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Last Updated: December 21, 2024

GARDASIL Drug Profile


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Summary for Tradename: GARDASIL
High Confidence Patents:0
Applicants:1
BLAs:2
Recent Clinical Trials: See clinical trials for GARDASIL
Recent Clinical Trials for GARDASIL

Identify potential brand extensions & biosimilar entrants

SponsorPhase
National Cancer Institute (NCI)Phase 2
PharmaJet, Inc.Phase 2
National Institutes of Health (NIH)Phase 2

See all GARDASIL clinical trials

Pharmacology for GARDASIL
Physiological EffectActively Acquired Immunity
Established Pharmacologic ClassInactivated Human Papillomavirus Vaccine
Chemical StructurePapillomavirus 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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for GARDASIL Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for GARDASIL Derived from Patent Text Search

These patents were obtained by searching patent claims

GARDASIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: GARDASIL

Introduction to GARDASIL

GARDASIL, developed by Merck & Co., is a vaccine designed to protect against human papillomavirus (HPV) infections, which are associated with various cancers and genital warts. The vaccine has been a significant player in the global healthcare market, particularly in the prevention of cervical cancer and other HPV-related diseases.

Global Market Size and Growth

The global GARDASIL market is projected to experience substantial growth. As of 2022, the market size was valued at $3.9 billion, and it is expected to reach $11.9 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 11.6% from 2023 to 2032[1].

Key Growth Factors

Several factors are driving the growth of the GARDASIL market:

Growing Awareness

Increasing awareness about the importance of HPV vaccination in preventing cervical cancer and other related diseases is a significant driver. Educational campaigns and healthcare initiatives are crucial in expanding the market[1].

Expanding Vaccination Programs

The expansion of vaccination programs in both developed and developing countries is creating a larger customer base for GARDASIL. This includes broader applications for the vaccine and increased dedication to global vaccination campaigns[1].

Rising HPV Infection Rates

High rates of HPV infections worldwide continue to drive the demand for vaccines, contributing to market growth. The persistent global burden of HPV-related diseases underscores the need for effective prevention measures like GARDASIL[1].

Emerging Markets

Emerging markets, particularly in the Asia-Pacific region, represent an untapped opportunity. The rising middle-class population in these regions is seeking access to preventive healthcare measures, including GARDASIL[1].

Advanced Formulations

Ongoing research and development to improve vaccine formulations and delivery methods are enhancing product efficacy and market competitiveness. Innovations in this area are expected to continue driving growth[1].

Regional Market Dynamics

Asia-Pacific

The Asia-Pacific region is the fastest-growing market for GARDASIL. Key trends include improving healthcare infrastructure, expanding access to vaccines in densely populated areas, and a heightened focus on preventive healthcare. Despite recent challenges in China, the region remains critical for GARDASIL sales[1][4].

Europe

Europe is the largest market for GARDASIL, driven by well-established healthcare systems and high vaccination rates. The region continues to support the growth of the vaccine through robust healthcare initiatives and awareness campaigns[1].

LAMEA (Latin America, Middle East, and Africa)

In LAMEA, trends involve increasing investments in healthcare infrastructure, awareness campaigns to combat cervical cancer, and collaborations with global health organizations to enhance vaccine accessibility. These efforts are contributing to market development in these regions[1].

Financial Performance of GARDASIL

Quarterly Sales

In the second quarter of 2024, GARDASIL sales reached $2.48 billion, which was little changed from the year-earlier period. However, this was below analysts' expectations of about $2.7 billion. Despite this, Merck expects revenue from GARDASIL to continue increasing, reaching $11 billion by 2030[4].

Annual Growth

In the first quarter of 2024, GARDASIL/GARDASIL 9 sales grew 14% to $2.2 billion, excluding the impact of foreign exchange, sales grew 17%. This growth is attributed to favorable product mix, including lower royalty rates related to GARDASIL/GARDASIL 9[5].

Gross Margin and Operating Expenses

The gross margin for Merck's vaccines portfolio, including GARDASIL, has seen an increase due to favorable product mix and lower royalty rates. In the third quarter of 2024, the non-GAAP gross margin was 80.5%, up from 77.0% in the third quarter of 2023. Operating expenses have also been managed effectively, with a focus on strategic investments in key growth products[2][3].

Challenges and Opportunities in the Chinese Market

Recent Decline in Shipments

Merck experienced a significant decline in GARDASIL shipments to China in the second quarter of 2024, attributed to various factors including an anti-bribery drive and reduced promotional efforts by its Chinese partner, Zhifei. Despite this, Merck remains optimistic about the Chinese market, citing over 120 million eligible women yet to be vaccinated against HPV[4].

Market Share and Competitive Landscape

Merck has not seen a reduction in its market share for GARDASIL, and the vaccine remains the market leader. The company is working closely with its partner to address the current challenges and is confident in the long-term potential of the Chinese market[4].

Competitive Landscape

The GARDASIL market is highly competitive, with several key players including Merck & Co., GlaxoSmithKline, and Sanofi Pasteur. These companies engage in various strategies such as innovation, mergers and acquisitions, and partnerships to maintain and expand their market share. New entrants are also focusing on enhancing vaccine formulations and expanding their geographical reach[1].

Mergers and Acquisitions

The GARDASIL market has seen several mergers and acquisitions aimed at expanding market presence and leveraging synergies to improve product offerings and profitability. These strategic moves help companies stay competitive and innovative in the market[1].

Key Takeaways

  • Substantial Growth: The global GARDASIL market is expected to grow from $3.9 billion in 2022 to $11.9 billion by 2032.
  • Regional Dynamics: The Asia-Pacific region is the fastest-growing market, while Europe remains the largest.
  • Financial Performance: GARDASIL sales have shown steady growth, with expectations of reaching $11 billion by 2030.
  • Challenges in China: Recent declines in shipments to China are temporary, and Merck remains optimistic about the market's potential.
  • Competitive Landscape: The market is highly competitive, with key players focusing on innovation and strategic partnerships.

FAQs

What is the projected growth rate of the GARDASIL market from 2023 to 2032?

The GARDASIL market is expected to grow at a CAGR of 11.6% from 2023 to 2032[1].

Which region is the fastest-growing market for GARDASIL?

The Asia-Pacific region is the fastest-growing market for GARDASIL[1].

What are the main factors driving the growth of the GARDASIL market?

Key factors include growing awareness, expanding vaccination programs, rising HPV infection rates, emerging markets, and advanced formulations[1].

How have GARDASIL sales performed in recent quarters?

In the second quarter of 2024, GARDASIL sales were $2.48 billion, slightly below expectations. However, sales grew 14% in the first quarter of 2024, excluding foreign exchange impacts[4][5].

What challenges is Merck facing in the Chinese market for GARDASIL?

Merck is facing a decline in shipments due to an anti-bribery drive and reduced promotional efforts by its partner, Zhifei. However, the company remains optimistic about the long-term potential of the Chinese market[4].

Sources

  1. Custom Market Insights: Global Gardasil Market Size, Trends, Share, Forecast 2032.
  2. Merck: Merck Announces Third-Quarter 2024 Financial Results.
  3. Merck: Q2 2024 Merck & Co Inc Earnings Call.
  4. BioPharma Dive: Merck shares slide as Gardasil sales drop in China.
  5. Business Wire: Merck Announces First-Quarter 2024 Financial Results.

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