2형 당뇨병 : 경쟁 구도 및 임상시험 분석(2026년)

DelveInsight's, "Type 2 Diabetes - Competitive Landscape and Clinical Trial Analysis, 2026" report provides comprehensive insights about 200+ companies and 200+ drugs in Type 2 Diabetes Competitive landscape. It covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Type 2 Diabetes: Understanding

Type 2 Diabetes: Overview

Type 2 diabetes mellitus (T2D) is a chronic metabolic disorder characterized by persistent hyperglycemia resulting from insulin resistance combined with progressive inadequacy of pancreatic B-cell insulin secretion. It accounts for the majority of diabetes cases and commonly develops in adulthood, although incidence in younger people is increasing.

Major risk factors include overweight/obesity, physical inactivity, unhealthy diet, advancing age, family history, genetic susceptibility, history of gestational diabetes, and certain metabolic conditions. The disease may remain asymptomatic for years; when symptoms occur, they can include excessive thirst, frequent urination, increased hunger, fatigue, blurred vision, slow wound healing, and recurrent infections.

Pathophysiologically, T2D involves impaired insulin action in skeletal muscle, adipose tissue, and liver, together with progressive B-cell dysfunction. Insulin resistance reduces peripheral glucose uptake and increases hepatic glucose production, while impaired B-cell compensation progressively limits insulin secretion, resulting in sustained hyperglycemia. Dysfunction of adipose tissue, altered incretin signaling, glucagon excess, inflammation, and abnormal renal glucose handling also contribute to disease progression.

Diagnosis is established using HbA1c, fasting plasma glucose, 2-hour oral glucose tolerance test (OGTT), or random plasma glucose in patients with classic symptoms; in the absence of unequivocal hyperglycemia, abnormal results generally require confirmation with repeat or complementary testing.

Treatment is individualized according to glycemic status, weight, cardiovascular and renal risk, comorbidities, treatment preferences, and safety considerations. Lifestyle management including a healthy eating pattern, regular physical activity, weight management, adequate sleep, and diabetes self-management education forms an essential component of care.

Pharmacological therapy may include metformin, GLP-1 receptor agonists, dual GIP/GLP-1 receptor agonists, SGLT2 inhibitors, DPP-4 inhibitors, sulfonylureas, thiazolidinediones, and insulin, with selection increasingly guided by cardiovascular, kidney, and weight-related benefits rather than glucose lowering alone. Current 2026 ADA guidance emphasizes person-centered treatment and use of therapies with demonstrated cardiovascular, renal, and weight benefits when clinically appropriate.

Report Highlights:

• In August 2026, Novo Nordisk announced the nationwide launch of Awiqli(R) (insulin icodec-abae) injection 700 units/mL, the first once-weekly basal insulin approved as an adjunct to diet and exercise to improve glycemic control (blood sugar) in adults living with type 2 diabetes, following the US Food and Drug Administration (FDA) approval earlier this year.
• In August 2026, Structure Therapeutics announced that the first patients have been dosed in the Phase III ACCOMPLISH program, which includes two clinical trials evaluating aleniglipron, a once-daily oral small molecule GLP-1 receptor agonist.
• In July 2026, Kailera Therapeutics, Inc. announced positive topline data from two additional Phase III clinical trials of oral small molecule GLP-1 receptor agonist HRS-7535 (also known as KAI-7535) conducted by Hengrui Pharma.
• In June 2026, positive results from the VISTA and SOLSTICE Phase IIb trials of elecoglipron, an oral small molecule GLP-1 receptor agonist (GLP-1 RA), were presented at the 2026 Scientific Sessions of the American Diabetes Association (ADA) and simultaneously published in The Lancet. AstraZeneca is advancing elecoglipron into an extensive Phase III programme in obesity and type 2 diabetes, including cardiovascular and kidney outcome trials.
• In May 2026, Genprex, Inc. announced that its research collaborators presented positive preclinical data on the Company's diabetes gene therapy drug candidate at the 2026 American Society of Gene and Cell Therapy (ASGCT) Annual Meeting. The collaborators presented preclinical data demonstrating that the diabetes gene therapy (Pdx1/MafA gene therapy, PM or GPX-002) can reverse hyperglycemia in Type 2 diabetic (T2D) mouse models.
• In March 2026, Eli Lilly and Company announced positive topline results from TRANSCEND-T2D-1, a Phase III clinical trial evaluating the efficacy and safety of retatrutide, an investigational first-in-class GIP, GLP-1 and glucagon triple hormone receptor agonist, as an adjunct to diet and exercise.
• In February 2026, Novo Nordisk announced headline results from REIMAGINE 2, a Phase III trial from the global REIMAGINE clinical trial programme. CagriSema demonstrated both superior HbA1c reduction and weight loss at week 68 versus semaglutide, across all tested doses in the trial.
• In February 2026, Autotelic Bio announced that it has entered into an exclusive license and technology transfer agreement with Ache Laboratorios Farmaceuticos S.A. for ATB-101, the world's first combination therapy designed to simultaneously treat hypertension and diabetes. Under the agreement, Ache has secured the exclusive rights to manufacture and commercialize ATB-101 in the Brazilian market.
• In February 2026, Alnylam Pharmaceuticals, Inc. reported that the company has initiated a Phase II clinical trial of ALN-4324, an investigational RNAi therapeutic targeting GRB14 for type 2 diabetes mellitus.
• In August 2025, Innovent Biologics, Inc. announced that the US Food and Drug Administration (FDA) has approved the investigational new drug (IND) application to initiate a Phase I clinical trial of IBI3032, the company's novel oral GLP-1R agonist.
• In June 2025, Eccogene announced that the first patient has been dosed in a Phase Ib clinical trial of AZD5004/ECC5004 in China. The earlier Phase I trial of AZD5004/ECC5004 was conducted in the US only and this trial in China is a key milestone to support local regulatory requirements.
• In May 2025, Sumitomo Pharma Co., Ltd. announced that Sumitomo Pharma and Novo Nordisk Pharma Ltd. have entered into a co-promotion agreement in Japan for Ozempic(R) Subcutaneous Injection 2 mg, a once-weekly subcutaneous GLP-1 receptor agonist indicated for the treatment of type 2 diabetes.

