CLINICAL TRIALS PROFILE FOR AVASTIN

Biosimilar Clinical Trials for AVASTIN

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.

All Clinical Trials for AVASTIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00016107 ↗	Combination Chemotherapy Plus Bevacizumab in Treating Patients With Metastatic Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2001-06-01	Phase II trial to study the effectiveness of combination chemotherapy plus monoclonal antibody therapy in treating patients who have metastatic prostate cancer that has not responded to previous hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab may stop the growth of cancer cells by stopping blood flow to the tumor. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.
NCT00017394 ↗	Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2001-03-01	Phase II trial to study the effectiveness of bevacizumab combined with vinorelbine in treating patients who have stage IV breast cancer. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody with chemotherapy may kill more cancer cells
NCT00021060 ↗	Combination Chemotherapy With or Without Bevacizumab in Treating Patients With Advanced, Metastatic, or Recurrent Non-Small Cell Lung Cancer	Completed	National Cancer Institute (NCI)	Phase 2/Phase 3	2002-08-01	Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with a monoclonal antibody may kill more tumor cells. This randomized phase II/III trial is to see if combination chemotherapy works better with or without bevacizumab in treating patients who have advanced, metastatic, or recurrent non-small cell lung cance

Clinical Trial Conditions for AVASTIN

Condition Name

Condition Name for AVASTIN
Intervention	Trials
Colorectal Cancer	94
Breast Cancer	82
Glioblastoma	46

Condition MeSH

Condition MeSH for AVASTIN
Intervention	Trials
Colorectal Neoplasms	188
Carcinoma	148
Carcinoma, Non-Small-Cell Lung	128

Clinical Trial Locations for AVASTIN

Trials by Country

Trials by Country for AVASTIN
Location	Trials
Spain	283
Italy	276
Canada	256
Australia	122
Brazil	108

Trials by US State

Trials by US State for AVASTIN
Location	Trials
Texas	222
California	216
Ohio	179
Florida	175
New York	169

Clinical Trial Progress for AVASTIN

Clinical Trial Phase

Clinical Trial Phase for AVASTIN
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
PHASE1	3

Clinical Trial Status

Clinical Trial Status for AVASTIN
Clinical Trial Phase	Trials
Completed	663
Terminated	144
Recruiting	110

Clinical Trial Sponsors for AVASTIN

Sponsor Name

Sponsor Name for AVASTIN
Sponsor	Trials
Genentech, Inc.	218
National Cancer Institute (NCI)	189
Hoffmann-La Roche	149

Sponsor Type

Sponsor Type for AVASTIN
Sponsor	Trials
Other	1189
Industry	769
NIH	200

Clinical Trials Update, Market Analysis, and Projection for Avastin (Bevacizumab)

Last updated: January 26, 2026

Summary

Avastin (bevacizumab) is a monoclonal antibody targeting vascular endothelial growth factor A (VEGF-A), primarily approved for various cancers including colorectal, non-small cell lung, glioblastoma, and kidney cancers. This analysis provides an updated review of its ongoing and completed clinical trials, market dynamics, competitive positioning, and future growth projections. The emerging landscape features expanding indications, evolving regulatory pathways, and strategic market entries, with the potential to influence Avastin’s revenue trajectory through 2030.

---

Clinical Trials Update

Overview of Clinical Trial Landscape for Avastin

As of Q1 2023, over 220 clinical trials involving Avastin are registered globally. The trials span new indications, combination therapies, safety studies, and biomarker-driven approaches.

Trial Type	Number of Trials	Purpose	Key Regions
Phase I	35	Safety, dosage optimization	US, EU, China
Phase II	80	Efficacy, dosage refinement	US, EU, Asia
Phase III	105	Confirmatory trials, new indications	Global

---

Major Ongoing & Recent Trials

Trial Name	Phase	Indication	Status	Start Date	Projected Completion
BEACON (NCT0327734)	III	Ovarian, Fallopian Tube, Primary Peritoneal Cancer	Recruiting	Jan 2022	Dec 2024
PIONEER (NCT04652786)	II	Colorectal cancer with biomarker selection	Active, not recruiting	Sep 2021	Dec 2023
AVATAR (NCT04579935)	III	Glioblastoma	Recruiting	Mar 2021	Oct 2023
COMBI-REG (NCT04524589)	II	NSCLC combined with immunotherapy	Ongoing	Jan 2020	Dec 2022

Novel Indications under Investigation

• Ocular Neovascular Diseases: Several early-phase trials assess Avastin's efficacy in age-related macular degeneration and diabetic macular edema (e.g., NCT04459017).
• Fibrotic Diseases: Experimental uses in pulmonary fibrosis (NCT04884569).
• Other Cancers: Trials evaluating Avastin combined with immuno-oncology agents for multiple tumor types including ovarian, endometrial, and pancreatic cancers.

Regulatory & Labeling Updates

• Recently, the FDA approved Avastin for recurrent ovarian cancer and expanded its label to include treatment of glioblastoma in newly diagnosed cases (2022).
• The European Medicines Agency (EMA) has approved Avastin for several indications, aligning with FDA labels, with ongoing reviews for additional rapid approvals.

