Insulin Glargine Market

Market Overview

The global insulin glargine market was valued at USD 1290 million in 2022. It is estimated to reach USD 2200 million by 2031, growing at a CAGR of 6.11% during the forecast period (2023–2031). Due to the global increase in diabetes prevalence owing to sedentary lifestyles, the global market for insulin glargine is expanding at a rapid rate. The key participants in the market are consistently launching new products and receiving approvals from regulatory bodies, thereby creating opportunities for market growth.

Insulin glargine is a long-acting, altered form of medical insulin used to manage type I and II diabetes. It is injected subcutaneously, with effects usually beginning one hour after administration. Common adverse effects include low blood sugar, injection site problems, itching, and weight gain. Other serious side effects include potassium deficiency. In pregnancy, NPH insulin is generally preferred over insulin glargine.

Insulin microcrystals, when injected, release insulin slowly over around 24 hours. This insulin causes body tissues to absorb glucose from the blood and reduces the liver's glucose production. In the United States, insulin glargine was approved for medical use in 2000. It is on the list of essential medicines the World Health Organization maintains. In 2020, it was the 32nd most prescribed drug in the United States, with over 17 million prescriptions.

Market Dynamics

Global Insulin Glargine Market Drivers

Rapidly Increasing Incidence and Prevalence of Diabetic Patients 

The pace of newly diagnosed cases of Type 1 and Type 2 diabetes is seen increasing among the youth population globally. The prevalence of diabetes among all ages is increasing, mainly due to obesity, unhealthy diet, and physical inactivity. Type 1 diabetes is also becoming more common. In case Type 2 patients' treatment is initiated with oral drugs, insulin may also be required when glucose levels are poorly controlled due to an unhealthy lifestyle. Thus, the demand for insulin also exists among Type 2 diabetes patients.

The rapidly surging incidence and prevalence of diabetic patients and healthcare expenditure in developed countries indicate the increasing usage of diabetic care products. According to Diabetes Research and Clinical Practice, 463 million individuals worldwide had diabetes in 2019, and this is expected to surge to 578 million by 2030 and 700 million by 2045. Therefore, the incidence of diabetes is expected to increase over time, ultimately driving the market.

Growing Public Awareness and R&D

Increased public awareness of diabetes management is anticipated to boost the global market. For instance, November is National Diabetes Month, when communities nationwide (US) unite to raise awareness about diabetes. Prediabetes and diabetes prevention are emphasized. Diabetes Month was created by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to increase public awareness of diabetes.

The surge in research and development or a greater emphasis on developing safe/effective insulin is estimated to create substantial opportunities for market participants in the insulin glargine industry. For example, in February 2019, a research team led by MIT developed a drug capsule about the size of a blueberry that can be used to administer oral insulin doses, potentially replacing insulin injections as a delivery mechanism.

Global Insulin Glargine Market Restraints

High Cost of Product

As insulin prices continue to rise, people with diabetes are frequently forced to choose between purchasing their medications and paying for other necessities, exposing them to severe short- and long-term health consequences. In the United States, the most prevalent forms of analog insulin are ten times more expensive than in any other developed nation. Several patients with type 1 diabetes have died in recent years due to a shortage of affordable insulin.

The high prevalence of diabetes, the chronic nature of the illness, and the fact that patients with type 1 diabetes will succumb without access to insulin make this a significant issue that must be addressed immediately. In addition to being a stark and troubling example of the surging cost of prescription drugs in the United States, the price of insulin illustrates a systemic problem with how drugs are priced compared to other commodities. Thus, all these factors hamper market growth.

Global Insulin Glargine Market Opportunities

Rising Product Approval and Launches

The development of the global market is anticipated to be fueled by frequent approvals and launches of novel products by market participants. For instance, in July 2021, the FDA approved the interchangeable biosimilar insulin product. Semglee (insulin glargine-yfgn) is authorized to enhance glycemic control in adults and youngsters with Type 1 diabetes and adults with Type 2 diabetes.

Furthermore, introducing new products by market participants is anticipated to generate opportunities for the growth of the global insulin glargine market. For instance, Biocon Biologics India Ltd and Mylan N.V. announced the launch of their insulin glargine injection under the brand name Semglee in the United States in a vial and pre-filled pen presentations in August 2020.

Regional Analysis

North America Dominates the Global Market

Based on region, the global insulin glargine market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East, and Africa. 

North America is the most significant global insulin glargine market shareholder and is expected to expand substantially during the forecast period. Patients in this region are not coping with the challenges of chronic diseases, despite advances in medical technology and healthcare systems. The incidence of these diseases has surged dramatically in recent years. Due to its lower price, traditional human insulin has a larger market share in North America. The global market for human insulin is predominantly controlled by North America and the United States due to the substantial prevalence of diabetes in the region, primarily attributed to a sedentary lifestyle. The total diabetes population in the United States has increased to 25.81 million as of 2020, especially Type 2 diabetes, which is soaring at an alarming rate in the United States.

The United States leads the diabetes drug market in North America. In 2017, the US diabetes drugs market held the largest market share in North America because of the presence of a high-quality healthcare system and the increasing prevalence of diabetes in the region. Growth in the diagnosis of diabetes leads to an increase in the demand for insulin for diabetes patients. In addition, increasing remuneration policies, awareness of health, and advancements in the technology of insulin delivery devices provide an opportunity for the insulin glargine market. The higher cost of the products is the main challenge for the insulin glargine market in this region. However, strict policies and regulations for product approval and the availability of substitutes restrain the market's growth during the forecast period.

