Anti-inhibitor coagulant complex - Biologic Drug Details

Summary for anti-inhibitor coagulant complex

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for anti-inhibitor coagulant complex

Recent Clinical Trials for anti-inhibitor coagulant complex

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Pediatric Brain Tumor Consortium	Phase 1
IRCCS San Raffaele	Phase 2
Janssen, LP	Phase 4

See all anti-inhibitor coagulant complex clinical trials

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

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.

2. General brand-side disclosures

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.

3. Patents from broad patent text search

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 anti-inhibitor coagulant complex Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for anti-inhibitor coagulant complex Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for anti-inhibitor coagulant complex Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Anti-Inhibitor Coagulant Complex

Introduction

Anti-inhibitor coagulant complex (AICC) is a critical biologic drug used to treat and manage bleeding episodes in patients with hemophilia A and B, particularly those with inhibitors to certain coagulation factors. This article delves into the market dynamics and financial trajectory of AICC, highlighting its clinical significance, market growth, and financial projections.

Clinical Significance of AICC

AICC is derived from human plasma and contains activated and precursor vitamin K-dependent clotting factors, including factors II, VII, IX, and X. It is used as a coagulation factor bypass therapy to restore hemostasis in patients with high inhibitor titers or those who rapidly develop inhibitors following exposure to factor products[1][5].

Market Growth and Expansion

The market for AICC is expected to continue its upward trend from 2021 to 2031. Projections indicate significant expansion driven by the increasing demand for effective treatments for hemophilia patients with inhibitors. The growth trajectory is supported by the need for prophylactic and on-demand therapies that can safely and effectively reduce the frequency of bleeding episodes[4].

Prophylactic Use and Efficacy

Studies have shown that AICC prophylaxis significantly reduces the frequency of joint and other bleeding events in patients with severe hemophilia A and factor VIII inhibitors. A clinical trial demonstrated a 62% reduction in all bleeding episodes and a 72% reduction in target-joint bleeding when AICC was used prophylactically compared to on-demand therapy[2].

Safety and Adverse Reactions

While AICC is effective, it comes with potential risks. Thromboembolic events, including venous thrombosis, pulmonary embolism, myocardial infarction, and stroke, can occur, especially with high doses or in patients with thrombotic risk factors. Other adverse reactions include gastrointestinal issues, anemia, hemarthrosis, and allergic reactions[1][5].

Market Size and Forecast

The global market for AICC is anticipated to grow substantially over the next decade. This growth is driven by the increasing prevalence of hemophilia, the lack of effective alternative treatments for patients with inhibitors, and advancements in healthcare infrastructure. The market is expected to benefit from the adoption of new breakthrough medicines and the expanding use of biologic treatments[4].

Financial Projections

Global spending on medicines, including biologics like AICC, is projected to reach nearly $1.5 trillion by 2025, with a compound annual growth rate (CAGR) of 4-7%. The growth in spending is driven by the adoption of new medicines, including those for rare and chronic conditions like hemophilia. The market for AICC will be influenced by pricing and access measures, as well as the impact of biosimilars and generics on overall healthcare spending[3].

Impact of Biosimilars and Generics

The introduction of biosimilars is expected to affect the spending on biologic medicines, including AICC. However, the specific impact on AICC will depend on regulatory, pricing, and competitive dynamics. Biosimilars could contribute to reduced costs and increased access, but their adoption will also be influenced by litigation and regulatory issues[3].

Pricing and Access

Pricing and access measures will play a crucial role in the financial trajectory of AICC. In developed markets, there will be a greater focus on pricing controls and the use of generics to offset increased costs. In pharmerging markets, access expansions will be critical, although these markets may struggle with economic constraints[3].

Patient Out-of-Pocket Costs

Despite rising brand prescription costs, patient out-of-pocket costs for AICC and other biologics are forecast to decline. This is due to the availability of generics, copay assistance programs, and expanded eligibility for Medicaid and other insurance plans[3].

Conclusion

The market for anti-inhibitor coagulant complex is poised for significant growth driven by its clinical efficacy, increasing demand, and the lack of effective alternative treatments for hemophilia patients with inhibitors. While safety concerns and thrombotic risks are important considerations, the overall financial trajectory suggests a robust market with substantial expansion potential.

Key Takeaways

• AICC is a critical treatment for hemophilia patients with inhibitors, offering significant reductions in bleeding episodes.
• The market for AICC is expected to grow substantially from 2021 to 2031.
• Safety concerns include thromboembolic events and allergic reactions.
• Financial projections indicate a CAGR of 4-7% in global medicine spending, influenced by biosimilars and generics.
• Pricing and access measures will be crucial in determining the market's financial trajectory.

FAQs

What is anti-inhibitor coagulant complex (AICC) used for?

AICC is used to treat, control, prevent, and decrease bleeding episodes in patients with hemophilia A and B, particularly those with inhibitors to certain coagulation factors.

What are the potential risks associated with AICC?

Potential risks include thromboembolic events (venous thrombosis, pulmonary embolism, myocardial infarction, and stroke), gastrointestinal issues, anemia, hemarthrosis, and allergic reactions.

How does AICC prophylaxis compare to on-demand therapy?

AICC prophylaxis significantly reduces the frequency of joint and other bleeding events compared to on-demand therapy, with a 62% reduction in all bleeding episodes and a 72% reduction in target-joint bleeding.

What is the expected market growth for AICC?

The market for AICC is expected to expand significantly from 2021 to 2031, driven by increasing demand and the lack of effective alternative treatments.

How do biosimilars impact the market for AICC?

Biosimilars are expected to contribute to reduced costs and increased access, but their adoption will be influenced by regulatory, pricing, and competitive dynamics.

Sources

1. Elsevier Health: Anti-inhibitor Coagulant Complex.
2. PubMed: Anti-inhibitor coagulant complex prophylaxis in hemophilia with inhibitors.
3. IQVIA: Outlook for Global Medicines through 2021.
4. Market Research Intellect: Anti-Inhibitor Coagulant Complex Market Size and Forecast.
5. Mayo Clinic: Anti-inhibitor coagulant complex (intravenous route).