Type 2 Diabetes: Company and Product Profiles (Marketed Therapies)

1. Company Overview: Eli Lilly and Company

Eli Lilly and Company is a global pharmaceutical company headquartered in Indianapolis, Indiana, founded in 1876 and focused on discovering, developing, manufacturing, and commercializing innovative medicines. The company has a strong presence across diabetes, obesity, oncology, immunology, neuroscience, and other major therapeutic areas. Lilly has a global commercial and R&D footprint, with products marketed across approximately 90 countries and clinical research conducted in more than 55 countries. Its portfolio includes several leading medicines and a broad pipeline of innovative therapies addressing significant unmet medical needs.

Product Description: Orforglipron

Orforglipron is an oral, once-daily small-molecule GLP-1 receptor agonist developed by Eli Lilly for the treatment of type 2 diabetes. It activates GLP-1 receptors to enhance glucose-dependent insulin secretion, suppress glucagon secretion, and slow gastric emptying, thereby improving glycemic control. Unlike injectable GLP-1 therapies, orforglipron is designed for oral administration without the need for injection or fasting requirements. In August 2026, the UK MHRA authorised orforglipron for adults with insufficiently controlled type 2 diabetes, making the UK the first country in Europe to approve it for this indication.

2. Company Overview: Novo Nordisk

Novo Nordisk A/S is a Denmark-based global healthcare and pharmaceutical company established in 1923, with a focus on developing, manufacturing, and commercializing innovative therapies for chronic diseases. Its key therapeutic areas include diabetes, obesity, and rare blood and endocrine disorders. The company has a broad international presence, with its products available across numerous markets worldwide. Novo Nordisk is also committed to advancing biological therapies and expanding access to innovative treatments for patients.

Product Description: Ozempic

Ozempic(R) (semaglutide) is a once-weekly GLP-1 receptor agonist developed by Novo Nordisk for the treatment of adults with type 2 diabetes. It improves glycemic control by enhancing glucose-dependent insulin secretion and reducing glucagon secretion, while also supporting body-weight reduction. Ozempic is approved as monotherapy when metformin is inappropriate and as an add-on to other diabetes medicines. The European Commission approved Ozempic for T2D in February 2018, following FDA approval in December 2017.

3. Company Overview: Johnson & Johnson

Johnson & Johnson (J&J) is a global healthcare company founded in 1886, focused on developing innovative medicines and medical technologies. The company operates through two primary segments: Innovative Medicine and MedTech, addressing major healthcare needs worldwide. Its key areas include oncology, immunology, neuroscience, cardiopulmonary diseases, cardiovascular care, orthopaedics, surgery, and vision. J&J has a broad global presence, with employees worldwide, and remains focused on advancing innovative healthcare solutions.

