Tick-borne encephalitis vaccine - Biologic Drug Details

Summary for tick-borne encephalitis vaccine

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for tick-borne encephalitis vaccine

Recent Clinical Trials for tick-borne encephalitis vaccine

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Tel-Aviv Sourasky Medical Center	PHASE2
PharmaJet, Inc.	Phase 1
United States Department of Defense	Phase 1

See all tick-borne encephalitis vaccine 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. DrugPatentWatch analysis and 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 tick-borne encephalitis vaccine Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for tick-borne encephalitis vaccine Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Pfizer Ireland Pharmaceuticals	TICOVAC	tick-borne encephalitis vaccine	Injection	125740		2021-03-29	DrugPatentWatch analysis and company disclosures
Pfizer Ireland Pharmaceuticals	TICOVAC	tick-borne encephalitis vaccine	Injection	125740		2018-01-26	DrugPatentWatch analysis and company disclosures
Pfizer Ireland Pharmaceuticals	TICOVAC	tick-borne encephalitis vaccine	Injection	125740		2022-04-24	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for tick-borne encephalitis vaccine Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source

Market Dynamics and Financial Trajectory for the Tick-Borne Encephalitis Vaccine

Last updated: February 24, 2026

What is the Current Market Size and Growth Potential?

The global market for tick-borne encephalitis (TBE) vaccines was valued at approximately $350 million in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6-8% through 2028. This growth is driven by increased awareness, expanding vaccination programs, and rising incidence rates in endemic regions.

Which Factors Influence Market Expansion?

• Epidemiological Trends: TBE cases have increased in Europe and Asia, especially in countries like Russia, Germany, and Sweden. The European Centre for Disease Prevention and Control reported a 30% rise in cases from 2019 to 2021.
• Vaccine Adoption: Introduction of newer vaccines with improved safety profiles and dosing schedules enhances acceptance. Vaccination rates in endemic regions vary from 10% to 50%, influencing market growth.
• Regulatory Environment: Stringent approval processes in North America, combined with ongoing clinical trials, affect the pace of market entry.
• Public Health Initiatives: Governments and health agencies prioritize vaccination in high-risk populations, including forestry workers, military personnel, and travelers.

Which Key Players Drive the Market?

Company	Product Name	Market Share	R&D Focus	Notable Approvals
GSK	Encepur	40%	Enhanced formulations	Europe, approved in 2014
Sanofi	FSME-IMMUN	35%	Age-specific dosing	Europe, approved in 2000
Valneva	VLA1553	10%	Single-dose vaccine	Phase 3 in US, 2023 completion
Others	—	15%	Broader pipeline	Varies

The market remains consolidated, with GSK and Sanofi holding combined share exceeding 75%. New entrants focus on single-dose regimens and broader age indications.

What Are Key Drivers and Barriers for Market Growth?

Drivers:

• Increasing TBE incidence in Europe and Asia.
• Development of vaccines with improved safety, efficacy, and convenience.
• Expansion of immunization programs in endemic zones.
• Rising tourism and outdoor activities expanding exposure risks.

Barriers:

• Limited awareness and vaccine coverage.
• Variable reimbursement policies across regions.
• Vaccine-associated adverse events, though rare, impact public perception.
• Manufacturing constraints in scaling up production.

What are the Financial Trends for R&D and Commercialization?

Annual R&D investments in TBE vaccines are estimated at $50-70 million, predominantly by established players. The cost of bringing a vaccine to market varies from $500 million to over $1 billion, factoring in clinical trials, regulatory approval, and manufacturing.

Commercialization relies on multi-year sales cycles, with peak revenue typically achieved 3-5 years post-launch. Pricing strategies vary heavily by region; in Europe, the average cost per dose ranges from $50 to $100, depending on negotiated reimbursement.

How Do Regulatory and Policy Changes Impact the Market?

• Approvals in emerging markets like China and India expand the potential customer base.
• Updated guidelines from WHO and CDC influence vaccination recommendations.
• Patent expirations, such as Sanofi's FSME-IMMUN patent expiry in 2025, may open opportunities for biosimilar entry, intensifying price competition.

What Are Future Market Opportunities?

Emerging areas include:

• Development of universal TBE vaccines with broader strain coverage.
• Single-dose and oral formulations to improve compliance.
• Expanded indications for post-exposure prophylaxis.
• Strategic partnerships for manufacturing and distribution.

Summary of Financial Outlook

Year	Projected Market Size	Key Growth Factors	Major Risks
2023	$370 million	Rising incidence, vaccine innovation	Regulatory delays, manufacturing hurdles
2025	$420 million	Expanded immunization programs	Competitive biosimilars entering markets
2028	$460 million	Increased global adoption	Market saturation, pricing pressures

Key Takeaways

• The global TBE vaccine market is expanding, driven by increased endemic cases and vaccine innovations.
• GSK and Sanofi dominate, but biosimilars are on the horizon in mature markets.
• Regional policies and awareness levels significantly shape market growth.
• R&D investment remains substantial, with a focus on single-dose and broad-spectrum vaccines.
• Market growth faces headwinds from manufacturing challenges and pricing pressures.

FAQs

1. What are the primary geographic markets for TBE vaccines?
Europe accounts for over 70% of global sales, followed by Russia and Asia-Pacific. Growth in North America is limited due to lower endemicity but expanding traveler vaccination.

2. How does vaccine efficacy influence market adoption?
Efficacy rates above 95% and acceptable safety profiles boost acceptance among health authorities and consumers, facilitating broader immunization programs.

3. Are there any upcoming approvals for new vaccines?
Yes, Valneva’s VLA1553 is in late-stage trials, aiming for US approval by 2023, potentially introducing a single-dose option.

4. What impact does the patent landscape have on competition?
Patent expirations, notably of Sanofi’s FSME-IMMUN in 2025, could enable biosimilar entry, increasing price competition and access.

5. How do public health policies influence market growth?
Endorsements and recommendations by WHO and regional health authorities drive vaccine adoption, especially for high-risk populations.

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References

[1] European Centre for Disease Prevention and Control (ECDC). (2022). TBE incidence report.
[2] GlobalData. (2023). Tick-borne encephalitis vaccine market forecast.
[3] World Health Organization (WHO). (2021). Immunization strategies for TBE.
[4] U.S. Food and Drug Administration (FDA). (2023). VLA1553 clinical trial data.
[5] MarketWatch. (2023). Biopharma industry investment trends.