According to WHO, Dengue is a viral infection caused by the dengue virus (DENV), transmitted to humans through the bite of infected mosquitoes. It is not contagious and does not spread directly from person to person. Dengue vaccines are specifically formulated to provide protection against the dengue disease, which is caused by four distinct serotypes of the dengue virus, namely serotype 1, serotype 2, serotype 3, and serotype 4.

Dengue vaccination has been recommended for individuals residing in or traveling to areas at risk of dengue fever by reputable organizations such as the World Health Organization (WHO), the U.S. Food and Drug Administration (FDA), the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), Pan American Health Organization (PAHO), the European Medicine Agency (EMA), and Brazil's National Health Surveillance Agency (ANVISA). Since October 30, 2022, two authorized dengue vaccines available in multiple countries are Dengvaxia, developed by Sanofi Pasteur, and QDENGA, developed by Takeda.

The Global Dengue Vaccine Market was valued around US $390.55MM in 2022 and is expected to reach US $1292.20MM by 2030 with a CAGR of 16.13% during the forecast period.

Factors Driving the Market

Drivers

Rising cases of dengue fever

In recent decades, the global incidence of dengue has grown dramatically. According to the World Health Organization, dengue fever is one of the top ten global health threats and the most rapidly spreading mosquito-borne disease in the world. There has been a 30-fold increase in global incidence over the past 50 years with severe dengue being a leading cause of serious illness and death in some Asian and Latin American countries. In Southeast Asia, countries such as Thailand, Indonesia, and the Philippines have reported high incidences of dengue fever. Similarly, countries in the Americas, including Brazil, Mexico, and Colombia, have experienced significant outbreaks.

Conventional strategies for dengue control rely heavily on reducing the number of water-holding containers that support mosquito breeding, and using insecticides to suppress the mosquito population. Also, using personal repellents and wearing protective clothing can help to prevent mosquito bites. However, it is still challenging to achieve sustained reductions in mosquito numbers from these methods, and dengue outbreaks can still occur.

As a result, vaccination is being considered as part of an integrated prevention and control strategy across the globe. The researchers and manufacturers are working towards producing dengue vaccines which protects against all four types of dengue. Thus, the rising cases of dengue fever acts as a driver for developing dengue vaccine and will contribute to the dengue vaccine market globally in the coming years.

Other drivers include growing consumer awareness related to health and hygiene as well as government initiatives.

Challenges

High Cost

The development of vaccines involves extensive research, preclinical and clinical trials, and regulatory approvals. These processes require substantial investments in research infrastructure, skilled personnel, and manufacturing facilities. Further, the vaccine production involves complex manufacturing processes, quality control measures, and adherence to regulatory standards. Distributing vaccines to various regions, especially in remote or resource-limited areas, can be logistically challenging and expensive. Maintaining a cold chain, which involves storing and transporting vaccines at specific temperatures, adds to the logistical complexities and costs.

Thus, the high costs associated with vaccine development, testing, production, and distribution are often passed on to the final product, making vaccines expensive. Dengue fever is prevalent in many low-income countries with limited healthcare budgets. Allocating resources for vaccines among competing health priorities can be challenging for these countries. The cost of dengue vaccines may exceed the available healthcare budgets, making them less affordable and accessible for the populations that need them the most, thereby hindering the market growth.

Other challenges include vaccine efficacy and safety concerns, regulatory hurdles, and public perceptions and acceptance.

Trends

Growing R&D activities

There is indeed growing research dedicated to developing a dengue vaccine. Scientists, pharmaceutical companies, and research institutions are actively working on various vaccine candidates and approaches.

For instance, DV1-DV4 vaccine candidate is transitioning into a human clinical study. This new vaccine construct was shown to have an excellent safety profile in a repeat dose Good Laboratory Practice grade toxicology study using a standard industry model. Furtehr, Àvida Biotech has developed a novel oral vaccine candidate for dengue that has completed proof of concept in a mouse model. This innovative vaccine does not necessitate cold transport or storage, offering potential advantages in terms of logistics and distribution. In addition, the University of Buffalo's Center for Integrated Global Biomedical Sciences will provide preclinical drug development expertise. Their involvement will support the advancement of research and development efforts in the field of biomedical sciences, ensuring comprehensive and effective preclinical testing and evaluation of potential drugs or treatments.

The ultimate goal of these growing researches is to develop safe, effective, and affordable dengue vaccines that can be integrated into national immunization programs and contribute to reducing the global burden of dengue fever.

Other trends include increase in partnership and global health initiatives.

Market Segmentation

By End-users

• Hospitals and pharmacies led the global dengue vaccine market in 2022
• Research laboratories will be the fastest growing segment during the forecast period.
  