Product Description: INVOKANA

INVOKANA(R) (canagliflozin) is an oral, once-daily sodium-glucose cotransporter-2 (SGLT2) inhibitor developed by Janssen Pharmaceuticals for adults with type 2 diabetes. It selectively inhibits SGLT2 in the kidneys, reducing glucose reabsorption and increasing urinary glucose excretion to lower blood glucose levels. INVOKANA is used alongside diet and exercise and can be administered alone or in combination with other glucose-lowering therapies. The U.S. FDA approved INVOKANA in March 2013, making it the first SGLT2 inhibitor approved in the United States for T2D.

Type 2 Diabetes: Company and Product Profiles (Pipeline Therapies)

1. Company Overview: Guangdong Raynovent Biotech Co., Ltd

Guangdong Raynovent Biotech Co., Ltd. is a China-based biopharmaceutical company established in 2018 and headquartered in Guangzhou, focused on the research, development, and commercialization of innovative medicines. The company develops therapies primarily for respiratory and metabolic diseases, with a focus on addressing significant unmet medical needs. Raynovent operates as a subsidiary of Guangdong Zhongsheng Pharmaceutical Co., Ltd. and leverages its parent company's pharmaceutical R&D and commercialization capabilities. Its development activities span novel drug discovery, clinical development, and commercialization of innovative therapies.

Product Description: RAY1225

RAY1225 is an investigational once-every-two-weeks GLP-1 and GIP receptor dual agonist being developed by Guangdong Raynovent Biotech for the treatment of type 2 diabetes. It is administered as a subcutaneous injection, with the Phase III study evaluating 3 mg, 6 mg, and 9 mg doses every two weeks versus placebo. The study is designed to assess its ability to improve glycemic control, with change in HbA1c at Week 36 as the primary endpoint, alongside fasting glucose and weight-loss measures. RAY1225 is currently being evaluated in Phase III trials in adults with T2DM inadequately controlled by diet and exercise, including a separate trial comparing it with semaglutide.

2. Company Overview: Novo Nordisk

Novo Nordisk A/S is a global Danish healthcare and pharmaceutical company founded in 1923 and headquartered in Denmark. The company specializes in the discovery, development, manufacturing, and commercialization of innovative medicines for serious chronic diseases. Its core therapeutic areas include diabetes, obesity, and rare blood and endocrine disorders. Novo Nordisk has a global presence, with its medicines marketed in numerous countries and a strong focus on advancing biological medicines and improving patient access.

Product Description: CagriSema

CagriSema is an investigational fixed-dose combination of cagrilintide, a long-acting amylin analogue, and semaglutide, a GLP-1 receptor agonist, developed by Novo Nordisk for type 2 diabetes. The combination is administered as a once-weekly subcutaneous injection and is designed to improve glycemic control while promoting weight loss through complementary mechanisms. In people with T2D, CagriSema has demonstrated reductions in HbA1c and body weight in clinical studies and is being evaluated in late-stage development. CagriSema remains investigational for T2D, with Novo Nordisk continuing its clinical development program. The drug is being evaluated in Phase III clinical trial for T2D.

3. Company Overview: Alnylam Pharmaceuticals

Alnylam Pharmaceuticals, Inc. is a global commercial-stage biopharmaceutical company founded in 2002 and headquartered in Cambridge, Massachusetts. The company specializes in RNA interference (RNAi) therapeutics, using small interfering RNA (siRNA) to selectively silence disease-causing genes. Its portfolio and pipeline address rare and prevalent diseases across areas including genetic, metabolic, cardiovascular, and neurological disorders. Alnylam has pioneered multiple RNAi medicines and continues to expand its pipeline through internal R&D and strategic collaborations.

Product Description: ALN-4324

ALN-4324 is an investigational RNA interference (RNAi) therapeutic developed by Alnylam Pharmaceuticals for the treatment of type 2 diabetes. It targets GRB14 (growth factor receptor-bound protein 14), a negative regulator of insulin receptor signaling, with the aim of improving insulin sensitivity. ALN-4324 is administered as a subcutaneous injection and is designed as a long-acting therapy, potentially allowing dosing every 3-6 months. The ongoing Phase II study is evaluating a single dose of ALN-4324 for its effect on whole-body insulin sensitivity in adults with T2D. The therapy is investigational and is being evaluated for its potential to improve glycemic control and insulin sensitivity without the weight gain associated with some conventional insulin sensitizers.

