Iowanews Headlines

Type 1 Diabetes Market Insight, Epidemiology and Market Forecast

Type 1 Diabetes Key Takeaways

• Type 1 Diabetes Market Size and Growth Projections: As per DelveInsight’s analysis, the total market size of Type 1 Diabetes in the 7MM is expected to surge significantly by 2034, driven by novel therapeutic introductions and expanding patient populations across the United States, EU4 countries, the United Kingdom, and Japan

• Type 1 Diabetes Patient Population Insights: The report provides the total Type 1 Diabetes potential pool across the seven major markets, with the United States representing approximately 56% of total diagnosed prevalent cases and Germany accounting for the highest cases (~30%) among EU4 and UK regions

• Leading Type 1 Diabetes Market Players: Leading Type 1 Diabetes companies, such as Eli Lilly and Company, Sanofi, Novo Nordisk, Provention Bio, Landos Biopharma, Diamyd Medical, Gan&Lee Pharmaceuticals, Zealand Pharma, Kamada, AstraZeneca, Histogen, Vertex Pharmaceuticals, Panbela Therapeutics, Arecor, Bioprojet, Novartis, ImCyse, Adocia, REMD Biotherapeutics, and others, are actively advancing the treatment landscape

• Type 1 Diabetes Pipeline Innovation: Some of the key Type 1 Diabetes therapies in the pipeline include REMD-477, Basal Insulin-FC (LY3209590), AWIQLI (insulin icodec), Zynquista (sotagliflozin), CNP-103, iTOL-102, and others, representing diverse mechanisms including weekly insulins, disease-modifying treatments, and immunomodulatory approaches

• Recent Regulatory Milestones:

  • September 2025: Lexicon Pharmaceuticals submitted new clinical data supporting Zynquista resubmission to FDA.

  • June 2025: Sanofi announced a $9.1 billion cash tender offer to acquire Blueprint Medicines, adding early-stage immunology assets to its portfolio.

  • June 2025: In a small Phase 1/2 study of 12 participants with severe T1D, a single infusion of stem-cell-derived islet cells led 10 of 12 to achieve sustained insulin independence and HbA1c < 7% at one year.

  • June 2025: A double-blind trial (NCT05537233) demonstrated that once-weekly semaglutide, added to automated insulin delivery, significantly improved glycemic control and weight management in adults with T1D.

  • April 2025: DexCom received FDA clearance for G7 15-Day Continuous Glucose Monitoring System.

  • February 2025: The FDA approved Merilog, the first rapid-acting insulin biosimilar to Novolog, for adults and pediatric patients with diabetes mellitus.

  • February 2025: COUR Pharmaceuticals obtained FDA IND clearance for CNP-103 nanoparticle therapy.

  • March 2024: Novo Nordisk secured positive CHMP opinion for AWIQLI weekly basal insulin.

Discover more recent advancements in the Type 1 Diabetes landscape @ Type 1 Diabetes Recent Developments.

Type 1 Diabetes Market Dynamics

The Type 1 Diabetes therapeutics market demonstrates robust momentum driven by unprecedented innovation in disease-modifying therapies and advanced insulin delivery systems. According to DelveInsight’s comprehensive Type 1 Diabetes Market Insight, Epidemiology and Market Forecast report, the current market landscape is dominated by insulin therapies as the mainstay treatment, with insulin aspart generating the highest revenue in 2023, followed by insulin glargine. However, the therapeutic paradigm is evolving rapidly with the introduction of TZIELD (teplizumab), recognized as the first disease-modifying treatment designed to delay Stage 3 type 1 diabetes, marking a revolutionary shift from symptomatic management to disease prevention strategies.

Market momentum continues to accelerate through the emergence of weekly insulin formulations, representing a significant advancement in patient convenience and adherence. The scientific rationale behind these innovations centers on addressing unmet medical needs including improved glycemic control, reduced dosing frequency, and preservation of pancreatic beta cells. Basal Insulin-FC from Eli Lilly and AWIQLI (insulin icodec) from Novo Nordisk exemplify this trend, offering once-weekly administration that could transform treatment compliance and patient quality of life.

The Type 1 Diabetes competitive landscape encompasses diverse therapeutic approaches beyond traditional insulin therapy, including anti-CD3 monoclonal antibodies, IL-8 inhibitors, diabetes vaccines, and allogeneic pancreatic islets. Clinical development activity remains intense across Phase II and Phase III trials, with companies pursuing complementary strategies to address different aspects of Type 1 Diabetes pathophysiology. Notable pipeline assets demonstrate innovative mechanisms of action, from immunomodulation to stem cell-derived pancreatic islets combined with tolerance-inducing agents.

