Bevacizumab - Biologic Drug Details

Summary for bevacizumab

Tradenames:	1
High Confidence Patents:	24
Applicants:	6
BLAs:	6
Suppliers: see list	6
Recent Clinical Trials:	See clinical trials for bevacizumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for bevacizumab

Recent Clinical Trials for bevacizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
BioNTech SE	PHASE2
Bristol-Myers Squibb	PHASE2
National Cancer Institute (NCI)	PHASE2

See all bevacizumab clinical trials

Recent Litigation for bevacizumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
GENENTECH, INC. v. DR. REDDYS LABORATORIES, INC.	2023-11-17
Genentech, Inc. v. Biogen MA Inc.	2023-07-13
Genentech, Inc. v. Samsung Bioepis Co. Ltd.	2020-06-28

See all bevacizumab litigation

PTAB Litigation

Petitioner	Date
Pfizer Inc.	2018-01-05

See all bevacizumab litigation

Pharmacology for bevacizumab

Mechanism of Action	Vascular Endothelial Growth Factor Inhibitors Vascular Endothelial Growth Factor-directed Antibody Interactions
Established Pharmacologic Class	Vascular Endothelial Growth Factor Inhibitor

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 bevacizumab Derived from Brand-Side Litigation

These patents were obtained from brand-side disclosures in response to biosimilar applications

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Patent Expiration
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004		2031-05-26
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004		2032-01-14
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004		2031-05-26
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004		2028-07-08
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085	February 26, 2004		2034-03-14

2) High Certainty: US Patents for bevacizumab 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.	AVASTIN	bevacizumab	Injection	125085		2036-03-28	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2033-09-12	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2036-12-09	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2035-02-04	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2036-03-30	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for bevacizumab 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.	AVASTIN	bevacizumab	Injection	125085		2036-03-28	Patent claims search
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2033-09-12	Patent claims search
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2036-12-09	Patent claims search
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2035-02-04	Patent claims search
Genentech, Inc.	AVASTIN	bevacizumab	Injection	125085		2036-03-30	Patent claims search

International Patents for bevacizumab

Country	Patent Number	Estimated Expiration
China	108602854
Singapore	193564
Japan	6050226
Spain	2270425
Finland	3388075

Supplementary Protection Certificates for bevacizumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C300238	Netherlands		PRODUCT NAME: NATALIZUMAB; REGISTRATION NO/DATE: EU/1/06/346/001 20060627
SZ 23/2006	Austria		PRODUCT NAME: NATALIZUMAB
C00804237/01	Switzerland		PRODUCT NAME: NATALIZUMABUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57273 03.05.2007
06C0024	France		PRODUCT NAME: NATALIZUMAB,ANTICORPS MONOCLONAL HUMANISE ANTI-INTEGRINE ALPHA-4; REGISTRATION NO/DATE: EU/1/06/346/001 20060627
122006000043	Germany		PRODUCT NAME: NATALIZUMAB; NAT. REGISTRATION NO/DATE: EU /1/06/346/001 20060627; FIRST REGISTRATION: EU EU/1/06/346/001 20060627

Market Dynamics and Financial Trajectory for the Biologic Drug: Bevacizumab

Last updated: December 9, 2025

Executive Summary

Bevacizumab (brand name Avastin) remains a cornerstone biologic in oncology since its FDA approval in 2004, primarily targeting vascular endothelial growth factor (VEGF-A) to inhibit tumor angiogenesis. Over the past two decades, its market landscape has evolved amidst competition from biosimilars, emerging therapies, and shifting healthcare policies. As of 2023, the global bevacizumab market is valued at approximately USD 7.5 billion, with projections estimating a compound annual growth rate (CAGR) of around 4.2% through 2030. Despite patent expirations and biosimilar entries, bevacizumab maintains significant clinical relevance, underpinned by its extensive indications, high revenue contribution, and ongoing research. This paper dissects the current market dynamics, examines financial trajectories, and evaluates future prospects in a complex biopharmaceutical environment.