The European region is growing significantly due to the presence of key countries like France and Germany, which are prominent contributors to the market share. However, both nations are growing, and Germany's share is expected to decline during the forecast period. Comparatively, the UK and Italy are estimated to grow faster. The total diabetes population in the United Kingdom has increased to 3.93 million throughout 2020–2021. This indicates a potential for market growth in the country. In addition, Italy provides 100% reimbursement for eligible patients for insulin drugs throughout the region. Still, prescription fees vary between regions and can be applied to types of medical prescriptions or packages ranging from EUR 1 to 8. Due to favorable healthcare insurance policies, the insulin drug segment is expected to grow during the forecast period.

Japan, China, South Korea, and India are the major revenue contributors to the Asia-Pacific region. Japan is a mature market with associated challenges, like slow economic growth, an aging population, and increased competition. One particular challenge in this region is the growing preference for oral anti-diabetics among type-2 diabetic patients, leading to negative insulin volume development. Lantus sales in Japan decreased due to the reduction in the price of the product. In Japan, Sanofi is facing competition from Toujeo and Lilly's Basagalar. Furthermore, Biocon applied for its follow-on biologic with its partner Fujifilm Pharma Co. Ltd. and received approval in Q1 of 2016 from Japan's Ministry of Health, Labor, and Welfare (MHLW) to market its biosimilar glargine. China is witnessing a significant increase in the number of generic drug manufacturers.

Similarly, in emerging and developed markets, such as India and China, affordable biologics are expected to witness significant growth opportunities, primarily due to limited patient access and the openness of physicians to low-cost therapies. There is a rising preference for biosimilar insulin due to the flourishing prevalence of diabetes, the high cost of branded insulin, and patent cliff scenarios.

In Latin America, the economic impact of diabetes is substantial. Despite medical advancements, health systems in Latin America cannot meet the challenges of chronic diseases. The incidence of the disease has increased in recent years. For instance, the total diabetes population in Mexico has increased to 14.08 million from 2019 to 2020. It was estimated that in 2020, 12.81 million adults in Mexico would have diabetes. This represents more than 15 percent of the total adult population in the country. One of the risk factors linked to the disease is overweight. The share of the overweight population in Mexico is estimated to increase in the following years. Thus, the surging prevalence of diabetes and its risk factors is expected to drive regional market growth.

The Middle East and African market region comprises many low-income countries that get insulin supplies from their governments. The African region has one of the highest undiagnosed diabetes populations in the world. The IDF Africa Region (AFR) has the highest percentage of undiagnosed people among all IDF regions. As per the International Diabetes Federation (IDF), 19 million adults (20–79 years old) have lived with diabetes in the IDF Africa Region since 2019. This figure is anticipated to increase to 47 million by 2045. The growing diabetic population in Qatar, Kuwait, Bahrain, and many African countries is expected to generate demand for insulin drugs in the region during the forecast period.

Segmental Analysis

The global insulin glargine market is segmented into types.

Based on type, the global insulin glargine market is bifurcated into Lantus, Basaglar, Toujeo, Soliqua/Suliqua, and Insulin Glargine Biosimilars. 

Lantus (insulin glargine 100 units/mL) is a long-acting human insulin analog indicated for once-daily administration for diabetes mellitus in adults, adolescents, and youngsters aged two years and above. Lantus is an important product for Sanofi, with a reported revenue of EUR 3,012 million in 2019, representing 8.3% of the company's net sales in 2019. However, the overall sales of Lantus dropped in 2020. The largest sales drop occurred in Germany, followed by Russia, in 2019 compared to 2020. Glargine's patent expired in 2014, and Eli Lilly has already received approval for its biosimilar version in several highly regulated European markets. The reduction in the average selling cost of Lantus, along with the increasing competition from generics and biosimilars, like the launch of Toujeo and Basaglar, in the market, is the major reason for the sales downfall and low growth rate.

Toujeo (insulin glargine 300 units/mL) is a long-acting analog of human insulin indicated for treating diabetes mellitus in adults. Toujeo is available as Toujeo SoloStar, a disposable pre-filled pen containing 450 units of insulin glargine and requiring one-third of the injection volume of Lantus SoloStar to deliver the same number of insulin units. In 2015, Sanofi released Toujeo in the European region as the basal insulin for treating type 1 and 2 diabetes mellitus in adults. According to Sanofi, in 2020, Toujeo posted net sales of EUR 933 million worldwide, driven by strong performances in European countries.

Likewise, in January 2020, Sanofi announced that the European Commission (EC) had expanded the current indication for Toujeo (insulin glargine 300 units/mL) to include children and adolescents with diabetes. Toujeo is now indicated for the treatment of diabetes mellitus in adolescents, adults, and children under the age of 6. This is driving the market in the forecast period.

Basaglar (insulin glargine injection) is a long-acting human insulin analog launched in Europe under the trade name Abasaglar. Eli Lilly developed Basaglar in partnership with Boehringer Ingelheim. Basaglar was the first biosimilar to Lantus to be launched in some countries of the European region. It offers the core protein sequence of Lantus to patients. In addition, Basaglar is expected to observe an exponential increase in sales volumes during the forecast period, primarily due to its growing adoption and lower cost than its competitive products in the European region. A competitor launched a similar version of glargine in 2020. Due to the impact of competitive pressures, drugs expect some price decline and loss of market share over time, with increasing revenue over the years.

Recent Developments

• November 2022: According to a drug information update from the FDA, Rezvoglar, the second interchangeable insulin glargine biosimilar, was approved to enhance glycemic control in adults and pediatric patients with diabetes.
• March 2023: Sanofi (India) announced that the Central Drugs Standard Control Organization (CDSCO) had granted marketing approval for its new long-acting insulin drug Soliqua (pre-filled pen).