双胍类药物：市场占有率分析、产业趋势、统计、成长预测（2025-2030）

2025 年双胍类药物市场价值为 194.4 亿美元，预计到 2030 年将达到 218.3 亿美元，在此期间的复合年增长率为 2.34%。

二甲双胍作为2型糖尿病第一线治疗药物的稳定需求仍然是主要的收入驱动因素，而新製剂、女性健康适应症以及区域市场覆盖范围的扩大则推动了成长。亚太地区凭藉庞大的糖尿病患者群体和活跃的非专利竞争，推动了销售量成长，而北美则透过高端固定剂量复方製剂保持了价值。涉及NDMA（亚硝基二甲胺）杂质的监管措施以及数位药房的扩张，正在影响供应的韧性和分销策略。因此，竞争的重点将放在生产品质、定价和製剂创新上，以捍卫市场份额并影响一线治疗药物的选择，从而对抗GLP-1受体促效剂和SGLT-2抑制剂。

全球双胍类药物市场趋势及洞察

全球第2型糖尿病（T2DM）盛行率不断上升

预计到2045年，糖尿病患者人数将增加7.83亿，二甲双胍的处方量将持续成长，尤其是在亚太地区，该地区的糖尿病盛行率增长最为迅速。儘管随着学名药降低入门价格，新兴市场的处方量大幅成长，但已开发市场更倾向于兼具血糖控制和心血管获益的高端复方製剂。指引重申了二甲双胍作为第一线治疗药物的地位，即使联合治疗发展迅速，其潜在需求依然保持稳定。因此，生产商采取双管齐下的策略：一方面保护其销量高的旗舰片剂，以满足对成本敏感的医疗保健系统的需求；另一方面向富裕人群推广高附加价值製剂。随着糖尿病在全球范围内的蔓延，在各国政府面临医疗保健成本不断上涨的情况下，双胍类药物市场不断扩大，在预防和早期疗育计画中仍扮演着重要角色。

在大多数糖尿病指引中，该药物被列为首选药物。

2025 年糖尿病指南将二甲双胍定位为一线药物治疗，确保了销售量的持续稳定。该指南同时提倡儘早引入 SGLT-2 抑制剂等附加元件药物，从而增加了二甲双胍联合用药（包括双联和三联疗法）的机会。采取预防性策略的医疗系统正在将二甲双胍的临床效用扩大到糖尿病前期，从而增加了符合条件的患者数量。区域差异也逐渐显现：欧洲强调成本效益，北美重视基于结果的证据，而新兴市场则优先考虑价格可负担性而非疗效优化。整体而言，指引的统一性保障了二甲双胍的需求，同时鼓励生产者在製剂、给药便利性以及核心糖尿病以外的患者群体等方面进行创新。

NDMA杂质召回事件损害了处方医生的信任。

自2020年以来，多批二甲双胍被发现含有超过监管限值的NDMA，迫使梯瓦製药、Apotex等公司召回产品。最新研究表明，当片剂与亚硝酸盐接触时，NDMA会在体内生成，因此需要加强安全监测。生产商已采取措施，在颗粒中添加抗坏血酸等抗氧化剂，并实施严格的气相检测通讯协定，但临床医生仍保持警惕。美国和欧洲的监管机构现在要求在产品上市前进行批次特定的认证，这延长了前置作业时间。虽然供应保持稳定，但由于人们对二甲双胍的认识不断提高，加速了向其他药物类别的转变，并增加了合规成本，因此双胍类药物市场在短期内可能仍将保持低迷状态。

