Smallpox (vaccinia) vaccine, live - Biologic Drug Details

Summary for smallpox (vaccinia) vaccine, live

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for smallpox (vaccinia) vaccine, live

Recent Clinical Trials for smallpox (vaccinia) vaccine, live

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Seoul National University Hospital	Phase 3
HK inno.N Corporation	Phase 3
CJ HealthCare Corporation	Phase 3

See all smallpox (vaccinia) vaccine, live clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for smallpox (vaccinia) vaccine, live Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for smallpox (vaccinia) vaccine, live Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for smallpox (vaccinia) vaccine, live Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Smallpox (Vaccinia) Vaccine

Introduction

The smallpox vaccine, developed against the variola virus, is a landmark in medical history, being the first vaccine ever created. Despite smallpox being eradicated in 1980, the vaccine market continues to evolve due to various factors, including bioterrorism concerns, advancements in vaccine technology, and the emergence of related diseases like monkeypox.

Historical Context and Eradication

Smallpox was eradicated in 1980 through a global campaign led by the World Health Organization (WHO) and supported by significant financial and political commitments. The campaign's success was attributed to political leadership, specific funding, and a well-organized program[2].

Current Market Size and Forecast

The global smallpox vaccine market was valued at $69.26 million in 2021 and is projected to reach $102.73 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 3.17% from 2023 to 2030. This growth is driven by contract manufacturing for vaccine development and the potential for future demand if smallpox cases reappear[1].

Market Segmentation

The smallpox vaccine market is segmented by type and geography.

By Type

• First Generation: These vaccines are the earliest forms and have been largely replaced due to their higher risk of side effects.
• Second Generation: These vaccines offer improved safety profiles compared to the first generation.
• Third Generation: These are the safest and most advanced, using attenuated vaccinia strains with milder side effects[5].
• Others: This includes any newer or experimental vaccine types.

By Geography

• North America: This region is expected to dominate the market due to large government stockpiles and significant research funding.
• Europe: Home to several key vaccine manufacturers and a strong healthcare infrastructure.
• Asia Pacific: Emerging as a fast-growing market due to increasing R&D investments and collaborations with multinational pharmaceutical companies[1][4].

Drivers and Restraints

Drivers

• Government Funding and Initiatives: Increased funding for research on antiviral medications and vaccine development is a key driver.
• Contract Manufacturing: The need for contract manufacturing to ensure rapid vaccine production in case of an outbreak drives market growth[1][4].
• Bioterrorism Concerns: Post-9/11, many governments have been building up vaccine stockpiles to counter potential bioterrorism threats[5].

Restraints

• Lack of Demand: Since smallpox has been eradicated, there is currently no routine demand for the vaccine from hospitals or government clinics.
• Manufacturing Challenges: Difficulties in vaccine manufacturing and the lack of knowledge about vaccination programs can hinder market growth[1].
• Side Effects: The risk of serious side effects from the vaccine, particularly from older generations, can limit its use[5].

Financial Impact and Cost-Effectiveness

The eradication of smallpox is one of the most cost-effective health interventions in history. The annual cost of the smallpox campaign between 1967 and 1979 was $23 million, with total contributions of $98 million from international donors and $200 million from endemic countries. The United States saves the equivalent of its contributions every 26 days due to the absence of smallpox-related costs[2].

Current Financial Trajectory

The smallpox treatment market, which includes vaccines, was valued at $67.5 million in 2023 and is expected to reach $78 million by 2030, growing at a CAGR of 2.1% from 2023 to 2030. This growth is fueled by increasing government funding and R&D investments in antiviral medications[4].

Stockpiles and Distribution

Since smallpox eradication, public vaccination is not routine, but governments maintain stockpiles to guard against reemergence. The World Health Organization once maintained a stockpile of 200 million doses, but most were destroyed in the late 1980s. After the September 11 attacks, production of smallpox vaccines resumed, and several companies have been building up their stockpiles[5].

Related Markets and Cross-Protection

The monkeypox vaccine market, closely related to the smallpox vaccine due to cross-protection, is also growing. The global monkeypox vaccine and treatment market is projected to reach $215.7 billion by 2034, growing at a CAGR of 10.7% from 2024 to 2034. This growth highlights the broader interest in vaccines against variola-related viruses[3].

Key Players

The market is dominated by several key players, including:

• SIGA Technologies, Inc.
• Bavarian Nordic A/S
• Emergent BioSolutions Inc.
• GlaxoSmithKline plc
• Sanofi
• Merck & Co., Inc.
• Pfizer Inc.
• Bharat Biotech International Ltd.
• Chimerix, Inc.[4].

Regional Insights

North America

This region benefits from large investments in R&D, leading to the development of cutting-edge vaccinations. The U.S. has significant government stockpiles and ongoing production to replace expired vaccines[4].

Asia Pacific

This region is growing rapidly due to increasing R&D investments and collaborations with multinational pharmaceutical companies. Countries like China, India, and Japan are prioritizing new drug development[4].

Conclusion

The smallpox vaccine market, though relatively small compared to other vaccine markets, is driven by critical factors such as government funding, contract manufacturing, and bioterrorism concerns. Despite the eradication of smallpox, the market continues to evolve with advancements in vaccine technology and the emergence of related diseases.

Key Takeaways

• The global smallpox vaccine market is projected to reach $102.73 million by 2030.
• The market is driven by government funding, contract manufacturing, and bioterrorism concerns.
• Third-generation vaccines are safer and more advanced.
• North America and Asia Pacific are key regions driving market growth.
• The monkeypox vaccine market also influences the smallpox vaccine market due to cross-protection.

FAQs

Q: What is the current market size of the smallpox vaccine market? A: The global smallpox vaccine market was valued at $69.26 million in 2021.

Q: What is the projected growth rate of the smallpox vaccine market? A: The market is projected to grow at a CAGR of 3.17% from 2023 to 2030.

Q: Who are the key players in the smallpox vaccine market? A: Key players include SIGA Technologies, Inc., Bavarian Nordic A/S, Emergent BioSolutions Inc., and others.

Q: Why is the smallpox vaccine market still relevant despite the eradication of smallpox? A: The market remains relevant due to bioterrorism concerns, contract manufacturing needs, and the potential for future outbreaks.

Q: How does the monkeypox vaccine market relate to the smallpox vaccine market? A: The monkeypox vaccine market is related due to cross-protection, with some vaccines offering protection against both diseases.

Sources

1. Verified Market Research: Smallpox Vaccine Market Size, Share, Trends, Opportunities.
2. Center For Global Development: Case 1: Eradicating Smallpox.
3. GlobeNewswire: Monkeypox Vaccine and Treatment Market Share Set to Reach USD 215.7 Billion by 2034.
4. Coherent Market Insights: Smallpox Treatment Market Size, Trends and Forecast to 2030.
5. Wikipedia: Smallpox vaccine.