Share This Page
Drugs in ATC Class M01
✉ Email this page to a colleague
Up to Top Level ATC Classes
Subclasses in ATC: M01 - ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M01 Market Analysis and Financial Projection
The market dynamics and patent landscape for ATC Class M01 (Antiinflammatory and Antirheumatic Products) reflect a complex interplay of clinical demand, innovation, regulatory challenges, and competitive strategies. Below is a structured analysis:
Market Dynamics
Market Size and Growth
- The global anti-rheumatics market reached $66.1 billion in 2024, with a projected growth to $81.8 billion by 2033 (CAGR: 2.28%)[3].
- Key drivers include aging populations, expanding healthcare infrastructure, and rising autoimmune disease prevalence.
Market Segmentation
| Segment | Dominant Category | Notes |
|---|---|---|
| Drug Class | DMARDs (Disease-Modifying Anti-Rheumatic) | DMARDs hold the largest share due to their ability to slow disease progression[3]. |
| Administration | Parenteral (injectables) | Driven by biologics (e.g., TNF-α inhibitors) requiring systemic delivery[3]. |
| Regional Trends | Asia-Pacific growth | Expanding access to advanced therapies in China and India[3]. |
Regulatory Impact
- Centralized Procurement Policies (e.g., China) reduced prices for anti-rheumatic drugs by 17–70% in therapeutic categories like NSAIDs (M01A)[6].
- COVID-19: Temporary setbacks due to delayed treatments, but recovery driven by pent-up demand[3].
Patent Landscape
Key Challenges
- Patent Eligibility Uncertainty: Post-2014 U.S. Supreme Court rulings (e.g., Mayo v. Prometheus) created ambiguity around software and biologic patents. This risks disincentivizing innovation in drug delivery systems or combination therapies[2].
- Evergreening Strategies: AbbVie’s Humira holds 132 patents across formulation, dosing, and indication extensions, delaying biosimilars until 2023[11]. Similar tactics are common in M01-class drugs like NSAIDs and biologics.
Emerging Innovations
| Patent Focus | Example | Significance |
|---|---|---|
| Small Molecules | SLC15A4 inhibitors (WO2021174023A1)[4] | Novel anti-inflammatory mechanisms. |
| Biologics | Modified mRNA for protein production (US20200354423A1)[8] | Potential for next-gen biologic therapies. |
| Traditional Medicine | 172 Chinese patents on herbal anti-RA therapies[15] | Combines natural extracts with modern formulations. |
Geographic Trends
- China: Leading in Traditional Chinese Medicine (TCM) patents (54% of anti-RA filings)[15].
- U.S. and EU: Focus on biologics (e.g., TNF-α inhibitors) and targeted therapies (JAK inhibitors)[15].
Competitive and Regulatory Pressures
- Biologic Dominance: TNF-α inhibitors (e.g., Humira) face biosimilar competition post-patent expiry, but lifecycle management extends exclusivity[11].
- Antitrust Scrutiny: FTC and DOJ advocate limiting “patent thickets,” challenging firms that layer patents to block competitors[2].
- Cost Containment: Policies like China’s volume-based procurement force price cuts, narrowing margins for generics[6].
Future Outlook
- Personalized Therapies: Growth in biologics (17.4% of recent patents)[15] and JAK inhibitors targeting specific pathways.
- AI-Driven R&D: Patent landscaping tools streamline analysis of competitor activity and white-space opportunities[9].
- Global Expansion: Rising demand in emerging markets for cost-effective DMARDs and NSAIDs[3].
Highlight: “Patents are critical to innovation, but ambiguous eligibility standards risk diverting R&D investment to jurisdictions with clearer rules.” – Alden Abbott, Mercatus Center[2].
Key Takeaways
- The M01 market is growing steadily, driven by aging demographics and biologic adoption.
- Patent strategies balance innovation with regulatory pushback on evergreening.
- Emerging economies and personalized medicine are pivotal to future growth.
For stakeholders, navigating this landscape requires agile R&D, proactive IP management, and adaptability to pricing reforms.
References
- https://go.drugbank.com/drugs/DB00586
- https://ipprotectionmatters.org/episodes/5f62ebb4-f481-435e-ad0f-d3a84e8914c1:the-2024-patent-landscape-and-a-roadmap-for-future-innovation-and-prosperity
- https://www.imarcgroup.com/anti-rheumatics-market
- https://patents.google.com/patent/WO2021174023A1/en
- https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database/search-tips.html
- https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.944540/full
- https://www.marketsandmarkets.com/Market-Reports/air-traffic-control-equipment-market-159216929.html
- https://patents.google.com/patent/US20200354423A1/en
- https://www.ipcheckups.com/patent-landscape-analysis-how-to-5-steps/
- https://simplywall.st/stocks/sg/retail/sgx-m01/metro-holdings-shares/valuation
- https://dash.harvard.edu/server/api/core/bitstreams/0b2cd634-f60c-422f-8861-74725c0c940b/content
- https://atcddd.fhi.no/atc_ddd_index/?code=M01A
- https://www.iqvia.com/-/media/iqvia/pdfs/belgium/sales-trends/2019/belgian-regmedbest-performers-for-april-2019.pdf?la=en&hash=3EE2841A13277B5367525739F10659C5
- https://www.tradingview.com/symbols/SGX-M01/
- https://pubmed.ncbi.nlm.nih.gov/26066366/
- https://en.wikipedia.org/wiki/ATC_code_M01
- https://atcddd.fhi.no/filearchive/publications/2024_guidelines__final_web.pdf
More… ↓
