Last updated: February 13, 2026
What Is the Market Position of NDC 71921-0216?
NDC 71921-0216 corresponds to Niraparib (brand name Zejula), a PARP inhibitor approved by the FDA for maintenance treatment of recurrent ovarian, fallopian tube, and primary peritoneal cancers. It also has approvals for certain breast and prostate cancers in other regions.
What Is the Current Market Size?
The global ovarian cancer treatment market reached approximately $2.5 billion in 2022, with PARP inhibitors accounting for a substantial share. Niraparib captured an estimated $1.2 billion of this, representing 48% of PARP inhibitor revenues in oncology.
Key market drivers:
- FDA approval in 2017 for ovarian cancer maintenance
- Expanding indications including first-line maintenance
- Growing prevalence of ovarian and breast cancers
Competitive landscape:
| Drug |
Market Share (2022) |
Approved Indications |
Price Range (per month) |
| Niraparib (Zejula) |
48% |
Ovarian, fallopian tube, primary peritoneal cancers |
$8,500 – $9,500 |
| Olaparib (Lynparza) |
35% |
Ovarian, breast, prostate, pancreatic cancers |
$7,000 – $9,000 |
| Rucaparib (Rubraca) |
17% |
Ovarian, prostate |
$7,500 – $9,000 |
How Is the Price of NDC 71921-0216 Currently Set?
Niraparib's wholesale acquisition cost (WAC) averages between $8,500 and $9,500 per month, with variations based on dosage and region. Most payers set net prices between $7,500 and $8,500, factoring in discounts and rebates.
Pricing pressures:
- Biosimilars and generics are not yet available in this class.
- Health insurers and pharmacy benefit managers negotiate significant discounts.
- Cost-effectiveness analyses in 2022 report an incremental cost-effectiveness ratio (ICER) of approximately $70,000 to $100,000 per quality-adjusted life year (QALY), influencing formulary decisions.
What Are Projected Market Trends?
The global PARP inhibitor market is expected to grow at a CAGR of 8.5% from 2023 to 2030, driven by:
- New indications in breast and prostate cancers.
- Expanded FDA approvals, including first-line maintenance in ovarian cancer, granted in 2020.
- Ongoing clinical trials exploring combinations with immunotherapies and other agents.
Market size forecasts:
| Year |
Estimated Market for Niraparib (USD) |
Comments |
| 2023 |
$1.4 billion |
Continued adoption |
| 2025 |
$2 billion |
Growth in first-line indications |
| 2030 |
$3.5 billion |
Inclusion in earlier treatment lines |
What Are the Key Market Drivers and Barriers?
-
Drivers:
- Rising global ovarian, breast, and prostate cancer incidence.
- Broader indications reducing unmet needs.
- Favorable reimbursement policies in the US and Europe.
- Clinical data supporting combination therapies.
-
Barriers:
- High drug costs impacting patient access.
- Competition from other PARP inhibitors with similar efficacy.
- Patent expirations forecasted around 2027, with potential for biosimilar entry reducing prices.
How Might Prices Evolve?
Pricing projections suggest a gradual decline:
- By 2025, the average monthly price could decrease to $7,500 to $8,000 due to negotiations, market saturation, and new competitors.
- Biosimilars or generics could enter the market around 2027, potentially reducing prices by 30–50% within two years of launch.
What Are the Key Factors Influencing Future Market and Price?
- Regulatory decisions expanding indications.
- Accelerated approval pathways or new clinical evidence.
- Competitive responses from branded and biosimilar drugs.
- Reimbursement policies and healthcare system economics.
Key Takeaways
Niraparib (NDC 71921-0216) has a strong market presence within the PARP inhibitor class, with current annual revenues near $1.2 billion. Its pricing remains high but is subject to downward pressure from competitors and potential biosimilar entries. Market growth will primarily depend on expanding indications, clinical trial results, and cost management strategies.
FAQs
1. When is Niraparib expected to face biosimilar competition?
Biosimilars are likely around 2027, contingent on patent completions and regulatory approvals.
2. Are additional indications expected to impact pricing?
Yes. Approvals for breast and prostate cancers may increase sales volume but could also trigger price negotiations.
3. How does Niraparib compare cost-wise to other PARP inhibitors?
Prices are similar, with monthly costs ranging from $7,000 to $9,500. Price differences depend mainly on contractual discounts.
4. What impact do clinical trial results have on pricing?
Positive results supporting broader or new indications can sustain or increase prices; negative results may cause price erosion.
5. How do payer policies influence the market?
Reimbursement restrictions and formulary placement significantly affect sales and pricing strategies.
Sources:
- IQVIA. "Global Oncology Market Data, 2022."
- FDA. "Zejula (Niraparib) Prescribing Information," 2022.
- EvaluatePharma. "Oncology Market Forecasts, 2022–2030."
- Murali, D. et al. "Cost-effectiveness of PARP inhibitors in ovarian cancer," JCO Oncology Practice, 2022.
- BioPharma Dive. "Biosimilar entry forecasts," 2023.
