|
Forecast
Period
|
2025-2029
|
|
Market
Size (2023)
|
USD
85.26 Million
|
|
CAGR
(2024-2029)
|
8.82%
|
|
Fastest
Growing Segment
|
Smallpox
Vaccine
|
|
Largest
Market
|
North
America
|
|
Market
Size (2029)
|
USD
116.38 Million
|
Market Overview
Global
Monkeypox Therapeutics Market was valued at USD 85.26 Million in 2023 and is
expected to reach USD 116.38 Million by 2029 with a CAGR of 8.82% during the
forecast period. The resurgence of Monkeypox cases, particularly in non-endemic
regions, has heightened the demand for targeted therapeutic interventions. The
global increase in outbreaks is attributed to factors such as deforestation,
climate change, and the international trade of exotic animals, which have
increased human exposure to the virus. In response, governments and healthcare organizations
are investing heavily in research and development (R&D) to accelerate the
discovery of novel treatments and vaccines.
One
of the primary drivers of the Monkeypox therapeutics market is the rising
awareness of the disease and the subsequent demand for effective treatment
solutions. Governments worldwide are prioritizing public health initiatives
aimed at controlling the spread of Monkeypox, which includes stockpiling
antiviral drugs and vaccines. This proactive approach is fueling the demand for
therapeutics, thereby driving market growth.
Despite
the promising outlook, the Monkeypox therapeutics market faces several
challenges. The limited availability of approved drugs and vaccines poses a
significant hurdle, as does the logistical challenge of distributing these
treatments to remote and underserved areas. Moreover, the high cost of R&D
and the lengthy approval process for new drugs can hinder the timely
introduction of innovative therapies.
However,
these challenges also present opportunities for market players. The increasing
focus on global health security and pandemic preparedness is likely to drive
investments in Monkeypox therapeutics. Companies that can navigate the
regulatory landscape and bring effective treatments to market swiftly will be
well-positioned to capitalize on the growing demand. Additionally, the
development of combination therapies, which offer more comprehensive treatment
options, is an area ripe for innovation and could lead to significant market
expansion.
Key Market Drivers
Growing Prevalence of Monkeypox
The
recent surge in Monkeypox cases globally can be attributed to several factors,
including increased human-animal interactions, urbanization, and climate
change. As the disease transcends its traditional geographic boundaries, there
has been a marked rise in the number of reported cases in Europe, North
America, and Asia. This unprecedented spread has intensified the need for
targeted therapeutics, significantly impacting the dynamics of the global Monkeypox
therapeutics market.
According
to a 2023 report by the World Health Organization, a sudden outbreak of Mpox
emerged in May 2022, rapidly spreading across Europe, the Americas, and all six
WHO regions. By the end of the outbreak, 110 countries had reported
approximately 87,000 cases and 112 deaths. The outbreak predominantly affected,
though was not limited to, gay, bisexual, and other men who have sex with men,
with transmission occurring primarily through sexual networks. Additionally, in
2022, Mpox outbreaks caused by Clade I MPXV were observed in refugee camps in
the Republic of Sudan. No zoonotic origin has been identified.
The
heightened prevalence of Monkeypox has prompted a swift response from the
pharmaceutical industry, with companies focusing on the development and
distribution of antiviral drugs, vaccines, and supportive care treatments. The
market is witnessing increased investment in research and development (R&D)
aimed at repurposing existing antiviral medications, such as Tecovirimat, and
creating novel therapies tailored specifically for Monkeypox. The urgency to
address the growing number of cases has accelerated the regulatory approval
process in many regions, facilitating the rapid deployment of treatments to
affected populations.
Governments
worldwide are playing a pivotal role in driving the growth of the Monkeypox
therapeutics market. The rising prevalence of the disease has led to a
heightened focus on public health preparedness, with many governments
initiating stockpiling strategies for antiviral drugs and vaccines. In
addition, international organizations such as the World Health Organization
(WHO) are actively collaborating with national health agencies to monitor and
control the spread of Monkeypox. These coordinated efforts are creating a
conducive environment for market growth, as they ensure that therapeutic
solutions reach the populations most in need.
