Drugs and patents in ATC class A10B - BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS

Last updated: July 29, 2025

Introduction

The ATC (Anatomical Therapeutic Chemical) classification system categorizes pharmaceuticals based on their therapeutic use. ATC Class A10B encompasses blood glucose-lowering drugs excluding insulins, including oral hypoglycemics, incretin-based therapies, and other oral agents. The increasing prevalence of diabetes mellitus worldwide—projected to reach 700 million cases by 2045, according to the International Diabetes Federation—fuels the growth of this pharmacological segment. Concurrent technological innovations and strategic patent filings shape the competitive landscape. This report offers an analysis of current market dynamics, patent activity, emerging trends, and strategic considerations.

Market Dynamics

Global Market Growth

The global market for blood glucose-lowering agents (excluding insulins) is experiencing sustained growth, driven by rising diabetes incidence, aging populations, and heightened awareness. As per research, the market was valued at approximately USD 20 billion in 2022, with projections indicating a CAGR of 8–10% through 2030. Factors such as increasing urbanization, sedentary lifestyles, and obesity contribute to this upward trend.

Regulatory and Reimbursement Environment

Stringent regulatory pathways for new drug approvals in regions like the U.S. (FDA) and Europe (EMA) influence market entry. Reimbursement policies increasingly favor cost-effective oral therapies over insulin injections due to convenience and adherence factors, stimulating innovation in this segment. Additionally, expanded indications for existing drugs are enhancing market access.

Therapeutic Trends

The therapeutic landscape is evolving, with a marked shift towards novel classes of oral agents:

GLP-1 receptor agonists (oral formulations): Recent breakthroughs have led to oral versions of peptide drugs traditionally administered via injection, e.g., Rybelsus (semaglutide). These drugs not only lower blood glucose but also promote weight loss, addressing comorbidities.
SGLT2 inhibitors: Beyond glycemic control, these drugs exhibit cardiovascular and renal benefits, expanding their therapeutic appeal. They hold a significant market share, with agents like dapagliflozin and empagliflozin leading.
DPP-4 inhibitors: Well-established, with ongoing development of next-generation agents for improved efficacy and safety profiles.
Emerging agents: Novel mechanisms, such as dual or triple inhibitors targeting multiple pathways, are under clinical investigation.

Market Challenges

Late-stage competition: Patent expiries for key drugs, such as sitagliptin and saxagliptin, have led to market erosion by generics.
Safety concerns: Adverse effects, especially with SGLT2 inhibitors (e.g., diabetic ketoacidosis), influence prescribing patterns and patient adherence.
Pricing pressures: Reimbursement constraints restrain pricing power, prompting pharmaceutical companies to innovate and differentiate.

Patent Landscape Analysis

Patent Filing Trends

Patent activity in the A10B class remains robust, driven by incremental innovations and formulation improvements. Top players like Novo Nordisk, Eli Lilly, and Merck lead filings, focusing on:

New chemical entities (NCEs): Development of proprietary molecules targeting blood glucose through novel mechanisms.
Extended-release formulations: Improving pharmacokinetics and patient compliance.
Combination therapies: Patent filings for fixed-dose combinations improve efficacy and adherence.
Delivery platforms: Innovation in oral peptide delivery and convenient dosing forms.

Annual patent filings peaked between 2015 and 2020, aligning with the advent of oral GLP-1 receptor agonists and SGLT2 inhibitors.

Key Patent Holders and Strategies

Novo Nordisk: Extensive patent portfolio on semaglutide formulations, including oral delivery technologies.
Eli Lilly: Patents for novel DPP-4 inhibitors and combination therapies.
Merck & Co.: Focus on SGLT2 inhibitors with broad claims covering chemical compositions and methods of use.
Emerging biotech firms: Focused on mineralocorticoid receptor antagonists and other adjunctive therapies, attempting to carve niche segments.

Patent Expiry and Patent Cliff

Major patents for foundational agents, such as sitagliptin (Januvia), are expected to expire by 2025–2028. This patent cliff prompts strategic patent filings for next-generation drugs and biosimilars. Companies are also pursuing secondary patents on formulations and methods of use, extending market exclusivity.