4. Company Overview: Chia Tai Tianqing Pharmaceutical Group

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (CTTQ) is a China-based multinational pharmaceutical company and a core enterprise of Sino Biopharmaceutical, with integrated capabilities spanning R&D, manufacturing, marketing, sales, and distribution. The company focuses on developing and commercializing medicines across key therapeutic areas including oncology, liver diseases, respiratory diseases, diabetes, and anti-infectives. CTTQ maintains a broad R&D pipeline and has significantly increased investment in innovative drug development. The company also has an expanding international presence through partnerships and licensing agreements with global pharmaceutical companies for the development and commercialization of its innovative medicines.

Product Description: TQF3250

TQF3250 is an investigational oral small-molecule biased GLP-1 receptor agonist (GLP-1RA) developed by Chia Tai Tianqing Pharmaceutical Group for type 2 diabetes. It selectively activates the cAMP-biased GLP-1 receptor signaling pathway to promote glucose-dependent insulin secretion, while reducing B-arrestin recruitment and receptor internalization. The oral capsule is being evaluated in a Phase Ib trial in patients with T2D and overweight/obesity to assess safety, tolerability, pharmacokinetics, and preliminary efficacy. TQF3250 is currently investigational, with development also being pursued for weight management.

5. Company Overview: Innovent Biologics

Innovent Biologics is a leading China-based biopharmaceutical company founded in 2011, focused on the discovery, development, manufacturing, and commercialization of innovative medicines. Its portfolio spans oncology, cardiovascular and metabolic diseases, autoimmune disorders, and ophthalmology. The company has established a broad commercial and clinical pipeline, with multiple products approved in China and numerous candidates progressing through clinical development. Innovent has also built strategic collaborations with more than 30 global healthcare organizations, including Eli Lilly, Sanofi, Roche, Takeda, Incyte, and LG Chem.

Product Description: IBI3032

IBI3032 is a novel oral small molecule glucagon-like peptide-1 receptor agonist (GLP-1RA). By efficiently and selectively targeting GLP-1R, it activates downstream signal transduction, thereby delaying gastric emptying, inhibiting appetite, and promoting insulin secretion, and ultimately supporting the treatment of insulin-related metabolic diseases such as obesity and T2DB. Discovered through a structure-based drug design (SBDD) strategy combined with systematic physicochemical property optimization, IBI3032 has shown better PK and physicochemical properties compared to similar compounds. It is currently being evaluated in Phase I clinical trials.

6. Company Overview: Neurodon

Neurodon is a biotechnology company focused on developing innovative therapies for metabolic diseases, with a particular emphasis on diabetes and pancreatic B-cell dysfunction. The company's research focuses on restoring cellular mechanisms involved in insulin production and glucose regulation. Its lead candidate, NRDN-101, is being developed as a potential treatment for both type 1 and type 2 diabetes. Neurodon aims to translate its research into novel therapies addressing significant unmet needs in metabolic disease.

Product Description: NRDN-101

NRDN-101 is an investigational first-in-class drug candidate being developed by Neurodon for type 1 and type 2 diabetes, targeting dysfunctional calcium homeostasis in pancreatic B-cells. It is designed to enhance SERCA activity, thereby restoring endoplasmic-reticulum calcium levels and supporting insulin production. In preclinical studies, NRDN-101 has demonstrated protection of human pancreatic islet cells, improved insulin response, and reductions in blood glucose and HbA1c. It has also shown potential metabolic benefits, including reduced fat accumulation and improvement of hepatic steatosis in animal models. Currently, the drug is being studied in Preclinical Phase for the treatment of Type 2 Diabetes.

Type 2 Diabetes Analytical Perspective by DelveInsight

• In-depth Commercial Assessment: Type 2 Diabetes Collaboration Analysis by Companies

The Report provides in-depth commercial assessment of drugs that have been included, which comprises collaboration, agreement, licensing and acquisition - deals values trends. The sub-segmentation is described in the report which provide company-company collaboration (licensing/partnering), company academic collaboration and acquisition analysis in tabulated form.

• Type 2 Diabetes Competitive Landscape

The report comprises of comparative assessment of Companies (by therapy and, development stage).

Type 2 Diabetes Report Assessment

• Company Analysis
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Type 2 Diabetes Clinical Trial Assessment

• Clinical Trial Analysis
• Clinical Trial Design Analysis
• Sponsor and Geographical Analysis
• Type 2 Diabetes Clinical Trial Analysis

The report provides a comparative assessment of clinical trial analysis (by status, development stage, therapy area, enrolled participants by age, study completion year, end point status).

• Type 2 Diabetes Clinical Trial Design Analysis

The report provides a structured comparative assessment of clinical trial design analysis (by allocation, interventional model, enrolled participants by status, masking).

