Last updated: February 14, 2026
What is the status and indicated use of NDC 78206-0123?
NDC 78206-0123 corresponds to Yescarta (axicabtagene ciloleucel), a CAR T-cell immunotherapy approved by the FDA for multiple relapsed or refractory B-cell non-Hodgkin lymphoma (NHL). It is indicated for adult patients with:
- Relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
- Primary mediastinal large B-cell lymphoma.
- Transformed follicular lymphoma.
Yescarta was approved in October 2017 and marketed by Gilead Sciences through its Kite Pharma division. It is a personalized cell therapy involving genetic modification of a patient's T cells.
What is the current market size and competitive landscape?
Market Size Estimate (2022-2023):
- The global CAR T-cell therapy market was valued at approximately $3.4 billion in 2022.
- The North American market represents roughly 80% of that value — around $2.7 billion in 2022.
- The target patient population for Yescarta consists of roughly 4,000-6,000 eligible patients annually in the US, considering the prevalence of relapsed/refractory large B-cell lymphoma.
Key Competitors:
- Kymriah (tisagenlecleucel) by Novartis: Approved for similar indications, including DLBCL in adults and pediatric ALL.
- Breyanzi (lisocabtagene maraleucel) by Bristol-Myers Squibb: Approved for relapsed/refractory large B-cell lymphoma.
- Other emerging therapies in development aim to expand efficacy and reduce manufacturing costs.
Market Dynamics:
- Demand is driven by increasing diagnosis rates for relapsed DLBCL.
- Growth constrained by high manufacturing costs, complex logistics, and safety concerns (e.g., cytokine release syndrome).
- New approvals broaden the patient base, potentially increasing sales.
What are recent sales and revenue trends?
Sales Data (2022-2023):
| Year |
Estimated US Sales |
Comments |
| 2022 |
~$775 million |
Steady growth as therapy gains acceptance |
| 2023 |
~$820 million |
Slight increase due to expanding indications and patient access |
Globally, sales are projected to approach $1 billion in the next 12 months, contingent on ongoing approval expansions.
Pricing Model:
- List price per treatment cycle: approximately $373,000 (per Gilead’s disclosures).
- Additional costs include hospital administration, pre-treatment assessments, and management of adverse events, increasing the total to roughly $400,000 to $500,000 per patient.
What are price projections for the next 3-5 years?
Factors Influencing Price Trends:
- Competitive pressures from Kymriah and Breyanzi.
- Manufacturing innovations reducing costs.
- Potential for biosimilar or generic competitors (not imminent given cell therapy complexity).
- Pricing and reimbursement policies, especially in Europe and Asia.
Projected Price Trajectory:
- Short-term (1-2 years): Stability at current price levels, with possible slight discounts in wider reimbursement markets.
- Mid-term (3-5 years): Possible price reductions of 10-15% driven by manufacturing efficiencies and increased competition.
- Long-term: As newer therapies enter the market, price discounts up to 25% may occur, but the therapeutic value and specialized manufacturing may sustain higher prices compared to small-molecule drugs.
What are key market risks and growth opportunities?
Market Risks:
- Manufacturing delays or failures affecting supply.
- Regulatory changes impacting pricing or reimbursement.
- Competition from novel therapies with improved safety profiles.
Growth Opportunities:
- Expansion of indications to include earlier lines of therapy.
- Development of allogeneic (off-the-shelf) CAR T products reducing costs.
- International market expansion, particularly in Europe, Asia, and Latin America.
- Combining CAR T therapies with other immuno-oncology agents to improve efficacy.
Summary and key insights
| Aspect |
Data/Estimate |
| Market Size (2023) |
~$2.7 billion in North America, with global sales nearing $3 billion |
| Annual Patient Volume |
4,000-6,000 patients in the US |
| Current List Price |
~$373,000 per treatment cycle |
| Short-term Price Trend |
Stable, with potential discounts <10% in 1-2 years |
| Mid-term Price Projection |
Slight reductions (10-15%) expected over 3-5 years due to cost efficiencies and competition |
| Growth Drivers |
Market expansion, indication broadening, manufacturing innovation |
| Risks |
Supply chain issues, regulatory shifts, competitive landscape changes |
Key Takeaways
- NDC 78206-0123 (Yescarta) remains a high-value cell therapy with substantial sales in North America.
- Market growth depends on expanding indications, manufacturing improvements, and international adoption.
- Pricing will likely decrease modestly over the next 3-5 years as competition and cost reductions impact market dynamics.
- Revenue projections for 2023 hover near $820 million globally, with potential to reach or exceed $1 billion in the coming years.
FAQs
Q1: How does the pricing of Yescarta compare to other CAR T therapies?
Yescarta's list price (~$373,000) is comparable to Kymriah (~$475,000), with Breyanzi generally lower (~$410,000), but pricing varies by region and reimbursement agreements.
Q2: Are there upcoming regulatory approvals that could influence the market?
Yes, expanding indications, such as earlier lines of therapy or different lymphoma subtypes, are under review and could shift market dynamics.
Q3: What factors could cause price reductions in the future?
Manufacturing efficiencies, biosimilar development, increased competition, and policy reforms could pressure prices downward.
Q4: What geographic markets most influence Yescarta sales?
North America accounts for approximately 80% of sales; Europe and Asia represent growth opportunities but face reimbursement and regulatory barriers.
Q5: How might emerging therapies impact the market?
Off-the-shelf (allogeneic) CAR T products and next-generation immunotherapies could compete with or supplement existing treatments, influencing pricing and market share.
Sources:
[1] Gilead Sciences, Yescarta FDA approval and pricing disclosures
[2] Global Market Insights, CAR T-cell therapy market report 2023
[3] IQVIA, healthcare market data 2022-2023
