CLINICAL TRIALS PROFILE FOR BEVACIZUMAB

Biosimilar Clinical Trials for bevacizumab

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02069704 ↗	Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients	Completed	Laboratorio Elea Phoenix S.A.	Phase 1	2014-10-29	This is a multicenter, open label, randomized bioequivalence study of BEVZ92 (bevacizumab biosimilar) and Avastin® with 2 parallel arms to compare the pharmacokinetic (PK) profile of BEVZ92 and Avastin® in combination with FOLFOX (any) or FOLFIRI chemotherapy. FOLFOX (any) or FOLFIRI will be chosen as per investigator criteria based on the hospital standard of care.
NCT02069704 ↗	Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients	Completed	Laboratorio Elea S.A.C.I.F. y A.	Phase 1	2014-10-29	This is a multicenter, open label, randomized bioequivalence study of BEVZ92 (bevacizumab biosimilar) and Avastin® with 2 parallel arms to compare the pharmacokinetic (PK) profile of BEVZ92 and Avastin® in combination with FOLFOX (any) or FOLFIRI chemotherapy. FOLFOX (any) or FOLFIRI will be chosen as per investigator criteria based on the hospital standard of care.
NCT02069704 ↗	Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients	Completed	Libbs Farmacêutica LTDA	Phase 1	2014-10-29	This is a multicenter, open label, randomized bioequivalence study of BEVZ92 (bevacizumab biosimilar) and Avastin® with 2 parallel arms to compare the pharmacokinetic (PK) profile of BEVZ92 and Avastin® in combination with FOLFOX (any) or FOLFIRI chemotherapy. FOLFOX (any) or FOLFIRI will be chosen as per investigator criteria based on the hospital standard of care.
NCT02069704 ↗	Bioequivalence Study Bevacizumab Biosimilar (BEVZ92) Versus Bevacizumab (AVASTIN®) in First-line Treatment mCRC Patients	Completed	mAbxience S.A	Phase 1	2014-10-29	This is a multicenter, open label, randomized bioequivalence study of BEVZ92 (bevacizumab biosimilar) and Avastin® with 2 parallel arms to compare the pharmacokinetic (PK) profile of BEVZ92 and Avastin® in combination with FOLFOX (any) or FOLFIRI chemotherapy. FOLFOX (any) or FOLFIRI will be chosen as per investigator criteria based on the hospital standard of care.

All Clinical Trials for bevacizumab

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006786 ↗	Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2000-11-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may stop the growth of colorectal cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus bevacizumab in treating patients who have advanced colorectal cancer.
NCT00006786 ↗	Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer	Completed	Eastern Cooperative Oncology Group	Phase 2	2000-11-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may stop the growth of colorectal cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus bevacizumab in treating patients who have advanced colorectal cancer.
NCT00015951 ↗	Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers	Completed	National Cancer Institute (NCI)	Phase 2	2001-04-01	RATIONALE: Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for hematologic cancer. PURPOSE: Phase II trial to study the effectiveness of bevacizumab combined with cytarabine and mitoxantrone in treating patients who have hematologic cancer.
NCT00015951 ↗	Bevacizumab, Cytarabine, and Mitoxantrone on Treating Patients With Hematologic Cancers	Completed	University of Maryland Greenebaum Cancer Center	Phase 2	2001-04-01	RATIONALE: Monoclonal antibodies such as bevacizumab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may be an effective treatment for hematologic cancer. PURPOSE: Phase II trial to study the effectiveness of bevacizumab combined with cytarabine and mitoxantrone in treating patients who have hematologic cancer.

Clinical Trial Conditions for bevacizumab

Condition Name

Condition Name for bevacizumab
Intervention	Trials
Colorectal Cancer	240
Metastatic Colorectal Cancer	144
Breast Cancer	137
Ovarian Cancer	114

Condition MeSH

Condition MeSH for bevacizumab
Intervention	Trials
Colorectal Neoplasms	565
Carcinoma, Non-Small-Cell Lung	288
Carcinoma	277
Lung Neoplasms	264

Clinical Trial Locations for bevacizumab

Trials by Country

Trials by Country for bevacizumab
Location	Trials
United States	7,752
China	639
Italy	631
Spain	510
Canada	396

Trials by US State

Trials by US State for bevacizumab
Location	Trials
California	413
Texas	366
New York	324
Florida	304
Ohio	301

