Pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) - Biologic Drug Details

Summary for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	2

Pharmacology for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein)

Physiological Effect	Actively Acquired Immunity
Established Pharmacologic Class	Inactivated Pneumococcal Vaccine
Chemical Structure	Pneumococcal Vaccines Vaccines, Conjugate 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

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. General 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 pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) Derived from Patent Text Search

No patents found based on company disclosures

Pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Pneumococcal 13-Valent Conjugate Vaccine (Diphtheria CRM197 Protein)

Introduction to Pneumococcal 13-Valent Conjugate Vaccine

The pneumococcal 13-valent conjugate vaccine, commonly known as Prevnar 13, is a crucial biologic drug developed to prevent diseases caused by Streptococcus pneumoniae. This vaccine is conjugated to the non-toxic diphtheria CRM197 protein, enhancing its immunogenicity and protective efficacy against pneumococcal infections.

Market Size and Growth Projections

The global pneumococcal vaccine market, which includes the 13-valent conjugate vaccine, is experiencing significant growth. As of 2023, the market size was over USD 8.13 billion and is projected to reach USD 17.55 billion by 2036, with a Compound Annual Growth Rate (CAGR) of around 6.1% during the forecast period of 2024-2036[1].

Key Growth Drivers

Increasing Prevalence of Pneumococcal Diseases

The rising prevalence of pneumonia across all age groups, particularly among older adults and those with underlying medical conditions, is a major driver of the market. This increased incidence has heightened the demand for efficient vaccines to prevent various pneumonia-causing strains of Streptococcus pneumoniae[5].

Expanded Use and Approval

Initially approved for infants and children up to 5 years, the 13-valent pneumococcal conjugate vaccine has recently received expanded approval for use in children from 6 weeks to 17 years. This expansion, based on studies demonstrating its serotype-specific immunogenicity and safety, has broadened its market reach[4].

Government Support and Immunization Programs

Various governments and global health organizations, such as Gavi, the Vaccine Alliance, have increased support for immunization programs by expanding coverage and access to pneumococcal vaccines. This support has led to the introduction of pneumococcal conjugate vaccines in national immunization programs of over 70 countries, creating new revenue streams for manufacturers[5].

Financial Trajectory

Revenue Generation

The pneumococcal vaccine market, driven largely by the 13-valent conjugate vaccine, is expected to generate significant revenue. The market's growth is attributed to the high efficacy of conjugate vaccines against pneumococcal disease, with Prevnar 13 being a major contributor due to its preference among healthcare providers[1][5].

Cost-Effectiveness

Studies have shown that the use of pneumococcal conjugate vaccines, including PCV13, is cost-effective. For instance, the CDC model found cost savings in scenarios where PCV20 alone or PCV15 in series with PPSV23 was used for adults aged ≥65 years. These cost-effectiveness estimates range from cost-saving to $39,000 per quality-adjusted life-year (QALY) gained for PCV20[2].

Technological and Scientific Advancements

Role of CRM197 Protein

The CRM197 protein, a genetically detoxified diphtheria toxin, plays a critical role in the pneumococcal conjugate vaccine. It serves as a carrier protein, rendering polysaccharides immunogenic and enhancing the vaccine's protective efficacy. CRM197 is used in various vaccines, including those for meningitis and pneumonia, and its market is projected to grow at a CAGR of 6.5% from 2024 to 2031[3].

Market Segmentation

Vaccine Type

The conjugate vaccine segment is expected to dominate the market due to its high efficacy against pneumococcal disease. Prevnar 13, being a 13-valent conjugate vaccine, holds a significant share in this segment[5].

Product Type

Prevnar 13 is anticipated to hold the largest share among pneumococcal vaccines due to its widespread use and preference among healthcare providers. This is attributed to its proven immunogenicity and safety profile[5].

Competitive Landscape

The pneumococcal vaccine market is characterized by a few key players, with Pfizer being a major player due to its development and manufacturing of Prevnar 13. Other players, such as Merck, also contribute to the market with their 15-valent pneumococcal conjugate vaccine (PCV15)[1][2].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of pneumococcal vaccines. The FDA's approval of new vaccines, such as PCV20 and PCV15, and the updated recommendations by the Advisory Committee on Immunization Practices (ACIP) simplify adult pneumococcal vaccine recommendations and are expected to improve vaccine coverage among adults[2].

Global Health Impact

The use of pneumococcal conjugate vaccines is expected to significantly reduce the incidence of pneumococcal diseases globally. For instance, the introduction of PCV13 has been shown to substantially reduce invasive pneumococcal diseases in a manner similar to its predecessor, PCV7[4].

Challenges and Opportunities

Challenges

Despite the growth, the market faces challenges such as the high development costs of new vaccines and the need for continuous research to address emerging serotypes. Additionally, there is ongoing debate about the toxicity of CRM197, although it has been genetically detoxified[3].

Opportunities

The increasing demand for vaccines in developing countries, supported by global health organizations, presents significant opportunities for market expansion. The development of new vaccines, such as those for Group B Streptococcus and malaria, which also utilize CRM197, further broadens the market potential[3][5].

Key Takeaways

• The global pneumococcal vaccine market is projected to grow significantly, reaching USD 17.55 billion by 2036.
• The 13-valent pneumococcal conjugate vaccine (Prevnar 13) is a major driver of this growth due to its high efficacy and expanded approval.
• Government support and immunization programs are crucial for market growth.
• The use of CRM197 protein enhances the immunogenicity of pneumococcal vaccines.
• The market is expected to be dominated by conjugate vaccines, with Prevnar 13 holding a significant share.

FAQs

Q: What is the projected market size of the pneumococcal vaccine market by 2036?

A: The global pneumococcal vaccine market is projected to reach USD 17.55 billion by 2036[1].

Q: Which vaccine type is expected to dominate the pneumococcal vaccine market?

A: The conjugate vaccine segment is expected to hold a dominant position due to its high efficacy against pneumococcal disease[5].

Q: What is the role of CRM197 protein in pneumococcal conjugate vaccines?

A: CRM197 is a genetically detoxified diphtheria toxin that serves as a carrier protein, rendering polysaccharides immunogenic and enhancing the vaccine's protective efficacy[3].

Q: How does government support impact the pneumococcal vaccine market?

A: Government support and global health organizations' funding have led to the introduction of pneumococcal conjugate vaccines in national immunization programs, creating new revenue streams for manufacturers[5].

Q: What are the cost-effectiveness estimates for using pneumococcal conjugate vaccines in adults?

A: Studies have shown that using PCV20 alone or PCV15 in series with PPSV23 for adults aged ≥65 years can be cost-saving, with estimates ranging from cost-saving to $39,000 per QALY gained[2].

Sources

1. Research Nester: Pneumococcal Vaccine Market Size & Share, Growth Report 2036.
2. CDC: Use of 15-Valent Pneumococcal Conjugate Vaccine and 20-Valent Pneumococcal Conjugate Vaccine.
3. Verified Market Research: CRM197 Market Size, Share, Trends & Forecast.
4. PubMed: 13-valent pneumococcal conjugate vaccine: a review of its use in infants, children, and adolescents.
5. Biospace: Pneumococcal Vaccines Market to hit US$ 12.51 billion by 2031.