Mazdutide Sales Forecast, and Market Size Analysis - 2034
상품코드:1909225
리서치사:DelveInsight
발행일:On Demand Report
페이지 정보:영문 30 Pages
라이선스 & 가격 (부가세 별도)
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한글목차
마즈두타이드(Mazdutide)의 주요 성장 촉진요인
1. 시장 점유율 확대 및 신규 환자 수 증가
중국에서 승인된 최초의 듀얼 글루카곤(GCG) 및 GLP-1 수용체 작용제인 마즈두타이드(IBI362/신타이드)는 비만 및 2형 당뇨병 치료 분야에서 빠르게 부상하고 있습니다.
중국 시장에서의 초기 채택 현황을 보면, 특히 비만과 동반 질환을 가진 환자에서 체중 조절과 대사 조절에 모두 효과가 있는 이중 작용기전에 대한 의사들의 관심이 높다는 것을 알 수 있습니다.
세계 시장 침투는 아직 초기 단계(중국 이외 지역에서는 임상 개발 중)이지만, 승인된 적응증에 대한 처방 채택이 증가하고 인지도가 높아짐에 따라 2025-2026년에 수량적 성장이 예상됩니다.
2. 중요한 적응증으로 확대
만성체중관리(비만) : 2025년 6월 중국에서 과체중 또는 비만 성인(합병증 유무에 따른 BMI 기준치)의 장기적인 체중관리 약물로 승인되었습니다. 마즈두타이드는 기존 GLP-1 치료제인 세마글루티드, 틸제파티드와 같은 기존 GLP-1 치료제에 새로운 선택지를 제공합니다.
2형 당뇨병(T2D) : 2025년 9월, 중국 NMPA로부터 성인 2형 당뇨병 환자의 혈당 조절을 적응증으로 승인받았습니다. 이는 체중 감량 효과를 넘어 광범위한 대사성 질환 관리 영역으로 중요한 상업적 입지를 확장하는 것을 의미합니다.
대사기능장애 및 간질환 연구: 대사기능장애 관련 지방간질환(MAFLD), 폐쇄성 수면무호흡증, 알코올 사용 장애에 대한 임상 평가가 진행 중입니다. 좋은 결과가 나오면 향후 적응증 확대 가능성을 시사합니다.
3. 지역적 확장
중국을 기점으로 한 세계 진출: 현재 중국 시장에 집중하고 있으며, Innovent Biologics(Eli Lilly와 파트너십을 맺고 있는)를 통해 규제 당국의 승인과 상업적 활동이 가장 활발하게 진행되고 있습니다.
새로운 세계 잠재력: 국제 승인(예: FDA 또는 EMA)이 신청 대기 중입니다. 유럽 및 미국 시장에 대한 규제 당국 신청은 현재 진행 중인 3상 프로그램 또는 추가 세계 임상시험이 완료된 후로 예정되어 있습니다.
아시아태평양 시장, 특히 중국은 비만과 2형 당뇨병 유병률이 높고, Healthy China 2030과 같은 국가적 건강정책이 지원되면서 고성장 지역으로 부상하고 있습니다.
4. 신규 적응증 승인
NMPA의 체중 조절 승인(2025년 6월) : 마즈두타이드는 과체중/비만 성인의 만성적인 체중 조절을 위해 중국에서 승인된 최초의 GCG/GLP-1 수용체 이중 작용제입니다.
NMPA의 혈당 조절 적응증 승인(2025년 9월) : 성인 2형 당뇨병 환자의 혈당 조절 적응증 추가 승인으로 임상 적용 범위 확대 및 매출 다변화를 기대할 수 있습니다.
파이프라인 확장: 이중 수용체 작용과 대사 개선 효과에 대한 데이터는 규제 당국이 새로운 증거를 평가하면서 MAFLD/NASH(비알코올성 지방간염) 및 기타 심대사 질환에 대한 향후 승인을 촉진할 수 있습니다.
5. 강력한 양적 및 임상적 추진력
확고한 임상 3상 결과: GLORY-1 시험 및 관련 연구(영향력 있는 학술지에 게재)에서 유의미한 체중 감소(예: 약 14.8%)와 심대사 지표 개선이 확인되어 임상의의 신뢰도를 높였습니다.
직접 비교 시험: 후기 단계 시험(예: DREAMS-3)에서 마즈두타이드는 세마글루티드 대비 우수한 체중 감소 효과와 혈당 조절 효과를 보여 중복된 환자군에서 경쟁력 있는 유효성을 입증했습니다.
이러한 임상 결과는 중국내 치료 가이드라인과 지역 전문가들의 합의된 성명서에 점점 더 많이 반영되고 있습니다.
6. 경쟁 우위 및 시장 동향
이중 작용기전의 우위: 마즈두타이드는 GLP-1 수용체와 글루카곤 수용체를 동시에 활성화시켜 식욕 억제, 에너지 소비 증가, 간 지방 대사 개선 등의 대사 효과를 촉진하여 단일 표적 GLP-1 치료제와의 차별화를 꾀하고 있습니다.
혁신을 촉진하는 시장 동향 : 맞춤형 의료, 통합적 대사 치료, 체중뿐만 아니라 광범위한 심장 대사 위험에 대처하는 약물에 대한 관심 증가가 마즈두타이드의 입지를 지원하고 있습니다.
리얼월드 데이터(RWE) : 중국의 지속적인 리얼월드 데이터 수집과 비교 유효성 연구는 보험사와 처방의사의 신뢰를 얻기 위해 매우 중요하며, 특히 세계 시장 진출이 가까워짐에 따라 더욱 중요해졌습니다.
경쟁 구도 : 마즈두타이드는 세마글루타이드, 틸제파티드, 레타토르티드 등 개발 중이거나 시판 중인 경쟁약물이 즐비한 GLP-1/듀얼아고니스트 시장에 진입하지만, 새로운 수용체 프로파일과 축적된 임상 데이터는 차별화된 틈새 시장 개발에 기여할 수 있을 것으로 예측됩니다. 기여할 수 있습니다.
세계 주요 7개국(미국, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본)의 마즈두타이드(Mazdutaide) 시장을 조사 분석했으며, 각국 시장 규모와 예측, 연구개발 활동, 경쟁 구도 등의 정보를 전해드립니다.
목차
제1장 리포트 개요
제2장 마즈두타이드 개요(비만 및 2형 당뇨병 등의 승인된 적응증, 비알코올성 지방성간질환, 수면무호흡증, 알코올 중독, 심부전, 비알코올성 지방간염, 다낭성난소증후군, 고요산혈증 등의 잠재적 적응증)
제품 상세
마즈두타이드 임상 개발
마즈두타이드 임상 연구
마즈두타이드 임상시험 정보
안전성과 유효성
기타 개발 활동
제품 개요
제3장 마즈두타이드의 경쟁 상황(출시 치료법)
제4장 경쟁 구도(후기 단계 새로운 마즈두타이드 요법)
제5장 마즈두티드 시장 평가
승인된/잠재적 적응증에서 마즈두타이드 시장의 전망
주요 7 시장 분석
주요 7 시장의 승인된/잠재적 적응증용 마즈두타이드 시장 규모
각국의 시장 분석
미국의 승인된/잠재적 적응증용 마즈두타이드 시장 규모
독일의 승인된/잠재적 적응증용 마즈두타이드 시장 규모
영국의 승인된/잠재적 적응증용 마즈두타이드 시장 규모
제6장 마즈두타이드 SWOT 분석
제7장 애널리스트의 견해
제8장 부록
제9장 DelveInsight의 서비스 내용
제10장 면책사항
제11장 DelveInsight 소개
제12장 리포트 구입 옵션
KSA
영문 목차
영문목차
Key Factors Driving Mazdutide Growth
1. Market Share Gains and New Patient Starts
Mazdutide (IBI362 / Xinermei) is emerging rapidly in the obesity and type 2 diabetes therapeutic landscape as the first-in-class dual glucagon (GCG) and GLP-1 receptor agonist approved in China.
Early uptake in the Chinese market shows strong physician interest in its dual mechanism for both weight and metabolic control, especially among patients with obesity and comorbid conditions.
Although global market penetration is still in early stages (outside China the drug remains in clinical development), prescription adoption in approved indications is expected to fuel volume growth in 2025-2026 as awareness strengthens.
2. Expansion Across Key Indications
Chronic Weight Management (Obesity): Approved in China in June 2025 for long-term management of overweight or obese adults (BMI thresholds with/without comorbidities), Mazdutide offers a new option alongside established GLP-1 therapies like semaglutide and tirzepatide.
Type 2 Diabetes (T2D): In September 2025, it gained approval from China's NMPA for glycemic control in adults with T2D, marking an important extension of its commercial footprint beyond weight loss to broader metabolic disease management.
Metabolic Dysfunction and Liver Disease Research: Clinical evaluations are ongoing for metabolic dysfunction-associated fatty liver disease (MAFLD), obstructive sleep apnea, and alcohol use disorder, suggesting future indication expansion opportunities if outcomes are positive.
3. Geographic Expansion
China First, Then Global: Launches currently focus on China, where regulatory approvals and commercial activities are most advanced via Innovent Biologics (in partnership with Eli Lilly).
Emerging Global Potential: International approvals (e.g., FDA or EMA) are pending; regulatory submissions in Western markets are anticipated after completion of ongoing Phase III programs or additional global trials.
The Asia-Pacific market, particularly China, is a high-growth region due to high obesity and type 2 diabetes prevalence and supportive national health initiatives like "Healthy China 2030."
4. New Indication Approvals
NMPA Weight Management Approval (June 2025): Mazdutide became the first dual GCG/GLP-1 receptor agonist sanctioned in China for chronic weight control in adults with overweight/obesity.
NMPA Glycemic Control Approval (September 2025): Subsequent approval for glycemic control in adults with T2D adds clinical breadth and revenue diversification.
Pipeline Extensions: Dual receptor action and positive metabolic effect data may support future approvals for MAFLD/NASH and other cardiometabolic conditions as regulators evaluate emerging evidence.
5. Strong Volume and Clinical Momentum
Robust Phase III Results: Trial data shows significant weight reduction (e.g., ~14.8%) and improvements in cardiometabolic parameters in GLORY-1 and related studies published in high-impact journals, strengthening clinician confidence.
Head-to-Head Comparisons: In late-stage studies (e.g., DREAMS-3), mazdutide has shown superior weight loss and glycemic control compared with semaglutide, underscoring competitive efficacy in overlapping patient populations.
These clinical results are increasingly factored into treatment guidelines and local expert consensus statements within China.
6. Competitive Differentiation and Market Trends
Dual Mechanism Advantage: Mazdutide's simultaneous activation of GLP-1 and glucagon receptors promotes enhanced metabolic effects - including appetite suppression, increased energy expenditure, and improved liver fat metabolism - that distinguish it from single-target GLP-1 therapies.
Market Trends Favoring Innovation: Rising interest in personalized medicine, integrated metabolic care, and agents addressing not just weight but broader cardiometabolic risks supports mazdutide's positioning.
Real-World Evidence (RWE): Ongoing real-world data collection in China and comparative effectiveness research will be critical for payer and prescriber confidence, especially as global market entry nears.
Competitive Landscape: Mazdutide enters a crowded GLP-1/dual agonist field with competitors like semaglutide, tirzepatide, and retatrutide in development or on market - but its novel receptor profile and emerging clinical data may help carve a differentiated niche.
Mazdutide Recent Developments
In December 2025, Innovent Biologics, a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that the results of two Phase III clinical studies of Mazdutide, the world's first approved glucagon (GCG)/glucagon-like peptide-1 (GLP-1) dual receptor agonist, in Chinese adults with type 2 diabetes (T2D) (DREAMS-1, DREAMS-2) have been published back-to-back in Nature as Accelerated Article Previews (AAP).
"Mazdutide Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of Mazdutide for approved indication like Obesity and Type 2 diabetes mellitus; as well as potential indications like Non-alcoholic fatty liver disease; Sleep apnoea syndrome; Alcoholism; Heart failure; Non-alcoholic steatohepatitis; Polycystic ovary syndrome and Hyperuricaemia in the 7MM. A detailed picture of Mazdutide's existing usage in approved and anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 -2034 is provided in this report along with a detailed description of the Mazdutide for approved and potential indications. The Mazdutide market report provides insights about Mazdutide's sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current Mazdutide performance, future market assessments inclusive of the Mazdutide market forecast analysis for approved and potential indications in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of Mazdutide sales forecasts, along with factors driving its market.
Mazdutide Drug Summary
Mazdutide is a dual agonist of the glucagon-like peptide-1 (GLP-1) receptor and glucagon receptor (GCGR), developed by Innovent Biologics and Eli Lilly under the name IBI362 or Xinermei. Approved in China in June 2025 for chronic weight management in adults with obesity or overweight (BMI >=24 kg/m2 with comorbidities or >=28 kg/m2), and for type 2 diabetes, it mimics natural hormones to suppress appetite, delay gastric emptying, increase energy expenditure, enhance fatty acid oxidation, and reduce liver fat. Administered as a once-weekly subcutaneous injection, Mazdutide delivers superior weight loss (up to 14% body weight reduction in 48 weeks), improved glycemic control, and additional metabolic benefits like lowered blood pressure, lipids, and waist circumference compared to GLP-1 monotherapy. The report provides Mazdutide's sales, growth barriers and drivers, post usage and approvals in multiple indications.
Scope of the Mazdutide Market Report
The report provides insights into:
A comprehensive product overview including the Mazdutide MoA, description, dosage and administration, research and development activities in approved indications like Obesity and Type 2 diabetes mellitus; as well as potential indications like Non-alcoholic fatty liver disease; Sleep apnoea syndrome; Alcoholism; Heart failure; Non-alcoholic steatohepatitis; Polycystic ovary syndrome and Hyperuricaemia.
Elaborated details on Mazdutide regulatory milestones and other development activities have been provided in Mazdutide market report.
The report also highlights Mazdutide's cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
The Mazdutide market report also covers the patents information, generic entry and impact on cost cut.
The Mazdutide market report contains current and forecasted Mazdutide sales for approved and potential indications till 2034.
Comprehensive coverage of the late-stage emerging therapies for respective indications.
The Mazdutide market report also features the SWOT analysis with analyst views for Mazdutide in approved and potential indications.
Methodology:
The Mazdutide market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.
Mazdutide Analytical Perspective by DelveInsight
In-depth Mazdutide Market Assessment
This Mazdutide sales market forecast report provides a detailed market assessment of Mazdutide for approved indication like Obesity and Type 2 diabetes mellitus; as well as potential indications like Non-alcoholic fatty liver disease; Sleep apnoea syndrome; Alcoholism; Heart failure; Non-alcoholic steatohepatitis; Polycystic ovary syndrome and Hyperuricaemia in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted Mazdutide sales data uptil 2034.
Mazdutide Clinical Assessment
The Mazdutide market report provides the clinical trials information of Mazdutide for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.
Mazdutide Competitive Landscape
The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.
Mazdutide Market Potential & Revenue Forecast
Projected market size for the Mazdutide and its key indications
Commercial partnerships, licensing deals, and M&A activity
Mazdutide Clinical Differentiation
Mazdutide Efficacy & safety advantages over existing drugs
Mazdutide Unique selling points
Mazdutide Market Report Highlights
In the coming years, the Mazdutide market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
The Mazdutide companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Mazdutide's dominance.
Other emerging products for Obesity and Type 2 diabetes mellitus; as well as potential indications like Non-alcoholic fatty liver disease; Sleep apnoea syndrome; Alcoholism; Heart failure; Non-alcoholic steatohepatitis; Polycystic ovary syndrome and Hyperuricaemia are expected to give tough market competition to Mazdutide and launch of late-stage emerging therapies in the near future will significantly impact the market.
A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of Mazdutide in approved and potential indications.
Analyse Mazdutide cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
Our in-depth analysis of the forecasted Mazdutide sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Mazdutide in approved and potential indications.
Key Questions:
What is the class of therapy, route of administration and mechanism of action of Mazdutide? How strong is Mazdutide's clinical and commercial performance?
What is Mazdutide's clinical trial status in each individual indications such as Obesity and Type 2 diabetes mellitus; as well as potential indications like Non-alcoholic fatty liver disease; Sleep apnoea syndrome; Alcoholism; Heart failure; Non-alcoholic steatohepatitis; Polycystic ovary syndrome and Hyperuricaemia and study completion date?
What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Mazdutide Manufacturers?
What are the key designations that have been granted to Mazdutide for approved and potential indications? How are they going to impact Mazdutide's penetration in various geographies?
What is the current and forecasted Mazdutide market scenario for approved and potential indications? What are the key assumptions behind the forecast?
What are the current and forecasted sales of Mazdutide in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
What are the other emerging products available and how are these giving competition to Mazdutide for approved and potential indications?
Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
How cost-effective is Mazdutide? What is the duration of therapy and what are the geographical variations in cost per patient?
Table of Contents
1. Report Introduction
2. Mazdutide Overview in approved indications like Obesity and Type 2 diabetes mellitus; as well as potential indications like Non-alcoholic fatty liver disease; Sleep apnoea syndrome; Alcoholism; Heart failure; Non-alcoholic steatohepatitis; Polycystic ovary syndrome and Hyperuricaemia
