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Precedence Statistics today announced the global virology market size reached $2.6 billion in 2022 and is projected to reach $4.26 billion by 2032, expanding at a CAGR of 5.10%.
The U.S. virology market reached $690 million in 2022 and is projected to expand at a CAGR of 5.20%, reaching around $1.14 billion by 2032.
The virology market encompasses the study, diagnosis, treatment, and prevention of viral infections. It includes research, pharmaceuticals, diagnostic tests, and vaccines related to viruses like HIV, influenza, and hepatitis, which is a significant driver for the growth of the virology market.
The rapid mutation rates of many viruses pose hurdles for drug and vaccine development, necessitating ongoing research and adaptability.
The quest for effective vaccines to prevent viral diseases has also driven growth in this market. Government investments and public health initiatives have played a pivotal role in shaping the industry landscape.
The continuous evolution of vaccine technology, including mRNA and vector-based platforms, has broadened the scope of virology research.
Furthermore, the need for vaccine booster shots to combat emerging virus variants ensures a sustained demand for virology products.
Furthermore, the resumption of global travel contributes to the rapid spread of viruses, emphasizing the importance of virology in understanding, preventing, and managing infectious diseases worldwide.
Alzamend Neuro, Inc. today announced that it has submitted an investigational new drug ("IND") application to the U.S. Food and Drug Administration ("FDA") for the initiation of AL001-PTSD01, a Phase IIA plasma/brain pharmacokinetics clinical study of AL001, for treatment of patients with post-traumatic stress disorder (PTSD).
After receipt of a "study may proceed" communication from the FDA, Alzamend plans to initiate a Phase IIA study to characterize AL001 improvements of lithium levels in the brain compared to a marketed lithium salt in PTSD patients.
Alzamend anticipates that the new drug application ("NDA") development program for PTSD may, for safety, qualify for a 505(b)(2) NDA pathway to FDA approval, which can be available to new formulations of an approved drug.
"There are only two drugs approved by the FDA and currently available in generic form for PTSD patients," said Stephan Jackman, Chief Executive Officer of Alzamend, in a press release on November 13, 2023.
"Being able to develop a next-generation lithium product (AL001) that would not routinely require therapeutic drug monitoring (TDM) could positively impact the 9 million Americans afflicted with PTSD."
"We look forward to providing more details regarding the study's timeline and market opportunity in the near future."
Although lithium products do not have an FDA-approved indication for PTSD, case reports suggest that lithium treatment may be useful for treating PTSD patients. In particular, treatment with low doses (300–600 mg/day) of lithium carbonate has been reported to provide effective treatment in the reduction of inappropriate anger, irritability, anxiety, and insomnia in those patients.
The clinical observation of mood swings beyond the normal range, but milder than those associated with BD, reportedly suggested the presence of a sub-threshold mood disorder in these PTSD patients.
It has also been proposed that treatment of trauma with lithium to forestall the development of PTSD may be provided by pharmacological induction of mild transient amnesia.
Lithium was the first mood stabilizer approved by the FDA and is still a first-line treatment option for BD but is underutilized, perhaps because of the need for TDM, that is, routine monitoring of lithium drug levels in blood to help assure safety and effectiveness.
Lithium was the first drug that required TDM by regulatory authorities in product labeling because the effective and safe range of therapeutic drug blood concentrations is narrow and well-defined for treating BD when using lithium salts. Excursions above this range can be toxic, and below can impair effectiveness.
AL001 is a novel lithium-delivery system that has the potential to provide the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium.
Results from Alzamend's recently completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer's patients and healthy subjects identified a maximum tolerated dose ("MTD") that an independent safety review committee vetted.
This MTD is designed to distribute more lithium to the brain but at lower systemic exposure, resulting in an improved safety profile compared to currently marketed lithium salts.
This MTD was assessed to be unlikely to require TDM.
PTSD is a mental and behavioral disorder that can develop because of exposure to a traumatic event, such as sexual assault, warfare, traffic collisions, child abuse, domestic violence, or other threats to a person's life.