Based on end-users, the market is divided into hospitals and pharmacies, government institutes, research laboratories, and specialty clinics. Hospitals and pharmacies led the global dengue vaccine market in 2022 and is expected to continue to lead the market during the forecast period. This segment contributed around 43% in 2022. Hospitals and clinics are the primary institutions responsible for treating and managing dengue fever cases. By administering the dengue vaccine, they help prevent the occurrence of dengue cases or reduce the severity of the disease in individuals who have been vaccinated. This plays a crucial role in controlling the spread of dengue and minimizing its impact on public health, thus contributed the market and will continue to contribute significantly in coming years.

Research laboratories will be the fastest growing segment during the forecast period with a CAGR of around 20%, owing to increasing need for dengue vaccine across the globe. Since there are only two vaccines available at present and that not worldwide there is a dire need to provide more dengue vaccines to beat the dengue virus and as a result there is growing research in laboratories to bring new solutions in the market, thus contributing to the market share.

By Regions

• North America led the dengue market in 2022 with the market share of around 53%.
• APAC will be the fastest growing region during the forecast period with a CAGR of around 22% during the forecast period.
  

By geography the market is divided into the North America, Europe, APAC, and others. North America led the dengue market in 2022 with the market share of around 53%. Increased awareness, affordability and availability of the dengue vaccine in the U.S are the prime factors for the high market share of North America region.

APAC will be the fastest growing region during the forecast period with a CAGR of around 22% due to the ongoing research efforts by different organizations and institutions to develop new dengue vaccines. Also, the presence of underdeveloped countries where dengue is common makes it a lucrative market for dengue vaccine manufacturers to sell the vaccine.

Competitive Landscape

The global dengue vaccine market is concentrated with only two players with approved dengue vaccines present in the market namely Sanofi Pasteur and Takeda.  

Sanofi Pasteur dominates the market. In 2015, Sanofi Pasteur introduced the first dengue vaccine. On May 1, 2019, Dengvaxia was approved by the U.S. FDA for use in children 9-16 years old living in an area where dengue is common (the U.S. territories of American Samoa, the U.S. Virgin Islands, and Puerto Rico), with laboratory-confirmed prior dengue virus infection. On January 22, 2020, the FDA approved the Sanofi Pasteur Inc. to supplement the Dengvaxia Biologics License Application. Dengvaxia is the only dengue vaccine recommended for routine use by the U.S. CDC's Advisory Committee on Immunization Practices (ACIP).

This is the first dengue vaccine in the market and now widely available in the countries such as the U.S., Europe, and is listed by the World Health Organization in 2023. Therefore, Sanofi Pasteur leads the market currently and will continue to lead the market in coming years.

Takeda Pharmaceuticals is the second revenue generator in the market. The company provides QDENGA® (TAK-003), an approved tetravalent dengue vaccine. This vaccine prevents dengue fever or Severe Dengue caused by any of the four serotypes of the dengue virus. QDENGA utilizes the dengue serotype two virus as its foundation, serving as the genetic framework for all four serotypes of dengue.
The primary component of QDENGA consists of live attenuated dengue viruses that replicate in a localized manner and stimulate both humoral and cellular immune responses against the four serotypes of the dengue virus.

At present it contributes very little share in the market around 10-12% since it has been authorized comparatively recently and is also available only in countries Indonesia, Europe, UK, and Brazil.

Companies Developing Dengue Vaccine and in Trial Phase

GlaxoSmithKline (GSK) – TDENV PIV (tetravalent dengue virus purified inactivated vaccine) is undergoing phase I trials as part of a collaboration between GSK and the Walter Reed Army Institute of Research (WRAIR).

Merck Co. & Inc. – Merck & Co. and Instituto Butantan co-developed V180 (Butantan-DV and TV003) adjuvanted, tetravalent subunit dengue vaccine candidate comprised truncated forms of envelope proteins (DEN-80E), derived from strains of all four dengue virus serotypes. According to
a phase 3 clinical study conducted in Brazil, the V180 vaccine was 79.6% effective in preventing dengue.

Codagenix – CodaVax-DENV in preclinical stage, is a next-generation tetravalent dengue vaccine candidate, whose vaccine design platform has enabled precise and rational attenuation of contemporary serotypes of all four strains of dengue virus through selective codon deoptimization. Through this strategic approach, Codagenix can achieve a well-balanced vaccine that is both safe and highly effective in generating immune responses.

Panacea Biotech – In collaboration with the Indian Council of Medical Research, the Panacea Biotech has launched phase l/ll trials in India for Tetravalent Panacea dengue vaccine. A phase 3 trial is likely to begin in mid-2023.

Emergex Vaccines – The company has successfully completed the Phase I clinical trial for its novel CD8+ T cell Dengue vaccine candidate. The vaccine candidate uses 100% synthetic vaccines to 'prime' naive CD8+ T-Cells to generate virus-specific CTL (CD8+ Cytotoxic T Lymphocyte cells). These CTLs are responsible for targeting and killing infected cells before the virus can undergo productive replication, effectively preventing the onset of viral infection and disease in the vaccinated individual.

