GARDASIL 9 Drug Profile

Summary for Tradename: GARDASIL 9

High Confidence Patents:	5
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for GARDASIL 9

Recent Clinical Trials for GARDASIL 9

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
MGB Pharma	PHASE1
National Institutes of Health (NIH)	Phase 2
National Cancer Institute (NCI)	Phase 2

See all GARDASIL 9 clinical trials

Pharmacology for GARDASIL 9

Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Inactivated Human Papillomavirus Vaccine
Chemical Structure	Papillomavirus Vaccines Vaccines, Inactivated

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 GARDASIL 9 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for GARDASIL 9 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
Merck Sharp & Dohme Llc	GARDASIL 9	human papillomavirus 9-valent vaccine, recombinant	Injection	125508	11,116,828	2038-12-04	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	GARDASIL 9	human papillomavirus 9-valent vaccine, recombinant	Injection	125508	11,638,754	2041-02-09	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	GARDASIL 9	human papillomavirus 9-valent vaccine, recombinant	Injection	125508	7,476,389	2026-01-13	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	GARDASIL 9	human papillomavirus 9-valent vaccine, recombinant	Injection	125508	7,482,015	2027-05-23	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	GARDASIL 9	human papillomavirus 9-valent vaccine, recombinant	Injection	125508	8,012,489	2023-07-28	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for GARDASIL 9 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
Merck Sharp & Dohme Llc	GARDASIL 9	human papillomavirus 9-valent vaccine, recombinant	Injection	125508	10,561,723	2036-07-21	Patent claims search

International Patents for GARDASIL 9

Country	Patent Number	Estimated Expiration
Cyprus	2015050
Ecuador	SP20032085
Hungary	S1500063
Eurasian Patent Organization	202091382
Nicaragua	202000040
Germany	122007000017
Costa Rica	20250169

Supplementary Protection Certificates for GARDASIL 9

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
300261	Netherlands		PRODUCT NAME: HPV11 VLP; NATIONAL REGISTRATION NO/DATE: EU/1/06/358/001-017 20060920; FIRST REGISTRATION: EU EU/1/06/357/001-017 20060920
122007000017	Germany		PRODUCT NAME: HPV11 VIRUS-LIKE PARTICLE; REGISTRATION NO/DATE: EU/1/06/357/001-017 EU/1/06/358/001-017 20060920
132007901583419	Italy		AUTHORISATION NUMBER(S) AND DATE(S): EU/1/07/419/001-009, 20070920
C201530072	Spain		PRODUCT NAME: PROTEINA L1 VPH 45; NATIONAL AUTHORISATION NUMBER: EU/1/15/1007; DATE OF AUTHORISATION: 20150610; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1007; DATE OF FIRST AUTHORISATION IN EEA: 20150610
122007000019	Germany		PRODUCT NAME: HPV6 VIRUS-LIKE PARTICLE; REGISTRATION NO/DATE: EU/1/06/357/001-017 EU/1/06/358/001-017 20060920
122007000018	Germany		PRODUCT NAME: HPV 16 VIRUS-LIKE PARTICLE; REGISTRATION NO/DATE: EU/1/06/357/001-017 EU/1/06/358/001-017 20060920
CR 2007 00010	Denmark		PRODUCT NAME: HPV TYPE 6 L1 PROTEIN; REG. NO/DATE: EU/1/06/357/001-017; EU/1/06/358/001-017 20060920

Market Dynamics and Financial Trajectory for GARDASIL 9

Last updated: September 22, 2025

Introduction

GARDASIL 9, a quadrivalent human papillomavirus (HPV) vaccine, has established itself as a cornerstone in the prevention of HPV-related diseases. Launched globally by Merck & Co., Inc., GARDASIL 9 offers protection against nine HPV types linked to cervical, vulvar, vaginal, anal, and oropharyngeal cancers, as well as genital warts. Its expanding market footprint and strong revenue trajectory mirror shifting epidemiological patterns, policy adaptations, and competitive dynamics.

Market Landscape and Demand Drivers

The global HPV vaccine market, projected to reach approximately $7.7 billion by 2030 (CAGR ~10%), reflects an accelerating demand for GARDASIL 9, driven by multiple factors. Increasing cervical cancer incidence, especially in low- and middle-income countries (LMICs), heightens the urgency for effective prophylaxis. WHO recommendations, including the 2020 global strategy advocating for 90% HPV vaccination coverage by 2030, further catalyze adoption in diverse regions. Additionally, expanding indications to adolescent boys bolster the market, acknowledging HPV's role in other cancers.

Key Market Segments and Geographic Hotspots

• High-Income Countries (HICs): United States, Europe, Japan dominate with established vaccination programs, where GARDASIL 9 is included in national immunization schedules. The United States reports over 90% coverage among school-aged girls and boys, contributing to steady revenue streams.

