During the period from 2023 to 2030, the global market for monkeypox vaccines and treatments is projected to expand at a compound annual growth rate (CAGR) of 11%. The market is anticipated to be driven by factors such as the rising incidence of monkeypox infection worldwide and the growing demand for treatment and prevention methods. Bavarian Nordic A/S, for instance, announced in July 2023 that it had received an additional order from the U.S. BARDA for 2.5 million doses of JYNNEOS. In addition, a surge in product approvals and the expansion of government initiatives to fund research on monkeypox infection are anticipated to fuel market growth. As of September 8, 2023, the CDC had recorded 56,609 cases and 18 fatalities worldwide. The United States and Europe report the greatest number of cases. Increasing incidence rates in these regions motivate market participants to create novel treatments to reduce the disease burden in their respective regions. Key players are adopting strategies such as new product development, mergers & acquisitions, and partnerships to increase their market share. Japan, for example, approved the monkeypox vaccine LC16 KMB in August 2023. SIGA Technologies, Inc., Chimerix, Inc., Bavarian Nordic, Sanofi SA, Emcure Pharma, and Jinan Jinda Pharmaceutical Chemistry Co., Ltd. are market leaders.
It is anticipated that the increasing incidence of monkeypox will increase the demand for new drugs and vaccines to treat this disease. This is expected to drive the growth of the global market for monkeypox treatment over the forecast period. According to data published by the Centers for Disease Control and Prevention as of August 9, 2023, there are 31,800 confirmed cases of monkeypox worldwide, of which 31,425 are in countries that have never reported monkeypox before. While 375 are in nations where monkeypox has been historically reported. In addition, according to a study published in the New England Journal of Medicine, between April and June 2023, 98% of monkeypox infections in 16 countries occurred among men who have sex with other men and LGBT communities. During the forecast period, it is anticipated that the market will expand at a rate proportional to the incidence of infection and demand for immunisation. As of 8 September 2023, 56,609 new cases of monkeypox infection had been reported worldwide, and the number is rising. In addition, as of September 6, 2023, according to CDC data, the United States had administered 461 049 vaccine doses.
On August 4, 2023, the United States Department of Health and Human Services declared a public health emergency due to the outbreak of monkeypox. This has increased the demand for vaccines and improved treatments for monkeypox. In addition, according to the Centers for Disease Control and Prevention, vaccine demand in the United States exceeds vaccine supply. The enormous demand for vaccines and treatments for monkeypox is expected to drive the global monkeypox treatment market.
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In addition, government initiatives pertaining to the supply, distribution, and availability of anti-infective vaccines are anticipated to contribute to market growth in the coming years. For instance, the Department of Health and Human Services announced in July 2023 that it would acquire an additional 144,000 doses of the JYNNEOS vaccine for the treatment of monkeypox infection in order to increase vaccine availability. In addition, the Health Resources and Services Administration allocated funds to expedite the distribution of JYNNEOS to the Ryan White HIV/AIDS Program (RWHAP) to increase the vaccination rate among high-risk populations.
In addition, government initiatives such as the U.S. Monkeypox Research Priorities, which aim to promote R&D and increase public awareness of monkeypox, are anticipated to stimulate expansion. In addition, the United States government and its international partners are redoubling their efforts to advance research on monkeypox. Government-supported infection-related research activities include, among others, clinical and epidemiologic observational modelling as well as vaccine and therapeutic clinical trials. In the coming years, such initiatives are anticipated to exponentially increase the demand for vaccinations.
In response to the current outbreak, the U.S. FDA announced in September 2023 additional measures to increase testing capacity and accessibility. Under this initiative, the FDA is expected to recommend EUA requests for monkeypox diagnostic tests and promote their use. As a result, these initiatives are anticipated to propel market expansion over the forecast period.
Regulatory approvals and EUAs continue to contribute to market expansion. In August 2023, for example, the U.S. FDA approved emergency use authorization for the intradermally injectable JYNNEOS vaccine for healthcare professionals 18 years and older who were determined to be at a higher risk of monkeypox infection. This approval allows two intradermal JYNNEOS injections to be administered four weeks apart.