KM Biologics – The company has successfully completed the phase I clinical study of KD-382, a live attenuated tetravalent vaccine developed to prevent dengue. This vaccine is designed to be effective against all four dengue virus serotypes, requiring only a single dose for protection. Being a live attenuated virus vaccine, it is expected to induce both neutralizing antibodies and cellular immunity, mimicking the immune response generated during a natural infection. One of the advantages of this vaccine is the potential for long-term persistence of neutralizing antibodies, which can contribute to sustained protection
against dengue.

Recent Developments

1. July 11, 2023: To extend access to dengue vaccines, the U.S. Food and Drug Administration (FDA) recently approved a supplement Biologics License Application (sBLA) for Dengue Tetravalent Vaccine, Live (Dengvaxia).
   
   
2. July 11, 2023: After a protracted review, Takeda has decided to withdraw the application for its dengue vaccine candidate, TAK-003, from the FDA. The decision comes after the FDA sought additional data that were not captured by the phase 3 TIDES trials used for the application. The company figured it couldn’t satisfy the agency’s needs within the current review cycle.
   
   
3. May 18, 2023: The Indian Council of Medical Research (ICMR), India’s apex agency for formulation, coordination and promotion of biomedical research, has tied up with two biotech companies — Panacea and Serum Institute of India (SII) — to conduct phase-III trials of their dengue vaccines.
   
   
4. December 16, 2022: TetraVax-DV (V180) Merck & Co and Instituto Butantan co-developed V180 (Butantan-DV and TV003) adjuvanted, tetravalent subunit dengue vaccine candidatecompriseds truncated forms of envelope proteins (DEN-80E), derived from strains of all four dengue virus serotypes. The V180 vaccine was 79.6% effective in preventing dengue, according to a phase 3
   clinical study conducted in Brazil. During this period, no serious dengue cases were reported in
   the participants.

Dengue Vaccine Market Scope

Table of Contents

1 INTRODUCTION OF GLOBAL DENGUE VACCINE MARKET

1.1 Overview of the Market

1.2 Scope of Report

1.3 Assumptions

2 EXECUTIVE SUMMARY

3 RESEARCH METHODOLOGY

3.1 Data Mining

3.2 Validation

3.3 Primary Interviews

3.4 List of Data Sources

4 GLOBAL DENGUE VACCINE MARKET OUTLOOK

4.1 Overview

4.2 Market Dynamics

4.2.1 Drivers

4.2.2 Restraints

4.2.3 Opportunities

4.3 Porters Five Force Model

4.3.1. Bargaining Power of Suppliers

4.3.2. Threat of New Entrants

4.3.3. Threat of Substitutes

4.3.4. Competitive Rivalry

4.3.5. Bargaining Power among Buyers

4.4 Value Chain Analysis

5 GLOBAL DENGUE VACCINE MARKET, BY APPLICATION

5.1 Overview

5.2 Hospitals and pharmacies

5.3 Government Institutes

5.4 Research laboratories

5.5 Specialty clinics

6 GLOBAL DENGUE VACCINE MARKET, BY GEOGRAPHY

6.1 Overview

6.2 North America

6.2.1 U.S.

6.2.2 Canada

6.3 Europe

6.3.1 Germany

6.3.2 U.K.

6.3.3 France

6.3.4 Rest of Europe

6.4 Asia Pacific

6.4.1 China

6.4.2 Japan

6.4.3 India

6.4.4 Rest of Asia Pacific

6.5 Rest of the World

6.5.1 South America

6.5.2 Middle East and Africa

7 GLOBAL DENGUE VACCINE MARKET COMPETITIVE LANDSCAPE

7.1 Overview

7.2 Company Market Ranking

7.3 Key Development Strategies

8 COMPANY PROFILES

8.1 Sanofi Pasteur

8.1.1. Company Overview

8.1.2. Key Executives

8.1.3. Operating Business Segments

8.1.4. Product Portfolio

8.1.5. Business Performance

8.1.6 Key News

8.2 Takeda Pharmaceutical Company Limited

8.2.1. Company Overview

8.2.2. Key Executives

8.2.3. Operating Business Segments

8.2.4. Product Portfolio

8.2.5. Business Performance

8.2.6. Key News

9 Appendix

9.1 Related Research

Global Dengue Vaccine Market Segmentation

Dengue Vaccine by End-user: Market Size & Forecast 2023-2030

• Hospitals and pharmacies
• Government institutes
• Research laboratories
• Specialty clinics

Dengue Vaccine by Geography: Market Size & Forecast 2023-2030

• North America (USA, Canada, Mexico)
• Europe (Germany, UK, France, Russia, Italy, Rest of Europe)
• Asia-Pacific (China, Japan, South Korea, India, Southeast Asia, Rest of Asia-Pacific)
• South America (Brazil, Argentina, Columbia, Rest of South America)
• Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, South Africa, Rest of MEA)

Major Players:

• Sanofi Pasteur
• Takeda Pharmaceuticals
• GlaxoSmithKline (GSK)
• Merck Co. & Inc.
• Codagenix
• Panacea Biotech
• Emergex Vaccines
• KM Biologics