Report Code : CVMI2603252601562 | Published Date : March 30, 2025
Market Overview
The global Biguanide market is mainly driven by its widespread use as an active pharmaceutical ingredient (API) in treating type 2 diabetes mellitus. Metformin, a leading compound in the biguanide class, is the most prescribed oral antidiabetic drug worldwide, due to its effectiveness, low cost, and safe profile. Besides diabetes, biguanides are being researched for uses in polycystic ovary syndrome (PCOS), cancer prevention, anti-aging treatments, and heart health.
Ongoing clinical trials and research into metformin's potential in geroprotection, immune modulation, and metabolic regulation are expanding the market's scope. The global diabetes burden, especially in Asia-Pacific and the Middle East, along with increasing demand for generic formulations, further drives growth.
Market Size and Forecast
Year |
Market Value (USD Billion) |
Notes |
2019 |
6.1 |
Based on metformin sales and generic manufacturer revenues |
2024 |
10.4 |
Reflects increased diabetes prevalence and low-cost generics |
2031 |
18.7 |
CAGR 8.4% (2024–2031) |
The global biguanide market is projected to surpass USD 18 billion by 2031, fueled by rising chronic disease rates and research into non-diabetic uses.
Primary Market Drivers
• Rising global diabetes prevalence and diagnosis rates
• Low cost and widespread availability of metformin generics
• Increasing use in PCOS and metabolic syndrome management
• Growing clinical interest in cancer and longevity research
• Favorable regulatory approvals and WHO essential medicine status
Market Challenges
• Gastrointestinal side effects limit long-term compliance
• Potential risks for patients with renal impairment
• Patent expirations reduce margins for branded drugs
• Slow progress in developing new biguanide derivatives
• Competition from newer antidiabetic drug classes (SGLT2, GLP-1)
Competitive Landscape
Company / Organization |
2024 Share |
Core Strengths |
Recent Moves |
Teva Pharmaceuticals |
14 % |
High-volume metformin generics |
Expanded into low-income country tenders (Q1 2024) |
Sun Pharma |
11 % |
Strong API and finished formulation network |
Opened new metformin plant in Gujarat (Q4 2024) |
Merck KGaA |
9 % |
Extended-release metformin R&D |
Gained approval for ER metformin combo (Q3 2024) |
Aurobindo Pharma |
8 % |
Large-scale supply to U.S. and EU |
Secured US DoD metformin supply contract (Q1 2025) |
Others (Dr. Reddy’s, Cipla, Lupin, Mylan) |
58 % |
Global footprint in generic manufacturing |
Gaining share via biosimilar-integrated supply chains |
Detailed Market Segmentation
By Indication
• Type 2 Diabetes – 74 %
• Polycystic Ovary Syndrome (PCOS) – XX %
• Cancer Adjunct Therapy – XX %
• Anti-aging & Longevity Research – XX %
• Others (Obesity, Cardiovascular Prevention) – XX %
By Formulation
• Immediate Release Tablets – 52 %
• Extended Release Tablets – XX %
• Liquid Formulations – XX %
• Combination Drugs – XX %
By Distribution Channel
• Hospital Pharmacies – 38 %
• Retail Pharmacies – XX %
• Online Pharmacies – XX %
• Institutional Supply / Tenders – XX %
Regional Analysis
• Asia-Pacific (34%) – Largest market due to diabetes burden in India, China, and Southeast Asia
• North America (XX%) – Strong generic penetration and institutional contracts
• Europe (XX%) – Focus on ER formulations and clinical trials in oncology/geriatrics
• Latin America & MEA (14%) – Growing use through government tender programs and WHO-backed distribution
Technology and Innovation
• Development of slow-release biguanide implants for sustained glucose control
• Novel metformin analogs targeting mitochondrial pathways in cancer cells
• Integration of metformin into wearable drug delivery patches
• AI-guided personalization of metformin dosing regimens
Regulatory Environment
• WHO inclusion of metformin in the Essential Medicines List (EML)
• US FDA and EMA approvals for combination therapies with SGLT2 and DPP-4 inhibitors
• Emerging biosafety guidelines for off-label oncology applications
• Regional labeling revisions to address lactic acidosis concerns
Recent Developments (Q4 2023 – Q2 2025)
• Sun Pharma launched eco-friendly metformin packaging in Asia (Q4 2024)
• Merck KGaA secured EMA approval for metformin-SGLT2 combo (Q3 2024)
• Aurobindo signed multi-year DoD supply contract in U.S. (Q1 2025)
• WHO announced large-scale procurement for Sub-Saharan Africa (Q2 2025)
• Teva began biosimilar-integrated metformin pilot in Latin America (Q1 2025)
Strategic Outlook
• Manufacturers should invest in improved delivery options like extended-release and implants.
