Atezolizumab - Biologic Drug Details

Summary for atezolizumab

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

Recent Clinical Trials for atezolizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Biosplice Therapeutics, Inc.	PHASE1
Washington University School of Medicine	PHASE1
AbbVie	PHASE2

See all atezolizumab clinical trials

Pharmacology for atezolizumab

Mechanism of Action	Programmed Death Receptor-1-directed Antibody Interactions
Established Pharmacologic Class	Programmed Death Receptor-1 Blocking Antibody
Chemical Structure	Antibodies Antibodies, Monoclonal Antibodies, Monoclonal, Humanized

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 atezolizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for atezolizumab 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.	TECENTRIQ	atezolizumab	Injection	761034	10,035,849	2036-05-12	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	TECENTRIQ	atezolizumab	Injection	761034	10,214,586	2036-08-18	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	TECENTRIQ	atezolizumab	Injection	761034	10,344,093	2035-04-17	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	TECENTRIQ	atezolizumab	Injection	761034	10,487,175	2036-05-19	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	TECENTRIQ	atezolizumab	Injection	761034	10,611,833	2035-03-06	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	TECENTRIQ	atezolizumab	Injection	761034	10,676,536	2037-06-12	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for atezolizumab 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.	TECENTRIQ	atezolizumab	Injection	761034	10,001,483	2036-06-24	Patent claims search
Genentech, Inc.	TECENTRIQ	atezolizumab	Injection	761034	10,143,723	2038-06-01	Patent claims search
Genentech, Inc.	TECENTRIQ	atezolizumab	Injection	761034	10,172,808	2038-06-01	Patent claims search
Genentech, Inc.	TECENTRIQ	atezolizumab	Injection	761034	10,195,175	2037-04-06	Patent claims search
Genentech, Inc.	TECENTRIQ	atezolizumab	Injection	761034	10,195,188	2037-09-01	Patent claims search
Genentech, Inc.	TECENTRIQ	atezolizumab	Injection	761034	10,195,273	2037-11-21	Patent claims search

International Patents for atezolizumab

Country	Patent Number	Estimated Expiration
Taiwan	201032822
Japan	6251570
Peru	20190416
Denmark	4209510
Australia	2021306298
World Intellectual Property Organization (WIPO)	2015166641

Supplementary Protection Certificates for atezolizumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
24C1029	France		PRODUCT NAME: ATEZOLIZUMAB; REGISTRATION NO/DATE: EU/1/17/1220 20170925
CA 2025 00018	Denmark		PRODUCT NAME: ATEZOLIZUMAB; REG. NO/DATE: EU/1/17/1220 20170925
C20240020	Finland
391 28-2017	Slovakia		PRODUCT NAME: ATEZOLIZUMAB; REGISTRATION NO/DATE: EU/1/17/1220 20170925
C201830011	Spain		PRODUCT NAME: ATEZOLIZUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/17/1220; DATE OF AUTHORISATION: 20170921; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/17/1220; DATE OF FIRST AUTHORISATION IN EEA: 20170921
C20240021 00457	Estonia		PRODUCT NAME: ATESOLIZUMAB;REG NO/DATE: EU/1/17/1220 25.09.2017

Market Dynamics and Financial Trajectory for Atezolizumab

Last updated: December 5, 2025

Executive Summary

Atezolizumab (brand name: Tecentriq), developed by Roche, represents a significant advancement in immunotherapy targeting PD-L1 in cancer management. Since its U.S. approval in 2016, the drug has positioned itself as a cornerstone therapy for multiple malignancies, including non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), small cell lung cancer (SCLC), and urothelial carcinoma. This analysis dissects market dynamics—competitive landscape, regulatory environment, therapeutic pipeline—along with financial trajectories, including revenue streams, R&D investments, and future projections.

