Increasing Applications and Rising Government Support is Propelling the Global Smallpox Treatment Market

Smallpox was an infectious disease caused by the variola virus. According to the US Centers for Disease Control and Prevention (CDC), the disease has been eradicated, with no cases occurring since 1977.  However, other diseases such as monkeypox (mpox) and cowpox are still a matter of concern and are caused by viruses belonging to the same family, that is, the Ortho poxviruses family. This is contributing significantly to the growth of the global smallpox treatment market. 

According to the CDC, in November 2024, the outbreak of mpox caused more than 100,000 cases in 122 total countries, including 115 countries where mpox was not previously reported. The outbreak was caused by the subclade IIb. To date, no other country has reported cases due to both clades, except the recent travel-associated clade I cases in Canada, Germany, India, Sweden, Thailand, the UK, Zambia, and Zimbabwe.

Global Numbers for Confirmed Mpox Cases and Location, since January 2024 

Source: US Centers for Disease Control and Prevention

Note: *** Locations include countries, territories, and other areas.

According to the European Medicines Agency, Tecovirimat SIGA can treat smallpox, monkeypox, and cowpox. It is also used to treat potential complications caused by the vaccination against smallpox. The drug can be used for adults and children weighing at least 13 kg. In addition to tecovirimat, brincidofovir, and globulin intravenous, among others, are the common drugs used to treat smallpox. Furthermore, these drugs are critical to the treatment of other diseases such as mpox. The rising incidence of mpox is promoting R&D in the market. 

• In November 2024, the Africa CDC launched a trial for an antiviral smallpox drug brincidofovir for the treatment of mpox. The trial will be conducted in the Democratic Republic of the Congo in partnership with Emergent BioSolutions. The study will include 50,000 mpox patients from across the continent. 

• In October 2024, BARDA procured additional doses of TEMBEXA (brincidofovir) from Emergent Biodefense Operations Lansing, under the Project BioShield (PBS) Act. The company will optimize manufacturing and delivery cadence to sustain production of TEMBEXA beginning in 2025 and will continue for the following four years.  

• In August 2024, the FDA approved a new indication for ACAM2000, to include the prevention of mpox disease in individuals.  ACAM2000 has been approved since 2007 for the prevention of smallpox disease. ACAM2000 is a live replicating vaccinia virus vaccine.   
• In August 2024, a study conducted in the Democratic Republic of the Congo, for the effect of tecovirimat on the duration of mpox lesions among children and adults with clade I mpox, resulted in no significant effect.   

• In May 2022, the FDA approved an intravenous (IV) formulation of TPOXX (tecovirimat) to treat smallpox. TPOXX is originally an oral formulation, which was approved in 2018. However, the IV formulation is an option for people who are unable to swallow the oral capsule. 

Additionally, Tecovirimat, brincidofovir, and globulin intravenous are a cure for various other medical conditions, such as relapse or refractory lymphoma including NK/T-cell Lymphoma, Primary Immunodeficiencies (PID), adenovirus (AdV) infection after hematopoietic stem cell transplantation, and neuromuscular disability and impairment in adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), among others. This is propelling the growth of the global smallpox treatment market.      

• In August 2024, SymBio Pharmaceuticals Ltd. submitted a Clinical Trial Notification to the Pharmaceuticals and Medical Devices Agency (PMDA) regarding the global Phase 1b/2 clinical trial of an intravenous formulation of brincidofovir (IV BCV) for the treatment of relapsed or refractory lymphoma including NK/T-cell Lymphoma.

• In June 2024, the FDA approved immune globulin intravenous, human-dira, Yimmugo by Biotest AG. The medication is used to treat patients with Primary Immunodeficiencies (PID). 

• In May 2024, SymBio Pharmaceuticals Ltd. announced the US Food and Drug Administration (FDA) approved to addition of a second indication, cytomegalovirus (CMV) infection after hematopoietic stem cell transplantation, to the clinical trial. Thus, the company has conducted a Phase 2a clinical trial of the intravenous formulation of brincidofovir for the treatment of adenovirus (AdV) infection after hematopoietic stem cell transplantation. 

• In January 2024, Takeda announced the US FDA approval of its GAMMAGARD LIQUID® [Immune Globulin Infusion (Human) 10% solution] as an intravenous immunoglobulin (IVIG) therapy to improve neuromuscular disability and impairment in adults with CIDP. The drug can be used for induction therapy. The liquid has not been studied in immunoglobulin-naive patients nor as maintenance therapy for periods longer than six months.

Owing to the increasing applications of the drugs used to treat smallpox, the government is making significant efforts to strategically regulate the production and use of such drugs, bolstering the global smallpox treatment market. For instance, in August 2024, BARDA procured $112.5 million worth of oral Tecovirimat (TPOXX) treatment courses, as part of ongoing and long-planned national preparedness efforts for emergencies involving smallpox. 

Additionally, in July 2023, the US government ordered $113 million for Siga Technologies’ oral TPOXX treatment courses and $25 million for the intravenous version of TPOXX for the Strategic National Stockpile.

The major players in the global smallpox treatment market include SIGA Technologies, Bavarian Nordic, EpiVax, Inc., CEL-SCI, Chimerix, Nano Therapeutics, Pvt Ltd, and Oncovir, Inc., among others. The market players are contributing significantly to the market growth by adopting various business strategies such as product development, R&D investments, partnerships, and mergers and acquisitions. For instance, in September 2024, Emergent BioSolutions Inc. secured approximately $400 million in orders in 2024 and 2025, for its vaccinia, smallpox, and mpox product portfolio. This includes the previously disclosed US government contract modification to procure ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live), and CNJ-016® [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV) contract options exercised in 2023 and 2024.