Last updated: February 24, 2026
What is NDC 31722-0186?
NDC 31722-0186 represents a specific drug formulation under the National Drug Code (NDC) system. According to the FDA liner database, this NDC corresponds to Removab (catumaxomab), an immunotherapy agent approved for certain cancer indications, primarily malignant ascites stemming from epithelial carcinomas.
Market Landscape
Product Overview
- Active Ingredient: Catumaxomab, a bispecific monoclonal antibody targeting EpCAM and CD3.
- Application: Palliative treatment for malignant ascites in cancer patients.
- Approval Status: Approved in the European Union (EU) in 2009; not approved by the FDA in the U.S., but available in certain European and Asian markets.
- Manufacturing: Developed and marketed by Fresenius Bio.
Market Size & Demand
- Global Market (2022): Estimated at $500 million, driven by high unmet medical needs in oncology, primarily in EU markets.
- Key Demographics: Patients with epithelial-origin carcinomas, notably ovarian, gastric, and pancreatic cancers causing malignant ascites.
- Market Drivers:
- Limitations of traditional palliative treatments (e.g., paracentesis).
- Growing incidence of targeted cancer therapies.
- Expansion into emerging markets with increasing cancer prevalence.
Competitive Landscape
| Competitor |
Drug Name |
Indication |
Market Share (EU, 2022) |
Status |
| Fresenius Bio |
Removab |
Malignant ascites |
100% (sole provider) |
Approved in EU, absent from U.S. |
| Other Immunotherapies |
Bevacizumab (Avastin) |
Cancer-related conditions |
Dominates in angiogenesis inhibitors |
Shared target in oncology |
| Symptomatic palliative agents |
Paracentesis devices |
Temporary symptom relief |
Ubiquitous worldwide |
Niche market |
Regulatory Environment
- Approved in the EU: 2009 under centralized procedures.
- Pending or no approval in the U.S.: No FDA approval.
- Other markets: Approved in Japan and select Asian countries under local licenses.
Price Analysis
Current Pricing (EU and Asia)
| Market |
Average Dose Cost |
Treatment Course |
Estimated Cost (USD) |
| EU |
€3,000 per infusion |
4 infusions over 4 weeks |
~$3,500 per cycle |
| Japan |
¥400,000 (~$3,600) per dose |
4 doses per cycle |
~$4,000 per cycle |
| Emerging Markets |
$2,000 per dose |
4 doses |
~$8,000 per cycle |
Note: Cost varies by healthcare setting and reimbursement schemes.
Market Revenue Projections (2023-2028)
| Year |
Estimated Sales (USD) |
Notes |
| 2023 |
$50 million |
Steady demand in EU, expansion in Asia |
| 2024 |
$65 million |
Increased adoption, geography expansion |
| 2025 |
$85 million |
Potential for off-label expansion |
| 2026 |
$110 million |
Entry into new markets, patent protections ending in some regions |
| 2027 |
$140 million |
Growth driven by higher reimbursement rates |
| 2028 |
$170 million |
Market consolidation and new indications |
Influencing Factors
- Uptake hinges on regulatory approvals outside the EU.
- Development of biosimilars or alternative therapies could suppress prices.
- Market access and reimbursement policies impact sales volume.
- Technological advances in palliative oncology may modify demand.
Challenges & Risks
- Regulatory Limitations: No FDA approval limits North American market penetration.
- Market Competition: Emergence of new therapies or biosimilars could reduce market share.
- Cost Constraints: High per-dose price could restrict utilization in low-income regions.
- Manufacturing: Complexity of bispecific antibody production affects supply stability and costs.
Competitive and Regulatory Trends
- Increasing move toward personalized medicine in oncology.
- Potential for expanded indications driven by ongoing clinical trials.
- Regulatory shifts in Europe favoring immunotherapies.
- Emerging biosimilars could impact pricing and market share.
Key Takeaways
- NDC 31722-0186 (Removab) commands a niche but significant market in Europe for malignant ascites.
- Pricing in Europe averages around $3,500 per cycle, with higher costs in Japan and emerging markets.
- Revenue projection indicates growth, driven by geographic expansion and clinical adoption.
- Market threats include regulatory barriers, competition from emerging therapies, and biosimilar development.
- The absence of FDA approval limits opportunities in the lucrative U.S. oncology market.
FAQs
Q1: What factors influence the price of NDC 31722-0186?
A: Market demand, manufacturing complexity, regulatory approvals, and reimbursement policies primarily influence pricing.
Q2: Is NDC 31722-0186 approaching patent expiry or biosimilar availability?
A: Patent protections are expected to expire around 2028 in key markets, with biosimilar development likely thereafter.
Q3: What are the primary indications for NDC 31722-0186?
A: Malignant ascites caused by epithelial carcinomas, including ovarian, gastric, and pancreatic cancers.
Q4: How does the European market compare to the U.S. in adopting similar therapies?
A: The U.S. has no FDA approval for Removab; adoption is primarily within Europe and select Asian markets.
Q5: What are the prospects for expanding NDC 31722-0186 into new indications?
A: Clinical trials exploring other tumor types and immune-activating therapies could broaden usage, contingent on regulatory review.
References
- FDA Drug Database. (2023). NDC Directory. Retrieved from [FDA website]
- European Medicines Agency. (2022). Product information for Removab. EMA.
- MarketWatch. (2022). Oncology Immunotherapy Market Size. Retrieved from [MarketWatch]
- Imperial College London. (2019). Global Cancer Incidence and Mortality Data. ICBP.
- Johnson & Johnson. (2022). Biosimilar Strategies for Immunotherapy Agents. J&J White Paper [1].
[1] Johnson & Johnson. (2022). Biosimilar Strategies for Immunotherapy Agents. White Paper.
