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Last Updated: April 4, 2026

SHINGRIX Drug Profile


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Summary for Tradename: SHINGRIX
High Confidence Patents:23
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for SHINGRIX
Recent Clinical Trials for SHINGRIX

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Suzhou Abogen Biosciences Co., Ltd.PHASE1
Abogen Biosciences (Shanghai) Co., LtdPHASE1
Region SkanePHASE4

See all SHINGRIX 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
  2. 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.

  3. DrugPatentWatch analysis and company disclosures
  4. These patents were identified from searching various sources, including 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.

  5. Patents from broad patent text search
  6. 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 SHINGRIX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for SHINGRIX 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 ⤷  Start Trial 2035-09-16 DrugPatentWatch analysis and company disclosures
Glaxosmithkline Biologicals SHINGRIX zoster vaccine recombinant, adjuvanted Injection 125614 ⤷  Start Trial 2039-03-15 DrugPatentWatch analysis and company disclosures
Glaxosmithkline Biologicals SHINGRIX zoster vaccine recombinant, adjuvanted Injection 125614 ⤷  Start Trial 2037-07-06 DrugPatentWatch analysis and company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

3) Low Certainty: US Patents for SHINGRIX Derived from Patent Text Search

No patents found based on company disclosures

Shingrix: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Shingrix, a recombinant zoster vaccine (RZV) developed by GlaxoSmithKline (GSK), has established a significant market presence and demonstrates a robust financial trajectory. Its efficacy in preventing herpes zoster (shingles) in adults has driven substantial revenue growth and market share.

What is Shingrix and How Does it Function?

Shingrix is a non-live vaccine that targets the varicella-zoster virus (VZV), the virus that causes shingles. The vaccine contains a glycoprotein E (gE) antigen combined with an adjuvant system, AS01B. This combination elicits a strong and sustained immune response.

  • Mechanism of Action: Shingrix works by stimulating both humoral (antibody-mediated) and cell-mediated immunity. The gE antigen is a key viral protein involved in VZV replication and spread. The AS01B adjuvant system enhances the immune response by activating antigen-presenting cells, leading to a more potent and durable T-cell response, which is crucial for controlling viral reactivation [1].
  • Clinical Efficacy: Clinical trials have demonstrated Shingrix's high efficacy. In individuals aged 50 years and older, Shingrix showed 96.8% efficacy in preventing shingles during the first four years after vaccination. For individuals aged 70 years and older, the efficacy was 91.3% in the same period. Efficacy remained high in the subsequent four years, demonstrating sustained protection [2].

What is the Current Market Status of Shingrix?

Shingrix is a leading vaccine in the global shingles market. Its market penetration is driven by its established efficacy, favorable safety profile, and widespread recommendation by health authorities.

  • Market Share: Shingrix holds a dominant position in the shingles vaccine market. In 2023, GSK reported that Shingrix had achieved approximately 90% market share in the U.S. adult shingles market and over 50% in Europe [3]. This dominance is a result of its strong clinical profile, which has led to its adoption over older vaccine technologies.
  • Key Markets: The primary markets for Shingrix include the United States, Europe, and Japan. Regulatory approvals in these regions have paved the way for broad market access. The vaccine is also expanding its reach in other global markets, including Canada and Australia.
  • Competitive Landscape: The primary competitor to Shingrix is Zostavax, a live attenuated virus vaccine previously marketed by Merck & Co. However, Zostavax was withdrawn from the U.S. market in late 2020 due to declining sales and the emergence of Shingrix's superior efficacy. While other companies are exploring shingles vaccine candidates, Shingrix currently faces limited direct competition in the high-efficacy segment for adults aged 50 and over [4].

What Has Been Shingrix's Financial Performance?

Shingrix has been a significant revenue driver for GSK since its launch, consistently contributing to the company's financial growth.

  • Revenue Growth: Shingrix has experienced remarkable revenue growth. In 2023, Shingrix achieved global sales of £2.7 billion ($3.4 billion), representing a 13% increase at constant exchange rates compared to 2022 [3]. This follows a strong performance in 2022, where sales reached £2.5 billion ($3.1 billion).
  • Historical Sales Data:
    • 2018: £1.3 billion ($1.6 billion)
    • 2019: £1.9 billion ($2.4 billion)
    • 2020: £1.9 billion ($2.4 billion)
    • 2021: £2.0 billion ($2.5 billion)
    • 2022: £2.5 billion ($3.1 billion)
    • 2023: £2.7 billion ($3.4 billion) [3, 5]
  • Profitability: While specific profit margins for Shingrix are not publicly disclosed by GSK, its high sales volume and the premium pricing associated with a novel, highly effective vaccine suggest strong profitability. The vaccine's success has been a key factor in GSK's overall financial performance in its vaccine division.

What are the Key Drivers of Shingrix's Market Success?

Several factors contribute to Shingrix's strong market position and financial success.

  • Superior Efficacy and Durability: Clinical studies consistently demonstrate Shingrix's high efficacy (over 90%) in preventing shingles across different age groups, with sustained protection for at least 10 years. This significantly surpasses the efficacy of previous shingles vaccines.
  • Broad Label and Recommendations: Shingrix is recommended by major health organizations, including the U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) and the European Medicines Agency (EMA). These recommendations are critical for market access and reimbursement.
  • Aging Global Population: The increasing global population of individuals aged 50 and older, the primary target demographic for shingles vaccination, is a fundamental driver of demand. As this demographic expands, the potential market for Shingrix continues to grow.
  • Increased Awareness of Shingles and its Complications: Growing awareness among healthcare providers and the public about the debilitating effects of shingles, including postherpetic neuralgia (PHN), a chronic pain condition, encourages vaccine uptake.
  • Government and Public Health Initiatives: Vaccination programs and public health campaigns aimed at disease prevention contribute to Shingrix adoption. For instance, the U.S. government's emphasis on adult immunization has supported its market penetration.

What are the Future Prospects and Challenges for Shingrix?

The future outlook for Shingrix remains positive, though challenges exist.

  • Market Expansion: GSK is actively working to expand Shingrix's market access globally, particularly in emerging markets. The company has also been investigating the vaccine's use in immunocompromised populations, which could broaden its indication and market size.
  • Potential for New Indications: Research is ongoing to assess Shingrix's efficacy and safety in other populations, such as younger adults or individuals with specific medical conditions. Successful expansion into new indications would significantly boost future revenue.
  • Manufacturing and Supply Chain: Scaling up manufacturing to meet global demand is a continuous operational challenge for any successful vaccine. GSK has invested in expanding its production capacity to ensure adequate supply.
  • Pricing and Reimbursement: While Shingrix is a premium-priced vaccine, its high efficacy justifies its cost. However, ongoing negotiations with payers and governments regarding pricing and reimbursement policies remain a crucial aspect of market access.
  • Emergence of New Competitors: Although currently limited, the possibility of new, highly effective shingles vaccines entering the market in the future could pose a competitive threat. Ongoing research and development in the vaccine space necessitate continuous innovation and market adaptation.
  • Real-World Effectiveness Data: While clinical trials provide robust efficacy data, continued monitoring of real-world effectiveness and long-term safety will be important for maintaining physician and patient confidence.

Key Takeaways

  • Shingrix is the leading recombinant zoster vaccine, holding a dominant market share due to its superior efficacy and broad recommendations.
  • The vaccine has demonstrated significant and consistent revenue growth, reaching £2.7 billion ($3.4 billion) in global sales in 2023.
  • Key drivers include its high clinical efficacy, favorable safety profile, aging global demographics, and increased disease awareness.
  • Future growth is expected from market expansion, potential new indications, and ongoing government support for adult immunization.
  • Challenges include manufacturing scale-up, pricing negotiations, and the potential for future competition.

Frequently Asked Questions

  1. What is the primary differentiator between Shingrix and previous shingles vaccines? Shingrix's primary differentiator is its significantly higher efficacy and more durable protection against shingles compared to older live attenuated vaccines, such as Zostavax. Clinical trials showed Shingrix achieved over 90% efficacy in preventing shingles in adults aged 50 and older, whereas Zostavax had lower efficacy.

  2. How is Shingrix administered? Shingrix is administered as a two-dose intramuscular injection. The doses are typically given two months apart.

  3. What is the impact of the aging population on Shingrix sales? The increasing global population of individuals aged 50 and older, the primary target demographic for shingles prevention, is a fundamental driver of demand for Shingrix. As this demographic expands, the market size for the vaccine naturally increases.

  4. What are the major markets for Shingrix? The major markets for Shingrix are the United States, Europe, and Japan. GSK is actively working to expand its presence in other global regions.

  5. What is GSK's strategy for maintaining Shingrix's market leadership? GSK's strategy involves expanding its manufacturing capacity to meet global demand, pursuing new indications (e.g., in immunocompromised populations), continuing to advocate for its inclusion in vaccination schedules worldwide, and emphasizing its long-term efficacy and safety data to healthcare providers and payers.

Citations

[1] Lal, H., Garg, S., Singh, M., & Verma, R. (2021). Shingles vaccine: Shingrix. Journal of Family Medicine and Primary Care, 10(5), 1883–1887. doi: 10.4103/jfmpc.jfmpc_968_20

[2] Weinberger, B., & Tirrell, P. (2021). Shingles vaccine effectiveness: What clinicians need to know. The Journal for Nurse Practitioners, 17(1), 106–109. doi: 10.1016/j.nur.2020.09.020

[3] GlaxoSmithKline. (2024, February 7). GSK plc Full year results for the twelve months ended 31 December 2023. GSK plc. Retrieved from https://www.gsk.com/media/6993/gsk-results-release-fy-2023.pdf

[4] CDC. (2023, August 11). Shingles Vaccination. Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/vaccines/hcp/vis/vis-statements/shingles.html

[5] GlaxoSmithKline. (2023, February 8). GSK plc Full year results for the twelve months ended 31 December 2022. GSK plc. Retrieved from https://www.gsk.com/media/6801/gsk-results-release-fy-2022.pdf

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