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Market Dynamics
Rising Diabetes Prevalence Fuels Global Market Growth
The steadily increasing number of diabetes cases worldwide is expected to significantly drive market growth over the forecast period. According to the World Health Organization (WHO), more than 422 million people globally live with diabetes primarily in low- and middle-income countries and the disease is directly responsible for over 1.5 million deaths annually. Both the prevalence and incidence of diabetes have been rising consistently over recent decades.
Looking ahead, the International Diabetes Federation (IDF) projects that by 2045, one in eight adults approximately 783 million people will be living with diabetes, marking a 46% increase from current figures. Notably, over 90% of these cases are type 2 diabetes, a condition influenced by a combination of socio-economic, demographic, environmental, and genetic factors.
Organizations such as Diabetes Australia recognize diabetes as the fastest-growing chronic disease globally, with rising case numbers reported across nearly every nation. In 2021 alone, diabetes contributed to approximately 6.7 million deaths worldwide.
In addition to the growing disease burden, other factors such as the aging global population and increased investment in research and development are expected to further support market expansion, particularly in the areas of diabetes management, biologics, and biosimilar therapies.
Market Segments
By Product (Long Acting Biosimilars, Rapid Acting Biosimilars, Premixed Biosimilars)
By Indication (Type 1 Diabetes, Type 2 Diabetes)
By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies)
By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa)
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Market Regional Share
North America Set to Dominate the Global Market
North America is projected to lead the global market over the forecast period, driven by strategic initiatives to produce cost-effective insulin and an increasing number of market developments focused on biosimilars.
A notable example comes from California, where the state government earmarked $100.7 million in the 20222023 budget for the CalRX Biosimilar Insulin Initiative, aimed at improving insulin accessibility and affordability.
This funding includes:
$50 million for the development of low-cost interchangeable biosimilar insulin products,
$50 million for establishing a state-based insulin manufacturing facility,
$700,000 annually (from 2023 to 2026) to support ongoing state operations related to the initiative.
These investments reflect a broader push to tackle high insulin costs and promote healthcare equity through domestic biosimilar production.
In addition, Meitheal Pharmaceuticals, a Chicago-based biopharmaceutical company, entered into an exclusive licensing agreement in September 2023 with Tonghua Dongbao Pharmaceutical to commercialize three insulin biosimilarsinsulin aspart, insulin lispro, and insulin glarginein the U.S. Under this agreement, Meitheal has full rights to develop and commercialize these biosimilars in the U.S., while Tonghua Dongbao retains manufacturing responsibilities.
Such partnerships and state-level investments position North America as a key driver of growth in the global biosimilars and biologics market, particularly in the diabetes care segment.
Market Key Players
Key players are Boehringer Ingelheim, Pfizer Inc., Biocon, Merck & Co., Eli Lilly & Co., NOVO Nordisk A/S, Sanofi S.A., Ypsomed AG, Amphastar Pharmaceuticals, Inc. and Julphar Gulf Pharmaceutical Industries.
Recent Developments
In November 2022, Biocon Biologics Ltd., an associate of Biocon Ltd. completed the acquisition of the multinational biosimilars business of its partner Viatris Inc. Biocon Biologics and Viatris have acquired all relevant permissions from essential multinational regulators including the U.S. Federal Trade Commission, the Competition Commission of India and the Reserve Bank of India, and its investors.
In October 2021, Sandoz association with Chinas Gan & Lee covering three biosimilar insulin products persists to create advancement, with the closing of a couple of Phase III trials concerning a suggested biosimilar to Lantus (insulin glargine).