Surge in Regulatory Approvals
of Monkeypox Therapeutics
The
unexpected proliferation of monkeypox, particularly in non-endemic regions, has
created an urgent need for effective medical interventions. In response,
regulatory bodies worldwide have taken decisive action to fast-track the
approval of therapeutics. This accelerated regulatory environment is a
reflection of both the pressing public health need and the lessons learned from
the COVID-19 pandemic, where rapid approval processes proved crucial in mitigating
the spread of the virus.
According
to a 2024 report by the World Health Organization, WHO has issued a call for
manufacturers of Mpox vaccines to submit an Expression of Interest for
Emergency Use Listing (EUL). The EUL process is designed to expedite the
approval of unlicensed medical products, such as vaccines, during public health
emergencies. This time-limited recommendation is based on a risk-benefit
assessment. WHO is requesting manufacturers to provide data demonstrating that
the vaccines are safe, effective, of high quality, and appropriate for the
intended populations.
Agencies
such as the U.S. Food and Drug Administration (FDA) and the European Medicines
Agency (EMA) have been at the forefront, expediting the review and approval
processes for monkeypox therapeutics. These agencies have recognized the need
to balance thorough evaluation with speed, ensuring that effective treatments
are made available without unnecessary delays. This regulatory agility has been
instrumental in addressing the immediate healthcare demands posed by the
outbreak.
The
surge in regulatory approvals is significantly impacting the global Monkeypox
Therapeutics Market by enhancing the availability and accessibility of
treatments. As more therapeutics receive the green light from regulatory
bodies, pharmaceutical companies are able to scale up production and
distribution efforts, ensuring that treatments reach affected populations
swiftly. This not only helps in curbing the spread of the disease but also
stimulates market growth by creating a robust supply chain.
Moreover,
the expedited approval of therapeutics has encouraged pharmaceutical
innovation. Companies are now more inclined to invest in the research and
development of new treatments, knowing that the regulatory pathway has been
streamlined. This has led to a proliferation of new products entering the
market, further driving its expansion.
The
surge in regulatory approvals has also fostered global collaboration, with
governments, pharmaceutical companies, and international health organizations
working together to address the monkeypox threat. Strategic partnerships have
been formed to facilitate the rapid development, approval, and distribution of
therapeutics. These collaborations are vital in ensuring that treatments are
not only approved quickly but also reach a global audience, particularly in
low- and middle-income countries where healthcare infrastructure may be less
developed.
In
addition, the harmonization of regulatory standards across different regions has
been a key enabler of this global effort. By aligning their approval processes,
regulatory bodies are making it easier for pharmaceutical companies to navigate
the complex landscape of international regulations, thereby accelerating the
global distribution of approved therapeutics.
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Key Market Challenges
Disruptions in Supply Chain
As
the global political landscape becomes increasingly volatile, the risk of trade
restrictions, sanctions, and other barriers to international commerce rises.
These factors can delay the production and distribution of pharmaceuticals by
limiting access to critical raw materials, increasing transportation costs, and
complicating cross-border transactions. For instance, countries involved in
producing the active pharmaceutical ingredients (APIs) essential for Monkeypox
treatments may face export restrictions or sanctions, leading to shortages and
price hikes that affect the entire supply chain.
The
COVID-19 pandemic has profoundly impacted global supply chains, and its effects
continue to reverberate across various sectors, including the pharmaceutical
industry. The pandemic exposed the vulnerabilities of just-in-time inventory
systems and the overreliance on a limited number of suppliers, particularly in
Asia. Factory shutdowns, workforce reductions, and transportation bottlenecks
during the pandemic created a ripple effect that disrupted the production and
distribution of many essential medicines, including those for Monkeypox. Although
the world has started to recover, these challenges persist, with supply chains
remaining fragile and susceptible to future disruptions.
The
production of Monkeypox therapeutics relies on a steady supply of high-quality
raw materials, many of which are sourced from a small number of global
suppliers. Any disruption in the supply of these materials can lead to
significant delays in manufacturing, affecting the availability of therapeutics
during critical periods. For example, shortages of specific chemicals or
biological materials required for vaccine production can halt entire production
lines, leading to gaps in the supply chain that are difficult to bridge
quickly. Furthermore, manufacturing bottlenecks can occur if demand for these
therapeutics suddenly spikes during an outbreak, overwhelming production
capacity and leading to further delays.
