Dengue tetravalent vaccine, live - Biologic Drug Details

Summary for dengue tetravalent vaccine, live

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for dengue tetravalent vaccine, live

Recent Clinical Trials for dengue tetravalent vaccine, live

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Takeda	Phase 3
Takeda	Phase 2
National Institutes of Health (NIH)	Phase 1

See all dengue tetravalent vaccine, live clinical trials

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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. General brand-side disclosures

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.

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 dengue tetravalent vaccine, live Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for dengue tetravalent vaccine, live Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for dengue tetravalent vaccine, live Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Dengue Tetravalent Vaccine, Live

Executive Summary

The dengue tetravalent vaccine market is experiencing rapid growth, driven by increasing incidence of dengue fever, advancements in vaccine technology, and collaborative efforts among pharmaceutical companies. Here, we delve into the market dynamics, financial projections, and key trends shaping the future of this critical biologic drug.

Market Size and Growth

The dengue vaccine market has seen significant expansion in recent years. In 2023, the market size was approximately $0.57 billion, which increased to $0.64 billion in 2024, reflecting a compound annual growth rate (CAGR) of 12%[1].

Forecasted Growth

By 2028, the market is projected to reach $1.02 billion at a CAGR of 12.3%[1]. This rapid growth is anticipated to continue, with the market expected to be worth $1,603.7 million by 2033, registering a CAGR of 12.9% during the forecast period[4].

Regional Breakdown

Asia-Pacific Dominance

The Asia-Pacific region was the largest market for dengue vaccines in 2023, driven by the high prevalence of dengue fever in this area. This region is expected to continue as a major hub for dengue vaccine demand due to the concentration of dengue fever cases and the presence of prominent regional pharmaceutical companies[1][4].

North America: Emerging Market

North America is forecasted to be the fastest-growing region in the coming years. This growth is attributed to increased travel, urbanization, and a rising demand for effective vaccines against dengue fever[1].

Key Trends and Drivers

Rising Incidence of Dengue

The increasing number of dengue fever cases globally is a significant driver of the market. For instance, the World Health Organization reported over 7 million dengue cases in the Americas in April 2024, up from 4.6 million in 2023[1].

Advancements in Vaccine Technology

The development of tetravalent vaccine formulations is a key trend. These vaccines offer protection against all four dengue virus serotypes in a single vaccine, enhancing efficacy and convenience[2].

Collaborative Efforts

Collaborations among pharmaceutical companies are accelerating the production and accessibility of dengue vaccines. For example, Takeda Pharmaceutical Company's partnership with Biological E. Limited aims to produce up to 50 million doses of the QDENGA (TAK-003) vaccine per year, supporting national immunization initiatives[3].

Competitive Landscape

Leading Companies

Sanofi Pasteur, Takeda Pharmaceutical Company, and the National Institute of Allergy and Infectious Diseases are among the leading players in the dengue vaccine market. Sanofi Pasteur's CYD-TDV (Dengvaxia) is currently the only licensed dengue vaccine, while Takeda's TAK-003 and the National Institute's TV003 are in advanced clinical trials[1][2].

Vaccine Formulations and Efficacy

Tetravalent Formulations

Tetravalent vaccines, such as CYD-TDV, TAK-003, and TV003, are designed to provide balanced protection against all four dengue virus serotypes. However, these formulations face challenges such as antigenic competition and the potential for adverse effects due to partial immunity[2].

CYD-TDV Efficacy

CYD-TDV has shown overall vaccine efficacy ranging from 56.5% to 60.8%, with higher protection against DENV3 and DENV4 but lower protection against DENV1 and DENV2. The vaccine's efficacy is also influenced by the baseline serostatus of the recipient[2].

TAK-003 Efficacy

Takeda's TAK-003 has demonstrated significant efficacy in clinical trials, reducing fever cases caused by confirmed dengue disease by 80% and hospitalizations due to dengue by 90% in children and adolescents[5].

Challenges and Future Directions

Antigenic Competition and ADE

One of the significant challenges in dengue vaccine development is antigenic competition within tetravalent formulations, which can skew the immune response. Additionally, the phenomenon of antibody-dependent enhancement (ADE) poses a risk of worsening symptoms upon subsequent heterotypic infection[2].

Research and Clinical Trials

Ongoing research and clinical trials are focused on enhancing vaccine efficacy and safety profiles. There is a heightened focus on developing combination vaccines and improving multi-strain and tetravalent vaccine formulations[1].

Market Segmentation

By Type

The market is segmented into live attenuated vaccines, chimeric live attenuated vaccines, inactivated vaccines, subunit vaccines, and nucleic acid-based vaccines. Each type has its own set of advantages and challenges[1].

By Route of Administration

Vaccines are administered via oral, parenteral, and other routes, each with different implications for efficacy and patient compliance[1].

By End-User

The market is segmented by end-users such as hospitals, clinics, government institutes, non-governmental organizations, and others. Governments are expected to account for a significant portion of the market demand[1].

Financial Projections and Investment

Market Value

The dengue vaccine market is expected to grow significantly, reaching $1,603.7 million by 2033. This growth is driven by increasing demand, advancements in technology, and collaborative efforts among stakeholders[4].

Investment in Research and Development

Pharmaceutical companies are investing heavily in research and development to overcome the challenges associated with dengue vaccine development. These investments are expected to yield new vaccine formulations and improve existing ones[1][4].

Key Takeaways

• The dengue vaccine market is growing rapidly, driven by increasing incidence of dengue fever and advancements in vaccine technology.
• Asia-Pacific is the largest market, with North America expected to be the fastest-growing region.
• Tetravalent vaccine formulations are a key trend, but they face challenges such as antigenic competition and ADE.
• Collaborative efforts among pharmaceutical companies are crucial for accelerating vaccine production and accessibility.
• The market is expected to reach $1,603.7 million by 2033, with a CAGR of 12.9%.

FAQs

What is the current market size of the dengue vaccine market?

The dengue vaccine market size was approximately $0.64 billion in 2024[1].

Which region is expected to be the fastest-growing for dengue vaccines?

North America is expected to be the fastest-growing region for dengue vaccines in the coming years[1].

What are the challenges faced by tetravalent dengue vaccine formulations?

Tetravalent formulations face challenges such as antigenic competition and the potential for adverse effects due to partial immunity and ADE[2].

Which companies are leading in the dengue vaccine market?

Sanofi Pasteur, Takeda Pharmaceutical Company, and the National Institute of Allergy and Infectious Diseases are among the leading players in the dengue vaccine market[1][2].

What is the projected market value of the dengue vaccine market by 2033?

The dengue vaccine market is expected to be worth $1,603.7 million by 2033[4].

Sources

1. Growth Trends in the Dengue Vaccines Industry, 2024-2028 & 2033 - ResearchAndMarkets.com via GlobeNewswire.
2. Current Development and Challenges of Tetravalent Live Attenuated Dengue Vaccines - Frontiers in Immunology.
3. Takeda and Biological E. Announce Collaboration for Dengue Vaccine - Takeda Newsroom.
4. Dengue Vaccines Market Size, Trends & Forecast by 2033 - Future Market Insights.
5. Dengue Tetravalent Vaccine (Live, Attenuated) Takeda - European Medicines Agency.