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Summary of Key Market Insights

Aspect	Data / Insight/Future Outlook
Current Market Size (2023)	USD 7.5 billion
CAGR (2023–2030)	4.2%
Main Revenue Regions	North America (45%), Europe (25%), Asia-Pacific (20%), Rest of World (10%)
Major Competitions	Biosimilars, newer targeted therapies for cancer
Patent Status	Patent expiry in 2019; biosimilars introduced worldwide
Leading Biosimilars	Bevacizumab-awwb (Amgen), Zirabev (Sandoz), Mvasi (Mylan/AbbVie)
Key Indications	Colorectal, non-small cell lung, kidney, cervical, ovarian cancers
Pricing Trends	Price reductions due to biosimilars, market-driven price stabilization

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What Are the Core Market Drivers for Bevacizumab?

Clinical Efficacy and Expanded Indications

Initially approved for metastatic colorectal cancer (mCRC), bevacizumab's versatility has expanded across:

• Non-small cell lung cancer (NSCLC)
• Glioblastoma
• Cervical and ovarian cancers
• Renal cell carcinoma

This diversification increases its revenue potential and preserves its clinical relevance.

Technological and Regulatory Factors

Regulatory pathways for biosimilars have matured, facilitating market entry and cost competition. The U.S. FDA approved the first biosimilar for bevacizumab in 2017, enabling more aggressive pricing strategies and expanding access.

Market Penetration in Emerging Economies

Growing healthcare infrastructure, rising cancer incidence, and cost-sensitive markets accelerate bevacizumab adoption in Asia-Pacific and Latin America, forging a robust growth pathway.

Rising Cancer Incidence and Aging Population

The forecasted increase in global cancer cases (by 47% from 2020 to 2040) underpins the sustained demand for anti-angiogenic therapies like bevacizumab.

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How Do Patent Expirations and Biosimilars Impact the Market?

Year	Patent Expiry	Biosimilar Entry	Market Impact
2019	US and EU patents	Bevacizumab-awwb (Amgen), Mvasi (Mylan), Zirabev (Sandoz)	Significant price reductions (~20-30%) in North America and Europe
2020–2023	Ongoing biosimilar approvals	Additional biosimilars (e.g., Herzuma, Bevaxima)	Increased market competition, erosion of exclusivity

Impact on Pricing

• Pre-expiry, per-vial prices ranged between USD 3,000–USD 5,000.
• Post-entry of biosimilars, prices have declined, with some fixed-dose vials now retailing at USD 1,500–USD 2,000.

Market Share Distribution

Market Share	Pre-biosimilar	Post-biosimilar (2023)
Original biologic	~85%	~40%
Biosimilars	~15%	~60%

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What Are the Future Market Trends and Financial Trajectories?

Projected Market Growth

• Compound Annual Growth Rate (CAGR): 4.2% (2023–2030).
• Market Valuation: Anticipated to reach USD 10.3 billion by 2030.
• Growth Drivers:
  • Broader indications, including combination regimens.
  • Increased access in emerging markets.
  • Ongoing clinical trials expanding approved uses.

Key Drivers of Revenue

Factor	Influence
Expanded Labeling for New Cancers	USD 1.2 billion revenue increase (2024–2028) expected
Biosimilar Price Competition	20–30% price reduction post-2019, pressure on revenue margins
Healthcare Policy Shifts (e.g., value-based care)	Focus on therapy efficiency and cost-effectiveness
Investment in Biosimilar Portfolio	Diversification to include next-generation biologics

Forecasted Revenue Contributions By Region

Region	2023 Revenue	2030 Projection	Notes
North America	USD 3.38B	USD 3.90B	Patent expiration impact, biosimilar competition
Europe	USD 1.88B	USD 2.17B	Stringent pricing controls, managed entry of biosimilars
Asia-Pacific	USD 1.50B	USD 2.10B	Growing adoption, increased healthcare expenditure
Rest of World	USD 0.75B	USD 1.16B	Emerging markets, increased cancer burden

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How Are Competitors and New Therapies Reshaping the Landscape?

Biosimilars and Cost Competition

Biosimilars for bevacizumab have captured significant market share due to:

• Regulatory Approvals: U.S. FDA (2017), European EMA (2018)
• Pricing Strategy: Price discounts up to 30%
• Market Penetration: Faster adoption in clinics seeking cost savings

Emerging Considerations

• Next-generation Biologics: Monoclonal antibodies and small molecule combinations
• TKIs (Tyrosine Kinase Inhibitors): Such as cabozantinib, lenvatinib, competing indirectly
• Immunotherapies: Immune checkpoint inhibitors increasingly combined with anti-angiogenics

Impact of Precision Medicine

Better patient stratification and biomarkers may refine bevacizumab use, optimizing outcomes and economic returns.

