Zoster vaccine recombinant, adjuvanted - Biologic Drug Details

Summary for zoster vaccine recombinant, adjuvanted

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for zoster vaccine recombinant, adjuvanted

Recent Clinical Trials for zoster vaccine recombinant, adjuvanted

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Colorado, Denver	Phase 2
GlaxoSmithKline	Phase 2
University of Rochester	Early Phase 1

See all zoster vaccine recombinant, adjuvanted 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 recombinant, adjuvanted Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for zoster vaccine recombinant, adjuvanted 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
Glaxosmithkline Biologicals	SHINGRIX	zoster vaccine recombinant, adjuvanted	Injection	125614	10,245,349	2035-09-16	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Biologicals	SHINGRIX	zoster vaccine recombinant, adjuvanted	Injection	125614	10,610,600	2039-03-15	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Biologicals	SHINGRIX	zoster vaccine recombinant, adjuvanted	Injection	125614	10,632,185	2037-07-06	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Biologicals	SHINGRIX	zoster vaccine recombinant, adjuvanted	Injection	125614	10,953,098	2038-10-02	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Biologicals	SHINGRIX	zoster vaccine recombinant, adjuvanted	Injection	125614	11,260,078	2038-07-25	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Biologicals	SHINGRIX	zoster vaccine recombinant, adjuvanted	Injection	125614	11,291,739	2040-09-24	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Biologicals	SHINGRIX	zoster vaccine recombinant, adjuvanted	Injection	125614	11,291,740	2040-08-12	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for zoster vaccine recombinant, adjuvanted 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

International Patents for zoster vaccine recombinant, adjuvanted

Country	Patent Number	Estimated Expiration
South Korea	20190027878
Singapore	11202100593P
Israel	234555
New Zealand	628449
Japan	7260554
Canada	3066792
Spain	2907847

Market Dynamics and Financial Trajectory for the Biologic Drug: Zoster Vaccine Recombinant, Adjuvanted

Last updated: August 13, 2025

Introduction

The recombinant, adjuvanted zoster vaccine, marketed as Shingrix, has transformed the prophylactic landscape against herpes zoster (shingles). Since its approval, Shingrix has positioned itself as a critical immunization tool for older adults and immunocompromised individuals, driving significant shifts in market dynamics and elevating its financial trajectory within the global vaccine industry. This comprehensive analysis details the evolving market landscape, key drivers, competitive forces, and financial outlook for this biologic drug.

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Market Overview

Herpes zoster affects approximately 1 million Americans annually, with incidence sharply increasing post age 50 (1). The vaccine's innovation lies in its recombinant glycoprotein E antigen combined with a potent adjuvant system (AS01B), which elicits robust and durable immunity, surpassing the efficacy of earlier live-attenuated vaccines. Approved by the FDA in 2017 and later by the EMA, Shingrix quickly gained prominence due to its superior efficacy (up to 97% in adults aged 50–69) and favorable safety profile (2).

The global zoster vaccine market, valued at roughly $2.4 billion in 2022, is expected to grow at a compounded annual growth rate (CAGR) of approximately 8-10% through 2030, driven by demographic shifts, increased awareness, and evolving vaccine landscapes (3).

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Market Drivers

1. Aging Population and Disease Burden

Rapid demographic aging is a primary catalyst. The World Health Organization estimates that the global population aged 60 years or above will double by 2050 to 2.1 billion (4). This trend amplifies the demand for shingles vaccination, especially with the burden of postherpetic neuralgia (PHN), a debilitating complication affecting 10-20% of shingles cases (1).

2. Enhanced Vaccine Efficacy and Duration

Shingrix's superior efficacy over the live-attenuated Zostavax, especially in immunocompromised and older populations, positions it as the preferred choice. Its estimated protection duration exceeds 4-5 years, with ongoing studies evaluating longer-term immunity (2).

3. Strategic Public Health Initiatives

Government programs and recommendations, notably CDC advisories promoting vaccination at age 50 and above, have substantially increased uptake. Increased reimbursement coverage and vaccination mandates have bolstered demand, especially in the United States and Europe (5).

4. Expanding Indications and Approvals

Recent trials assessing efficacy in immunocompromised adults, including hematopoietic stem cell transplant recipients, have broadened market applicability. Expansion into pediatric and other vulnerable groups is under exploration, promising future growth opportunities (6).

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Competitive Landscape

1. Dominance of Shingrix

Shingrix controls over 90% of the current zoster vaccine market share, owing to its efficacy and pharmacovigilance profile. Its robust pipeline, including potential new formulations or indications, sustains its market leadership.

2. The Role of Zostavax

Zostavax, the earlier live-attenuated vaccine, experienced declining usage due to lower efficacy (around 51%) and waning immunity. Its market share continues to diminish, observing phased-out distribution in various regions (7).

3. Emerging Competitors and Biosimilars

There are no direct biosimilars for Shingrix currently on the market; however, efforts are underway by biotech firms focusing on alternative recombinant or mRNA-based shingles vaccines, which could intensify competition in the next decade. Companies like Vaxcyte and Moderna are exploring such innovations (8).

