The global biosimilar market size is estimated to grow from USD 25,125.36 million in 2022 at 17.6% CAGR (2023-2032) to reach an estimated USD 1,26,019.67 million by 2032, as a result of the rising prevalence of cancer, and cost effectivity of biosimilars.

91% of the 6.4 billion prescriptions written for patients in the United States in 2021 were for generic or biosimilar medications. Biosimilars accounted for $7 billion in savings in 2021

Biosimilars are biological products that are highly similar to and have no clinically meaningful differences from, an existing FDA-approved reference product. They are also referred to as follow-on biologics, subsequent-entry biologics, or biogenerics. Biosimilars are not identical to their reference products, as they are derived from living cells that may have slight differences in their manufacturing processes. However, they have demonstrated similar efficacy, safety, and quality as their reference products in rigorous clinical trials.

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Around 39 biosimilars are approved and 22 biosimilars are marketed, reported as of September 2022.

Biosimilars offer significant cost savings compared to their reference products, making them an attractive option for patients, healthcare providers, and payers. The biosimilar market has been growing rapidly in recent years, driven by patent expirations of several biologic drugs and increasing demand for affordable biologic treatments.

The development and approval of biosimilars involve complex regulatory processes, as they are subject to more rigorous requirements compared to traditional generic drugs. Biosimilar manufacturers must demonstrate a high degree of similarity to their reference products in terms of quality, safety, and efficacy through extensive clinical studies. This involves conducting head-to-head comparisons of the biosimilar and the reference product in clinical trials to demonstrate their similarity.

Additionally, chronic diseases like rheumatoid arthritis, anemia, leukopenia, inflammatory bowel disease, psoriasis, and different types of cancer are treated with biosimilars. Moreover, these medications should cost 10 to 40% less than their reference products. More patients will have access to these medications as a result, which encourages adherence and enhances health outcomes for those patients who most need them. Biosimilars may cause patients to switch to more affordable treatments. They might also increase competition in the market for biologics, forcing businesses to change their prices in order to draw in and keep customers. In fact, it has been calculated that in their first ten years on the market, FDA-approved biosimilars could save consumers and the healthcare system up to $250 billion.

The Promising Role of Biosimilars in Addressing the Cancer Burden

Biosimilars are emerging as a promising option for cancer treatment, offering a more affordable and accessible alternative to expensive biologic drugs. Biologics are complex, large-molecule drugs that are derived from living cells and are widely used in cancer treatment. However, the high cost of biologics has limited access to cancer treatment for many patients, especially in developing countries.

Biosimilars, on the other hand, are designed to be highly similar to the original biologic drug, with no clinically meaningful differences in terms of safety, efficacy, and quality. They offer a more affordable alternative to biologics while maintaining similar clinical outcomes.

Several biosimilars have been approved for cancer treatment, including biosimilars of monoclonal antibodies used in the treatment of breast cancer, colorectal cancer, and non-Hodgkin’s lymphoma. Biosimilars of granulocyte colony-stimulating factor (G-CSF) have also been approved for the treatment of neutropenia, a common side effect of chemotherapy. The oncology applications accounted for contributing the largest market share of around 24.29% in 2022 and are further projected to continue their dominance and register the fastest growth in the upcoming years.

The use of biosimilars in cancer treatment has the potential to increase access to life-saving treatments for patients, particularly in low- and middle-income countries where cost is a major barrier to treatment. Biosimilars can also help reduce the financial burden on healthcare systems, allowing more patients to receive the treatment they need. Biosimilars have become an important part of cancer treatment as they offer more affordable and accessible options for these critical therapies.

However, there are also concerns about the safety and efficacy of biosimilars, as they are not exact copies of the original biologic drug. While regulatory agencies require biosimilars to undergo extensive testing and clinical trials before approval, some experts argue that more research is needed to fully understand the long-term safety and efficacy of biosimilars. Biosimilars have the potential to play a significant role in addressing the growing burden of cancer worldwide, by improving access to affordable and effective treatments. However, ongoing research and monitoring will be necessary to ensure that biosimilars are safe and effective for patients.

Biosimilars also offer significant cost savings for healthcare systems and insurers, which has led to greater investment in their development and increased collaboration between biosimilar manufacturers and healthcare providers. As more biosimilars become available, patients will have greater access to affordable and effective treatments, improving their quality of life and overall health outcomes.

In-house Manufacturing Strategies Positioning Companies to Dominate the Biosimilar Market

In-house manufacturing strategies have become increasingly popular among biosimilar companies as a means to gain a competitive edge in the market. By bringing manufacturing capabilities in-house, companies can improve their control over the production process, reduce costs, and accelerate the time to market their products. One of the prominent advantages of in-house manufacturing is the ability to optimize the manufacturing process and ensure quality control. This can be particularly important for biosimilar companies, where the ability to produce high-quality products is essential for gaining market acceptance. By bringing manufacturing in-house, companies can better manage the entire manufacturing process, from raw materials sourcing to final product testing, and ensure that their products meet or exceed regulatory requirements.

In addition to quality control, in-house manufacturing can also lead to cost savings. By eliminating the need to outsource production to third-party manufacturers, companies can reduce costs associated with transportation, warehousing, and other logistical expenses. Moreover, in-house manufacturing can lead to greater efficiency in the manufacturing process, reducing waste and increasing yields.

Another advantage of in-house manufacturing is the ability to accelerate the time to market for biosimilar products. By having control over the manufacturing process, companies can streamline the process and reduce the time required to manufacture and test their products. This can be particularly important in the rapidly evolving biosimilar market, where speed to market can be a critical factor in gaining a competitive advantage.

Thus, in-house manufacturing strategies can position biosimilar companies to dominate the market by enabling them to produce high-quality products, reduce costs, and accelerate the time to market for their products.

Biosimilars Market Top Companies

• Novartis
• Synthon Pharmaceuticals, Inc.
• TevaPharmaceutical Industries Ltd.
• LG Life Sciences
• Celltrion
• Biocon
• Hospira
• Merck Serono
• Biogen idec, Inc.
• Genentech

Segments Covered in the Report

By Product

• Monoclonal Antibodies
• Somatropin
• Insulin
• Erythropoietin
• Follitropin
• Others

By Application

• Oncology
• Growth Hormonal Deficiency
• Blood Disorders
• Chronic & Autoimmune Disorders
• Infectious Disease
• Others

By Manufacturer

• Contract Research and Manufacturing Services
• In-house

By Geography

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa