Biguanides Market
By Type;
Metformin, Phenformin, and OthersBy Dosage Form;
Tablets and Oral SolutionsBy Formulation;
Immediate Release and Extended ReleaseBy Distribution Channel;
Hospital Pharmacies, Retail Pharmacies, and Online PharmaciesBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031).Introduction
Global Biguanides Market (USD Million), 2021 - 2031
In the year 2024, the Global Biguanides Market was valued at USD 780.18 million. The size of this market is expected to increase to USD 1,619.78 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 11.0%.
Biguanides Market
*Market size in USD million
CAGR 11.0 %
Study Period | 2025 - 2031 |
---|---|
Base Year | 2024 |
CAGR (%) | 11.0 % |
Market Size (2024) | USD 780.18 Million |
Market Size (2031) | USD 1,619.78 Million |
Market Concentration | Low |
Report Pages | 342 |
Major Players
- Bayer
- Mylan
- Teva
- Takeda
- Actavis
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Biguanides Market
Fragmented - Highly competitive market without dominant players
The global biguanides market is witnessing substantial growth, driven by increasing prevalence of diabetes and rising demand for effective antidiabetic medications. Biguanides, a class of oral hypoglycemic agents, have been pivotal in the management of type 2 diabetes mellitus (T2DM) for several decades. Metformin, the most commonly prescribed biguanide, remains a cornerstone in diabetes treatment due to its efficacy in lowering blood glucose levels, favorable safety profile and additional benefits such as weight loss and cardiovascular protection.
As the incidence of diabetes continues to rise globally, the market for biguanides is expanding, reflecting the urgent need for effective diabetes management strategies. The World Health Organization (WHO) estimates that the number of people with diabetes has quadrupled over the past three decades, making it a critical public health issue. This surge in diabetes prevalence is primarily driven by factors such as increasing urbanization, sedentary lifestyles, unhealthy dietary habits and rising obesity rates.
In addition to the growing diabetic population, the market is also influenced by advancements in pharmaceutical research and development. Innovations aimed at improving the bioavailability and patient adherence of biguanides, along with the development of combination therapies that enhance therapeutic outcomes, are contributing to market growth. Furthermore, the expanding healthcare infrastructure in emerging economies and increasing awareness about diabetes management are expected to bolster the demand for biguanides.
Regulatory support and favorable reimbursement policies in various regions also play a significant role in the market's expansion. Governments and healthcare organizations are focusing on improving access to diabetes medications, thereby ensuring that more patients receive timely and effective treatment. The ongoing research into the broader therapeutic applications of biguanides, beyond diabetes management, such as in cancer and aging-related diseases, also holds promise for future market growth.
Global Biguanides Market Recent Developments
- In August 2023, Akums Drugs and Pharmaceuticals Limited introduced new diabetes solutions: Vildagliptin SR and Metformin SR tablets. This gives the diabetic patient effective glycemic control. It helps the patient in preventing hypoglycemia and weight gain during medication.
- In August 2023, Dr Reddy’s Laboratories announced the launch and distribution of Saxagliptin and Metformin Hydrochloride Extended-Release Tablets in the U.S. It helps to improve glycemic control in adults with type 2 diabetes mellitus.
Biguanides Segment Analysis
In this report, the Biguanides Market has been segmented by Type,Dosage Form , Formulation, Distrubtion channel And Geography
Biguanides Market, Segmentation by Type
The Biguanides Market has been segmented by Type into and Metformin, Phenformin.And others
Metformin
Metformin accounts for nearly 85% of the Biguanides Market, making it the most widely used drug in diabetes management. Its effectiveness in controlling blood glucose levels, affordability and favorable safety profile contribute to its dominance. Increasing adoption in both developed and emerging economies continues to drive market growth.
Phenformin
Phenformin holds less than 5% of the market share due to its restricted use in many countries. While it was once a popular biguanide, safety concerns, particularly the risk of lactic acidosis, have led to limited clinical application. However, niche research in oncology and other therapeutic areas sustains minimal demand.
Others
The Others segment, representing around 10% of the market, includes experimental or less commonly prescribed biguanides. This category benefits from ongoing research into novel formulations and alternative indications. Though smaller in scale, it offers potential opportunities for niche therapeutics.
Biguanides Market, Segmentation by Dosage Form
The Biguanides Market has been segmented by Dosage Form into Tablets and Oral Solutions
Tablets
Tablets dominate the Biguanides Market with around 78% share, driven by their convenience, accurate dosing, and widespread patient preference. They are the most commonly prescribed form, especially for metformi, and offer extended-release options to improve patient compliance. The strong presence of generics further supports their market leadership.
Oral Solution
The oral solution segment accounts for approximately 22% of the market, catering primarily to patients who face difficulty swallowing tablets, such as elderly individuals or pediatric cases. This dosage form offers flexibility in titration and absorption but has relatively lower adoption due to storage requirements and shorter shelf life.
