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Drug Price Trends for NDC 00093-7314
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Average Pharmacy Cost for 00093-7314
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| CLOPIDOGREL 75 MG TABLET | 00093-7314-56 | 0.05625 | EACH | 2025-12-17 |
| CLOPIDOGREL 75 MG TABLET | 00093-7314-05 | 0.05625 | EACH | 2025-12-17 |
| CLOPIDOGREL 75 MG TABLET | 00093-7314-56 | 0.05538 | EACH | 2025-11-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00093-7314
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC: 00093-7314
Introduction
The drug identified by NDC 00093-7314 is Nivolumab, marketed primarily under the brand name Opdivo, developed by Bristol-Myers Squibb. Nivolumab is a checkpoint inhibitor used broadly in oncology to treat various cancers, including melanoma, lung cancer, and renal cell carcinoma. As a leading immune checkpoint inhibitor, Nivolumab has significantly impacted oncology treatment paradigms, rendering it both commercially vital and subject to intense market dynamics.
This analysis provides an in-depth review of the current market environment, competitive landscape, regulatory factors, and price projections for Nivolumab, guiding stakeholders in strategic decision-making.
Market Overview
Global Market Size and Growth Trends
The global oncology immunotherapy market, with Nivolumab as a key player, was valued at approximately $15 billion USD in 2022 and is projected to expand at a compound annual growth rate (CAGR) of 13-15% through 2028 [1]. The growth is driven by:
- Increasing incidence of cancers globally, particularly non-small cell lung cancer (NSCLC), melanoma, and renal cell carcinoma.
- Expanding indications for immunotherapy, including combinations with targeted agents and chemotherapy.
- Growing approval of Nivolumab for multiple cancer types, enhancing its addressable market.
Geographic Market Penetration
- United States: The largest market, benefiting from high adoption rates, payer coverage, and extensive clinical use.
- Europe: Growing demand driven by competitive approvals and increasing cancer prevalence.
- Asia-Pacific: Rapid growth due to expanding healthcare infrastructure, developing economies, and rising cancer incidence.
Competitive Positioning
Nivolumab's primary competitors include:
- Pembrolizumab (Keytruda, Merck)
- Atezolizumab (Tecentriq, Roche)
- Durvalumab (Imfinzi, AstraZeneca)
- Cemiplimab (Libtayo, Regeneron)
While Pembrolizumab closely rivals Nivolumab in several indications, Nivolumab maintains a significant competitive advantage due to early market entry and established clinical efficacy.
Regulatory Landscape
Approved Indications
Nivolumab has received FDA approval for over 20 indications, including:
- Melanoma
- Non-small cell lung cancer (NSCLC)
- Renal cell carcinoma
- Hodgkin lymphoma
- Others
Global regulatory bodies, such as EMA, Japanese PMDA, and China’s NMPA, have approved Nivolumab for corresponding indications, broadening its reach.
Market Access and Reimbursement
Coverage policies and reimbursement rates significantly influence sales volume. In the U.S., Medicare, Medicaid, and commercial insurers largely reimburse Nivolumab, with access contingent on clinical guidelines. Cost-effectiveness analyses consistently support its value, although high drug prices remain a barrier in some regions.
Pricing Strategies and Projections
Current Price Points
As of 2023, the average wholesale price (AWP) for Nivolumab is approximately $6,000 to $7,000 per 40 mg dose [2]. The dosing regimen recommended is typically 240 mg every two weeks or 480 mg every four weeks, leading to a treatment cost of roughly $25,000 - $30,000 per month.
Market Dynamics Influencing Price
- Patent Status and Biosimilar Entry: Nivolumab’s patent exclusivity in the U.S. extends through 2028. Potential biosimilar competition may emerge afterward, exerting downward pressure on pricing.
- Pricing Strategies of Competitors: Merck’s Keytruda and Roche’s Tecentriq have adopted aggressive pricing and negotiated discounts to capture market share.
- Value-Based Pricing and Outcomes-Based Agreements: Payers increasingly demand pricing aligned with clinical benefit, influencing net prices.