Type 1 Diabetes drug development challenges persist around balancing efficacy with safety profiles, particularly concerning diabetic ketoacidosis risk with SGLT inhibitors and immune suppression requirements for cellular therapies. However, emerging solutions like COUR Pharmaceuticals’ nanoparticle approach and iTolerance’s immunomodulator combinations offer promising strategies to overcome traditional limitations. The market opportunity continues expanding through deeper disease understanding, rising prevalence, and regulatory pathways increasingly supportive of innovative therapeutic approaches targeting autoimmune mechanisms rather than solely managing symptoms.

Download the Type 1 Diabetes Market report to understand which factors are driving the therapeutic market @ Type 1 Diabetes Market Trends.

Type 1 Diabetes Epidemiology

The Type 1 Diabetes epidemiological landscape across the seven major markets reveals substantial patient burden with distinct geographic and demographic patterns driving market dynamics through 2034. The United States dominates the global prevalence, representing approximately 56% of total diagnosed prevalent cases across the 7MM, establishing its position as the primary market for therapeutic development and commercial opportunity. Within the European region, Germany accounts for the highest Type 1 Diabetes diagnosed prevalent cases, comprising roughly 30% of total cases among EU4 countries and the United Kingdom, with approximately 230,000 German patients aged over 40 years reported in 2023.

The Type 1 Diabetes epidemiological segmentation demonstrates significant age-related distribution patterns, with nearly half of reported Type 1 Diabetes cases in the United States occurring among individuals aged 40 and above in 2023, challenging traditional perceptions of Type 1 Diabetes as predominantly a pediatric condition. The total diagnosed prevalent cases across the 7MM show steady growth projections through the forecast period of 2024-2034, driven by improved diagnostic capabilities, increased disease awareness, and expanding screening programs in at-risk populations.

The eligible patient pool encompasses multiple treatment categories including newly diagnosed patients requiring immediate insulin therapy, established patients eligible for advanced delivery systems, and at-risk individuals suitable for disease-modifying interventions like TZIELD. Geographic segmentation reveals varying treatment penetration rates, with developed markets showing higher adoption of advanced therapies including continuous glucose monitoring systems and insulin pump technologies. The total treated cases demonstrate increasing treatment rates across all age segments, supported by expanding healthcare infrastructure and improved access to specialized diabetes care. Forecast projections through 2034 indicate continued epidemiological growth driven by enhanced survival rates, aging populations, and evolving diagnostic criteria capturing previously unidentified cases across the seven major markets.

Discover evolving trends in the Type 1 Diabetes epidemiology forecasts @ Type 1 Diabetes Patient Pool Analysis.

Key Type 1 Diabetes Companies and Treatment Market Context

The clinical and regulatory landscape for Type 1 Diabetes therapeutics encompasses established insulin therapies alongside breakthrough disease-modifying treatments reshaping therapeutic paradigms. Current treatment options remain anchored by multiple daily insulin injections as the standard of care, with approved therapies including TZIELD from Sanofi, TOUJEO/LANTUS XR from Sanofi, LYUMJEV from Eli Lilly and Company, and FIASP from Novo Nordisk providing comprehensive glycemic management solutions. The regulatory environment demonstrates increasing receptivity to innovative approaches, evidenced by TZIELD’s groundbreaking FDA approval as the first therapy to delay Type 1 Diabetes onset in at-risk individuals.

The Type 1 Diabetes clinical pipeline activity spans diverse therapeutic modalities with companies pursuing complementary development strategies across immunomodulation, advanced insulin delivery, and regenerative medicine approaches. Key players include Eli Lilly and Company (Basal Insulin-FC LY3209590), Novo Nordisk (AWIQLI insulin icodec), REMD Biotherapeutics (REMD-477), Lexicon Pharmaceuticals (Zynquista sotagliflozin), COUR Pharmaceuticals (CNP-103), and innovative collaborations like the NLS Pharmaceutics, Kadimastem, and iTolerance partnership developing iTOL-102 as a potential cure combining stem cell-derived pancreatic islets with immunomodulation.

