Last updated: February 20, 2026
What is the drug identified by NDC 31722-0805?
NDC 31722-0805 corresponds to Acalabrutinib (Calquence), a Bruton’s tyrosine kinase (BTK) inhibitor approved by the FDA for the treatment of certain hematologic malignancies, specifically chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and mantle cell lymphoma (MCL).
Market Size and Demand Drivers
Current Market Composition
| Segment |
Market Data |
Notes |
| Total Addressable Market (TAM) |
Estimated $4.6 billion globally in 2022 |
Based on epidemiology and current treatment patterns |
| Key Patient populations |
20,000+ patients in the US (per FDA data) |
CLL accounts for approximately 15,000 cases in US annually |
| Market growth rate |
Compound annual growth rate (CAGR) of 8% (2022-2027) |
Driven by increasing diagnosis rates, expanding indications, and longer patient survival |
Competitive Landscape
| Competitors |
Market Share (2022) |
Key Attributes |
| Ibrutinib (Imbruvica) |
65% |
First-in-class BTK inhibitor, broader indications |
| Acalabrutinib (Calquence) |
20% |
More selective BTK inhibitor, fewer off-target effects |
| Other BTK inhibitors or alternatives |
15% |
Includes zanubrutinib (Bruknvq) |
Market Dynamics
- Physician Adoption: Growing preference for second-generation BTK inhibitors due to better safety profile.
- Regulatory Expansions: FDA approvals for new indications are expanding potential market size.
- Pipeline Competition: Multiple drugs under development (e.g., pirtobrutinib) might impact future market shares.
Price Analysis
Current Pricing and Revenue
| Pricing Element |
Details |
| Wholesale acquisition cost (WAC) per patient |
Approximately $7,000–$9,000 per month (per 2022 data) |
| Annual treatment cost |
$84,000–$108,000 |
| Average annual revenue per patient |
Approx. $90,000, with variability depending on treatment duration and payer mix |
Price Trends
- Initial Launch Price (2019): Around $8,200/month, consistent with the launch.
- Price Adjustments: No significant discounts or price cuts reported in 2022; likely to remain stable without major policy shifts.
Market Penetration and Revenue Projections
| Year |
Estimated Patients (US) |
Potential Revenue (USD billions) |
Assumptions |
| 2023 |
4,000 |
0.36 |
20% market share of target patient base |
| 2024 |
4,800 |
0.432 |
20% growth driven by new indications and expanded use |
| 2025 |
6,000 |
0.54 |
Market penetration reaches 30%, new approvals boost adoption |
Influence of Biosimilars and Generics
Currently, no biosimilars or generics are available for acalabrutinib, providing a temporary market exclusivity window. After patent expiration (expected around 2030), prices are likely to decline, potentially by 30-50%.
Regulatory and Policy Impact
- FDA has approved acalabrutinib for CLL/SLL (2019) and MCL (2020).
- Breakthrough Therapy designation and accelerated approvals have facilitated rapid market entry.
- Medicare and private payers are favoring oral Oncologic therapies with high pricing, sustaining revenue.
Key Market Opportunities and Risks
Opportunities
- Expansion into additional indications, including Waldenström’s macroglobulinemia.
- Development of combination regimens with other targeted therapies.
- Growth in emerging markets with increasing access to cancer treatments.
Risks
- Potential price competition from other BTK inhibitors.
- Patent challenges and biosimilar entry post-2030.
- Regulatory delays or adverse safety signals.
Price Projection Summary
| Year |
Estimated Market Revenue (USD billions) |
Price per Patient (per month USD) |
Notes |
| 2023 |
0.36 |
$7,000–$9,000 |
Stable prices; market expansion measurable |
| 2024 |
0.432 |
$7,000–$9,200 |
Slight price increase linked to inflation |
| 2025 |
0.54 |
$7,000–$9,200 |
Market saturation, price stabilization |
Key Takeaways
- The acalabrutinib market is driven by its specific indication use, with revenues impacted by patient penetration and reimbursement policies.
- Prices remain stable in the short term, with potential declines post-patent expiry.
- Market growth depends heavily on expanding indications, competition, and biosimilar entry.
- Upcoming pipeline options and regulatory decisions could influence long-term pricing and market share.
FAQs
Q1: What is the competitive advantage of acalabrutinib over first-generation BTK inhibitors?
A1: It has higher selectivity for BTK and fewer off-target effects, resulting in a better safety profile.
Q2: How long is the patent protection for acalabrutinib?
A2: Patent expiry is projected around 2030, with some patents possibly extending protections to 2032.
Q3: Are biosimilars expected to impact prices soon?
A3: Biosimilars are unlikely before 2030; patent expiration and market entry will be key inflection points.
Q4: What is the US market share estimate for acalabrutinib?
A4: Approximately 20–25% of the BTK inhibitor market, with room for growth.
Q5: How could new indications affect price and market size?
A1: Approved additional indications could expand the market, increasing revenue and justified pricing strategies.
References
- [1] EvaluatePharma. (2022). Oncology market report.
- [2] FDA. (2019). Approval of acalabrutinib for CLL.
- [3] IQVIA. (2022). Market dynamics report.
- [4] Maiti, S., et al. (2022). BTK inhibitors comparative review. Journal of Hematology.
- [5] U.S. Patent and Trademark Office. (2022). Patent expiry dates for acalabrutinib.
