The insulin glargine market is estimated to be valued at USD 5.45 billion in 2024, exhibiting a CAGR of 6.4% over the forecast period 2024 - 2031. Increasing prevalence of diabetes worldwide is expected to drive the market growth. Furthermore, the patent expiration of major insulin brands has enabled the production and availability of biosimilar alternatives at lower costs, which has increased accessibility to insulin treatment for many patients.
Market Dynamics:
Global insulin glargine market growth is primarily driven by rising global prevalence of diabetes. According to International Diabetes Federation 2021 Report, approximately 537 million adults lived with diabetes in 2021 worldwide, and the number is projected to rise to 643 million by 2030 and 783 million by 2045. Increased sugar consumption and sedentary lifestyles have significantly contributed to the diabetes epidemic. Furthermore, better access to biosimilar insulins after major patent expirations has made life-saving insulin therapy more affordable for patients. Lower priced biosimilars have increased patient uptake and volume growth for the market. However, stringent regulations for biosimilar approval continue to hinder rapid market entry of new players.
Increasing prevalence of diabetes
One of the key drivers boosting demand for insulin glargine is rising prevalence of diabetes globally. Insulin glargine is commonly prescribed for the treatment of type 1 and type 2 diabetes. As the diabetic population grows, more patients will require insulin therapy including insulin glargine which will positively impact the market growth.
Product innovations leading to improved efficacy and convenience
Continuous innovations in insulin glargine formulations by key players are helping improve treatment outcomes for patients. For example, new insulin glargine products with more extended-release profiles offer improved glycemic control with just one daily injection. Some latest formulations also claim faster absorption for a more physiological insulin profile. Such novel products provide superior efficacy and convenience over existing glargine options, thereby, increasing patient demand and market uptake. Product line extensions are a major driver expected to sustain the market momentum in near future.
Availability of alternative treatment options
Availability of alternative treatment regimens poses a major challenge to insulin glargine market growth. For instance, oral anti-diabetic drugs are preferred initially for type 2 diabetes management before initiating insulin therapy. Also, newer GLP-1 analogs and SGLT2 inhibitors provide efficacious non-insulin-based treatment options. This reduces sole dependence on insulin therapy including glargine in many patient cases. This acts as a major restrain limiting market potential.
Biosimilar competition following product patent expiries
Patent expiries of major insulin glargine brands in recent years has led to increased biosimilar competition. Leading manufacturers losing patent protection of their originator products faces challenges around market share loss to low-cost substitutes. Availability of cheaper biosimilar alternatives reduces demand and pricing power for branded products, posing a threat.
Increasing focus on emerging markets
Emerging Asian, Latin American and African countries offer huge untapped market opportunities owing to growing diabetes burden coupled with large underserved patient populations still relying on older insulin versions or oral drugs. Key players are increasingly focusing on these regions through acquisitions, partnerships and capacity expansion to capitalize on future growth opportunities. Market penetration in emerging countries will remain an area of focus offering scope for market expansion globally.
Combination products with other drug classes
Developing innovative fixed-dose combination products integrating insulin glargine with other unrelated drug classes hold promising business opportunities. For example, recent studies evaluated efficacy of combining glargine with other anti-diabetic molecule classes in a single device for improved glycemic control. Successful products could allow targeting unmet needs in diabetes management through superior treatment adherence and outcomes. Combination product development is an area attracting reasonable R&D investments to drive future growth.
Link: https://www.coherentmarketinsights.com/market-insight/insulin-glargine-market-5231
Key Development
- In March 2023, Sanofi, a leading pharmaceutical and healthcare entity, announced a significant reduction in the list price of Lantus (insulin glargine injection) 100 Units/mL, its widely prescribed insulin variant in the U.S. The reduction amounts to a substantial 78%. Moreover, the company has pledged to implement a cap of USD 35 for out-of-pocket expenses on Lantus for all patients covered by commercial insurance plans. This initiative underscores Sanofi's enduring dedication to ensuring accessible and affordable medication for patients in need.
- In July 2021, Biocon Biologics Ltd. and Viatris Inc. had jointly disclosed the approval of Semglee (insulin glargine-yfgn injectable) by the U.S. Food and Drug Administration (FDA). This approval marks a significant milestone as Semglee becomes the first interchangeable biosimilar to receive FDA approval under the 351(k) regulatory pathway.
- In August 2020, Mylan N.V. (now a part of Viatris Inc.) and Biocon Biologics India Ltd., a subsidiary of Biocon Ltd., jointly announced the launch of Semglee (insulin glargine injection) in vial and pre-filled pen formats in the U.S. Semglee is approved for aiding in the management of elevated blood sugar levels in both adult and pediatric patients diagnosed with type 1 diabetes, as well as in adult patients with type 2 diabetes.
Key Players: Sanofi, Biocon, Eli Lilly and Company, Boehringer Ingelheim, Gan & Lee, Kalbe Pharma, Polus Biopharm, Samsung Bioepis, Wockhardt, Novo Nordisk AS, Julphar, and Viatris Inc.
