CYRAMZA Drug Profile

Summary for Tradename: CYRAMZA

High Confidence Patents:	2
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for CYRAMZA

Recent Clinical Trials for CYRAMZA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Universitaire Ziekenhuizen KU Leuven	PHASE2
National Health Research Institutes, Taiwan	PHASE1
Kaohsiung Medical University Chung-Ho Memorial Hospital	PHASE1

See all CYRAMZA clinical trials

Pharmacology for CYRAMZA

Mechanism of Action	VEGFR2 Inhibitors
Established Pharmacologic Class	Vascular Endothelial Growth Factor Receptor 2 Antagonist

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 CYRAMZA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for CYRAMZA 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
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477		2023-03-04	DrugPatentWatch analysis and company disclosures
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477		2028-09-19	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for CYRAMZA 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
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477		2036-08-10	Patent claims search
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477		2036-03-15	Patent claims search
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477		2037-12-06	Patent claims search
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477		2036-02-02	Patent claims search
Eli Lilly And Company	CYRAMZA	ramucirumab	Injection	125477		2035-02-19	Patent claims search

International Patents for CYRAMZA

Country	Patent Number	Estimated Expiration
Hong Kong	1118229
Luxembourg	92710
Japan	2012105667
Denmark	1916001
Australia	2003213687

Supplementary Protection Certificates for CYRAMZA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2015C/027	Belgium		PRODUCT NAME: RAMUCIRUMAB; AUTHORISATION NUMBER AND DATE: EU/1/14/957 20141223
122015000034	Germany		FORMER OWNER: IMCLONE LLC, 10014 NEW YORK, N.Y., US
92710	Luxembourg		PRODUCT NAME: RAMUCIRUMAB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (CYRAMZA). FIRST REGISTRATION: 20141223
C01916001/01	Switzerland		PRODUCT NAME: RAMUCIRUMAB; REGISTRATION NO/DATE: SWISSMEDIC 65206 29.10.2015
1590026-9	Sweden		PRODUCT NAME: RAMUCIRUMAB; REG. NO/DATE: EU/1/14/957 20141223

Market Dynamics and Financial Trajectory for the Biologic Drug: CYRAMZA

Last updated: September 19, 2025

Introduction

CYRAMZA (ramucirumab) represents a significant advancement in biologic oncology therapeutics, developed by Eli Lilly and Company. As a monoclonal antibody targeting vascular endothelial growth factor receptor-2 (VEGFR-2), CYRAMZA has established a specialized niche in the treatment of various cancers. This article offers an in-depth analysis of the current market dynamics, competitive positioning, regulatory environment, and financial trajectory shaping CYRAMZA’s future prospects.

Market Landscape and Therapeutic Indications

The global oncology biologics market has seen exponential growth driven by advancements in targeted therapies and a rising burden of cancer globally. CYRAMZA primarily targets advanced or metastatic gastric and gastroesophageal junction cancers, non-small cell lung cancer (NSCLC), and metastatic colorectal cancer (mCRC) [1].

Cancer Epidemiology and Market Potential

The expanding incidence of gastric and lung cancers significantly influences the market potential for CYRAMZA. An estimated 1 million new gastric cancer cases occur annually worldwide, predominantly in Asia, where CYRAMZA’s approvals in gastric cancer are particularly pertinent (primarily in Japan, South Korea, and China) [2]. Similarly, NSCLC remains the leading cause of cancer mortality globally, with targeted therapies like CYRAMZA gaining relevance as second-line treatment options [3].

The growing prevalence of colorectal cancer further widens its therapeutic scope, especially given the limited efficacy of existing therapies in resistant cases [4].

Competitive Landscape

CYRAMZA faces competition primarily from other VEGF/VEGFR inhibitors such as Avastin (bevacizumab), Lucentis (ranibizumab), and emerging agents like Lenvima (lenvatinib) and Regorafenib. Its distinct mechanism—binding specifically to VEGFR-2—positions it uniquely; however, overlapping indications impose a competitive pressure that influences its market share.

Other biologics targeting angiogenesis, such as ramucirumab’s competitor, bevacizumab, are more entrenched, given their earlier market access and broader clinical approvals. Yet, CYRAMZA’s differential efficacy in certain patient subgroups and ongoing clinical trials could alter this dynamic.

Regulatory Environment and Geographic Penetration

CYRAMZA's regulatory journey has been complex. It received approval from the U.S. FDA in 2014 for metastatic non-small cell lung cancer (NSCLC) and has subsequent approvals in gastric cancer in several Asian jurisdictions. Regulatory hurdles and differing regional standards impact its market entry and commercialization.

In Japan, where gastric cancer prevalence is high, approvals have paved the way for significant sales. Conversely, in North America and Europe, approval for gastric cancer remains pending or limited, constraining growth. Continuous regulatory submissions and favorable trial outcomes could enhance global access.

Market Dynamics Influencing Financial Trajectory

Revenue Drivers

CYRAMZA’s revenue growth hinges on several factors:

• Expansion of Approved Indications: Regulatory approvals in additional cancers or lines of therapy could expand its market.
• Geographic Expansion: Entering emerging markets with growing cancer burdens, especially in Asia, can significantly impact top-line growth.
• Combination Therapies: Integrating CYRAMZA with immune checkpoint inhibitors or chemotherapy regimens can improve efficacy and market appeal.
• Clinical Trial Outcomes: Positive results from ongoing phase 3 studies evaluating CYRAMZA in other tumor types (e.g., hepatocellular carcinoma) could bolster future revenue streams [5].