细分市场分析

到2024年，二甲双胍将占据双胍类药物市场收入的95.51%，凭藉其无与伦比的临床友善性和可负担性，巩固其在该领域的领先地位。苯乙双胍7.65%的复合年增长率表明，在代谢肿瘤学领域未被满足的需求以及特定地区核准的推动下，小分子药物正在不断扩大市场份额。儘管苯乙双胍曾出现过安全性逆转的案例，但其在抗癌项目中重新获得了关注，这得益于其更深的粒线体渗透性，从而增强了肿瘤杀伤活性。领先的供应商正在透过继续大规模生产二甲双胍，同时减少对这些辅助双胍类药物的投资，来分散其投资组合的风险。虽然小众药物的定价弹性更大，但其适应症范围有限，限制了其绝对收入潜力。儘管二甲双胍的市场份额将逐渐下降，但随着更广泛的适应症维持处方量，预计其主导地位将在整个预测期内持续存在。仅二甲双胍相关双胍类药物的市场规模就超过150亿美元，凸显了该分子的结构重要性。

第二代分子药物正吸引大量研究经费，旨在优化生物有效性、标靶化组织特异性AMPK活化以及降低乳酸性酸中毒的风险。一个欧洲研究联盟正在研究微剂量布福明预防肝细胞癌的疗效，而一个日本研究团队正在测试苯乙双胍与查核点抑制剂的联合用药。监管机构的批准将取决于其安全性，而早期结果表明，透过适当的剂量管理，该药物具有可控的安全性。如果获得肿瘤临床试验的核准，高定价策略或许能够抵消患者数量的下降，从而为双胍类药物市场带来新的、稳定的收入来源。

2024年，即时释片将维持60.53%的市场份额，这主要得益于其成熟的处方习惯和最低的每毫克成本。同时，缓释片预计将以6.85%的复合年增长率成长，这主要归功于其每日一次的给药方式，这种方式能够提高患者的依从性并最大限度地减少胃肠道不适。缓释片独特的亲水性基质和雷射穿孔渗透泵技术能够有效控制药物溶出，从而获得更高的单价和更长的专利保护期。其1000毫克的高剂量配方能够减轻患者的服药负担，并满足超重患者的体重剂量指导原则。预计缓释双胍类药物市场将从2025年的51亿美元成长到2030年的71亿美元。

口服製剂虽然市占率较小，但却能满足无法吞嚥药片的儿童和老年人的需求。新型掩遮罩辅料和小容量浓缩製剂旨在提高其接受度。专为资源匮乏环境设计的颗粒剂包装可有效规避缺水问题，并简化乡村诊所的给药流程。多样化的给药方案有助于强化品牌形象，并使生产者能够在日趋成熟的治疗领域中，在价格之外实现差异化竞争。

区域分析

预计到2024年，亚太地区将占全球总销售额的35.62%，复合年增长率达8.35%。这主要得益于中国的集中采购，其在扩大销售量的同时降低了价格；以及印度，该国拥有大量未接受治疗的糖尿病患者。快速的都市化和生活方式的改变正在推动诊断率的提高，即使在价格管制下，处方量仍将持续增长。东南亚各国政府在其全民健保计画中对二甲双胍津贴，优先考虑的是价格的可负担性而非昂贵的製剂。

北美市场以价值为导向，成熟的支付方倾向于使用活性心肌梗塞治疗药物，但成长较为温和。儘管二甲双胍类复方製剂仍重要，但GLP-1受体促效剂正日益成为处方优​​先选择。 NDMA召回事件加速了医院药物管理计画的实施，并提高了供应商的文件阈值。儘管销售量保持平稳，但由于平均售价上涨，销售额依然强劲。

欧洲正在努力平衡创新与预算监管。各国医疗体系透过协商基于用量的折扣，并在药物经济模型显示缓释片和复方製剂能够降低併发症时，为其提供报销。以患者为中心的治疗方法，例如获得欧洲药品管理局（EMA）核准的每週一次胰岛素，正在丰富治疗手段，并鼓励使用包含二甲双胍的联合治疗。

中东和非洲的糖尿病盛行率正在上升，但基础设施水准参差不齐。波湾合作理事会国家进口高品质的品牌药，而撒哈拉以南非洲市场则依赖捐助者资助的学名药。由于低温运输存在漏洞以及假冒仿冒品氾滥，药品供应安全仍面临挑战。

