According to our new research study on “Biosimilars Market Forecast to 2028 – COVID-19 Impact and Global Analysis – by Disease Indication, Drug Class, Route of Administration, and End User,” the biosimilars market size is expected to grow from US$ 18,435.89 million in 2021 to US$ 136,069.53 million by 2028; it is estimated to record a CAGR of 34.8% during 2021–2028. The report highlights the trends prevailing in the market, along with market drivers and deterrents. Factors driving the biosimilars market growth are the increasing prevalence of chronic diseases and cost effectiveness of biosimilars drugs. However, high-cost involvement and complexities in biosimilars product manufacturing hinder the biosimilars market growth.
Biosimilars offer potential benefits to every stakeholder in the health system by providing a lower cost but equally effective treatment option such as biologics. During 2017–2018, the National Health Service (NHS) saved US$ 401.10 million by switching from using ten expensive medicines to better value and equally effective alternatives such as biologics, expecting even more savings to be achieved in the future. The potential savings from using biosimilars can also be used to fund other new treatments. The uptake of biosimilars has been slower in the US than the uptake in European Union (EU) countries. The EU is leading in biosimilars approvals, utilization, and cost savings awareness.
Most health systems have developed protocols, incentives, and diverse reimbursement and procurement policies to ensure biosimilars to improve potential savings. However, the decision to prescribe or switch to a biological medicine for an individual patient, whether an originator or biosimilars medicine, is taken by the responsible clinician in consultation with the patient and their family/carers.
According to the report on biosimilars by Cardinal Health in 2022, biosimilars treatment options are proven to be as safe and effective as originator biologics. Biosimilars are approved through an abbreviated FDA pathway to expand patient access to high-quality, lower-cost care. As of January 2022, there are 33 FDA-approved biosimilars in the US, 21 commercially available on the market. The market entrance of biosimilars leads to greater competition, thereby lowering costs and increasing the accessibility and affordability of these critical treatments. Therefore, the cost effectiveness of biosimilars drugs fuels the biosimilars market growth.
Based on disease indication, the global biosimilars market is segmented into cancer, diabetes, autoimmune diseases, and other diseases. In 2021, the cancer segment accounted for the largest market share, whereas the autoimmune diseases segment is expected to register a CAGR of 36.1% during the forecast period. According to the Centers for Disease Control National Diabetes Statistics Report, about 3.9% of the population in the UK have diabetes. Insulin is a crucial therapy for millions of people with partial or complete insulin deficiency. The high cost of insulin treatment and the increasing number of diabetes patients on insulin therapy present a true challenge to healthcare systems. This is where insulin biosimilars represent an opportunity to reduce costs while maintaining quality and safety. Biosimilars products could reduce the cost of insulin for people suffering from diabetes, thus, promoting the biosimilars market growth.
The World Health Organization (WHO) has undertaken important actions to promote better access to biosimilars insulins and medical devices for diabetes care. The US Food and Drug Administration approved the first interchangeable biosimilars insulin product in 2021, indicated to improve glycemic control in adults and pediatric patients affected by Type 1 diabetes mellitus and adults by Type 2 diabetes mellitus. Semglee is biosimilars and interchangeable with its reference product Lantus. Semglee is the first interchangeable biosimilars product approved to treat diabetes. Approval of these insulin products can provide patients with additional safe, high-quality, and potentially cost-effective options for treating diabetes.
Furthermore, the FDA approved the second interchangeable insulin glargine biosimilars, Rezvoglar, to improve glycemic control in adults and pediatric patients suffering from diabetes, according to a drug information update from the agency. FDA approved insulin glargine-aglr as a biosimilars to insulin glargine in December 2021. Rezvoglar is the second biosimilars insulin to be deemed interchangeable in the US following approval of insulin glargine-yfgn (Semglee, Mylan) as interchangeable biosimilars insulin in July 2021. The FDA approval means patients can receive Semglee or Rezvoglar at their pharmacy in place of insulin glargine. Owing to the above-mentioned factors, the biosimilars market growth for the disease indication segment is likely to propel during the forecast period.
Biocon Ltd, Sanofi-Aventis, Celltrion Inc., Amgen Inc., Pfizer Inc., Samsung Bioepis, Sanofi SA, Coherus BioSciences Inc, Dr. Reddy’s Laboratories Ltd, Eli Lilly and Co, Sandoz AG, and Teva Pharmaceutical Industries Ltd. are a few prominent players operating in the biosimilars market.
Companies are launching new and innovative products and services to sustain their position in the biosimilars market. This boosts the biosimilars market growth. In April 2020, Samsung Bioepis announced the launch of ONTRUZANT in the US for early and metastatic HER2-overexpressing breast cancer and metastatic gastric cancer.
The report segments the global biosimilars market as follows:
Based on disease indication, the biosimilars market is segmented into cancer, diabetes, autoimmune diseases, and others. Based on drug class, the market is classified into granulocyte colony-stimulating factors, human growth hormone, insulin, TNF blockers and monoclonal antibodies, erythropoietin-stimulating agents, and others (osteoporosis, etc). By route of administration, the biosimilars market is segmented into intravenous, subcutaneous, and others. Based on end users, the market is classified into hospitals, speciality clinics, homecare, and others. By geography, the biosimilars market is segmented into North America (the US, Canada, and Mexico), Europe (the UK, Germany, France, Italy, Spain, and the Rest of Europe), Asia Pacific (China, Japan, India, Australia, South Korea, and the Rest of Asia Pacific), the Middle East & Africa (the UAE, Saudi Arabia, South Africa, and the Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and the Rest of South & Central America).
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