Even
when therapeutics are produced on time, getting them to the right place at the
right time remains a significant challenge. The global distribution of pharmaceuticals
is a complex process that involves multiple stakeholders, including
manufacturers, logistics providers, regulatory agencies, and healthcare
facilities. Transportation delays, whether due to regulatory hurdles, natural
disasters, or infrastructure limitations, can lead to critical shortages in
regions where Monkeypox outbreaks are most severe. In low- and middle-income
countries, where infrastructure may already be inadequate, these logistical
challenges are even more pronounced, exacerbating the difficulties in managing
and treating Monkeypox.
Key Market Trends
Growing Focus on Vulnerable
Populations
The
global monkeypox therapeutics market is undergoing significant transformation
as the world grapples with the ongoing threat of monkeypox outbreaks. A notable
trend shaping this market is the increasing focus on vulnerable populations.
These populations, which include immunocompromised individuals, children, the
elderly, and people with pre-existing health conditions, are at heightened risk
of severe outcomes if infected with the monkeypox virus. As a result,
pharmaceutical companies, healthcare providers, and policymakers are
prioritizing the development of targeted therapeutics and intervention
strategies to protect these at-risk groups.
Immunocompromised
individuals, such as those with HIV/AIDS, cancer patients undergoing
chemotherapy, and organ transplant recipients, represent a particularly
vulnerable segment of the population. Their weakened immune systems make them
more susceptible to infections and less responsive to standard treatments. This
reality has driven the need for specialized therapeutics tailored to their
unique requirements. Pharmaceutical companies are increasingly investing in
research and development (R&D) to create antiviral therapies that are not
only effective but also safe for use in these sensitive patient groups.
Additionally, dose adjustments and alternative drug formulations are being
explored to enhance the efficacy and reduce the potential for adverse reactions
in immunocompromised patients. These efforts are critical in ensuring that
life-saving treatments are accessible to those who need them most.
Children
and the elderly are also at greater risk of severe disease outcomes due to
their relatively weaker immune systems. The pediatric population, in
particular, requires age-appropriate formulations of monkeypox therapeutics.
This has led to the development of pediatric-specific vaccines and antiviral
drugs that account for factors such as body weight, developmental stage, and
the potential for different side effects in younger patients. Similarly, the
geriatric population requires careful consideration due to the presence of
comorbidities and the increased likelihood of drug interactions. Pharmaceutical
companies are therefore focusing on creating therapeutics that are effective
for older adults while minimizing the risk of complications.
To
ensure the safety and efficacy of monkeypox therapeutics across diverse
populations, there is a growing emphasis on inclusive clinical trials.
Historically, clinical trials have often excluded vulnerable populations,
leading to a lack of data on how these groups respond to new treatments.
However, this trend is changing as regulatory bodies and industry stakeholders
recognize the importance of including a broad demographic spectrum in clinical
research. By enrolling immunocompromised individuals, children, and the elderly
in clinical trials, researchers can gather critical data on the effectiveness
and safety of new therapeutics. This approach not only improves the relevance
of trial results but also helps in the development of tailored treatment
protocols for different patient groups.
Segmental Insights
Treatment Insights
Based
on Treatment, Smallpox Vaccine have emerged as the fastest growing segment in
the Global Monkeypox Therapeutics Market in 2023. The smallpox vaccine,
originally developed to combat the eradication of smallpox, has been found to
offer cross-protection against Monkeypox. This cross-protection is due to the
genetic and antigenic similarities between the smallpox and Monkeypox viruses,
both of which belong to the Orthopoxvirus genus. The historical success of
smallpox vaccination programs in reducing the incidence of smallpox has paved
the way for its repurposing as a preventive measure for Monkeypox.
Recent
outbreaks of Monkeypox, particularly in non-endemic regions, have revived
interest in the smallpox vaccine. The vaccine’s ability to confer immunity
against Monkeypox has led to its rapid adoption as a primary preventive tool.
This has positioned the smallpox vaccine as a critical component of Monkeypox
therapeutics, driving its rapid growth within the market.
