The anti-hyperglycemic agents market is valued at USD 50.23 billion in 2025. As per FMI's analysis, the anti-hyperglycemic agents market will grow at a CAGR of 4.7% and reachUSD 80.05 billion by 2035. The anti-hyperglycemic agents market has been steadily growing due to the increasing prevalence of diabetes worldwide and the growing awareness regarding blood glucose monitoring.
In 2024, the industry for anti-hyperglycemic agents saw significant changes, especially with the launch of biosimilars and generics. Glenmark Pharmaceuticals introduced Lirafit, the first biosimilar of Liraglutide, as a more affordable option for the treatment of type 2 diabetes. The launch improved access to sophisticated treatment for patients, particularly in the developing world.
This growth is driven by progress in drug discovery, increased healthcare access, and an aging population prone to type 2 diabetes Anti-hyperglycemic agents include insulin and non-insulin drugs, which are crucial for managing blood glucose levels and preventing diabetes-related complications. Rising trends of combination therapies and the creation of innovative delivery techniques are other growth epiphanies of the sector.
Key Market Insights
| Metric | Key Insights |
|---|---|
| Industry Size (2025E) | USD 50.23 billion |
| Industry Size (2035F) | USD 80.05 billion |
| CAGR (2025 to 2035) | 4.7% |
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The anti-hyperglycemic agents sector is the increasing rates of diabetes worldwide and growing need for effective and accessible treatment solutions. Disruptive Innovation in drug classes including GLP-1 receptor agonists and biosimilars is transforming the competitive landscape. Pharma companies that focus on new therapies and emerging industry will benefit as the sector grows, while those that are slow to adapt will lag.
Accelerate Biosimilar and Novel Drug Development
Invest in R&D to develop biosimilars and next-generation anti-hyperglycemic agents such as GLP-1 receptor agonists and SGLT2 inhibitors, which are gaining rapid adoption due to their efficacy and patient compliance benefits.
Expand into High-Growth Emerging Markets
Align go-to-market strategies with expanding diabetic populations in regions like Asia-Pacific and Latin America by tailoring pricing, regulatory, and access models to local segment dynamics.
Strengthen Strategic Partnerships and Distribution Networks
Pursue collaborations with regional healthcare providers, digital health platforms, and distribution partners to enhance reach, streamline supply chains, and capture underserved patient segments more effectively.
| Probability - Impact | |
|---|---|
| 1. Regulatory hurdles or delays in drug approvals | Medium - High |
| 2. Pricing pressures from governments and payers | High - High |
| 3. Disruption in supply chains or raw material shortages | Medium - Medium |
| Priority | Immediate Action |
|---|---|
| Expand Biosimilar Portfolio | Conduct a feasibility study on pipeline expansion for GLP-1 biosimilars |
| Regional Segment Penetration | Initiate local stakeholder mapping and regulatory alignment in APAC region |
| Enhance Commercial Reach | Launch incentive-based pilot with key distribution and pharmacy partners |
To stay ahead, in the company increasing demand for anti-hyperglycemic agents, the client would be best served by ensuring the expedited development of its biosimilars, particularly with regard to GLP-1 receptor agonists and fixed-dose combinations that have shown to enhance adherence. This intelligence clearly demonstrates the pressing need to pivot from a generalized sector strategy to a targeted strategy focusing on high-growth, regulation-ready emerging economies. Now the roadmap has to incorporate your regionalized launch plans, approach to regulatory coordination, and a reworked partnership model with digital health and retail pharmacy ecosystems.
