Nivolumab - Biologic Drug Details

Summary for nivolumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	2
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for nivolumab

Recent Clinical Trials for nivolumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
CatalYm GmbH	PHASE2
Boston Scientific Corporation	PHASE2
Center Eugene Marquis	PHASE2

See all nivolumab clinical trials

Pharmacology for nivolumab

Mechanism of Action	Programmed Death Receptor-1-directed Antibody Interactions
Established Pharmacologic Class	Programmed Death Receptor-1 Blocking Antibody

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for nivolumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for nivolumab Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554		2036-04-28	DrugPatentWatch analysis and company disclosures
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554		2038-12-21	DrugPatentWatch analysis and company disclosures
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554		2036-11-30	DrugPatentWatch analysis and company disclosures
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554		2036-07-14	DrugPatentWatch analysis and company disclosures
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554		2037-06-02	DrugPatentWatch analysis and company disclosures
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554		2023-07-02	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for nivolumab Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554		2036-06-24	Patent claims search
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554		2035-02-04	Patent claims search
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554		2036-07-12	Patent claims search
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554		2035-08-27	Patent claims search
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554		2033-08-30	Patent claims search
Bristol-myers Squibb Company	OPDIVO	nivolumab	Injection	125554		2035-11-24	Patent claims search

International Patents for nivolumab

Country	Patent Number	Estimated Expiration
Brazil	PI0610235
Philippines	12017501774
Russian Federation	2007145419
South Korea	102702287
South Korea	20240135058
South Korea	102515509

Supplementary Protection Certificates for nivolumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C02161336/01	Switzerland		PRODUCT NAME: NIVOLUMAB; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 65660 30.11.2015
PA2015052,C2161336	Lithuania		PRODUCT NAME: NIVOLUMABAS; REGISTRATION NO/DATE: EU/1/15/1014 20150624
1590072-3	Sweden		PRODUCT NAME: NIVOLUMAB; REG. NO/DATE: EU/1/15/1014 20150624
555	Finland
2015/068	Ireland		PRODUCT NAME: NIVOLUMAB; REGISTRATION NO/DATE: EU/1/15/1014 20150619
CA 2015 00070	Denmark		PRODUCT NAME: NIVOLUMAB; REG. NO/DATE: EU/1/15/1014 20150624

Market Dynamics and Financial Trajectory for Nivolumab: A Comprehensive Analysis

Last updated: December 9, 2025

Executive Summary

Nivolumab (brand name: Opdivo), developed by Bristol-Myers Squibb, is a breakthrough immune checkpoint inhibitor targeting PD-1, approved for multiple oncology indications. The drug has experienced rapid market expansion since its 2014 FDA approval, driven by demonstrated efficacy across diverse cancers and evolving treatment landscapes. This analysis explores the key market drivers, competitive landscape, regulatory trends, revenue forecasts, and strategic outlook for nivolumab over the next decade.

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What are the core market dynamics influencing nivolumab's trajectory?

1. Growing Oncology Treatment Paradigm Shift

The global cancer therapeutics market is projected to reach $263.8 billion by 2027 (CAGR: 7.4%), with immunotherapy playing a central role [1]. Nivolumab, as an immune checkpoint inhibitor (ICI), complements and, in some cases, replaces traditional chemotherapies, aligning with the shift toward targeted, durable, and personalized treatments.

2. Expansion of Approved Indications

Initially approved for melanoma, nivolumab's indications now include:

Indication	Year of Approval	Key Patient Population	Estimated US Market (2022)	References
Melanoma	2014	9,000 new cases/year [2]	$2.4 billion	[3]
Non-small cell lung cancer (NSCLC)	2015	236,000 cases/year [4]	$4.9 billion	[5]
Hodgkin lymphoma	2016	8,500 cases/year [6]	$0.8 billion	[7]
Renal cell carcinoma (RCC)	2016	79,000 cases/year [8]	$1.2 billion	[9]
Other (Hepatocellular carcinoma, etc.)	2017-2023	Diverse populations	Incremental growth	[10]

The pipeline includes additional approvals for gastric, esophageal, and head and neck cancers, fueling product lifecycle extension.

3. Competitive Landscape and Evolving Pipeline

Nivolumab faces competition from pembrolizumab (Keytruda), cemiplimab, atezolizumab, and durvalumab. However, its broad label portfolio and demonstrated survival benefits underpin sustained market dominance. The competitive landscape:

Competitor	Status	Indications	Market Share (2022)	Strengths	References
Pembrolizumab	Approved since 2014	Multiple same indications	40%	Larger label, high efficacy	[11]
Cemiplimab	2018	Cutaneous squamous cell carcinoma	Niche	Strong in skin cancers	[12]
Atezolizumab	2016	Lung, bladder	10%	Combination potential	[13]

4. Regulatory and Reimbursement Environment

Regulatory agencies increasingly accept real-world evidence (RWE) to expand indications (e.g., NSCLC, melanoma). Reimbursement landscapes are favorable in major markets, with payers viewing ICIs as cost-effective due to survival benefits, though pricing pressure persists.

5. Pricing and Revenue Trends

Year	Revenue (USD millions)	Growth %	Comments
2014	$68	-	First approval, initial sales
2018	$3,806	282%	Multiple approvals, global expansion
2020	$8,893	134%	COVID-19 pandemic impact, license expansion
2022	$9,711	9.2%	Market maturity, patent cliff concerns

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How is the financial trajectory shaping for nivolumab?

1. Revenue Forecasts (2023-2030)

Based on market expansion, pipeline approvals, and pricing trends, analysts project:

Year	Estimated Revenue (USD millions)	Compound Annual Growth Rate (CAGR)	Assumptions/Factors
2023	$10,200	5%	Market saturation, pipeline approvals, pricing pressures
2025	$12,500	7.5%	Anticipated approvals, expanded indications, biosimilar competition
2030	$16,200	7%	Broader global access, combination regimens

2. Key Revenue Drivers

• Indication Expansion: Additional approvals for gastric, esophageal, and liver cancers.
• Geographic Penetration: Increasing adoption in Asia-Pacific, Latin America, and Africa.
• Combination Therapies: Efficacy of nivolumab with chemotherapy, targeted agents, and other immunotherapies (e.g., Opdivo + Yervoy in melanoma and RCC) enhances sales.

3. Cost and Margin Dynamics

• Manufacturing Costs: Biologics manufacturing costs are high but decreasing due to innovations in cell-culture technologies.
• Pricing Pressures: Governments in Europe and the US are pushing for value-based pricing to curb costs, impacting margins.
• Patent Expiry and Biosimilars: Patent cliffs post-2027 open opportunities for biosimilars, potentially reducing prices by 30-50%.

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What are the strategic considerations for stakeholders?

1. Companies' R&D and Pipeline Focus

• Emphasis on combination regimens and biomarker-driven therapy.
• Validation of PD-L1 expression as a predictive biomarker.
• Development of next-generation PD-1 inhibitors with improved efficacy and safety.

2. Market Entry and Expansion Strategies

• Strategic licensing and collaborations with regional biotech firms.
• Focus on orphan indications for niche markets.
• Investment in biosimilar development anticipating patent expirations.

3. Regulatory and Policy Impact

• An increasing trend toward accelerated approvals and conditional authorizations.
• Evolving policies favoring value-based care and patient access programs.

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How does nivolumab compare with key competitors?

Aspect	Nivolumab	Pembrolizumab	Cemiplimab	Atezolizumab	Durvalumab
First Approval	2014	2014	2018	2016	2017
Main Indications	Melanoma, NSCLC, RCC, others	Same as nivolumab	Skin cancers	Lung, bladder	Lung, melanoma
Approval Speed	Fast	Similar	Slightly later	Similar	Similar
Revenue (2022)	$9.7B	$17.7B	$0.5B	$3.4B	Data pending

Note: Market shares vary by indication and geography.