Market positioning reflects strategic differentiation through mechanism of action diversity, with established players leveraging insulin optimization while emerging companies target disease modification and immune tolerance induction. Drug profiles demonstrate advancing from traditional glucose-lowering approaches toward comprehensive disease management, including COUR’s antigen-specific tolerance nanoparticles targeting underlying autoimmunity and Rise Therapeutics’ R-5780 expanding from oncology into autoimmune applications. Development milestones continue accelerating through 2025, with multiple FDA interactions including IND clearances, positive regulatory meetings, and breakthrough therapy designations supporting expedited development pathways. Commercial arrangements increasingly emphasize strategic partnerships and acquisitions, exemplified by Sanofi’s acquisition of Provention Bio to secure TZIELD’s market position and expand disease-modifying therapy portfolios across global markets.

Delve deeper into the major and specialised companies in the Type 1 Diabetes market @ Type 1 Diabetes Competitive Landscape.

Conclusion

DelveInsight’s comprehensive Type 1 Diabetes market analysis reveals a transformative therapeutic landscape poised for significant growth through 2034, driven by innovative disease-modifying treatments, advanced insulin delivery systems, and expanding patient populations across the seven major markets. With the United States commanding 89% market share and TZIELD establishing the first disease-modifying treatment paradigm, the market presents substantial opportunities for pharmaceutical companies developing next-generation therapies targeting both symptom management and underlying autoimmune mechanisms. The convergence of weekly insulin formulations, immunomodulatory approaches, and regenerative medicine solutions positions the Type 1 Diabetes market for unprecedented therapeutic advancement and improved patient outcomes.

Scope of the Type 1 Diabetes Market Report

• Comprehensive Type 1 Diabetes Market Analysis: The Type 1 Diabetes therapeutics market report covers a segment of key events, executive summary, descriptive overview explaining causes, signs and symptoms, pathogenesis, and currently available therapies

• Type 1 Diabetes Epidemiological Insights: Comprehensive insight into Type 1 Diabetes epidemiology segments and forecasts, future growth potential of diagnosis rate, and disease progression along with country-specific treatment guidelines

• Current and Emerging Type 1 Diabetes Therapeutics: All-inclusive account of both current and emerging therapies, along with elaborative profiles of late-stage and prominent therapies impacting the current treatment landscape

• Type 1 Diabetes Market Forecasting and Analysis: Detailed review of therapeutics market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale covering 7MM drug outreach

• Strategic Business Intelligence: Edge in developing business strategies through SWOT analysis, expert insights/KOL views, patient journey, and treatment preferences driving the 7MM market

• Type 1 Diabetes Pipeline and Development Activities: Type 1 Diabetes pipeline analysis covering Phase III and Phase II stages, key companies involved in developing targeted therapeutics, collaborations, acquisitions, mergers, licensing, and patent details

• Type 1 Diabetes Market Access and Reimbursement: Country-wise accessibility and reimbursement scenarios, cost-effectiveness of current therapies, accessibility programs, out-of-pocket costs, and federal/state prescription drug program insights

• Type 1 Diabetes Qualitative Market Intelligence: SWOT analysis covering strengths, weaknesses, opportunities, and threats in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility

• Key Opinion Leader Perspectives on Type 1 Diabetes: Primary research with 10+ KOLs providing insights on evolving treatment landscape, patient therapy switching, drug uptake, and accessibility challenges

• Geographic Coverage: United States, EU4 countries (Germany, France, Italy, Spain), United Kingdom, and Japan with detailed country-specific analysis

• Study Timeline: Historical data from 2020 with comprehensive forecasting through 2034, providing long-term market perspective for strategic planning

Table of Contents

1. Key Insights

2. Executive Summary of Type 1 Diabetes

3. Competitive Intelligence Analysis for Type 1 Diabetes

4. Type 1 Diabetes Market Overview at a Glance

5. Type 1 Diabetes: Disease Background and Overview

6. Type 1 Diabetes Patient Journey

7. Type 1 Diabetes Epidemiology and Patient Population

8. Treatment Algorithm, Current Treatment, and Medical Practices

9. Type 1 Diabetes Unmet Needs

10. Key Endpoints of Type 1 Diabetes Treatment

11. Type 1 Diabetes Marketed Products

12. Type 1 Diabetes Emerging Therapies

13. Type 1 Diabetes: Seven Major Market Analysis

14. Attribute analysis

15. 7MM: Market Outlook

16. Access and Reimbursement Overview of Type 1 Diabetes

17. KOL Views

18. Type 1 Diabetes Market Drivers

19. Type 1 Diabetes Market Barriers

20. Appendix

21. DelveInsight Capabilities

22. Disclaimer

23. About DelveInsight

About DelveInsight

DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.

Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Arpit Anand
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Las Vegas
State: Nevada
Country: United States
Website: https://www.delveinsight.com/consulting/due-diligence-services