Market Overview
| Study Period | 2021 - 2032 |
|---|---|
| Forecast Data Period | 2027 - 2032 |
| Base Year Market Size (2026) | USD 1.44 Billion |
| Market Size (2027) | USD 1.47 Billion |
| Market Size (2032) | USD 1.67 Billion |
| Growth Rate (2027 - 2032) | 2.59 % |
| Market Concentration | Medium |
Major Players *Disclaimer: Major Players sorted in no particular order Image © Mordor Intelligence. Reuse requires attribution under CC BY 4.0. | |
North America Biguanide Market Analysis by Mordor Intelligence
The North America Biguanide Market size is projected to expand from USD 1.44 billion in 2026 and USD 1.47 billion in 2027 to USD 1.67 billion by 2032, registering a CAGR of 2.59% between 2027 and 2032.
The COVID-19 pandemic positively impacted the North American Biguanide Market. Diabetes and uncontrolled hyperglycemia are risk factors for poor outcomes in patients with COVID-19 including an increased risk of severe illness or death. People with diabetes have a weaker immune system, the COVID-19 complication aggravates the condition, and the immune system gets weaker very fast. People with diabetes have more chances to get into serious complications rather than normal people.
Biguanides continue to represent the foundation of type 2 diabetes management across North America, with metformin remaining the recommended first-line pharmacological therapy for most newly diagnosed patients. The widespread adoption of metformin is supported by its established clinical efficacy, favorable safety profile, low treatment cost, and inclusion in major diabetes treatment guidelines. Furthermore, the availability of extended-release formulations and fixed-dose combinations with newer antidiabetic drug classes has strengthened its utilization across the United States and Canada, supporting the growth of the North America biguanide market.
As Type 2 diabetes is associated with both poorer clinical outcomes during the COVID-19 pandemic and an increased risk of death in such hospitalized patients, the role of glucose control has been emphasized to improve the prognosis. Metformin is the first-line choice for the management of hyperglycemia in T2DM. Besides being an important glucose-lowering agent, metformin also has significant anti-inflammatory. Therefore, metformin has been a potential candidate for treating patients affected by COVID-19 infection, with type 2 diabetes, as well as an excellent antidiabetic (glucose-lowering) agent during COVID-19 pandemic times.
In North America, till April 2022, the United States is having the highest COVID cases around 82 million, the country also registered the highest death rate. According to the Diabetes Voice article published in May 2020, close to 40,000 deaths of people who are having diabetes. Pandemic emergency has created a rise in remote care from both patients and providers and removed many long-standing regulatory barriers.
The North America biguanide market continues to benefit from the entrenched position of metformin in diabetes treatment algorithms across the United States and Canada. As the standard first-line pharmacological therapy for newly diagnosed type 2 diabetes patients, metformin is often initiated early and maintained throughout the treatment pathway, even when additional drug classes are introduced. This long-term treatment persistence has enabled biguanides to retain substantial prescription volumes despite the growing adoption of newer therapies such as GLP-1 receptor agonists and SGLT-2 inhibitors.
Therefore, owing to the aforementioned factors the studied market is anticipated to witness growth over the analysis period.
Note: Market numbers in this report are based on Mordor Intelligence's proprietary estimation framework, which combines nine months of actuals with Q4 projections for base year 2026.
North America Biguanide Market Trends and Insights
Rising diabetes prevalence
The diabetes population in the North American region is expected to rise by more than 1% over the forecast period.
The Centers for Disease Control and Prevention National Diabetes Statistics Report 2022 estimated that more than 130 million adults are living with diabetes or prediabetes in the United States. Type 2 diabetes is more common, and diabetes is more consequential among communities of color, those who live in rural areas, and those with less education, lower incomes, and lower health literacy.
According to the Division of Metabolism and Endocrinology Products in the FDA, 'Patients want effective treatment options for diabetes that are as minimally intrusive on their lives as possible, and the FDA welcomes the advancement of new therapeutic options that can make it easier for patients to control their condition.' Metformin is typically the first medication used to treat type 2 diabetes due to its wide range of efficacy, safety, and mechanisms of action. Metformin and other anti-diabetic drug combinations include a low risk of hypoglycemia, provide beta cell protection, offer cardio-renal benefits, and are safe for patients with kidney or liver conditions and senior citizens.
