Plasma Protease C1-inhibitor Treatment Market
By Devices;
C1-Inhibitor – (C1-Esterase Inhibitor and Recombinant Inhibitor), Kallikrein Inhibitor (Kalbitor), and Selective Bradykinin B2 Receptor Antagonist (Firazyr)By Dosage Type;
Lyophilized and Liquid/InjectableBy Application;
Intravenous Administration and Subcutaneous AdministrationBy End User;
Hospital Pharmacies and Independent Pharmacies and OutletsBy Geography;
North America, Europe, Asia Pacific, Middle East & Africa, and Latin America - Report Timeline (2021 - 2031).Introduction
Global Plasma Protease C1-inhibitor Treatment Market (USD Million), 2021 - 2031
In the year 2024, the Global Plasma Protease C1-inhibitor Treatment Market was valued at USD 6,013.66 million. The size of this market is expected to increase to USD 18,564.32 million by the year 2031, while growing at a Compounded Annual Growth Rate (CAGR) of 17.5%.
Plasma Protease C1-inhibitor Treatment Market
*Market size in USD million
CAGR 17.5 %
Study Period | 2025 - 2031 |
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Base Year | 2024 |
CAGR (%) | 17.5 % |
Market Size (2024) | USD 6,013.66 Million |
Market Size (2031) | USD 18,564.32 Million |
Market Concentration | Low |
Report Pages | 334 |
Major Players
- Shire plc
- Pharming Group N.V.
- Sanquin
- CSL Limited
Market Concentration
Consolidated - Market dominated by 1 - 5 major players
Plasma Protease C1-inhibitor Treatment Market
Fragmented - Highly competitive market without dominant players
The Global Plasma Protease C1-inhibitor Treatment Market is a rapidly evolving sector within the biopharmaceutical industry, driven by the increasing prevalence of hereditary angioedema (HAE) and other conditions associated with C1-inhibitor deficiencies. C1-inhibitor is a crucial protein that regulates the complement and contact system pathways in the immune response, and its deficiency can lead to severe, life-threatening conditions characterized by sudden swelling episodes.
Advancements in biotechnology and medical research have led to significant improvements in the development and distribution of C1-inhibitor therapies. These therapies, which include plasma-derived and recombinant C1-inhibitors, are designed to prevent and manage acute attacks of angioedema, providing critical relief and improving the quality of life for patients.
The market is characterized by a growing number of product approvals, strategic partnerships, and increasing investment in research and development. Key players in this market are focusing on expanding their product portfolios, enhancing production capabilities, and extending their geographical reach to cater to the rising demand.
The awareness and diagnosis rates of HAE and related disorders are increasing globally, further driving the demand for effective C1-inhibitor treatments. As healthcare systems and insurance coverages improve, accessibility to these treatments is expected to rise, fostering market growth.
Global Plasma Protease C1-inhibitor Treatment Market Recent Developments
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In December 2019, KalVista Pharmaceuticals, Inc., a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of small molecule protease inhibitors, announced results of the Phase 2 clinical trial evaluating the use of KVD001 in patients with diabetic macular edema (DME).
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in October 2017, KalVista Pharmaceuticals, Inc. entered into a collaboration agreement with Merck, known as MSD outside the U.S. and Canada for KVD001 (investigational plasma kallikrein inhibitors). The company’s investigational intravitreal (IVT) injection candidate is currently in development for potential treatment of diabetic macular edema (DME).
Plasma Protease C1-inhibitor Treatment Market Segment Analysis
In this report, the Plasma Protease C1-inhibitor Treatment Market has been segmented by Drug Class, Dosage Type, Application, End User and Geography.
Plasma Protease C1-inhibitor Treatment Market, Segmentation by Drug Class
The Plasma Protease C1-inhibitor Treatment Market has been segmented by Drug Class into C1-Inhibitor, Kallikrein Inhibitor (Kalbitor) and Selective Bradykinin B2 Receptor Antagonist (Firazyr).
C1-Inhibitor
Accounts for over 45% of the market, driven by its effectiveness in hereditary angioedema management and broad use in both prophylactic and on-demand treatment. High adoption in developed healthcare systems supports strong market penetration.
