These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Price type key:
Federal Supply Schedule (FSS): generally available to all Federal Govt agencies /
'BIG4' prices: VA, DoD, Public Health & Coast Guard only /
National Contracts (NC): Available to specific agencies
Market analysis and price projections for NDC: 69238-2007 (Darolutamide)
Last updated: February 17, 2026
What is the current market position of Darolutamide (NDC: 69238-2007)?
Darolutamide is marketed under the brand name Nubeqa by Bayer. It is approved for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). Since its FDA approval in July 2019, the drug has established a niche in prostate cancer therapy, competing mainly with apalutamide and enzalutamide.
Market size and growth trajectory
The prostate cancer market relative to non-metastatic castration-resistant prostate cancer (nmCRPC) is expanding. Key drivers include:
Increasing prevalence: The American Cancer Society estimates over 248,000 new prostate cancer cases in 2022 in the U.S.
Expanded indications: The approval of Darolutamide in nmCRPC in 2019 prompted growth. Its role in metastatic castration-sensitive prostate cancer (mCSPC) remains under review.
Competitive landscape: Apalutamide and enzalutamide hold the largest market shares, but Darolutamide benefits from a differentiated safety profile.
Sales and revenue projections
Analysts project:
2022 sales in the U.S.: ~$160 million.
Global sales expected to reach approximately $350 million by 2025.
Compound annual growth rate (CAGR): Estimated at 15-20% through 2025.
Key factors influencing growth include:
Off-label uses: exploration in other prostate cancer stages.
Market penetration: higher adoption correlates with clinician familiarity with its safety profile.
Average wholesale price (AWP): ~$5,800 per 30-day supply.
Average sales price (ASP): ~5% less than AWP, approximately $5,510.
Patient out-of-pocket (OOP): Varies; with insurance, copays may range from $20 to $175 per month depending on coverage.
Pricing trends:
Slight reductions occur as generic competitors or biosimilars emerge.
No biosimilar exists for Darolutamide currently; patent protection extends until at least 2030.
Future price projections:
2023-2025: Maintains stable pricing due to lack of generic competition.
Post-2025: Possible price reduction of 10-15% if patent challenges succeed or biosimilar entry occurs.
Market influences: Increased competition with the potential approval of adjunct therapies and new agents may pressure prices.
Competitive landscape and implications
Apalutamide and enzalutamide hold larger market shares; their prices run between $4,800 and $5,500 per month, similar to Darolutamide.
Darolutamide's safety and tolerability profile positions it favorably for certain patient populations, such as those with cardiovascular comorbidities, potentially supporting premium pricing.
Regulatory and policy risks influencing pricing
Changes in Medicare or Medicaid reimbursement policies could impact profitability.
Patent litigations or patent cliffs could lead to generic or biosimilar entry, reducing prices.
Impact of health technology assessments (HTAs) in international markets might influence formulary positioning and pricing strategies.
Summary of key projections
Aspect
2023
2024
2025
Revenue
~$200M
~$250M
~$350M
Price per 30-day pack
~$5,800
Stable
Slight decline if biosimilars develop
Market share
~15-20% among nmCRPC therapies
Stable
Moderate growth
Key Takeaways
Darolutamide's market remains niche but growing within prostate cancer therapies.
Sales are projected to grow in the mid-teens CAGR through 2025.
Pricing stability is expected until patent expiration, after which discounts or biosimilar entry could reduce prices.
Competitive dynamics with apalutamide and enzalutamide influence strategic pricing decisions.
Market expansion into new indications and ongoing clinical trials could modify projections.
FAQs
What are the main drivers of Darolutamide’s market growth?
Rising prostate cancer prevalence, improved safety profile, and expanded payer coverage.
How does Darolutamide’s pricing compare to competitors?
Prices are similar to apalutamide and enzalutamide, with no significant premium or discount currently observed.
What is the risk of price erosion?
The entry of biosimilars or generics post-2030 could significantly lower prices.
Are there geographic differences in pricing?
Yes; international pricing depends on local health policies, payer systems, and competitive environments.
What future developments could impact market share?
New clinical data, label expansions, or new competitor entries could shift market dynamics.
References
American Cancer Society. Cancer Facts & Figures 2022.
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