Last updated: January 1, 2026

Executive Summary

The ATC Class A10B encompasses drugs primarily designed to lower blood glucose levels, excluding insulins. This class forms a critical segment within the diabetes treatment market, especially given the rising global prevalence of type 2 diabetes (T2D). Technological advancements, the advent of novel drug classes like SGLT2 inhibitors, GLP-1 receptor agonists, and fixed-dose combinations have transformed this landscape, fueling market growth and intensifying patent activity. However, patent expirations and increasing biosimilar entries threaten revenue streams and market stability. This analysis reviews current market dynamics, assesses the evolving patent landscape, and provides strategic insights for industry stakeholders.

Market Overview and Growth Drivers

Global Diabetes Prevalence and Market Growth

Prevalence: According to the International Diabetes Federation (IDF), approximately 537 million adults experienced diabetes worldwide in 2021, projected to reach 643 million by 2030 [1].
Market Size (2022): The global blood glucose lowering drugs market, excluding insulins, was valued at USD 50 billion, with a compound annual growth rate (CAGR) of approximately 8% projected through 2028 [2].
Key Drivers:
- Rising T2D prevalence
- Favorable reimbursement policies
- Growing adoption of combination therapies
- Expanded indications beyond glycemic control, including cardiovascular benefits

Market Segmentation

Segment	Key Drugs	Estimated Market Share (2022)	Growth Trend
Sulfonylureas	Glibenclamide, Glimepiride	25%	Declining due to safety concerns
Biguanides	Metformin	40%	Stable, dominant first-line therapy
SGLT2 Inhibitors	Dapagliflozin, Empagliflozin, Ertugliflozin	15%	Rapid growth, expanding indications
GLP-1 Receptor Agonists	Semaglutide, Liraglutide	15%	Accelerated uptake, cardiovascular benefits
Others	DPP-4 inhibitors, alpha-glucosidase inhibitors	5%	Niche roles

Emerging Trends in Market Dynamics

Innovation in Drug Classes

SGLT2 Inhibitors: Offer additional benefits such as weight loss and cardiovascular risk reduction, enlarging their clinical footprint.
GLP-1 Receptor Agonists: Gaining distinctive market share owing to proven cardiovascular outcomes, for instance, semaglutide's recent approval for weight management.
Combination Therapies: Growing prevalence of fixed-dose combinations (FDCs), e.g., empagliflozin/linagliptin, streamline management, enhance adherence, and extend patent life cycles.

Regulatory and Reimbursement Influences

The FDA’s priority review for drugs demonstrating superior cardiovascular safety[3].
Growing reimbursement support for novel agents from Western healthcare payers.
Policies incentivize innovations that reduce cardiovascular events, influencing market strategies.

Competitive Landscape

Dominated by a handful of global players maintaining patent protections; e.g., AstraZeneca, Novo Nordisk, Lilly, and Merck.
Entry of biosimilars, especially targeting SGLT2 inhibitors post-patent expiry.

Patent Landscape Overview

Patent Types in ATC Class A10B

Patent Category	Purpose and Characteristics	Typical Duration	Notable Strategies
Compound Patents	Protect novel active molecules	20 years from filing	Patents for chemical structures
Formulation Patents	Innovative delivery methods, extended-release formulations	15-20 years	Use of novel carriers or combinations
Method of Use Patents	Specific therapeutic applications or indications	10-15 years	Label claims for specific patient subsets
Manufacturing Patents	Manufacturing processes, cost reduction, or stability improvements	15-20 years	Advanced synthesis methods

Major Patent Holders and Key Patents

Company	Notable Patents	Patent Expiry Range	Strategic Focus
AstraZeneca	Dapagliflozin chemical composition, FDC patents	2026–2030	SGLT2 inhibitors innovation
Eli Lilly	Dulaglutide (GLP-1 receptor agonist) patents	2024–2027	Long-acting GLP formulations
Novo Nordisk	Semaglutide formulation and use patents	2025–2028	BITs and new delivery methods
Merck	Ertugliflozin core molecule patents	2023–2026	SGLT2 inhibitors extensions

Patent Abrogation and Biosimilar Entry

First wave of patent cliff: occurred circa 2022 for some SGLT2 inhibitors (e.g., dapagliflozin), leading to biosimilar proliferation.
Impacts: price competition, market share erosion, increased focus on novel molecules or formulation patents to extend exclusivity.

Comparative Analysis: Key Drug Classes

Drug Class	Mechanism	Marketed Drugs	Patent Status	Revenue (USD, 2022)	Future Outlook
Biguanides (Metformin)	Decreases hepatic glucose production	Metformin	Off-patent	20 billion	Continues dominance; generics
SGLT2 Inhibitors	Increase glycosuria	Dapagliflozin, Empagliflozin, Ertugliflozin	2023–2030 (patents expiry)	15 billion (2022)	Rapid growth; biosimilars enter
GLP-1 RAs	Enhance insulin secretion, suppress appetite	Semaglutide, Liraglutide	2024–2028	12 billion	Expanding indications, biosimilars
DPP-4 Inhibitors	Prolong active incretin levels	Sitagliptin, Saxagliptin	2024–2026	3 billion	Mature; market slowly consolidating

Market Challenges and Opportunities

Challenges

Patent expiry leading to biosimilar influx
Pricing pressure and reimbursement cuts
Safety concerns and adverse effects influencing drug adoption
Regulatory hurdles for new drug approvals
Market saturation for older drug classes

Opportunities

Development of dual or triple FDCs
Personalized medicine approaches
Expanding indications for cardiovascular and renal benefits
Innovative delivery systems: injectables, oral GLP-1 formulations
Strategic partnerships and licensing to extend patent life

Comparison with Other ATC Classes

Aspect	A10B (Blood Glucose Lowering Drugs)	A10A (Insulins)	A10BA (Blood Glucose Lowering Drugs, Excl. Insulins, Agents for Type 2 Diabetes)
Market Size (2022)	USD 50 billion	USD 40 billion	Overlap with A10B, with a growing trend towards non-insulin therapies
Innovation Pace	Rapid, novel classes frequent	Moderate	Accelerating with oral GLP-1 and SGLT2 agents
Patent Expirations	2023–2035	2022–2026	Increasing patent cliff, biosimilar threats
Market Drivers	Cardiovascular outcomes, adherence	Basal insulin needs	Focus on cardiovascular and renal benefits

Regulatory and Policy Landscape

Region	Key Policies	Impact on Market	Recent Developments
United States (FDA)	Priority reviews for CV-beneficial drugs	Faster approvals for innovative agents	2022 approval of semaglutide for weight management
European Union	Emphasis on biosimilars and generics	Price reductions; increased competition	Biosimilar regulations strengthening
Japan	Reimbursement incentives for new medicines	Uptake acceleration	Pre-market approvals for new oral GLP-1 formulations

Key Patent Litigation and Litigation Trends

Ongoing patent litigations between originators and biosimilar entrants, e.g., Dapagliflozin patents vs. generic challengers.
Patent challenges focused on formulation, method of use, and manufacturing processes.
Increased use of patent thickets and complementary litigation to delay biosimilar entry.

Conclusion: Strategic Insights for Industry Stakeholders

Innovation Focus: Prioritize development of multi-mechanism agents and formulations extending patent life.
Monitoring Patent Expiries: Track imminent patent cliffs to plan biosimilar strategies.
Market Expansion: Leverage cardiovascular and renal benefits to broaden indications.
Regulatory Engagement: Collaborate with authorities to expedite approvals and align with policies favoring novel mechanisms.
Combat Competitive Pressures: Utilize patent fencing, strategic alliances, and licensing to maintain market share.

Key Takeaways

The global blood glucose lowering drug market beyond insulins is growing rapidly, driven by innovative drug classes with cardiovascular and renal benefits.
Patent landscape shows a mix of active compound patents, formulation innovations, and method of use protections, with expiries scheduled through 2030.
Biosimilar competition, patent litigations, and regulatory policies significantly shape the competitive environment.
Strategic patent management and continuous innovation are essential to sustain market share.
The future of this market hinges on expanding indications, optimizing formulations, and navigating patent landscapes effectively.

FAQs

Q1: How are patent expiries influencing the growth of biosimilars in A10B drugs?
A: Patent expiries, particularly for SGLT2 inhibitors like dapagliflozin, open opportunities for biosimilar manufacturers, increasing competition and potentially reducing prices, thus impacting revenues of original drug developers.

Q2: What role do combination therapies play in the current market dynamics?
A: Fixed-dose combinations enhance adherence, extend patent life, and integrate multiple mechanisms, positioning them as strategic products to maintain market dominance and address unmet patient needs.

Q3: Which new drug classes are expected to dominate in the next five years?
A: SGLT2 inhibitors and GLP-1 receptor agonists are expected to lead growth, owing to cardiovascular and weight-loss benefits, coupled with ongoing pipeline innovations.

Q4: How is regulatory policy shaping innovation in this ATC class?
A: Policies favor drugs with proven cardiovascular benefits, expedite approvals for breakthrough therapies, and encourage biosimilar entry, all influencing strategic R&D decisions.

Q5: What are the primary challenges for patent protection in this space?
A: Challenges include patent cliffs, patent litigation by biosimilar competitors, patent thickets, and evolving regulatory standards that can weaken enforceability of certain patents.

References

[1] International Diabetes Federation. IDF Diabetes Atlas, 2021 Edition.
[2] MarketWatch. "Blood Glucose Lowering Drugs Market Size, Share & Trends Analysis," 2022.
[3] U.S. Food and Drug Administration. Guidance on Cardiovascular Outcome Trials, 2021.

Note: Data and projections are based on publicly available sources as of 2022-2023 and are subject to change with market developments.

Drugs in ATC Class A10B

Subclasses in ATC: A10B - BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS

Market Dynamics and Patent Landscape for ATC Class: A10B – Blood Glucose Lowering Drugs, Excluding Insulins