According to the NIH, about 3.6%, or roughly 9 million, adults in the U.S. have PTSD in a given year, and 9% of people develop it at some point in their life.
Children may also experience very stressful events that affect their thoughts and feelings.
In much of the world, rates for a given year are between 0.5% and 1% of the population.
As of November 13, 2023, the FDA has not approved an Alzheimer's disease-related vaccine candidate.
NOte: On Dec. 11, 2023, the headline was updated.
According to a recent study, a seasonal analysis revealed that Brazil's most significant risk of Zika and Chikungunya disease occurs during the summer when higher temperatures occur.
The resurgence was identified in northeast Brazil between 2019 and 2021 for Zika and in 2021 for Chikungunya.
As of November 8, 2023, over 26,659 Zika cases have been reported in Brazil this year.
Published by the journal Scientific Reports on October 21, 2023, this trend is related to the increased Ae. aegypti mosquito infestation levels due to the decreased time for larval development.
And the increased proportion of infectious mosquitoes, given the decreased intrinsic incubation periods of the viruses in the vector.
Studies conducted in China, the United States, and the Brazilian states of Rio de Janeiro and São Paulo also indicated that temperature influenced the distribution patterns of Ae. aegypti and Ae. albopictus, consequently affecting the incidence of diseases they transmit.
The small but significant differences (from 0.7 to 2.6 ∘C) in the average temperature between the high-risk and no-risk areas for both diseases are worth consideration, wrote these researchers.
For example, Banu et al. showed that an increase of 1 ∘C could be related to a future rise in arbovirus disease cases.
In recent decades, consistent and widespread warming has been observed throughout Brazil, with greater extreme heat occurring during spring and summer.
From a prevention perspective, Zika vaccine candidates continue in clinical trials. However, the U.S. FDA recently approved the first Chikunynga vaccine.
Valneva SE today announced that the U.S. Food and Drug Administration (FDA) approved IXCHIQ®, the Company’s single-dose, live-attenuated vaccine indicated for the prevention of disease caused by chikungunya virus (CHIKV) in individuals 18 years of age and older who are at increased risk of exposure to CHIKV.
This indication is approved under accelerated approval based on anti-CHIKV neutralizing antibody titers. Valneva had received a Priority Review Voucher from the FDA.
“Infection with chikungunya virus can lead to severe disease and prolonged health problems, particularly for older adults and individuals with underlying medical conditions,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a press release on November 9, 2023.
“Today’s approval addresses an unmet medical need and is an important advancement in preventing a potentially debilitating disease with limited treatment options.”
Valneva reported final pivotal Phase 3 data for the vaccine in March 2022, showing a 98.9% seroresponse rate at 28 days with a single vaccination and final lot-to-lot consistency results in May 2022.
IXCHIQ-induced seroresponse was sustained over time with a 96.3% seroresponse rate six months post-vaccination.
The Company’s pivotal Phase 3 results were published in the Lancet in June 2023.
Valneva will continue to evaluate antibody persistence for at least five years. Continued approval for this indication is contingent upon verification of clinical benefit in confirmatory studies.
With this U.S. approval, IXCHIQ becomes the world’s first licensed chikungunya vaccine available to address this unmet medical need and the third vaccine Valneva has brought from early R&D to approval.
The Company will hold an analyst call and a webcast at 3:00 pm CET or 9:00 am EDT on November 13, 2023. The link will be available on the Company’s investor page.
Chikungunya outbreaks are primarily found in Africa, the Americas, Asia, and the Indian subcontinent. CHIKV outbreaks are related to other vaccine-preventable travel diseases, such as dengue, measles, and polio.
The U.S. CDC published Recommendations for Chikungunya Vaccine Use Among Adult Travelers on October 26, 2023.
GC Biopharma announced today that it has applied to the Korean Ministry of Food and Drug Safety for the marketing approval of "GC1109", an anthrax vaccine jointly developed by the company and the Korea Disease Control and Prevention Agency (KDCA).
