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Pneumococcal Disease - Pipeline Insight, 2025

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    Clinical Trials

  • 80 Pages
  • July 2025
  • Region: Global
  • DelveInsight
  • ID: 5262028
This “Pneumococcal Disease - Pipeline Insight, 2025” report provides comprehensive insights about 18+ companies and 20+ pipeline drugs in Pneumococcal Disease pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Pneumococcal Disease: Understanding

Pneumococcal Disease: Overview

Pneumococcal Disease, commonly known as whooping cough, is a highly contagious respiratory disease Pneumococcal disease refers to a group of infections caused by the bacterium Streptococcus pneumoniae (pneumococcus), which is a major cause of illness and death worldwide. This pathogen can lead to a wide range of conditions, from mild respiratory tract infections such as sinusitis and otitis media to more severe and potentially life-threatening invasive diseases like pneumonia, meningitis, and bacteremia. While pneumococcus can be part of the normal flora in the upper respiratory tract, it can become harmful, especially in individuals with compromised immune systems. Infants, young children, the elderly, and those with chronic medical conditions are particularly vulnerable. The disease spreads through respiratory droplets, often via coughing or sneezing, and its impact is especially significant in areas with limited access to vaccines and healthcare. Preventive measures, including pneumococcal vaccination, play a crucial role in reducing the incidence and severity of this disease.

The signs and symptoms of pneumococcal disease can vary widely depending on the type and severity of the infection. Common symptoms of non-invasive forms, such as sinusitis or otitis media, include nasal congestion, ear pain, fever, and general malaise. In more serious invasive forms like pneumonia, individuals may experience high fever, chills, chest pain, cough with mucus, and difficulty breathing. Meningitis caused by Streptococcus pneumoniae can present with neck stiffness, severe headache, confusion, and sensitivity to light, and in some cases, seizures. Bacteremia may result in symptoms such as fever, fatigue, and rapid heart rate. In young children and infants, symptoms may be less specific and can include irritability, poor feeding, and lethargy. Early recognition and treatment are critical to managing severe pneumococcal infections and preventing complications.

The pathophysiology of pneumococcal disease begins with the colonization of the upper respiratory tract by Streptococcus pneumoniae, a gram-positive encapsulated bacterium. Under certain conditions - such as weakened immunity, viral co-infection, or epithelial damage - the bacteria can invade sterile sites like the lungs, bloodstream, or central nervous system, leading to diseases such as pneumonia, bacteremia, and meningitis. The polysaccharide capsule of S. pneumoniae is a major virulence factor, allowing it to evade phagocytosis and complement-mediated killing. The bacterium also produces enzymes and toxins, such as pneumolysin, which contribute to tissue damage, inflammation, and further spread of infection. The host immune response, while aimed at eliminating the pathogen, can also lead to collateral tissue injury, particularly in severe or invasive cases, driving many of the clinical manifestations of the disease.

The treatment and management of pneumococcal disease depend on the severity and site of infection but typically involve prompt antibiotic therapy. Penicillin or other beta-lactam antibiotics are commonly used; however, due to increasing resistance, alternative agents such as cephalosporins, macrolides, or fluoroquinolones may be prescribed based on susceptibility testing. In cases of severe or invasive infections like meningitis or bacteremia, intravenous antibiotics and supportive care (e.g., oxygen therapy, fluids, or intensive care support) may be necessary. Vaccination is a key preventive measure, with pneumococcal conjugate (PCV) and polysaccharide (PPSV) vaccines recommended for infants, older adults, and individuals with certain chronic health conditions. Early diagnosis, appropriate antibiotic use, and vaccination together form the cornerstone of effective management and prevention of complications.

"Pneumococcal Disease - Pipeline Insight, 2025" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Pneumococcal Disease pipeline landscape is provided which includes the disease overview and Pneumococcal Disease treatment guidelines. The assessment part of the report embraces, in depth Pneumococcal Disease commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Pneumococcal Disease collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights
The companies and academics are working to assess challenges and seek opportunities that could influence Pneumococcal Disease R&D. The therapies under development are focused on novel approaches to treat/improve Pneumococcal Disease.

Pneumococcal Disease Emerging Drugs Chapters

This segment of the Pneumococcal Disease report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Pneumococcal Disease Emerging Drugs

PCV21: Sanofi

PCV21 is a next-generation 21-valent pneumococcal conjugate vaccine developed collaboratively by Sanofi and SK bioscience to address the global burden of invasive pneumococcal disease (IPD). By incorporating over 20 serotypes of Streptococcus pneumoniae, PCV21 aims to provide broader protection against strains not covered by existing vaccines. This vaccine is designed for both pediatric and adult populations, with the goal of reducing the incidence of IPD worldwide. The development of PCV21 underscores the commitment of both companies to advance public health through innovative vaccination strategies. Currently, the drug is in Phase III stage of its development for the treatment of Pneumococcal Disease.