Clinical Trial Progress for bevacizumab

Clinical Trial Phase

Clinical Trial Phase for bevacizumab
Clinical Trial Phase	Trials
PHASE4	12
PHASE3	37
PHASE2	196

Clinical Trial Status

Clinical Trial Status for bevacizumab
Clinical Trial Phase	Trials
Completed	1144
Recruiting	556
Terminated	234

Clinical Trial Sponsors for bevacizumab

Sponsor Name

Sponsor Name for bevacizumab
Sponsor	Trials
Genentech, Inc.	335
National Cancer Institute (NCI)	322
Hoffmann-La Roche	192

Sponsor Type

Sponsor Type for bevacizumab
Sponsor	Trials
Other	2929
Industry	1538
NIH	340

Clinical Trials Update, Market Analysis, and Projection for Bevacizumab

Last updated: October 27, 2025

Introduction

Bevacizumab, marketed under the name Avastin, is a monoclonal antibody that inhibits vascular endothelial growth factor A (VEGF-A), impeding angiogenesis—a process critical for tumor growth and metastasis. Approved by the U.S. Food and Drug Administration (FDA) in 2004, bevacizumab has become a cornerstone in oncology treatment, notably for colorectal, lung, brain, and kidney cancers. This article provides a comprehensive update on clinical trials, analyzes current market conditions, and offers future market projections, aiding stakeholders in strategic decision-making.

Clinical Trials Update

Ongoing and Recent Clinical Trials

The landscape of bevacizumab-related research remains dynamic, with numerous ongoing clinical trials aimed at expanding its indications, improving efficacy, and reducing adverse effects. According to ClinicalTrials.gov, as of Q1 2023, over 150 active studies involve bevacizumab, spanning various cancer types and combinatorial therapies.

Emerging Oncology Indications

Recent phase II and III trials are exploring bevacizumab's utility beyond its traditional indications. Notably:

• Glioblastoma: Trials like NCT03358545 evaluate the efficacy of bevacizumab combined with immune checkpoint inhibitors for recurrent glioblastoma. Early data suggest enhanced progression-free survival (PFS), though overall survival (OS) benefits remain under investigation.
• Ovarian and Fallopian Tube Cancers: Studies such as NCT02583379 are assessing the combination of bevacizumab with chemotherapeutic agents, with preliminary results indicating improved PFS.
• Non-Oncology Applications: Investigations into its anti-angiogenic potential for age-related macular degeneration (AMD) and diabetic retinopathy, though these are in early phases or preclinical stages.

Combination Therapies and Biomarker-Driven Approaches

Recent trials emphasize combination regimens integrating bevacizumab with immunotherapies (e.g., PD-1/PD-L1 inhibitors). For example, NCT03406949 examines bevacizumab with atezolizumab in non-small cell lung cancer (NSCLC), demonstrating promising response rates and manageable safety profiles. Moreover, research into predictive biomarkers, such as circulating VEGF levels and genetic markers, aims to optimize patient selection and response prediction.

Clinical Trial Challenges and Limitations

While advances are notable, challenges persist:

• Resistance Development: Tumor resistance to anti-VEGF therapy remains a significant hurdle, often leading to relapse.
• Adverse Events: Hypertension, bleeding, and impaired wound healing are common side effects complicating long-term use.
• Biomarker Validation: The lack of reliable biomarkers hampers personalized treatment strategies.

Market Analysis

Historical Market Performance

Bevacizumab's initial success catalyzed its broad adoption, with global sales peaking at approximately $6.8 billion in 2017 (IQVIA), primarily driven by its use in colorectal, lung, and renal cell carcinomas. Despite patent expirations and biosimilar entries, it maintains a significant footprint in oncology.

Market Dynamics and Competitive Landscape

• Patent Expiry and Biosimilars: The expiration of the original patent in major markets (e.g., Europe in 2018, US in 2018 for some formulations) has led to increased biosimilar competition, reducing prices and expanding accessibility.
• Biosimilar Approvals: Notable biosimilars such as Amgen's Mvasi (2017) and Samsung Bioepis' Bemgalasim (biosimilar to Avastin) have gained regulatory approval, intensifying market competition.
• Geographic Market Variations: Developed markets dominate bevacizumab utilization, but emerging markets, particularly China and India, exhibit growing adoption driven by cost considerations and expanding cancer incidence.