Kallikrein Inhibitor (Kalbitor)
Holds approximately 30% share, favored for its targeted action in reducing bradykinin production during acute attacks. Its subcutaneous administration and rapid onset make it a preferred choice in emergency care settings.
Selective Bradykinin B2 Receptor Antagonist (Firazyr)
Represents close to 25% share, with growing demand due to its self-administration convenience and efficacy in symptom relief. Increasing awareness among patients is boosting its utilization in home-based treatment protocols.
Plasma Protease C1-inhibitor Treatment Market, Segmentation by Dosage Type
The Plasma Protease C1-inhibitor Treatment Market has been segmented by Dosage Type into Lyophilized and Liquid/Injectable.
Lyophilized
Accounts for nearly 55% of the market, valued for its extended shelf life and stability during storage and transport. Widely preferred in hospital and clinical settings, especially where long-term inventory management is essential.
Liquid/Injectable
Holds around 45% share, driven by its ready-to-use formulation that supports rapid administration in emergency cases. Increasing adoption in homecare treatment protocols is contributing to its strong market growth.
Plasma Protease C1-inhibitor Treatment Market, Segmentation by Application
The Plasma Protease C1-inhibitor Treatment Market has been segmented by Application into Intravenous Administration and Subcutaneous Administration
Intravenous Administration
Represents approximately 60% of the market, favored for its ability to deliver rapid therapeutic effects during acute hereditary angioedema (HAE) attacks. Commonly used in hospital settings, it ensures precise dosing and immediate symptom relief.
Subcutaneous Administration
Accounts for nearly 40% of the market, driven by its convenience for self-administration and reduced treatment time. Increasing preference in homecare settings supports patient compliance and long-term therapy management.
Plasma Protease C1-inhibitor Treatment Market, Segmentation by End User
The Plasma Protease C1-inhibitor Treatment Market has been segmented by End User into Hospital Pharmacies and Independent Pharmacies and Outlets.
Hospital Pharmacies
Hold around 65% of the market share, serving as the primary distribution point for acute care treatments in hereditary angioedema (HAE) cases. These settings ensure timely availability of critical medications and expert guidance for optimal therapeutic outcomes.
Independent Pharmacies and Outlets
Account for approximately 35% of the market, catering to outpatient needs and enhancing accessibility in community settings. Their role in patient counseling and flexible service hours supports better adherence to long-term treatment regimens.
Plasma Protease C1-inhibitor Treatment Market, Segmentation by Geography
In this report, the Plasma Protease C1-inhibitor Treatment Market has been segmented by Geography into five regions; North America, Europe, Asia Pacific, Middle East & Africa and Latin America.
Regions and Countries Analyzed in this Report
Plasma Protease C1-inhibitor Treatment Market Share (%), by Geographical Region
North AmericaRepresents about 45% of the market, driven by advanced healthcare infrastructure, high diagnosis rates, and strong adoption of innovative therapies for hereditary angioedema (HAE). Favorable reimbursement policies further enhance treatment accessibility.
EuropeAccounts for nearly 30% of the market, supported by robust research initiatives, centralized healthcare systems, and high patient awareness. Regulatory support accelerates the approval and adoption of novel C1-inhibitor therapies.
Asia PacificHolds around 15% of the market, with growth fueled by expanding healthcare infrastructure, increasing disease awareness, and rising demand for advanced treatment options in emerging economies.
Middle East & AfricaCaptures approximately 5% of the market, with gradual improvements in diagnostic capabilities and growing investments in specialized therapeutic care for rare disorders like HAE.
Latin AmericaRepresents about 5% of the market, with access improving through government-led healthcare programs and increasing partnerships with international pharmaceutical companies to introduce advanced treatment solutions.
Market Trends
This report provides an in depth analysis of various factors that impact the dynamics of Global Plasma Protease C1-inhibitor Treatment Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.
Drivers, Restraints and Opportunity Analysis
Drivers :
- Increasing Prevalence of Hereditary Angioedema (HAE)
- Advancements in Biotechnology
- Improved Diagnostic Techniques
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Rising Awareness of C1-inhibitor Deficiencies - The rising awareness of C1-inhibitor deficiencies represents a significant shift in the landscape of rare diseases, particularly hereditary angioedema (HAE). In recent years, efforts from patient advocacy groups, healthcare professionals, and pharmaceutical companies have collectively contributed to increased recognition and understanding of these conditions.
