Meningococcal group b vaccine - Biologic Drug Details

Summary for meningococcal group b vaccine

Tradenames:	2
High Confidence Patents:	0
Applicants:	2
BLAs:	2
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for meningococcal group b vaccine

Recent Clinical Trials for meningococcal group b vaccine

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Sanofi Pasteur, a Sanofi Company	PHASE1
Amgen	Phase 3
University of North Carolina, Chapel Hill	Phase 2

See all meningococcal group b 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 meningococcal group b vaccine Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for meningococcal group b 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
Glaxosmithkline Biologicals	BEXSERO	meningococcal group b vaccine	Injection	125546	8,273,360	2021-01-17	DrugPatentWatch analysis and company disclosures
Glaxosmithkline Biologicals	BEXSERO	meningococcal group b vaccine	Injection	125546	8,663,656	2023-10-02	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	TRUMENBA	meningococcal group b vaccine	Injection	125549	10,500,285	2036-05-16	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	TRUMENBA	meningococcal group b vaccine	Injection	125549	10,874,726	2034-12-04	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	TRUMENBA	meningococcal group b vaccine	Injection	125549	11,395,833	2040-10-30	DrugPatentWatch analysis and company disclosures
Wyeth Pharmaceuticals Llc	TRUMENBA	meningococcal group b vaccine	Injection	125549	11,577,001	2037-11-02	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for meningococcal group b 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
Glaxosmithkline Biologicals	BEXSERO	meningococcal group b vaccine	Injection	125546	11,031,102	2035-11-13	Patent claims search
Glaxosmithkline Biologicals	BEXSERO	meningococcal group b vaccine	Injection	125546	11,244,744	2037-06-06	Patent claims search
Glaxosmithkline Biologicals	BEXSERO	meningococcal group b vaccine	Injection	125546	9,707,154	2034-04-23	Patent claims search
Wyeth Pharmaceuticals Llc	TRUMENBA	meningococcal group b vaccine	Injection	125549	11,031,102	2035-11-13	Patent claims search
Wyeth Pharmaceuticals Llc	TRUMENBA	meningococcal group b vaccine	Injection	125549	11,244,744	2037-06-06	Patent claims search
Wyeth Pharmaceuticals Llc	TRUMENBA	meningococcal group b vaccine	Injection	125549	9,707,154	2034-04-23	Patent claims search

International Patents for meningococcal group b vaccine

Country	Patent Number	Estimated Expiration
European Patent Office	2115002
Canada	3042751
New Zealand	753034
European Patent Office	2527363
China	103906525
Mexico	2015011071

Market Dynamics and Financial Trajectory for the Biologic Drug: Meningococcal Group B Vaccine

Last updated: July 29, 2025

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Introduction

The meningococcal group B vaccine (MenB) represents a critical advancement in infectious disease prophylaxis, targeting Neisseria meningitidis serogroup B—a leading cause of bacterial meningitis and septicemia among infants, adolescents, and young adults worldwide. As the global landscape shifts with evolving epidemiology, regulatory policies, and technological innovations, understanding the market dynamics and financial insights surrounding MenB vaccines becomes vital for stakeholders including pharmaceutical companies, healthcare providers, policymakers, and investors.

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Epidemiological and Market Drivers

Rising Disease Burden and Public Health Priorities

Serogroup B meningococcal disease poses severe health risks with high morbidity and mortality rates, especially in infants and young children. Worldwide, the disease exhibits significant regional variation, with higher incidences reported in sub-Saharan Africa, Europe, and North America. Recent epidemiological reports suggest an uptick in cases within high-income countries, partly driven by pathogen evolution and better diagnostic capabilities (CDC, 2022). This increasing disease burden incentivizes immunization programs and heightens demand for effective vaccination options.

Regulatory Approvals and New Product Launches

The approval of domestically developed MenB vaccines, such as Bexsero (GSK) and Trumenba (Pfizer), catalyzed vaccine adoption globally. FDA, EMA, and other regulatory bodies have streamlined approval processes, particularly for high-risk adult populations and adolescents. The recent approval of next-generation vaccines with broader serogroup coverage and improved safety profiles enhances market potential.

Vaccination Strategies and Public Policies

Governments' inclusion of MenB vaccines in immunization schedules varies significantly. In countries like the UK and Australia, MenB vaccination campaigns for infants and adolescents have led to increased uptake. Conversely, some regions lack widespread inclusion due to cost-effectiveness concerns, limited awareness, or infrastructural challenges. These variations dictate regional market growth trajectories.

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Market Dynamics

Competitive Landscape and Patent Landscape

The MenB vaccine market is characterized by intense competition among major pharmaceutical firms—primarily GSK and Pfizer. Bexsero and Trumenba dominate the market with distinct antigenic compositions and immunization regimens. Patent expirations and biosimilar developments are unlikely in the near term, given the complexity of biologic manufacturing and regulatory hurdles, ensuring market dominance of these incumbents.

