The Human Insulin Market Size was valued at USD 1.98 billion in 2023 and is projected to grow from USD 2.07 Billion in 2024 to USD 2.81 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 3.85% during the forecast period (2024 - 2032). Improvements in formulation and the increased prevalence of diabetes are the main market drivers boosting market expansion.
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
The first cycle of the Medicare Drug Price Negotiation Program is seeing the U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), send its initial offers to participating drug companies on the first ten prescription drugs that were selected for negotiation. This has been made possible by a law enacted by the President called the Inflation Reduction Act that lowers the costs of prescriptions so much that now, just like other federal agencies such as the U.S. Department of Veterans Affairs do in terms of negotiating drug prices, Medicare can directly negotiate prescription drug prices with pharmaceutical firms. Those who are being offered these initial offers consider them as key milestones in realizing this historic rule.
In its announcement late last month, where it stated that it would significantly reduce its insulin products, Eli Lilly and Company also announced plans to launch Rezvoglar, an interchangeable insulin glargine biosimilar, at a price 78% lower than that of Lantus. Biosimilar insulin aglr was approved as a fourth biosimilar with interchangeability designation in November 2022. Lilly had previously approved this product by the FDA in December 2021, making it the second-ever interchangeable insulin product after Semglee(insulin glargine-fun), which was authorized in July 2021. The manufacturer said that starting April 1st, 2023, KwikPens will be available to patients for $92 for a five-pack when they use insurance; otherwise, each pack will cost $137 without insurance. Since we’re talking about Lilly, here’s something you ought to know: Humulin – recombinant human insulin, and Humalog ‘s generic name is reference insulin lispro. Rezvoglar can fall under this bracket or category alongside two major unbranded products from Lilly, namely Humulin (recombinant human insulin) and Humalog (reference insulin lispro).
FDA has approved Biocon Biologic’s Semglee insulin glargine for interchangeability biosimilar referencing Lantus. This approval has brought hopes of a more competitive insulin market with few brands and high prices. It’s been long anticipated before the FDA made its first decision on a biosimilar in 2021, the year that was largely dedicated to addressing the needs of COVID-19 treatments and vaccines. It is possible to substitute it for Lantus without physicians’ permission because the FDA gave it an interchangeable designation. All states have passed laws in anticipation of interchangeable biosimilars, and conditions under which pharmacists can switch these agents have been described.
Human Insulin Market Trends
With the introduction of insulin analogs, replacement methods that more nearly resemble the physiology of the average person have been proposed. Furthermore, many studies show that, compared to conventional human insulin, insulin analogs have faster offset and onset of insulin impact due to their closer-to-normal pharmacodynamic and pharmacokinetic profiles. Additionally, basal insulin analogs (such as long-acting insulin detemir and insulin glargine) have reportedly been shown to have sound effects on weight, reduced hypoglycemia, and less fluctuation. As a result, these considerations encourage the use of analog insulin products worldwide.
The leading causes of the rise in diabetes worldwide are obesity and a sedentary lifestyle. In the previous decades, the prevalence of diabetes has increased dramatically, and it is predicted that this trend will continue in the decades to come. The number of people with diabetes will increase in the following years, according to the "IDF Diabetes Atlas Tenth edition 2021." It is anticipated to grow to 643.0 million in 2030 and 783.0 million in 2045. A sizable portion of the population also has type 1 diabetes. For people with type 1 diabetes, insulin is necessary for daily glycemic management.
A study published in Diabetologia, the journal of the European Association for the Study of Diabetes (EASD), projected that over 9.0 million persons worldwide have type-1 diabetes. Additionally, the International Diabetes Federation estimates that around 10.0% of all people with diabetes have type 1 diabetes. This aspect, which has increased demand for human insulin globally, will drive the market's expansion throughout the forecast period. Therefore, such factors related to the insulin has enhanced the market CAGR of Human Insulin across the globe in the recent years.
However, formulation advancements are another crucial is another factor driving the growth of the Human Insulin market revenue.
The Market segments of Human Insulin, based on type, includes analog and traditional human insulin. The analog insulin segment held the majority share in 2022, contributing to around ~65-67% of the Human Insulin Market revenue. Due to the growing benefits analog insulin offers over conventional human insulin. Analog insulin has superior adherence to therapy and glycemic control, according to several articles and whitepapers that have been published. In addition, compared to conventional products, it does not carry as significant a risk of hypoglycemia. Analogue insulins also have a quick and consistent rate of action, according to Diabetes.co.uk.
The Human Insulin Market data has been bifurcated by Diabetes Type into Diabetes 1 and Diabetes 2. The Diabetes 1 segment dominated the market in 2022 and is projected to be the faster-growing segment during the forecast period, 2022-2030. This is because rising of the prevalence of diabetes and patients with type 1 diabetes, daily require insulin injections to manage blood glucose levels. For persons with type 1 diabetes, insulin is the most crucial medication, according to the International Diabetes Federation (IDF). These elements should propel this market segment.
