Human papillomavirus 9-valent vaccine, recombinant - Biologic Drug Details

Summary for human papillomavirus 9-valent vaccine, recombinant

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	3
Recent Clinical Trials:	See clinical trials for human papillomavirus 9-valent vaccine, recombinant

Recent Clinical Trials for human papillomavirus 9-valent vaccine, recombinant

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Merck Sharp & Dohme Corp.	Early Phase 1
Boston Medical Center	Early Phase 1
Merck Sharp & Dohme Corp.	Phase 3

See all human papillomavirus 9-valent vaccine, recombinant clinical trials

Pharmacology for human papillomavirus 9-valent vaccine, recombinant

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

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Market Dynamics and Financial Trajectory for the Human Papillomavirus 9-Valent Vaccine, Recombinant

Introduction

The human papillomavirus (HPV) 9-valent vaccine, recombinant, has emerged as a crucial tool in the prevention of HPV-related cancers and diseases. This vaccine, commonly known as GARDASIL 9, is developed by Merck and has been gaining significant traction in the global healthcare market. Here, we delve into the market dynamics and financial trajectory of this biologic drug.

Market Segmentation

The global HPV vaccines market is segmented based on the type of vaccine, with the 9-valent HPV vaccine being one of the key segments. Currently, the market includes bivalent, quadrivalent, and 9-valent HPV vaccines. As of 2022, the quadrivalent HPV vaccine segment holds the largest market share, but the 9-valent HPV vaccine segment is anticipated to register the highest Compound Annual Growth Rate (CAGR) of 5.4% during the forecast period[1].

Growth Drivers

Several factors are driving the growth of the 9-valent HPV vaccine market:

Expanded Age Indication

The FDA's approval for an expanded age indication for GARDASIL 9 to include women and men ages 27 to 45 has significantly broadened the target population. This expansion is expected to be a primary driving factor for the market during the forecast period[3][4].

Increasing Demand

There is a rising demand for HPV vaccines, particularly in areas where supply is limited. This demand is driven by the increasing awareness of HPV-related cancers and the effectiveness of the vaccine in preventing these diseases[4].

Government and Corporate Investments

Governments and pharmaceutical companies are investing heavily in the development and distribution of HPV vaccines. These investments are expected to expand the market and create new investment opportunities[4].

Cost-Effectiveness

The cost-effectiveness of the 9-valent HPV vaccine is a critical factor in its adoption, especially in low-resource settings.

Economic Analysis

Studies have shown that the 9-valent HPV vaccine is very cost-effective compared to the current 2- and 4-valent vaccines, provided the added cost does not exceed certain thresholds. For example, in Kenya and Uganda, the vaccine is considered cost-effective if the added cost per vaccinated girl does not exceed specific international dollar amounts, which vary based on different scenarios[2].

Affordability and Access

Despite its cost-effectiveness, affordability remains a challenge. The vaccine's price, although justified by its health benefits, is higher than that of the 2- and 4-valent vaccines. However, financial support options and insurance coverage can mitigate out-of-pocket costs for patients. For instance, in the U.S., 92.3% of patients with commercial insurance paid no out-of-pocket costs for GARDASIL 9, while 80% of those with costs paid between $0.01 and $290 per shot[5].

Market Size and Projections

The global HPV vaccine market is projected to experience substantial growth.

Market Size

The market is expected to reach $10.8 billion by 2030, growing at a CAGR of 12.4% from 2022 to 2030. This growth is driven by increasing demand, expanded age indications, and investments in vaccine development[4].

Regional Growth

The Asia-Pacific region is anticipated to register faster growth compared to North American and European markets. This is due to increasing awareness and government initiatives to improve vaccination rates in these regions[4].

Competitive Landscape

Merck's GARDASIL 9 is currently the leading 9-valent HPV vaccine in the market.

Market Leadership

GARDASIL 9 includes the greatest number of HPV types in any available HPV vaccine, protecting against seven HPV types that cause approximately 90% of cervical cancer cases and 80% of high-grade cervical lesions worldwide[3].

Regulatory Approvals

The FDA's priority review and subsequent approvals for expanded age indications have strengthened GARDASIL 9's market position. This regulatory support is crucial for the vaccine's widespread adoption[3].

Health Impact

The health impact of the 9-valent HPV vaccine is significant.

Cancer Prevention

The vaccine prevents cancers caused by the nine HPV types it targets, including cervical, vulvar, vaginal, and anal cancers. It also protects against genital warts caused by HPV types 6 and 11[3].

Public Health Benefits

Widespread vaccination with the 9-valent HPV vaccine can lead to a substantial reduction in HPV-related diseases, thereby improving public health outcomes and reducing healthcare costs associated with these diseases.

Key Takeaways

• The 9-valent HPV vaccine market is expected to grow significantly, driven by expanded age indications, increasing demand, and investments in vaccine development.
• The vaccine is cost-effective, especially in low-resource settings, provided the added cost does not exceed certain thresholds.
• Affordability and access remain critical challenges, but financial support options and insurance coverage can help mitigate these issues.
• The Asia-Pacific region is anticipated to register faster growth compared to other regions.
• Merck's GARDASIL 9 is the leading 9-valent HPV vaccine, with significant health benefits in preventing HPV-related cancers and diseases.

FAQs

Q: What is the projected market size for the HPV vaccine market by 2030?

The global HPV vaccine market is projected to reach $10.8 billion by 2030, growing at a CAGR of 12.4% from 2022 to 2030[4].

Q: Which segment of the HPV vaccine market is expected to grow the fastest?

The 9-valent HPV vaccine segment is anticipated to register the highest CAGR of 5.4% during the forecast period[1].

Q: What is the significance of the FDA's approval for an expanded age indication for GARDASIL 9?

The FDA's approval for an expanded age indication for GARDASIL 9 to include women and men ages 27 to 45 has significantly broadened the target population and is expected to be a primary driving factor for the market during the forecast period[3][4].

Q: How cost-effective is the 9-valent HPV vaccine compared to other HPV vaccines?

The 9-valent HPV vaccine is very cost-effective compared to the current 2- and 4-valent vaccines, provided the added cost does not exceed specific thresholds. For example, in Kenya and Uganda, the vaccine is considered cost-effective if the added cost per vaccinated girl does not exceed certain international dollar amounts[2].

Q: What are the out-of-pocket costs for patients receiving GARDASIL 9 in the U.S.?

In the U.S., 92.3% of patients with commercial insurance paid no out-of-pocket costs for GARDASIL 9, while 80% of those with costs paid between $0.01 and $290 per shot[5].

Sources

1. The Insight Partners, "HPV Vaccine Market: 5.73Bn by 2028, Human Papillomavirus Vaccine Market Type, Dosage Growing at 5 Percent CAGR Lead by 9-Valent HPV Vaccine Segment Global Analysis by The Insight Partners," Biospace, May 26, 2023.
2. Kiatpongsan S, Kim JJ, "Costs and Cost-Effectiveness of 9-Valent Human Papillomavirus (HPV) Vaccination in Two East African Countries," PLoS ONE, September 2014.
3. Merck, "FDA Grants Priority Review to Merck’s Supplemental Biologics License Application (sBLA) for GARDASIL®9 in Women and Men Ages 27 to 45 for the Prevention of Certain HPV-Related Cancers and Diseases," June 13, 2018.
4. Allied Market Research, "Human Papillomavirus (HPV) Vaccine Market Size Report, 2030," Allied Market Research.
5. Merck, "Cost Information for GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)," GARDASIL 9.