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What are the regulatory and reimbursement policies influencing nivolumab's trajectory?

Policy Aspect	Impact	Examples	References
Accelerated Approvals	Faster access to markets	US FDA, EMA	[14]
Reimbursement Ratios	Affects pricing strategies	US, EU, Japan	[15]
Value-based Pricing	Cost-effectiveness assessments	NICE, ICER	[16]
Patent Extensions	Market exclusivity	Patent law	[17]

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What are the key uncertainties and risks?

Risk	Description	Mitigation Strategies
Patent Expiry	Loss of market exclusivity from 2027	Developing biosimilars, pipeline diversification
Competition	Efficacy of rival ICIs	Combination approaches, biomarkers
Regulatory Changes	Stricter approvals, pricing reforms	Strategic R&D, adaptive commercialization
Market Saturation	Maturing markets	Geographic expansion, orphan indications

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Key Takeaways

• Nivolumab's market has grown substantially since its 2014 launch, driven by multiple indications and international expansion.
• Revenue forecasts show steady growth through 2030 but face headwinds from biosimilar entry, pricing pressures, and competitive innovations.
• A strategic focus on combination therapies, biomarker-driven approvals, and global access will be vital.
• Managing patent cliffs and leveraging pipeline developments will safeguard long-term financial performance.
• Stakeholders should monitor policy shifts, competitive movements, and technological innovations to optimize their positioning.

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FAQs

Q1: What are the primary indications expected to drive nivolumab sales in the next five years?
A: Melanoma, NSCLC, gastric and esophageal cancers, with emerging indications in liver and head & neck cancers.

Q2: How does the entry of biosimilars affect nivolumab's future revenue?
A: Biosimilars could reduce biologic prices by up to 50%, impacting margins and overall sales starting around 2027 after patent expiry.

Q3: What role do combination therapies play in nivolumab's market expansion?
A: Combining nivolumab with agents like Yervoy, targeted therapies, or chemotherapy enhances efficacy, expanding label indications and increasing sales.

Q4: Which regions offer the most promising growth opportunities for nivolumab?
A: Asia-Pacific, Latin America, and Africa due to rising cancer prevalence, expanding healthcare infrastructure, and favorable pricing/reimbursement policies.

Q5: How are regulatory agencies influencing nivolumab's market trajectory?
A: Accelerated approvals, acceptance of RWE, and expanded indications are enabling rapid market access but also increasing regulatory complexity.

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References

[1] MarketsandMarkets, "Oncology Drugs Market," 2021.

[2] American Cancer Society, "Cancer Facts & Figures 2022."

[3] Bristol-Myers Squibb, "Opdivo Prescribing Information," 2022.

[4] Globocan, "Lung Cancer Statistics," 2022.

[5] IQVIA, "Pharmaceutical Market Data," 2022.

[6] Hodgkin Lymphoma Society, "Hodgkin Disease Incidence," 2021.

[7] Bristol-Myers Squibb, "Opdivo in Hodgkin Lymphoma," 2022.

[8] American Cancer Society, "Renal Cell Carcinoma," 2022.

[9] GlobalData, "Oncology Market Forecast," 2022.

[10] European Medicines Agency, "Recent Approvals," 2023.

[11] Statista, "Pembrolizumab Revenue," 2022.

[12] AstraZeneca, "Cemiplimab Development," 2021.

[13] Pharma Intelligence, "Atezolizumab Market Share," 2022.

[14] FDA, "Accelerated Approval Program," 2022.

[15] WHO, "Reimbursement Policies," 2021.

[16] NICE, "Cost-Effectiveness Analyses," 2022.

[17] U.S. Patent Office, "Biologic Patent Laws," 2022.

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