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Last Updated: December 25, 2024

C1 esterase inhibitor (human) - Biologic Drug Details


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Summary for c1 esterase inhibitor (human)
Tradenames:2
High Confidence Patents:0
Applicants:2
BLAs:2
Suppliers: see list2
Pharmacology for c1 esterase inhibitor (human)
Mechanism of ActionKallikrein Inhibitors
Physiological EffectDecreased Vascular Permeability
Established Pharmacologic ClassHuman C1 Esterase Inhibitor
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for c1 esterase inhibitor (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for c1 esterase inhibitor (human) Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for c1 esterase inhibitor (human) Derived from Patent Text Search

No patents found based on company disclosures

C1 esterase inhibitor (human) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: C1 Esterase Inhibitor (Human)

Introduction

The C1 esterase inhibitor (human) market is experiencing significant growth, driven by the increasing demand for effective treatments of hereditary angioedema (HAE) and other related conditions. Here, we delve into the market dynamics, financial trajectory, and key factors influencing this biologic drug market.

Market Size and Growth

The global plasma protease C1-inhibitor market was valued at USD 3.51 billion in 2023 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 9.6% to reach USD 7.96 billion by 2032[1][3].

Drivers of Market Growth

Several factors are driving the growth of the C1 esterase inhibitor market:

Increasing Awareness and Diagnosis of HAE

Hereditary Angioedema (HAE) affects approximately 1 in 50,000 people globally, with varying prevalence rates across different regions. As awareness and diagnostic capabilities improve, the number of diagnosed cases is increasing, leading to higher demand for C1 esterase inhibitors[1][3][5].

Advancements in Medical Technology

The development of recombinant human C1 inhibitors has provided safer and more reliable treatment options compared to traditional plasma-derived inhibitors. This innovation has expanded the market by offering improved efficacy and accessibility[1][3].

Healthcare Expenditure and Infrastructure

Higher healthcare spending and advanced healthcare infrastructures, particularly in regions like North America and Europe, have created a favorable environment for the growth of the C1-INH market. This trend facilitates earlier diagnosis and treatment initiation, boosting market demand[1][3].

Pharmaceutical Research and Development

Pharmaceutical companies are intensifying their investment in research and development to refine the efficacy and accessibility of C1-inhibitor-based therapies. This includes innovations in product formulations, delivery methods, and expanded indications, further expanding the market reach[1][3].

Market Segmentation

The global plasma protease C1-inhibitor market is segmented based on several criteria:

Distribution Channels

Hospital pharmacies dominate the market, primarily due to their critical role in acute care settings and specialist treatment of conditions like HAE. Retail and online pharmacies also play significant roles, though to a lesser extent[1].

Geographic Regions

North America holds a dominant position in the market, driven by the high prevalence of HAE in the U.S. Europe and the Asia Pacific region are also significant markets, with the latter experiencing growth due to the rising prevalence of chronic inflammatory diseases and an aging population[1][3][5].

Drug Class

C1 inhibitors lead the market, accounting for a significant portion of global revenue. The development of recombinant human C1 inhibitors has further solidified their position by offering safer and more effective treatment options[3].

Key Players and Market Landscape

The global plasma protease C1-inhibitor treatment market features a highly consolidated vendor landscape. Key companies operating in this market include Shire plc, Pharming Group N.V., CSL Limited, and Sanquin. These companies are focused on innovation, regulatory compliance, and market education to expand their market share[5].

Mechanism of Action and Clinical Use

C1 esterase inhibitors, such as Berinert, Cinryze, and Haegarda, are used to prevent and treat angioedema attacks associated with HAE. These drugs regulate the complement and contact coagulation systems by inhibiting proteases like C1s, kallikrein, factor XIIa, and XIa, thereby preventing excessive inflammation and maintaining hemostatic balance[2].

Dosage and Administration

C1 esterase inhibitors are administered intravenously or subcutaneously. For instance, Cinryze is used for routine prophylaxis against acute HAE attacks in patients six years of age and older, with a long duration of action requiring administration every 3-4 days[2][4].

Adverse Effects and Interactions

Patients should be aware of potential adverse effects, including hypersensitivity reactions and thromboembolic events. Drug interactions, such as those with certain contraceptives, can also increase the risk of thromboembolism[2].

Regional Market Insights

North America

The U.S. leads in the plasma protease C1-inhibitor market due to the high prevalence of HAE and significant investments in research and development. The robust healthcare infrastructure and regulatory environment in the U.S. facilitate the swift introduction and adoption of advanced therapies[1][3][5].

Europe

The UK and France are key markets in Europe, driven by advancements in medical technology and rising healthcare expenditure. The development of recombinant human C1 inhibitors and increased investment in gene therapy and antisense oligonucleotides are also contributing factors[3].

Asia Pacific

This region is experiencing significant growth due to the rising prevalence of chronic inflammatory diseases and an aging population. The entry of new players offering innovative formulations and delivery methods is further facilitating market expansion[3].

Financial Trajectory

The financial trajectory of the C1 esterase inhibitor market is robust, with projected growth driven by increasing demand and advancements in technology. Here are some key financial highlights:

  • Market Size: The global market was valued at USD 3.51 billion in 2023 and is expected to reach USD 7.96 billion by 2032[1].
  • CAGR: The market is projected to grow at a CAGR of 9.6% from 2024 to 2032[1].
  • Revenue Growth: The market revenue is expected to more than double over the forecast period, driven by the critical role of C1-INH in treating HAE and other conditions[1][3].

Key Takeaways

  • The global plasma protease C1-inhibitor market is driven by increasing awareness and diagnosis of HAE, advancements in medical technology, and higher healthcare spending.
  • The market is dominated by hospital pharmacies and led by North America due to the high prevalence of HAE in the U.S.
  • Key players are investing heavily in research and development to improve the efficacy and accessibility of C1-inhibitor-based therapies.
  • The market is expected to grow significantly, with a projected CAGR of 9.6% from 2024 to 2032.

FAQs

What is the primary use of C1 esterase inhibitors?

C1 esterase inhibitors are used to prevent and treat angioedema attacks associated with hereditary angioedema (HAE) by regulating the complement and contact coagulation systems[2].

Which regions dominate the C1 esterase inhibitor market?

North America, particularly the U.S., dominates the market due to the high prevalence of HAE. Europe and the Asia Pacific region are also significant markets[1][3][5].

What are the key drivers of the C1 esterase inhibitor market growth?

Key drivers include increasing awareness and diagnosis of HAE, advancements in medical technology, higher healthcare spending, and significant investments in research and development by pharmaceutical companies[1][3].

What are the common adverse effects of C1 esterase inhibitors?

Common adverse effects include hypersensitivity reactions and thromboembolic events. Patients should also be aware of potential drug interactions that can increase the risk of thromboembolism[2].

How are C1 esterase inhibitors administered?

C1 esterase inhibitors are administered intravenously or subcutaneously, with a long duration of action requiring administration every 3-4 days for prophylaxis[2][4].

Sources

  1. Polaris Market Research: Plasma Protease C1-inhibitor Market Size & Industry Report, 2032.
  2. DrugBank: Human C1-esterase inhibitor: Uses, Interactions, Mechanism of Action.
  3. Grand View Research: Plasma Protease C1-inhibitor Market Size Report, 2030.
  4. Cinryze: Frequently Asked Questions About CINRYZE®.
  5. Transparency Market Research: Global Plasma Protease C1-inhibitor Treatment Market Survey Report 2025.

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