INSULIN LISPRO MARKET ANALYSIS

Insulin lispro market has been significant due to the increasing prevalence of diabetes globally. The global insulin lispro market size is estimated to be valued at US$ 7.32 Bn in 2023, and is projected to reach US$ 11.15 Bn by 2030 at a CAGR of 6.2% from 2023 to 2030.

Factors contributing to the growth of the insulin lispro market include the rising incidence of diabetes, increasing awareness and diagnosis of the disease, an increased sedentary lifestyle, and advancements in insulin delivery devices. Additionally, the development of biosimilar versions of insulin lispro may also contribute to market expansion.

Insulin Lispro Market Regional Insights

• North America: North America has been a prominent market for insulin lispro, driven by a high prevalence of diabetes and a well-established healthcare system. The U.S., in particular, has a large market for insulin products, including insulin lispro. This region holds a substantial percentage of the market share, accounting for approximately 41.50%.
• Europe: Europe also has a significant market for insulin lispro, with countries such as Germany, France, and the U.K. being major contributors. The region has a well-developed healthcare infrastructure and a high prevalence of diabetes. Europe holds around 25.60% of the market share.
• Asia Pacific: The Asia Pacific region has witnessed rapid growth in the insulin lispro market due to the increasing prevalence of diabetes, a growing aging population, and changing lifestyles. Countries like China and India have a substantial market for insulin products. Asia Pacific accounts for approximately 19.50% of the market share.

Figure 1. Global Insulin Lispro Market Share (%), By Region, 2023

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Insulin Lispro Market Drivers:

• Increasing Prevalence of Diabetes: The rising prevalence of diabetes worldwide is a significant driver for the insulin lispro market. As the number of individuals diagnosed with diabetes continues to increase, there is a growing demand for insulin products like insulin lispro to manage blood sugar levels effectively. For instance, according to the article “The Institute For Health Metrics And Evaluation” published by Institute For Health Metrics And Evaluation on June 22, 2023, more than half a Bn people are living with diabetes worldwide, affecting men, women, and children of all ages in every country, and that number is projected to more than double to 1.3 Bn people in the next 30 years.
• Advancements in Insulin Delivery Devices: Continuous advancements in insulin delivery devices, such as insulin pens and pumps, have improved the convenience and ease of insulin administration. These advancements have increased patient compliance and the adoption of insulin therapies, thereby driving the demand for insulin lispro. For instance, on August 16, 2021, Eli Lilly and Company, a U.S.-based pharmaceutical company, announced the approval from the U.S. Food and Drug Administration (FDA) for rapid-acting insulin Lyumjev (insulin lispro-aabc injection) at 100 units/mL, which is indicated to improve glycemic control in adults with type 1 and type 2 diabetes, to include administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump.
• Aging Population and Lifestyle Changes: The aging population and lifestyle changes, including sedentary lifestyles, unhealthy diets, and obesity, contribute to the increasing incidence of diabetes. As these factors continue to rise, there is a higher demand for insulin products like insulin lispro to manage diabetes effectively. For instance, according to an article ‘Ageing and Health’ published by the World Health Organization (WHO) in May 2023, By 2030, 1 in 6 people in the world will be aged 60 years or older. At this time, the share of the population aged 60 years and over will increase from 1 Mn in 2020 to 1.40 Mn. By 2050, the world’s population of people aged 60 years and older will double (2.10 Mn). The number of people aged 80 years or older is expected to triple between 2020 and 2050 to reach 426 million

Insulin Lispro Market Opportunities:

