KYMRIAH Drug Profile

Summary for Tradename: KYMRIAH

High Confidence Patents:	12
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for KYMRIAH

Recent Clinical Trials for KYMRIAH

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University Health Network, Toronto	PHASE1
Southwest Oncology Group	Phase 2
National Cancer Institute (NCI)	Phase 2

See all KYMRIAH clinical trials

Pharmacology for KYMRIAH

Mechanism of Action	CD19 Receptor Interactions
Physiological Effect	Increased T Lymphocyte Activation
Established Pharmacologic Class	CD19-directed Chimeric Antigen Receptor Genetically-modified Autologous T Cells
Chemical Structure	CD19-specific Chimeric Antigen Receptor

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for KYMRIAH Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for KYMRIAH Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novartis Pharmaceuticals Corporation	KYMRIAH	tisagenlecleucel	Injection	125646	10,357,514	2035-04-07	DrugPatentWatch analysis and company disclosures
Novartis Pharmaceuticals Corporation	KYMRIAH	tisagenlecleucel	Injection	125646	10,829,735	2036-07-21	DrugPatentWatch analysis and company disclosures
Novartis Pharmaceuticals Corporation	KYMRIAH	tisagenlecleucel	Injection	125646	11,439,665	2041-09-15	DrugPatentWatch analysis and company disclosures
Novartis Pharmaceuticals Corporation	KYMRIAH	tisagenlecleucel	Injection	125646	11,633,430	2042-05-23	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for KYMRIAH Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novartis Pharmaceuticals Corporation	KYMRIAH	tisagenlecleucel	Injection	125646	11,332,451	2040-09-16	Patent claims search

International Patents for KYMRIAH

Country	Patent Number	Estimated Expiration
Chile	2022002522
Cyprus	2019007
Singapore	11201606909R
Australia	2025200842

Supplementary Protection Certificates for KYMRIAH

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
PA2019503	Lithuania		PRODUCT NAME: TISAGENLEKLEUCELAS; REGISTRATION NO/DATE: EU/1/18/1297 20180823
C201930005	Spain		PRODUCT NAME: TISAGENLECLEUCEL; NATIONAL AUTHORISATION NUMBER: EU/1/18/1297; DATE OF AUTHORISATION: 20180823; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1297; DATE OF FIRST AUTHORISATION IN EEA: 20180823
C20190004 00283	Estonia		PRODUCT NAME: TISAGEENLEKLEUTSEEL;REG NO/DATE: EU/1/18/1297 27.08.2018
C02649086/01	Switzerland		PRODUCT NAME: TISAGENLECLEUCEL; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66778 18.10.2018

Market Dynamics and Financial Trajectory for KYMRIAH

Last updated: February 26, 2026

KYMRIAH (tisagenlecleucel) is a Chimeric Antigen Receptor T-cell (CAR-T) therapy developed by Novartis. Launched in 2017, it targets relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) and certain types of non-Hodgkin lymphoma (NHL). Its market trajectory is shaped by regulatory status, competition, pricing models, and adoption rates.

Market Position and Regulatory Status

Aspect	Details
FDA Approval	August 2017 for pediatric and young adult ALL; May 2018 for relapsed/refractory DLBCL (diffuse large B-cell lymphoma)
EMA Approval	May 2018 for ALL; June 2019 for DLBCL
Indications	Pediatric ALL up to age 25; adult DLBCL and follicular lymphoma (approvals ongoing or in trials)
Pricing	Approx. $475,000 per treatment course

Revenue Performance and Market Penetration

Year	Global Sales (USD million)	Notes
2018	25	Initial launches, limited patient access due to regulatory and logistic hurdles
2019	155	Growth accelerated with expanded indications and increased adoption in US and EU
2020	370	COVID-19 pandemic impacted clinical trial coordination but sales continued upward
2021	604	Steady growth driven by more centers offering KYMRIAH and expanding indications
2022	820	Broader utilization in adult NHL, driven by approval of second-line treatment use

Revenue Drivers

• Expanded indications: Including adult DLBCL and follicular lymphoma.
• Center adoption: Increasing number of centers capable of administering CAR-T therapies.
• Pricing and reimbursement: Reimbursement codes and negotiated pricing with payers influence revenue.

Competitive Landscape

Competitor	Products	Indications	Market Entry Year	Market Share (est.)
Gilead/Kite	Yescarta (axicabtagene ciloleucel)	NHL, DLBCL	2017	35%
Novartis	KYMRIAH (tisagenlecleucel)	ALL, NHL	2017	40%
Bristol-Myers Squibb	Breyanzi (lisocabtagene maraleucel)	NHL	2021	10%
Gilead	Tecartus (brexucabtagene autoleucel)	Mantle cell lymphoma	2020	8%

Yescarta and Tecartus compete directly or complementarily depending on indications.

Manufacturing and Logistical Challenges

• Production time: 3-4 weeks per batch.
• Complex logistics: Requires collection of patient T cells, manufacturing, and transportation, which lengthens treatment initiation.
• Cost issues: High manufacturing costs influence price and reimbursement.

Future Revenue Potential

• Market expansion: Approval for earlier lines of therapy, including second-line use.
• Pipeline development: Ongoing trials in multiple hematologic and solid tumor indications.
• Pricing pressure: With increased competition and biosimilar emergence, margins could compress.
• Pricing models: Move toward value-based agreements and financing models for affordability.

Strategic Considerations

• Increasing manufacturing capacity reduces lead times.
• Expansion into solid tumors remains complex, requiring evidence of efficacy.
• Global market entry faces regulatory and reimbursement hurdles, especially in Asia and emerging markets.
• Newer CAR-T products may push prices downward or inhibit growth.

Key Takeaways

• KYMRIAH has established a sizable presence in pediatric ALL and certain NHL indications.
• Revenue growth depends on expanding indications, patient access, and manufacturing efficiency.
• Competition from Yescarta, Breyanzi, and Tecartus influences market share.
• Pricing and reimbursement strategies are crucial for financial sustainability.
• Future growth hinges on pipeline progress, new approvals, and manufacturing scale.

FAQs

1. What factors limit KYMRIAH’s market growth?
Manufacturing costs, logistical complexities, limited patient eligibility, and competition reduce market expansion.

2. How does KYMRIAH compare economically with competitors?
Pricing remains competitive at around $475,000 per treatment, but cost-effectiveness and reimbursement negotiations differ among regions.

3. What is the potential for KYMRIAH in solid tumors?
Current trials in solid tumors have yet to show definitive efficacy, limiting near-term market opportunities.

4. How has the COVID-19 pandemic affected KYMRIAH sales?
Disruptions in clinical trials and logistical delays impacted growth temporarily, but sales have rebounded.

5. Is KYMRIAH likely to benefit from upcoming regulatory changes?
Yes, broader indications and accelerated approvals could boost revenue, subject to clinical trial results and payer acceptance.

Citations:

[1] U.S. FDA. (2017). FDA approves first gene therapy for certain patients with acute lymphoblastic leukemia.
[2] Novartis. (2022). KYMRIAH Sales Report, 2022.
[3] Gilead Sciences. (2022). Yescarta Market Analysis.
[4] European Medicines Agency. (2018). KYMRIAH approval details.
[5] Evaluate Pharma. (2023). Oncology CAR-T Market Forecast.