According to MRFR analysis, the Global Insulin Biosimilars Market Overview is expected to reach USD 1.68 billion by 2032 at a CAGR of 14.6% during the forecast period of 2023 to 2032.
A disease in which the body’s ability to produce or respond to the hormone insulin is impaired, resulting in abnormal metabolism of carbohydrates and elevated levels of glucose in the blood is termed as diabetes. Biosimilar insulin is designed to be highly similar to the original, or reference, insulin product described in a patent. As patents for major branded insulin products start to expire, a number of biosimilar insulin are expected to launch in the coming years.
The USFDA approved new insulin glargine Basaglar, for type 1 and type 2 diabetes which is a biosimilar version of Sanofi’s basal insulin Lantus (insulin glargine). Additionally, Lilly and Boehringer Ingelheim’s biosimilar insulin glargine has got approval through the European Medicines Agency’s (EMA’s) Biosimilar pathway. Such ongoing approvals by the respective authorities are expected to drive the growth of the insulin biosimilars market. An analysis conducted by the FDA revealed that the US marketed biosimilars typically launched with 15% to 35% lower initial list prices than comparative list prices of reference products. Additionally, even with only 1 generic on the market, list prices can drop by 31% to 39%. The reduction in cost helps patients to adhere to the treatment, thereby increasing the preference for biosimilar products.
FDA hopes to spur insulin biosimilar development with easier clinical trial requirements. In the draft guidance, the agency proposed guidelines reducing the need for clinical trials to test insulin biosimilars for the potential to provoke immune system reactions. Similarly, European regulators stopped recommending immunogenicity trials for insulin biosimilars since 2015.
The global insulin biosimilars market is currently dominated by a few market players. The key players are involved in expansion, acquisition, and strategic collaborations to maintain their global footprint. For instance, India-based Biocon and US-based partner Mylan announced in October 2019 the launch of the first insulin glargine biosimilar in Australia available on the Pharmaceutical Benefits Scheme (PBS). Almost two million Australians have diabetes, with approximately 280 Australians developing diabetes every day.
Regional Analysis
The market has been divided, by region, into the Americas, Europe, Asia-Pacific, and the Middle East & Africa.
The Americas are anticipated to hold the largest market share owing to the higher number of diagnosed patients undergoing treatment, available healthcare infrastructure, and the presence of prominent players in this region. The insulin biosimilars market in the Americas has further been branched into North America and Latin America, with the North American market divided into the US and Canada.
The European insulin biosimilars market report has been categorized as Western Europe and Eastern Europe. The Western European market has further been classified as Germany, France, the UK, Italy, Spain, and the rest of Western Europe. The insulin biosimilars market in Asia-Pacific has been segmented into Japan, China, India, South Korea, Australia, and the rest of Asia-Pacific. Due to the rising prevalence of diabetes and the expansion of healthcare facilities, the market in Asia-Pacific is expected to be the fastest-growing. The insulin biosimilars market in the Middle East & Africa has been divided into the Middle East and Africa.
Segmentation:
The global insulin biosimilars market has been segmented based on type and indication.
The market, based on type, has been divided into rapid-acting biosimilars, long-acting biosimilars, and premixed biosimilars. The long-acting biosimilars are likely to hold maximum market share in the global insulin biosimilars market owing to its benefits in the treatment for diabetes. Pre-mixed insulins are pre-formulated combinations of rapid-acting and long-acting insulin; they provide an approximation of basal/bolus therapy with the advantage of fewer total injection.
Based on indication, the insulin biosimilars market has been bifurcated into type I diabetes and type II diabetes. The type II diabetes segment is anticipated to hold a larger share in the market due to a large number of patients suffering from the condition as compared to type I diabetes.
Key Players:
Some of the key players in the global insulin biosimilars market are Sanofi S.A., Boehringer Ingelheim, Eli Lilly & Co., NOVO Nordisk A/S, Biocon, Merck & Co., Mylan N.V., Pfizer Inc., Sandoz, Fresenius Kabi, and others.
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