Biguanides Market, Segmentation by Formulation
The Biguanides Market has been segmented by Formulation into Immediate Release and Extended Release
Immediate Release
Immediate release formulations hold approximately 65% of the Biguanides Market, offering rapid absorption and quick therapeutic action. They are widely prescribed due to cost-effectiveness and broad availability in generic forms, making them a preferred option for initial treatment of type 2 diabetes.
Extended Release
Extended release formulations account for nearly 35% of the market, driven by their ability to maintain stable drug levels over an extended period. These formulations improve patient compliance by reducing dosing frequency and are especially beneficial for patients experiencing gastrointestinal side effects with immediate release variants.
Biguanides Market, Segmentation by Distribution Channel
The Biguanides Market has been segmented by Distribution Channel into Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies
Hospital Pharmacies
Hospital pharmacies dominate nearly 45% of the biguanides market, serving as the primary distribution channel for patients receiving treatment within healthcare facilities. Their direct connection to hospitals ensures efficient medication management, timely dispensing, and improved patient adherence to prescribed therapies.
Retail Pharmacies
With a market contribution of about 35%, retail pharmacies remain a cornerstone for biguanide distribution. They offer accessible medication supply points, especially beneficial for individuals requiring long-term diabetes management. Added pharmacist guidance further enhances patient confidence and treatment effectiveness.
Online Pharmacies
Online pharmacies currently hold close to 20% market share and are experiencing rapid growth. Their appeal lies in convenience, home delivery, and cost savings, making them increasingly attractive for patients seeking continuous access to biguanides without frequent in-person visits.
Biguanides Market, Segmentation by Geography
In this report, the Biguanides Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East & Africa and Latin America.
Regions and Countries Analyzed in this Report
Biguanides Market Share (%), by Geographical Region.
North America
North America dominates the Biguanides Market, contributing around 35% of the global share. The region benefits from advanced healthcare infrastructure, strong R&D activities, and high prevalence of diabetes. Increasing awareness and accessibility of metformin, the leading biguanide, further propel market growth in this region.
Europe
Europe holds close to 28% of the market, driven by rising diabetes cases and government initiatives promoting diabetes management. The availability of generic biguanides and well-established healthcare systems support widespread adoption. Growing investments in research also enhance the development of novel formulations.
Asia Pacific
Asia Pacific is a rapidly expanding market segment, accounting for approximately 25%. Factors such as increasing diabetes prevalence, improving healthcare facilities, and rising awareness contribute to market growth. Emerging economies like China and India play a pivotal role in expanding the regional demand.
Middle East & Africa
The Middle East & Africa region represents around 7% of the Biguanides Market. Though healthcare infrastructure is still developing, growing diabetes incidence and government efforts toward better healthcare access are driving demand. Increasing urbanization and lifestyle changes are expected to fuel future growth.
Latin America
Latin America contributes roughly 5% to the market, with gradual growth attributed to increasing diabetes prevalence and improving healthcare systems. Growing adoption of biguanides in countries like Brazil and Mexico, supported by favorable reimbursement policies, is bolstering market expansion.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Biguanides Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers:
- Increasing Diabetes Prevalence
- Efficacy of Metformin
- Rising Obesity Rates
-
Advancements in R&D - Advancements in research and development (R&D) within the global biguanides market are pivotal in shaping the future of diabetes treatment and expanding the therapeutic applications of these medications. Biguanides, particularly Metformin, have been a cornerstone in the management of type 2 diabetes mellitus (T2DM) for decades due to their efficacy and safety profile. Ongoing R&D efforts aim to enhance the effectiveness, tolerability, and broader applicability of biguanides, addressing current challenges and exploring new opportunities in diabetes care and beyond.
One of the significant areas of advancement in R&D involves improving the formulation and delivery mechanisms of biguanides. Traditional oral formulations of Metformin have been effective but can sometimes lead to gastrointestinal side effects, such as nausea and diarrhea, which impact patient adherence. Researchers are developing extended-release formulations and alternative delivery methods, such as transdermal patches and inhalation therapies, to improve drug absorption, reduce side effects, and enhance patient compliance. These advancements aim to provide more personalized treatment options that cater to individual patient needs and preferences.
R&D efforts are focused on understanding the molecular mechanisms of action underlying biguanides' therapeutic effects. Metformin, for instance, not only lowers blood glucose levels by reducing hepatic glucose production and improving insulin sensitivity but also exerts anti-inflammatory and anti-cancer effects through various pathways. Researchers are exploring these mechanisms to uncover potential new indications for biguanides beyond diabetes management. Clinical trials are investigating Metformin's role in treating polycystic ovary syndrome (PCOS), cardiovascular diseases, and even certain cancers, suggesting a broader spectrum of therapeutic benefits beyond its original use.
Advancements in pharmacogenomics and personalized medicine are also driving R&D in the biguanides market. Genetic variations among individuals can influence drug metabolism and response, impacting treatment outcomes. Researchers are leveraging genomic data and biomarker research to develop personalized treatment strategies that optimize the efficacy and safety of biguanides based on individual patient profiles. This approach aims to tailor dosage regimens and identify patients who may benefit most from specific biguanide therapies, thereby improving overall treatment outcomes and patient satisfaction.