Pricing, Reimbursement, and Access

Pricing strategies for MenB vaccines are influenced by factors including manufacturing costs, country-specific healthcare budgets, and analytical cost-effectiveness assessments. High vaccine prices can impede widespread adoption, especially in low- and middle-income nations where reimbursement systems are less robust. Recent negotiations and tiered pricing models aim to improve access, but pricing remains a pivotal determinant of market expansion.

Manufacturing and Supply Chain Considerations

Manufacturing biologics like MenB vaccines involves sophisticated technology and stringent quality controls, limiting rapid capacity expansion. Supply chain disruptions, as observed during the COVID-19 pandemic, pointed to vulnerabilities that could impede consistent supply, affecting market stability.

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Financial Trajectory and Revenue Forecasts

Current Revenue Landscape

The global meningococcal vaccine market, valued at approximately USD 1.2 billion in 2022, includes multiple subsegments—covering serogroups A, C, W, Y, and B. MenB vaccines accounted for around 60% of this segment, reflecting their pivotal role in immunization protocols (GlobalData, 2023). Revenue projections indicate a compound annual growth rate (CAGR) of approximately 8-10% over the next five years, driven by new country introductions and expanded indications.

Forecasted Growth Drivers

• Introduction in Emerging Markets: Increasing awareness and funding initiatives, such as Gavi support, are expected to facilitate broader access in low-income countries, unlocking untapped markets.
• Innovative Vaccine Platforms: Next-gen MenB vaccines employing novel adjuvants or mRNA technology could yield higher efficacy and coverage, prompting higher market penetration and premium pricing.
• Regulatory Approvals for Additional Age Groups: Extending indications to broader populations enhances revenue streams.

Risks and Challenges

Factors constraining growth include vaccine hesitancy, high pricing, and inconsistent public health policies. Additionally, competition from combination vaccines and alternative prophylactic strategies could limit incremental revenues.

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Global Market Expansion and Regional Insights

North America and Europe

These regions represent mature markets with high vaccine coverage and established healthcare infrastructure. Market growth hinges on policy changes, improved awareness, and incremental adoption in adult populations. The US, Europe, and Japan collectively contribute over 65% of global MenB vaccine revenues.

Asia-Pacific and Latin America

Emerging markets such as India, China, Brazil, and Mexico pose significant growth opportunities due to their vast populations, rising healthcare budgets, and expanding immunization initiatives. However, challenges include regulatory timelines, affordability, and distribution logistics.

Africa and Low-income Countries

While disease burden is high, vaccine access remains limited. Gavi's support and global health initiatives are crucial to expanding coverage, presenting both philanthropic impact and affordability challenges for manufacturers.

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Future Outlook

The outlook for the meningococcal group B vaccine market is broadly optimistic, tied to technological innovations, policy shifts, and increasing disease awareness. Biotech advances, such as mRNA platforms, could revolutionize vaccine manufacturing, potentially reducing costs and improving efficacy. Additionally, global initiatives targeting vaccine equity should broaden market access, contributing to sustained financial growth.

Nevertheless, market sustainability depends on strategic alliance formations, continuous R&D investment, and navigating complex regulatory landscapes. Vaccines with broader serogroup coverage or multivalent formulations may command premium pricing and compete effectively in a crowded space.

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Key Takeaways

• The global MenB vaccine market is experiencing steady growth driven by increasing epidemiological burden, regulatory approvals, and expanding immunization strategies.
• Major players, GSK and Pfizer, dominate the market; patent protections and technological barriers sustain their market share.
• Pricing, reimbursement policies, and healthcare infrastructure significantly influence market access, especially in low- and middle-income countries.
• Market expansion prospects are promising in emerging markets through global health programs and regional disease burden.
• Innovation in vaccine technology and broader indications are key to future revenue growth, while addressing challenges like vaccine hesitancy and manufacturing constraints remains critical.

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FAQs

1. What are the main challenges facing the MenB vaccine market?
Key challenges include high manufacturing costs, vaccine hesitancy, pricing barriers, regulatory variability across regions, and supply chain disruptions.

2. How does the inclusion of MenB vaccines in national immunization schedules impact market growth?
Inclusion in national schedules leads to increased demand, higher coverage rates, and stimulates market expansion through government procurement and public health initiatives.

3. Are there emerging technologies that could disrupt the MenB vaccine market?
Yes. Innovations like mRNA-based vaccines and universal meningococcal vaccines could enhance efficacy, reduce costs, and transform manufacturing and distribution paradigms.

4. What role do public-private partnerships play in expanding MenB vaccine access?
Partnerships, especially with organizations like Gavi, facilitate funding, technical support, and distribution, especially in low-income regions, influencing market dynamics and growth.

5. What is the long-term revenue outlook for MenB vaccines?
With sustained innovation, policy support, and increased global coverage, the market is projected to grow at a CAGR of approximately 8-10% over the next five years, reaching new revenue heights.

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Sources

1. Centers for Disease Control and Prevention (CDC). Meningococcal Disease. 2022.
2. GlobalData. Meningococcal Vaccine Market report. 2023.