Type 1 Diabetes Market Size, Epidemiology, In-Market Drugs Sales, Pipeline Therapies, and Regional Outlook 2025-2035

Market Overview:

The type 1 diabetes market reached a value of USD 5.9 Billion across the top 7 markets (US, EU4, UK, and Japan) in 2024. Looking forward, IMARC Group expects the top 7 major markets to reach USD 9.6 Billion by 2035, exhibiting a growth rate (CAGR) of 4.65% during 2025-2035.

The type 1 diabetes market has been comprehensively analyzed in IMARC's new report titled "Type 1 Diabetes Market Size, Epidemiology, In-Market Drugs Sales, Pipeline Therapies, and Regional Outlook 2025-2035". Type 1 diabetes, sometimes known as juvenile diabetes or insulin-dependent diabetes, refers to a chronic autoimmune disorder in which the pancreas produces very little to no insulin, the hormone responsible for regulating blood sugar levels. Some of the common symptoms associated with the ailment often emerge suddenly and can include excessive thirst, frequent urination, unexplained weight loss, constant fatigue, increased hunger, blurry vision, slow healing of wounds, etc. Individuals suffering from this disorder may also experience mood swings, irritability, and a general feeling of being unwell. The diagnosis of type 1 diabetes involves a comprehensive evaluation by a healthcare professional. It typically begins with a thorough medical history assessment and physical examination. Various blood tests, such as fasting plasma glucose levels and hemoglobin A1c, are commonly used to measure blood sugar levels and assess long-term glucose control. Additionally, the presence of specific antibodies associated with the ailment, including islet cell antibodies and glutamic acid decarboxylase antibodies, may be tested. These diagnostic procedures help confirm the absence of insulin production and distinguish type 1 diabetes from other forms of diabetes.

The increasing cases of immune system dysregulation, in which the immune cells mistakenly target and destroy the insulin-producing beta cells in the pancreas, are primarily driving the type 1 diabetes market. In addition to this, the escalating utilization of artificial pancreas systems that aim to optimize glucose control and reduce the burden of diabetes self-management by minimizing the need for manual adjustments is also bolstering the market growth. Moreover, the rising demand for beta cell replacement therapies, which involve transplanting functional insulin-producing beta cells into patients to restore normal insulin production, is further creating a positive outlook for the market. Besides this, the widespread adoption of insulin pens on account of their several associated benefits, such as ease of use, dose flexibility, discreetness, etc., is acting as another significant growth-inducing factor. Additionally, the emerging popularity of sensor-augmented pump therapy, since it allows for more precise insulin dosing and improved glucose control compared to conventional insulin pump therapy, is expected to drive the type 1 diabetes market in the coming years.

IMARC Group's new report provides an exhaustive analysis of the type 1 diabetes market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for type 1 diabetes and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc., have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the type 1 diabetes market in any manner.

Recent Developments:

• In June 2025, Vertex Pharmaceuticals announced simultaneous presentation and publication of updated data from the Phase 1/2 portion of the Phase 1/2/3 FORWARD-101 clinical trial of zimislecel (VX-880), an investigational stem cell-derived, fully differentiated islet cell therapy, in people with type 1 diabetes with impaired hypoglycemic awareness and severe hypoglycemic events.
• In December 2024, MannKind Corporation disclosed six-month results from its Phase 3 INHALE-1 study of Afrezza (insulin human) Inhalation Powder in children and adolescents (aged 4-17 years of age). MannKind expects to submit a request for a supplemental new drug application (sNDA) meeting with the U.S. FDA to discuss the data and filing timeline.
• In March 2024, Novo Nordisk announced that it had received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Awiqli (once-weekly basal insulin icodec) to treat diabetes in adults.
• In March 2023, Imcyse stated completion of patient enrollment in its Phase 2 IMPACT (IMCY-0098 Proof of ACtion in type 1 diabetes) trial of its lead product candidate IMCY-0098, a proinsulin-derived Imotope engineered to halt the progression and prevent early-onset type 1 diabetes.

Key Highlights:

• Diabetes is a major cause of heart and blood vessel disease, kidney failure, nerve damage, blindness, and lower limb amputation.
• Around 18.7 million of the 537 million people with diabetes worldwide live in low-income and middle-income countries (LMIC), where there is also an increase in the number of children, adolescents, and young adults diagnosed with type 1 diabetes.
• Type 1 diabetes makes up an estimated 5–10% of all diabetes cases.
• The type 1 diabetes incidence in children aged < 15 years increased annually by 5.3% among all children, especially in boys aged 10–14 years by 8.1%, over the past 23 years.
• Males were 1.3 times as likely to be newly diagnosed (incidence) with type 1 diabetes as females.