Restraints:
- Side Effects
- Competition from Other Antidiabetic Drugs
- Regulatory Hurdles
-
Limited Awareness in Developing Regions - Limited awareness about diabetes and its management in developing regions poses a significant challenge in the global biguanides market. Despite the increasing prevalence of diabetes in these regions, awareness about the disease, its risk factors, and available treatment options remains inadequate among both healthcare professionals and the general population.
One of the primary reasons for limited awareness is the lack of comprehensive healthcare infrastructure and resources in developing regions. Rural areas often face shortages of trained healthcare professionals and access to essential medical services, including diabetes education and screening programs. This scarcity impedes early diagnosis and proper management of diabetes, delaying treatment initiation and increasing the risk of complications.
Cultural beliefs and misconceptions about diabetes contribute to the low awareness levels. In many developing countries, there may be stigma associated with chronic diseases like diabetes, leading to reluctance in seeking medical care or adhering to prescribed treatments. Traditional healers and alternative medicine practices may also influence healthcare-seeking behaviors, further complicating efforts to promote evidence-based diabetes management practices.
Limited access to information and educational resources exacerbates the awareness gap. Public health campaigns and educational initiatives about diabetes prevention, symptoms, and treatment options are often underfunded or not prioritized in resource-constrained settings. This results in a lack of understanding among individuals about the importance of lifestyle modifications, regular monitoring of blood glucose levels, and adherence to prescribed medications, including biguanides like Metformin.
Opportunities:
- Development of New Formulations
- Expanding Therapeutic Applications
- Increasing Healthcare Access in Emerging Markets
-
Combination Drug Development - Combination drug development in the context of the global biguanides market represents a promising avenue to enhance diabetes management and address specific patient needs. Combination therapies involve the strategic pairing of different drugs with complementary mechanisms of action to achieve synergistic effects, improve efficacy, and potentially reduce side effects compared to monotherapy. In the realm of biguanides, particularly with Metformin as the foundational drug, combination drug development focuses on integrating it with other classes of antidiabetic agents or medications targeting related health conditions.
Combination therapies aim to enhance glycemic control by targeting multiple pathways involved in glucose regulation. For instance, combining Metformin with sulfonylureas, which stimulate insulin secretion from pancreatic beta cells, or with dipeptidyl peptidase-4 (DPP-4) inhibitors, which enhance insulin release and suppress glucagon secretion, can provide additive benefits in lowering blood glucose levels. Such combinations are designed to achieve more comprehensive glycemic control and reduce the risk of hyperglycemia without increasing the dose of individual agents, thereby minimizing potential adverse effects.
Metformin is renowned for its ability to improve insulin sensitivity in peripheral tissues. However, in cases where insulin resistance remains a significant issue, combining Metformin with thiazolidinediones (TZDs) or sodium-glucose cotransporter-2 (SGLT-2) inhibitors can synergistically improve insulin sensitivity and glucose uptake by different mechanisms. This approach not only helps manage insulin resistance more effectively but also contributes to weight management and cardiovascular benefits associated with certain combinations.
Diabetes is closely linked with an increased risk of cardiovascular diseases. Combination therapies that incorporate agents with proven cardiovascular benefits, such as glucagon-like peptide-1 (GLP-1) receptor agonists or SGLT-2 inhibitors, alongside Metformin, can provide comprehensive cardiovascular risk management. These combinations have shown efficacy in reducing cardiovascular events, including heart attacks and strokes, and improving overall cardiovascular outcomes in diabetic patients.
Competitive Landscape Analysis
Key players in Global Biguanides Market include:
- Bayer
- Mylan
- Teva
- Takeda
- Actavis
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Type
- Market Snapshot, By Dosage Form
- Market Snapshot, By Formulation
- Market Snapshot, By Distribution Channel
- Market Snapshot, By Region
- Biguanides Market Trends
- Drivers, Restraints and Opportunities
- Drivers
- Increasing Diabetes Prevalence
- Efficacy of Metformin
- Rising Obesity Rates
- Advancements in R&D
- Restraints
- Side Effects
- Competition from Other Antidiabetic Drugs
- Regulatory Hurdles
- Limited Awareness in Developing Regions
- Opportunities
- Development of New Formulations
- Expanding Therapeutic Applications
- Increasing Healthcare Access in Emerging Markets
- Combination Drug Development
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
-
Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Biguanides Market, By Type, 2021 - 2031 (USD Million)
- Metformin
- Phenformin
- Others
- Biguanides Market, By Dosage Form, 2021 - 2031 (USD Million)
- Tablets
- Oral Solutions
- Biguanides Market, By Formulation, 2021 - 2031 (USD Million)
- Immediate Release
- Extended Release
- Biguanides Market, By Distribution Channel, 2021 - 2031 (USD Million)
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
- Biguanides Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN (Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Biguanides Market, By Type, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Bayer
- Mylan
- Teva
- Takeda
- Actavis
- Company Profiles
- Analyst Views
- Future Outlook of the Market