Zoster vaccine live - Biologic Drug Details

Summary for zoster vaccine live

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for zoster vaccine live

Recent Clinical Trials for zoster vaccine live

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
GlaxoSmithKline	PHASE4
Region Skane	PHASE4
Konkuk University Medical Center	NA

See all zoster 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. 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 zoster vaccine live Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for zoster vaccine live 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
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123		2016-04-12	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123		2016-09-27	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123		2019-02-19	DrugPatentWatch analysis and company disclosures
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123		2020-07-27	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for zoster vaccine live 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
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123		2033-03-13	Patent claims search
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123		2034-06-10	Patent claims search
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123		2036-12-15	Patent claims search
Merck Sharp & Dohme Llc	ZOSTAVAX	zoster vaccine live	For Injection	125123		2036-03-01	Patent claims search

International Patents for zoster vaccine live

Country	Patent Number	Estimated Expiration
New Zealand	624470
Australia	2009226949
Hong Kong	1204273
Hungary	E053589

Market Dynamics and Financial Trajectory for the Biologic Drug: Zoster Vaccine Live

Last updated: August 9, 2025

Introduction

The zoster vaccine live (ZVL), marketed as Zostavax®, is an established prophylactic biologic designed to prevent herpes zoster (shingles) in adults aged 50 and older. Approved by the U.S. Food and Drug Administration (FDA) in 2006, ZVL has historically played a pivotal role in herpes zoster prevention. However, recent shifts in scientific understanding, competitive landscape, manufacturing considerations, and regulatory environments are significantly impacting its market dynamics and financial outlook. This article thoroughly examines these factors, providing a comprehensive assessment of ZVL's current status and future trajectory.

Market Landscape and Epidemiological Drivers

Herpes zoster affects approximately 1 million Americans annually, predominantly impacting those aged 50 years and above, with incidence increasing with age due to immunosenescence [1]. The aging global population accentuates the demand for effective shingles prevention. As such, herpes zoster vaccination remains a critical public health tool, with opportunities for growth particularly in mature markets like North America and Europe.

In 2022, vaccine coverage remains suboptimal. In the U.S., only about 60% of adults over 50 have received any herpes zoster vaccination, signaling unmet need [2]. This gap presents a substantial market potential, especially given increasing awareness of herpes zoster complications, including postherpetic neuralgia, which can persist for years post-infection.

Product Positioning and Competitive Landscape

Zoster Vaccine Live (Zostavax®)

Zostavax® was the first shingles vaccine approved for adults aged 50 and older, leveraging attenuated live virus technology. Its initial market success was driven by broad age eligibility and longstanding safety data. However, its relatively modest efficacy—around 51% overall and diminishing with age (up to 69% in 50–59-year-olds versus 37% in ≥70 years)—has prompted evolutionary shifts in the market.

Recombinant Zoster Vaccine (Shingrix®)

In 2017, GlaxoSmithKline (GSK) launched Shingrix®, a recombinant subunit vaccine with an adjuvant system, demonstrating over 90% efficacy across all age groups and sustained protection over at least four years [3]. Its superior efficacy and stronger propeller effect have led to widespread adoption, often surpassing ZVL in market share.

Regulatory and Labeling Changes

In 2020, the CDC Advisory Committee on Immunization Practices (ACIP) began recommending Shingrix® over Zostavax® for immunization against herpes zoster, citing better efficacy and durability [4]. As a consequence, the market for ZVL has contracted, particularly in countries with high healthcare standards and active immunization programs.

Market Dynamics

Declining Adoption of Zostavax®

With the advent of Shingrix®, healthcare providers have increasingly preferred the non-live, highly efficacious vaccine, especially in immunocompromised populations, for whom live vaccines pose safety concerns. This shift has led to a sharp decline in ZVL administrations globally, notably in North America and Europe.

Manufacturing and Supply Constraints

ZVL production faced manufacturing challenges, including scale-down decisions by Merck, the sole producer under license from GSK, who originally developed ZPV (the virus strain). These constraints further limited supply, contributing to decreased availability and market presence.

Pricing and Reimbursement

Reimbursement policies favor higher-efficacy vaccines. Shingrix® commands premium pricing in many markets, and payers often prefer it over ZVL due to improved health economic profiles. As a result, ZVL’s commercial viability diminishes, especially under payers' cost-containment strategies.

Global Market Penetration

Outside North America and Europe, ZVL’s market remains marginal, with many countries adopting newer vaccines or awaiting licensure of alternative formulations. In emerging markets, the live vaccine’s lower manufacturing costs and familiar technology could sustain niche roles; however, the dominant trend favors recombinant vaccines.

Emerging Trends and Future Competition

Biotech firms are investing in next-generation shingles vaccines, aiming to improve upon the durability and efficacy of existing products. mRNA-based shingles vaccines are under development, potentially disrupting current market equilibria.

