Press release
Sanofi's CABLIVI Market Performance and Pipeline Competition Analyzed in DelveInsight's Forecast Report | CABLIVI Sets New Standard in aTTP Therapy
CABLIVI Market
Sanofi's innovative therapy CABLIVI (caplacizumab-yhdp) has emerged as a game-changing treatment in the rare disease space, particularly for acquired thrombotic thrombocytopenic purpura (aTTP). As the first FDA-approved nanobody therapy for this life-threatening condition, CABLIVI marks a significant leap in hematology, offering a highly targeted mechanism of action that distinguishes it from conventional treatments. With rising global awareness of aTTP, improved diagnostics, and the increasing need for precision therapies, CABLIVI has secured a firm foothold in the rare disease therapeutics market.
Download Sample report to know in detail about CABLIVI drugs impact in the market - https://www.delveinsight.com/report-store/cablivi-drug-insight-and-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
CABLIVI (caplacizumab-yhdp) Overview
Developed by Ablynx NV, a Sanofi subsidiary, CABLIVI functions by binding to the A1 domain of von Willebrand factor (vWF), inhibiting its interaction with platelets. This action helps in reducing platelet consumption and clot formation, the hallmark of aTTP. Its clinical use combines plasma exchange and immunosuppressive therapy, targeting both the symptoms and underlying mechanisms of this rare clotting disorder.
In 2024, CABLIVI recorded global sales of €249 million, reflecting a healthy 9.7% year-over-year growth. This uptick is attributed to rising diagnosis rates and strategic launches across European and other global markets. The US remains a major driver, owing to improved screening and early identification of eligible patients.
CABLIVI Dosing and Administration: A Targeted Therapeutic Protocol
CABLIVI's administration is precisely structured to ensure optimal outcomes:
• Day 1: Patients receive an 11 mg IV bolus at least 15 minutes before plasma exchange, followed by an 11 mg SC injection post-procedure.
• During Plasma Exchange: 11 mg SC injections are administered once daily post-treatment.
• Post Plasma Exchange: Continue daily SC injections for 30 days after the final plasma exchange. If clinical indicators, such as persistently low ADAMTS13 activity, remain, the therapy may be extended for up to 28 additional days.
• Discontinuation: CABLIVI should be halted if more than two recurrences of aTTP occur during treatment.
CABLIVI at a Glance
• Drug Name: CABLIVI (caplacizumab-yhdp)
• Molecule Type: Monoclonal antibody fragment
• Developer: Ablynx NV (Sanofi)
• Indication: Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
• Mechanism of Action: Platelet aggregation inhibitor; vWF inhibitor
• Routes of Administration: Intravenous (IV), Subcutaneous (SC)
Explore CABLIVI's future potential in the thrombocytopenia space @ CABLIVI Market Potential - https://www.delveinsight.com/sample-request/cablivi-drug-insight-and-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Understanding Thrombocytopenia and CABLIVI's Market Potential
Thrombocytopenia-a condition characterized by a platelet count below 150,000/μL-can arise due to multiple factors, including heparin-induced thrombocytopenia, chemotherapy, chronic liver disease, immune thrombocytopenia (ITP), and aTTP. Among the 7MM, the United States accounted for ~40% of thrombocytopenia cases in 2023, per DelveInsight estimates.
Treatment strategies vary depending on the cause and severity, with the primary goals being to prevent bleeding and improve quality of life. A wide range of therapies are approved in the US for different subtypes, including:
• MULPLETA
• DOPTELET
• TAVALISSE
• PROMACTA
• NPLATE
• CABLIVI
• GAMMAPLEX
• OCTAGAM
• RHOPHYLAC
• PRIVIGEN
Additionally, danaparoid, argatroban, and lepirudin are utilized in heparin-induced cases.
For chronic liver disease-related thrombocytopenia, surgical and interventional options such as splenectomy, splenic artery embolization, and TIPSS placement are common.
The US thrombocytopenia market represents 60% of the total 7MM market, far outpacing the EU4, UK, and Japan. Growth will likely be powered by expanding diagnosis, new drug launches, and greater therapy adoption.
Dive into comprehensive insights @ Thrombocytopenia Market Report - https://www.delveinsight.com/sample-request/cablivi-drug-insight-and-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
CABLIVI Emerging Competitors and Pipeline Therapies
CABLIVI faces robust pipeline competition from promising therapies in late-stage development. Notable contenders include:
• Rilzabrutinib (Sanofi) - Phase III data for ITP presented at ASH 2024.