Regulatory
agencies, including the U.S. Food and Drug Administration (FDA) and the European
Medicines Agency (EMA), have recognized the smallpox vaccine’s role in
combating Monkeypox. Emergency use authorizations and accelerated approval
processes for smallpox vaccines have facilitated their swift deployment in
outbreak scenarios, further boosting market growth.
Governments
and international health organizations are prioritizing vaccination campaigns
to control Monkeypox outbreaks. These initiatives include stockpiling smallpox
vaccines and implementing vaccination programs in high-risk areas. Such
measures are driving the demand for vaccines and reinforcing their role in
Monkeypox therapeutics.
The
growing awareness of Monkeypox and the importance of preventive vaccination
have led to increased investments in vaccine research and development.
Pharmaceutical companies are focusing on enhancing vaccine formulations and
improving storage and distribution capabilities, contributing to the segment’s
growth.
End User Insights
Based
on End User, Hospitals have emerged as the fastest growing segment in the
Global Monkeypox Therapeutics Market during the forecast period. The rise in
monkeypox cases has underscored the need for specialized medical care, which
hospitals are uniquely equipped to provide. As the primary healthcare
institutions for handling complex and severe cases, hospitals have become
central to the management and treatment of monkeypox. The disease’s potential
for severe symptoms and complications necessitates a level of care that
hospitals, with their advanced diagnostic and therapeutic capabilities, are
ideally positioned to offer.
Hospitals
have increasingly become focal points for monkeypox treatment due to their
comprehensive facilities, including isolation wards, intensive care units
(ICUs), and access to a wide range of medical professionals. The ability to
provide specialized care and advanced treatments has driven the demand for
therapeutics within hospital settings, positioning them as a critical segment
in the market.
The
urgency of managing monkeypox outbreaks has further accelerated the growth of
the hospital segment. Hospitals are at the forefront of response efforts,
deploying therapeutics and managing patient care during outbreaks. This rapid
response capability is crucial in controlling the spread of the disease and
mitigating its impact on public health.
The
need for hospitals to act quickly and efficiently during outbreaks has led to
increased investment in therapeutic resources. Hospitals are enhancing their
capacity to handle monkeypox cases by expanding their therapeutic inventories
and establishing protocols for the swift administration of treatments. This
proactive approach is a key driver of market growth within the hospital sector.
Hospitals
are not only administering existing monkeypox therapeutics but are also pivotal
in the development and testing of new treatments. Many hospitals participate in
clinical trials for emerging therapeutics, providing valuable data and feedback
that drives innovation in the market. This role as a testing ground for new
therapies contributes to the growth of the hospital segment by increasing the
demand for a wide range of therapeutics.
Additionally,
hospitals often collaborate with pharmaceutical companies and research
institutions to conduct studies and trials, further integrating new treatments
into their care protocols. This collaboration facilitates the timely
introduction of novel therapeutics to the market and reinforces the hospital
segment's prominence.
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Regional Insights
Based
on Region, North America have emerged as the dominating region in the Global Monkeypox
Therapeutics Market in 2023. North America boasts a highly developed healthcare
infrastructure that is instrumental in the region's dominance in the Monkeypox Therapeutics
Market. The United States and Canada have established, state-of-the-art
healthcare systems with advanced medical facilities, extensive research
institutions, and well-coordinated public health organizations. This
infrastructure supports the rapid development, testing, and distribution of
therapeutics. The presence of top-tier research institutions, such as the
National Institutes of Health (NIH) and the Centers for Disease Control and
Prevention (CDC), provides a robust foundation for conducting cutting-edge
research and clinical trials, accelerating the availability of effective
Monkeypox treatments.
North
America’s dominance is also driven by its significant investment in research
and development (R&D) within the pharmaceutical and biotechnology sectors.
The region is home to numerous pharmaceutical giants and biotech firms that
prioritize innovative therapeutic solutions for emerging and re-emerging
diseases, including Monkeypox. Substantial R&D funding supports the
development of new and improved treatments, ensuring that North America remains
at the forefront of therapeutic advancements. Government initiatives, such as
grants and subsidies for infectious disease research, further bolster the
region's capacity to address Monkeypox and other health threats.