One of the primary drivers behind this heightened awareness is the growing body of clinical research and scientific literature elucidating the pathophysiology, diagnosis, and management of C1-inhibitor deficiencies. As our understanding of these conditions improves, healthcare providers are better equipped to identify and diagnose patients, even those with milder or atypical presentations. Moreover, advancements in diagnostic techniques, such as genetic testing and biomarker analysis, have facilitated earlier and more accurate diagnosis of C1-inhibitor deficiencies, further contributing to rising awareness.
Patient advocacy organizations have played a pivotal role in raising awareness of C1-inhibitor deficiencies by providing support, resources, and education to patients, caregivers, and healthcare professionals. These organizations not only advocate for improved access to treatments and healthcare services but also serve as platforms for sharing personal experiences and fostering a sense of community among those affected by C1-inhibitor deficiencies. Through awareness campaigns, educational initiatives, and outreach efforts, patient advocacy groups have helped destigmatize these conditions and empower patients to actively participate in their care.
In addition to grassroots efforts, pharmaceutical companies have also contributed to raising awareness through disease awareness campaigns, physician education programs, and promotional activities for C1-inhibitor treatments. These initiatives aim to educate healthcare providers about the importance of early diagnosis and appropriate management of C1-inhibitor deficiencies, ultimately improving patient outcomes and quality of life.
Restraints :
- High Treatment Costs
- Limited Awareness in Developing Regions
- Stringent Regulatory Requirements
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Adverse Effects and Safety Concerns - Adverse effects and safety concerns are critical considerations in the Global Plasma Protease C1-inhibitor Treatment Market, influencing treatment decisions, patient outcomes, and regulatory approvals. While C1-inhibitor therapies have revolutionized the management of conditions like hereditary angioedema (HAE), they are not without risks.
One of the primary safety concerns associated with C1-inhibitor treatments is the potential for hypersensitivity reactions or allergic responses, which can range from mild to severe and may include symptoms such as rash, itching, swelling, or difficulty breathing. These reactions can occur during or shortly after infusion and require prompt recognition and intervention to mitigate risks to the patient's health.
There is a risk of transmission of infectious agents with plasma-derived C1-inhibitor products, despite stringent donor screening and manufacturing processes. While steps are taken to minimize this risk through viral inactivation and removal methods, the possibility of infectious transmission remains a safety consideration, particularly in regions with higher prevalence of blood-borne pathogens.
Thrombotic events, such as deep vein thrombosis or pulmonary embolism, have been reported in association with C1-inhibitor treatments, although the exact mechanisms and risk factors are not fully understood. Healthcare providers must carefully assess the individual risk-benefit profile of each patient before initiating treatment, particularly in those with pre-existing cardiovascular or thrombotic conditions.
Long-term safety data for C1-inhibitor therapies are still evolving, highlighting the importance of post-marketing surveillance and pharmacovigilance efforts to monitor and mitigate potential risks. Healthcare providers play a crucial role in identifying and reporting adverse events, contributing to ongoing safety assessments and informing clinical practice guidelines.
Opportunities :
- Emerging Markets Expansion
- Innovative Drug Development
- Personalized Medicine Approaches
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Telemedicine and Remote Patient Monitoring - Telemedicine and remote patient monitoring have emerged as powerful tools in transforming healthcare delivery, particularly in the context of managing chronic conditions such as hereditary angioedema (HAE) and other plasma protease C1-inhibitor deficiencies. These technologies enable healthcare providers to remotely assess, monitor, and manage patients, offering numerous benefits for both patients and healthcare systems.
For patients with C1-inhibitor deficiencies, telemedicine provides convenient access to specialized care, regardless of geographic location. Through virtual consultations, patients can connect with healthcare providers, including allergists, immunologists, and hematologists, without the need for travel, reducing the burden of time and cost associated with in-person visits. This is especially advantageous for individuals living in rural or underserved areas, where access to specialized care may be limited.
