Therapeutic Approaches to Monkeypox: Global Market Trends, Clinical Developments, and Future Directions

The emergence of Monkeypox, now called Mpox, as a significant global public health concern has gained attention, especially after the widespread outbreak. This viral zoonosis, closely related to smallpox, presents symptoms ranging from mild to severe, with the potential for serious complications. Historically, Mpox cases were mostly found in Central and West Africa, but the recent spread to over 100 countries has highlighted the urgent need for effective therapeutic interventions. According to NLM 2024 data, before this epidemic, no countries outside Central and Western Africa had documented the monkeypox virus's (MPXV) epidemiology.

However, an outbreak involving 79 patients in the United States in 2003 was traced back to the importation of infected rodents from Ghana. Until May 2022, 31 nations outside the traditional endemic zones reported the arrival of MPXV, which rapidly spread across the globe. In response, on June 22, 2022, the World Health Network (WHN) declared the outbreak a pandemic, reporting 3,417 active MPXV cases across 58 countries. The therapeutic landscape for Mpox is evolving, with several antiviral agents showing promise due to their efficacy against related orthopoxviruses. Despite the availability of these treatments, there remains a critical gap in therapeutic options specifically tailored for Mpox, underscoring the need for continued research and development. This article aims to explore the current global market trends, clinical developments, and future directions in therapeutic approaches to Mpox. As the world continues to confront the public health implications of this virus, understanding these dynamics is essential for improving public health responses and advancing clinical care.

Global Market Trends in Monkeypox Therapeutics

The market for monkeypox therapeutics is rapidly evolving as countries and pharmaceutical companies are prioritizing the development of treatments and preventive measures. The notable trends in the monkeypox therapeutics market are increasing demand for vaccines and antivirals, growing focus on preventive measures, expansion of research & development and many others.

1. Increased Demand for Vaccines and Antivirals

The increase in monkeypox cases especially in Europe and North America region has led to a higher demand for vaccines and antivirals, impacting global trends in monkeypox treatment. According to data from the World Economic Forum, Europe is at the centre of the 2022 monkeypox outbreak, accounting for over 80% of global cases. This rise in cases has emphasized the need for effective treatments, resulting in faster regulatory approvals and an expansion of available treatment options. In January 2022, the European Medicines Agency (EMA) approved tecovirimat, an antiviral originally developed for smallpox, for use against monkeypox. However, its use in monkeypox outbreaks is still limited, as experience with these treatments is relatively new. The World Health Organization (WHO) recommends the use of MVA-BN and LC16 vaccines for preventing monkeypox, with ACAM2000 as an alternative when the preferred vaccines are not available. The increasing demand for vaccines and antiviral treatments highlights the urgent need for broader access to these treatments as the global healthcare industry tackles the challenges posed by the spread of monkeypox.

2. Focus on Preventive Measures                                                  

The global market is increasingly focusing on preventive strategies against monkeypox, with a particular emphasis on using smallpox vaccines for cross-protection. Countries with existing smallpox vaccination programs are reviewing their policies and considering reintroducing vaccines for high-risk populations. The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) have played crucial roles in developing vaccination protocols and distribution strategies. According to WHO data from June 2022, interim guidance for the clinical management and infection prevention of monkeypox has been established in response to the multi-country monkeypox outbreak. This guidance addresses various populations, including those with mild to severe disease, sexually active individuals, pregnant or breastfeeding women, and children. It also encompasses clinical management considerations such as therapeutics, nutritional support, mental health services, and post-infection follow-up. This will help to tackle with the ongoing public health challenge posed by monkeypox.

3. Expansion of Research & Development

Pharmaceutical companies and research institutions are working quickly to develop new therapeutics and vaccines for monkeypox due to its global spread. This urgency has led regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to expedite the approval processes for these vaccines and treatments, fostering an environment conducive to innovation. Various vaccine candidates are currently being researched, including mRNA-based platforms that have shown promise in eliciting strong immune responses against the monkeypox virus (MPXV). For instance, two quadrivalent mRNA vaccines, mRNA-A-LNP and mRNA-B-LNP, have proven effective in generating MPXV-specific antibodies and cellular immunity in animal models, indicating their potential for large-scale application in controlling outbreaks. Additionally, existing smallpox vaccines are being repurposed and adapted for monkeypox, and studies emphasize the need for next-generation vaccines that are safe and effective. The collaborative efforts are crucial in addressing the public health challenges posed by monkeypox and ensuring that innovative solutions can be rapidly brought to market to mitigate the impact of this re-emerging virus.