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What Regulatory Policies Influence the Market?

Policy Aspect	Impact on Market and Financials	Examples
Biosimilar Approval Pathways	Accelerate biosimilar entry, cut costs	FDA’s 351(k) pathway
Price Negotiation and Reimbursement Policies	Potentially lower reimbursement rates, revenue impact	CMS negotiates drug prices in Medicare
Patent Litigation and Market Exclusivity	Extend or curtail market dominance	Patent litigation delays biosimilar entry, e.g., Allergan case

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Comparison: Bevacizumab vs. Emerging Therapies

Aspect	Bevacizumab	Emerging Therapies
Mechanism of Action	Anti-VEGF-A monoclonal antibody	Checkpoint inhibitors, TKIs, bispecifics
Indications	Multiple solid tumors	Expanded or targeted indications
Cost	USD 1,500–USD 3,000 per dose (biosimilars lower)	Varies; often higher or tailored
Clinical Evidence	Extensive, decades of data	Varied, ongoing trials
Market Position	Established, widely adopted	Growing, innovative pipeline

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Key Challenges and Risks

• Price erosion: Due to biosimilars and aggressive pricing strategies.
• Regulatory hurdles: Stringent requirements for new indications or biosimilar approval.
• Market saturation: In primary indications like mCRC and NSCLC.
• Clinical exclusivity: Limiting early biosimilar market penetration in some regions.

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Conclusion: Market Outlook & Investment Considerations

Bevacizumab’s longevity as a therapeutic agent hinges on its proven efficacy, expanding indications, and market adaptation to biosimilar competition. Despite patent expirations and pricing pressures, its broad clinical footprint sustains its revenue streams. Strategic investments should focus on biosimilar portfolio expansion, clinical research for new indications, and regional market penetration, especially in emerging economies. Regulatory landscapes continue to evolve favorably for biologics, while healthcare systems emphasize value-based care, which could influence future pricing and reimbursement.

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Key Takeaways

1. Steady Growth Trajectory: The global bevacizumab market is projected to grow at 4.2% CAGR, reaching over USD 10 billion by 2030.
2. Biosimilar Impact: Biosimilars have significantly eroded traditional revenue, but also increased market access and affordability.
3. Indication Expansion: Ongoing clinical trials and label expansions promise continued revenue growth.
4. Regional Divergence: North America remains dominant, yet Asia-Pacific offers substantial growth opportunities.
5. Competitive Landscape: Real-time competitor strategies, biosimilar approvals, and emerging therapies pose both threat and opportunity.

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FAQs

Q1: How do biosimilars affect the profitability of bevacizumab?
Biosimilars typically reduce per-unit revenue by 20–30%, leading to overall margin compression. However, increased market volume and broader access can offset some declines.

Q2: What are the primary regulatory barriers for biosimilar entry?
Regulatory agencies require demonstration of biosimilarity through extensive analytical, preclinical, and clinical studies, potentially delaying market entry and increasing development costs.

Q3: Which regions offer the most growth potential for bevacizumab?
Emerging economies in Asia-Pacific and Latin America show high growth potential due to increasing cancer prevalence and expanding healthcare coverage.

Q4: Are there any new therapeutic developments threatening bevacizumab’s market share?
Yes. Therapies such as immune checkpoint inhibitors combined with anti-angiogenics, and novel targeted agents, could complement or replace bevacizumab in certain indications.

Q5: How are healthcare policies influencing bevacizumab pricing?
Price controls and reimbursement policies in regions like Europe and some U.S. programs are tightening margins; however, they also incentivize biosimilar adoption, which can benefit payers and patients.

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References

[1] U.S. Food and Drug Administration. (2017). Approval of Bevacizumab biosimilar.
[2] MarketWatch. (2023). Global Bevacizumab Market Size & Share.
[3] IQVIA. (2022). Biologic & Biosimilar Market Data.
[4] European Medicines Agency. (2018). Zirabev biosimilar approval.
[5] WHO. (2020). Cancer statistics and projections.
[6] Frost & Sullivan. (2022). Biopharmaceuticals & Biosimilars Market Outlook.