis

The COVID-19 pandemic disrupted healthcare systems globally, and India was no exception. During the pandemic, there were disruptions in clinical trials, manufacturing delays, and logistical challenges. However, the pandemic also increased awareness about healthcare affordability and the need for cost-effective treatments like biosimilars, especially in chronic disease management.

Key Players

1. Pfizer Inc.: A leading global pharmaceutical company, Pfizer is involved in the development of biosimilars in areas like oncology, immunology, and cardiology.
2. Eli Lilly and Company: Eli Lilly is actively involved in the development of biosimilars, particularly in diabetes and oncology.
3. Celltrion Healthcare: A key player in the Indian biosimilars market, Celltrion offers biosimilar infliximab and other biologics for chronic diseases.

FAQ

1. What are the advantages of biosimilars? Biosimilars offer lower costs compared to reference biologics, increasing affordability and accessibility for patients in need of biologic therapies.

2. Are biosimilars as safe as reference biologics? Yes, biosimilars are rigorously tested for safety, efficacy, and quality. Regulatory agencies like the FDA and CDSCO ensure that biosimilars meet the required standards.

3. Why is India an important market for biosimilars? India has a large and growing patient population with chronic diseases, and biosimilars offer an affordable alternative to expensive biologic therapies, making them essential for improving healthcare access.