India Biosimilars Market Research Report, 2030

Biosimilars, a category of biological medical products, closely emulate original reference biologic drugs, ensuring comparable safety, purity, and potency without clinically significant differences. Unlike generic drugs, which are exact copies of small-molecule chemical drugs, biosimilars cannot replicate their reference biologics precisely due to inherent biological complexity and variability. In India, the adoption of biosimilars has gained momentum, with significant contributions to healthcare accessibility and affordability, backed by robust regulatory frameworks and growing market acceptance. India boasts an impressive portfolio of over 95 approved biosimilars domestically, a feat unrivaled by any other nation, underscoring its formidable presence in the biosimilar arena. Regulatory strides have been made in the Indian biosimilar sphere, with collaborative efforts between the Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) culminating in the formulation of comprehensive guidelines governing similar biologics. India has a thriving biosimilar ecosystem in comparison to other countries and because of that Indian pharmaceutical companies have risen as the global market leaders in biosimilars. India approved its first biosimilar much before the United States and Europe. The first biosimilar was approved and marketed in India in 2000 for hepatitis B, although no specific guideline was available at that time for the development and marketing of biosimilar in India. Indian companies are taking multiple steps to involve them in manufacturing and marketing to tap this huge potential. Biosimilars approved and used in India mainly consist of the vaccines, monoclonal antibodies, insulin, and recombinant proteins. India has achieved the distinction of being the second largest supplier of vaccines in the world. Various biosimilars have been approved by India for use in different diseases. According to the research report, “India Biosimilars Market Research Report, 2030” published by Actual Market Research, the India Biosimilars market is projected to grow with 20.66% CAGR by 2025-30. Increased demand for cost-effective healthcare solutions is a primary driver of the biosimilar market in India. Biosimilars offer more economical treatment options compared to originator biologics, making them preferable for patients and healthcare providers seeking accessible therapies. The impending expiration of patents on several biologic drugs creates significant market opportunities for biosimilar manufacturers in India. With patents reaching their expiry, it paves the way for the development and commercialization of biosimilar products, enabling companies to introduce more affordable alternatives. India’s cost competitiveness, burgeoning manufacturing base, intellectual prowess, and well-established marketing and distribution networks confer it with distinct advantages over its counterparts. The escalating healthcare awareness, augmented purchasing power, and enhanced access to medical services within India augur well for heightened domestic demand for economically viable biosimilars. The country has huge potential to tap the global biosimilars market, which is fast emerging. As India is regarded as the global pharmacy of the world with its supply of affordable high quality generic medicines to the world, India can equally gain the same reputation in the biosimilars space. Already India is meeting more than 60 per cent of global vaccine demand and given the huge off patent regime ahead for branded biologics.

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India now accounts for a sizable portion of the global market for biosimilars. When a biological product is referred to be "biosimilar," it means that it is very similar to another biological product that has already acquired regulatory clearance. They have the same efficacy and safety profiles as the reference product and are used to treat a number of disorders, including diabetes, autoimmune diseases, and cancer. India has a substantial and rapidly growing biosimilar sector as a result of the availability of low-cost production facilities and a sizeable labour pool of highly trained scientific and technical professionals. In India, the incidence of chronic diseases including cancer, hypertension, and diabetes is rising, which is fueling an increase in demand for biosimilars across the country. Because they are frequently less expensive than other pharmaceuticals, biosimilars are a viable choice for individuals who require long-term care. The nation's healthcare system is also changing, with a stronger emphasis now placed on ensuring everyone has access to inexpensive treatment. In India, the Central Drugs Standard Control Organization (CDSCO) is the regulatory body in charge of approving biosimilars. The World Health Organization (WHO) and other international regulatory bodies' rules are followed by the CDSCO. Indian biosimilars market is poised to huge growth rate owing to the increase in acceptance of the biosimilars and the rise in R&D activities by the life science industries in developing the biosimilars in the market. For instance, Novartis AG has entered into collaboration with Indian biopharmaceutical company, Biocon in development and commercial multiple biosimilars in oncology and immunology. In addition, new product launches and entry of completely new market players such as Aurobind Pharma into biosimilars projected to boost the market growth over the forecast period. Monoclonal antibodies are leading the biosimilars industry in India due to a convergence of clinical, economic, and policy-driven factors that have accelerated their adoption and development. These biologic drugs are pivotal in the treatment of chronic and life-threatening diseases such as cancer, rheumatoid arthritis, and other autoimmune disorders conditions with rapidly growing prevalence across the Indian population. Given the high cost of originator monoclonal antibodies, biosimilars offer a significantly more affordable alternative, addressing the pressing need for accessible advanced therapies in a country where out-of-pocket healthcare expenditure remains high. Indian pharmaceutical companies, notably Biocon, Dr. Reddy’s Laboratories, Intas Pharmaceuticals, and Cipla, have strategically prioritized monoclonal antibody biosimilars in their pipelines due to the substantial market potential both domestically and internationally. These firms benefit from India's well-established biologics manufacturing infrastructure and skilled workforce, allowing them to produce complex biosimilars at competitive costs. Additionally, the support of regulatory agencies such as the Central Drugs Standard Control Organization (CDSCO) and the introduction of biosimilar-specific guidelines by the Indian government have streamlined the approval process, promoting faster market access. India's robust export capabilities have further incentivized local players to develop monoclonal antibody biosimilars to meet global demand, particularly in regulated markets like Europe and emerging economies. Oncology is leading the biosimilars industry in India primarily due to the increasing cancer burden, high treatment costs of biologic therapies, and the urgent need for accessible alternatives. Cancer incidence in India has been rising steadily, with millions diagnosed annually, particularly with breast cancer, lung cancer, and colorectal cancer all of which often require expensive biologic treatments such as monoclonal antibodies and targeted therapies. Original biologic drugs used in oncology, like trastuzumab, bevacizumab, and rituximab, are prohibitively priced for a vast majority of Indian patients, making biosimilars a vital solution for affordable cancer care. Indian pharmaceutical companies have swiftly recognized this demand-supply gap and have invested heavily in the development and manufacturing of oncology biosimilars. Companies like Biocon, Intas Pharmaceuticals, Dr. Reddy’s Laboratories, and Reliance Life Sciences have developed world-class oncology biosimilars that are not only being used domestically but also exported to key international markets, strengthening India’s global footprint in cancer treatment innovation. The regulatory environment in India has also evolved to support this growth, with the Central Drugs Standard Control Organization (CDSCO) and Department of Biotechnology issuing guidelines to expedite the development and approval of biosimilars, particularly those that address life-threatening diseases like cancer. Additionally, public and private healthcare providers in India are increasingly integrating biosimilar oncology drugs into their treatment protocols due to their demonstrated safety, efficacy, and cost-effectiveness. This is especially significant in a country where a large portion of the population relies on government-funded or out-of-pocket healthcare systems. Moreover, oncology biosimilars are often among the first to be fast-tracked in regulatory approvals due to their life-saving potential.

