DNA Vaccines Market Demand, Growth, Size, Competitive Landscape and Market Forecast 2023-2030

Global DNA Vaccines Market is segmented By Type (Human DNA Vaccines, Animal DNA Vaccines), By Application (Human Diseases, Veterinary Diseases), By End User (Human Health, Animal Health, Research), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030

DNA Vaccines Market Overview

The Global DNA Vaccines Market is estimated to reach at a CAGR of 42.03% during the forecast period (2023-2030). DNA vaccines work by injecting a genetically modified plasmid containing the DNA sequence encoding the antigen(s) against which an immune response is desired, causing cells to produce the antigen directly and eliciting a protective immunological response. DNA vaccines are superior to traditional vaccines because they elicit a wider range of immune response types.  Moreover, DNA vaccines use a DNA molecule and include adjuncts to help the DNA molecule enter specific target cells. The market is divided into two types: human DNA vaccines and animal DNA vaccines. These vaccines are used to prevent both human and animal diseases.

DNA Vaccines Market SUMMARY AND SCOPE

DNA Vaccines Market Dynamics and Trends

Rapid immunology and molecular biology development are critical in escalating market growth. Increased HIV, hepatitis, and other diseases, increased government investment in DNA vaccines, and an increase in the number of antibiotic-resistant pathogens have created a need for effective and low-cost vaccination, which is one of the major factors driving the expansion of the DNA vaccine market. 

The Increasing Clinical Trials for DNA Vaccines to Treat Infectious Diseases are Expected to Drive Market Growth.

Entos Pharmaceuticals Inc. conducted a Phase I/II clinical study in healthy adults to evaluate the safety, tolerability, and immunogenicity of receiving two intramuscular injections of Covigenix VAX-001/-1b 28 days apart. Covigenix VAX-001/-1b is a plasmid DNA vaccine that uses Entos Pharmaceuticals' Fusogenix PLV platform to express key antigenic determinants from SARS-CoV-2. The first phase of this research was completed in Canada. The Phase II study will be completed in Burkina Faso, Senegal, and South Africa by December 2023.

Furthermore, the University of Wisconsin, Madison, has conducted a Phase-II trial on the treatment of castrate-resistant, metastatic prostate cancer that will compare the use of one versus two DNA vaccines delivered concurrently with PD-1 blockade using pembrolizumab, followed by treatment with pembrolizumab alone and delivered over a long period (for a maximum of 2 years (32 cycles) or until radiographic progression). 

The hypothesis to be tested is that administering two vaccines with PD-1 blockade will increase the frequency and magnitude of tumor-directed CD8+ T cells, increasing the percentage of patients experiencing objective anti-tumor effects measured by PSA declines and objective radiographic responses. The research will be completed in December 2025. Therefore, increasing clinical trials in preparing DNA vaccines to treat infectious diseases has driven the market in the forecast period.

Challenges Associated With DNA Vaccines are Expected to Hamper the Market.

DNA vaccines must overcome numerous extracellular and intracellular barriers to successfully transfect genes and stimulate the production of exogenous proteins. DNA vaccines must be protected from DNase degradation and phagocytic elimination via the reticuloendothelial system for intravenous delivery (RES). 

Furthermore, non-specific interactions with other proteins must be used to overcome inactivation in DNA vaccines. Similarly, for intradermal, subcutaneous and intraperitoneal vaccination, the DNA vaccine must be protected from degradation and elimination while reaching targeted immune cells to stimulate an effective immune response. 

The most critical challenges for oral delivery are resistance to the harsh gastric conditions of the digestive tract and the protective mucosal membrane that prevents foreign pathogens and particulates from entering the body. Thus, from the above factors, the market is expected to be hampered in the forecast period.

COVID-19 Impact on DNA Vaccines Market

DNA vaccines are an extremely appealing emerging technology because they can reduce the time it takes to produce vaccines against novel viral threats to a few weeks, allowing for rapid response to emerging pathogens such as SARS-CoV-2, the virus that causes COVID-19. The DNA vaccine approach is appealing because, unlike conventional vaccines, it allows for precise control over antigen design, is easily adapted to new, emerging pathogens, elicits both humoral and cell-mediated immunity, and allows for rapid scalability while being simple to manufacture. 

Moreover, the companies are working on a DNA vaccine adjuvant compatible with current DNA vaccine methods, such as electroporation devices. This improves immune responses from a single dose, allowing two to three times as many people to be vaccinated with a given vaccine stock, greatly reducing the time required to develop protective herd immunity. This holds great promise for mitigating the current pandemic's negative effects and would drastically alter the timeline for vaccine development in response to future viral threats. 

For instance, Innovative Genomics Institute is working on a CRISPR-based DNA-vaccine enhancer for COVID-19, drastically reducing the time it takes to develop vaccines against current and future viral threats. The Laboratory for Genomics Research (LGR), a collaboration between UC Berkeley/UCSF (IGI) and GlaxoSmithKline, is funding this research. As a result, the above factors are expected to drive the market during the forecast period.

