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Last Updated: January 20, 2025

PEDVAXHIB Drug Profile


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Summary for Tradename: PEDVAXHIB
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for PEDVAXHIB
Recent Clinical Trials for PEDVAXHIB

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Johns Hopkins Bloomberg School of Public HealthPhase 4
Merck Sharp & Dohme Corp.Phase 4

See all PEDVAXHIB clinical trials

Pharmacology for PEDVAXHIB
Physiological EffectActively Acquired Immunity
Established Pharmacologic ClassInactivated Haemophilus Influenzae B Vaccine
Chemical StructureHaemophilus Vaccines
Vaccines, Inactivated
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. General brand-side disclosures
  4. 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.

  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 PEDVAXHIB Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PEDVAXHIB Derived from Company Disclosures

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for PedvaxHIB

Introduction to PedvaxHIB

PedvaxHIB is a conjugate vaccine designed to protect against Haemophilus influenzae type b (Hib), a bacterium that can cause severe infections such as meningitis, epiglottitis, and septic arthritis, particularly in children. Here, we will delve into the market dynamics and financial trajectory of PedvaxHIB.

Market Size and Growth

The global conjugate vaccine market, which includes PedvaxHIB, is experiencing significant growth. As of 2023, the global conjugate vaccine market was valued at approximately USD 19.01 billion and is projected to grow at a Compound Annual Growth Rate (CAGR) of 9.60% from 2024 to 2030[1].

Segment Analysis

PedvaxHIB is one of the key products within the conjugate vaccine market. The market for PedvaxHIB, along with other conjugate vaccines, is segmented based on product, brand, disease, pathogen, patient, and region. Here are some key points regarding PedvaxHIB:

Market Estimates and Forecasts

  • The market estimates and forecasts for PedvaxHIB from 2018 to 2030 indicate a steady demand driven by the need to prevent Hib infections. The forecasts suggest that the market for PedvaxHIB will continue to grow, albeit at a rate that may vary depending on regional health policies and vaccination programs[1].

Competitive Landscape

  • PedvaxHIB competes with other Hib vaccines such as Hiberix and ACT-HIB. The competitive landscape is influenced by factors such as regulatory approvals, pricing strategies, and the introduction of new vaccines. For instance, the recent approvals of new conjugate vaccines like CAPVAXIVE for pneumococcal infections highlight the dynamic nature of the market[1].

Drivers of Growth

Several factors drive the growth of the PedvaxHIB market:

Rising Incidence of Infectious Diseases

  • The increasing incidence of infectious diseases globally is a significant driver. Hib infections, despite being preventable, still pose a significant health burden, especially in regions with limited access to vaccines[1].

Regulatory Approvals

  • Regulatory approvals for new conjugate vaccine products are crucial. For example, the approval of new vaccines like CAPVAXIVE by the U.S. FDA in June 2024 sets a precedent for innovation and expansion in the market[1].

Public Health Initiatives

  • Public health initiatives and vaccination programs play a vital role. Organizations like Gavi have significantly impacted the global vaccine market by introducing new vaccines, expanding supplier networks, and reducing vaccine prices, which in turn increases access to vaccines like PedvaxHIB[4].

Challenges and Considerations

Immunogenicity Concerns

  • There have been instances where the immunogenicity of certain lots of PedvaxHIB has been questioned. For example, the CDC reported that 16 lots of PedvaxHIB may have had lower than expected immunogenicity, which can impact consumer trust and market performance[5].

Pricing and Accessibility

  • Pricing is a critical factor, especially in low- and middle-income countries (LMICs). Efforts by organizations like Gavi to reduce vaccine prices through pooled procurement and market shaping have been instrumental in making vaccines more accessible. However, the cost of PedvaxHIB can still be a barrier in some regions[4].

Financial Performance

The financial performance of PedvaxHIB is closely tied to the overall conjugate vaccine market:

Revenue Projections

  • The revenue from PedvaxHIB is expected to grow as part of the broader conjugate vaccine market. With the market projected to reach USD 38.27 billion by 2031, growing at a CAGR of 11% from 2024 to 2031, PedvaxHIB is likely to contribute significantly to this growth[2].

Market Share

  • The market share of PedvaxHIB within the conjugate vaccine segment will depend on its competitive positioning, regulatory environment, and public health policies. As new vaccines are introduced, the market share may fluctuate, but the overall demand for Hib vaccines is expected to remain strong[1].

Regional Dynamics

The market dynamics for PedvaxHIB vary by region:

Developed Markets

  • In developed markets, the demand for PedvaxHIB is driven by established vaccination programs and high regulatory standards. These markets tend to have higher pricing and better access to healthcare services[1].

Emerging Markets

  • In emerging markets, particularly LMICs, the demand is driven by public health initiatives and efforts to increase vaccine accessibility. Organizations like Gavi play a crucial role in these regions by pooling demand and negotiating lower prices with suppliers[4].

Key Takeaways

  • Growing Market: The conjugate vaccine market, including PedvaxHIB, is expected to grow significantly due to rising infectious disease incidence and regulatory approvals.
  • Regulatory Impact: Recent approvals of new conjugate vaccines and ongoing public health initiatives drive market growth.
  • Challenges: Immunogenicity concerns and pricing issues need to be addressed to maintain market trust and accessibility.
  • Financial Projections: PedvaxHIB is expected to contribute to the overall growth of the conjugate vaccine market, reaching USD 38.27 billion by 2031.
  • Regional Variations: Market dynamics vary by region, with developed markets driven by established vaccination programs and emerging markets influenced by public health initiatives.

FAQs

  1. What is PedvaxHIB used for?

    • PedvaxHIB is a conjugate vaccine used to protect against Haemophilus influenzae type b (Hib) infections.
  2. What is the current market size of the conjugate vaccine market?

    • The global conjugate vaccine market was valued at approximately USD 19.01 billion in 2023[1].
  3. What is the projected growth rate of the conjugate vaccine market?

    • The market is expected to grow at a CAGR of 9.60% from 2024 to 2030[1].
  4. What are the key drivers of the PedvaxHIB market?

    • The key drivers include the rising incidence of infectious diseases, regulatory approvals for new vaccines, and public health initiatives.
  5. How does Gavi impact the market for PedvaxHIB?

    • Gavi impacts the market by introducing new vaccines, expanding supplier networks, and reducing vaccine prices through pooled procurement and market shaping[4].

Sources

  1. Research and Markets: Conjugate Vaccine Market Size, Share & Trends Analysis Report By Product, Brand, Disease, Pathogen, Patient, and Region.
  2. Verified Market Research: In-Depth Industry Outlook: Conjugate Vaccine Market Size, Forecast.
  3. Taylor & Francis Online: Haemophilus influenzae type b disease in the era of conjugate vaccines.
  4. GIZ: Market Shaping and Market Access in the Global Vaccines Market.
  5. CDC: Report of PedvaxHIB Lots with Questionable Immunogenicity.

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