The widespread availability of generic metformin has established biguanides as one of the highest-volume prescription segments within the North American oral antidiabetic drug segment. Large-scale procurement by healthcare systems, pharmacy benefit managers, and retail pharmacy chains has contributed to consistent product penetration, while ongoing demand for first-line diabetes therapy continues to support market growth.
Owing to the rising rate of obesity, the increasing prevalence, and the factors mentioned above, the market is likely to continue to grow.
Canada holds the highest market share in the North America Biguanide Market in the current year
Canada holds the highest market share of about 53% in the North American Biguanide Market in the current year.
According to Diabetes Canada, 2022 figures show the continued rising trend of diabetes rates in Canada with no signs of leveling or decreasing. Diabetes continues to affect more Canadians than ever before. The new diabetes figures show a steady, continued increase in diabetes in the country, with 11.7 million Canadians living with diabetes or prediabetes. More than 5.7 million Canadians are living with diagnosed diabetes.
Diabetes reduces lifespan, and people with the disease are likely to experience blindness and be hospitalized for amputations, kidney failure, heart attacks, strokes, and heart failure. First-line therapy used in patients with Type-2 diabetes is metformin monotherapy. Other options must be considered when metformin is contraindicated or not tolerated or when treatment goals are not achieved after three months of use at the maximum tolerated dose. Dipeptidyl peptidase-4 inhibitors, sodium-glucose cotransporter-2 inhibitors, and glucagon-like peptide-1 agonists are generally used to supplement treatment with metformin.
There is currently no national drug coverage system in Canada. There is a mix of public and private coverage. Governments pay 40% of the costs. 40% of the costs are paid by private insurance, usually arranged through employee benefit plans. Individuals pay 20% of the costs, usually premiums, deductibles, and co-pays for public and private coverage. The cash market for prescription drugs is relatively small in Canada. However, the out-of-pocket impact is not insignificant when patients include high dollar-value contributions.
The market is expected to grow due to the factors above during the forecast period.
Competitive Landscape
The North American Biguanidemarket is fragmented, with manufacturers like Takeda, Merck, Sanofi, GlaxoSmithKline, Bristol-Myers Squibb, and Boehringer Ingelheim Pharmaceuticals having a global market presence. The market is highly competitive due to generic drug manufacturers' presence.
North America Biguanide Industry Leaders
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Sanofi Aventis
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Bristol-Myers Squibb
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Glenmark Pharmaceuticals
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Takeda Pharmaceuticals
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Merck & Co., Inc.
- *Disclaimer: Major Players sorted in no particular order
Recent Industry Developments
- February 2023: Zydus Lifesciences Limited received tentative approval from the USFDA for Invokamet tablets (canagliflozin and metformin hydrochloride combination). Canagliflozin and metformin combination products are indicated as an adjunct to diet and exercise. It is to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing metformin or canagliflozin. It is also used in patients already treated with canagliflozin and metformin.
- July 2022: Zydus Lifesciences announced that it had received final approval from the USFDA to market Empagliflozin and Metformin Hydrochloride tablets in multiple strengths. Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. They are also used to lower the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease.
North America Biguanide Market Report Scope
Biguanides are a class of diabetes medications used for people with type 2 diabetes. The North American Biguanide Market is segmented into geography (United States, Canada, and the rest of North America). The report offers the value (in USD) and volume (in units) for the above segments. Further, the report will cover a segment-wise breakdown (value and volume) for all the countries covered under the Table of Contents.
Geography
| United States |
| Canada |
| Rest of North America |
| Geography | United States |
| Canada | |
| Rest of North America |
Key Questions Answered in the Report
How big is the North America Biguanide Market?
The North America Biguanide Market size is expected to reach USD 1.47 billion in 2027 and grow at a CAGR of 2.59% to reach USD 1.67 billion by 2032.
What is the current North America Biguanide Market size?
In 2026, the North America Biguanide Market size is expected to reach USD 1.44 billion.
Who are the key players in North America Biguanide Market?
Sanofi Aventis, Bristol-Myers Squibb, Glenmark Pharmaceuticals, Takeda Pharmaceuticals and Merck & Co., Inc. are the major companies operating in the North America Biguanide Market.
What years does this North America Biguanide Market cover, and what was the market size in 2025?
In 2025, the North America Biguanide Market size was estimated at USD 1.40 billion. The report covers the North America Biguanide Market historical market size for years: 2021, 2022, 2023, 2024, 2025, and 2026. The report also forecasts the North America Biguanide Market size for years: 2027, 2028, 2029, 2030, 2031, and 2032.