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Market Barriers and Challenges

1. Cost and Reimbursement Constraints

Shingrix's higher price point ($150–$170 per dose) presents hurdles, especially in low- and middle-income markets. Reimbursement variability may impede uptake, despite public health recommendations.

2. Supply Chain and Manufacturing Constraints

Manufacturing complexity associated with its adjuvant system and protein antigen can lead to supply chain constraints, impacting timely delivery and strategic planning.

3. Vaccine Hesitancy and Public Awareness

Vaccine hesitancy persists, often fueled by misconceptions about vaccine safety or necessity. Educational initiatives are crucial in sustaining high coverage levels.

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Financial Trajectory and Growth Projections

1. Revenue Forecasts

Projected revenues for Shingrix and the broader zoster vaccine segment are expected to grow from approximately $2.4 billion in 2022 to over $5 billion by 2030, driven by increased uptake and expanding indications (3). The United States will continue as the largest market, accounting for over 50% of global revenues.

2. Pricing Strategies and Market Penetration

Pharmaceutical companies are exploring tiered pricing models, bundling strategies, and patient assistance programs to enhance market penetration, especially in emerging markets.

3. R&D and Pipeline Developments

Investments into next-generation vaccines, such as mRNA-based shingles vaccines, are anticipated to disrupt existing market dynamics. Their potential for lower cost, easier manufacturing, and flexibility could lead to accelerated adoption and price competition.

4. Regulatory and Policy Impact

Ongoing licensing agreements and health policy shifts, such as inclusion in national immunization schedules, directly influence revenue trajectories. For example, expanded CDC recommendations in the US to include adults aged 50–64 have markedly increased demand (5).

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Future Outlook and Trends

1. Global Expansion

As developed nations achieve high coverage, focus shifts towards low- and middle-income countries (LMICs). Strategic partnerships and differential pricing will be essential to capture emerging markets.

2. Innovative Delivery Platforms

Technological advances, including nanoparticle delivery systems and mRNA platforms, are poised to open new avenues, potentially offering longer durability, easier administration, and cost reductions.

3. Integration with Broader Vaccination Programs

The integration of shingles vaccination into comprehensive immunization schedules, especially for aging populations, will bolster sustainability and revenue streams.

4. Digital and Data-Driven Strategies

Leveraging health data analytics and digital health tools will optimize vaccination campaigns, track efficacy, and personalize immunization strategies to maximize market share.

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Key Takeaways

• The recombinant, adjuvanted zoster vaccine, Shingrix, has established itself as the leading prophylactic against shingles, driven by its high efficacy and expanding indications.
• Demographic shifts, public health policies, and increased awareness will sustain double-digit growth rates globally through 2030.
• Market dominance faces challenges from manufacturing complexities, cost considerations, and potential novel competitors, including mRNA-based vaccines.
• Strategic efforts in emerging markets, technological innovations, and policy adoption remain pivotal to expanding market reach and revenue.
• Partnerships, pricing strategies, and ongoing R&D investments will determine the long-term financial trajectory, with prospects for disruptors reshaping the competitive landscape.

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FAQs

Q1: What distinguishes Shingrix from earlier shingles vaccines?
A1: Shingrix offers superior efficacy (~97%) compared to the live-attenuated vaccine (Zostavax), with longer-lasting immunity and a favorable safety profile, especially in older and immunocompromised individuals.

Q2: What are the main factors driving the growth of the zoster vaccine market?
A2: The primary drivers include global aging populations, increased awareness and recommendations for vaccination, improved vaccine efficacy, and expanding indications.

Q3: Are biosimilars or alternative technologies likely to challenge Shingrix?
A3: While no biosimilars exist currently, experimental vaccines utilizing mRNA technology or alternative recombinant platforms could introduce competition in the coming decade.

Q4: How does vaccine cost impact market penetration?
A4: Higher vaccine prices can limit adoption, particularly in resource-constrained settings, despite reimbursement programs and public health initiatives.

Q5: What future developments could influence the financial trajectory of the zoster vaccine?
A5: Advances in vaccine technology, broader regulatory approvals, increased global deployment, and inclusion in national immunization schedules will shape future growth.

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Sources

1. Gagliardi AM, et al. “Herpes Zoster: Epidemiology and Vaccine Landscape,” Infectious Disease Reports, 2021.
2. Centers for Disease Control and Prevention. “Shingrix Vaccine Information,” CDC.gov, 2022.
3. Market Research Future. “Global Zoster Vaccine Market Analysis & Forecast to 2030,” 2022.
4. World Health Organization. “Aging and Health,” 2021.
5. CDC Advisory Committee on Immunization Practices. “Updated Recommendations for Zoster Vaccination,” MMWR, 2021.
6. Cytomegalovirus, Vaxcyte, and Moderna clinical trial data.
7. Johnson & Johnson. “Zostavax Discontinuation Notice,” 2017.
8. Pharmaceutical pipelines and industry reports, 2022.