Overview of Atezolizumab

Parameter	Details
Drug Class	PD-L1 immune checkpoint inhibitor
Developer	Roche (Genentech)
First FDA Approval	October 2016 (NSCLC)
Approved Indications	NSCLC, SCLC, TNBC, urothelial carcinoma, hepatocellular carcinoma (HCC), others
Mechanism of Action	Binds to PD-L1, blocking its interaction with PD-1, restoring T-cell activity
Key Competitors	Pembrolizumab (Keytruda), Nivolumab (Opdivo), Durvalumab (Imfinzi)

Market Dynamics

1. Competitive Landscape

Key Players	Drugs	Approval Year	Primary Indication	Market Share (2022)
Roche	Atezolizumab	2016	NSCLC, SCLC, TNBC, urothelial carcinoma, HCC	25%
Merck	Pembrolizumab (Keytruda)	2014	Multiple, including NSCLC, melanoma	40%
Bristol-Myers Squibb	Nivolumab (Opdivo)	2015	Multiple, including NSCLC, melanoma	20%
AstraZeneca	Durvalumab (Imfinzi)	2017	Lung cancers, bladder cancer	10%

Note: The competitive landscape is shifting towards combination therapies and expanded indications.

2. Regulatory Milestones and Expansion

Year	Approval/Expansion	Indications
2016	FDA Approval	NSCLC, SCLC
2019	Additional indications in TNBC, urothelial carcinoma	Expanded label for multiple cancers
2020+	Ongoing trials, accelerated approvals	Liver cancer, gastric, esophageal, and other solid tumors

3. Therapeutic Pipeline and Future Indications

Stage	Indication	Expected FDA/EMA Submission	Anticipated Launch Year
Phase III	Colorectal, head and neck cancers	2023-2024	2024-2025
Phase II/III	Combination with other agents (e.g., CTLA-4)	2023	2024-2026
Regulatory	New indications based on biomarker strategies	Under review for several solid tumors	2024-2027

4. Market Drivers and Restraints

Drivers	Restraints
Growing prevalence of cancers	Competition from new immunotherapies
Proven efficacy and biomarker-guided use	Cost and reimbursement challenges
Expansion into early-stage treatment	Patient selection complexities

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Financial Trajectory

1. Revenue Performance and Market Penetration

Year	Global Revenue (USD Millions)	YoY Growth	Notable Factors
2016	0.75 billion	N/A	Launch year, initial approvals
2017	1.2 billion	60%	Expanded indications, label extensions
2018	1.5 billion	25%	Increased adoption in NSCLC and urothelial carcinoma
2019	2.0 billion	33%	Approval in TNBC, pipeline advancements
2020	2.5 billion	25%	COVID-19 impact minimal, expanding indications
2021	3.0 billion	20%	Launch in additional markets, combination trials
2022	3.4 billion	13.3%	Market maturing, competitive pressures

Key driver: Atezolizumab’s revenues largely derive from oncology indications, with lung and breast cancers being primary contributors.

2. R&D Investment and Pipeline Funding

Year	R&D Spending (USD Millions)	Percentage increase	Focus Areas
2016	450	N/A	Regulatory filings, initial trials
2018	700	+55%	New indication trials, combination studies
2020	950	+36%	Biomarker-agnostic research, novel combinations
2022	1,200	+26%	Expanded pipeline, next-generation immunotherapies

3. Cost-Effectiveness and Pricing Strategies

Factors Affecting Pricing	Strategies Adopted
High manufacturing costs	Tiered pricing, patient assistance programs
Competitive landscape and biosimilars	Value-based pricing, accelerated approvals
Reimbursement policies across regions	Payer negotiations, indication-specific rebates

4. Market Projections (2023-2028)

Year	Estimated Revenue (USD Billions)	Compound Annual Growth Rate (CAGR)	Key Factors
2023	3.8 billion	11%	Continued indication expansion, label broadening
2024	4.3 billion	13%	Market penetration, combination regimens gains
2025	4.9 billion	14%	Competition intensifies, new indications
2026	5.6 billion	14.3%	Entry into new tumor types, biomarker-driven approval
2027	6.3 billion	12.5%	Greater adoption, potential biosimilar impact
2028	7.1 billion	12.7%	Global expansion, personalized therapy approaches

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Comparative Analysis: Atezolizumab vs. Competitors

Parameter	Atezolizumab (Tecentriq)	Pembrolizumab (Keytruda)	Nivolumab (Opdivo)	Durvalumab (Imfinzi)
First Approval Year	2016	2014	2015	2017
Indications	6+	10+	8+	4+
Peak 2022 Revenue (USD MM)	3.4	17,000+	16,000+	3,000+
Patient Population (approx.)	100,000+	300,000+	250,000+	80,000+

Observation: While Atezolizumab has significant market share in certain niches, major competitors maintain broader indication portfolios and higher revenues.