Legal Landscape and Patent Challenges

Patent litigations focus on patent validity, patent term extensions, and patentability of formulations. Off-label use patents and method-of-use claims are critical battlegrounds. Patent challenges by generic firms are common as market exclusivity diminishes.

Emerging Trends and Innovations

Oral Peptides and Biologics

Recent advances aim to develop oral formulations of peptide drugs like GLP-1 receptor agonists, traditionally injectable. Technologies such as protective carriers, permeation enhancers, and nanoparticle encapsulation underpin these efforts, promising improved patient adherence.

Personalized Medicine

Pharmacogenomics influences drug selection and dosing, with ongoing research into genetic markers predicting response to specific agents.

Digital Health Integration

Smart inhalers, digital adherence tools, and remote monitoring are increasingly embedded within therapy regimens. Patents covering digital health integrations are emerging, offering competitive advantages.

Biosimilars

Patent expiries are catalyzing the entry of biosimilar molecules, especially for GLP-1 agents. Regulatory pathways aim to facilitate biosimilar approval, intensifying price competition.

Strategic Considerations for Stakeholders

Innovators: Focus on novel mechanisms, delivery systems, and combination formulations. Secure robust patent protection, including secondary patents, to prolong exclusivity.
Generic Manufacturers: Prepare for patent expiries by developing biosimilars and alternative formulations, investing in patent challenges, and licensing.
Investors: Monitor patent filings, pipeline progress, and regulatory developments for high-growth potential assets.
Regulators: Streamline approval pathways for innovative oral biologics and biosimilars, balancing safety and access.

Conclusion

The A10B class remains a dynamic, innovation-driven segment, pivotal to diabetes management. Patents are central to competitive advantage, with key players leveraging technological advancements to extend exclusivity. The ongoing evolution toward oral biologics, combination therapies, and personalized approaches heralds a transformative era. Strategic patent protection, regulatory navigation, and continued R&D investment will determine market leadership in this expanding field.

Key Takeaways

The global demand for blood glucose-lowering drugs (excluding insulins) is growing faster than ever, driven by diabetes prevalence and technological innovations.
Patent activity remains intensely competitive, with key players securing protections for novel formulations, delivery platforms, and combination therapies.
Patent expiries for major drugs are prompting a wave of biosimilar and generic entries, increasing price competition and market complexity.
Emerging innovations, notably oral peptide formulations and digital health integrations, are reshaping the therapeutic landscape.
Stakeholders should prioritize innovative R&D, robust patent strategies, and adaptive regulatory approaches to capitalize on opportunities.

FAQs

1. What are the primary innovative trends driving the A10B segment?
Advancements include the development of oral GLP-1 receptor agonists, dual/multifunctional agents targeting multiple pathways, and biologic delivery platforms that improve bioavailability and patient compliance.

2. How does patent expiration impact market competition in this class?
Patent expiry for key agents opens market opportunities for biosimilars and generics, leading to price reductions and increased access but also intensifies R&D efforts for next-generation therapies.

3. Which are the leading patent filers in the A10B class?
Major pharmaceutical companies like Novo Nordisk, Eli Lilly, and Merck are leading patent filers, focusing on new chemical entities, formulations, and combination therapies.

4. What are the main challenges faced by innovators in this segment?
These include regulatory hurdles, safety concerns with emerging therapies, patent litigation, and price pressures from biosimilar entrants.

5. What role does digital health play in the future of blood glucose-lowering therapies?
Digital health solutions, such as apps and remote monitoring devices, are increasingly integrated with pharmacotherapy, enriching patient adherence, real-world data collection, and personalized treatment adjustments.

References

International Diabetes Federation. IDF Diabetes Atlas, 10th ed. 2021.
Grand View Research. Blood Glucose Monitoring & Control Market Size, Share & Trends Analysis Report, 2022.
U.S. Food and Drug Administration. Guidance for Industry and FDA Staff: Patent Considerations in Licensing. 2020.
ClinicalTrials.gov. Various trials involving A10B agents, 2022–2023.
European Medicines Agency. List of approved diabetes medicines, 2023.

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, Excl. Insulins