AV0328: Alopexx

AV0328 is a synthetic vaccine designed to target poly N-acetyl glucosamine (PNAG), a substance found on the surface of a wide range of bacterial, fungal, and parasitic pathogens. In pre-clinical studies, targeting PNAG has shown effectiveness in preventing and treating infections caused by over 15 different pathogens. Clinical studies demonstrated that AV0328 is well-tolerated with no serious adverse events observed. The vaccine induced antibodies capable of killing a wide range of PNAG-expressing pathogens, reaffirming its potential as a broad-spectrum antimicrobial solution. Currently, the drug is in Phase II stage of its development for the treatment of Pneumococcal Disease.

V-212: Virometix

Dynavax Technologies is developing Tdap-1018, an investigational booster vaccine for tetanus, diphtheria, and Pneumococcal Disease. It combines inactivated toxins and acellular Pneumococcal Disease antigens to stimulate the immune system, promoting antibody production. By activating B cells and T cells, it aims to build a strong immune response and long-lasting memory. Currently, the drug is in Phase I stage of its development for the treatment of Pneumococcal Disease.

Pneumococcal Disease: Therapeutic Assessment

This segment of the report provides insights about the different Pneumococcal Disease drugs segregated based on following parameters that define the scope of the report.

Major Players in Pneumococcal Disease
  • There are approx. 18+ key companies which are developing the therapies for Pneumococcal Disease. The companies which have their Pneumococcal Disease drug candidates in the most advanced stage, i.e. Phase III include, Sanofi.
Phases
The report covers around 20+ products under different phases of clinical development, like:
  • Late stage products (Phase III)
  • Mid-stage products (Phase II)
  • Early-stage product (Phase I) along with the details of:
  • Pre-clinical and Discovery stage candidates
  • Discontinued & Inactive candidates
Route of Administration
Pneumococcal Disease pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as:
  • Oral
  • Intravenous
  • Subcutaneous
  • Parenteral
  • Topical
Molecule Type
Products have been categorized under various Molecule types, such as:
  • Recombinant fusion proteins
  • Small molecule
  • Monoclonal antibody
  • Peptide
  • Polymer
  • Gene therapy
Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Pneumococcal Disease: Pipeline Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Pneumococcal Disease therapeutic drugs key players involved in developing key drugs.

Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Pneumococcal Disease drugs.

Pneumococcal Disease Report Insights
  • Pneumococcal Disease Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs
Pneumococcal Disease Report Assessment
  • Pipeline Product Profiles
  • Therapeutic Assessment
  • Pipeline Assessment
  • Inactive drugs assessment
  • Unmet Needs
Key Questions

Current Treatment Scenario and Emerging Therapies:
  • How many companies are developing Pneumococcal Disease drugs?
  • How many Pneumococcal Disease drugs are developed by each company?
  • How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Pneumococcal Disease?
  • What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Pneumococcal Disease therapeutics?
  • What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
  • What are the clinical studies going on for Pneumococcal Disease and their status?
  • What are the key designations that have been granted to the emerging drugs?
Key Players
  • Sanofi
  • Alopexx
  • Virometix
  • GPN Vaccines
  • Inventprise Inc.
  • GlaxoSmithKline
  • Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
  • Vaxcyte, Inc.
  • Alopexx
  • Sinovac Life Sciences Co., Ltd.
Key Products
  • PCV21
  • AV0328
  • V-212
  • Gamma-PN3
  • IVT PCV-25
  • AFX3772
  • PCV26
  • VAX-24
  • AV0328
  • Sinovac PCV13

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Table of Contents

IntroductionExecutive Summary
Pneumococcal Disease: Overview
  • Introduction
  • Causes
  • Pathophysiology
  • Signs and Symptoms
  • Diagnosis
  • Treatment
Pipeline Therapeutics
  • Comparative Analysis
Therapeutic Assessment
  • Assessment by Product Type
  • Assessment by Stage and Product Type
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type
Pneumococcal Disease - Analytical Perspective
Late Stage Products (Phase III)
  • Comparative Analysis
PCV21: Sanofi
  • Product Description
  • Research and Development
  • Product Development Activities
Mid Stage Products (Phase II)
  • Comparative Analysis
AV0328: Alopexx
  • Product Description
  • Research and Development
  • Product Development Activities
Early Stage Products (Phase I)
  • Comparative Analysis
V-212: Virometix
  • Product Description
  • Research and Development
  • Product Development Activities
Preclinical and Discovery Stage Products
  • Comparative Analysis
Drug Name: Company Name
  • Product Description
  • Research and Development
  • Product Development Activities
Inactive Products
  • Comparative Analysis
Pneumococcal Disease Key CompaniesPneumococcal Disease Key ProductsPneumococcal Disease - Unmet NeedsPneumococcal Disease - Market Drivers and BarriersPneumococcal Disease - Future Perspectives and ConclusionPneumococcal Disease Analyst ViewsPneumococcal Disease Key CompaniesAppendix
List of Tables
Table 1 Total Products for Pneumococcal Disease
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products
List of Figures
Figure 1 Total Products for Pneumococcal Disease
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • Sanofi
  • Alopexx
  • Virometix
  • GPN Vaccines
  • Inventprise Inc.
  • GlaxoSmithKline
  • Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd
  • Vaxcyte, Inc.
  • Alopexx
  • Sinovac Life Sciences Co., Ltd.