BETASERON Drug Profile

Summary for Tradename: BETASERON

High Confidence Patents:	5
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for BETASERON
Recent Clinical Trials:	See clinical trials for BETASERON

See drug prices for BETASERON

Recent Clinical Trials for BETASERON

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Biogen	Phase 4
National Institutes of Health (NIH)	Phase 2
MediciNova	Phase 2

See all BETASERON 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 BETASERON Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for BETASERON Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471		2039-03-29	Company disclosures
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471		2004-03-28	Company disclosures
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471		2003-05-13	Company disclosures

3) Low Certainty: US Patents for BETASERON Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471		2033-01-08	Patent claims search
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471		2032-04-02	Patent claims search
Bayer Healthcare Pharmaceuticals Inc.	BETASERON	interferon beta-1b	For Injection	103471		2035-07-15	Patent claims search

International Patents for BETASERON

Country	Patent Number	Estimated Expiration
Australia	2008683
South Korea	910009900
Germany	3376271

Supplementary Protection Certificates for BETASERON

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 10/1996	Austria		PRODUCT NAME: BETAFERON - INTERFERON BETA-1B
96C0019	Belgium		PRODUCT NAME: BETAFERON INTERFERON BETA-1B; REGISTRATION NO/DATE: EU/1/95/003/001 19951130
SPC/GB96/019	United Kingdom

BETASERON Market Analysis and Financial Projection Experimental

Beta Interferon Drugs Market: Understanding the Dynamics and Financial Trajectory of Betaseron

Introduction to Beta Interferon Drugs

Beta interferon drugs are a class of biologic medications that play a crucial role in treating various chronic conditions, most notably multiple sclerosis (MS). These drugs are part of the broader category of interferons, which are naturally produced proteins that help the body fight off infections and other biological threats.

Market Size and Growth Projections

The global beta interferon market is substantial and growing. As of 2023, the market stands at approximately US$ 3.6 billion and is projected to reach US$ 4.8 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 3% over the next decade[1][3][5].

Key Drivers of Market Growth

Rising Prevalence of Multiple Sclerosis

One of the primary drivers of the beta interferon market is the increasing prevalence of multiple sclerosis. MS is a chronic inflammatory demyelinating disease that affects the nervous system, and beta interferon drugs are among the first line of disease-modifying therapies (DMTs) for this condition. Globally, 2.3 million people are living with MS, with 85% of these cases classified as relapsing-remitting MS (RRMS)[1].

Advancements in R&D

Continuous research and development in MS treatments are also driving the market forward. New drug discoveries and advancements in existing treatments, such as the use of CRISPR-Cas9 to engineer tumor cells to release immunomodulatory agents like interferon-β, are boosting the growth of the beta interferon market[5].

Increasing Cancer Cases

In addition to MS, the rising number of cancer cases, particularly aggressive forms like triple-negative breast cancer, is increasing the demand for beta interferon drugs. These drugs are being explored for their potential in cancer treatment due to their immunomodulatory effects[1].

Market Segmentation

By Type

The beta interferon market is segmented into three main types: Interferon Beta-1A, Interferon Beta-1B, and Peginterferon Beta-1A. Each of these types has different administration routes and therapeutic applications[1].

By Route of Administration

Beta interferon drugs can be administered via intramuscular, subcutaneous, or intravenous routes. The choice of administration route depends on the specific drug and the patient's condition[1].

By Geography

The market is geographically segmented, with North America leading in terms of revenue share. However, the Asia-Pacific region is exhibiting the fastest growth rate due to increasing healthcare expenditure and awareness about MS treatments[3].

Financial Trajectory of Betaseron

Market Value and Growth

Betaseron, a brand of Interferon Beta-1B, is one of the key products in the beta interferon market. The overall market for beta interferon drugs, which includes Betaseron, is expected to grow from US$ 4.22 billion in 2023 to US$ 5.55 billion by 2030, at a CAGR of 4.0%[5].