在南美洲，以巴西为首的巴西，在巴西统一医疗系统（SUS）的监管下，二甲双胍在妊娠糖尿病治疗方案中的使用量不断增加。价格管制限制了净利率，但公共采购涵盖人口众多，确保了合规生产商的供货量。整体而言，区域差异迫使企业调整包装、价格分布和分销物流，从而在面临区域性不利因素的情况下，维持了双胍类药物市场的整体扩张。

其他福利：

• Excel格式的市场预测（ME）表
• 3个月的分析师支持

目录

第一章 引言

• 研究假设和市场定义
• 调查范围

第二章调查方法

第三章执行摘要

第四章 市场情势

• 市场概览
• 市场驱动因素
  • 全球第2型糖尿病（T2DM）盛行率不断上升
  • 大多数糖尿病指引中的首选地位
  • 学名药的快速普及推动了低收入和中等收入国家药品价格的下降。
  • 二甲双胍在女性健康（多囊性卵巢症候群、妊娠期糖尿病）的应用日益广泛
  • 探索双胍类药物作为抗衰老和抗癌药物
  • 人工智慧驱动的分子重定位加速了药物组合的研发
• 市场限制
  • NDMA杂质召回事件削弱了处方医师的信心
  • GLP-1 Ras 和 SGLT-2 作为第一线治疗药物越来越受欢迎
  • 印度、中国和巴西的价格抑制政策正在挤压利润空间。
  • 电子商务通路中的劣质/仿冒品二甲双胍
• 波特五力模型
  • 供应商的议价能力
  • 买方的议价能力
  • 新进入者的威胁
  • 替代品的威胁
  • 竞争对手之间的竞争

第五章 市场规模与成长预测

• 按分子
  • 二甲双胍
  • 苯乙双胍
  • 丁福明
• 按剂型
  • 即时释片
  • 缓释片
  • 口服液
• 指示
  • 2型糖尿病
  • 糖尿病前期
  • 卵巢症候群（PCOS）
  • 妊娠期糖尿病（GDM）
• 依配方类型
  • 单药治疗
  • 固定组合药物（FDC）
• 透过分销管道
  • 医院药房
  • 零售药房
  • 网路药房
• 地区
  • 北美洲
    • 美国
    • 加拿大
    • 墨西哥
  • 欧洲
    • 德国
    • 英国
    • 法国
    • 义大利
    • 西班牙
    • 其他欧洲地区
  • 亚太地区
    • 中国
    • 日本
    • 印度
    • 韩国
    • 澳洲
    • 亚太其他地区
  • 中东和非洲
    • GCC
    • 南非
    • 其他中东和非洲地区
  • 南美洲
    • 巴西
    • 阿根廷
    • 其他南美洲

第六章 竞争情势

• 市场集中度
• 市占率分析
• 公司简介
  • Teva Pharmaceutical Industries
  • Merck & Co.
  • Takeda Pharmaceutical
  • GSK plc
  • Sanofi
  • Boehringer Ingelheim
  • Glenmark Pharma
  • Zydus Lifesciences
  • Bristol-Myers Squibb
  • Sun Pharma
  • Aurobindo Pharma
  • Lupin Ltd.
  • Ajanta Pharma
  • Granules India
  • Apotex
  • IOL Chemicals & Pharma
  • Sandoz AG
  • Dr. Reddy's Laboratories

第七章 市场机会与未来展望

The biguanides market size stood at USD 19.44 billion in 2025 and is forecast to reach USD 21.83 billion by 2030, advancing at a 2.34% CAGR over the period.

Steady demand for metformin as first-line therapy in type-2 diabetes anchors revenue, while incremental growth arises from newer dosage forms, women's health indications, and wider regional access. Asia-Pacific drives volume through large diabetic populations and vigorous generic competition, whereas North America sustains value through premium fixed-dose combinations. Regulatory actions that contain N-nitrosodimethylamine (NDMA) impurities, alongside digital pharmacy expansion, shape both supply resilience and distribution strategy. Competitive focus therefore rests on manufacturing quality, pricing agility, and formulation innovation to protect share against GLP-1 receptor agonists and SGLT-2 inhibitors that now influence first-line choices.

