SGLT2 억제제 : 시장 규모, 대상 환자층, 경쟁 구도 및 시장 예측(2036년)

Key Highlights:

• The approved drug for SGLT2 inhibitors includes FARXIGA (dapagliflozin), INPEFA (sotagliflozin), JARDIANCE (empagliflozin), BRENZAVVY (bexagliflozin), STEGLATRO (ertugliflozin), INVOKANA (canagliflozin), and others for different indications including type 2 diabetes, CHF, CKD, and others.
• The emerging pipeline for SGLT2 inhibitors is constraints which includes YG1699 (Youngene Therapeutics). The combination of approved SGLT2 inhibitors is being investigated for various indications, including metabolic dysfunction-associated steatohepatitis, and others, which could lead to significant changes in the market during the forecast period.
• The SGLT2 inhibitors treatment market is rapidly growing, primarily driven by the rising incidence of diabetes and the expanding range of indications for these drugs. Initially developed for the treatment of type 2 diabetes, SGLT2 inhibitors are now increasingly utilized for their cardiovascular benefits, which have also led to the discovery of additional renal benefits, further broadening their therapeutic use.

DelveInsight's "SGLT2 Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast - 2036" report delivers an in-depth understanding of SGLT2 Inhibitors, addressable patient pool, competitive landscape, and future market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the UK, and Japan.

The SGLT2 Inhibitors market report provides insights around existing treatment practices in patients with SGLT2 Inhibitors, approved (if any) and emerging SGLT2 Inhibitors, market share of individual therapies, patient pool eligible for treatment with SGLT2 Inhibitors, along with current and forecasted 7MM SGLT2 Inhibitors market size from 2022-2036 by therapies and by indication. The report also covers current unmet needs and challenges while incorporating new classes in treatment paradigm, variations in accessibility and acceptability of new SGLT2 Inhibitors in different geographies, along with insights on SGLT2 Inhibitors pricing reimbursements to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain), and the UK
• Japan

Study Period: 2022-2036

SGLT2 Inhibitors Overview

Sodium-glucose cotransporter 2 (SGLT2) inhibitors act on SGLT2 receptors in the kidneys, which is responsible for reabsorbing glucose from the urine back into the bloodstream.

SGLT2 inhibitors stand out for their ability to provide cardiovascular and kidney protection, in addition to managing blood sugar. Unlike other treatments, they also promote weight loss and help lower blood pressure, offering a comprehensive approach to managing type 2 diabetes and related complications.

Target Patient Pool Analysis

• According to DelveInsight's analysis, the number of prevalent cases of CHF in Japan were ~3,864,000 in 2025.
• As per DelveInsight's estimates, the prevalence of heart failure was seen more in male (~55%) as compare to female (~45%) in 2025 in the US.
• Among the EU4 and the UK, Germany had the highest prevalence of CKD, followed by the UK, with Italy having the lowest prevalence in 2025.
• According to DelveInsight's estimation, the prevalent cases of AMI was ~ 828,800 in Japan.
• In 2025, the estimated prevalent cases of DKD were ~15,042,000 in the US.

SGLT2 Inhibitors Drug Chapters

The drug chapter segment of the SGLT2 Inhibitors report encloses a detailed analysis of marketed therapies and late-stage (Phase III and Phase II) therapies. It also helps understand the SGLT2 Inhibitors clinical trial details, pharmacological action, agreements and collaborations related to SGLT2 Inhibitors, their approval timelines, patent details, advantages and disadvantages, latest news and press releases.

SGLT2 Inhibitors Marketed Drugs

FARXIGA/FORXIGA: AstraZeneca

FARXIGA/FORXIGA (dapagliflozin), developed by AstraZeneca, is indicated in patients with type 2 diabetes mellitus to improve the control of blood glucose in addition to diet and exercise. Other indications include minimizing the hospitalization attributed to heart failure in type 2 diabetes mellitus patients with underlying cardiovascular illness or several cardiovascular risk factors. It also received approval for managing CKD by US FDA in April 2021. In May 2023, FARXIGA had been approved in the US to reduce the risk of cardiovascular death, hospitalization for heart failure and urgent heart failure visits in adults with heart failure.

In June 2024, FARXIGA (dapagliflozin) has been approved by the US FDA to improve glycemic control in pediatric patients with type-2 diabetes aged 10 years and older.

JARDIANCE: Boehringer Ingelheim

JARDIANCE (empagliflozin), developed by Boehringer Ingelheim, and co-market with Eli Lilly. It is used to reduce the risk of cardiovascular death and hospitalization due to heart failure in adults, as well as to reduce the risk of cardiovascular death in adults with type 2 diabetes. Additionally, it helps lower blood sugar in adults and children aged 10 years and older with type 2 diabetes, when used alongside diet and exercise.

In September 2023, the US FDA approved JARDIANCE to reduce the risk of sustained decline in estimated glomerular filtration rate (eGFR), end-stage kidney disease, cardiovascular death and hospitalization in adults with CKD at risk of progression.

SGLT2 Inhibitors Emerging Drugs

YG1699: Youngene Therapeutics

YG1699 is a dual inhibitor of SGLT1/SGLT2. It offers all the benefits of SGLT2 inhibition, while also providing SGLT1 inhibition to enhance efficacy. YG1699 carries unique potential to help patients with type 1 diabetes mellitus better control their blood glucose levels, particularly after meals, and improve their overall quality of life. In addition, the associated benefits of dual SGLT1 and SGLT2 inhibition may reduce the risks associated with diabetes, including cardiovascular disease and diabetic nephropathy.

The company is investigating the drug in various trials, including heart failure, type 2 diabetes, and diabetes with severe CKD in Phase I, and type 1 diabetes in Phase II in China.

The company conducted a Phase I trial for YG1699 in type 1 diabetes in the US, but there have been no further updates on this trial from the company.

The company is now actively involved in planning and developing the clinical research protocol for YG1699 in heart failure study in the US.

The FDA has approved several drugs as single-ingredient products or in combination with other medications, such as JARDIANCE and SYNJARDY (empagliflozin and metformin hydrochloride), STEGLATRO (ertugliflozin) and metformin, and others. Despite a constrained pipeline, some companies are expanding their offerings by combining these approved drugs with other therapies.

These combinations with SGLT2 inhibitors includes:

Zibotentan/Balcinrenone/Baxdrostat and Dapagliflozin: AstraZeneca

A Phase III trial is underway for balcinrenone and dapagliflozin in heart failure with CKD, baxdrostat and dapagliflozin in CKD and prevention of heart failure, and zibotentan and dapagliflozin in CKD with high proteinuria.

Pemafibrate and Tofogliflozin: Kowa Company

The company is conducting a Phase II trial for pemafibrate/tofogliflozin in the treatment of metabolic dysfunction-associated steatohepatitis. Pemafibrate is a selective PPARa modulator, while tofogliflozin is an SGLT2 inhibitor.

Drug Class Insights

The Drug Class Insights section will provide comprehensive information on SGLT2 Inhibitors as a class. This will include a broad overview of the class and its role in treating specific conditions. Insights may cover the historical clinical development of SGLT2 Inhibitors, their mechanism of action, their subtypes and future commercial prospects. Additionally, the section will provide detailed information about current trends, challenges, and future prospects for this class of drugs.

SGLT2 Inhibitors Market Outlook

This section will include details on changing SGLT2 Inhibitors market dynamics post initiation of clinical development activities of the inhibitor. It will also provide a detailed summary and comparison of all the therapies being developed by leading players in this space. This section will highlight the advantages of one therapy over the other after assessment based on parameters such as data availability in the form of safety and efficacy, number of patients enrolled in each trial, and trial's inclusion criteria. There will be a Key focus on the importance of development and need for the commercial success of these targeted therapies to achieve treatment goals that physicians and patients are looking for. It will also sum up all the early stage players active in this space.

SGLT2 Inhibitors Drugs Uptake

This section focuses on the uptake rate of potential SGLT2 Inhibitors already launched and expected to be launched in the market during 2022-2036, which depends on the competitive landscape, safety, efficacy data, and order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

SGLT2 Inhibitors Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

SGLT2 Inhibitors Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for SGLT2 Inhibitors.

KOL Views

To keep up with current and future market trends, we incorporate Key physicians, Therapy Area Researcher's, and other Industry Experts' opinions working in the domain through primary research to fill in the data gaps and validate our secondary research. 25+ Key Opinion Leaders (KOLs) were contacted for insights on SGLT2 Inhibitors' incorporation in the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along with challenges related to accessibility.

Qualitative Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst's discretion and assessment of the cost analysis and existing and evolving treatment landscape.

Market Access and Reimbursement

This section will include insights around the standard HTA pricing, recent reformations in 2024 and modifications in reimbursement process in the 7MM. For example, In the United States, a multi payer model exists when it comes to drug pricing regime, which is currently undergoing significant changes, with recent federal legislation, such as the Prescription Drug Pricing Reform provisions of the Inflation Reduction Act, significantly altering the pricing regime under certain federal programs. Whereas in Germany, the market access differs from the systems followed in many other countries as no pricing and reimbursement approval is required during launch of a new therapy.

Moreover, this section will also provide details on reimbursement of approved therapy, if any.

Scope of the Report:

• The report covers a segment of key events, an executive summary, target patient pool, epidemiology and market forecasts, information around patient journey and varying biomarker testing rates
• Additionally, an all-inclusive account of the current and emerging therapies drug chapters, insights on SGLT2 Inhibitors addressable patient pool
• A detailed review of the SGLT2 Inhibitors market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, and treatment preferences that help in shaping and driving the 7MM SGLT2 Inhibitors market.
• Market Size of Inhibitors by therapies and indication will be provided

SGLT2 Inhibitors Report Key Strengths

• 11 Years SGLT2 Inhibitors Market Forecast
• The 7MM Coverage
• SGLT2 Inhibitors Competitive Landscape of current and emerging therapies
• SGLT2 Inhibitors Total Addressable patient population
• Drugs Uptake and Key Market Forecast Assumptions
• Approved and Emerging therapy Profiles
• Physician's perspectives/KOL opinions
• Biomarker testing and Patient journey
• Qualitative Analysis (SWOT and Analyst Views)
• SGLT2 Inhibitors Market Size by therapy and indication
• Existing and Future Market Opportunity
• Unmet Needs

FAQs:

• What was the SGLT2 Inhibitors total market size, the market size by therapies, market share (%) distribution in 2022, and what would it look like by 2036? What are the contributing factors for SGLT2 Inhibitors market growth?
• Which drug is going to be the largest contributor by 2036?
• What is the market access and reimbursement scenario of SGLT2 Inhibitors?
• What are the pricing variations among different geographies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?

Reasons to Buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the SGLT2 Inhibitors Market.
• Understand the existing SGLT2 Inhibitors market opportunities and future trends in varying geographies
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility and acceptability of emerging treatment options along with unmet need of current therapies
• Details on report methodology, top indications covered, market assumptions, patient journey and KOLs to strengthen the pharmaceutical companies' development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of SGLT2 Inhibitors

4. Key Events

5. SGLT2 Inhibitors Market Overview At A Glance

• 5.1. Market Share (%) Distribution of SGLT2 Inhibitors By Therapy in 2025
• 5.2. Market Share (%) Distribution of SGLT2 Inhibitors By Therapy in 2036

6. Background And Overview

7. Target Population

8. SGLT2 Inhibitors Marketed Drugs

• 8.1. Key Competitors
  • 8.1.1. Product Description
  • 8.1.2. Regulatory Milestones
  • 8.1.3. Other Developmental Activities
  • 8.1.4. Ongoing Clinical Development
  • 8.1.5. Safety and Efficacy

9. SGLT2 Inhibitors Emerging Drugs

• 9.1. Key Competitors
  • 9.1.1. Product Description
  • 9.1.2. Other Development Activities
  • 9.1.3. Clinical Development
    • 9.1.3.1. Clinical Trials Information
  • 9.1.4. Safety and Efficacy

10. SGLT2 Inhibitors: The 7MM Analysis

• 10.1. Key Findings
• 10.2. Market Outlook
• 10.3. Key Market Forecast Assumptions
• 10.4. Total Market Size of SGLT2 Inhibitors in the 7MM
  • 10.4.1. Market Size of SGLT2 Inhibitors By Therapies In the 7MM
  • 10.4.2. Market Size of SGLT2 Inhibitors By Indication In the 7MM
• 10.6. United States Market
  • 10.6.1. Total Market Size of SGLT2 Inhibitors in the United States
  • 10.6.2. Market Size of SGLT2 Inhibitors By Therapies in the United States
• 10.7. EU4 and the UK Market
  • 10.7.1. Total Market Size of SGLT2 Inhibitors in EU4 and the UK
  • 10.7.2. Market Size of SGLT2 Inhibitors By Therapies in EU4 and the UK
• 10.8. Japan Market
  • 10.8.1. Total Market Size of SGLT2 Inhibitors in Japan
  • 10.8.2. Market Size of SGLT2 Inhibitors By Therapies in Japan

11. Unmet Needs

12. SWOT Analysis

13. KOL Views

14. Market Access and Reimbursement

• 14.1. United States
  • 14.1.1. Centre for Medicare & Medicaid Services (CMS)
• 14.2. EU4 and the UK
  • 14.2.1. Germany
  • 14.2.2. France
  • 14.2.3. Italy
  • 14.2.4. Spain
  • 14.2.5. United Kingdom
• 14.3. Japan
  • 14.3.1. MHLW

15. Appendix

• 15.1. Bibliography
• 15.2. Report Methodology

16. Delveinsight Capabilities

17. Disclaimer

18. About DelveInsight