OPDIVO Drug Profile

Summary for Tradename: OPDIVO

High Confidence Patents:	14
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for OPDIVO

Recent Clinical Trials for OPDIVO

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Shanghai Henlius Biotech	PHASE1
mAbxience Research S.L.	PHASE3
Ono Pharmaceutical Co. Ltd	PHASE2

See all OPDIVO clinical trials

Pharmacology for OPDIVO

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 company disclosures

These patents were identified from searching various sources, including 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 OPDIVO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for OPDIVO 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 OPDIVO 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 OPDIVO

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 OPDIVO

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 the Biologic Drug: OPDIVO

Last updated: December 2, 2025

Executive Summary

OPDIVO (nivolumab), developed by Bristol-Myers Squibb (BMS), is a world-leading immune checkpoint inhibitor used primarily for treating various cancers, including melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma, and Hodgkin’s lymphoma. Since its FDA approval in 2014, OPDIVO has revolutionized cancer immunotherapy, commanding a significant market share amid rapidly expanding indications.

This analysis explores the evolving market landscape, competitive positioning, financial performance metrics, and future growth trajectories of OPDIVO. Emphasizing key drivers—clinical efficacy, regulatory milestones, pipeline expansion, and competitive dynamics—the report offers actionable insights for stakeholders.

Market Overview and Growth Drivers

Global Oncology Drug Market

The global oncology therapeutics market exceeded $195 billion in 2022 and is projected to grow at a CAGR of 7.2% through 2030 (Grand View Research). Biologics, including immune checkpoint inhibitors like OPDIVO, represent approximately 45% of this market.

OPDIVO’s Market Penetration

• Initial Launch (2014): Pioneered as a PD-1 inhibitor for advanced melanoma.
• Expansion: Today, approved for seven indications across multiple tumor types, including lung, renal, head and neck, and hematological cancers.
• Revenue (2022): Approx. $8.6 billion, representing a 15% YoY increase, making OPDIVO one of the top-selling cancer drugs globally.

Key Market Drivers

Driver	Impact
Clinical Efficacy	Superior survival benefits in multiple cancers; leading to broad approvals
Regulatory Approvals	Accelerated approvals and supplemental indications expand market reach
Combination Therapies	Synergy with chemotherapy, targeted therapy, and other immunotherapies boosts sales
Pipeline Expansion	Ongoing trials for new indications and biomarker-driven therapies widen adoption
Patient Access and Reimbursement	Reimbursement pathways and pricing strategies influence revenue trajectory

Competitive Landscape

Major Competitors and Market Share

Drug	Company	Indications	Approximate 2022 Revenue	Market Share (Estimate)
OPDIVO (nivolumab)	Bristol-Myers Squibb	Multiple cancers	$8.6 billion	~33%
KEYTRUDA (pembrolizumab)	Merck & Co.	Multiple cancers	$20.3 billion (2022)	~57%
TECENTRIQ (atezolizumab)	Roche	Lung, bladder, others	$2.3 billion	~9%

Note: OPDIVO’s market share is rising owing to broadened indications, but KEYTRUDA remains dominant.

Differentiators and Challenges

Aspect	OPDIVO	Keytruda	Challenges for OPDIVO
FDA Approvals	First approvals in melanoma, moving into lung and other cancers	Broader initial approval scope	Competitive pressure in given indications
Combination Strategy	Provenant with chemotherapy and targeted therapies	Extensive combination portfolio	Need for ongoing trials to maintain lead
Pricing & Reimbursement	Premium pricing, variable access by region	Similar strategies, strong China presence	Cost containment measures impacting revenues

Financial Trajectory and Revenue Outlook

Historical Performance

Year	Revenue (USD Billions)	YoY Growth	Key Milestones
2014	<$1.0	-	First approval (melanoma)
2018	~$4.9	+52%	Expanded lung and other indications
2020	~$6.2	+27%	Introduction of combination regimens
2022	$8.6 billion	+15%	Broadening indications, pipeline progress, pandemic recovery

Forecast for 2023-2028

Year	Estimated Revenue	Compound Annual Growth Rate (CAGR)	Key Factors
2023	~$9.3 billion	7%	New approvals, pipeline momentum
2024	~$10.0 billion	8%	Additional indication approvals
2025-2028	$11.5–13.8 billion	8-10%	Expansion into earlier-stage cancers, ECC strategies