Remote patient monitoring complements telemedicine by enabling continuous tracking of key health indicators, such as symptom severity, treatment adherence, and medication side effects. For patients with C1-inhibitor deficiencies, remote monitoring can help identify early signs of angioedema attacks, allowing for timely intervention and prevention of complications. Wearable devices, mobile applications, and web-based platforms facilitate real-time data collection and communication between patients and healthcare providers, promoting proactive management of the condition.
Telemedicine and remote patient monitoring also enhance patient engagement and self-management capabilities. Through telehealth platforms, patients can access educational resources, treatment guidelines, and self-care strategies, empowering them to take an active role in managing their condition. Regular remote monitoring encourages adherence to treatment regimens and lifestyle modifications, leading to better health outcomes and improved quality of life for patients with C1-inhibitor deficiencies.
Competitive Landscape Analysis
Key players in Global Plasma Protease C1-inhibitor Treatment Market include :
- Shire plc
- Pharming Group N.V.
- Sanquin
- CSL Limited
In this report, the profile of each market player provides following information:
- Company Overview and Product Portfolio
- Key Developments
- Financial Overview
- Strategies
- Company SWOT Analysis
- Introduction
- Research Objectives and Assumptions
- Research Methodology
- Abbreviations
- Market Definition & Study Scope
- Executive Summary
- Market Snapshot, By Drug Class
- Market Snapshot, By Dosage Type
- Market Snapshot, By Application
- Market Snapshot, By End User
- Market Snapshot, By Region
- Plasma Protease C1-inhibitor Treatment Market Trends
- Drivers, Restraints and Opportunities
- Drivers
- Increasing Prevalence of Hereditary Angioedema (HAE)
- Advancements in Biotechnology
- Improved Diagnostic Techniques
- Rising Awareness of C1-inhibitor Deficiencies
- Restraints
- High Treatment Costs
- Limited Awareness in Developing Regions
- Stringent Regulatory Requirements
- Adverse Effects and Safety Concerns
- Opportunities
- Emerging Markets Expansion
- Innovative Drug Development
- Personalized Medicine Approaches
- Telemedicine and Remote Patient Monitoring
- Drivers
- PEST Analysis
- Political Analysis
- Economic Analysis
- Social Analysis
- Technological Analysis
- Porter's Analysis
- Bargaining Power of Suppliers
- Bargaining Power of Buyers
- Threat of Substitutes
- Threat of New Entrants
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Competitive Rivalry
- Drivers, Restraints and Opportunities
- Market Segmentation
- Global Plasma Protease C1-inhibitor Treatment Market, By Drug Class, 2021 - 2031 (USD Million)
- C1-Inhibitor
- C1-Esterase Inhibitor
- Recombinant Inhibitor
- Kallikrein Inhibitor (Kalbitor)
- Selective Bradykinin B2 Receptor Antagonist (Firazyr)
- C1-Inhibitor
- Plasma Protease C1-inhibitor Treatment Market, By Dosage Type, 2021 - 2031 (USD Million)
- Lyophilized
- Liquid/Injectable
- Plasma Protease C1-inhibitor Treatment Market, By Application , 2021 - 2031 (USD Million)
- Intravenous Administration
- Subcutaneous Administration
- Plasma Protease C1-inhibitor Treatment Market, By End User , 2021 - 2031 (USD Million)
- Hospital Pharmacies
- Independent Pharmacies and Outlets
- Plasma Protease C1-inhibitor Treatment Market, By Geography, 2021 - 2031 (USD Million)
- North America
- United States
- Canada
- Europe
- Germany
- United Kingdom
- France
- Italy
- Spain
- Nordic
- Benelux
- Rest of Europe
- Asia Pacific
- Japan
- China
- India
- Australia & New Zealand
- South Korea
- ASEAN(Association of South East Asian Countries)
- Rest of Asia Pacific
- Middle East & Africa
- GCC
- Israel
- South Africa
- Rest of Middle East & Africa
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of Latin America
- North America
- Global Plasma Protease C1-inhibitor Treatment Market, By Drug Class, 2021 - 2031 (USD Million)
- Competitive Landscape
- Company Profiles
- Shire plc
- Pharming Group N.V.
- Sanquin
- CSL Limited
- Company Profiles
- Analyst Views
- Future Outlook of the Market