Last updated: February 12, 2026
Overview
NDC 00093-0948 is identified as Tranexamic Acid (marketed under various brand names such as Lysteda for oral formulation and Cyklokapron for IV). The drug primarily treats bleeding disorders, including heavy menstrual bleeding, trauma-induced bleeding, and surgical hemorrhage.
Market Size and Trends
The global tranexamic acid market was valued at approximately $400 million in 2022 and is expected to grow at a Compound Annual Growth Rate (CAGR) of around 6% through 2030 [1].
Key Drivers:
- Increasing prevalence of bleeding disorders.
- Rising surgeries and trauma cases requiring hemostatic agents.
- Expanding use in developing markets.
Major Players and Market Share
Pfizer dominates as the primary supplier in the U.S., with significant market control via Lysteda and Cyklokapron. Other competitors include Teva Pharmaceutical Industries and Fresenius Kabi. Pfizer’s market share in 2022 was estimated at 60%-70% in the U.S.
Price Analysis
Wholesale acquisition costs (WAC) for tranexamic acid vary based on formulation and dosage.
| Formulation |
Typical WAC per unit |
Dosage |
Notes |
| Oral (Lysteda) 650 mg tablets |
$100 – $150 per pack (30 tablets) |
1300 mg three times daily |
Approximate retail price: $600 – $900/month |
| IV (Cyklokapron) 1 g/10 mL |
$15 – $25 per vial |
1 g every 6-8 hours |
Hospital inpatient pricing varies — often higher than outpatient prices |
U.S. Price Trends
- Oral tablet prices have remained relatively stable since 2018, with minor increases due to raw material costs and generic competition.
- IV formulations are more variable, influenced by hospital procurement strategies and supply chain factors.
Regulatory Status
The drug has FDA approval for heavy menstrual bleeding (Lysteda) and IV use for bleeding episodes or prophylaxis. No sudden patent expiries are expected until after 2030, allowing Pfizer and competitors to maintain pricing power.
| Forecasted Price Trajectory (Next 5 Years) |
Year |
Oral (per pack) |
IV (per vial) |
Comments |
| 2023 |
$150 |
$20 |
Stable prices, generic entries moderately impact premiums |
| 2025 |
$155 |
$22 |
Incremental cost increases, potential for added value with formulations |
| 2027 |
$160 |
$24 |
Market saturation stabilizes, new formulations may influence pricing |
| 2030 |
$165 |
$26 |
Marginal increase expected, driven by raw material costs |
Potential Influencing Factors
- New formulations or delivery mechanisms may alter pricing dynamics.
- Off-label use expansion could increase demand, affecting prices.
- Patent expirations or biosimilar developments could lower prices post-2030.
Key Takeaways
- The tranexamic acid market is expected to grow steadily, driven by increasing clinical applications.
- Pfizer leads with a dominant market share; pricing for both oral and IV forms has remained relatively stable.
- Price projections suggest small annual increases, influenced mainly by raw material costs and competitive pressures.
- Market evolution may be impacted by drug formulation innovations or regulatory changes.
FAQs
-
What factors influence the pricing of tranexamic acid?
Manufacturing costs, raw material prices, market competition, and regulatory factors.
-
How does generic competition impact pricing?
Introduction of generics tends to lower prices; however, Pfizer retains market dominance through brand recognition and formulary preferences in hospitals.
-
What are the primary markets for tranexamic acid?
The U.S., Europe, and emerging markets in Asia and Latin America.
-
When are patent expirations expected for key formulations?
No significant patent expiries are anticipated before 2030 for the main formulations.
-
Could new delivery methods affect the market?
Yes, innovations like sustained-release formulations or oral gels could expand usage, potentially altering price dynamics.
Sources
[1] Market Research Future. "Tranexamic Acid Market Analysis," 2023.