If approved, "GC1109" will be the world's first recombinant anthrax vaccine.
'GC1109' contains a protective antigen as its active pharmaceutical ingredient, produced by recombinant DNA technology. This delivers two types of proteins, comprising anthrax toxin, lethal factor, and edema factor, into cells.
In the Phase II clinical trial, the vaccine's immunogenicity and safety were demonstrated with healthy volunteers. Subjects who received intramuscular administration of GC1109 generated antibodies sufficient to neutralize anthrax toxins, while adverse drug reactions or solicited adverse events were similar to those of the placebo group.
In the animal efficacy study, GC1109 induced neutralizing antibody, which remained at a high level even six months after the 4th dose of the vaccine, with a high survival rate against the bacillus anthracis spore challenge.
GC Biopharma stated in a press release on November 5, 2023, "We believe in the significance of our journey to localize the anthrax vaccine in terms of securing vaccine sovereignty while promoting public health and national security."
"GC Biopharma will continue to lead the localization of critical medicines and contribute to the stable supply of basic medical supplies as it has been doing for other vaccines and blood products since the foundation of the company."
Since it is unethical to expose human volunteers to lethal Bacillus anthracis, and field trials are not feasible due to a low incidence of anthrax, human clinical efficacy studies for an anthrax vaccine cannot be conducted.
In such cases, under the "Animal Rule" of The Special Act for Promotion of the Development and Emergency Supply of Medical Products in Response to Public Health Crisis, animal efficacy data can be used to establish the vaccine's clinical benefit if the evidence from the animal studies provides substantial grounds for the product's effectiveness.
Anthrax, caused by Bacillus anthracis, is a Class 1 infectious disease by the Infectious Disease Control and Prevention Act, with a lethality rate of up to 97% if untreated.
To prepare against potential bioterrorism and consequent national crisis, GC Biopharma, under the research project supported by KDCA, has been developing a recombinant vaccine for anthrax since 2002.
GC Biopharma (formerly Green Cross Corporation) is a biopharmaceutical company that delivers life-saving and life-sustaining protein therapeutics and vaccines.
According to the U.S. CDC, people get infected with anthrax when spores get into the body. When this happens, the spores can be activated and become anthrax bacteria.
Then, the bacteria can multiply, spread out in the body, produce toxins (poisons), and cause severe illness.
The good news is anthrax is not contagious.
You cannot catch anthrax from another person the way you might catch a cold or the flu.
In rare cases, person-to-person transmission has been reported with cutaneous anthrax, where discharges from skin lesions might be infectious, says the CDC.
The Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford announced the launch of a new project to initiate early development of prototype vaccines against the Junín virus.
CEPI confirmed on October 2, 2023, that it would provide up to $25 million to Oxford for preclinical and Phase I clinical development of a vaccine against the Junín virus using Oxford's ChAdOx platform
This seldom-discussed virus was selected as an exemplar of the Arenavirus family, which includes the Lassa virus, Junin virus, Machupo virus, Guanarito virus, and lymphocytic choriomeningitis virus.
Arenavirus infections are responsible for multiple deadly hemorrhagic fevers with epidemic and pandemic potential. Junín virus can cause Argentine Haemmorhagic Fever, with symptoms including muscular pain, dizziness, rashes, and a 15-30% case fatality.
Dr. Richard Hatchett, CEO of CEPI, commented in a press release, "This new project will harness the University of Oxford's extensive vaccinology experience and its innovative ChAdOx vaccine technology – one of only a handful of vaccine platforms proven to work at speed, scale, and low cost – to expand the world's scientific knowledge on arenavirus vaccines."
"The project will generate vital resources for the proposed Global Vaccine Library, helping accelerate efforts to reduce vaccine development timelines to 100 days when faced with future threats."
The data and materials generated by this new project could give the world a head start in rapidly developing safe and effective vaccines against Arenaviruses within 100 days of their identification, potentially stopping a future pandemic in its tracks, wrote CEPI.
