Last updated: February 20, 2026
What is the drug associated with NDC 00536-1247?
The National Drug Code (NDC) 00536-1247 corresponds to Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor manufactured by Bristol-Myers Squibb. Approved by the FDA for multiple cancer indications, including melanoma, non-small cell lung cancer (NSCLC), and renal cell carcinoma.
What is the current market landscape for nivolumab?
Market size and volume
- In 2022, the global immuno-oncology market was valued at approximately USD 10 billion and is projected to grow at a CAGR of 12% to reach USD 22 billion by 2030 [1].
- North America remains the dominant region, holding over 50% of the market share in 2022, driven by rising cancer incidence, reimbursement policies, and approved indications.
- In the US, the number of patients eligible for nivolumab-based therapies exceeds 600,000 annually, primarily for melanoma, NSCLC, and renal cell carcinoma [2].
Competitive landscape
Key competitors include:
- Pembrolizumab (Keytruda, Merck)
- Atezolizumab (Tecentriq, Genentech)
- Durvalumab (Imfinzi, AstraZeneca)
- Avelumab (Bavencio, Pfizer/Biogen)
Market shares (2022):
| Drug |
Market Share |
Indications |
| Nivolumab |
45% |
Melanoma, NSCLC, RCC, others |
| Pembrolizumab |
37% |
Lung cancer, melanoma, others |
| Others |
18% |
Multiple small competitors |
Pricing dynamics
- List price in the United States: approximately USD 17,000 per 40 mg vial. The average patient receives 240 mg every 2 weeks, translating into USD 102,000 per month per patient.
- Actual negotiated prices with payers are typically 20–30% lower than list price.
- Reimbursement strategies have driven payers to favor nivolumab based on proven efficacy.
How are prices expected to evolve?
Factors influencing future pricing
- Patent expiration: Key patents for nivolumab expire between 2028 and 2030, opening the market for biosimilars.
- Biosimilar entry: Expected biosimilar competitors could drive prices down by 30–50% within 2–3 years post-approval.
- Regulatory and policy trends: Price regulation efforts and value-based pricing models could reduce costs, especially outside the US.
- Market penetration: Broadening indications and increased use in earlier treatment lines could sustain high revenues even as unit prices decline.
Price projections (next 5 years)
| Year |
Estimated Average Price per 240 mg Dose |
Notes |
| 2023 |
USD 102,000 |
Current list price, adjusted for negotiations |
| 2024 |
USD 95,000–100,000 |
Slight decline due to negotiated discounts |
| 2025 |
USD 80,000–85,000 |
Biosimilar competition emerging, volume increases |
| 2026 |
USD 70,000–75,000 |
More biosimilar entries, further price declines |
| 2027 |
USD 60,000–65,000 |
Biosimilar market established, generic pricing dynamics |
Revenue impact
- If the volume of treated patients increases by 10–15% annually, total revenues could stabilize despite price declines.
- Current revenues for nivolumab are estimated at USD 4.5 billion in the US alone, with global sales approaching USD 8 billion.
Strategic considerations for stakeholders
- Manufacturers should plan for biosimilar approvals around 2028–2030.
- Payers and providers need to adapt to evolving reimbursement strategies to balance costs and access.
- R&D focus on new indications and combination therapies could sustain high pricing and market share.
Key Takeaways
- The market for nivolumab is mature in the US but expanding globally.
- Price reductions are inevitable due to patent expiry and biosimilar competition.
- The drug’s revenue will depend on continued approval of new indications and patient volume growth.
- Investors should monitor biosimilar approval timelines and regulatory policies affecting pricing.
- Cost management through negotiations will remain critical for profit optimization.
FAQs
1. When will biosimilars for nivolumab likely enter the market?
Biosimilar applications are expected to be filed from 2026 onward, with approvals anticipated around 2028–2030, aligned with patent expirations [3].
2. How much can prices decline with biosimilar competition?
Biosimilar prices are projected to be 30–50% lower than brand-name counterparts, depending on market dynamics and payer negotiations.
3. What indications are most significant for future growth?
Melanoma, NSCLC, and renal cell carcinoma remain primary drivers, with expanding use in combination therapies and earlier lines of treatment.
4. How do international markets differ in pricing?
European and Asian markets face more regulation and price controls, typically resulting in prices 20–40% lower than US levels.
5. What policies could influence future pricing?
Price regulation, value-based reimbursement, and governmental negotiation rights could reduce drug prices outside the US.
References
[1] MarketsandMarkets. (2022). Immuno-oncology Market Size and Forecast.
[2] IQVIA. (2022). US Oncology Market Trends.
[3] FDA. (2022). Biosimilar Approval Timeline and Patent Expiries.
