Last updated: February 15, 2026
Overview of the Product
NDC 23155-0746 refers to a multiple sclerosis (MS) treatment, specifically tisagenlecleucel (Kymriah). It is a CAR-T cell therapy developed by Novartis, approved by the FDA in 2017 for certain blood cancers, primarily pediatric and young adult acute lymphoblastic leukemia (ALL). It is not approved for MS, suggesting possible misclassification or composite data referencing a product in similar therapeutic areas.
Clarification of Product Indication
Given the NDC code, it is more likely associated with a biologic, possibly for hematologic malignancies rather than MS. The NDC does not correspond to a common MS treatment, such as interferons, glatiramer acetate, or newer oral agents.
Market Context
If the product is a licensed biologic or gene therapy:
- Indication: Hematologic malignancies, with a primary use in acute lymphoblastic leukemia.
- Sales Dynamics: The global CAR-T therapy market reached approximately $2.7 billion in 2022, projected to grow at a CAGR of over 20% through 2027, driven by expanded indications and ongoing clinical trials.
- Competitive Landscape: Includes Kymriah (Novartis), Yescarta (Gilead), and Tecartus (Gilead). These therapies are high-cost, with list prices exceeding $400,000 per treatment, factoring in manufacturing complexity.
If the product is misclassified and is a different biologic:
- Market size: Determined by the approved therapeutic area, age group, and unmet needs.
- Pricing benchmarks: Ranged between $20,000 to $100,000 annually for chronic biologics in autoimmune indications.
Pricing Factors
- Manufacturing Complexity: CAR-T products are complex and personalized, underlying high costs.
- Regulatory Status: FDA approvals influence price stability and reimbursement.
- Market Penetration: Reimbursement policies in the U.S. and Europe restrict or enable access.
- Indication Expansion: Additional approvals tend to increase market size and revenue potential.
Price Projections
Assuming the product is a CAR-T therapy:
| Year |
Estimated Price per Treatment |
Rationale |
| 2023 |
$425,000 |
Current list price for Kymriah and Yescarta |
| 2025 |
$400,000 - $450,000 |
Slight adjustment based on reimbursement pressures |
| 2030 |
$375,000 - $425,000 |
Price compression or value-based pricing models |
If the product serves autoimmune or chronic indications:
| Year |
Estimated Annual Cost |
Rationale |
| 2023 |
$30,000 - $50,000 |
Typical for biologics in autoimmune conditions |
| 2025 |
$25,000 - $45,000 |
Market pressures and biosimilar entry sway prices |
Market Share and Revenue Projections
If the therapy gains broad approval and payer coverage:
- 2025: US sales estimated to reach $1.2 billion.
- 2030: Potential to exceed $3 billion, driven by expansion in indications and geographic markets.
Risks and Uncertainties
- Regulatory changes affecting reimbursement.
- Advancements in competing therapies or biosimilars.
- Manufacturing capacity and supply chain constraints.
- Clinical trial results indicating efficacy or safety issues.
Key Takeaways
- The NDC code likely corresponds to a high-cost biologic or cell therapy with substantial market value.
- Prices for CAR-T therapies currently hover around $425,000 per treatment.
- Market size expands with broader indications and geographic rollout, potentially generating multi-billion dollar revenues.
- Price projections show slight downward pressure over time due to reimbursement and market competition.
- Accurate forecasts depend on approval status, market access, and pricing strategies.
Frequently Asked Questions
-
Is NDC 23155-0746 a CAR-T therapy or a different biologic?
It is most consistent with a CAR-T therapy like Kymriah, primarily indicated for hematologic cancers.
-
What factors influence the pricing of biologics like this?
Manufacturing complexity, regulatory environment, competition, and reimbursement policies.
-
How does the market for this therapy compare globally?
The U.S. accounts for over 50% of sales; Europe and Asia markets are growing but face pricing and approval challenges.
-
What are the main risks for investment in therapies like this?
Regulatory hurdles, yield from indications, reimbursement pressures, and manufacturing bottlenecks.
-
What future developments might impact market size?
New indications, combination therapies, biosimilar entry, and technological advancements in cell therapy.
Citations
[1] Market Data Forecast, 2022. "Global CAR-T Cell Therapy Market."
[2] Novartis, 2017. FDA Approval of Kymriah.
[3] EvaluatePharma, 2023. "Biologics Pricing and Market Trends."
[4] IQVIA, 2022. "Biopharmaceutical Market Access and Reimbursement Data."
[5] Allied Market Research, 2023. "Gene Therapy Market Forecast."
