Published Date : 2023-04-17
Published Date : 2023-04-17
Updated On : 2024-03-09
Pages : 152
Thelansis’s “Staphylococcus Aureus Bacteremia (SAB) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2023 To 2033" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Staphylococcus Aureus Bacteremia treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Staphylococcus aureus bacteremia (SAB) is a severe bloodstream infection linked to significant illness and death. It leads to various complications, such as infective endocarditis, device-related infections, osteoarticular metastases, pleuropulmonary issues, and recurrent infections. Initially, SAB was categorized into healthcare-associated and community-acquired types. However, with advancements in molecular differentiation and understanding, a new classification emerged: healthcare-associated community-onset. Presently, SAB is categorized into three groups: community-acquired, healthcare-associated community-onset, and healthcare-associated hospital-onset. Community-acquired SAB pertains to individuals without prior healthcare contact, including injection drug users and those with spontaneous osteoarticular infections. These cases often present with multiple complications like endocarditis, renal failure, shock, respiratory distress, or disseminated intravascular coagulation. Healthcare-associated community-onset SAB encompasses patients with recent healthcare exposure, such as hospitalization within the past 90 days, receiving intravenous therapy, wound care, skilled nursing, or residing in healthcare facilities. Healthcare-associated hospital-onset SAB refers to infections contracted within healthcare settings. It is commonly associated with central-line infections, ventilator-associated pneumonia, or surgical site infections. Methicillin-resistant strains often cause these cases and are a leading cause of nosocomial infections. Risk factors for SAB include age, underlying medical conditions, injection drug use, and the presence of intravascular catheters or prosthetic devices. Early recognition of these factors is crucial during patient assessment. SAB can be classified as complicated or uncomplicated. Uncomplicated cases are defined by exclusion of endocarditis, absence of implanted prostheses, negative follow-up blood cultures, defervescence within 72 hours of antibiotic therapy, and no evidence of metastatic infection. Complications of SAB may involve the central nervous system, embolic phenomena, metastatic infections, or recurrent infections within 12 weeks. Predictors of complicated SAB include community acquisition, persistently positive blood cultures, persistent fever, and systemic skin findings. Uncomplicated SAB typically requires at least two weeks of intravenous antibiotic therapy, while complicated cases necessitate four to six weeks. Treatment selection depends on methicillin susceptibility, with preferred agents including penicillinase-resistant penicillins, first-generation cephalosporins, vancomycin, and daptomycin. Beta-lactams, particularly anti-staphylococcal penicillins like nafcillin, are commonly used as first-line agents for MSSA bacteremia.
North America- the United States and Canada
Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
Other countries- Japan & China
This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.
KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs
- Data Inputs with sourcing
- Market Event and Product Event
- Country-specific Forecast Model
- Market uptake and patient share uptake
- Attribute Analysis
- Analog Analysis
- Disease burden and pricing scenario
- Summary and Insights
Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.
The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.
Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.
This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.
S. no | Asset | Company | Stage |
1 | Ceftobiprole | Basilea Pharmaceutica | Phase 3 |
2 | CF-301 | ContraFect | Phase 2 |
3 | AP-SA02 | Armata Pharmaceuticals, Inc. | Phase 2 |
4 | Delpazolid | LegoChem Biosciences, Inc | Phase 2 |
5 | Dalbavancin | Advanz Pharma | Phase 3 |
KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.
COUNTRY | No. Of KOLs |
USA | 17 |
GERMANY | 4 |
UK | 4 |
SPAIN | 3 |
FRANCE | 2 |
ITALY | 3 |
JAPAN | 3 |
CHINA | 4 |
Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.
1. Staphylococcus Aureus Bacteremia (SAB) – Key Findings Summary |
1.1. Clinical findings |
1.1.1. Disease overview |
1.1.2. Therapeutic practices |
1.1.3. Future outlook |
1.2. Commercial findings |
1.2.1. Staphylococcus Aureus Bacteremia (SAB) market scenario 2023 |
1.2.2. Staphylococcus Aureus Bacteremia (SAB) market scenario 2028 |
1.2.3. Staphylococcus Aureus Bacteremia (SAB) market scenario 2033 |
2. Staphylococcus Aureus Bacteremia (SAB) Overview |
2.1. Disease Introduction |
2.2. Pathophysiology |
2.3. Signs and Symptoms |
2.4. Risk Factors |
2.5. Etiology |
2.6. Classification |
2.7. Pathogenesis |
2.8. Diagnosis |
2.9. Complications |
2.10. Treatment Algorithm |
2.10.1. Treatment in US (guidelines) |
2.10.2. Treatment in EU-5 (guidelines) |
2.10.3. Treatment in Japan (guidelines) |
2.10.4. Treatment in China (guidelines) |
2.11. Treatment Goals for Staphylococcus Aureus Bacteremia (SAB) |
2.12. Referral Patterns |
2.12.1. Referral Scenario in US |
2.12.2. Referral Scenario in EU-5 |
2.12.3. Referral Scenario in Japan |
2.12.4. Referral Scenario in China |
2.13. Staphylococcus Aureus Bacteremia (SAB) Prognosis |
2.14. Healthcare burden |
2.14.1. Healthcare burden in US |
2.14.2. Healthcare burden in EU-5 |
2.14.3. Healthcare burden in Japan |
2.14.4. Healthcare burden in China |
2.15. Unmet Needs in Staphylococcus Aureus Bacteremia (SAB) management |
2.16. Market Opportunity for Staphylococcus Aureus Bacteremia (SAB) |
2.17. KOL Comments on current and upcoming/expected treatment practices in Staphylococcus Aureus Bacteremia (SAB) |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Staphylococcus Aureus Bacteremia (SAB) Epidemiology in US (2023-2033) |
3.2.1.1. Incidence of Staphylococcus Aureus Bacteremia (SAB) |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Staphylococcus Aureus Bacteremia (SAB) Epidemiology in EU-5 (2023-2033) |
3.2.2.1. Incidence of Staphylococcus Aureus Bacteremia (SAB) |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Staphylococcus Aureus Bacteremia (SAB) Epidemiology in Japan (2023-2033) |
3.2.3.1. Incidence of Staphylococcus Aureus Bacteremia (SAB) |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Staphylococcus Aureus Bacteremia (SAB) Epidemiology in China (2023-2033) |
3.2.4.1. Incidence of Staphylococcus Aureus Bacteremia (SAB) |
3.2.4.2. Diagnosed cases |
3.2.4.3. Treatable Patient Pool |
3.2.4.4. Epidemiology Trends |
3.3. Epidemiology Trends (World-wide) |
4. Market Outlook |
4.1. US Staphylococcus Aureus Bacteremia (SAB) Market Forecast 2023-2033 |
4.1.1. Market Progression (Futuristic) |
4.1.2. Market Trends and Expectations |
4.1.2.1. Worst case scenario |
4.1.2.2. Base Case Scenario |
4.1.2.3. Best Case Scenario |
4.1.3. Drivers and Barriers |
4.2. UK Staphylococcus Aureus Bacteremia (SAB) Market Forecast 2023-2033 |
4.2.1. Market Progression (Futuristic) |
4.2.2. Market Trends and Expectations |
4.2.2.1. Worst case scenario |
4.2.2.2. Base Case Scenario |
4.2.2.3. Best Case Scenario |
4.2.3. Drivers and Barriers |
4.3. France Staphylococcus Aureus Bacteremia (SAB) Market Forecast 2023-2033 |
4.3.1. Market Progression (Futuristic) |
4.3.2. Market Trends and Expectations |
4.3.2.1. Worst case scenario |
4.3.2.2. Base Case Scenario |
4.3.2.3. Best Case Scenario |
4.3.3. Drivers and Barriers |
4.4. Germany Staphylococcus Aureus Bacteremia (SAB) Market Forecast 2023-2033 |
4.4.1. Market Progression (Futuristic) |
4.4.2. Market Trends and Expectations |
4.4.2.1. Worst case scenario |
4.4.2.2. Base Case Scenario |
4.4.2.3. Best Case Scenario |
4.4.3. Drivers and Barriers |
4.5. Italy Staphylococcus Aureus Bacteremia (SAB) Market Forecast 2023-2033 |
4.5.1. Market Progression (Futuristic) |
4.5.2. Market Trends and Expectations |
4.5.2.1. Worst case scenario |
4.5.2.2. Base Case Scenario |
4.5.2.3. Best Case Scenario |
4.5.3. Drivers and Barriers |
4.6. Spain Staphylococcus Aureus Bacteremia (SAB) Market Forecast 2023-2033 |
4.6.1. Market Progression (Futuristic) |
4.6.2. Market Trends and Expectations |
4.6.2.1. Worst case scenario |
4.6.2.2. Base Case Scenario |
4.6.2.3. Best Case Scenario |
4.6.3. Drivers and Barriers |
4.7. Japan Staphylococcus Aureus Bacteremia (SAB) Market Forecast 2023-2033 |
4.7.1. Market Progression (Futuristic) |
4.7.2. Market Trends and Expectations |
4.7.2.1. Worst case scenario |
4.7.2.2. Base Case Scenario |
4.7.2.3. Best Case Scenario |
4.7.3. Drivers and Barriers |
4.8. China Staphylococcus Aureus Bacteremia (SAB) Market Forecast 2023-2033 |
4.8.1. Market Progression (Futuristic) |
4.8.2. Market Trends and Expectations |
4.8.2.1. Worst case scenario |
4.8.2.2. Base Case Scenario |
4.8.2.3. Best Case Scenario |
4.8.3. Drivers and Barriers |
4.9. Key Expected Milestones (world-wide) Impacting the Market |
5. Competitive Landscape |
5.1. Pipeline Therapies Overview |
5.1.1. Phase III Therapies |
5.1.1.1. Current Status |
5.1.1.2. Trial details, results |
5.1.1.3. Approval Timeline |
5.1.1.4. Likelihood of approval |
5.1.1.5. Expected Product Positioning |
5.1.1.2. All other Phase III Therapies ….. |
5.1.1.3. Attribute Analysis of Phase III molecules |
5.1.2. Phase II and Phase I/II Therapies |
5.1.2.1. Current Status |
5.1.2.2. Trial details, results |
5.1.2.3. Approval Timelines |
5.1.3. List of active Pre-clinical Therapies |
5.1.3.1. Status in Staphylococcus Aureus Bacteremia (SAB) |
5.1.3.2. Company positioning |
5.1.3.2. All other pre-clinical therapies |
5.1.4. List of Inactive/discontinued assets |
5.1.4.1. Business impact of discontinuations on current pipeline |
5.1.5. Potential winners from Staphylococcus Aureus Bacteremia (SAB) Pipeline |
5.1.5.1. Potential Blockbusters across the pipeline |
6. Regulatory/Approval Scenario |
6.1. Regulatory/Approval Framework in US |
6.1.1. Policy Framework |
6.1.2. Payer Expectations |
6.2. Regulatory/Approval Framework in UK |
6.2.1. Policy Framework |
6.2.2. Payer Expectations |
6.3. Regulatory/Approval Framework in France |
6.3.1. Policy Framework |
6.3.2. Payer Expectations |
6.4. Regulatory/Approval Framework in Germany |
6.4.1. Policy Framework |
6.4.2. Payer Expectations |
6.5. Regulatory/Approval Framework in Italy |
6.5.1. Policy Framework |
6.5.2. Payer Expectations |
6.6. Regulatory/Approval Framework in Spain |
6.6.1. Policy Framework |
6.6.2. Payer Expectations |
6.7. Regulatory/Approval Framework in Japan |
6.7.1. Policy Framework |
6.7.2. Payer Expectations |
6.8. Regulatory/Approval Framework in China |
6.8.1. Policy Framework |
6.8.2. Payer Expectations |
7. Clinical Trial Assessment – Current and Future Paradigm |
7.1. Distribution of Primary Endpoints across trials |
7.2. Distribution of Secondary Endpoints across trials |
7.3. Evolution and acceptance of surrogate endpoints |
7.4. Key Investigator initiated trials |
7.5. Attrition analysis |
7.5.1. Suspended/Discontinued Assets |
7.5.2. Failed Trials, Reasons and Business Impact |
7.5.3. Terminated Trials, Reasons and Business Impact |
7.5.4. Withdrawn Trials, Reasons and Business Impact |
7.6. Trial enrollment scenario and challenges |
7.7. Clinical Trial Guidance (across geographies) |
8. Thelansis Commentary |
8.1. Key Unmet needs in Staphylococcus Aureus Bacteremia (SAB) |
8.2. Possible Best-case Clinical Trial Strategies |
8.3. Possible Best Case Targeted Product Profile (TPP) |
8.4. Possible Best-case Market positioning strategies |
8.5. Possible Best-case Market Access Strategies |
8.6. Possible Best-case LCM Strategies |
8.7. Overall View on Staphylococcus Aureus Bacteremia (SAB) Market in Dollar Value |
9. Report Methodology |
9.1. Secondary research |
9.2. Primary research |
9.3. Data collation |
9.4. Insight Generation |
10. About Thelansis |
10.1. Our Capabilities |
10.2. Our Services |
10.3. Our Contacts |
10.4. Disclaimer |