Report Overview

According to the deep-dive market assessment study by Growth Plus Reports, the global DNA vaccines market was valued at US$ 5.28 billion in 2022 and is expected to register a revenue CAGR of 7.9% to reach US$ 10.47 billion by 2031.

DNA Vaccines Market Fundamentals

Vaccination involves stimulating the immune system with an infectious agent or components of an infectious agent that has been modified in such a way that no harm or disease is caused, however, ensuring that when the host is confronted with that infectious agent, the immune system can adequately neutralize it before it causes any harm. For more than a century, vaccination has been accomplished through one of two methods: either the introduction of specific antigens against which the immune system directly reacts or the introduction of live weakened infectious agents that replicate within the host without causing disease and synthesize the antigens that subsequently prepare the immune system. 

A whole new approach to vaccination has recently been discovered. It comprises the direct injection of a plasmid bearing the DNA sequence encoding the antigen(s) against which an immunological response is desired, and it relies on in situ synthesis of the target antigen. This method has several potential advantages over traditional methods, including the stimulation of both B- and T-cell responses, increased vaccine durability, the absence of any infectious agent, and the relative ease of large-scale production. As proof of the principle of DNA vaccination, immune responses in animals have been obtained using genes from a variety of infectious agents, including influenza virus, hepatitis B virus, human immunodeficiency virus, rabies virus, lymphocytic chorio-meningitis virus, malarial parasites, and mycoplasmas. In some circumstances, disease protection in animals has also been attained. However, the utility and benefits of DNA vaccines must be evaluated case by case, and their applicability should be determined by the nature of the agent being vaccinated against, the nature of the antigen, and the sort of immune response required for protection. The field of DNA vaccination is fast evolving. Scientists are currently developing vaccines with additional components that aid the entrance of DNA into cells, target specific cells, or enhance the immune response through adjuvants. Finally, the line between a complex DNA vaccination and a basic viral vector may be blurred. Several features of the immune response induced by DNA vaccines are unknown. Even so, significant progress has been made toward using these types of vaccines in people, and clinical trials have begun.

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DNA Vaccines Market Dynamics 

The ability of DNA vaccines to target specific antigens, decreased risk of infection compared to conventional vaccines, and greater stability drive revenue growth in the global DNA vaccination market. Additionally, large-scale manufacturing and reduced storage needs are expected to benefit market expansion. An increase in instances of cancer and infectious diseases in humans and animals, as well as a rise in the demand for DNA vaccines due to benefits, such as the reduced risk of infection, easy transportation, and room temperature stability, are driving the DNA vaccines market revenue growth. Furthermore, the increasing prevalence of antibiotic-resistant infections fuels the expansion of the DNA vaccines market. Likewise, developing innovative vaccines using DNA technology and the high growth potential in developing nations present opportunities for manufacturers to tap into and capitalize on the market.

DNA vaccines are being developed for various traditional pharmaceutical applications, including cancer, allergies, and infectious disorders. With the introduction of Gardasil by Merck, the larger vaccination business demonstrated its ability to produce vaccines with non-traditional applications and high potential. DNA vaccines are prepared to follow this developing strategy, which has the potential to produce enormous future market potential. New biotechnologies and nanotechnologies are driving DNA vaccine development. Emerging delivery technologies, including electroporation (EP), unique vaccine formats, such as DNA prime-adenovector boost, and novel molecular adjuvant technologies, are critical to DNA vaccines attaining their full potential. Technological advancements are enabling humans to achieve more efficacy.

The main concerns about DNA vaccines include the immunological impact, tissue distribution and persistence after injection, and whether the DNA vaccines would leak into the environment. As a result, the development of DNA vaccines becomes more difficult. One of the problems for players in the DNA vaccines market is the limited efficacy of plasmid-based approaches, which prevents their usage in constructing more accurate human cell models.

DNA Vaccines Market Ecosystem 

The global DNA vaccines market has been analyzed from three perspectives: type, application, and region. 

DNA Vaccines Market by Type 

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Based on region, the global DNA vaccines market has been segmented into human DNA vaccines and animal DNA vaccines.

The animal DNA vaccines segment is likely to dominate the market during the forecast period. This is due to the shortage of human DNA vaccines in the market and the increase in the prevalence of canine melanoma and other animal diseases. Animal vaccines are third-generation vaccines that contain DNA that codes for specific pathogen proteins. This DNA is injected into the host body and produces a protein, which triggers an immunological response. Furthermore, the robust pipeline of human-targeted vaccines is expected to contribute to market expansion.

DNA Vaccines Market by Application

Based on application, the global DNA vaccines market has been segmented into human and animal diseases.