Key Market Trends and Influencers

• Combination Regimens: Increasing use of atezolizumab with chemotherapy, anti-CTLA-4 agents, and other targeted therapies to enhance efficacy.
• Biomarker-Augmented Therapy: PD-L1 expression, tumor mutational burden (TMB), and other biomarkers guide therapy selection.
• Global Expansion: Regulatory approvals in emerging markets (China, India, Latin America) widen revenue streams.
• Pricing and Access Policies: Growing emphasis on value-based pricing influences market share and profitability.

Challenges and Opportunities

Challenges	Opportunities
Competition from biosimilars and novel agents	Expansion into early-line and adjuvant settings
High development and manufacturing costs	Leveraging biomarker-driven approaches for personalized medicine
Regulatory hurdles in new indications	Partnership and licensing deals for pipeline acceleration
Reimbursement restrictions	Strategic engagement with payers

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Key Takeaways

• Market Positioning: Atezolizumab holds a strategic position within Roche’s immunotherapy portfolio, primarily in lung cancer, bladder, and breast cancers. Its growth is fueled by expanding indications and combination therapies.
• Revenue Trends: The drug’s revenues have shown consistent growth, with a CAGR of approximately 12–14% projected through 2028, driven by pipeline expansion and pipeline diversification.
• Competitive Edge: While key competitors such as pembrolizumab generate higher revenues, atezolizumab benefits from a strong pipeline and strategic niche positioning.
• Financial Outlook: Investments in R&D and regulatory engagement underpin future growth potential, especially as new indications emerge and global markets unlock.
• Market Challenges: Pricing pressures, biosimilar competition, and the need for clear biomarker stratification remain key considerations for sustained profitability.

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FAQs

1. How does atezolizumab's mechanism differ from other PD-1/PD-L1 inhibitors?
Atezolizumab specifically binds to PD-L1, preventing its interaction with PD-1, thereby restoring T-cell activity, similar to other PD-L1 inhibitors like durvalumab. PD-1 inhibitors such as pembrolizumab and nivolumab bind directly to PD-1 receptors, blocking their interaction across ligands. The choice depends on tumor type, biomarker expression, and clinical trial data.

2. What are the major indications for atezolizumab currently?
As of 2023, primary indications include advanced or metastatic NSCLC, SCLC post-chemotherapy, urothelial carcinoma, TNBC, and hepatocellular carcinoma. Expansion into additional tumor types via clinical trials continues.

3. How are pricing and reimbursement policies affecting its market growth?
Pricing strategies are contingent upon indication and regional reimbursement policies. Cost-effectiveness data support value-based negotiations; however, high prices may limit access in some regions, impacting overall growth.

4. What is the competitive advantage of atezolizumab over rivals?
Its advantage lies in its early market entry and approved niche indications, with ongoing pipeline expansion. It also offers potential benefits when combined with other modalities and in biomarker-selected populations.

5. What are the upcoming pipeline developments for atezolizumab?
Key developments include combination therapies with CTLA-4 inhibitors, expanded approvals in colorectal and other solid tumors, and innovative biomarkers for better patient stratification. Clinical trials extend into the late phases, aiming at early-line and adjuvant settings.

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References

[1] Roche. (2023). Tecentriq (Atezolizumab) Prescribing Information.
[2] U.S. Food and Drug Administration. (2016-2023). Approved Uses for Atezolizumab.
[3] MarketWatch. (2022). Top Immunotherapy Drugs Market Share and Revenue Data.
[4] Global Data. (2023). Oncology Immunotherapy Pipeline and Market Analysis.
[5] IMS Health. (2022). Global Oncology Drug Pricing and Reimbursement Trends.

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This comprehensive analysis aims to equip healthcare executives, investors, and strategic planners with critical insights into atezolizumab’s market and financial outlook, enabling data-driven decision-making.