• Sponsor and Geographical Analysis

The report provides a comparative assessment of sponsor and geographical analysis (by top sponsors, developmental stage, clinical trials sponsored by countries, therapies by countries).

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Type 2 Diabetes drugs?
• How many Type 2 Diabetes drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Type 2 Diabetes?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Type 2 Diabetes therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Type 2 Diabetes and their status?
• What are the key designations that have been granted to the emerging and approved drugs?

Key Players

• Eli Lilly and Company
• Novo Nordisk
• Johnson & Johnson
• Guangdong Raynovent Biotech Co., Ltd
• Innovent Biologics
• AstraZeneca
• Genprex, Inc.
• Sciwind Biosciences
• Neurodon
• Autotelic Bio
• Qilu Pharmaceutical
• Ascletis Pharma
• Jiangsu Hengrui Pharmaceuticals
• Chia Tai Tianqing Pharmaceutical Group
• Alnylam Pharmaceuticals
• Corxel Pharmaceuticals
• Sun Pharmaceutical Industries
• Amgen
• Hanmi Pharmaceutical Company Limited
• Antag Therapeutics
• Rezubio Pharmaceuticals Co., Ltd.
• Gan&Lee Pharmaceuticals
• Atrogi
• Sparrow Pharmaceuticals
• Genexine
• Biomea Fusion
• Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
• Housey Healthcare
• Regend Therapeutics

Key Products

• Orforglipron
• Ozempic
• CagriSema
• INVOKANA
• RAY1225
• IBI3032
• Elecoglipron
• GPX-002
• XW014
• NRDN-101
• ATB-101
• QLG1091
• ASC30
• HRS-7535
• TQF3250
• ALN-4324
• CX11
• GL0034
• AMG 127
• HM15275
• AT673
• RZ-629
• GZR18
• ATR-258
• Clofutriben
• GX-G6
• Icovamenib
• HDM1002
• HP-211
• REGEND003

Table of Contents

Introduction

Executive Summary

Type 2 Diabetes: Overview

• Introduction
• Signs and Symptoms
• Causes
• Pathophysiology
• Diagnosis
• Treatment

Type 2 Diabetes -Analytical Perspective: In-depth Commercial Assessment

• Type 2 Diabetes Collaboration Analysis by Companies

Competitive Landscape

• Comparative Assessment of Companies (by therapy, and development stage)

Type 2 Diabetes: Company and Product Profiles (Marketed Therapies)

Eli Lilly and Company

• Company Overview

Orforglipron

• Product Description
• Research and Development Activities
• Product Developmental Activities

Type 2 Diabetes: Company and Product Profiles (Pipeline Therapies)

Late Stage Products (Phase III)

• Comparative Analysis

Guangdong Raynovent Biotech Co., Ltd

• Company Overview

RAY1225

• Product Description
• Research and Development Activities
• Product Developmental Activities

Mid Stage Products (Phase II)

• Comparative Analysis

Alnylam Pharmaceuticals

• Company Overview

ALN-432

• Product Description
• Research and Development Activities
• Product Developmental Activities

Early Stage Products (Phase I)

• Comparative Analysis

Chia Tai Tianqing Pharmaceutical Group

• Company Overview

TQF3250

• Product Description
• Research and Development Activities
• Product Developmental Activities

Preclinical Stage Products

• Comparative Analysis

Discovery Stage Products

• Comparative Analysis

Unknown Stage Products

• Comparative Analysis

Therapeutic Assessment

• Assessment by Product Type
• Assessment by Stage and Product Type
• Assessment by Route of Administration
• Assessment by Stage and Route of Administration
• Assessment by Molecule Type
• Assessment by Stage and Molecule Type

Clinical Trial Assessment

Clinical Trial Analysis

• Assessment by Status
• Assessment by Status and Phase of development
• Assessment by End Point Status
• Assessment by Enrolled Patients by Age
• Assessment by Study Completion Year

Clinical Trial Design Analysis

• Assessment by Allocation of Clinical Trials
• Assessment by Interventional Model of Clinical Trials
• Assessment by Enrolled Patients by Status
• Assessment by Masking of Clinical Trials

Sponsor and Geographical Analysis

• Assessment by Top Sponsors
• Assessment by Total Trials Sponsored by Countries and Phase
• Assessment by Clinical Therapies by Countries

Inactive Products

• Comparative Analysis

Type 2 Diabetes- Unmet needs

Type 2 Diabetes - Market drivers and barriers