Clinical Developments

• Vaccines:  In September 2023, BioNTech SE announced a strategic partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop mRNA-based vaccine candidates for the prevention of mpox (formerly monkeypox). This partnership is significant due to the global attention mpox received during the outbreak that began in May 2022, emphasizing the need for effective vaccines against this infectious disease. CEPI is providing up to $90 million to support the development of the BNT166 vaccine, which aims to address the severe complications associated with mpox, a member of the Orthopoxvirus family. While existing smallpox vaccines have shown some efficacy in preventing monkeypox, the development of new vaccines is crucial to enhance protection and respond effectively to future outbreaks.

• Antiviral Drugs:  In August 2024, the National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) announced topline results from the PALM 007 clinical trial. The trial investigated the antiviral drug tecovirimat (also known as TPOXX) for treating monkeypox (mpox) in the Democratic Republic of the Congo (DRC). A total of 597 hospitalized patients took part in the trial. The trial did not achieve its primary goal of showing a significant improvement in the time it took for lesions to heal within 28 days for those receiving tecovirimat compared to those who received a placebo. However, the analysis indicated that patients who began treatment within seven days of developing symptoms and those with severe disease showed meaningful improvements from the drug. The safety profile of tecovirimat was found to be similar to that of the placebo, and the study emphasized the need for early treatment to achieve better outcomes. These findings are part of ongoing efforts to improve treatment options for monkeypox, which has been a major health concern in the DRC since the outbreak began in 2022. The study was initiated in September 2023 in response to the urgent need for effective treatments as monkeypox cases continue to rise globally.

• Supportive Care:   Supportive care is crucial in treating monkeypox (mpox), especially since specific antiviral treatments are limited. This approach focuses on managing symptoms and overall patient well-being, particularly for those with severe forms of the disease. Key strategies include pain management, caring for skin lesions, and monitoring for complications such as secondary infections. Nurses are essential in carrying out these supportive measures, which involve implementing infection prevention protocols, educating patients about the contagious nature of the disease, and providing psychosocial support to reduce anxiety and fear associated with the illness. Recent guidelines have been developed to standardize supportive care for different mucocutaneous manifestations of monkeypox, drawing on strategies used for similar conditions. These recommendations aim to improve outpatient management, decrease hospital admissions, and enhance the quality of care for affected individuals, addressing both the physical and emotional needs of patients during an outbreak.

Future Direction

  The approach to treating monkeypox (mpox) is evolving as we gain a better understanding of the virus and its treatment options. Currently, several antiviral medications initially developed for smallpox, such as tecovirimat, brincidofovir, and cidofovir, are being studied for their effectiveness against monkeypox due to genetic similarities between the viruses. Tecovirimat has shown the most promise, proving to be both safe and effective in clinical settings. Studies suggest that early administration of this antiviral can lead to better clinical outcomes. While brincidofovir and cidofovir also exhibit antiviral activity against orthopoxviruses, their use is limited by potential side effects and the risk of developing resistance. Vaccinia immunoglobulin is another potential therapeutic option, which can be used for pre- or post-exposure prophylaxis. Given the higher risk of severe infection among certain populations such as immunocompromised individuals and specific demographic groups, it is crucial to prioritize vaccination and treatment for these populations. Symptomatic management is essential alongside robust public health measures to control outbreaks. However, there is an urgent need for more comprehensive clinical guidelines and research to establish effective treatment protocols, especially for vulnerable groups such as pregnant women and children. The development of novel antiviral agents targeting different mechanisms of action could further enhance therapeutic options, ensuring a more effective response to future monkeypox outbreaks.

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