Interferon alfa-n3 (human leukocyte derived) - Biologic Drug Details

Summary for interferon alfa-n3 (human leukocyte derived)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1

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 interferon alfa-n3 (human leukocyte derived) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for interferon alfa-n3 (human leukocyte derived) Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for interferon alfa-n3 (human leukocyte derived) Derived from Patent Text Search

No patents found based on company disclosures

Interferon alfa-n3 (human leukocyte derived) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Interferon Alfa-n3 (Human Leukocyte Derived)

Market Overview

The global interferons market, which includes interferon alfa-n3, is poised for significant growth driven by increasing demand for immunotherapy treatments. As of 2021, the global interferons market was valued at US$ 9.1 billion and is projected to reach US$ 13.8 billion by 2032, growing at a CAGR of 3.9% from 2022 to 2032[1].

Key Market Trends

Several trends are driving the growth of the interferons market, including:

Increasing Prevalence of Chronic Diseases

The rising prevalence of diseases such as multiple sclerosis, hepatitis B, hepatitis C, and various types of cancer is a major driver. For instance, multiple sclerosis affects approximately 2.5 million individuals worldwide, with the number of women diagnosed increasing annually[1].

Product Innovation and Development

The ongoing development of novel interferon beta products, such as Biogen Inc.'s PLEGRIDY, which received FDA approval for a new intramuscular injectable route, is a significant factor. Such innovations enhance treatment options and efficacy, contributing to market growth[1].

Biosimilar Development

Pharmaceutical companies are investing in the development of interferon biosimilars to compete with or replace original, more expensive brands. This trend is expected to increase market competition and accessibility of interferon treatments[1].

Financial Trajectory

Current Market Valuation

Interferon alfa-n3, such as Alferon N Injection®, is part of the broader interferons market. In 2021, the global interferons market was valued at US$ 9.1 billion, with a projected valuation of US$ 13.8 billion by 2032[1].

Revenue Growth

The market is expected to expand at a CAGR of 3.9% from 2022 to 2032. This growth is driven by the increasing demand for interferon-based treatments and the introduction of new products and biosimilars[1].

Regional Market Performance

The USA, Germany, the United Kingdom, China, and Japan are the top 5 countries driving demand for interferons. The USA alone accounted for nearly 92.8% of the North American interferons market in 2021, indicating a strong revenue base in this region[1].

Manufacturing and Regulatory Landscape

Manufacturing Capacity

Companies like Hemispherx Biopharma, which produces Alferon N Injection®, have invested in facility enhancements to increase manufacturing capacity. For example, Hemispherx completed an $8 million facility enhancement project in 2015 to improve the production process for Alferon N Injection®[2].

Regulatory Approvals

Regulatory approvals are crucial for the commercial success of interferon products. Alferon N Injection®, for instance, is approved for certain STD infections, but faces regulatory hurdles for other indications. The FDA's approval process, including pre-approval inspections and stability data submissions, is a critical step in bringing these products to market[2].

Challenges and Opportunities

Financial Pressures

The high cost of biologic therapies, including interferons, imposes significant financial pressure on healthcare systems globally. This has led to a focus on developing biosimilars to reduce costs and increase accessibility[1].

Market Competition

The market is highly competitive, with key players such as Roche, Merck & Co., Bristol-Myers Squibb, Biogen Inc., and Bayer AG. The entry of biosimilars is expected to increase competition, potentially reducing prices and expanding market reach[1].

Key Success Factors

Product Adoption and Usage

The adoption of interferon alfa-n3 and other interferon products depends on their efficacy, safety profile, and ease of administration. Novel administration routes, such as the intramuscular injectable route for PLEGRIDY, can enhance patient compliance and market adoption[1].

Pipeline Assessment

The development pipeline for interferons is robust, with multiple products in various stages of clinical trials. The success of these products in trials will be a key factor in future market growth[1].

Reimbursement Outlook

Reimbursement policies play a crucial role in the financial trajectory of biologic drugs. Favorable reimbursement policies can significantly impact the market penetration and revenue growth of interferon alfa-n3 and similar products[1].

Examples and Case Studies

Hemispherx Biopharma's Alferon N Injection

Hemispherx Biopharma's Alferon N Injection® is a highly purified, natural-source interferon alfa-n3. Despite regulatory challenges, the company has made significant strides in manufacturing and commercializing this product. The collaboration with Impatients ("myTomorrows") to provide access to this product in South America highlights the potential for international sales and market expansion[2].

Quotes from Industry Experts

"The increasing prevalence of multiple sclerosis and other chronic diseases is driving the demand for interferon-based treatments. The development of novel interferon beta products and biosimilars is expected to further augment this growth."[1]

Illustrative Statistics

• The global interferons market is expected to grow from US$ 9.1 billion in 2021 to US$ 13.8 billion by 2032, at a CAGR of 3.9%[1].
• The USA accounted for nearly 92.8% of the North American interferons market in 2021[1].
• More than fifteen human interferons are already available in the market, with the number expected to rise in the upcoming decade[1].

Key Takeaways

• The global interferons market, including interferon alfa-n3, is projected to grow significantly due to increasing demand for immunotherapy treatments.
• The market is driven by the rising prevalence of chronic diseases, product innovations, and the development of biosimilars.
• Regulatory approvals and manufacturing capacity enhancements are critical for the commercial success of these products.
• Financial pressures and market competition are key challenges, while favorable reimbursement policies and robust development pipelines are crucial success factors.

FAQs

What is the current market size of the global interferons market?

The global interferons market was valued at US$ 9.1 billion in 2021[1].

What is the projected growth rate of the global interferons market from 2022 to 2032?

The market is expected to grow at a CAGR of 3.9% from 2022 to 2032[1].

Which regions are driving the demand for interferons?

The USA, Germany, the United Kingdom, China, and Japan are the top 5 countries driving demand for interferons[1].

What are the key challenges facing the interferons market?

High financial pressures on healthcare systems and regulatory hurdles are significant challenges. However, the development of biosimilars and favorable reimbursement policies offer opportunities for growth[1].

Which companies are key players in the interferons market?

Key companies include Roche, Merck & Co., Bristol-Myers Squibb, Biogen Inc., Bayer AG, and others[1].

Cited Sources

1. Future Market Insights: Interferons Market Size, Industry Share & Trends - 2032.
2. Annual Reports: Form 10-K Securities and Exchange Commission - Annual Reports.
3. GlobeNewswire: Global Cancer Immunotherapy Market Opportunity, Dosage, Price and Clinical Trials Insight 2020-2026.
4. Duke University: The Effect on Federal Spending of Legislation Creating a Regulatory Pathway for Follow-on Biologic Drugs.