Market Drivers

• Expanding Indications: Clinical trials indicating potential benefits in new cancer types.
• Combination Regimens: Growing evidence supporting bevacizumab's effectiveness alongside immunotherapies.
• Personalized Medicine: Advances in biomarker research may enhance treatment efficacy, broadening its application.

Market Constraints

• Safety Concerns: Adverse events limit long-term use in some patient populations.
• Cost and Reimbursement: High treatment costs pose barriers, especially in low- and middle-income countries.
• Regulatory Scrutiny: Variability in approval status across jurisdictions influences market accessibility.

Market Projection and Future Outlook

Growth Forecast

The global bevacizumab market was valued at approximately $4.5 billion in 2022, with projections indicating a compound annual growth rate (CAGR) of 5.8% until 2030 (Research and Markets). The market is expected to reach over $8 billion by 2030, driven by new indications, biosimilar proliferation, and ongoing clinical research.

Key Factors Influencing Future Market Trends

• Innovations in Combination Therapy: As immuno-oncology evolves, combination regimens incorporating bevacizumab are likely to become standard in more cancer types, notably lung, ovarian, and recurrent glioblastoma.

• Expansion into Non-Oncology Indications: Although still exploratory, anti-VEGF therapies' potential role in AMD and diabetic retinopathy may diversify applications, albeit contributing modestly to revenues.

• Regulatory and Reimbursement Policies: Favorable policies and reimbursement frameworks in emerging markets will catalyze broader access and sales growth.

• Personalized Treatment Paradigms: Biomarker-driven patient stratification will optimize efficacy, possibly leading to targeted, smaller patient cohorts and higher treatment success rates.

Risks and Opportunities

• Patent Litigations and Biosimilar Entry: Patent disputes could delay commercialization or impact pricing strategies.
• Resistance and Side Effects: Addressing resistance mechanisms and adverse effects might enhance long-term utility.
• Innovative Competitors: Novel anti-angiogenic agents and targeted therapies could erode market share unless bevacizumab adapts accordingly.

Conclusion

Bevacizumab remains a fundamental component of cancer therapy, with ongoing clinical trials exploring its expanding role. The landscape anticipates continued growth driven by innovative combination regimens, biosimilar competition, and potential new indications. Strategic investment in biomarker research and personalized approaches will be essential for maximizing its market potential. Stakeholders should monitor clinical developments and regulatory shifts to navigate the evolving landscape effectively.

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Key Takeaways

• Clinical advancements are focusing on expanding bevacizumab's indications, especially in glioblastoma, ovarian, and lung cancers, with promising early trial results.
• Market evolution is characterized by biosimilar proliferation, resulting in price competition and broader access, yet patent expiration remains a factor influencing dynamics.
• Growth projections point toward a robust CAGR of nearly 6% through 2030, driven by new clinical evidence and geographic market expansion.
• Personalized medicine through biomarker-guided therapy is poised to optimize outcomes and sustain market relevance.
• Challenges such as resistance, adverse effects, and high costs must be addressed to sustain long-term growth and maximize patient benefit.

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FAQs

1. How is the clinical efficacy of bevacizumab changing in emerging indications?
Recent trials suggest improved progression-free survival in several cancers beyond its traditional uses, especially when combined with immunotherapies. However, long-term benefits and overall survival improvements require further validation.

2. What is the impact of biosimilars on the bevacizumab market?
Biosimilars have significantly reduced treatment costs and increased accessibility, leading to increased market penetration. They also intensify competition but may affect profit margins for originator manufacturers.

3. Are there ongoing efforts to mitigate bevacizumab's adverse effects?
Yes. Research focuses on dose optimization, combination strategies, and identifying biomarkers to select suitable patients, reducing the incidence of hypertension, bleeding, and wound healing issues.

4. What are potential future applications of bevacizumab outside oncology?
Early research explores its role in ocular diseases like AMD and diabetic retinopathy. However, these are in nascent stages, and oncology remains its primary domain.

5. How will personalized medicine influence bevacizumab’s market?
Genomic and biomarker-based stratification will improve patient selection, increase treatment efficacy, and reduce unnecessary exposure, thereby expanding its use in tailored therapeutic regimens.

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Sources

[1] IQVIA, "Global Oncology Market Data, 2017."
[2] ClinicalTrials.gov, "Bevacizumab Clinical Trials," accessed Q1 2023.
[3] Research and Markets, "Global Bevacizumab Market Forecast to 2030," 2022.
[4] FDA, "Approved Drugs and Therapeutic Biological Products," 2023.