• Ianalumab (Novartis) - Phase III trials (VAYHIT1 & VAYHIT2) in progress; regulatory filings expected from 2025 onward.
• Mezagitamab (Takeda) - Late-breaking Phase IIb data released in mid-2024.
• PF-06835375 (Pfizer)
• Povetacicept (Vertex)
• Cevidoplenib (Genosco/Oscotec)
• Efgartigimod (ARGX-113) (Argenx)
These therapies may challenge CABLIVI's market share, especially if they demonstrate superior efficacy or pricing flexibility.
Track emerging therapies in the thrombocytopenia landscape @ CABLIVI Market Positioning Compared to Other Drugs - https://www.delveinsight.com/sample-request/cablivi-drug-insight-and-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
CABLIVI's Strategic Milestones and Market Expansion
Key events that have shaped CABLIVI's success trajectory include:
• June 2022: Sanofi presented long-term efficacy and safety data from the post-HERCULES study at the European Hematology Association (EHA) Congress.
• February 2019: The FDA approved CABLIVI as the first therapy specifically for aTTP, a major milestone in rare hematology.
• September 2018: The European Commission granted CABLIVI market authorization, acknowledging its first-in-class nanobody-based approach.
• July 2017: Sanofi and Ablynx announced a collaboration for developing Nanobody-based treatments across immune-inflammatory conditions.
Stay updated on regulatory and R&D progress @ CABLIVI FDA Approval - https://www.delveinsight.com/sample-request/cablivi-drug-insight-and-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
CABLIVI Market Dynamics and Future Outlook
CABLIVI's growth story is underpinned by a growing number of diagnosed aTTP patients, a rare but often under-recognized condition. Enhanced awareness, coupled with Sanofi's strong commercial infrastructure, is accelerating CABLIVI's uptake across multiple regions. Its ability to reduce microthrombi formation, shorten plasma exchange duration, and prevent relapses makes it a compelling therapeutic choice.
However, CABLIVI is not without its challenges. The high treatment cost, hospital-based administration, and complexity of reimbursement remain hurdles to broad accessibility. Furthermore, competition from traditional therapies and emerging agents could temper its long-term market dominance. Regulatory constraints and the demand for more long-term safety data may also affect growth momentum.
Despite these headwinds, the CABLIVI market is projected to expand steadily, driven by ongoing clinical trials, label expansion opportunities, and incentives for orphan drug development. Strategic alliances and improved reimbursement models could further accelerate market penetration, especially in underserved areas.
Explore CABLIVI's commercial trajectory and pipeline competitiveness @ CABLIVI Market Drug Report - https://www.delveinsight.com/sample-request/cablivi-drug-insight-and-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr
Table of Contents:
1. Report Introduction
2. CABLIVI Overview in Thrombocytopenia
2.1. Product Detail
2.2. Clinical Development
2.2.1. Clinical studies
2.2.2. Clinical trials information
2.2.3. Safety and efficacy
2.3. Regulatory Milestones
2.4. Other Developmental Activities
2.5. Product Profile
3. Competitive Landscape (Marketed Therapies)
4. Competitive Landscape (Late-stage Emerging Therapies)
5. CABLIVI Market Assessment
5.1. Market Outlook of CABLIVI in Thrombocytopenia
5.2. 7MM Analysis
5.2.1. Market Size of CABLIVI in the 7MM for Thrombocytopenia
5.3. Country-wise Market Analysis
5.3.1. Market Size of CABLIVI in the United States for Thrombocytopenia
5.3.2. Market Size of CABLIVI in Germany for Thrombocytopenia
5.3.3. Market Size of CABLIVI in France for Thrombocytopenia
5.3.4. Market Size of CABLIVI in Italy for Thrombocytopenia
5.3.5. Market Size of CABLIVI in Spain for Thrombocytopenia
5.3.6. Market Size of CABLIVI in the United Kingdom for Thrombocytopenia
5.3.7. Market Size of CABLIVI in Japan for Thrombocytopenia
6. SWOT Analysis
7. Analysts' Views
8. Appendix
8.1. Bibliography
8.2. Report Methodology
9. DelveInsight Capabilities
10. Disclaimer
11. About DelveInsight
12. Report Purchase Options
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