CABLIVI: Transforming the Treatment Landscape for Rare Blood Disorders | Market Outlook, Forecast & Strategic Insights by DelveInsight

DelveInsight's latest report, "CABLIVI Market Size, Forecast, and Market Insight," presents an in-depth evaluation of caplacizumab-yhdp - an innovative antibody fragment targeting von Willebrand factor (vWF) and specifically developed for adults diagnosed with acquired thrombotic thrombocytopenic purpura (aTTP).

The comprehensive analysis spans the 7MM (the US, EU4 - Germany, France, Italy, Spain - plus the UK and Japan) and delivers detailed insights into CABLIVI's historical performance and projected market evolution from 2020 to 2034. The report further explores product attributes, intellectual property considerations, competitive intelligence, and the status of investigational therapies entering the same domain.

CABLIVI Snapshot
• Drug Name: CABLIVI (caplacizumab-yhdp)
• Developer: Ablynx NV (Sanofi)
• Molecule Type: Monoclonal antibody fragment
• Indication: Acquired Thrombotic Thrombocytopenic Purpura (aTTP)
• Mechanism: Platelet aggregation and vWF inhibitor
• Administration: IV and SC

Discover CABLIVI's long-term positioning in thrombocytopenia therapies @ CABLIVI Market Potential - https://www.delveinsight.com/report-store/cablivi-drug-insight-and-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

A Major Therapeutic Breakthrough in Rare Hematology
CABLIVI (caplacizumab-yhdp), developed by Ablynx NV (a Sanofi company), has redefined treatment paradigms for aTTP, a rapidly progressing and life-threatening hematologic emergency. As the first FDA-approved nanobody-based therapy for this disorder, CABLIVI introduces an advanced, highly targeted approach that addresses the core pathophysiology of platelet-rich microthrombi formation.
Growing disease recognition, increasing diagnostic accuracy, and the global call for precision therapies have further reinforced CABLIVI's presence in the rare disease market.

Therapeutic Overview: CABLIVI (caplacizumab-yhdp)
CABLIVI functions by selectively binding to the A1 domain of vWF, thereby preventing abnormal platelet adhesion and aggregation - a defining feature of aTTP. The therapy is administered alongside plasma exchange and immunosuppressive interventions, allowing it to address both acute symptoms and underlying disease mechanisms.
Global Commercial Performance
In 2024, CABLIVI generated €249 million in worldwide revenue, marking a 9.7% year-over-year increase. This growth was primarily supported by improved diagnostic pathways, expanding patient identification, and continued geographic rollouts. The United States remains the primary growth engine.

CABLIVI Administration: Structured Dosing for Optimal Benefit
CABLIVI is administered under a precisely defined regimen:
• Day 1:
 11 mg IV bolus (≥15 minutes before first plasma exchange)
 11 mg SC injection post-exchange
• During Plasma Exchange:
 11 mg SC administered daily after each session
• Post Plasma Exchange:
 Daily 11 mg SC injections for 30 days after the final exchange
 Extension up to 28 days permitted if ADAMTS13 levels remain low
• Discontinuation:
 Therapy should cease after more than two recurrences during the treatment course

Understanding Thrombocytopenia: Disease Impact & Market Opportunity
Thrombocytopenia, described as a platelet count below 150,000/μL, can result from multiple clinical conditions - including HIT, chemotherapy toxicity, chronic liver disease, ITP, and aTTP.
DelveInsight estimates that the US represented approximately 40% of all thrombocytopenia cases in 2023 across the 7MM.
A broad therapeutic arsenal is currently approved in the US for various thrombocytopenia manifestations:
• MULPLETA
• DOPTELET
• TAVALISSE
• PROMACTA
• NPLATE
• CABLIVI
• GAMMAPLEX
• OCTAGAM
• RHOPHYLAC
• PRIVIGEN
HIT-associated cases use agents such as danaparoid, argatroban, and lepirudin, while liver-associated thrombocytopenia often calls for splenectomy, splenic artery embolization, or TIPSS.
With 60% of the combined 7MM thrombocytopenia market, the US continues to dominate this therapeutic segment. Market expansion will be driven by disease recognition, updated treatment algorithms, and a steady influx of novel therapies.

Download free CABLIVI's sample report @ CABLIVI Market Potential - https://www.delveinsight.com/report-store/cablivi-drug-insight-and-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

CABLIVI Competitive Landscape: Emerging Threats to CABLIVI
Several late-stage candidates are progressing rapidly and may challenge CABLIVI's market share:
• Rilzabrutinib (Sanofi) - Phase III ITP results presented at ASH 2024
• Ianalumab (Novartis) - Phase III trials ongoing; filings expected 2025+
• Mezagitamab (Takeda) - Late-breaking Phase IIb data revealed in 2024
• PF-06835375 (Pfizer)
• Povetacicept (Vertex)
• Cevidoplenib (Genosco/Oscotec)
• Efgartigimod (Argenx)
These agents may offer competitive advantages in efficacy, durability, or pricing.

Compare future pipelines @ 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

Milestones Driving CABLIVI's Expansion
Key developments shaping CABLIVI's commercial and clinical success include:
• June 2022: Long-term results from post-HERCULES presented at EHA
• February 2019: US FDA approval for aTTP
• September 2018: European Commission authorization
• July 2017: Sanofi-Ablynx collaboration on Nanobody platforms

Follow regulatory progress @ CABLIVI FDA Approval - https://www.delveinsight.com/report-store/cablivi-drug-insight-and-market-forecast?utm_source=openpr&utm_medium=pressrelease&utm_campaign=apr

CABLIVI Market Dynamics and Future Growth Drivers
CABLIVI's expansion is closely tied to improved diagnostic vigilance, broader disease awareness, and Sanofi's global commercialization efforts. The therapy's ability to reduce microvascular thrombosis, shorten plasma exchange timelines, and lower relapse rates makes it an essential option for clinicians treating aTTP.
However, several factors may influence long-term market penetration:
• High treatment cost and reimbursement complexity
• Hospital-dependent administration
• Competitive pressure from both established and emerging therapies
• Need for extended long-term safety data
Despite these challenges, CABLIVI's market outlook remains optimistic. Ongoing trials, potential label expansions, orphan drug incentives, and improved reimbursement frameworks are expected to sustain growth across key geographies.

Explore CABLIVI's commercial evolution @ 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. Introduction to the Report
2. CABLIVI in Thrombocytopenia
• Product Profile
• Clinical Development
• Efficacy & Safety Insights
• Regulatory Milestones
• Additional Development Activities
3. Existing Marketed Therapies
4. Late-Stage Pipeline Landscape
5. CABLIVI Market Outlook
• Forecast in Thrombocytopenia
• 7MM Market Assessment
• Country-wise Breakdown (US, Germany, France, Italy, Spain, UK, Japan)
6. SWOT Assessment
7. Expert Opinions
8. Appendix
• Bibliography
• Methodology
9. DelveInsight Capabilities
10. Disclaimer
11. About DelveInsight
12. Purchase & Licensing Options

Contact Us:
Ankit Nigam
Manager Marketing
info@delveinsight.com
+14699457679

About DelveInsight
DelveInsight is a leading Life Science market research and business consulting company recognized for its off-the-shelf syndicated market research reports and customized solutions to firms in the healthcare sector.

This release was published on openPR.