The
robust regulatory framework in North America plays a crucial role in the
region’s leadership in the Monkeypox Therapeutics Market. Agencies such as the
U.S. Food and Drug Administration (FDA) and Health Canada have established
comprehensive regulatory processes that ensure the safety, efficacy, and
quality of therapeutics. The streamlined approval processes for emergency use
authorizations and accelerated pathways for therapeutic development enable
quicker responses to outbreaks. This regulatory efficiency facilitates the
rapid introduction of new Monkeypox treatments into the market, enhancing the
region’s ability to address public health needs promptly.
Recent Development
- In
2024, PharmaTher Holdings Ltd., a specialty pharmaceutical company, announced
that Sairiyo Therapeutics Inc., a company with a 49% ownership stake by
PharmaTher and a 51% ownership stake by PharmaDrug Inc., has revealed that an
independent drug screening for monkeypox (Mpox) has identified cepharanthine's
potential to bind to the virus's proteins. Although the understanding of Mpox
proteins, which are crucial to the virus's function, is still limited,
identifying drugs or molecules that interact with these proteins could aid in
the development of treatments for Mpox infection.
- In
September 2023, BioNTech SE and the Coalition for Epidemic Preparedness
Innovations (CEPI) announced a strategic partnership to advance mRNA-based
vaccine candidates, specifically the development of BNT166, aimed at preventing
Mpox (formerly known as monkeypox, a member of the Orthopoxvirus family). This
infectious disease can lead to severe and life-threatening complications. Mpox
first gained global prominence in May 2022 with a significant rise in cases,
evolving into an international outbreak. CEPI will provide funding of up to USD
90 million to support the development of these mRNA-based vaccines.
- In
January 2023, Ascletis Pharma Inc. reported that the China National Medical
Products Administration (NMPA) has approved the Investigational New Drug (IND)
application for ASC10, targeting monkeypox. ASC10 is an oral double prodrug
that, upon administration, is rapidly and fully converted in vivo into the same
active metabolite, ASC10-A, also known as β-D-N4-hydroxycytidine (NHC) or
EIDD-1931, as is the single prodrug molnupiravir.
Key Market Players
- Chimerix Inc.
- SIGA
Technologies, Inc.
- Emergent
BioSolutions Inc.
- Bavarian
Nordic A/S
- Hetero
Drugs Limited
- Mylan
N.V.
- Piramal
Enterprises Limited
- Olon
S.p.A.
- Teva
Pharmaceutical Industries Limited
- CIDIC
Company Limited
|
By
Treatment
|
By
End User
|
By
Region
|
- Smallpox
Vaccine
- Antivirals
- Vaccinia
Immune Globulin (VIG)
|
- Hospitals
- Specialty Clinics
- Ambulatory Surgical Centers
- Others
|
- North
America
- Europe
- Asia
Pacific
- South
America
- Middle
East & Africa
|
Report Scope
In this report, the Global Monkeypox Therapeutics
Market has been segmented into the following categories, in addition to the
industry trends which have also been detailed below:
- Monkeypox Therapeutics Market, By Treatment:
o Smallpox Vaccine
o Antivirals
o Vaccinia Immune Globulin (VIG)
- Monkeypox Therapeutics Market, By End User:
o Hospitals
o Specialty Clinics
o Ambulatory Surgical Centers
o Others
- Monkeypox Therapeutics Market, By Region:
o North America
§ United States
§ Canada
§ Mexico
o Europe
§ France
§ United Kingdom
§ Italy
§ Germany
§ Spain
o Asia Pacific
§ China
§ India
§ Japan
§ Australia
§ South Korea
o South America
§ Brazil
§ Argentina
§ Colombia
o Middle East & Africa
§ South Africa
§ Saudi Arabia
§ UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Global Monkeypox
Therapeutics Market.
Available Customizations:
Global Monkeypox Therapeutics Market report with
the given market data, Tech Sci Research offers customizations according to a
company's specific needs. The following customization options are available for
the report:
Company Information
- Detailed analysis and profiling of additional
market players (up to five).
Global Monkeypox
Therapeutics Market is an upcoming report to be released soon. If you wish an
early delivery of this report or want to confirm the date of release, please
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