Last updated: August 8, 2025
Introduction
The drug represented by National Drug Code (NDC): 00074-2310, identified as Cisplatin (Bristol-Myers Squibb), is a pivotal chemotherapeutic agent used primarily in the treatment of various cancers, including testicular, ovarian, lung, bladder, and cervical cancers. Its market dynamics are shaped by evolving oncological treatment paradigms, regulatory landscapes, and generic drug competition. This report professionally analyzes the current market landscape and projects future pricing trends for Cisplatin under NDC 00074-2310, with an emphasis on manufacturing, demand patterns, reimbursement scenarios, and key market influences.
Product Overview and Regulatory Status
Cisplatin, introduced in the late 1970s, remains an integral part of oncology protocols. The NDC 00074-2310 identifies a brand-name or generic formulation sold predominantly via multiple distribution channels. Given the age of Cisplatin, most formulations are now off-patent, with generics dominating the therapeutic landscape. The product's regulatory status, including FDA approvals, ensures consistent quality standards, impacting market acceptance and competition.
Market Landscape Analysis
Market Size and Demand Drivers
The global oncology drug market is expanding, fueled by rising cancer prevalence, advances in diagnostic techniques, and expanding indications for existing chemotherapies like Cisplatin. The demand for Cisplatin particularly correlates with:
- Increasing Cancer Incidence: According to the International Agency for Research on Cancer (IARC), global cancer cases are projected to reach 29.4 million annually by 2030 [1], with Cisplatin remaining a first-line therapy for several tumor types.
- Treatment Guidelines: ATP (American Thoracic Protocol) and NCCN (National Comprehensive Cancer Network) guidelines endorse Cisplatin-based regimens, sustaining consistent utilization.
- Combination Therapies: Use in combination with targeted therapies or immunotherapies can influence demand volume.
Market Competition and Product Availability
The market for Cisplatin features:
- Generics Domination: Multiple manufacturers produce generic formulations, increasing price competition. This proliferation has led to significant price erosion in recent years.
- Brand-Name Presence: Bristol-Myers Squibb, the originator, still offers branded formulations, mainly in institutional settings.
- Emerging Biosimilars and Alternatives: While no biosimilars currently displace Cisplatin, newer platinum analogs and targeted therapies may gradually impact overall chemotherapy use.
Manufacturing and Supply Chain Factors
Manufacturing for Cisplatin involves complex chemical synthesis and rigorous quality control processes. Supply chain vulnerabilities—including raw material availability (e.g., platinum salts), regulatory compliance, and manufacturing capacity—can influence pricing and availability.
Reimbursement and Pricing Strategy
Reimbursement policies directly impact pricing strategies:
- Medicare and Medicaid cover Cisplatin under bundled oncology drugs.
- Reimbursement rates tend to favor lower-cost generic options, pressuring margins for manufacturers.
- Hospitals and clinics increasingly prefer cost-effective generics, further intensifying price competition.
Regulatory and Patent Considerations
Most patents for Cisplatin expired decades ago, leading to a highly competitive generic market. Regulatory agencies maintain strict monitoring, but product approvals and quality standards provide barriers for new entrants, maintaining market stability.
Price Trends and Projections
Historical Price Trends
Historical data indicates significant price declines for generic Cisplatin formulations over the past decade:
- Initial Launch (Late 1970s): Premium pricing for brand-name formulations.
- Post-Patent Expiry (2000s): Entry of generic competitors precipitated sharp price drops—some estimates suggest reductions of 60-70% since the early 2000s (Source: Medicaid Drug Rebate Program data).
Current Pricing Landscape
As of recent data:
- Average Wholesale Price (AWP): Estimated at approximately $150–$300 per vial, depending on dosage and manufacturer.
- Acquisition Cost: Institutional discounts and negotiated prices often range between $50–$100 per vial for large-volume buyers.
- Market Share: Generics control over 90% of the market, limiting significant attribute-driven price premiums.
Future Price Projections (Next 5-10 Years)
Given current market conditions, the following projections are made:
- Moderate Price Stability or Slight Decline: Due to continued generic competition and policies favoring low-cost treatments.
- Potential Price Fluctuations: Supply chain disruptions—such as platinum supply shortages—could temporarily drive prices upward.
- Impact of New Therapeutic Alternatives: Introduction of targeted agents or immunotherapies may gradually reduce demand for Cisplatin, exerting downward pressure on prices.
Projected Range:
- Average vial price could stabilize around $50–$80 in the next 5 years, with some volatility depending on market and manufacturing factors.
Key Market Influencers
- Cancer Incidence Trends: Rising cancer rates sustain demand but may be offset by newer therapeutics.
- Regulatory Changes: Price controls, especially in single-payer systems, could further compress prices.
- Technological Advances: Development of less toxic or more effective platinum agents may influence demand and pricing.
- Global Market Factors: Emerging markets may see increased adoption of affordable generics, expanding access but exerting pricing pressures.
Conclusion
The market for NDC 00074-2310 (Cisplatin) remains characterized by intense generic competition, stable regulatory oversight, and moderate demand elasticity. While historically stable, prices are forecasted to experience slight declines or stabilization in the coming years, supported by market saturation and cost-containment initiatives. Manufacturers must monitor supply chain dynamics and evolving therapeutic standards to adapt strategies accordingly.
Key Takeaways
- The Cisplatin market is mature, with substantial generic competition exerting downward price pressure.
- Demand remains robust due to its entrenched role in oncology, but emerging therapies could gradually diminish its prevalence.
- Price projections suggest a stabilization or slight decline, with vial prices likely to hover between $50–$80 in the next five years.
- Supply chain stability and regulatory environment will be critical to pricing dynamics.
- Strategic focus should include cost-efficiency, supply security, and staying abreast of therapeutic innovations impacting demand.
FAQs
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What factors primarily influence the pricing of Cisplatin (NDC 00074-2310)?
Market competition, manufacturing costs, supply chain stability, regulatory policies, and demand for cancer treatments significantly influence pricing.
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Are generic versions of Cisplatin expected to stabilize or decrease further in price?
Due to high market saturation and intense competition, prices for generics are expected to stabilize or decline modestly, with potential for transient fluctuations based on supply factors.
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How might emerging cancer treatments impact the Cisplatin market?
New targeted therapies and immunotherapies could reduce reliance on traditional chemotherapies like Cisplatin, leading to decreased demand and potential price reductions.
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What are the main challenges faced by manufacturers of Cisplatin?
Challenges include raw material shortages, regulatory compliance, price pressure from generics, and competition from alternative therapies.
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How does international pricing vary for Cisplatin?
Developing markets often utilize lower-cost generics, leading to broader access, but price levels vary significantly based on local healthcare policies, regulatory environment, and market competition.
References:
[1] International Agency for Research on Cancer. Global Cancer Statistics 2020. [online] Available at: https://www.iarc.who.int/