• Governments and NGOs will continue using tenders to enhance access to chronic care.
• Clinical studies on anti-aging and cancer prevention will expand indications for biguanide.
• Price competition will increase among generic producers in high-burden regions.
Methodology
Clearview Market Insights compiled API production data, hospital and retail prescription audits, and international procurement reports across 30+ countries. Projections integrate diabetes incidence, pricing trends, and emerging clinical research domains.
About Clearview Market Insights
Clearview Market Insights delivers precise pharmaceutical intelligence with a focus on chronic care, generics, and global access strategies.
Reasons To Buy
• Identify expansion opportunities in diabetes and PCOS treatment segments
• Monitor global manufacturing and tender activity for metformin
• Assess clinical innovation in oncology and anti-aging applications
• Benchmark competitors in extended-release and biosimilar-integrated offerings
Scope
• Revenue, volume, and pricing trends for biguanide products (2019–2031)
• Segmentation by indication, formulation, and region
• Profiles of key generic and branded players
• Regulatory developments and R&D directions
Key Players
- Merck & Co.
- Teva Pharmaceuticals
- Sun Pharmaceutical
- Zydus Cadila
- Aurobindo Pharma
- Bristol-Myers Squibb
Global Biguanide Market Report
- 1. Global Biguanide Market Research Report
- 1.1 Study Objectives
- 1.2 Global Biguanide Market - Overview
- 1.3 Reason to Read This Report
- 1.4 Methodology and Forecast Analysis
- 2.1 Global Biguanide Market Research Report – Detailed Scope and Definitions
- 2.1.1 By Product Type
- 2.1.2 By Application
- 2.1.3 By Distribution Channel
- 2.1.4 By Region
- 3.1. Drivers - Macro-Economic Based, Supply Side, and Demand Side Drivers
- 3.2. Restraints – By Product Type, By Application, By Distribution Channel, By Country
- 3.3. Opportunities – By Product Type, By Application, By Distribution Channel, By Country
- 3.4. Trends – By Product Type, By Application, By Distribution Channel, By Country
- 3.5. PEST Analysis
- 3.6. Porters Five Rule Analysis
- 3.7. Company’s Share Analysis (CSA) by Region or By Country
- 3.8. Global Biguanide Market Research Report – DROTs Impact Analysis
- 4.1. Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 4.2. Annual Market Trend Assessment – Year-on-Year (YoY) Growth Analysis (%)
- 4.3. Incremental Market Value/Volume Opportunity between 2019 - 2023 and 2024 - 2031
- 4.4. Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 5.1 Metformin
- 5.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 5.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 5.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 5.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 5.2 Phenformin
- 5.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 5.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 5.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 5.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 5.3 Buformin
- 5.3.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 5.3.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 5.3.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 5.3.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 5.4 Others
- 5.4.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 5.4.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 5.4.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 5.4.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 6.1 Type 2 Diabetes
- 6.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 6.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 6.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 6.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 6.2 Polycystic Ovary Syndrome (PCOS)
- 6.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 6.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 6.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 6.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 6.3 Others
- 6.3.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 6.3.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 6.3.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 6.3.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 7.1 Hospital Pharmacies
- 7.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 7.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 7.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 7.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 7.2 Retail Pharmacies
- 7.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 7.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 7.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 7.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 7.3 Online Pharmacies
- 7.3.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 7.3.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 7.3.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 7.3.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.1 North America
