Insulin Biosimilars Market: Overview
The size of the global market for insulin biosimilars was estimated at USD 2.6 billion in 2021 and is anticipated to increase at a CAGR of 5.2%. The market for insulin biosimilars is anticipated to expand due to rising Type I diabetes prevalence and the cost of current insulin medications. One of the chronic illnesses with the fastest global growth rates is diabetes. In recent decades, its prevalence has steadily risen. According to the World Health Organization, 537 million adults globally will have diabetes in 2021, with one in ten developing further forms of the disease. Government authorities are also focusing on approving insulin biosimilars owing to a huge financial load in terms of payments. Additionally, older and more obese populations are more prone to chronic illnesses. The senior population worldwide was estimated by the World Bank Group to be over 727 million in 2020. Over the next three decades, this population is projected to quadruple, reaching almost 1.5 billion in 2050.
Major pharmaceutical and healthcare businesses have recently seen a phenomenal increase in R&D efforts to create biosimilar versions of biologics. An essential tactic for fostering long-term growth is to concentrate on R&D. Several biotech and pharmaceutical businesses are concentrating on M&A, partnerships, and collaborations to establish leadership in terms of customer retention and to increase the scope of their current product lines. For instance, Biogen and Samsung Biologics formed Samsung Bioepis in January 2021 as part of their strategic alliance, and the company has since introduced multiple biosimilar versions of the drugs infliximab, etanercept, adalimumab, and trastuzumab in Europe.
Furthermore, it is projected that the efficiency of biosimilar insulin used to treat diabetes will be combined with cheap prices to create new growth opportunities for the market for these products worldwide. Many businesses are focusing on creating medical devices that allow the self-administration of biosimilar insulin less painfully. Semglee, a groundbreaking insulin medication created by India's Biocon, received United States clearance in July 2021. Semglee, created by Bengaluru-based Biocon Biologics, is interchangeable with and biosimilar to Lantus, a long-acting insulin product that has already received US approval. A factor like this is anticipated to fuel the demand for insulin biosimilars worldwide.
Insulin Biosimilars Market: COVID-19 Impact
The COVID-19 pandemic caused the market to suffer. The tactics created to stop the spread of SARS-CoV-2 during the epidemic caused a pause and disruption in the supply of medications. Type-1 diabetes individuals are influenced more by Covid-19. Since people with diabetes already have weakened immune systems, COVID-19 causes those immune systems to deteriorate rapidly. Significant problems are more likely to occur in people with diabetes than in healthy people. In addition, fewer prescriptions for insulin have been written, according to hospitals. However, the impact of COVID-19 began to wane in several nations after the second quarter of 2021, which gave the market new life.
Insulin Biosimilars Market: Drivers
Increased Diabetes Prevalence Worldwide to Drive Up Insulin Demand Worldwide
According to estimates, the main market drivers are the rising rates of type 1 diabetes, particularly in emerging economies in Asia and North America. The prevalence of diabetes has increased due to an increase in sedentary lifestyles in the United States and some Asia Pacific nations. As diabetes awareness has expanded, so has the number of type 1 diabetes diagnoses. A study by Health Action International in 2016 found that over 100 million individuals need insulin, with 10–20% of those having type 2 diabetes. Since people with type 1 diabetes depend on insulin, it is anticipated that the insulin market will develop faster than expected throughout the projection period.
Biosimilars Patents Expiring and Research Towards New Indications to Attract New Manufacturers Driving Market Growth
Most early biologic medicines lost their patent protection in the first half of the 20th century; nevertheless, many of today's top-selling drugs are anticipated to do the same in the following years. This is opening up new possibilities for insulin biosimilar medicines. Nearly 20 insulin biologics' patents will expire by 2023, which could increase the number of biosimilars used in cancer.
Biosimilars on the market are used to treat various illnesses and conditions, such as type 1 and type 2 diabetes, postmenopausal osteoporosis, and problems with the growth hormone. Oncology, autoimmune diseases, diabetes, and hepatitis are among the main target therapeutic areas for which numerous biosimilars are developing. In addition, biosimilars can be created to treat other chronic diseases such as hepatitis E, adult T-cell leukemia, obesity, meningitis, and breast cancer.
Insulin Biosimilars Market: Restraints
Complexity in Production of Biosimilars to Hamper Market’s Growth
Creating biosimilars is a difficult and expensive process that needs a lot of money, technical know-how, clinical trial experience, scientific criteria, and quality control procedures. In contrast to generic medication development, biosimilar makers must invest comparably in clinical studies and post-approval safety monitoring systems.