In addition, the EMA's human medicines committee recommended in July 2023 that IMVANEX's indication be expanded to include protection against monkeypox infection. Due to the similarity between smallpox and monkeypox, IMVANEX has been considered an effective vaccine since its approval in 2013. In addition, rising R&D expenditures and the use of smallpox vaccine as an off-label product for vaccination against monkeypox are expected to propel the global market.
The major restraint for the global monkeypox treatment market is the increasing side effects of the drugs used to treat this disease; consequently, this can hinder the market's expansion. Drugs used to treat monkeypox can cause mild stomach upset, dry mouth, decreased concentration, and depression.
In 2021, the drugs segment dominated the market with a 70.0% share. Several factors, including an increase in the number of patients with monkeypox, the increased use of antiviral drugs, and the high cost of symptomatic treatment, are driving the expansion. In July 2023, the United Kingdom approved SIGA's tecovirimat (oral) for the treatment of monkeypox and other indications in adults and children with body weights greater than 13 kg. In addition to being approved for the treatment of monkeypox in Europe, the drug is also authorised for use in other European nations. Vaccines are expected to grow at a significant rate during the forecast period. Increasing adoption of vaccines for monkeypox infection, rising vaccination awareness, and extensive R&D efforts to develop novel products are expected to contribute to the growth of the segment. Additionally, various government initiatives to expand access to vaccines are anticipated to stimulate segment growth. The HHS, for instance, facilitated an agreement between Grand River Aseptic Manufacturing and Bavarian Nordic in August 2023 to establish the first U.S. finish and fill line for the JYNNEOS vaccine.
In 2021, the male segment held more than 90 percent of the market's revenue share. This segment's demand is primarily driven by the higher prevalence of monkeypox among men compared to women. According to the CDC, approximately 13,826 males were infected with the virus. Consequently, the greater prevalence of infection in men compared to women is likely to contribute to segment growth. In addition, an increase in the number of vaccine doses administered to men has contributed to an increase in segment share. In the United States, until September 6, 2023, more than 90 percent of total JYNNEOS vaccine doses are administered to males.
In 2021, hospitals held a revenue share of greater than 75.0%, a position they are expected to maintain throughout the forecast period. As a result of the outbreak of monkeypox, hospitalisations and the demand for therapeutic products in hospitals for symptomatic treatment are expected to increase. Additionally, government organisations including the American Hospital Association and the Department of Health and Human Services are implementing initiatives to improve the treatment and continuous monitoring of patients with monkeypox infections, resulting in an increase in the hospital's patient population. The segment of specialty clinics is anticipated to grow at the highest rate during the forecast period. This market segment's expansion is influenced by rising immunisation awareness and high infection rates.
In 2021, the oral segment held a market share of greater than 65.0%. The increased demand for oral route therapeutics, the ease of administration, and the cost-effectiveness of oral products all contribute to the segment's growth. Moreover, the majority of common medications, including tecovirimat and brincidofovir, are administered orally. During the forecast period, the injectables market segment is anticipated to expand by double digits. Increasing demand for vaccines, greater bioavailability of injectable products, rapid onset of action of treatment products, and decreased likelihood of first-pass metabolism in intravenous products are factors contributing to the expansion of this market segment. In addition, the injectable route enhances the immunogenicity of the vaccine and minimises adverse reactions at the injection site. JYNNEOS is a vaccine administered subcutaneously in two doses (0.5 mL) four weeks apart.
North America dominated the market in 2021 with a revenue share greater than 40.0% due to the presence of a large number of leading players and the diverse strategic initiatives they had implemented. Moreover, an increase in disease prevalence and a rise in public vaccination awareness are expected to stimulate regional market growth. Additionally, government support and increased R&D expenditures are expected to generate lucrative growth opportunities for the North American region. During the forecast period, Asia-Pacific is anticipated to experience the most rapid expansion. The increasing incidence of monkeypox infections and the increase in research and development for the creation of preventative and therapeutic options are among the key market drivers. Increasing infection rates in Asia-Pacific countries such as Australia, Singapore, and India are anticipated to drive market growth.