- 8.1.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.1.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.1.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.1.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.2 Europe
- 8.2.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.2.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.2.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.2.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.3 Asia-Pacific
- 8.3.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.3.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.3.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.3.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.4 Latin America
- 8.4.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.4.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.4.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.4.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.5 Middle East & Africa
- 8.5.1 Market Performance Review & Future Outlook: Assessing 2019 - 2023 and Predicting 2024 - 2031 Trends (USD Millions)
- 8.5.2 Annual Market Trend Assessment – Yearly Growth Observation (Y-O-Y)(%)
- 8.5.3 Incremental Market Value/Volume Opportunity between 2019 - 2023 and From 2024 to 2031
- 8.5.4 Market Shares Analysis in Years - 2019, 2023, 2024 and 2031
- 8.6 Global Biguanide Market - Opportunity Analysis Index, By Product Type, By Application, By Distribution Channel, and Region, 2024 - 2031
- 9.1 By Product Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 9.1.1 Metformin
- 9.1.2 Phenformin
- 9.1.3 Buformin
- 9.1.4 Others
- 9.2.1 Type 2 Diabetes
- 9.2.2 Polycystic Ovary Syndrome (PCOS)
- 9.2.3 Others
- 9.3.1 Hospital Pharmacies
- 9.3.2 Retail Pharmacies
- 9.3.3 Online Pharmacies
- 9.4.1 United States
- 9.4.2 Canada
9.6 Regional Trends Analysis
9.7 North America Global Biguanide Market Research Report - Company Profiles- 9.7.1 Company 1 (United States)
- 9.7.2 Company 2 (Canada)
- 9.7.3 Company 3 (Canada)
- 10.1 By Product Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 10.1.1 Metformin
- 10.1.2 Phenformin
- 10.1.3 Buformin
- 10.1.4 Others
- 10.2.1 Type 2 Diabetes
- 10.2.2 Polycystic Ovary Syndrome (PCOS)
- 10.2.3 Others
- 10.3.1 Hospital Pharmacies
- 10.3.2 Retail Pharmacies
- 10.3.3 Online Pharmacies
- 10.4.1 Germany
- 10.4.2 United Kingdom
- 10.4.3 France
- 10.4.4 Spain
- 10.4.5 Italy
- 10.4.6 Russia
- 10.4.7 Netherlands
- 10.4.8 Poland
- 10.4.9 Rest of Europe
10.6 Regional Trends Analysis
10.7 Europe Global Biguanide Market Research Report - Company Profiles- 10.7.1 Company 1 (Germany)
- 10.7.2 Company 2 (United Kingdom)
- 10.7.3 Company 3 (United Kingdom)
- 11.1 By Product Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 11.1.1 Metformin
- 11.1.2 Phenformin
- 11.1.3 Buformin
- 11.1.4 Others
- 11.2.1 Type 2 Diabetes
- 11.2.2 Polycystic Ovary Syndrome (PCOS)
- 11.2.3 Others
- 11.3.1 Hospital Pharmacies
- 11.3.2 Retail Pharmacies
- 11.3.3 Online Pharmacies
- 11.4.1 China
- 11.4.2 Japan
- 11.4.3 India
- 11.4.4 South Korea
- 11.4.5 Australia & NZ
- 11.4.6 ASEAN
- 11.4.7 Rest of Asia-Pacific
11.6 Regional Trends Analysis
11.7 Asia-Pacific Global Biguanide Market Research Report - Company Profiles- 11.7.1 Company 1 (China)
- 11.7.2 Company 2 (Japan)
- 11.7.3 Company 3 (Japan)
- 12.1 By Product Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 12.1.1 Metformin
- 12.1.2 Phenformin
- 12.1.3 Buformin
- 12.1.4 Others
- 12.2.1 Type 2 Diabetes
- 12.2.2 Polycystic Ovary Syndrome (PCOS)
- 12.2.3 Others
- 12.3.1 Hospital Pharmacies
- 12.3.2 Retail Pharmacies
- 12.3.3 Online Pharmacies
- 12.4.1 Brazil
- 12.4.2 Mexico
- 12.4.3 Argentina
- 12.4.4 Peru
- 12.4.5 Colombia
- 12.4.6 Rest of Latin America
12.6 Regional Trends Analysis
12.7 Latin America Global Biguanide Market Research Report - Company Profiles- 12.7.1 Company 1 (Brazil)
- 12.7.2 Company 2 (Mexico)
- 12.7.3 Company 3 (Mexico)
- 13.1 By Product Type Analysis 2019 - 2023 and Forecast, 2024 - 2031 by Market Assessment (USD Mn), Yearly Growth Rate (%), and Market Presence (%)
- 13.1.1 Metformin
- 13.1.2 Phenformin
- 13.1.3 Buformin
- 13.1.4 Others
- 13.2.1 Type 2 Diabetes
- 13.2.2 Polycystic Ovary Syndrome (PCOS)
- 13.2.3 Others
- 13.3.1 Hospital Pharmacies
- 13.3.2 Retail Pharmacies
- 13.3.3 Online Pharmacies
- 13.4.1 Saudi Arabia
- 13.4.2 UAE
- 13.4.3 South Africa
- 13.4.4 Egypt
- 13.4.5 Israel
- 13.4.6 Rest of Middle East and Africa
13.6 Regional Trends Analysis
13.7 Middle East & Africa Global Biguanide Market Research Report - Company Profiles- 13.7.1 Company 1 (Saudi Arabia)
- 13.7.2 Company 2 (UAE)
- 13.7.3 Company 3 (UAE)
- 14.1 Strategic Dashboard of Top Market Players
14.2 Company Profiles (Introduction, Financial Assessments, Portfolio of Offerings, Milestones and Achievements, Strategic Initiative, and SWOT Analysis)- 14.2.1 Merck & Co.
- 14.2.2 Teva Pharmaceuticals
- 14.2.3 Sun Pharmaceutical
- 14.2.4 Zydus Cadila
- 14.2.5 Aurobindo Pharma
- 14.2.6 Bristol-Myers Squibb
16. Principal Presumptions and Acronyms