GAZYVA Drug Profile

Summary for Tradename: GAZYVA

High Confidence Patents:	7
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for GAZYVA

Recent Clinical Trials for GAZYVA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
City of Hope Medical Center	Phase 2
Bristol-Myers Squibb	Phase 2
Oregon Health and Science University	Phase 1

See all GAZYVA clinical trials

Pharmacology for GAZYVA

Mechanism of Action	CD20-directed Antibody Interactions
Established Pharmacologic Class	CD20-directed Cytolytic 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 GAZYVA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for GAZYVA 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
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486	10,035,848	2035-01-08	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486	10,092,569	2035-02-20	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486	10,159,675	2036-12-01	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486	10,220,072	2037-12-06	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for GAZYVA 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
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486	10,035,848	2035-01-08	Patent claims search
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486	10,092,569	2035-02-20	Patent claims search
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486	10,159,675	2036-12-01	Patent claims search
Genentech, Inc.	GAZYVA	obinutuzumab	Injection	125486	10,220,072	2037-12-06	Patent claims search

International Patents for GAZYVA

Country	Patent Number	Estimated Expiration
Cyprus	2015001
European Patent Office	2380911
Eurasian Patent Organization	201891289
Singapore	10201911330V

Supplementary Protection Certificates for GAZYVA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C300711	Netherlands		PRODUCT NAME: OBINUTUZUMAB EN ALLE VARIANTEN; REGISTRATION NO/DATE: EU/1/14/937 20140723
2016/009	Ireland		PRODUCT NAME: OBINUTUZUMAB; NAT REGISTRATION NO/DATE: EU/1/14/937/001 20140723; FIRST REGISTRATION NO/DATE: IRELAND EU/1/14/937/001, 23/07/2014
2016C/008	Belgium		PRODUCT NAME: OBINUTUZUMAB; AUTHORISATION NUMBER AND DATE: EU/1/14/937 20140724
C01692182/01	Switzerland		PRODUCT NAME: OBINUTUZUMAB; REGISTRATION NO/DATE: SWISSMEDIC 63172 10.06.2014

Market Dynamics and Financial Trajectory for GAZYVA (Obinutuzumab)

Last updated: November 30, 2025

Executive Summary

GAZYVA (obinutuzumab) is a monoclonal antibody biologic approved for treating several hematologic malignancies, primarily chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). Since its approval by the FDA in 2013, GAZYVA has experienced variable commercial performance driven by factors such as competitive landscape, pricing strategies, clinical efficacy, and evolving treatment paradigms. This report examines key market dynamics, financial trajectories, competitive forces, regulatory influences, and future outlooks shaping GAZYVA’s commercial trajectory. The overall analysis reveals a cautiously optimistic forecast, grounded in increasing adoption, potential expansion into new indications, and ongoing market challenges.

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1. Summary of GAZYVA: Composition, Indications, and Approval Timeline

Attribute	Details
Generic Name	Obinutuzumab
Manufacturer	Roche/Genentech
FDA Approval Year	2013 (for CLL, in combination with chlorambucil)
Approved Indications	- Chronic lymphocytic leukemia (CLL) - Follicular lymphoma (FL) - Marginal zone lymphoma (MZL) (under review/expansion)
Key Clinical Data	- Improved progression-free survival (PFS) over rituximab in FL and CLL (e.g., GALLIUM trial for FL)

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2. Market Size and Growth Drivers

2.1 Global Hematologic Malignancies Market Overview

Segment	Estimated Market Size (2022)	CAGR (2022–2027)	Key Drivers
CLL	\$10.2 billion	7%	Aging populations, increased diagnosis, novel therapies
Follicular Lymphoma	\$8.5 billion	6.5%	Better diagnostics, combination regimens
MZL/Other Indications	\$3.1 billion	8%	Emerging approvals, unmet needs

Source: Market Research Future, 2022 [1]

2.2 Competitive Landscape and Share

Drug	Market Segment	Market Share (2022)	Notes
Rituximab	CD20 antibody (monotherapy or combination)	~40%	First-in-class, widespread use
Obinutuzumab (GAZYVA)	Clonal B-cell malignancies	~15%	Competitive but niche; gains via clinical efficacy data
Ofatumumab	Alternative anti-CD20	~10%	Less prevalent, specific indications
Other	Emerging biologics	~35%	Targeted agents, small molecules

Note: GAZYVA’s market share varies regionally and by indication.

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3. Financial Trajectory and Revenue Trends

3.1 Revenue Milestones and Trends

Year	Approximate Revenue	Notes
2013	\$0.2 billion	Initial launch in CLL
2015	\$0.5 billion	Expansion to FL; increased adoption
2018	\$1.2 billion	Peak sales driven by increased indications and combination regimens
2020	\$1.1 billion	COVID-19 impact, revised utilization patterns
2022	\$1.3 billion	Partial recovery, renewed interest in combination therapy

Source: Roche Annual Reports [2]

3.2 Key Factors Influencing Revenue

Factor	Impact	Comments
Pricing Strategies	High	Premium pricing in developed markets, negotiations influence net sales
Competition	Moderate	Rituximab biosimilars entering markets; ofatumumab niche
Regulatory Approvals & Label Expansion	Positive	Possible indications expansion (e.g., MZL, CLL + obinutuzumab + chlorambucil)
Market Penetration & Adoption	Variable	Slower than initial expectations due to reimbursement hurdles and physicians’ preference for other agents

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4. Market Dynamics

4.1 Competitive Landscape and Key Players

Metric	GAZYVA (Obinutuzumab)	Rituximab (Rituxan)	Ofatumumab	New Entrants
Mechanism	Type II anti-CD20 monoclonal	Type I anti-CD20	Fully human anti-CD20	Various targeted agents
Efficacy	Superior in PFS in some trials	Standard-of-care since 1997	Niche applications	Emerging
Pricing	Premium	Lower (biosimilar options)	Lower	Varies
Regulatory Status	Approved for selected indications	Broad approval	Limited	Under review

Note: Biosimilar entries for rituximab (e.g., Pfizer’s Truxima, Celltrion’s Herzuma) are exerting downward pressure on manufacturing prices and reimbursement.

