Last updated: February 27, 2026
What is NDC 58657-0456?
NDC 58657-0456 is the National Drug Code for Zejula (niraparib), a poly (ADP-ribose) polymerase (PARP) inhibitor approved for ovarian, fallopian tube, primary peritoneal cancers, and other indications such as maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer in patients with a complete or partial response to platinum-based chemotherapy.
Market Size and Growth Dynamics
Current Market Landscape
The global ovarian cancer therapeutics market was valued at approximately USD 4.6 billion in 2022. The PARP inhibitor segment accounts for around USD 2.0 billion, driven primarily by the sales of drugs including Zejula, Lynparza, and Rubraca.
Key Competitors
| Drug Name |
Manufacturer |
Indications |
Market Share (2022) |
Pricing (Wholesale Acquisition Cost) |
| Zejula (niraparib) |
GlaxoSmithKline |
Ovarian, fallopian tube, peritoneal cancers |
25% |
USD 6,950/month (approximate) |
| Lynparza (olaparib) |
AstraZeneca |
Multiple cancers, including ovarian and breast |
45% |
USD 8,200/month |
| Rubraca (rucaparib) |
Clovis Oncology |
Recurrent ovarian cancer |
15% |
USD 7,300/month |
Zejula maintains a solid position in the U.S. market, particularly for maintenance treatment of ovarian cancer post-chemotherapy.
Forecasted Market Growth
The ovarian cancer therapeutics market is projected to grow at a compound annual growth rate (CAGR) of 6.8% from 2022 to 2030, driven by:
- Increasing incidence rates, with over 313,000 new cases globally in 2020.
- Expanded indications for PARP inhibitors.
- Launch of biosimilars and generics reducing costs.
Price Projections
Factors Influencing Price Trends
- Patent expirations: Zejula's patent protection is expected to expire in 2026 in the U.S., opening the market for biosimilars and generics.
- Reimbursement policies: Increasing access through insurance coverage influences net prices.
- Market competition: Entry of biosimilars could reduce prices by 20%-30%.
Short-term Price Outlook (2023-2025)
Before patent expiry, Zejula's monthly price is expected to hover around USD 6,950–7,200. Post-patent expiration, prices could fall to USD 4,500–USD 5,000 per month, aligning with current biosimilar pricing trends for targeted cancer therapies.
Long-term Price Projections (2026 and beyond)
- Biosimilar introduction expected to reduce prices for Zejula by approximately 30%, reaching USD 3,800–USD 4,000/month.
- Market consolidation may stabilize prices around USD 4,000/month by 2030.
Regulatory and Policy Impact
- The FDA approved Zejula under expedited pathways in certain indications, influencing early market penetration.
- Insurance coverage and Medicare policies may impact access and pricing, especially regarding out-of-pocket costs for patients.
Investment and R&D Outlook
- GSK invests heavily in expanding Zejula's indication portfolio and combination therapies.
- Entry into combination regimens with immunotherapies could impact market share and pricing dynamics.
Key Takeaways
- Zejula is a key PARP inhibitor in ovarian cancer, with an approximate USD 6,950/month price.
- Market growth driven by increasing incidence and expanded indications.
- Price pressures expected post-patent expiration around 2026, possibly leading to a 30% reduction.
- Biosimilar entry is the primary driver for future price declines.
- Regulatory and reimbursement policies will significantly influence net pricing and market access.
FAQs
-
When does patent expiration for Zejula occur?
Expected in 2026, opening the market for biosimilars and generics.
-
What is the main competitor to Zejula?
Lynparza, with a market share of approximately 45% in ovarian cancer.
-
How much could prices decline after biosimilar entry?
Prices may drop by 20%-30%, potentially reaching USD 4,000/month.
-
What indications does Zejula cover?
Ovarian, fallopian tube, and primary peritoneal cancers, as well as maintenance therapy in recurrent cases.
-
What is the market growth forecast for ovarian cancer treatments?
CAGR of 6.8% from 2022 through 2030.
Sources
[1] IQVIA, "Global Oncology Market Data," 2022.
[2] DelveInsight, "Ovarian Cancer Market Insights," 2022.
[3] FDA Database, "Approved Drugs and Patent Data," 2023.
[4] MarketWatch, "PARP Inhibitors Market Analysis," 2022.
[5] GlaxoSmithKline, "Zejula Product Label," 2023.
