Insulin Biosimilars Market Trends:
Analyzing Industry Developments 20232030
The global market for insulin biosimilars is expected to witness significant expansion, driven by the
escalating prevalence of Type 1 diabetes and the soaring costs of current insulin medications.
According to industry experts, the market size of insulin biosimilars reached USD 2.6 billion in 2021,
with a projected compound annual growth rate (CAGR) of 5.2% in the coming years.
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The rising global incidence of diabetes, one of the fastest-growing chronic illnesses, has contributed
to the expanding market for insulin biosimilars. The World Health Organization estimates that by
2021, 537 million adults worldwide will have diabetes, with one in ten individuals developing
additional forms of the disease. Governments are also focusing on approving insulin biosimilars to
alleviate the financial burden of healthcare expenses. Furthermore, the aging population and
increasing obesity rates have made people more susceptible to chronic illnesses. The World Bank
Group reported that the global senior population surpassed 727 million in 2020 and is projected to
reach nearly 1.5 billion by 2050.
To foster long-term growth, major pharmaceutical and healthcare companies have intensified their
research and development efforts in creating biosimilar versions of biologics. These companies are
adopting strategic measures such as mergers and acquisitions, partnerships, and collaborations to
establish market leadership, enhance customer retention, and expand their product portfolios.
Notably, Biogen and Samsung Biologics formed Samsung Bioepis in January 2021, resulting in the
introduction of multiple biosimilar versions of drugs in Europe, including infliximab, etanercept,
adalimumab, and trastuzumab.
The market for insulin biosimilars is poised to benefit from the combination of improved efficacy in
diabetes treatment and affordable prices, creating new growth opportunities worldwide. Several
companies are focusing on developing medical devices that enable the less painful selfadministration of biosimilar insulin. In July 2021, Biocon, an Indian-based biopharmaceutical
company, received clearance from the United States for Semglee, an innovative biosimilar insulin
medication. Semglee, which is interchangeable with and biosimilar to Lantus, has already gained US
approval. This development is expected to drive the demand for insulin biosimilars globally.
However, the COVID-19 pandemic has had an adverse impact on the insulin biosimilars market.
Efforts to contain the spread of the virus caused disruptions in the supply of medications, including
insulin. Individuals with Type 1 diabetes are particularly vulnerable to COVID-19 due to their
weakened immune systems. The pandemic resulted in a decline in insulin prescriptions in hospitals.
Nevertheless, as the impact of COVID-19 subsides in various countries after the second quarter of
2021, the market is experiencing a resurgence.
Key drivers propelling the insulin biosimilars market include the increasing prevalence of diabetes
worldwide, especially in emerging economies in Asia and North America. The awareness and
diagnosis of Type 1 diabetes have risen alongside the expanding incidence of diabetes due to
sedentary lifestyles. As more people with Type 1 diabetes depend on insulin for treatment, the
insulin market is expected to grow rapidly during the forecast period.
The expiration of patents for various biologic medicines, including insulin, coupled with research
exploring new indications, is attracting new manufacturers to enter the market. Approximately 20
patents for insulin biologics are set to expire by 2023, presenting opportunities for the development
of biosimilars used in the treatment of diabetes and other conditions such as cancer.
Despite the promising prospects, the production of biosimilars presents challenges that could hinder
market growth. The complex and costly process requires substantial investment in research and
development, clinical trials, quality control procedures, and adherence to regulatory standards.
Manufacturers must demonstrate the comparability of biosimilars to their biological counterparts,
necessitating extensive preclinical and/or clinical evidence.
Among the segments within the insulin biosimilars market, long-acting biosimilars are expected to
dominate due to their prolonged release formulation, providing all-day blood sugar control without
peaking. This segment's popularity is attributed to its ability to enable more people with Type 1
diabetes to achieve higher glucose targets, resulting in reduced hypoglycemia rates and improved
quality of life. The development of long-acting insulin analogs aims to minimize hypoglycemia and
enhance treatment adherence.
Type 1 diabetes is anticipated to dominate the market, exhibiting the fastest growth rate. The
diagnosis of Type 1 diabetes is increasing globally, with a significant number of new cases reported
each year. The availability of insulin for treating Type 1 diabetes in developed countries is expected to
drive this market segment. The prevalence of diabetes-related chronic diseases and the increasing
adoption of insulin delivery devices are influencing the global Type 1 diabetes epidemic.
North America currently holds the largest market share in the global insulin biosimilars market,
driven by the dominance of branded products and the region's high disease prevalence. The United
States, in particular, has witnessed multiple product approvals, increasing demand for biosimilars,
and a strong presence of key market players. The Asia Pacific region is projected to experience
significant growth due to factors such as a growing geriatric population, an increase in collaborations
for biosimilar development, government initiatives, and the presence of renowned Indian companies
with strong R&D and manufacturing capabilities.
In light of the market's potential, various players are actively participating in the insulin biosimilars
market, including Eli Lilly and Company, H. Boehringer Sohn AG & Ko. KG, Novo Nordisk A/S,
Wockhardt Ltd., Momenta Pharmaceuticals, Inc., and Ypsomed AG.
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