Biosimilars are biological products that have active properties that are similar to those of a previously licensed drug and have no clinically relevant differences in terms of safety and effectiveness. Insulin biosimilars are biosimilars that are indistinguishable from the reference insulin product and have already been approved or licensed by the FDA. Biosimilars are made using similar manufacturing procedures to those used by the patented product, but not necessarily identical to those used by the patent holder.
Patents for insulin formulations were about to expire or had already expired due to an increase in insulin manufacturers from both developed and developing countries. This necessitated the need for biosimilar insulin approvals in highly regulated markets.
COVID-19 Impact analysis
- COVID-19 disease has infected millions of individuals around the world at the beginning of 2021. Most sectors have been severely impacted, except medical supplies and life support products, and the human insulin sectors have been severely hit. COVID-19 is anticipated to increase the number of diabetes cases, and as the pathophysiology of COVID-19-induced diabetes is more recognized, there will be more patients in need of targeted therapies.
- COVID-19 may induce T1D by destroying insulin-producing cells in the pancreas, either directly or as a result of inflammation caused by the immune system combating the virus. The COVID-19 virus may thrive in high-blood-glucose environments, which could lead to T2D. This is projected to lead to the development of insulin biosimilars.
Top Impacting Factors
The market is being propelled by an increase in elderly population, high prevalence of Type 1, Type 2, and gestational diabetes, and surge in need for fast-acting insulin analogs.
Government agencies' increased investment in R&D activities related to insulin biosimilars boosts the market growth.
Furthermore, the low cost of biosimilar insulin for diabetes treatment, combined with its efficacy, is expected to open up new growth opportunities for the global insulin biosimilars market.
Several firms are focusing on the development of medical devices that make biosimilar insulin delivery less painful and self-delivered. The global insulin biosimilars market is predicted to grow as a result of this aspect.
Furthermore, insulin manufacturing companies are expected to lose their patents in the near future, providing abundant development prospects for the global insulin biosimilars market.
However, generic manufacturers are likely to take a smaller chunk of the amount owing to their local presence which would restrain the growth of the market.
Market Trends
New product launches to flourish the market
- In March 2019, Eli Lilly announced that the company is introducing a lower-priced authorized generic of its originator insulin lispro brand, Humalog, into the U.S. market. Eli Lilly has indicated that the list price of its authorized generic will be 50 percent lower than the current list price of Humalog and that it will be marketed under a different subsidiary brand. This strategy has been observed in other areas of the industry, with a recent example being Gilead launching authorized generics of its hepatitis C drugs Harvoni and Epclusa at a 75 percent list price discount to the brands, under its subsidiary company Asegua Therapeutics. Like Gilead and other companies that have adopted this strategy, Eli Lilly has done so under growing political and public pressures to lower its drug prices.
- In August 2020, Mylan N.V. and Biocon Biologics India Ltd., announced the U.S. launch of Semglee™ (insulin glargine injection) in vial and pre-filled pen presentations, approved to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes. It is not recommended for the treatment of diabetic ketoacidosis. Semglee, which received final approval from the U.S. Food and Drug Administration (FDA), has an identical amino acid sequence to Sanofi's Lantus® and is approved for the same indications.
Key Benefits of the Report
- This study presents the analytical depiction of the Insulin Biosimilars along with the current trends and future estimations to determine the imminent investment pockets.
- The report presents information related to key drivers, restraints, and opportunities along with detailed analysis of the Insulin Biosimilars market share.
- The current market is quantitatively analyzed to highlight the Insulin Biosimilars market growth scenario.
- Porter’s five forces analysis illustrates the potency of buyers & suppliers in the market.
- The report provides a detailed Insulin Biosimilars market analysis based on competitive intensity and how the competition will take shape in coming years.
Questions answered in the Insulin Biosimilars Report
- Who are the leading market players active in the Insulin Biosimilars market?
- What current trends will influence the market in the next few years?
- What are the driving factors, restraints, and opportunities in the market?
- What future projections would help in taking further strategic steps?
- What is "Insulin Biosimilars "?
- What is "Insulin Biosimilars " Market prediction in the future?
- Who are the leading global players in the "Insulin Biosimilars " Market?
- What are the current trends and predicted trends?
- What are the key benefits of the "Insulin Biosimilars " Market report?
Insulin Biosimilars Market, by Product Type Report Highlights
| Aspects | Details |
 By Product Type |
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 By Indicative |
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 By End User |
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 By Region |
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 Key Market Players | Sandoz, Fresenius Kabi, Merck & Co., Eli Lilly & Co., Pfizer Inc, Sanofi S.A, Boehringer Ingelheim, Biocon, Mylan N.V., others., NOVO Nordisk A/S |
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