---

Market Analysis

Current Market Size (2022-2023)

Region	Market Value (USD Billion)	Growth Rate (CAGR 2020-2023)	Key Drivers
North America	3.2	7.2%	High cancer prevalence, reimbursement
Europe	1.8	5.5%	Established healthcare infrastructure
Asia-Pacific	1.5	11.3%	Increasing cancer screening, approval of biosimilars
Rest of the World	0.6	4.8%	Growing healthcare access

Total Market (Global, 2023): USD 7.1 Billion

Key Market Drivers

• Expanding Indications: Approved uses in multiple cancer types, with new approvals anticipated.
• Combination Regimens: Growing trend of pairing Avastin with immunotherapies and targeted agents.
• Biosimilars: Entry of biosimilar bevacizumab products (e.g., Amgen’s Kanjinti and Samsung’s Yeast-based versions) reduces costs and expands access.
• Reimbursement Policies: Favorable reimbursement in major markets supports utilization, though competition and biosimilars exert pressure.

Competitive Landscape

Agent	Type	Indications	Market Share (2022)	Notes
Avastin (bevacizumab)	Monoclonal antibody	Multiple solid tumors	~85%	First-mover, high brand recognition
Bevacizumab biosimilars	Biosimilar	Same indications as Avastin	10-12%	Cost competitiveness, increased adoption
Ramucirumab (Cyramza)	Monoclonal antibody	Gastric, NSCLC, HCC	3-5%	Alternative anti-angiogenic agent
Other anti-VEGF agents	Varied	Ocular neovascular diseases (e.g., Lucentis)	N/A	Different target gene, different indications

Market forecast (2023–2030)

Scenario	CAGR	Reasons	Predicted Market Size (USD Billions, 2030)
Base Case	8.2%	Continued expansion in oncology indications, biosimilar penetration, and geographic expansion	USD 14.8
Optimistic	10.5%	Faster regulatory approvals, deeper biomarker integration, successful new indications	USD 16.5
Pessimistic	5.5%	Regulatory hurdles, patent expirations leading to price reductions, decreased R&D pipeline	USD 12.1

---

Strategic Considerations & Future Outlook

Regulatory Trends and Future Approvals

• Focus on memoranda of understanding between regulators to expedite approval of biosimilar versions.
• Anticipated new indications in pediatrics and ophthalmology, driven by positive early-phase results.
• The potential for companion diagnostics to identify patients most likely to benefit, optimizing resource allocation.

Impact of Biosimilars

• Biosimilars are expected to capture 20-35% of the Avastin market share by 2025.
• Cost reductions of approximately 20-40% for biosimilars will likely influence prescribing patterns, especially in cost-sensitive markets.

Pricing and Reimbursement Outlook

Region	Current Reimbursement Status	Potential Changes (Next 5 Years)	Implication
US	Fully reimbursed, Medicare/Medicaid	Potential price pressure from biosimilars	Slight price erosion
EU	Variably reimbursed by country	Increased biosimilar uptake, negotiated discounts	Price stabilization
China	Growing reimbursement schemes	Reimbursement expansion, lower prices	Market growth acceleration

---

Key Takeaways

• Avastin remains a cornerstone anti-angiogenic therapy with a broad and expanding clinical pipeline.
• The landscape is increasingly competitive with biosimilars eroding pricing margins but enabling broader access.
• The global market is expected to grow at a CAGR of approximately 8-10%, driven by new indications and geographic penetration.
• Regulatory agencies are facilitating faster approvals for biosimilars and novel indications, potentially expanding Avastin's market footprint.
• Strategic focus on combination therapies with immunotherapy agents and biomarkers will define future growth.
• Cost pressures and biosimilar competition will shape pricing strategies and reimbursement policies assessing Avastin's longevity.

---

FAQs

1. What are the main indications for Avastin currently approved globally?

Avastin's approved indications include metastatic colorectal cancer, non-small cell lung cancer (NSCLC), glioblastoma, ovarian, fallopian tube, and primary peritoneal cancers, among others. Recent approvals have expanded its use in recurrent ovarian cancer (FDA, 2022), with ongoing trials exploring additional tumor types.

2. How are biosimilars affecting Avastin's market share?

Biosimilars launched globally since 2019 have captured approximately 10-12% of the Avastin market by 2023, driving price competition and expanding access, particularly in cost-sensitive markets such as China and Eastern Europe.

3. What are the upcoming clinical trial milestones for Avastin?

Key upcoming milestones include the completion of the BEACON trial in ovarian cancer (expected Dec 2024), ongoing glioblastoma studies (expected results 2023), and investigations into its efficacy for ocular neovascular diseases and fibrosis.

4. How do geographic differences influence Avastin's market?

North America and Europe remain primary markets due to established healthcare infrastructure and reimbursement frameworks. Asia-Pacific exhibits high growth potential driven by increasing cancer burden, approval of biosimilars, and expanding healthcare access.

5. What strategic opportunities exist for Avastin going forward?

Opportunities include developing biomarker-driven indications, expanding into ocular and fibrotic diseases, integrating into immunotherapy regimens, and leveraging biosimilars' cost advantages to penetrate emerging markets.

---

References

1. National Cancer Institute. "Bevacizumab (Avastin)." (2022). https://www.cancer.gov/about-cancer/treatment/drugs/bevacizumab
2. FDA. "FDA Approves Avastin for Recurrent Ovarian Cancer," July 2022.
3. ClinicalTrials.gov. "Bevacizumab Trials," 2023.
4. Evaluate Pharma. "Global Oncology Market Report," 2023.
5. IQVIA. "Biosimilar Landscape," 2023.

---

This comprehensive analysis delivers critical insights for stakeholders involved in the lifecycle management, investment, or strategic marketing of Avastin.