• Emerging Markets: Latin America, Southeast Asia, and sub-Saharan Africa exhibit rapid growth potential due to strengthening healthcare infrastructure, international support initiatives, and rising awareness. GAVI's vaccine support programs have facilitated procurement and distribution in LMICs.

Competitive Dynamics and Market Share

GARDASIL 9 faces competition from Cervarix (GlaxoSmithKline), a bivalent HPV vaccine, and nonavalent vaccines under development targeting additional HPV types. However, GARDASIL 9 maintains a dominant position, accounting for approximately 65-70% of the global HPV vaccine market (as of latest reports), owing to its broad coverage, proven efficacy, and extensive clinical data. Merck’s strategic collaborations with governments and strong vaccine supply chains reinforce its market leadership.

Regulatory and Policy Influences

Regulatory approvals across multiple jurisdictions—FDA, EMA, and WHO—facilitate market access. The FDA’s approval of GARDASIL 9 for use in males aged 9-45 expanded its target population, subsequently impacting revenue streams positively. Policymakers' inclusion of GARDASIL 9 in immunization schedules directly correlates with sales growth.

Pricing Strategies and Reimbursement Landscape

Pricing policies vary regionally. In HICs, vaccination is often reimbursed or covered by insurance schemes, supporting higher price points ($150–$180 per dose). In LMICs, tiered pricing and GAVI support enable broader access. High vaccine pricing, driven by manufacturing costs and R&D investments, supports a healthy profit margin, although pricing pressures and increased competition could influence future margins.

Financial Trajectory and Revenue Outlook

Since its 2014 U.S. approval, GARDASIL 9 has demonstrated consistent revenue growth. Merck reported vaccine sales of approximately $3.2 billion in 2021, with projections indicating a compound annual growth rate (CAGR) of 8-10% over the next five years. This growth hinges on increasing vaccination coverage, expanded indications, and persistent unmet needs in LMICs.

Pipeline and Innovation Impact

Merck continues to invest in next-generation HPV vaccines with broader coverage and therapeutic potential, potentially disrupting current market dynamics. Nonetheless, GARDASIL 9’s established efficacy and widespread acceptance suggest sustained revenue dominance, at least in the medium term.

Challenges and Opportunities

• Challenges: Vaccine hesitancy, especially regarding adolescent immunization; pricing pressures, particularly in LMICs; emerging biosimilars or non-injectable formulations; and evolving regulatory landscapes.
• Opportunities: New indications, including therapeutic vaccines for HPV-related cancers; integrating HPV vaccination with broader cancer prevention strategies; digital health initiatives to improve uptake; and expanded collaborations to address HPV-related health disparities globally.

Conclusion

GARDASIL 9’s market remains robust, buoyed by global health initiatives, regulatory approvals, and expanding demographics. Its financial trajectory appears resilient, supported by steady market penetration and strategic expansion efforts. Nonetheless, competitive pressures and evolving healthcare policies will necessitate ongoing innovation and adaptation to sustain growth.

Key Takeaways

• GARDASIL 9 is a market leader in HPV vaccines, with a dominant share driven by broad coverage and proven efficacy.
• The global HPV vaccine market is poised for sustained growth, fueled by increasing disease burden awareness and policy momentum.
• The vaccine’s revenue trajectory is optimistic, with projections indicating continuous growth supported by expanding vaccination programs worldwide.
• Challenges such as vaccine hesitancy and pricing pressures require strategic mitigation to maintain market position.
• Opportunities lie in expanding indications, therapeutic developments, and global health collaborations to maximize market impact.

FAQs

1. What factors contribute to GARDASIL 9’s market dominance?
Its extensive coverage of nine HPV types, proven safety and efficacy, inclusion in national immunization programs, and robust manufacturing and distribution channels underpin GARDASIL 9’s market leadership.

2. How are global health policies affecting GARDASIL 9 sales?
Policies promoting HPV vaccination, especially targeting adolescent girls and boys, significantly influence demand. WHO recommendations and GAVI support facilitate access in LMICs, expanding the market.

3. What competitive threats does GARDASIL 9 face?
Emerging HPV vaccines with broader or therapeutic indications, biosimilar entries, and breakthrough non-invasive delivery systems pose potential threats to market share.

4. How does pricing influence GARDASIL 9’s market penetration?
Pricing strategies tied to reimbursement policies, especially in different economic regions, impact vaccine accessibility and overall sales volume.

5. What are the future prospects for GARDASIL 9’s revenue growth?
Continued global vaccination efforts, policy expansion, and potential new indications support a stable to growing revenue trajectory over the next five to ten years.

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References

1. MarketsandMarkets. "HPV Vaccines Market by Type, Age Group, and Region." 2022.
2. World Health Organization. "Global Strategy to Accelerate the Elimination of Cervical Cancer." 2020.
3. Merck & Co., Inc. Annual Reports (2021, 2022).
4. IQVIA. "Global Oncology and Vaccines Market Reports," 2022.
5. GAVI Alliance. "HPV Vaccine Introduction in Low-Income Countries," 2022.