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Drugs in ATC Class L01EM
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Drugs in ATC Class: L01EM - Phosphatidylinositol-3-kinase (Pi3K) inhibitors
| Tradename | Generic Name |
|---|---|
| ALIQOPA | copanlisib dihydrochloride |
| VIJOICE | alpelisib |
| ZYDELIG | idelalisib |
| >Tradename | >Generic Name |
Showing 1 to 3 of 3 entries
L01EM Market Analysis and Financial Projection
The market for Phosphatidylinositol-3-kinase (PI3K) inhibitors (ATC Class L01EM) is experiencing significant growth and innovation, driven by advancements in cancer therapeutics and evolving intellectual property strategies. Here's a detailed analysis:
Market Dynamics
Growth Projections
- The global PI3K inhibitor market was valued at $126.37 million in 2023, projected to reach $214.4 million by 2032 at a 6% CAGR [5].
- Key drivers include rising cancer incidence, expanding applications in autoimmune diseases, and investment in oncology R&D [5][13].
Therapeutic Shifts
- From hematologic to solid tumors: While early PI3K inhibitors targeted blood cancers like chronic lymphocytic leukemia (e.g., idelalisib and duvelisib), newer agents like alpelisib (Novartis) are approved for HR+/HER2- breast cancer with PIK3CA mutations [3][14].
- Combination therapies: Trials exploring PI3K inhibitors with immune checkpoint inhibitors aim to overcome resistance and improve outcomes [13].
Regional and Sector Trends
- Norway’s consumption patterns: In 2019, L01EM drugs accounted for 7% of total protein kinase inhibitor use measured in DDDs/1000/day, with imatinib dominating most metrics except cost [1][11].
-
Market segmentation: Segment Key Subcategories Drug Type Class I inhibitors, dual PI3K/mTOR inhibitors Application Breast cancer (44%), hematologic malignancies (32%) End Users Hospitals (55%), specialty clinics (30%) [5]
Patent Landscape
Strategic Innovations
- Formulation patents: Incyte secured patents for PI3Kγ inhibitors targeting cancers and autoimmune diseases, with claims covering combinations like JAK/PI3K dual inhibitors [4][10].
- Delivery systems: RenovoRx’s Trans-Arterial Micro-Perfusion (TAMP) platform expanded its IP portfolio to 18 patents, enhancing localized delivery [2].
Legal Challenges
- Invalidations: Courts rejected patents lacking technical specificity (e.g., Seagen’s antibody-drug conjugate patent) [2].
- Section 101 scrutiny: Patents combining natural components (e.g., AAV sequences) face rejection unless solving technical problems [2].
Upcoming Expirations
- Xarelto (rivaroxaban): Molecule patent expires in February 2025, with generics poised for entry [2].
- Post-expiry dynamics: Small-molecule drugs lose 47% pricing power to generics within five years, while biologics retain 80% [2].
Key Drugs and Developers
| Drug (Brand) | Developer | Indication | 2023 Market Share |
|---|---|---|---|
| Alpelisib (Piqray) | Novartis | PIK3CA-mutated breast cancer | 34% |
| Duvelisib (Copiktra) | Verastem | Relapsed CLL/SLL | 22% |
| Inavolisib | Roche | HR+/HER2- breast cancer (Phase III) | Pipeline leader |
Pipeline highlights: Over 40 clinical trials are testing PI3K inhibitors in solid tumors, with Roche’s inavolisib leading first-line breast cancer trials [3][13].
Regulatory and Competitive Pressures
- FDA/EMA approvals: Accelerated pathways for breakthrough therapies (e.g., alpelisib’s 2019 approval) [3][14].
- Safety concerns: Toxicity issues (e.g., infections, liver damage) prompted withdrawals of older inhibitors like ZYDELIG [13].
Future Outlook
- Biomarker-driven adoption: Focus on PIK3CA mutations and CDKN2A deletions for patient stratification [5].
- Dual-target inhibitors: Compounds like gedatolisib (PI3K/mTOR) aim to reduce resistance [6].
"The future of PI3K inhibitors lies in precision delivery and combinatorial approaches to mitigate toxicity while maximizing efficacy." — Industry Analyst [5].
Key Takeaways
- PI3K inhibitors are transitioning from hematologic to broader solid tumor applications.
- Patent strategies prioritize formulation innovation and localized delivery systems.
- Post-2025, generics will reshape small-molecule markets, while biologics retain dominance.
FAQs
Q: What is driving PI3K inhibitor market growth?
A: Rising cancer prevalence, targeted therapy demand, and pipeline expansion into solid tumors [3][5].
Q: How do patent expirations affect pricing?
A: Small-molecule drugs drop to 53% of originator prices within five years vs. biologics at 80% [2].
Q: Which regions lead adoption?
A: North America (45% market share), with Asia-Pacific growing fastest (9.2% CAGR) [5][13].
References
- https://www.ntnu.no/ojs/index.php/norepid/article/view/4041/3728
- https://www.drugpatentwatch.com/p/atc-class/L01
- https://www.prnewswire.com/news-releases/pi3k-inhibitors-market-to-observe-stunning-growth-during-the-study-period-20202034--delveinsight-302227420.html
- https://www.pharmaceutical-technology.com/data-insights/incyte-gets-grant-for-inhibitors-of-pi3k-for-treating-various-diseases/
- https://www.researchandmarkets.com/reports/6052548/phosphatidylinositol-3-kinase-inhibitor-market
- https://pubmed.ncbi.nlm.nih.gov/23488930/
- https://atcddd.fhi.no/atc_ddd_index/?code=L01EM&showdescription=yes
- https://atcddd.fhi.no/atc_ddd_index/?code=L01E&showdescription=yes
- https://patents.google.com/patent/WO2012107544A1/ja
- https://patents.justia.com/assignee/incyte-corporation
- https://www.ntnu.no/ojs/index.php/norepid/article/view/4041/3728
- https://patents.google.com/patent/CA2925601A1/en
- https://www.prnewswire.com/news-releases/pi3k-inhibitors-market-to-observe-stunning-growth-during-the-study-period-20202034--delveinsight-302227420.html
- https://go.drugbank.com/drugs/DB12015
- https://www.bioworld.com/articles/716579-new-pi3k-inhibitors-disclosed-in-forschungsverbund-berlin-patent
- https://www.fhi.no/contentassets/1b4b603c4ecf410588d584d5062cc9b8/legemiddelforbruket-i-norge-20172021.pdf
- https://www.thebusinessresearchcompany.com/report/leukocyte-adhesion-deficiency-management-global-market-report
- https://go.drugbank.com/drugs/DB11952
- https://www.prnewswire.com/news-releases/pi3k-inhibitors-market-to-observe-stunning-growth-during-the-study-period-20202034--delveinsight-302227420.html
- https://www.youtube.com/watch?v=Slv8GSXXhx8
- https://go.drugbank.com/drugs/DB12015
- https://atcddd.fhi.no/atc_ddd_index/?code=L01EM03
- https://pharmacy.moh.gov.my/sites/default/files/document-upload/msom-2018-2022-15102024_0.pdf
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