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
GlaxoSmithKline	Phase 2
University of Colorado, Denver	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

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
Singapore	11202100593P
Japan	2023099685
World Intellectual Property Organization (WIPO)	2013132452

Market Dynamics and Financial Trajectory for Zoster Vaccine Recombinant, Adjuvanted

Last updated: March 6, 2026

What is the Current Market Size and Forecast for the Zoster Vaccine Recombinant, Adjuvanted?

The global market for zoster vaccines has grown significantly since the approval of recombinant, adjuvanted formulations. The market was valued at approximately $1.2 billion in 2022 and is projected to reach $3.4 billion by 2030, exhibiting a compound annual growth rate (CAGR) of around 13.4% during this period (Fortune Business Insights, 2023).

Key factors impacting market size include increasing aging populations, rising awareness about shingles complications, and expanding vaccine coverage policies across countries.

How Does the Market for Zoster Vaccines Differ from Traditional Options?

Two main vaccines dominate: Shingrix (Recombinant Zoster Vaccine, adjuvanted) and Zostavax (live attenuated). Shingrix has captured over 90% of the market since its approval in 2017 due to superior efficacy (over 90%) and longer-lasting immunity, compared to Zostavax's approximate 50% efficacy and declining immunity over time (CDC, 2022).

Shingrix's recombinant, adjuvanted technology, which enhances immune response, positions it as the preferred option for immunocompromised and older populations.

What Are the Key Drivers and Barriers Influencing Market Growth?

Drivers:

• Aging Populations: The demographic shift leads to increased shingles incidence. The World Health Organization projects that the population aged 60+ will double by 2050, amplifying demand.
• Vaccine Efficacy: Superior efficacy and safety profile of recombinant, adjuvanted vaccines encourage uptake.
• Expanded Guidelines: Recommendations by agencies like CDC favor RZV (Shingrix) for adults aged 50+ and immunocompromised individuals, boosting coverage.

Barriers:

• Pricing and Reimbursement: High costs and inconsistent reimbursement policies in certain markets slow adoption.
• Manufacturing Constraints: Complex production processes increase costs and limit supply.
• Patient Awareness: Limited awareness about shingles and vaccine benefits hampers demand, especially in emerging markets.

What Are the Competitive and Patent Landscapes?

Shingrix is developed by GlaxoSmithKline (GSK). It is protected by patents filed in multiple jurisdictions, with primary patent protection expected to expire around 2030, opening opportunities for biosimilar entrants (GSK, 2022).

Competitors include Merck, which markets Zostavax, though its market share has declined. No approved biosimilars are currently available, but patent expiry may catalyze a wave of biosimilar development.

Financial Trajectory and Investment Outlook

GSK reported sales of approximately £1.6 billion (~$2.2 billion) for Shingrix in 2022, with sales virtually unchanged from 2021 due to supply constraints. The company's projections suggest sales growth to reach approximately £3 billion (~$4.1 billion) annually by 2025, driven by expanding global distribution and booster dose programs.

Investors should note that the global market expansion relies on:

• Regulatory approvals in emerging markets.
• Reimbursement policy enhancements.
• Continuous pipeline development, including potential new formulations or combination vaccines.

Territory-Specific Dynamics

United States: Dominates the market with high vaccination rates. The CDC recommends two doses for adults aged 50+ and immunocompromised individuals. Reimbursement policies favor vaccination, supporting high uptake.

Europe: Growing markets due to aging demographics and national immunization programs, with reimbursement increasing in countries like Germany and the UK.

Emerging Markets: Present significant growth potential but face challenges regarding awareness, healthcare infrastructure, and pricing strategies.

Potential Risks and Opportunities

Risks: Patent expiry leading to biosimilar competition, pricing pressures, and regulatory hurdles potentially restraining growth.

Opportunities: Expanding indications, such as use in immunocompromised populations earlier in disease course, and developing combination vaccines targeting multiple herpes zoster strains or other pathogens.

Key Financial Metrics Summary

Metric	2022 Estimates	2025 Projections	Notes
Global market size	$1.2 billion	$3.4 billion	CAGR of 13.4%
GSK Shingrix sales	$2.2 billion	~$4.1 billion	Stabilized in 2022, projected growth
Patent expiry	2030	-	Opens biosimilar markets

Conclusion

The recombinant, adjuvanted zoster vaccine market is characterized by rapid growth driven by demographic trends and superior product efficacy. Market expansion hinges on regulatory approvals in new regions, reimbursement policies, and the evolution of biosimilar competition.

Key Takeaways

• The market is projected to more than double by 2030, driven by aging populations and guideline updates.
• Shingrix dominates with high efficacy, leading to sustained sales; patent protections extend until 2030.
• High costs and uneven reimbursement landscapes in emerging markets limit growth potential.
• Patent expiry around 2030 presents opportunities for biosimilar entrants.
• Clinical pipeline developments may open new indications and boost future revenues.

FAQs

1. When will biosimilars for Shingrix likely enter the market?
Biosimilar development is expected to accelerate after patent expiry around 2030, though regulatory pathways could influence timelines.

2. How does Shingrix efficacy compare to Zostavax?
Shingrix exhibits over 90% efficacy in preventing shingles and postherpetic neuralgia, whereas Zostavax offers approximately 50% efficacy with waning immunity over time.

3. What countries are leading in vaccine adoption?
The United States and European nations lead, supported by strong regulatory endorsement and reimbursement systems.

4. Are there new indications for this vaccine?
Potential future indications include use in immunocompromised populations and possibly as part of combination vaccines, pending clinical trials and approval.

5. How might pricing pressures affect market growth?
Pricing pressures, especially from biosimilars and in markets with strict reimbursement policies, could temper revenue growth post-2030.

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References

1. Fortune Business Insights. (2023). Global Zoster Vaccine Market Size, Share & Industry Report.
2. CDC. (2022). Shingles vaccination recommendations and efficacy data.
3. GSK. (2022). Shingrix patent portfolio and filing details.