Biguanide Market - By Product Type: Metformin, Phenformin, Buformin, Others; By Application: Type 2 Diabetes, Polycystic Ovary Syndrome (PCOS), Others; By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies; By Region: North America, Europe, Asia-Pacific, Latin America, Middle East & Africa.
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.
• 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
• 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
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