Regional Variance
High Variance
Convergent and Divergent Perspectives on ROI
Consensus
Variance
Shared Challenges
Regional Differences
Manufacturers
Distributors
Healthcare Providers
Alignment
Divergence
Conclusion: Variance vs. Consensus
| Countries | Impact of Policies and Regulations |
|---|---|
| United States | Affordable Care Act (ACA): Affects pricing and reimbursement for diabetes treatments, pushing for broader insurance coverage of anti- hyperglycemic drugs. - FDA Drug Approval Process: Stringent approval processes for new anti- hyperglycemic agents and biosimilars . - State-Level Regulations: States like California have enacted laws to regulate drug pricing (e.g., California's "Proposition 12") that affect insulin pricing. |
| Western Europe | European Medicines Agency (EMA) Regulations: Drugs must be approved by EMA for marketing within the EU. - EU Health Strategy 2023 to 2027: Encourages better access to diabetes treatment, including reducing barriers to drug entry. - Reimbursement Policies: European countries have national health insurance systems that affect pricing and reimbursement of anti- hyperglycemic agents, with emphasis on cost-effectiveness. |
| Japan | Japan's Pharmaceuticals and Medical Devices Agency (PMDA): Regulates the approval of all pharmaceuticals and medical devices. - Health Insurance System: Japan’s national health insurance system sets reimbursement rates for anti- hyperglycemic drugs, influencing their segment availability. - Drug Price Control: The government regularly reviews and sets the maximum price for drugs. |
| South Korea | Ministry of Food and Drug Safety (MFDS): Regulates the approval and distribution of anti- hyperglycemic drugs in South Korea. - National Health Insurance: The government determines the reimbursement for diabetes medications, emphasizing cost-efficiency. - Drug Price Negotiation: The MFDS negotiates the price of medications annually, impacting the accessibility of new drugs. |
| China | National Medical Products Administration (NMPA): Oversees the approval of all pharmaceutical products in China. - Drug Price Regulation: The Chinese government controls drug prices, including anti- hyperglycemic agents, through the National Reimbursement Drug List (NRDL). - Market Access Rules: New drugs must be included in the NRDL to be covered by health insurance, which can influence industry success. |
| India | Drug Control Department: Regulates the approval of anti- hyperglycemic drugs through the Central Drugs Standard Control Organization (CDSCO). - National Health Insurance: While still in early stages, government initiatives are starting to drive more access to diabetes treatment. - Price Control: India has a Drug Price Control Order (DPCO) that limits the cost of essential drugs, including anti- hyperglycemic agents. |
| Brazil | Brazilian Health Regulatory Agency (ANVISA): Responsible for drug approval and oversight. - SUS (Unified Health System): Provides free access to anti- hyperglycemic agents under the government-funded health system. - Industry Access Challenges: New drugs often face barriers in pricing and reimbursement under SUS, which can affect segment penetration. |
The largest share of anti-hyperglycemic agents sector is accounted by the United States, which is driven by the high prevalence of diabetes, the growing geriatric population, and a strong healthcare industry.
In addition, a growing emphasis on personalized medicine, as well as the increasing use of digital health technologies, including continuous glucose monitoring (CGM), will fuel the expansion of the sector. United States is still the major in research and development, where large pharmaceutical companies and biotechnology companies can invest huge amounts of money to find new treatments.
In theanti-hyperglycemicagents’sector, the United Kingdom is likely to witness a CAGR of 4.5% during 2025 to 2035. As the UK faces an accelerating diabetes epidemic, driven up by increasing obesity rates and an ageing population, the need for novel and better diabetes therapeutics will become increasingly pressing.
The introduction of biosimilars in particular is growing increasingly relevant in the UK, where there is an overwhelming demand for alternatives to biologic therapies. The UK sector has challenges due to pressure on the healthcare budget and limited number of new medications that will be approved for reimbursement to the public.
The French sector for anti-hyperglycemic agents is projected to expand at a CAGR of 4.3% during the period 2025 2035. France has a universal healthcare system, which generally provides a wide access to diabetes treatment. Nonetheless, industry access can be difficult for novel anti-hyperglycemic agents because reimbursement policies and pricing controls in France are quite strict.
The approval process is governed by the French Medicines Agency (ANSM), which ensures treatment quality is guaranteed. There is also a trend toward personalized medicine, which will increase the need for newer, more specific anti-hyperglycemic agents.
Between 2025 and 2035, the anti-hyperglycemic agents sector in Germany is anticipated to grow at a CAGR of 4.8%, based on demand generated by rising patients as well as Germany’s reputation for state-of-the-art medical technology. Germany is among the largest pharmaceutical sectors in Europe, with an established healthcare infrastructure that provides universal access to medicines.
Diabetes is one of the leading chronic diseases in Germany, particularly among older adults, creating a constant need for effective treatments. Quality standards and efficacy are guided by the Federal Institute for Drugs and Medical Devices (BfArM) and are a core part of the German healthcare system where the focus of the healthcare system is cost-effective care.
The Italy anti-hyperglycemic agents sector is predicted to exhibit a CAGRof 4.1% during the period 2025 to 2035. Most Italians have access to diabetes medications through the Italian public healthcare system in which budgetary constraints on public health expenditure and drug price controls can restrict the supply of new treatments.
Therefore, the use of generic anti-hyperglycemic agents in the country is widespread. There is a growing tidal wave of biosimilars, which are a cheaper alternative for patients. Therapies with improved patient compliance features should start to see wider interest in marketplace.
South Korea will hold the CAGR of 5.0% in the anti-hyperglycemicagentssector during 2025 to 2035. The country is experiencing a drastically increasing diabeticdemographic because of the obstreperous changes in lifestyle, urbanization, and an aging society. South Korea provides a well-known vast diabetic treatment through the National Health Insurance Service (NHIS.
The sector is moving towards solutions that are driven by technology, which consist of CGM systems as well as insulin pumps. The approval process is governed by the Korean Food and Drug Administration (KFDA), with high standards for drug efficacy and safety.