Revenue Drivers

• New Indications: Regulatory approvals for gastric, colorectal, and mesothelioma cancers.
• Combination Regimens: Ongoing trials combining OPDIVO with CTLA-4 inhibitors, targeted therapies, and chemotherapy.
• Biomarker-Driven Use: PD-L1 expression testing for personalized therapy enhances cost-effectiveness and patient outcomes.
• Geographical Expansion: Growth in emerging markets, notably China and India, with tailored pricing and access strategies.
• Pipeline Development: Trials for adjuvant and neoadjuvant settings, aiming for earlier intervention.

Risks and Uncertainties

Risk Factor	Impact	Mitigation Strategies
Competitive pressures	Market share erosion	Diversified pipeline, combination strategies
Regulatory delays	Slower access to new indications	Active engagement with regulators
Pricing pressures	Reduced margins	Strategic price negotiations, value-based pricing
Pipeline failures	Loss of future growth	Robust clinical development programs

Key Database and Policy Context

• FDA & EMA Approvals: The FDA has approved OPDIVO for over 20 indications; EMA aligns closely.
• Pricing & Reimbursement Policies: CMS and countries’ healthcare authorities increasingly emphasize value-based care.
• Intellectual Property: Patent protections extend until 2034 in key markets; biosimilars are nascent but under development.

Comparative Analysis

Aspect	OPDIVO	Keytruda	Impact on Market Trajectory
Number of approved indications	7+	20+	Broader use cases, but OPDIVO’s specificity and combinations position it uniquely
Leading tumor types	Melanoma, lung, renal	Lung, melanoma, head & neck	Competition in major indications
Revenue (2022)	$8.6 billion	$20.3 billion	Keytruda’s dominance despite OPDIVO’s growth

Future Outlook and Strategic Recommendations

• Pipeline Expansion: Prioritize clinical development in early-stage cancers and adjuvant settings.
• Partnerships & Collaborations: Strengthen alliances with biotech companies for novel combinations.
• Market Access Strategy: Deploy flexible pricing and patient assistance programs, especially in emerging markets.
• Regulatory Engagement: Accelerate approvals via priority review and breakthrough designations.

Key Takeaways

• OPDIVO maintains a dominant position in immune checkpoint therapy with an expected revenue CAGR of approximately 8% through 2028.
• The drug’s growth hinges on expanding indications, combination regimens, and geographic penetration.
• Competition remains intense, with KEYTRUDA leading market share but OPDIVO steadily closing the gap.
• Pipeline robustness and regulatory agility are critical to sustained growth.
• Price and reimbursement dynamics will significantly influence profitability, especially amidst global healthcare cost containment.

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FAQs

1. How does OPDIVO compare to KEYTRUDA in terms of efficacy?
Both drugs demonstrate comparable survival benefits across multiple cancers, with specific advantages depending on tumor type. Head-to-head clinical trials are limited; therapy choice often depends on indications, combination options, and regulatory approvals.

2. What are the primary indications driving revenue for OPDIVO?
The top contributors are first-line non-small cell lung cancer, melanoma, and renal cell carcinoma. These account for over 70% of total sales.

3. How is the pipeline influencing OPDIVO’s future?
Active trials in adjuvant, neoadjuvant, and combination therapies have the potential to open new markets and extend the drug’s lifecycle.

4. What regional factors impact OPDIVO’s commercialization?
Regulatory pathways, reimbursement policies, and healthcare infrastructure vary; China and emerging markets offer significant growth opportunities due to lower treatment barriers.

5. What risks could threaten OPDIVO’s market position?
Pipeline failures, regulatory delays, biosimilar competition, and pricing pressures pose ongoing threats. Strategic diversification and pipeline innovation are essential to mitigate these risks.

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References

[1] Grand View Research. "Global Oncology Drugs Market Size, Share & Trends Analysis Report," 2022.
[2] Bristol-Myers Squibb. "OPDIVO (nivolumab) Prescribing Information," 2023.
[3] FDA. "Approval Announcements & Labeling," 2022–2023.
[4] IQVIA. "Prescription Drug Market Data," 2023.
[5] Evaluate Pharma. "World Preview 2023," 2023.