Last updated: July 28, 2025
Introduction
NDC 13668-0271 corresponds to Zejula (niraparib), a PARP inhibitor primarily utilized in the treatment of specific ovarian and breast cancers. Given its significant place in oncology, analyzing Zejula's market landscape and projecting its future pricing trajectory is critical for stakeholders, including pharmaceutical companies, investors, healthcare providers, and payers. This report offers a comprehensive assessment rooted in current market dynamics, competitive positioning, regulatory environment, and potential future trends.
Market Overview
Product Profile
Niraparib (Zejula) is marketed by GlaxoSmithKline (GSK) and approved by the FDA for the maintenance treatment of ovarian, fallopian tube, or primary peritoneal cancer in patients who respond to platinum-based chemotherapy. Its mechanism involves inhibiting PARP enzymes, causing synthetic lethality in BRCA-mutated cancer cells, thus providing targeted therapy benefits.
Market Size and Growth
The global ovarian cancer therapeutics market was valued at approximately USD 3.4 billion in 2022 and is projected to grow at a CAGR of 7-8% through 2027[1]. Varied factors contribute to this growth:
- Rising prevalence of ovarian and breast cancers.
- Expanding indications for PARP inhibitors.
- Increased adoption of personalized medicine.
Zejula's market share is estimated at approximately 20-25% within the PARP inhibitor segment, competing alongside Lynparza (olaparib) and Talzenna (talazoparib). The drug’s initial launch in 2017 provided a foothold, with subsequent extensions into first-line maintenance therapy, driving revenue expansion.
Key Market Drivers
- Expanding Indications: Beyond ovarian cancer, niraparib is being evaluated for prostate and other solid tumors, broadening its application scope.
- Regulatory Progress: Positive results from ongoing clinical trials and FDA approvals for additional indications could boost sales.
- Increasing Patient Pool: Aging populations and improved diagnostics are increasing the diagnosed patient base.
Market Challenges
- Pricing Pressures: Biosimilar and generic PARP inhibitors poised to enter markets as patents expire.
- Reimbursement Policies: Concerns over high drug costs and payer uptake may impact access.
- Competition: Lynparza’s established presence and multiple label approvals challenge niraparib's market penetration.
Regulatory Environment
Zejula received regulatory approval in multiple geographies, notably under Breakthrough Therapy designation in the U.S., facilitating accelerated development and market entry. Patent exclusivity extends to 2027-2029, with patent disputes and legal challenges anticipated that could influence pricing and market share.
Competitive Landscape
| Product |
Mechanism |
Market Share |
Regulatory Status |
Key Indications |
| Niraparib (Zejula) |
PARP inhibitor |
20-25% |
Approved in US, EU, Japan |
Ovarian, breast, prostate cancers |
| Olaparib (Lynparza) |
PARP inhibitor |
~50% |
Approved for multiple indications |
Ovarian, breast, pancreatic, prostate |
| Talazoparib |
PARP inhibitor |
Smaller niche |
Approved, mainly metastatic breast cancer |
HER2-negative breast cancer |
Lynparza’s broader label portfolio and early market entry give it a competitive edge. However, niraparib’s once-daily dosing and approved indication for maintenance therapy in different patient subgroups sustain its market relevance.
Pricing Analysis
Current Pricing Benchmarks
In the US, wholesale acquisition costs (WAC) for Zejula range between USD 12,000 to USD 15,000 per month, translating to annual costs roughly USD 144,000 to USD 180,000[2]. These prices are subject to discounts, rebates, and payer negotiations, which significantly influence net revenue.
Factors Influencing Pricing
- Patent Status: Patent expiration around 2027-2029 opens avenues for biosimilar competition, exerting downward pressure on prices.
- Market Competition: Entry of biosimilars for olaparib and other PARP inhibitors could reduce Zejula’s price point.
- Regulatory Approvals: Expanded indications may command higher prices due to perceived value.
- Negotiation Power of Payers: Payer resistance to high-cost therapies can limit reimbursement prices.
Price Projections (2023-2030)
| Year |
Projected Average Monthly Price (USD) |
Notes |
| 2023 |
\$12,500 - \$15,000 |
Existing pricing with typical rebates and discounts |
| 2025 |
\$11,000 - \$13,500 |
Early biosimilar entries in select markets |
| 2027 |
\$9,000 - \$11,000 |
Patent expiry approaches, biosimilar competition emerges |
| 2030 |
\$7,000 - \$9,000 |
Increased biosimilar penetration and competitive pressure |
Assumptions:
- Patent expiry results in at least 30-40% price reductions due to biosimilar entry.
- Market uptake remains strong owing to confirmed efficacy and expanding indications.
- Price reductions may vary geographically, influenced by local reimbursement policies.
Future Market and Pricing Outlook
Market Expansion: Ongoing clinical trials aim to extend niraparib’s indications. Approval for additional cancers could catalyze sales, maintaining upward growth despite price decreases.
Biosimilar Impact: A predictable erosive effect on prices post-patent expiry is planned, though market fragmentation and dose-specific biosimilars might delay significant price reductions.
Pricing Strategies: GSK might adopt tiered pricing schemes, patient assistance programs, and value-based contracting to sustain revenue streams in mature markets.
Regulatory and Legislative Factors: Regulatory initiatives targeting drug pricing transparency and negotiations could influence future pricing models, notably in the US healthcare system.
Conclusion
The market for NDC 13668-0271 (Zejula) stands at a pivotal juncture, with robust demand driven by expanding indications and clinical adoption in maintenance therapy for ovarian and breast cancers. However, pricing faces downward pressure from patent expiration and biosimilar competition, forecasted to reduce average prices by approximately 40-50% over the next decade.
Long-term profitability will hinge on successful indication expansion, differentiated positioning, and strategic negotiations. Stakeholders should monitor regulatory, competitive, and technological developments to optimize investment and commercialization strategies.
Key Takeaways
-
Market Dynamics: The global PARP inhibitor market is rapidly growing, with Zejula holding a significant but increasingly challenged position.
-
Pricing Trends: Current US prices range from USD 12,000 to USD 15,000 monthly, with projected reductions driven by biosimilar competition and patent expiry.
-
Growth Opportunities: Additional FDA approvals and combination therapies could extend Zejula’s market relevance.
-
Challenges: Patent cliffs, generic entry, payer resistance, and emerging competitors necessitate adaptive pricing and marketing strategies.
-
Strategic Recommendations: Invest in ongoing clinical trials, pursue early indication diversification, and prepare for biosimilar competition to safeguard market share and revenue potential.
FAQs
1. When is patent expiry for Zejula, and how will it impact pricing?
Patent protection is expected to expire around 2027-2029, after which biosimilar competitors are likely to enter, exerting downward pressure on prices by 30-50%.
2. Are there emerging competitors that could challenge Zejula’s market share?
Yes. Olaparib (Lynparza) and talazoparib are established competitors with broader indications, while biosimilars could further impact pricing and market positioning.
3. How are regulatory developments influencing Zejula’s market prospects?
Expanded label approvals and accelerated pathways support sales growth, though future legislative reimbursement reforms may influence pricing strategies.
4. What are the key factors that could alter future price projections?
Biosimilar market entry, regulatory changes, patent litigation outcomes, and clinical trial results for new indications are critical factors.
5. How should investors approach Zejula’s valuation amid these market dynamics?
Assess long-term potential considering indication expansion, pipeline progress, patent status, and competitive landscape, while remaining cautious of impending pricing pressures.
Sources:
[1] MarketsandMarkets. "Ovarian Cancer Therapeutics Market." 2022.
[2] GoodRx. "Zejula (niraparib) Pricing." 2023.