4.2 Policy and Reimbursement Environment

Region	Policy Highlights	Impact on GAZYVA	Notes
United States	CMS reimbursement via Part B	Favorable but price negotiations ongoing	Value-based contracting emerging
European Union	National reimbursement decisions	Varies significantly	Some markets favor biosimilars
Japan & APAC	Local pricing controls	Supply chain flexibility valuable	Growing adoption with marketed biosimilars

4.3 Technological and Treatment Paradigm Shifts

Trend	Effect on GAZYVA	Description
Emergence of small molecule inhibitors	Competitive pressure	BTK inhibitors (e.g., ibrutinib) replacing some monoclonals in CLL
Combination regimens	Growth opportunities	GAZYVA combined with frontline chemo or targeted agents boosts sales
Biomarker Driven Therapy	Potential limitation	Evolving precision medicine could influence selection

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5. Regulatory and Developmental Trends

5.1 Potential Expansion and New Indications

Area	Status	Potential Impact
Marginal Zone Lymphoma (MZL)	Under review	New revenue source if approved
CLL + Obinutuzumab + Ibrutinib	Clinical trials	Future combination strategies

5.2 Biosimilar Market Impact

Year	Biosimilar Launch	Expected Impact
2023–2025	Rituximab biosimilars in major markets	Pricing pressure on GAZYVA, sales erosion

Source: Merck’s biosimilar strategies, regulatory agencies [3]

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6. Future Outlook and Financial Projections

6.1 Revenue Forecasting (2023–2028)

Year	Projected Revenue	Growth Rate	Key Assumptions
2023	\$1.4 billion	+7.7%	Increased indications, successful biosimilar competition managed through market differentiation
2024	\$1.6 billion	+14.3%	Expansion into MZL, new combination protocols
2025	\$1.8 billion	+12.5%	Market expansion in Asia, further label updates
2026	\$2.0 billion	+11.1%	Competition intensifies, strong niche positioning
2027	\$2.2 billion	+10%	Saturation in mature markets, innovative formulations

Note: These are conservative estimates reflecting ongoing market trends, patent considerations, and competitive shifts.

6.2 Key Drivers of Growth

• Expansion into new indications such as MZL or potential earlier-line treatments.
• Combination therapies — especially with BTK inhibitors, BCL-2 inhibitors, or novel immunotherapies.
• Market penetration in emerging economies with supportive regulatory pathways.
• Pricing strategies to navigate biosimilar competition while maintaining premium positioning.

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7. Comparative Analysis: GAZYVA vs. Competitors

Attribute	GAZYVA	Rituximab (biosimilar)	Obinutuzumab (other brands)	Emerging agents
Clinical efficacy	Proven in PFS improvements; specific indications	Similar efficacy but slower PFS improvements	Variable; depends on indication	Varied; targeted small molecules converge
Pricing	Premium	Lower via biosimilars	Similar to GAZYVA	Varies greatly
Patent status	Patents expiring in key markets	Biosimilar availability	Same	N/A
Market share	15–20%	Increasing	Niche	Growing

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8. Key Challenges and Opportunities

Challenges	Opportunities
Biosimilar competition exerting price pressure	Differentiation via enhanced clinical data and expanded indications
Market saturation in high-income economies	Market expansion into emerging markets
Evolving treatment paradigms favoring small molecules	Strategic partnerships for combination regimens
Regulatory hurdles for label expansion	Accelerated approval pathways in key territories

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Key Takeaways

• GAZYVA remains a key player in the hematologic malignancies biologic market, with steady revenue growth projected over the next five years.
• Competitive pressures from biosimilars and emerging therapies necessitate strategic differentiation, including indication expansion and combination therapies.
• The drug’s success relies heavily on regional reimbursement policies, clinical trial outcomes, and market acceptance.
• The expanding landscape of targeted therapies presents both challenges and opportunities for GAZYVA’s market penetration.
• Roche’s strategic focus on indication expansion, clinical efficacy, and market access will determine GAZYVA's future financial trajectory.

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FAQs

1. How does GAZYVA compare to rituximab in terms of efficacy?
GAZYVA has demonstrated superior progression-free survival (PFS) over rituximab in specific trials, such as the GALLIUM study for follicular lymphoma, though overall survival benefits remain comparable.

2. What are the main factors influencing GAZYVA’s market share?
Key factors include clinical efficacy, approval of biosimilars, reimbursement policies, physician prescribing habits, and expansion into new indications.

3. How will biosimilar competition affect GAZYVA’s revenue?
Biosimilars for rituximab are likely to compress prices and erode GAZYVA’s market share, especially in commoditized markets. Differentiation strategies and indication expansion are critical to mitigate this impact.

4. Are there prospects for GAZYVA in indications beyond CLL and FL?
Yes, ongoing clinical trials target MZL, and future label extensions could open new revenue streams if approved. Additionally, combination regimens are a growing segment.

5. What are the regulatory prospects for GAZYVA in emerging markets?
Most emerging markets are accelerating approvals for established biologics like GAZYVA, but reimbursement systems and market access remain hurdles. Strategic partnerships are vital.

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References

[1] Market Research Future, "Global Hematology Market," 2022.
[2] Roche Annual Reports (2013–2022).
[3] U.S. FDA and EMA approval and biosimilar policy updates, 2022.