The human disease application is further segmented into oncology, infectious disease, and allergies. The veterinary disease segment is sub-segmented into canine melanoma vaccines, West Nile Innovator, Life tide-SW5, and Apex-IHN. The increasing prevalence of these diseases is resulting in profitable prospects for manufacturers of animal DNA vaccines. Furthermore, DNA vaccines are more effective and less expensive than conventional vaccines. They are suitable for mass vaccination. DNA vaccines have been proposed as potential treatments for poultry ailments. They can be used for rapid vaccinations against various infections and are relatively simple to design, manufacture, and store.

DNA Vaccines Market by Region

Based on region, the global DNA vaccines market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. 

North America is expected to account for a considerable revenue share of the global market during the forecast period. Its dominance in the region is due to the approval of specific treatments only in the regional market. Furthermore, increased spending on animal healthcare, improved purchasing power, and several key regional players contribute to market revenue growth. Well-established veterinary organizational structures have also played an important role in driving expansion avenues in the regional market. North America dominates the market for DNA vaccines due to rapid development in immunology and molecular biology, an increase in the cases of HIV, cancer, hepatitis, and other diseases, a rise in government investments in DNA vaccines, and an increase in the number of antibiotic-resistant pathogens. According to the CDC, around 2.8 million antibiotic-resistant infections are registered in the United States, and around 35,000 patients die from antibiotic-resistant diseases. The increasing cases of such conditions in the country are expected to drive regional market expansion.

The Asia Pacific DNA vaccines market is showing revenue growth at a rapid pace owing to increased investments in DNA vaccine R&Ds, notably in third-generation vaccination technology, improved clinical trials, government support, and well-established healthcare facilities and infrastructure in the region. The growing target population base, large unmet clinical requirements, increased disposable income, and growth in awareness of the benefits of immunization in developing countries are propelling revenue growth in the Asia Pacific market. For instance, the assistance provided by the Japanese government in conducting clinical trials for the development of DNA vaccines is primarily driving the country’s DNA vaccines market expansion. AnGes, a Japanese biopharmaceutical company, announced the launch of phase 2 clinical trials of its DNA vaccines against coronavirus in December 2020. Such activities are projected to fuel the expansion of the regional DNA vaccines market in the next few years.

DNA Vaccines Market Competitive Landscape

The major players in the DNA vaccines market have been investing heavily in R&D operations to improve organic growth in the next years. These main firms have also implemented various methods to increase their market penetration worldwide. Some notable market growth strategies include developing and launching novel products, mergers and acquisitions, portfolio diversification, and the expansion of numerous distribution channels around the world. These strategies are expected to fuel growth avenues in the global market during the forecast period. Furthermore, players are focusing on broadening their presence through partnerships and subsidiaries to strengthen their global market domination.

The prominent players in the global DNA vaccines market include:

• Inovio Biomedical Corp.
• Merck & Co.
• Mitsubishi Tanabe
• Dendreon Corporation
• Eli-Lilly & Company
• ASTELLAS PHARMA
• Dynavax Technologies
• Sanofi S.A.
• Tekmira Pharmaceuticals
• Geovax Labs, Inc.
• GlaxoSmithKline Corp
• Protein Sciences Corp.

DNA Vaccines Market Strategic Developments

• In March 2023, India’s first and only DNA vaccine candidate for dengue showed promising results, marking a significant advancement in DNA vaccination research. In preliminary experiments on mice, the candidate produced a strong immunological response and increased survival rates after disease exposure. Scientists at the National Centre for Biological Sciences (NCBS), Bengaluru, have been working on the DNA vaccine candidate since 2019 in conjunction with nine institutions in India, Africa, and the United States.
• In February 2022, Eli Lilly & Company invested US$ 700 million in a cutting-edge laboratory in Boston Seaport to boost its DNA-based R&D efforts. At the new facility, researchers and scientists from New York and Boston were expected to work together to solve diseases with major unmet needs using RNA- and DNA-based technologies.
• In October 2020, Boehringer Ingelheim, a global leader in animal health, collaborated with Henke-Sass and Wolf to develop a new needle-free intramuscular vaccines injection apparatus for pigs from weaning to the nursery. Beginning in December 2020, this new device was anticipated to be available to swine breeders in the majority of countries across the world under the trademarks FreVAXTM (Boehringer Ingelheim) and EPIG (through Henke-Sass, Wolf).
• In February 2020, Merck and Company launched a new, independent, publicly traded company focusing on its Women’s Health, trusted Heritage Brands, and Biosimilars divisions
• In January 2020, Automazioni VX Inc. and MSD Animal Health, a division of Kenilworth & Merck, introduced the Innoject Pro, a novel engineered subcutaneous chick immunization technology. Innoject Pro improves injection precision and stability during the immunization process, lowering stress in chicks and boosting operator safety. This IPPE was held in Atlanta in the year 2020. The technology was expected to be used with the MSD Innovax vaccines line, providing long-term protection against poultry infectious diseases. Innoject Pro also has a unique disinfection system that sprays disinfectant on the injection needles, which helps in biosecurity and contamination reduction.

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