The global market for insulin biosimilars is witnessing remarkable growth, with an estimated value of USD 2.6 billion in 2021. It is projected to expand at a CAGR of 5.2% in the coming years. This surge can be attributed to the increasing prevalence of Type 1 diabetes worldwide and the growing cost of current insulin medications. Diabetes, one of the fastest-growing chronic illnesses globally, has witnessed a steady rise in its prevalence over the past few decades. According to the World Health Organization, it is estimated that by 2021, 537 million adults worldwide will have diabetes, with one in ten individuals developing additional forms of the disease. To combat the financial burden associated with diabetes treatment, government authorities are focusing on approving insulin biosimilars. Additionally, the aging population and the rise in obesity levels further contribute to the increased susceptibility to chronic illnesses. The senior population worldwide is expected to reach nearly 1.5 billion by 2050, as projected by the World Bank Group.
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R&D Efforts and Strategic Alliances
To tap into the immense potential of the insulin biosimilars market, major pharmaceutical and healthcare companies have intensified their research and development (R&D) efforts. Concentrating on R&D is seen as a vital strategy for long-term growth. Several biotech and pharmaceutical companies are actively engaging in mergers and acquisitions, partnerships, and collaborations to strengthen customer retention and expand their product lines. A notable example is the partnership between Biogen and Samsung Biologics, which led to the formation of Samsung Bioepis in January 2021. This collaboration has resulted in the introduction of multiple biosimilar versions of drugs such as infliximab, etanercept, adalimumab, and trastuzumab in Europe.
Unlocking New Growth Opportunities
The combination of the effectiveness of biosimilar insulin in diabetes treatment and affordable pricing is anticipated to create new growth opportunities in the global market for insulin biosimilars. Many companies are focusing on developing medical devices that allow the self-administration of biosimilar insulin with reduced pain. An innovative insulin medication called Semglee, created by India’s Biocon, received clearance from the United States in July 2021. Semglee is interchangeable with and biosimilar to Lantus, a long-acting insulin product that has already received US approval. This development is expected to drive the demand for insulin biosimilars on a global scale.
COVID-19 Impact
The COVID-19 pandemic had a significant impact on the insulin biosimilars market. The measures implemented to contain the spread of the SARS-CoV-2 virus disrupted the supply of medications, including insulin. Individuals with Type 1 diabetes were particularly affected by COVID-19 due to their weakened immune systems. The rapid deterioration of immune systems in diabetic patients increased the likelihood of severe complications. Hospitals reported a decrease in the number of insulin prescriptions during the pandemic. However, as the impact of COVID-19 began to diminish in several countries after the second quarter of 2021, the market regained momentum.
Driving Factors
Increased Diabetes Prevalence Worldwide
The rising rates of Type 1 diabetes, especially in emerging economies in Asia and North America, are among the primary drivers of the insulin biosimilars market. Sedentary lifestyles in the United States and certain Asia Pacific nations have contributed to an increase in diabetes prevalence. The awareness about diabetes and the subsequent rise in Type 1 diabetes diagnoses have further fueled the demand for insulin. A study by Health Action International revealed that over 100 million individuals require insulin, with 10–20% of them having Type 2 diabetes. As people with Type 1 diabetes rely on insulin, the insulin market is expected to witness faster growth than initially anticipated.
Expired Patents and Research Advancements
The expiration of patents for several early biologic medicines presents new opportunities for insulin biosimilar medications. Nearly 20 patents for insulin biologics are set to expire by 2023, leading to an increase in the use of biosimilars in cancer treatment. Biosimilars are being developed to address various illnesses and conditions, including Type 1 and Type 2 diabetes, postmenopausal osteoporosis, and growth hormone-related issues. The main target therapeutic areas for biosimilars include oncology, autoimmune diseases, diabetes, and hepatitis. Furthermore, biosimilars can potentially treat chronic diseases such as hepatitis E, adult T-cell leukemia, obesity, meningitis, and breast cancer.
Challenges in Production
The production of biosimilars poses significant challenges due to the complexity and high costs involved. It requires substantial investments in money, technical expertise, clinical trial experience, scientific criteria, and quality control processes. Unlike generic medication development, biosimilar manufacturers must allocate resources for extensive clinical studies and post-approval safety monitoring. Controlling variability during the manufacturing process is another crucial issue in biosimilar production. Regulatory agencies may demand additional preclinical and/or clinical evidence to demonstrate the equivalence of biosimilars to their biologic counterparts in terms of safety and efficacy.