DNA Vaccines Market Segmentation Analysis

The Animal DNA Vaccines Segment is Expected to Hold the Largest Market Share in the Global DNA Vaccines Market     

The animal DNA vaccines segment accounted for the largest market share in 2022. DNA vaccination protects an animal against disease by injecting it with genetically engineered DNA that causes cells to produce an antigen directly, resulting in a protective immunological response. Several DNA vaccines have been approved for veterinary use, and promising research has been conducted to treat viral, bacterial and parasitic diseases and several tumor types. 

Moreover, DNA vaccines only had approval for veterinary use due to the limited immune response generated in humans. The Growing incidence of canine melanoma & other animal diseases, rising vaccine development, increasing product approvals and technological advancement in the DNA vaccines for animals are the factors to drive the market in the forecast period. 

For instance, Currently, four DNA vaccines are commercially available for veterinary use: Two protect against viral disease in horses (West-Nile Innovator R, Fort Dodge) and salmonids (Apex-IHN R, Aqua Health Ltd.), one prevents the development of carcinoma in dogs (Oncept TM, Merial Health Ltd.), and another expresses growth hormone-releasing hormone, a gene-therapy treatment that decreases perinatal piglet morbidity (LifeTide R SW5, VGX Animal Health).

Furthermore, on July 25, 2022, Applied DNA Sciences, Inc. announced the publication of a manuscript containing data demonstrating that a linear DNA vaccine successfully elicited neutralizing antibodies and cellular immunity against SARS-CoV-2. 

The manuscript, authored by LineaRx, the Company's majority-owned biotherapeutics subsidiary, and LineaRx's development partner, EvviVax, S.R.L., further establishes the utility of the LinearDNA ("linDNA) platform as a large-scale enzymatic production approach to prophylactic and therapeutic veterinary vaccine applications. Thus, from the above factors, the market segment accounted for the largest market share in the forecast period.

Global DNA Vaccines Market Geographical Share

North America Region Holds the Largest Market Share in the Global DNA Vaccines Market  

North America region accounted for the largest market share in 2022. The increase in the cases of HIV, cancer, hepatitis, and other diseases, an increase in government investment in DNA vaccines, a growing number of livestock animals, rising technological advancements in the vaccine, increasing clinical trials and the presence of key players in the region are the factors driving market growth in the forecast period. 

For instance, on January 31, 2023, Washington University School of Medicine conducted a Pilot Study to Assess the Safety, Feasibility, and Preliminary Efficacy of a Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients with Recurrent Brain Tumors. The study will be completed by July 31, 2027. 

Moreover, several human trials are currently underway to evaluate the potential of DNA vaccine candidates against various infectious diseases. These include vaccines against infectious diseases caused by HIV, Ebola, Zika, influenza, herpes virus, and human papillomavirus. Thus, from the above factors, the North American region accounted for the largest market share in the forecast period.

Global DNA Vaccines Companies and Competitive Landscape

Major key players in the DNA vaccines market are Inovio Pharmaceuticals, Inc., Merck & Co., Mitsubishi Tanabe, Dendreon Corporation, ASTELLAS PHARMA, Dynavax Technologies, Sanofi, Tekmira Pharmaceuticals, GlaxoSmithKline Corp and Protein Sciences Corp.

On February 22, 2022, Eli Lilly & Company invested USD 700 million in a state-of-the-art facility in Boston Seaport to advance its DNA-based research and development activities. Researchers and scientists from New York and Boston will collaborate at the new laboratory to build on their expertise in RNA- and DNA-based technologies to develop cures for diseases with significant unmet needs. 

Inovio Pharmaceuticals, Inc.:

Overview:

Inovio Pharmaceuticals is dedicated to developing DNA vaccines, a new generation of vaccines to prevent and treat cancer and infectious diseases. SynCon's "universal" vaccines provide broad cross-strain protection against known and newly emerging pathogens such as influenza. Initial human data show that Inovio's proprietary electroporation delivery technology is safe and significantly increases gene expression and immune responses. 

Inovio's clinical programs include vaccines for HPV/cervical cancer (therapeutic), avian flu and HIV. Inovio is developing universal influenza vaccines in collaboration with scientists from the University of Pennsylvania, the Public Health Agency of Canada's National Microbiology Laboratory and the National Institutes of Health's Vaccine Research Center. Merck, ChronTech, the University of Southampton, the National Cancer Institute, and the HIV Vaccines Trial Network are among the other partners and collaborators.

Product Portfolio:

SynCon: SynCon “universal” vaccines are designed to provide broad cross-strain protection against known as well as newly emergent strains of pathogens such as influenza.

The Global DNA Vaccines Market Report Would Provide an Access to an Approx. 45+ Market Data Tables, 40+ Figures and 180 Pages.