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Drugs in ATC Class A10BA
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Drugs in ATC Class: A10BA - Biguanides
| Tradename | Generic Name |
|---|---|
| INVOKAMET | canagliflozin; metformin hydrochloride |
| INVOKAMET XR | canagliflozin; metformin hydrochloride |
| KAZANO | alogliptin benzoate; metformin hydrochloride |
| XIGDUO XR | dapagliflozin; metformin hydrochloride |
| >Tradename | >Generic Name |
Showing 1 to 4 of 4 entries
A10BA Market Analysis and Financial Projection
The ATC Class A10BA (Biguanides) market, primarily driven by type 2 diabetes management, is shaped by evolving therapeutic demand and patent dynamics. Here's a detailed analysis:
Market Overview
Biguanides, particularly metformin, dominate as first-line treatments for type 2 diabetes due to their efficacy, safety, and cost-effectiveness[4][6][12]. Key metrics include:
- Market Size: Estimated at USD 5.1–5.2 billion in 2023, projected to reach USD 6.19–7.57 billion by 2030–2032, with a CAGR of 2.07–5.42%[4][6][7][12].
- Growth Drivers:
- Rising Diabetes Prevalence: Over 90% of diabetes cases are type 2, with global prevalence expected to rise from 463 million (2019) to 578 million (2030)[4][18].
- Cost-Effectiveness: Metformin’s affordability and established safety profile sustain demand despite competition[12][18].
- Market Restraints:
- Generic Competition: Patent expirations (e.g., metformin) led to price erosion and reduced profitability for originators[2][20].
- Newer Drug Classes: SGLT-2 inhibitors and GLP-1 agonists challenge biguanides’ market share[2][5].
Patent Landscape
Key Insights:
- Compound Patents: Core biguanide compounds like metformin have long expired (e.g., phenformin patent expired in 1964[10]), enabling widespread generic production[20].
- Formulation/Combination Patents:
- Active patents protect extended-release formulations (e.g., Glumetza®) and combinations (e.g., metformin + SGLT-2 inhibitors)[6][17].
- Example: US Patent 8,668,931 (expiring 2027–2036) covers metformin-thiazolidinedione combinations[17].
- Regional Variations:
- US: Metformin faces Paragraph IV litigation, with 10 active patents and 127 NDAs for generics[20].
- Europe: Linagliptin (non-biguanide DPP-4 inhibitor) retains formulation patents until 2033, indirectly affecting competitive dynamics[9].
Competitive Landscape
- Key Players: Merck & Co., Teva, Lupin, and Bristol-Myers Squibb lead through generics and strategic alliances[6][12][18].
- Market Segmentation:
- By Formulation: Extended-release tablets (USD 3.6 billion by 2032) dominate due to improved patient compliance[6].
- By Region: North America holds 38.2% market share (2023), while Asia-Pacific grows rapidly (74% diabetes prevalence increase by 2030)[12][18].
Opportunities and Challenges
| Opportunities | Challenges |
|---|---|
| Emerging markets (Asia-Pacific, Latin America)[2][18] | Gastrointestinal side effects[12] |
| Digital health integration (wearables, telemedicine)[2] | Kidney function contraindications[2] |
| Research into non-diabetic uses (e.g., cancer, cardiovascular)[2] | Regulatory hurdles for new entrants[2] |
Future Outlook
- Generics Dominance: Post-2025, biosimilar and generic competition will intensify, particularly for combination therapies[9][20].
- Innovation Focus: Companies invest in sustained-release formulations and personalized medicine to differentiate products[6][17].
- Regional Growth: Africa and the Middle East show untapped potential but lag in healthcare infrastructure[18].
Highlight: "Biguanides’ role in diabetes management remains irreplaceable, but their future hinges on innovation beyond glucose control." – Industry Report[6].
Key Takeaways
- Biguanides maintain a stronghold in diabetes care, driven by cost and efficacy.
- Metformin’s generics dominate, but formulation patents extend revenue streams.
- Competition from newer drug classes necessitates continuous R&D investment.
For stakeholders, navigating patent expirations and capitalizing on digital health integration are critical to sustaining growth in this evolving market.
References
- https://www.rxreasoner.com/atccodes/A10BA
- https://markwideresearch.com/biguanides-market/
- https://www.360iresearch.com/library/intelligence/biguanides
- https://www.grandviewresearch.com/industry-analysis/biguanides-market-report
- https://www.scielo.br/j/bjps/a/gTrpb5mpwGBvtQq5ZCS896K/
- https://www.gminsights.com/industry-analysis/biguanides-market
- https://www.globenewswire.com/news-release/2023/08/17/2727575/0/en/Biguanides-Market-Size-Share-Analysis-Growth-Trends-Forecasts-2023-2028.html
- https://pmc.ncbi.nlm.nih.gov/articles/PMC5459444/
- https://www.greyb.com/blog/trajenta-patent-expiration/
- https://patents.google.com/patent/US2467371A/en
- https://www.canada.ca/en/patented-medicine-prices-review/services/npduis/analytical-studies/mir-antidiabetic-drugs-2012-2021.html
- https://www.polarismarketresearch.com/industry-analysis/biguanides-market
- https://www.greyb.com/blog/diabetes-drug-patents-expiring/
- https://pmc.ncbi.nlm.nih.gov/articles/PMC10653475/
- https://patents.google.com/patent/US6515117B2/en
- https://www.globenewswire.com/news-release/2025/03/20/3046446/0/en/Metformin-CAS-657-24-9-Industry-Research-2025-Global-and-Regional-Market-Trends-2019-2024-and-Forecasts-2025-2029-Patents-Manufacturers-Suppliers-Trade-Prices-Supply-Demand-End-use.html
- https://patents.justia.com/patent/8668931
- https://www.omrglobal.com/industry-reports/biguanide-market
- https://dataintelo.com/report/global-antidiabetic-biguanides-market
- https://www.drugpatentwatch.com/p/generic-api/metformin+hydrochloride
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