The CAGR for Japan in the anti-hyperglycemicagents sector is expected to be around 4.2% from 2025 to 2035. Japan, which has one of the oldest populations in the world, is experiencing a surge in the prevalence of diabetes and worsening type 2 diabetes.
Diabetes care in Japan has renewed preventive intervention on chronic diseases by implementing large measures through the Japanese government; however, chronic disease remains a prevalence burden. The country has a strong health care system, emphasizing innovation in treatments, but high drug prices and an aging population pose challenges. The Pharmaceuticals and Medical Devices Agency (PMDA) is responsible for the approval of new anti-hyperglycemic agents with a priority on the efficacy and safety.
China sector for anti-hyperglycemic agents is expected to grow at a CAGR of 6.0% during the period 2025 to 2035, supported by a progressive rise in the number of patients with diabetes and the progression of middle class.
Fast-aging and increasingly urbanized Chinese population, the need for effective diabetes treatment can only grow. Drug approval is overseen by the National Medical Products Administration (NMPA), and in recent years, there has been a growing regulatory ease towards biosimilars as well as generic drugs, which has also helped bring down costs of diabetes management.
The anti-hyperglycemic agents sector will grow at a CAGR of 4.6% in Australia and New Zealand from 2025 to 2035. Both countries experience soaring rates of diabetes fueled by obesity and lifestyle changes. The nations have developed healthcare systems with government programs designed to mitigate the impact of chronic conditions such as diabetes.
While in Australia, the PBS (Pharmaceutical Benefits Scheme) has made anti-hyperglycemic agents affordable via subsidization for the majority of the population. The pressures on drug pricing and the government’s emphasis on cost-effective treatments may restrict the availability of some newer therapies.
Sodium-Glucose Cotransport-2 (SGLT-2) inhibitors are anticipated to be the most profitable segment between 2025 and 2035 with a CAGR of 6.2%, witnessing tremendous growth on the back of a mix of growing adoption, new indications, and patient-beneficial benefits.
This class, represented by medications such as empagliflozin, canagliflozin, and dapagliflozin, has emerged as one of the most sought-after treatment options for the management of type 2 diabetes, and its industry share will keep on increasing throughout the forecast period. The success of SGLT-2 inhibitors is largely due to their dual advantages - not only do they lower blood glucose, but they also offer cardiovascular and renal protection.
Online Pharmacies will be the most profitable segment between 2025 and 2035, with the highest growth spurred on by growing digitalization of healthcare and consumers' growing preference for home delivery and convenience services with a CAGR of 7.5%.
The trend towards e-commerce and digital healthcare solutions has been gaining pace, particularly in the wake of the COVID-19 pandemic, and is also set to persist. Internet pharmacies have tremendous benefits for long-term patients such as those with diabetes, in that they provide convenient access, home delivery, and cost comparison.
Players are becoming competitive in the anti-hyperglycemicagents sector with their pricing, innovative approach, partnerships, and organic and inorganic growth strategies. Pricing is an important factor, leading many companies to strategically price their drugs so as to offer a competitive price for the generic equivalents to parallel products, including Metformin and DPP-4 inhibitors. Top firms are investing heavily behind R&D to bring forward new drugs and combination therapies that can manage wider areas of diabetes, including cardiovascular risk and chronic kidney disease.
Market Share Analysis
(Source: The Economic Times)
(ETHealthworld.com)
The most prevalent medications are Biguanides (such as Metformin), DPP-4 inhibitors (such as Sitagliptin), SGLT-2 inhibitors (such as Empagliflozin), and Sulfonylureas (such as Glibenclamide). These drugs reduce blood sugar levels and increase insulin sensitivity.
Demand for such treatments is vastly different across sectors, with significant prevalence in Europe and North America, where the more developed healthcare systems and the larger diabetic population contribute to high demand.
Diabetes medicines are predominantly distributed through retail pharmacies, hospital pharmacies, and more and more through online pharmacies. Online pharmacies have grown significantly as a result of the increase in e-commerce, with patients having the ease of receiving treatment at home.
SGLT-2 inhibitors and GLP-1 receptor agonists have exhibited remarkable advantages in long-term control of blood sugar, especially among patients with comorbidities such as cardiovascular disease.
Digital health technologies, such as telemedicine and internet pharmacies, have significantly enhanced the availability and convenience of diabetes care.
the industry is segmented into Biguanides, Alpha-glucosidase inhibitors, Dopamine-D2 Receptor Agonist, Sodium-glucose Cotransport-2 (SGLT-2) inhibitor, Dipeptidyl Peptidase-4 (DPP-4) Inhibitors, Sulfonylureas, Meglitinides, and Others
the industry is segmented into Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies
the industry is segmented into North America, Latin America, Europe, East Asia, South Asia, Oceania, The Middle East & Africa
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Anti-Hyperglycemic Agents Market
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