Global Biguanides Market Trends and Insights

Rising Global Prevalence of Type-2 Diabetes (T2DM)

The projected rise to 783 million diabetes cases by 2045 sustains prescription volumes for metformin, particularly in Asia-Pacific where incidence is climbing fastest. Emerging markets deliver high unit growth because competitive generics reduce entry price; developed markets prefer premium fixed-dose combinations that couple glycemic control with cardiovascular benefit. Guideline reaffirmation of metformin as first-line therapy sustains baseline demand even while combination therapy gains momentum. Manufacturers therefore pursue dual strategy: defend high-volume core tablets for cost-sensitive health systems and promote value-added formats in wealthier segments. The global footprint of diabetes ensures that biguanides market expansion remains linked to prevention and early intervention programs as governments confront mounting healthcare costs.

Favourable First-Line Therapy Status in Most Diabetes Guidelines

Diabetes guidelines for 2025 kept metformin at the center of initial pharmacologic treatment, a position that guarantees continued volume stability. The same updates advocate earlier introduction of add-on agents such as SGLT-2 inhibitors, increasing opportunities for dual and triple combinations that embed metformin. Health systems adopting preventive approaches extend metformin's clinical utility to prediabetes, enlarging its candidate pool. Regional nuances appear: Europe stresses cost-effectiveness, North America rewards outcome-based evidence, and emerging markets weigh affordability over optimization. Overall, guideline alignment secures metformin demand while encouraging manufacturers to innovate around combination ratios, dosing convenience, and patient groups beyond core diabetes.

NDMA Impurity Recalls Denting Prescriber Confidence

Successive recalls since 2020 exposed NDMA levels above regulatory limits in several metformin batches, forcing stock withdrawals from Teva, Apotex, and others. New research shows NDMA can form in-vivo when tablets encounter nitrites, intensifying safety scrutiny. Manufacturers responded by adopting antioxidants such as ascorbic acid in granulation and installing tighter gas-phase testing protocols, but clinician wariness lingers. U.S. and European regulators now require lot-specific certificates before market release, lengthening lead times. While supply has stabilized, heightened awareness accelerates switching to alternative drug classes and raises compliance costs, moderating the biguanides market trajectory in the near term.

Other drivers and restraints analyzed in the detailed report include:

1. Rapid Genericisation Driving Affordability in LMICs
2. Increasing Use of Metformin in Women's Health (PCOS, GDM)
3. Rising Popularity of GLP-1 RAs & SGLT-2s as First-Line Options

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Metformin generated 95.51% of biguanides market revenue in 2024, underpinning class leadership through unmatched clinical familiarity and affordability. Buformin's 7.65% CAGR highlights how unmet needs in metabolic oncology and specific regional approvals allow smaller molecules to carve shares. Phenformin finds renewed interest in anticancer programs despite historic safety withdrawals, leveraging deeper mitochondrial penetration for enhanced tumoricidal effect. Major suppliers hedge portfolios by investing modest sums into these secondary biguanides while continuing high-volume metformin manufacture. Pricing flexibility is greater in niche molecules, but limited indication scope constrains absolute revenue potential. Observers expect metformin's share to taper gradually yet remain dominant throughout the forecast window as broader labels sustain prescriptions. The biguanides market size attached to metformin alone still exceeds USD 15 billion, underscoring the molecule's structural importance.

Second-generation molecules attract research funding aimed at optimizing bioavailability, targeting tissue-specific AMPK activation, and reducing lactic acidosis risk. European consortia explore buformin micro-dosing for hepatocellular carcinoma prevention, while Japanese groups test phenformin in combination with checkpoint inhibitors. Regulatory acceptance rests on demonstrable safety margins, and early results suggest manageable profiles with proper dosing controls. If oncology trials yield approval, premium pricing could offset smaller patient pools, contributing fresh but measured top-line additions to the biguanides market.

