Share This Page
Drugs in ATC Class L01EH
✉ Email this page to a colleague
Drugs in ATC Class: L01EH - Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors
| Tradename | Generic Name |
|---|---|
| LAPATINIB DITOSYLATE | lapatinib ditosylate |
| NERLYNX | neratinib maleate |
| TUKYSA | tucatinib |
| TYKERB | lapatinib ditosylate |
| >Tradename | >Generic Name |
Showing 1 to 4 of 4 entries
L01EH Market Analysis and Financial Projection
The market dynamics and patent landscape for HER2 tyrosine kinase inhibitors (TKIs), classified under ATC code L01EH, reflect rapid innovation and significant growth driven by clinical advancements and strategic patenting. Here's an in-depth analysis:
Market Dynamics
Growth Drivers
- Rising Cancer Prevalence: Breast cancer remains a key focus, with Australia projecting 20,640 new cancer cases (12.7% being breast cancer) in 2022[3][14], while India anticipates 250,000 breast cancer cases by 2030[3][14]. HER2 inhibitors are critical for blocking oncogenic signaling pathways.
- Pipeline Innovation: Novel agents like DZD1516 (a BBB-penetrant HER2 TKI) and tucatinib (approved for HER2+ metastatic breast cancer) are expanding treatment options[3][6]. ENHERTU, though an antibody-drug conjugate (ADC), achieved $2.57B in global sales in 2023, doubling from 2022[1].
- Market Expansion: The HER2 inhibitors market is projected to grow at a CAGR of 9% (2021–2028)[9], fueled by tumor-agnostic approvals (e.g., ENHERTU for HER2+ solid tumors in 2024)[1] and combination therapies.
Key Players
- AstraZeneca/Daiichi Sankyo: Dominated 2023 sales with ENHERTU ($1.28B revenue for AstraZeneca), though U.S. sales forecasts were revised downward to $1.58B[1].
- Seagen: Markets tucatinib, part of a combination therapy for HER2+ metastatic colorectal cancer[6][13][19].
- Jiangsu HengRui: Developing pyrotinib, an irreversible HER2 TKI with 136 clinical trials and 90 international patents[18].
Challenges
- High Costs: Treatment expenses and patent extensions delay generics. For example, kinase inhibitors average 14–15 years of market exclusivity[17].
- Biosimilar Competition: Herceptin’s patent expiry threatens its $7B+ market, pushing innovation toward next-gen TKIs and ADCs[12].
Patent Landscape
Innovation Trends
- Dominant Players: Roche leads HER2 biologics with 22% of patent filings (1,092 applications)[2][10][20]. Emerging technologies include bispecific antibodies (e.g., targeting HER2/HER3)[4] and ADCs.
- Sequence Analysis: A 2023 study analyzed HER2 monoclonal antibody (mAb) patents, revealing:
- 64% target novel mAbs with unique binding domains.
- 36% optimize existing therapies (e.g., trastuzumab)[2][10][20].
- Geographic Hotspots: China and the U.S. are hubs for newcomers, with Jiangsu HengRui’s pyrotinib trials spanning Phase I–III[18].
Key Patents
| Drug | Patent Focus | Company | Expiry Insights |
|---|---|---|---|
| Tucatinib | Combination therapy with anti-HER2 mAbs | Seagen | Protected until 2039[5][13] |
| Neratinib | Extended adjuvant use | Puma Biotechnology | EP oppositions ongoing[15] |
| Pyrotinib | Irreversible HER2/EGFR inhibition | Jiangsu HengRui | 90 international patents[18] |
Cost-Effectiveness and Access
- Neratinib vs. Lapatinib: Neratinib + capecitabine is cost-effective ($-13,294.86/QALY ICER) compared to lapatinib, offering 0.17 additional QALYs[16].
- Biosimilars: Trastuzumab biosimilars could reduce costs but face delayed entry due to litigation and exclusivity strategies[12][17].
Future Outlook
- Novel Biologics: Multispecific antibodies, cell therapies, and ADC combinations are trending[2][15][20].
- Global Expansion: Emerging markets (Asia-Pacific, Middle East) are growth frontiers, driven by rising healthcare investment[9].
- Regulatory Milestones: Tumor-agnostic approvals and CNS-targeted TKIs (e.g., DZD1516) will reshape treatment paradigms[3][18].
"ENHERTU’s recent FDA approval marks a pivotal shift toward precision oncology, offering hope for HER2+ cancers with limited options." [1]
This evolving landscape underscores the interplay of innovation, strategic patenting, and accessibility challenges, positioning HER2 TKIs as transformative agents in oncology.
References
- https://www.delveinsight.com/blog/enhertu-for-her2-positive-solid-tumors
- https://sklqrcm.um.edu.mo/202308301n/
- https://www.mordorintelligence.com/industry-reports/tyrosine-kinase-inhibitors-market
- https://patents.google.com/patent/US10519247B2/en
- https://pubchem.ncbi.nlm.nih.gov/patent/US11666572
- https://atcddd.fhi.no/atc_ddd_index/?code=L01EH&showdescription=no
- https://www.biochempeg.com/article/302.html
- https://atcddd.fhi.no/atc_ddd_index/?code=L01EH01
- https://www.databridgemarketresearch.com/reports/global-her2-inhibitors-market
- https://sklqrcm.um.edu.mo/202308301n/
- https://www.oaepublish.com/articles/cdr.2019.92
- https://www.globaldata.com/store/report/pharmapoint-her2-positive-breast-cancer-global-drug-forecast-and-market-analysis-to-2025/
- https://atcddd.fhi.no/atc_ddd_index/?code=L01EH&showdescription=no
- https://www.mordorintelligence.com/industry-reports/tyrosine-kinase-inhibitors-market
- https://www.businesswire.com/news/molecularlab/20250224366580/en
- https://www.frontiersin.org/journals/oncology/articles/10.3389/fonc.2023.1221969/full
- https://gabi-journal.net/overview-of-the-patent-expiry-of-non-tyrosine-kinase-inhibitors-approved-for-clinical-use-in-the-eu-and-usa.html
- https://www.drugpatentwatch.com/p/drugs-in-development/drugname/pyrotinib
- https://atcddd.fhi.no/atc_ddd_index/?code=L01EH&showdescription=no
- https://sklqrcm.um.edu.mo/202308301n/
- https://www.drugs.com/availability/generic-tukysa.html
- https://pmc.ncbi.nlm.nih.gov/articles/PMC10236985/
- https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2022.1089066/full
- https://atcddd.fhi.no/atc_ddd_index/?code=L01EH&showdescription=yes
- https://www.mordorintelligence.com/industry-reports/tyrosine-kinase-inhibitors-market
- https://www.promarketreports.com/reports/tucatinib-54560
- https://pubchem.ncbi.nlm.nih.gov/patent/US11666572
- https://sklqrcm.um.edu.mo/202308301n/
- https://www.biospace.com/press-releases/metastatic-her2-positive-breast-cancer-market-to-reach-usd-3-108-1-million-by-2035-impelled-by-significant-progress-in-monoclonal-antibodies-antibody-drug-conjugates-adcs-and-tyrosine-kinase-inhibitors-tkis
- https://www.cognitivemarketresearch.com/lapatinib-market-report
- https://www.drugpatentwatch.com/p/patent/12048698
- https://atcddd.fhi.no/atc_ddd_index/?code=L01EH&showdescription=no
More… ↓