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Nikita Jabrela

Business Development Manager

In-house manufacturers are leading the biosimilars industry in India due to their ability to exercise end-to-end control over the complex biologics development and production process, which is critical for maintaining quality, ensuring cost efficiency, and meeting regulatory standards. Developing biosimilars is a far more intricate process than traditional generics because biologics are large, complex molecules that require sophisticated technologies and stringent quality control across every stage from cell line development and fermentation to purification and formulation. Indian pharmaceutical companies like Biocon Biologics, Dr. Reddy’s Laboratories, Intas Pharmaceuticals, and Zydus Lifesciences have invested heavily in establishing vertically integrated manufacturing facilities that enable them to oversee each phase of biosimilar development under one roof. This integration reduces dependency on third-party suppliers, minimizes production delays, enhances intellectual property protection, and improves margins by eliminating outsourcing costs. Additionally, in-house manufacturing allows Indian firms to meet both domestic and global regulatory requirements more effectively. Many of these companies have received approvals from stringent international regulators like the U.S. FDA and EMA, which bolsters their reputation and competitiveness in global markets. The Indian government’s supportive policies, such as financial incentives under its “Make in India” initiative and the promotion of biotech parks and innovation hubs, further encourage local manufacturing and R&D capabilities. These in-house operations also facilitate faster scalability, which is crucial in responding to growing demand for biosimilars both in India where affordability and accessibility are paramount and in export destinations across South America, Africa, and Southeast Asia. Considered in this report • Historic Year: 2019 • Base year: 2024 • Estimated year: 2025 • Forecast year: 2030 Aspects covered in this report • Biosimilars Market with its value and forecast along with its segments • Various drivers and challenges • On-going trends and developments • Top profiled companies • Strategic recommendation

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By Product • Monoclonal Antibodies • Insulin • Erythropoietin • Others (Includes recombinant glycosylated and non-glycosylated proteins) By Application • Oncology • Chronic & Autoimmune Disorders • Blood Disorders • Growth Hormonal Deficiency • Infectious Disease • Others (Filgrastim/Pegfilgrastim, Teriparatide, Somatropin, Etanercept) By Manufacturer • In-house • Contract Research and Manufacturing Services The approach of the report: This report consists of a combined approach of primary as well as secondary research. Initially, secondary research was used to get an understanding of the market and listing out the companies that are present in the market. The secondary research consists of third-party sources such as press releases, annual report of companies, analyzing the government generated reports and databases. After gathering the data from secondary sources primary research was conducted by making telephonic interviews with the leading players about how the market is functioning and then conducted trade calls with dealers and distributors of the market. Post this we have started doing primary calls to consumers by equally segmenting consumers in regional aspects, tier aspects, age group, and gender. Once we have primary data with us we have started verifying the details obtained from secondary sources. Intended audience This report can be useful to industry consultants, manufacturers, suppliers, associations & organizations related to this industry, government bodies and other stakeholders to align their market-centric strategies. In addition to marketing & presentations, it will also increase competitive knowledge about the industry.