
Cold Agglutinin Disease (CAD)
Description
MarketVue®: Cold Agglutinin Disease
The MarketVue®: Cold Agglutinin Disease market landscape report combines primary (KOL interviews and survey data) and secondary market research to empower strategic decision-making and provide a complete view of the market.Every MarketVue® includes a disease overview, epidemiology (US and EU5), current treatment, unmet needs, pipeline and access and reimbursement chapter.
Topics covered in this report:
• Disease overview: Review the disease pathophysiology and potential druggable targets
• Epidemiology: Understand prevalence, diagnosed and drug-treated prevalence of the population and key market segments
• Current treatment: Understand the treatment decision tree and strengths and weaknesses of current on-label and off-label treatment
• Unmet needs: Identify opportunities to address treatment or disease management gaps
• Pipeline analysis: Compare current and emerging therapy clinical development strategy; their performance on efficacy, safety, and delivery metrics; and their potential to address unmet needs
• Value and access: Review the evidence needed to assess and communicate value to key stakeholders (e.g., providers, payers, regulators) and learn what competitors have done or are doing
Methodology:
Research for the MarketVue®: Cold Agglutinin Disease report is supported by 9 qualitative interviews with key opinion leaders, a quantitative survey with 25 U.S. physicians and secondary research.
Geographies covered:
United States plus epidemiology for EU5 (France, Germany, Italy, Spain, United Kingdom)
Key companies mentioned:
• Sanofi/Genzyme
• Swedish Orphan Biovitrum AB (SOBI)
• Apellis Pharmaceuticals
• Novartis
Key drugs mentioned:
• Rituximab (Rituxan)
• Bendamustine
• Fludarabine (Fludara)
• Sutimlimab (Enjaymo)
• Corticosteroids
• Venetoclax (Venclexta)
• Bortezomib (Velcade)
• Ibrutinib (Imbruvica)
• Iptacopan (Fabhalta)
• Pegcetacoplan (Empaveli)
• SAR445088
Please note: the online download version of this report is for a global site license.
Table of Contents
33 Pages
- 1. DISEASE OVERVIEW
- A rare, cold-activated, autoimmune bone marrow disorder characterized by hemolytic anemia
- Figure 1.1. Classical complement pathway in CAD
- CAD is characterized by anemia-related and cold-associated symptoms
- Table 1.1. Clinical presentation of CAD
- Figure 1.2. Hematologist-reported segmentation of their CAD patient population
- 2. EPIDEMIOLOGY & PATIENT POPULATIONS
- Disease definition
- Figure 2.1 – Diagnosed prevalent cases of CAD by region
- Table 2.1 – Diagnosed prevalent and drug-treated patients in the U.S. and EU5
- 3. DIAGNOSIS AND CURRENT TREATMENT
- Diagnosis overview
- Figure 3.1. Diagnostic pathway for CAD patients
- B-cell and complement-directed therapy are the current standards of care
- Overview
- Figure 3.2. Treatment goals for CAD
- Figure 3.3. Current treatment patient share
- Treatment flow for CAD
- Figure 3.4. Treatment algorithm for CAD
- Rituximab-based regimens are the most widely used treatments for CAD in US and EU
- Figure 3.5. Hematologist rating (n=25) of current therapy effectiveness in CAD
- Figure 3.6. Hematologist-reported percentage of CAD patients who are refractory to rituximab
- There is room for improvement over existing treatments
- Hematologists’ opinions on current treatments
- Severity of anemia and dosing are critical drivers of treatment choice between rituximab and Enjaymo
- Enjaymo is the first and only USFDA-approved drug for primary CAD
- Enjaymo is viewed favorably in the US and EU, with a few reservations
- Figure 3.7. Enjaymo’s advantages observed in clinical practice
- Figure 3.8. Percentage of hematologists who rated Enjaymo as “extremely favorable” for its attributes
- Figure 3.9. Percentage of hematologists familiar with Enjaymo
- Hematologists’ perception of Enjaymo
- Key treatment dynamics that shape disease management and drug use in CAD
- Table 3.1 Must-know CAD treatment dynamics
- Figure 3.10. Hematologist-reported percentage of patients with unsatisfactory outcomes with current CAD treatments
- Complement pathway inhibition is the future of CAD therapy
- Figure 3.11. Important dynamics of CAD market evolution
- 4. UNMET NEED
- Overview
- Figure 4.1 – Top unmet needs in CAD
- Figure 4.2 – Physician-reported unmet needs in CAD
- Important unmet needs in treating CAD remain
- Figure 4.3 – Three unmet needs in CAD despite the addition of sutimlimab as a treatment option
- Non-clinical barriers to care - physician perspective
- Figure 4.4 – Percent of hematologists who see this as a barrier to receiving drug therapy
- 5. PIPELINE ANALYSIS
- Overview
- Figure 5.1. Number of emerging CAD therapies whose clinical trial primary end points target top unmet needs
- Pipeline for CAD is limited
- Table 5.1. Comparison of ongoing trials of complement-mediated therapies in CAD
- Emerging therapies are complement inhibitors
- Figure 5.2. Percentage of hematologists who rated the following emerging therapies as “promising”
- Figure 5.3. Percentage of hematologists who rated emerging target or approach as “promising”
- 6. VALUE & ACCESS
- Overview
- Table 6.1 – Current therapy pricing
- Table 6.2 – Typical commercial payer coverage of Rituxan and Enjaymo (e.g., United Healthcare, Aetna, BlueCross BlueShield, Cigna)
- Key market access dynamics that will continue to shape treatment use
- Figure 6.1 – CAD patients by insurance type
- Thoughts from european physicians surrounding current and future access to CAD therapies
- Drug Analogue: Soliris, Ultomiris, and Empaveli in PNH
- Overview
- Commercial payer requirement of drug analogues
- Table 6.3. Summary of commercial insurance requirements for Empaveli, Ultomiris, and Soliris
- Drug Analogue: Soliris in PNH
- Overview
- Figure 6.2. Annual cost (WAC) of Soliris (000s), 2007 – 2021
- Figure 6.3. Key market access pillars for Soliris in PNH
- Drug Analogue: Empaveli and Ultomiris in PNH
- Overview
- Figure 6.4. Strategies used by Ultomiris and Empaveli to compete with Soliris
- Thoughts from European physicians surrounding current and future access to CAD therapies
- 7. METHODOLOGY
- Primary market research approach
- Epidemiology methodology
Pricing
Currency Rates
Questions or Comments?
Our team has the ability to search within reports to verify it suits your needs. We can also help maximize your budget by finding sections of reports you can purchase.