Drugs:

Afrezza is a man-made, ultra rapid-acting inhaled insulin that starts lowering blood sugars in ~12 minutes for adults suffering from type 1 diabetes. The drug is available in 4-unit, 8-unit and 12-unit single-dose cartridges of insulin powder, which can be used, as prescribed by a health care professional, in combination with various other diabetes medications to achieve target blood sugar levels.

IMCY-0098, developed by ImCyse, is designed to halt the progression of type 1 diabetes by specifically targeting and eliminating the immune cells that attack and destroy beta cells in the pancreas. It achieves this through a unique approach called an Imotope, which is a modified peptide designed to induce a specific immune response.

VX-880 is an experimental allogeneic stem cell-derived, fully differentiated, insulin-producing islet cell treatment made with unique technology. VX-880 is being tested for people with type 1 diabetes who have impaired hypoglycemic awareness and severe hypoglycemia. This therapeutic agent has the potential to help the body regulate glucose levels by restoring pancreatic islet cell activity, which includes glucose-responsive insulin production. It is administered via an infusion into the hepatic portal vein and requires long-term immunosuppressive medication to protect the islet cells from immunological rejection.

Time Period of the Study

• Base Year: 2024
• Historical Period: 2019-2024
• Market Forecast: 2025-2035

Countries Covered

• United States
• Germany
• France
• United Kingdom
• Italy
• Spain
• Japan

Analysis Covered Across Each Country

• Historical, current, and future epidemiology scenario
• Historical, current, and future performance of the type 1 diabetes market
• Historical, current, and future performance of various therapeutic categories in the market
• Sales of various drugs across the type 1 diabetes market
• Reimbursement scenario in the market
• In-market and pipeline drugs

Competitive Landscape:

This report also provides a detailed analysis of the current type 1 diabetes marketed drugs and late-stage pipeline drugs.

In-Market Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

Late-Stage Pipeline Drugs

• Drug Overview
• Mechanism of Action
• Regulatory Status
• Clinical Trial Results
• Drug Uptake and Market Performance

*Kindly note that the drugs in the above table only represent a partial list of marketed/pipeline drugs, and the complete list has been provided in the report.

Key Questions Answered in this Report:

Market Insights

• How has the type 1 diabetes market performed so far and how will it perform in the coming years?
• What are the markets shares of various therapeutic segments in 2024 and how are they expected to perform till 2035?
• What was the country-wise size of the type 1 diabetes across the seven major markets in 2024 and what will it look like in 2035?
• What is the growth rate of the type 1 diabetes across the seven major markets and what will be the expected growth over the next ten years?
• What are the key unmet needs in the market?

Epidemiology Insights

• What is the number of prevalent cases (2019-2035) of type 1 diabetes across the seven major markets?
• What is the number of prevalent cases (2019-2035) of type 1 diabetes by age across the seven major markets?
• What is the number of prevalent cases (2019-2035) of type 1 diabetes by gender across the seven major markets?
• What is the number of prevalent cases (2019-2035) of type 1 diabetes by type across the seven major markets?
• How many patients are diagnosed (2019-2035) with type 1 diabetes across the seven major markets?
• What is the size of the type 1 diabetes patient pool (2019-2024) across the seven major markets?
• What would be the forecasted patient pool (2025-2035) across the seven major markets?
• What are the key factors driving the epidemiological trend type 1 diabetes of?
• What will be the growth rate of patients across the seven major markets?

Type 1 Diabetes: Current Treatment Scenario, Marketed Drugs and Emerging Therapies

• What are the current marketed drugs and what are their market performance?
• What are the key pipeline drugs and how are they expected to perform in the coming years?
• How safe are the current marketed drugs and what are their efficacies?
• How safe are the late-stage pipeline drugs and what are their efficacies?
• What are the current treatment guidelines for type 1 diabetes drugs across the seven major markets?
• Who are the key companies in the market and what are their market shares?
• What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the type 1 diabetes market?
• What are the key regulatory events related to the type 1 diabetes market?
• What is the structure of clinical trial landscape by status related to the type 1 diabetes market?
• What is the structure of clinical trial landscape by phase related to the type 1 diabetes market?
• What is the structure of clinical trial landscape by route of administration related to the type 1 diabetes market?