Figure 2: Human Insulin Market, by Diabetes Type, 2022 & 2030 (USD billion)
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
Based on Distribution Channels, the Human Insulin Market segmentation has been segmented into Hospital Pharmacy, Retail & Online Pharmacies, and others. Retail & Online Pharmacy held the most significant segment share in 2022; The retail & online pharmacies market sector is expected to grow as a result of the entry of major corporations like Amazon & Walmart into the industry and the release of cost-effective insulin products. For instance, Walmart introduced the analo insulin brand ReilOn in June 2021. Both vials and pens are available. This medication costs between 58.0% and 75.0% less than the cost of comparable branded insulin products.
The fastest-growing segment in the Human Insulin industry is Hospital Pharmacy. Due to the expansion of hospital facilities worldwide.
By Region, the study provides market insights into North America, Europe, Asia-Pacific, and the Rest of the World. The North America Human Insulin market is expected to exhibit a significant CAGR growth during the study period. The insulin drug market in North America is driven by several factors, including the considerable presence of the major insulin makers, fierce competition among businesses, and the rising prevalence of type 1 diabetes. For instance, the American Diabetes Association (ADA) estimates that 1.6 million Americans, including 187,000 children and teenagers, have type-1 diabetes. American market to capture a sizable piece of the global market.
Further, the significant countries studied in the market report are The U.S., Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.
Figure 3: HUMAN INSULIN MARKET SHARE BY REGION 2022 (%)
Source: Secondary Research, Primary Research, MRFR Database and Analyst Review
Europe, Human Insulin market accounts for the second-largest market share. The expansion of essential players in this area is responsible for its growth. Further, the Germany market of Human Insulin held the largest market share, and the UK market of Human Insulin was the fastest-growing market in the European region.
Asia-Pacific Human Insulin Market is expected to grow at the fastest CAGR from 2022 to 2030. due to various variables, including an increase in the target and geriatric populations, the number of partnerships for the development of biosimilars, the geographic growth of essential companies, and the active involvement of charitable and governmental organizations in the market. Moreover, China's market of Human Insulin held the largest market share, and the India market of Human Insulin was the fastest-growing market in the Asia-Pacific region.
Human Insulin Key Market Players & Competitive Insights
Major market companies are investing significant money in R&D to expand their product portfolios, which will fuel further market growth for human insulin. In addition, market participants are launching key developments, entering into contracts, acquiring companies, increasing investments, and working with other organizations, among other significant market changes, to expand their global footprint. To grow and thrive in a more cutthroat and competitive market climate, competitors in the human insulin industry must provide affordable products.
Making products locally to cut operational costs is one of the leading business methods producers use in the market of Human Insulin to benefit customers and grow the market sector. In recent years, Human Insulin industry has provided medicine with some of the most significant benefits. The Human Insulin market major player such as Biocon, Eli Lilly, and others are working to expand the market demand by investing in research and development activities.
Bangalore-based Biocon Limited is a biopharmaceutical firm run by Indians. In 1978, Kiran Mazumdar-Shaw started it. The business produces generic active medicinal ingredients distributed to about 120 nations, including the US and Europe. In April 2022, With the award of a three-year, $90.0 million contract from the Malaysian Ministry of Health to sell recombinant human insulin known as Insugen, Biocon expanded its presence in a rising market like Malaysia.
Also, With operations throughout 18 nations, Eli Lilly and Company is an American pharmaceutical company with its main office in Indianapolis, Indiana. Approximately 125 countries sell their products. The business was established in 1876 and is named after Colonel Eli Lilly, a pharmacist, and American Civil War soldier. In September 2021, Eli Lilly & Company decreased the cost of the Lispro injectable in the United States, enabling patients to pay less out-of-pocket and making it more widely accessible.
Key Companies in the market of Human Insulin includes
Human Insulin Industry Developments
November 2023: Biocon Biologics wins $90 million contract from Malaysian government to supply human insulin. Biocon Biologics, a subsidiary of Biocon, has won a $90 million contract from the Malaysian government to supply human insulin. The contract is for a period of five years and will start in 2024. This is the largest contract that Biocon Biologics has won for its human insulin products.
October 2023: Eli Lilly launches new human insulin analog in China. Eli Lilly has launched a new human insulin analog, Lyumjev, in China. Lyumjev is a rapid-acting insulin that is designed to start working faster than other insulins, making it ideal for people with diabetes who need to manage their blood sugar levels after meals.
September 2023: Novo Nordisk announces price cuts for human insulin in low- and middle-income countries. Novo Nordisk has announced that it will cut the prices of its human insulin products by up to 50% in low- and middle-income countries. This move is part of Novo Nordisk's commitment to making insulin more affordable for people with diabetes in all parts of the world.
August 2023: Sanofi launches new human insulin formulation in India. Sanofi has launched a new formulation of its human insulin product, Lantus, in India. The new formulation is designed to be more stable and easier to administer.
July 2023: WHO adds human insulin to list of essential medicines. The World Health Organization (WHO) has added human insulin to its list of essential medicines. This means that human insulin is now considered to be an essential medicine for the treatment of diabetes.
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