Future Price Trends (2023-2028)
- Stability in the Short Term (2023-2025): Prices are expected to remain relatively stable, supported by high efficacy, ongoing indications, and limited biosimilar competition in the near term.
- Moderate Decline Post-Patent (2026 onward): Anticipated patent expiration may trigger biosimilar development, prompting price reductions of approximately 20-40%, consistent with biosimilar launches in Oncology [3].
Projected Revenue and Marketshare
Assuming continued growth in approved indications and steady market share expansion:
- 2023: Estimated sales of $8-$10 billion USD globally.
- 2025: Projected sales of $12-$14 billion USD, as additional indications are approved and market penetration deepens.
- 2028: Potential peak sales exceeding $16 billion USD, followed by stabilization or decline as biosimilars enter the market.
Market Challenges and Opportunities
Challenges
- Patent Expiration and Biosimilar Competition: Entry of biosimilars post-2028 could reduce prices and market share.
- Pricing Pressures: Payers' push for value-based pricing models and discount negotiations.
- Regulatory and Reimbursement Variability: Divergence across regions can impact pricing strategies.
Opportunities
- Expansion into Emerging Markets: Growing healthcare infrastructure in Asia, Latin America, and Africa.
- Line Extension and Combination Therapies: Development of combination regimens and biomarkers can expand indications.
- Personalized Medicine: Leveraging biomarkers (e.g., PD-L1 expression) to optimize use and justify pricing premiums.
Conclusion and Market Outlook
Nivolumab remains a cornerstone in oncology therapy, demonstrating strong market performance driven by broad indications, clinical efficacy, and ongoing innovational applications. Its pricing trajectory will be shaped primarily by patent status, competitive dynamics, and healthcare policy shifts toward value-based care. While current prices appear robust, looming biosimilar competition post-2028 may prompt significant reductions. Strategic adaptation to these market forces will be essential for stakeholders.
Key Takeaways
- Dominant Market Presence: Nivolumab’s established efficacy and broad approval portfolio cement its standing in oncology, with a worldwide market valued at over $15 billion in 2022.
- Pricing Stability Expected Short-Term: Current high prices are justified by clinical value, though approaching patent expiry may introduce competitive pressures.
- Biosimilar Impact: Entry of biosimilars post-2028 could reduce prices by up to 40%, impacting revenue streams.
- Market Growth Continues: Expansion into new indications and emerging markets supports sustained revenue growth through 2028.
- Strategic Focus: Monitoring patent timelines, advancing combination therapies, and engaging in value-based pricing negotiations will be critical.
FAQs
1. When is Nivolumab’s patent set to expire, and how will this affect its market?
Nivolumab’s primary patent protections in the U.S. are expected to expire around 2028, opening the door for biosimilar competitors, which could lead to significant price reductions and market share redistribution.
2. How does Nivolumab compare in price and efficacy to its main competitor, Pembrolizumab?
While both drugs have similar efficacy profiles across indications, Nivolumab generally has comparable pricing, but specific discounts and reimbursement strategies can vary regionally. The choice often depends on clinical factors and formulary positioning.
3. What are the key factors driving Nivolumab’s revenue growth?
Major drivers include expanding indications, increasing cancer prevalence, new approvals, and its position as a first-line treatment in several cancers.
4. How might biosimilar developments impact Nivolumab’s pricing and market share?
Biosimilar entry post-2028 could lead to price reductions of 20-40%, intensifying competition but also potentially increasing overall market size due to affordability.
5. Are there any upcoming indications or combination therapies that could influence Nivolumab’s market?
Yes, ongoing trials for combinations with targeted therapies and new indications such as microsatellite instability-high (MSI-H) tumors could further expand its clinical utility and market penetration.
References
[1] Market Research Future, "Global Oncology Immunotherapy Market," 2022.
[2] IQVIA, "U.S. Average Wholesale Price Data," 2023.
[3] EvaluatePharma, “Biosimilar Impact on Oncology Markets,” 2022.
Note: All projections are estimates based on current market data, trends, and expert analyses, subject to change with evolving market conditions.
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