The capacity to control variability during the manufacturing process, where the final products are similar to their biological products, is another important problem in the production of biosimilars. Manufacturing biosimilars should adhere to established quality standards for both safety and efficacy. To prove that the manufacturing process has no bearing on the product's efficacy or safety and that there is no difference between the biosimilar and the biologic medication, regulatory agencies may ask for more preclinical and/or clinical evidence.
Insulin Biosimilars Market: Segment Overview
Long-Acting Biosimilars to Dominate Market due to its Prolonged Release Formulation
Unlike rapid-acting insulin, long-acting insulin does not peak. They had a whole day of blood sugar control. The manner of action is comparable to the action of insulin ordinarily released by the pancreas to help manage blood sugar levels between meals. The ability of more people with type 1 diabetes mellitus to achieve higher glucose targets, with decreased hypoglycemia rates and a better quality of life, can be linked to the segment's increased popularity. The development of long-acting insulin analogs was done to lower hypoglycemia and boost adherence.
With Rising Cases, Type 1 Diabetics to Dominate Market
Type 1 diabetes is predicted to have the fastest CAGR growth rate. The increase in type 1 diabetes diagnosis is mostly to blame for this. According to the International Diabetes Federation (2017), 28,000 children under the age of 19 are diagnosed with type 1 diabetes yearly in Europe. The growing availability of insulin treating type 1 diabetes in developed countries is anticipated to drive this market segment. With the rise in chronic diseases linked to diabetes, insulin delivery device usage has recently increased. Growing public awareness and technological advancements in insulin delivery devices are two major factors influencing the global type 1 diabetes epidemic.
Insulin Biosimilars Market: Regional Landscape
North America to Acquire Major Market Share due to Increase in New Products Approvals
In terms of revenue, North America dominated the market, mostly because of the dominance of branded goods and the region's rising disease prevalence. In 2020, the CDC estimated that 37.3 million Americans had diabetes, of whom 28.7 million had been diagnosed, and 8.5 million had not. Additionally, 96 million adults age 18 and older have prediabetes. Novo Nordisk A/S, Eli Lilly and Company, and Sanofi are a few of the main companies currently active in this area. However, Semglee and Rezvoglar, two new insulin biosimilars from Mylan/Biocon and Eli Lilly and Company, respectively, have received FDA approval in the United States.
With the increasing number of product approvals, expanding demand for biosimilars, and regional presence of top market participants, the U.S. accounted for the biggest revenue share in the North American market. It has excellent commercialization potential and is anticipated to provide biosimilar manufacturers with various alternatives. There are currently many market participants in the United States, including Merck & Co., Inc., Mylan Pharmaceuticals, Inc., and Amgen, Inc. For instance, Amneal Pharmaceuticals' FYLNETRA, a biosimilar medication of Neulasta, was granted a biologics license by the U.S. FDA in May 2022.
The Asia Pacific is predicted to experience significant growth during the forecast period due to growing geriatric and target populations, an increase in collaborations for the development of biosimilars, geographic expansion of key players, and active government involvement and nonprofit sectors in the market space. Health awareness campaigns and scientific conferences may also aid regional market expansion to manage this disease. The Indian biosimilars market is anticipated to expand at a profitable CAGR during the forecast period due to the increased need for affordable medications, the existence of contract manufacturing companies, and favorable governmental regulations. Around 127 biosimilars had been authorized in India as of January 2022, largely thanks to the strong R&D and manufacturing skills of well-known Indian businesses like Zydus Cadila, Biocon, Intas, Reliance Life Sciences, Sun Pharma, Dr.Reddys, and Lupin.
Global Insulin Biosimilars Market: Competitive Landscape
In March 2022, the Juvenile Diabetes Research Foundation (JDRF) launched a new partnership with Civica to fight the nation's insulin cost challenge. Civica, a nonprofit generic pharmaceutical company, has launched its Insulin Initiative, which aims to drive affordability and accessibility for all Americans, regardless of insurance status. Civica will manufacture one long-acting insulin biosimilar, Sanofi's Lantus (insulin glargine), and two rapid-acting insulins, Novo Nordisk's Novolog (insulin aspart) and Eli Lilly's Humalog (insulin aspart) (insulin lispro). In July 2021, Biocon Biologics Ltd. and Viatris Inc. announced that the FDA had approved Semglee® (insulin glargine-yfgn injectable) as the first interchangeable biosimilar product under the 351(k) regulatory process.
Few of the 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.
Global Insulin Biosimilars Market is Segmented as Below:
By Disease Indication
Key Elements Included In The Study: Global Insulin Biosimilars Market
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