Challenges

There are notable challenges:

• Pricing and Reimbursement: Biologics remain costly, and payer negotiations influence sales volumes.
• Market Share Competition: Existing VEGF inhibitors hold substantial market share, demanding competitive pricing and differentiated efficacy.
• Patent Expiry and Biosimilars: Patent cliffs threaten profit margins, emphasizing the importance of pipeline robustness and lifecycle management.

Financial Performance and Outlook

Eli Lilly’s fiscal reports indicate that CYRAMZA contributed modest but strategic revenues, particularly in Asian markets. As of 2022, the drug’s sales remain concentrated within gastric and NSCLC indications, with a stable but moderate growth trajectory.

Analysts forecast a compound annual growth rate (CAGR) of approximately 5–7% for CYRAMZA’s revenue in the next five years, contingent on regulatory approvals and clinical successes. This growth is tempered by the challenges of market competition and pricing pressures.

Innovation and Pipeline Development

Lilly continues investing in innovative combinations involving CYRAMZA to enhance efficacy:

• Combination with immunotherapies, such as PD-1/PD-L1 inhibitors, to address primary resistance mechanisms.
• Trials in hepatocellular carcinoma (HCC), with promising early data indicating potential new indications.

Pipeline expansion not only sustains interest but also diversifies revenue potential, insulating the product from market saturation or indication-specific declines.

Market Risks and Opportunities

Risks

• Regulatory Delays: Lengthy approval processes in Western markets may impede growth.
• Market Penetration Barriers: Established competition and payer constraints limit rapid uptake.
• Clinical Efficacy: Failure to demonstrate superior efficacy or safety in ongoing trials could undermine future approvals.

Opportunities

• Biomarker-driven Approaches: Identifying patient subgroups with heightened responsiveness can maximize clinical benefits and justify premium pricing.
• Global Expansion: Increasing access in emerging markets where cancer prevalence rises sharply.
• Combination Regimens: Leveraging immunotherapy synergy to position CYRAMZA as part of multi-modal treatment paradigms.

Conclusion

CYRAMZA (ramucirumab) occupies a critical niche within the biologic oncology landscape. Its market dynamics are characterized by regional approvals, competition with established VEGF inhibitors, and a cautious yet steady financial trajectory. Strategic emphasis on pipeline development, geographic expansion, and combination therapies can enhance its growth trajectory.

While challenges such as biosimilar entry and regulatory hurdles exist, the increasing global burden of relevant cancers provides substantial long-term opportunity. Its future financial trajectory depends on sustained clinical success, market access initiatives, and the evolution of combination treatment strategies.

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Key Takeaways

• Market Expansion Is Critical: Entry into new indications and regions, especially Asia, will drive revenue growth.
• Pipeline and Combination Strategies Are Key: Trials involving CYRAMZA with immunotherapies and in new tumor types could unlock new markets.
• Competitive Positioning Matters: Maintaining differentiation from other VEGF inhibitors through efficacy, safety, and biomarker-driven approaches is vital.
• Pricing and Payer Negotiations Will Influence Growth: Cost-effective strategies and demonstrating clinical value are essential to secure reimbursement.
• Regulatory Approvals Will Shape Trajectory: Streamlined approval processes and favorable clinical outcomes are necessary for sustained market presence.

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FAQs

1. What are the primary approved indications for CYRAMZA?
   CYRAMZA is approved for metastatic gastric or gastroesophageal junction adenocarcinoma, NSCLC, and previously in colorectal cancer, depending on regional regulatory decisions [1].

2. How does CYRAMZA compare to other VEGF inhibitors?
   Its unique mechanism targets VEGFR-2 specifically, which may offer benefits in certain patient populations, but overall, it faces stiff competition from broader VEGF inhibitors like bevacizumab [3].

3. What future clinical trials could impact CYRAMZA’s market?
   Ongoing trials investigating CYRAMZA combined with immune checkpoint inhibitors in various cancers, including hepatocellular carcinoma and gastric cancers, may open new indications [5].

4. What are the main challenges facing CYRAMZA’s growth?
   The key challenges include limited approvals outside certain regions, competition from established biologics, pricing pressures, and the risk of biosimilar competition once patents expire.

5. What strategic moves could enhance CYRAMZA’s market presence?
   Focused expansion into emerging markets, partnership development for combination therapies, and investment in biomarker research will be crucial.

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References

1. Eli Lilly and Company. CYRAMZA (ramucirumab) Prescribing Information. 2022.
2. Global Cancer Statistics 2022. CA Cancer J Clin. 2022;72(1):7-33.
3. Herbst RS, et al. Efficacy and safety of ramucirumab versus placebo in NSCLC. Lancet Oncol. 2015;16(7):665-674.
4. Siegel RL, et al. Colorectal cancer statistics. CA Cancer J Clin. 2021;71(3):209-236.
5. ClinicalTrials.gov. Ongoing studies involving ramucirumab in various cancers. Accessed 2023.