Last updated: February 22, 2026
What is the Therapeutic Use of NDC 42291-0695?
NDC 42291-0695 corresponds to Capmatinib, marketed as Tabrecta. Capmatinib is an oral tyrosine kinase inhibitor targeting MET exon 14 skipping mutations and MET amplifications. It primarily treats adult patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations.
Market Size and Competitive Landscape
Therapy Adoption and Prevalence
- Target Population: NSCLC patients with MET exon 14 skipping mutations constitute around 3-4% of all NSCLC cases. Estimates suggest approximately 30,000 new cases annually in the U.S. with MET exon 14 alterations.
- Market Penetration: As of 2023, Capmatinib has gained FDA approval (May 2020) and is primarily used in second-line settings following platinum-based chemotherapy. Its adoption depends on diagnostic testing rates.
Competitors
| Drug |
Mechanism |
Indication |
Launch Date |
Market Share (2023) |
Price Range (USD) |
References |
| Capmatinib |
MET inhibitor |
MET exon 14 skipping mutation positive NSCLC |
2020 |
~60% |
10,000 – 12,000/month |
[1][2] |
| Tepotinib |
MET inhibitor |
MET exon 14 skipping positive NSCLC |
2020 |
~25% |
9,500 – 11,500/month |
[3] |
| Crizotinib |
ALK, ROS1, MET inhibitor |
NSCLC, MET alterations |
2011 |
10% |
8,000 – 10,000/month |
[4] |
Market Dynamics
- Growing importance of companion diagnostics increases initial testing but may slow overall penetration if testing access remains limited.
- Resistance to Capmatinib develops in some patients, limiting overall duration of therapy.
- Pricing strategies are similar across first-line MET inhibitors but are subject to payer negotiations and formulary inclusion.
Price Trends and Projections
Current Pricing (2023)
- Monthly wholesale acquisition cost (WAC): $10,000 to $12,000 per month.
- Typical treatment duration: 6-12 months, depending on response and resistance.
Pricing Drivers
- Licensing agreements restrict price reductions; cost considerations are largely driven by payers.
- The introduction of generics is unlikely due to patent protection extending into the late 2020s.
- Price inflation aligned with innovations in diagnostic testing and combination therapies.
Future Price Projection (2025-2030)
| Scenario |
Assumptions |
Price Estimate (USD/month) |
Rationale |
| Continued demand with limited generic entry |
Patent protection remains; no new competition |
$11,000 – $13,000 |
Stable pricing due to IP protection; inflation driven by healthcare inflation |
| Slight decrease due to market competition |
Entry of biosimilars or enhanced diagnostics |
$8,000 – $10,000 |
Price pressure from diagnostics, increased payer negotiation options |
| Increased price due to combination therapies |
Use with other targeted agents or immunotherapies |
$12,000 – $15,000 |
Rising treatment complexity, potential for combination patent strategies |
Market Entrance Implication
The expected incremental decrease in price is offset by demand growth driven by increased testing and broader indications. Price stability is likely until patent expiration, projected around 2027-2028.
Policy Impact and Pricing Regulations
- U.S.: Pricing mainly influenced by Medicare, Medicaid, and private payers, with continued pressure for value-based pricing.
- Global Markets: Lower prices in Europe, Canada, and emerging markets due to price-setting policies and healthcare budget constraints.
Key Takeaways
- NDC 42291-0695 (Capmatinib) has a limited but growing market primarily within NSCLC with MET exon 14 skipping mutations.
- Monthly treatment costs range from $10,000 to $12,000, with future prices likely to stabilize or slightly decline due to increased competition and diagnostics.
- The competitive landscape remains concentrated with early entrants, and patent protections defend current pricing until late 2020s.
- Adoption depends on the availability and reimbursement of companion diagnostics.
- Market dynamics signal steady revenue streams with potential for volume growth over the next five years.
FAQs
Q1: What factors influence the pricing of Capmatinib?
Pricing is driven by patent protections, manufacturing costs, payer negotiations, and demand for diagnostic testing.
Q2: How does the competitive landscape affect future prices?
Entry of biosimilars or alternative MET inhibitors, along with enhanced diagnostics, could lead to price reductions.
Q3: What is the market potential for Capmatinib outside the U.S.?
Limited by regulatory approval timelines and healthcare system differences but expected to expand as approvals increase.
Q4: Are combination therapies expected to impact pricing?
Yes, combining Capmatinib with other therapies could increase treatment costs, potentially raising average monthly prices.
Q5: When are patent protections set to expire?
Likely around 2027-2028, after which generic competition may influence prices.
References
[1] FDA. (2020). FDA approves first targeted therapy for lung cancer patients with specific genetic mutation.
[2] IQVIA. (2023). U.S. Oncology Market Data.
[3] EMA. (2022). European approval of Tepotinib for NSCLC with MET exon 14 skipping mutations.
[4] NCCN. (2023). Guidelines for Non-Small Cell Lung Cancer.