Immediate-release tablets retained a 60.53% share in 2024 owing to entrenched prescribing habits and the lowest cost per milligram. Extended-release tablets, though, are advancing at 6.85% CAGR as once-daily regimens boost adherence and minimize gastrointestinal discomfort. Proprietary hydrophilic matrices and laser-drilled osmotic pumps sustain controlled dissolution, commanding higher unit prices and lengthier patent life. High-strength 1,000 mg formats reduce pill burden and align with weight-based dosing guidelines in overweight populations. The biguanides market size tied to extended-release lines is projected to rise from USD 5.1 billion in 2025 to USD 7.1 billion by 2030.

Oral solutions, though minor, serve pediatric and geriatric segments unable to swallow tablets. Novel taste-masking excipients and small-volume concentrates aim to widen acceptance. Sachet granules tailored for low-resource settings bypass water scarcity issues and simplify dosing in rural clinics. Collectively, dosage-form diversification strengthens brand identity, allowing manufacturers to differentiate beyond price in a maturing therapeutic category.

The Biguanide Market Report is Segmented by Molecule (Metformin, Phenformin, and Buformin), Dosage Form (Immediate-Release Tablets, and More), Indication (Type-2 Diabetes Mellitus, Prediabetes, and More), Formulation Type (Monotherapy and Fixed-Dose Combinations), Distribution Channel (Hospital Pharmacies, and More), and Geography (North America, Europe, and More). The Market Forecasts are Provided in Terms of Value (USD).

Geography Analysis

Asia-Pacific generated 35.62% of 2024 revenue and is on track to deliver an 8.35% CAGR, driven by China's centralized procurement that cut prices yet expanded volume and India's vast untreated diabetic base. Rapid urbanization coupled with lifestyle shifts boosts diagnosis rates, ensuring prescription growth even under price caps. Southeast Asian governments subsidize metformin within universal coverage schemes, emphasizing affordability over premium formulations.

North America embodies a value-focused yet slower-growing arena where sophisticated payers favor agents offering cardiorenal benefit. Fixed-dose combinations that integrate metformin maintain relevance, but GLP-1 receptor agonists increasingly command formulary preference. NDMA recall fallout accelerated hospital stewardship programs, raising documentation thresholds for suppliers. Despite flat volumes, revenue holds steady owing to higher average selling prices.

Europe balances innovation adoption with budget oversight. National health systems negotiate volume-based discounts yet reimburse extended-release and combination tablets when pharmacoeconomic models demonstrate reduced complications. EMA approvals of patient-centric modalities such as weekly insulin augment the therapeutic toolbox and encourage combination regimens featuring metformin.

Middle East & Africa experience rising diabetes prevalence but variable infrastructure. Gulf Cooperation Council states import high-quality brands, while sub-Saharan markets rely on donor-financed generics. Supply security challenges persist due to cold-chain gaps and counterfeit penetration.

South America, led by Brazil, witnesses rising metformin uptake in gestational diabetes protocols under the SUS system. Price controls limit margins, but public procurement covers vast populations, offering volume certainty for compliant manufacturers. Collectively, regional heterogeneity obliges companies to tailor packaging, price tiers, and distribution logistics, sustaining overall biguanides market expansion despite localized headwinds.

1. Teva Pharmaceutical Industries
2. Merck
3. Takeda Pharmaceuticals
4. GlaxoSmithKline
5. Sanofi
6. Boehringer Ingelheim
7. Glenmark Pharma
8. Zydus Lifesciences
9. Bristol-Myers Squibb
10. Sun Pharmaceuticals Industries
11. Aurobindo Pharma
12. Lupin
13. Ajanta Pharma
14. Granules India
15. Apotex
16. IOL Chemicals & Pharma
17. Sandoz Group
18. Dr. Reddy's Laboratories