Segment Overview
Dominance of Long-Acting Biosimilars
Long-acting biosimilars have emerged as the dominant segment in the insulin biosimilars market, thanks to their prolonged release formulation. Unlike rapid-acting insulin, long-acting insulin provides consistent blood sugar control throughout the day without peaking. This type of insulin closely mimics the natural insulin released by the pancreas between meals to regulate blood sugar levels. The growing popularity of long-acting biosimilars can be attributed to their ability to help more individuals with Type 1 diabetes achieve optimal 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.
Rise of Type 1 Diabetes Cases
Type 1 diabetes is expected to witness the highest growth rate in the market. The increase in diagnoses of Type 1 diabetes is the primary driver for this segment. According to the International Diabetes Federation, Europe alone records 28,000 new cases of Type 1 diabetes in children under the age of 19 each year. The availability of insulin for the treatment of Type 1 diabetes in developed countries is anticipated to drive this market segment. The prevalence of chronic diseases associated with diabetes has also led to an increase in the use of insulin delivery devices. Growing public awareness and advancements in insulin delivery devices significantly contribute to addressing the global Type 1 diabetes epidemic.
Regional Landscape
North America Takes the Lead
North America dominates the insulin biosimilars market, primarily due to the prevalence of branded products and the increasing disease burden in the region. In 2020, the Centers for Disease Control and Prevention estimated that 37.3 million Americans had diabetes, with 28.7 million being diagnosed and 8.5 million undiagnosed. Additionally, 96 million adults in the United States aged 18 and older have prediabetes. Companies such as Novo Nordisk A/S, Eli Lilly and Company, and Sanofi are actively involved in this market. Recent FDA approvals of Semglee and Rezvoglar, two insulin biosimilars from Mylan/Biocon and Eli Lilly and Company, respectively, have further solidified the market presence in the United States.
Growth Potential in Asia Pacific
The Asia Pacific region is expected to experience significant growth in the insulin biosimilars market. Factors contributing to this growth include the increasing geriatric population, collaborations for biosimilar development, geographic expansion of key players, and active involvement of governments and nonprofit sectors. Health awareness campaigns and scientific conferences also contribute to the regional market expansion. The Indian biosimilars market is projected to witness profitable growth during the forecast period due to the demand for affordable medications, the presence of contract manufacturing companies, and favorable governmental regulations. India has authorized around 127 biosimilars as of January 2022, thanks to the strong R&D and manufacturing capabilities of Indian companies.
Competitive Landscape
In March 2022, the Juvenile Diabetes Research Foundation (JDRF) partnered with Civica, a nonprofit generic pharmaceutical company, to address the insulin cost challenge in the United States. Civica launched its Insulin Initiative, aiming to increase affordability and accessibility for all Americans, irrespective of their insurance status. As part of this initiative, Civica will manufacture a long-acting insulin biosimilar, Sanofi’s Lantus, along with two rapid-acting insulins, Novo Nordisk’s Novolog and Eli Lilly’s Humalog. Additionally, Semglee, developed by Biocon Biologics Ltd., received FDA approval as the first interchangeable biosimilar product in July 2021.
Leading players in the insulin biosimilars market include Eli Lilly and Company, H. Boehringer Sohn AG & Ko. KG, Novo Nordisk A/S, Wockhardt Ltd., Momenta Pharmaceuticals, Inc., and Ypsomed AG. These companies are actively contributing to the growth of the market through innovative research, strategic alliances, and the introduction of biosimilar products.
Conclusion
The insulin biosimilars market is witnessing significant growth as it revolutionizes diabetes treatment worldwide. With the increasing prevalence of diabetes, the expiration of patents, and research advancements, biosimilar insulin offers a promising solution. However, the production of biosimilars poses challenges, and the market is highly competitive. The dominance of long-acting biosimilars and the rise in Type 1 diabetes cases are notable trends. North America leads the market, while the Asia Pacific region shows immense growth potential. Overall, the insulin biosimilars market is poised to transform diabetes management and improve the lives of millions of patients worldwide.
Frequently Asked Questions (FAQs)
- What is the estimated value of the global insulin biosimilars market? The global insulin biosimilars market was valued at USD 2.6 billion in 2021.
- What is driving the growth of the insulin biosimilars market? The growth of the market is driven by the rising prevalence of Type 1 diabetes worldwide and the increasing cost of current insulin medications.
- How has the COVID-19 pandemic impacted the insulin biosimilars market? The COVID-19 pandemic initially disrupted the supply of medications, including insulin. However, as the impact of the pandemic diminished in several countries, the market regained momentum.
- What are the challenges in the production of biosimilars? The production of biosimilars is complex and expensive, requiring significant investments, technical expertise, clinical trial experience, and adherence to quality control procedures.
- Which region dominates the insulin biosimilars market? North America currently dominates the market, owing to the prevalence of branded products and the increasing disease burden in the region.
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