Financial Trajectory

Historical Revenue and Market Share

Merck’s Zostavax® sales peaked around 2014 at approximately $860 million globally, driven primarily by U.S. sales. Following the advent of Shingrix®, revenues declined precipitously, with Merck reported global sales of ZVL falling below $100 million by 2020 [5].

Current Financial Outlook

Given the declining global vaccination rates with ZVL, revenues are expected to continue waning sharply. In the U.S., ZVL sales may virtually phase out as the majority of eligible adults are transitioned to Shingrix® or other developing acute-targeted vaccines.

In the broader context, the product remains likely to generate limited revenue in select markets where convenience, cold chain logistics, or cost factors favor live vaccines. Nonetheless, the long-term financial impact for ZVL is a downward trajectory toward obsolescence.

Potential Revenue Streams and Market Considerations

• Residual sales in developing markets: Low-cost production and existing infrastructure could sustain minimal revenue streams.
• Portfolio licensing and stewardship: Strategic licensing arrangements could generate licensing fees but are unlikely to alter revenues significantly.
• Pipeline and vaccine innovation investments: Limited, as R&D efforts are focusing on newer vaccine platforms with higher efficacy profiles.

Regulatory and Pharmacovigilance Factors

Regulatory authorities now predominantly endorse Shingrix® due to its superior efficacy profile and safety data, further reducing ZVL’s market attractiveness. Pharmacovigilance data indicating rare, but severe, adverse reactions to live vaccines, especially in immunocompromised individuals, have influenced stakeholders' preferences.

In some regions, regulatory measures limit ZVL use to specific populations or restrict its approval status altogether, compounding its market decline.

Strategic Implications for Stakeholders

Pharmaceutical companies managing ZVL portfolios confront the challenge of balancing residual market health with declining revenues. They must consider whether to maintain manufacturing to serve niche markets, phase out production entirely, or pivot investments toward next-generation vaccines.

Payers and healthcare systems are revising vaccination guidelines, increasingly emphasizing highly efficacious vaccines, adversely impacting the financial prospects of ZVL.

Conclusion

The market dynamics of Zoster Vaccine Live encapsulate a classic case of technological obsolescence driven by scientific advancements, regulatory shifts, and evolving payer preferences. The trajectory indicates diminishing revenues, with foreseeable phasing out in most developed markets. Future financial prospects hinge on niche applications, emerging generic or biosimilar competitors, and potential innovations in herpes zoster vaccines.

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Key Takeaways

• Rapid Market Contraction: Since the advent of Shingrix®, ZVL’s market share has contracted sharply, with residual sales primarily in select regions or populations.
• Efficacy and Safety Edge: Superior efficacy and durability of Shingrix®, coupled with safety concerns related to live vaccines, favor its dominance.
• Market Decline Forecast: Merck’s ZVL revenues are projected to decline towards negligible levels within the next few years, with limited opportunities for revival.
• Emerging Competition: Next-generation vaccine platforms, including mRNA and protein-based candidates, threaten to further erode ZVL’s market share.
• Strategic Outlook: Stakeholders should prioritize transitioning patients to more efficacious vaccines and explore opportunities in low-income markets where live vaccines may retain relevance.

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FAQs

1. Will Zoster Vaccine Live (Zostavax®) regain market share?
It is unlikely. The superior efficacy and safety profile of newer vaccines, particularly Shingrix®, have cemented its market dominance, and current evidence suggests ZVL will continue its decline.

2. Are there specific populations where ZVL still holds value?
Yes. In some low-income or developing regions, where cold-chain logistics and cost are prohibitive for newer vaccines, ZVL may remain relevant temporarily, though its market is shrinking.

3. What are the alternatives to ZVL for herpes zoster prevention?
The primary alternative is Shingrix®, a recombinant subunit vaccine with better efficacy. Other candidate vaccines in clinical development include mRNA-based shingles vaccines.

4. How do regulatory agencies influence the market trajectory for ZVL?
Regulatory bodies advocating for higher-efficacy vaccines and restricting live vaccine use in immunocompromised populations accelerate the decline of ZVL as a preferred product.

5. What is the long-term financial outlook for Merck’s ZVL portfolio?
Given the trend, revenues are expected to diminish significantly, potentially ceasing in major markets within 3-5 years unless new indications or formulations are developed.

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References

[1] Yawn BP, et al. "Herpes Zoster and Postherpetic Neuralgia." JAMA, 2022.
[2] Centers for Disease Control and Prevention (CDC). "Herpes Zoster Vaccination Coverage — United States." MMWR, 2022.
[3] Tseng HF, et al. "Effectiveness and Duration of Protection of the Zoster Vaccine." J Infect Dis, 2018.
[4] CDC Advisory Committee on Immunization Practices (ACIP). "Updated Recommendations for Herpes Zoster Vaccination." MMWR, 2020.
[5] Merck Annual Reports, 2014-2022.