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Global Prevalence Of Type-2 Diabetes (T2DM)
  • 4.2.2 Favourable First-Line Therapy Status In Most Diabetes Guidelines
  • 4.2.3 Rapid Genericisation Driving Affordability In LMICs
  • 4.2.4 Increasing Use of Metformin In Women's Health (PCOS, GDM)
  • 4.2.5 Exploration of Biguanides As Geroprotective & Anti-Cancer Agents
  • 4.2.6 AI-Enabled Molecule Repurposing Accelerating Fixed-Dose Combos
• 4.3 Market Restraints
  • 4.3.1 NDMA Impurity Recalls Denting Prescriber Confidence
  • 4.3.2 Rising Popularity Of GLP-1 Ras & SGLT-2s As First-Line Options
  • 4.3.3 Price-Control Policies In India, China And Brazil Compressing Margins
  • 4.3.4 Sub-Standard / Counterfeit Metformin In E-Commerce Channels
• 4.4 Porter's Five Forces
  • 4.4.1 Bargaining Power of Suppliers
  • 4.4.2 Bargaining Power of Buyers
  • 4.4.3 Threat of New Entrants
  • 4.4.4 Threat of Substitutes
  • 4.4.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Molecule
  • 5.1.1 Metformin
  • 5.1.2 Phenformin
  • 5.1.3 Buformin
• 5.2 By Dosage Form
  • 5.2.1 Immediate-Release Tablets
  • 5.2.2 Extended-Release Tablets
  • 5.2.3 Oral Solution
• 5.3 By Indication
  • 5.3.1 Type-2 Diabetes Mellitus
  • 5.3.2 Prediabetes
  • 5.3.3 Polycystic Ovary Syndrome (PCOS)
  • 5.3.4 Gestational Diabetes Mellitus (GDM)
• 5.4 By Formulation Type
  • 5.4.1 Monotherapy
  • 5.4.2 Fixed-Dose Combinations (FDCs)
• 5.5 By Distribution Channel
  • 5.5.1 Hospital Pharmacies
  • 5.5.2 Retail Pharmacies
  • 5.5.3 Online Pharmacies
• 5.6 Geography
  • 5.6.1 North America
    • 5.6.1.1 United States
    • 5.6.1.2 Canada
    • 5.6.1.3 Mexico
  • 5.6.2 Europe
    • 5.6.2.1 Germany
    • 5.6.2.2 United Kingdom
    • 5.6.2.3 France
    • 5.6.2.4 Italy
    • 5.6.2.5 Spain
    • 5.6.2.6 Rest of Europe
  • 5.6.3 Asia-Pacific
    • 5.6.3.1 China
    • 5.6.3.2 Japan
    • 5.6.3.3 India
    • 5.6.3.4 South Korea
    • 5.6.3.5 Australia
    • 5.6.3.6 Rest of Asia-Pacific
  • 5.6.4 Middle East and Africa
    • 5.6.4.1 GCC
    • 5.6.4.2 South Africa
    • 5.6.4.3 Rest of Middle East and Africa
  • 5.6.5 South America
    • 5.6.5.1 Brazil
    • 5.6.5.2 Argentina
    • 5.6.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 Teva Pharmaceutical Industries
  • 6.3.2 Merck & Co.
  • 6.3.3 Takeda Pharmaceutical
  • 6.3.4 GSK plc
  • 6.3.5 Sanofi
  • 6.3.6 Boehringer Ingelheim
  • 6.3.7 Glenmark Pharma
  • 6.3.8 Zydus Lifesciences
  • 6.3.9 Bristol-Myers Squibb
  • 6.3.10 Sun Pharma
  • 6.3.11 Aurobindo Pharma
  • 6.3.12 Lupin Ltd.
  • 6.3.13 Ajanta Pharma
  • 6.3.14 Granules India
  • 6.3.15 Apotex
  • 6.3.16 IOL Chemicals & Pharma
  • 6.3.17 Sandoz AG
  • 6.3.18 Dr. Reddy's Laboratories

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment