Published Date : 2023-06-27
Published Date : 2023-06-27
Updated On : 2024-05-15
Pages : 154
Thelansis’s “Babesiosis 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 Babesiosis treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).
Babesiosis is an infection of parasitic nature instigated by protozoa belonging to the genus Babesia. The species of Babesia have been categorized into four distinct clades. Babesia microti, classified as a Clade 1 organism, is the most prevalent and comprehensively described species. The primary mode of acquiring Babesiosis is through tick bites carrying the protozoa. Given that the parasite infects erythrocytes (red blood cells), the infection can also be contracted through blood transfusion, thereby affecting individuals not exposed to endemic areas. Babesia predominantly infects red blood cells, often appearing oval or pear-shaped. The ring form and peripheral location in the red blood cell can lead to misinterpretation of the smear for Plasmodium falciparum. However, unlike Plasmodium, hemolysis is rare in Babesiosis. The increased aggregation and rigidity of the red blood cells often result in acute respiratory distress and noncardiogenic pulmonary edema. Fragmentation of red blood cells can also lead to capillary blockage in various organs. The spleen, responsible for trapping damaged red cells, can become enlarged. Patients lacking a spleen tend to experience a more severe disease course. Asymptomatic Babesia infection may persist subclinically for months to years in otherwise healthy individuals, particularly those under 40. Symptomatic Babesiosis typically commences after a 1- to 2-week incubation period with nonspecific symptoms, including myalgia, headache, fever, chills, fatigue, malaise, and arthralgia. In healthy individuals, symptoms usually resolve after a week. In others, hepatosplenomegaly may occur with mild neutropenia, mild to moderately severe hemolytic anemia, jaundice, and thrombocytopenia. Noncardiac pulmonary edema can develop in severe disease. Asymptomatic patients usually do not require treatment, but therapy is indicated for patients with persistent high fever, rapidly increasing parasitemia, and falling hematocrit. The combination of atovaquone and azithromycin administered for 7 to 10 days has fewer adverse effects. It is as effective as traditional therapy with quinine plus clindamycin in patients with mild to moderate Babesiosis. The adult dosage is atovaquone 750 mg orally every 12 hours and azithromycin 500 to 1000 mg on the first day, followed by a daily dose of 250 to 1000 mg. In children weighing over 5 kg, the dosage is atovaquone 20 mg/kg orally twice a day plus azithromycin 10 mg/kg once, then 5 mg/kg daily for 7 to 10 days. Quinine 650 mg orally three times a day plus clindamycin 600 mg orally three times a day or 300 to 600 mg IV four times a day for 7 to 10 days can also be used. The pediatric dosage is quinine 10 mg/kg orally three times a day plus clindamycin 7 to 14 mg/kg three times daily. Quinine plus clindamycin is considered the standard of care for severely ill patients. Recipients of quinine must be monitored closely for adverse effects. In patients suffering from severe illness with high parasitemia (more than 10% of erythrocytes), exchange transfusion has been employed as a treatment method. The future health condition of Babesiosis patients is largely dependent on the nature of their symptoms. A majority of patients exhibit no symptoms and generally have a favorable prognosis. Some may experience an infection similar to the flu, which typically results in a positive outcome. However, patients with severe forms of the disease may face a lengthy recovery period marked by multiorgan dysfunction and, in some cases, death. This is particularly common in patients who do not have a spleen. Symptoms of Babesiosis can persist for 6-8 weeks, while patients without symptoms may go undiagnosed for several years. It is recommended that all patients who test positive for the disease three months after initial treatment undergo another round of treatment, regardless of whether they have experienced seizures. Approximately one-fifth of patients with Babesiosis may be co-infected with Lyme disease. These patients tend to have a more prolonged course.
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 | Tafenoquine | 60 Degrees Pharmaceuticals LLC | Phase 2 |
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. Babesiosis – 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. Babesiosis market scenario 2023 |
1.2.2. Babesiosis market scenario 2028 |
1.2.3. Babesiosis market scenario 2033 |
2. Babesiosis 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 Babesiosis |
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. Babesiosis 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 Babesiosis management |
2.16. Market Opportunity for Babesiosis |
2.17. KOL Comments on current and upcoming/expected treatment practices in Babesiosis |
3. Epidemiology |
3.1. Epidemiology Overview |
3.2. Epidemiology by Geography |
3.2.1. Babesiosis Epidemiology in US (2023-2033) |
3.2.1.1. Incidence of Babesiosis |
3.2.1.2. Diagnosed cases |
3.2.1.3. Treatable Patient Pool |
3.2.1.4. Epidemiology Trends |
3.2.2. Babesiosis Epidemiology in EU-5 (2023-2033) |
3.2.2.1. Incidence of Babesiosis |
3.2.2.2. Diagnosed cases |
3.2.2.3. Treatable Patient Pool |
3.2.2.4. Epidemiology Trends |
3.2.3. Babesiosis Epidemiology in Japan (2023-2033) |
3.2.3.1. Incidence of Babesiosis |
3.2.3.2. Diagnosed cases |
3.2.3.3. Treatable Patient Pool |
3.2.3.4. Epidemiology Trends |
3.2.4. Babesiosis Epidemiology in China (2023-2033) |
3.2.4.1. Incidence of Babesiosis |
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 Babesiosis 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 Babesiosis 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 Babesiosis 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 Babesiosis 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 Babesiosis 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 Babesiosis 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 Babesiosis 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 Babesiosis 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 Babesiosis |
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 Babesiosis 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 Babesiosis |
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 Babesiosis 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 |