Revenue Streams

The revenue for Betaseron and other beta interferon drugs comes primarily from hospital pharmacies and retail pharmacies. Hospital pharmacies have historically earned the highest revenue, but online pharmacies are expected to see significant growth in the coming years[3].

Competitive Landscape

The beta interferon market is highly competitive, with key players such as Biogen, Merck KGaA, Novartis AG, and Bayer AG. These companies are focusing on producing advanced drugs and adopting various marketing strategies, including partnerships, mergers, and regional expansion, to maintain and increase their market share[1][3][5].

Challenges and Restraints

Pricing Pressure

The entry of follow-on biologic products (FOBs) or biosimilars can exert downward pressure on the prices of original biologic drugs like Betaseron. This competition can lead to significant cost savings for consumers but may also impact the revenue of pioneer manufacturers[2][4].

Regulatory Environment

The regulatory environment plays a crucial role in the beta interferon market. Abbreviated regulatory approval pathways can expedite the entry of FOBs, which can increase competition and reduce prices. However, the lack of automatic substitution for FOBs may slow their market share acquisition[4].

Key Players and Their Strategies

Major players in the beta interferon market are investing heavily in research and development to produce advanced drugs. For example, Eiger BioPharmaceuticals, Inc. is working towards emergency-use approval for peginterferon lambda for COVID-19 treatment, highlighting the innovative approaches companies are taking to expand their product portfolios[1].

Regional Outlook

North America

North America dominates the beta interferon market due to the high prevalence of MS and the presence of key market players. The region's advanced healthcare infrastructure and high healthcare expenditure also contribute to its leading position[3].

Asia-Pacific

The Asia-Pacific region is expected to exhibit the fastest growth rate due to increasing healthcare awareness, rising disposable incomes, and government initiatives to improve healthcare access[3].

Impact of Research and Development

Continuous R&D activities are crucial for the growth of the beta interferon market. Innovations such as the use of CRISPR-Cas9 technology to engineer cells that release interferon-β are opening new therapeutic avenues and driving market growth[5].

Conclusion

The beta interferon market, including drugs like Betaseron, is poised for steady growth driven by the increasing prevalence of MS, advancements in R&D, and rising cancer cases. Despite challenges such as pricing pressure from biosimilars and regulatory complexities, the market is expected to expand significantly over the next decade.

Key Takeaways

• The global beta interferon market is projected to grow from US$ 3.6 billion in 2023 to US$ 4.8 billion by 2033.
• The market is driven by the rising prevalence of multiple sclerosis and advancements in R&D.
• North America leads the market, but the Asia-Pacific region is expected to grow the fastest.
• Key players are focusing on producing advanced drugs and adopting various marketing strategies.
• The entry of biosimilars can exert downward price pressure but also increase market access.

FAQs

What is the primary driver of the beta interferon market?

The primary driver of the beta interferon market is the increasing prevalence of multiple sclerosis (MS), a chronic inflammatory demyelinating disease.

Which region dominates the beta interferon market?

North America dominates the beta interferon market due to the high prevalence of MS and the presence of key market players.

What are the different types of beta interferon drugs?

The beta interferon market is segmented into Interferon Beta-1A, Interferon Beta-1B, and Peginterferon Beta-1A.

How is the entry of biosimilars affecting the beta interferon market?

The entry of biosimilars can exert downward price pressure on original biologic drugs, leading to cost savings for consumers but potentially impacting the revenue of pioneer manufacturers.

What is the projected CAGR of the beta interferon market from 2023 to 2030?

The beta interferon market is expected to grow at a CAGR of 4.0% from 2023 to 2030[5].

Sources

1. Fact.MR: Beta Interferon Market Size, Share & Trends Report to 2033.
2. ASPE: Economic Analysis of Availability of Follow-on Protein Products.
3. Acumen Research and Consulting: Interferon Beta Drugs Market Size, Share and Analysis | Forecast.
4. Federal Trade Commission: Emerging Health Care Issues: Follow-on Biologic Drug Competition.
5. Coherent Market Insights: Interferon Beta Drugs Market Size, Trends and Forecast to 2030.