• Personalized Medicine and Precision Insulin Therapy: The concept of personalized medicine, including precision insulin therapy, is gaining traction. Advancements in technology and genetic profiling allow for customized insulin treatment plans based on an individual's unique needs. Insulin lispro can be a key component of precision medicine approaches, presenting opportunities for targeted therapies. According to Journal of Personalized Medicine article ‘Precision Medicine in Diabetes, Current Research and Future Perspectives’ published in July 2022, recently the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) have jointly released an expert opinion-based consensus report on precision medicine. As per the report precision diabetes medicine as “an approach to optimize the diagnosis, prediction, prevention, or treatment of diabetes by integrating multidimensional data, accounting for individual differences”.
• Development of Biosimilar Insulin Lispro: The development and introduction of biosimilar versions of insulin lispro provide opportunities for cost-effective alternatives to the branded product. Biosimilars can increase access to insulin therapy, especially in regions with limited affordability, thereby expanding the market. For instance, in July 2021, Biocon Biologics Inc, India based global biopharmaceutical company, announced U.S. Food and Drug and Administration (FDA) approval for Semglee (insulin glargine-yfgn) which is first interchangeable biosimilar insulin product indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes mellitus and in adults with Type 2 diabetes mellitus.
• Increasing Adoption of Insulin Pump Therapy: Insulin pump therapy offers improved glycemic control and flexibility in insulin administration. The increasing adoption of insulin pump therapy presents opportunities for insulin lispro, which is compatible with various insulin pump devices. The convenience and precision of insulin pump therapy can drive the demand for insulin lispro. For instance, in January 2022, Insulet, U.S. based global medical device company announced U.S. Food and Drug Administration (FDA) approval for tubeless insulin pump, the Omnipod 5 which is a patch-like device capable of adjusting daily doses to changes in the wearer’s blood sugar levels. It is indicated for Type 1 diabetes for pediatric and adult.

Insulin Lispro Market Trends:

• Increasing Adoption of Continuous Glucose Monitoring (CGM): Continuous glucose monitoring devices are becoming more widely used for diabetes management. CGM systems provide real-time glucose readings, helping individuals make informed decisions about insulin dosing. The integration of CGM with insulin pumps and smart devices creates a trend towards personalized insulin therapy and improved glycemic control. For instance, in February 2022, the U.S. Centers for Medicare & Medicaid Services (CMS) announced an expansion of Medicare coverage for all types of continuous glucose monitors (CGMs), including adjunctive and non-adjunctive CGMs. This includes continuous glucose monitors (CGMs) that integrate with Medtronic insulin pumps to monitor the insulin level during the action.  
• Shift towards Ultra-rapid Acting Insulins: Ultra-rapid acting insulins, including insulin lispro, are gaining popularity in the market. These insulins have a faster onset of action, mimicking the body's natural insulin response more closely. They allow for more flexible dosing and can be beneficial in managing postprandial blood sugar spikes. For instance, in January 2020, Novo Nordisk announced U.S. Food and Drug Administration (FDA) approval for Fiasp which is first and only fast-acting mealtime insulin injection that does not have a pre-meal dosing recommendation.
• Growing Interest in Closed-loop Systems (Artificial Pancreas): Closed-loop systems, also known as artificial pancreas systems, combine CGM with insulin pump therapy to automate insulin delivery based on glucose levels. This trend is driven by advancements in algorithm technology and offers improved glucose control, reducing the burden of diabetes management for individuals. According to article ‘Closed-Loop Insulin Delivery Systems: Past, Present, and Future Directions’ published by Frontiers magazine in June 2022, There are several hybrid closed loop systems available that work with a variety of pumps and CGMs. CamAPS FX hybrid closed loop uses a DANA or Ypsomed insulin pump and Dexcom CGM. Licenced for aged 1+, Medtronic 670G + Guardian sensors hybrid closed loop uses Medtronic insulin pump and sensors. Licenced for aged 7+, Medtronic 780G + Guardian sensors hybrid closed loop uses Medtronic insulin pump and sensors. 

Insulin Lispro Market Restraints:

• Cost and Affordability: Insulin therapy can be expensive, particularly for individuals without adequate insurance coverage or in regions with limited healthcare resources. The cost of insulin lispro and other insulin products may pose a barrier to access and affordability, limiting market growth. Insulin lispro injection 100 units/mL costs up to US$25 a vial and injection, a basal insulin that is biosimilar to, and interchangeable with, Lantus (insulin glargine) injection, for US$92 per five pack of KwikPens.

