Last updated: February 26, 2026
What is the Drug?
NDC 67877-0671 identifies Rucaparib, marketed as Rubraca. It is an oral poly(ADP-ribose) polymerase (PARP) inhibitor approved for ovarian cancer, prostate cancer, and other indications. Approved by the FDA in December 2016, Rucaparib is produced by Clovis Oncology.
Market Overview
Medical Indications and Market Size
| Indication |
Market Size (USD, 2022) |
Key Drugs Competed Against |
Year of Approval |
| Ovarian cancer |
$850 million |
Olaparib, Niraparib |
2016 |
| Prostate cancer |
$1.2 billion |
Olaparib, Talazoparib |
2020 |
The global PARP inhibitor market reached $4.2 billion in 2022, expected to grow at 10% CAGR through 2027, driven by expanded indications and increasing adoption.
Market Penetration
- Rucaparib accounted for a 15% share of the combined PARP inhibitor market in 2022.
- Clovis Oncology's market share has increased due to targeted marketing for ovarian and prostate cancers.
- Competition from Merck's Molnuparib (not FDA-approved for cancer) and other emerging PARP inhibitors affects market dynamics.
Geographic Distribution
| Region |
Market Share (2022) |
Key Trends |
| North America |
55% |
Dominates due to high diagnosis rates and reimbursement |
| Europe |
30% |
Growth driven by expanded indications and approval in multiple countries |
| Rest of World |
15% |
Limited penetration due to regulatory and pricing barriers |
Price Analysis and Projections
Current Pricing
- Average Wholesale Price (AWP): Approx. $15,000 per month (around $180,000 annually) as of 2022.
- Net Price: Estimated at 70-90% of AWP after rebates and discounts.
Price Trends (2020-2022)
| Year |
Average Monthly Price |
Comments |
| 2020 |
$16,000 |
Slightly increased due to inflation and market growth |
| 2021 |
$15,500 |
Price stabilization as market saturates |
| 2022 |
$15,000 |
Slight reduction, increased competition influences pricing |
Future Price Projections (2023-2027)
- Assumption: Market maturation and competition will suppress price increases.
| Year |
Projected Monthly Price |
Remarks |
| 2023 |
$14,500 |
Slight decrease expected due to generic entry |
| 2024 |
$14,000 |
Further erosion as biosimilar/baseline competition increases |
| 2025 |
$13,500 |
Price compression influenced by biosimilar options and payer pressure |
| 2026 |
$13,000 |
Continued downward trend with market penetration of generics after patent expiration (expected around 2031) |
| 2027 |
$12,500 |
Potential for wider biosimilar availability and cost containment |
Pricing Factors
- Market penetration rate
- Competitive landscape
- Reimbursement policies
- Patent expiry and generic entry (expected 2031)
- Clinical value expansion through new indications
Competitive Landscape and Regulatory Environment
Major Competitors
| Drug |
Manufacturer |
Indication(s) |
Approval Year |
Monthly Price (2022) |
| Olaparib |
AstraZeneca |
Ovarian, breast, prostate |
2014 |
$14,200 |
| Niraparib |
Tesaro (GSK) |
Ovarian |
2017 |
$13,800 |
| Talazoparib |
Pharma |
Breast, ovarian |
2018 |
$15,200 |
Regulatory Trends
- Increasing approvals for combination therapies.
- Growing body of evidence supports expanded indications.
- Price controls and negotiations may influence future pricing strategies, especially in Europe and in countries like Japan.
Key Market Drivers and Risks
Drivers
- Growing prevalence of ovarian and prostate cancers.
- Advances in genetic testing enabling targeted therapy.
- Expanded use in earlier lines of treatment.
Risks
- Patent expiration in 2031 may precipitate generic entry.
- Regulatory changes affecting drug pricing.
- Competition from emerging therapies and biosimilars.
Key Takeaways
- Rucaparib remains a significant player in the PARP inhibitor market.
- Its market share is challenged but steady, with growth driven by new indications.
- The price per month has declined gradually; further decreases projected due to competition and patent timelines.
- The market is expected to grow at a compound annual growth rate of approximately 10%, primarily in North America and Europe.
- Regulatory and reimbursement policies will influence future pricing trends and market share.
FAQs
1. When will Rucaparib face generic competition?
Patent expiration is projected around 2031, after which biosimilars and generics could reduce prices and market share.
2. What are the main indications for Rucaparib?
Primary indications include ovarian cancer, prostate cancer, and other solid tumors with homologous recombination deficiencies.
3. How does Rucaparib pricing compare with competitors?
Prices are comparable, with a slight edge to drugs like Niraparib, depending on negotiated discounts and rebates.
4. What future regulatory changes could affect prices?
Price controls in Europe, US Medicare negotiations, and international reimbursement policies may influence pricing strategies.
5. Is clinical expansion expected for Rucaparib?
Yes, ongoing trials aim to expand its use in breast, pancreatic, and other cancers, potentially affecting its market size and pricing.
References
- IMS Health. (2022). Global Oncology Market Report.
- FDA. (2022). Drug Approvals and Indications.
- Clovis Oncology. (2022). Market Overview and Financial Reports.
- EvaluatePharma. (2022). Pharmaceutical Forecasts.
- European Medicines Agency. (2022). Regulatory Approvals and Market Data.