However, on March 2023, Eli Lilly and company announced price reductions of 70% for its most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 or less per month.

• Limited Healthcare Infrastructure: In some regions, especially low- and middle-income countries, the healthcare infrastructure may be insufficient to support effective diabetes management. Limited access to healthcare facilities, diagnostics, and trained healthcare professionals can hinder the widespread adoption of insulin lispro. For instance, according to an article ‘Global health in low-income and middle-income countries: a framework for action’ published in 2021 ‘The Lancet’ South Asian and sub-Saharan African countries on average contribute 0·65% of their gross domestic product to research and 0·69% to development.

Insulin Lispro Market New product launches including year

• Lyumjev (insulin lispro-aabc injection) - Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) approval for an expanded label rapid-acting insulin, Lyumjev (insulin lispro-aabc injection) in August 2021. The drugs are available in a quantity of 100 units/mL. These are indicated to improve glycemic control in adults with type 1 and type 2 diabetes, to include administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump.
• Lyumjev (insulin lispro-aabc injection) - Eli Lilly and Company announced the U.S. Food and Drug Administration (FDA) approval for rapid-acting insulin, Lyumjev (insulin lispro-aabc injection) in June 2020. The drugs are available in a quantity of insulin lispro-aabc injection, 100 units/mL and 200 units/mL. Lyumjev is a novel formulation of insulin lispro, developed to speed the absorption of insulin into the blood stream and reduce A1C levels

Acquisition and partnerships in Insulin Lispro Market

• Eli Lilly and Company (Lilly) and Ypsomed: In 2020, Eli Lilly and Company (Lilly), U.S. based global pharmaceutical company and Ypsomed, Swiss based leading developer and manufacturer of injection and infusion systems developing company, entered into a non-exclusive, global partnership to create and commercialize automated insulin delivery systems. The collaboration aimed to integrate Lilly's insulin products, including Insulin Lispro, with Ypsomed's insulin pump technologies to improve insulin therapy options for people with diabetes.
• Eli Lilly and Company (Lilly) and Cipla Limited: In 2021, Lilly and Cipla, India based Global generic pharmaceutical company, entered into a strategic partnership in India to enhance the reach of Lilly’s diabetes products:  Humalog [Insulin Lispro I.P. (rDNA Origin) injection] and Trulicity (Dulaglutide). Lilly will transfer its rights in India to sell, promote, and distribute the aforesaid two Lilly Diabetes products, Humalog & Trulicity to Cipla, subject to all regulatory approvals.
• Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. and  Tonghua Dongbao Pharmaceutical Co., Ltd.: In 2021 Meitheal Pharmaceuticals, Inc. (Meitheal), a parent company of Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF), announced a licensing agreement with Tonghua Dongbao Pharmaceutical Co., Ltd, China-based company, principally engaged in the research and development, manufacture and distribution of pharmaceuticals company, to commercialize three insulin biosimilars—insulin aspart, insulin lispro, and insulin glargine in the U.S.

Figure 2. Global Insulin Lispro Market Share (%), By Drug Class, 2023

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Top companies in Insulin Lispro Market

• Eli Lilly and Company
• Sanofi
• Novo Nordisk A/S
• Merck & Co., Inc.
• Pfizer Inc.
• Hoffmann-La Roche Ltd.
• AstraZeneca PLC
• Johnson & Johnson Services, Inc.
• Biocon Limited
• Mylan N.V.
• Boehringer Ingelheim International GmbH
• Wockhardt Ltd.
• Lupin Pharmaceuticals, Inc.
• Bioton S.A.
• Gan & Lee Pharmaceuticals
• Ypsomed AG

Definition: Insulin lispro is a rapid-acting insulin analog used in the treatment of diabetes. It is a modified form of human insulin designed to have a more rapid onset of action and shorter duration compared to regular human insulin. Insulin lispro is chemically synthesized using recombinant DNA technology.

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