Omalizumab - Biologic Drug Details

Summary for omalizumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for omalizumab
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for omalizumab

Recent Clinical Trials for omalizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Jasper Therapeutics, Inc.	Phase 1/Phase 2
University of California, Davis	Phase 3
Kashiv BioSciences, LLC	Phase 3

See all omalizumab clinical trials

Recent Litigation for omalizumab

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Janssen Biotech, Inc. v. Amgen Inc.	2022-11-29
AbbVie Inc. v. Alvotech hf.	2021-05-28
Alvotech USA Inc. v. Abbvie Inc	2021-05-11

See all omalizumab litigation

PTAB Litigation

Petitioner	Date
GEMoaB Monoclonals GmbH et al.	2019-12-20
	2017-12-20

See all omalizumab litigation

Pharmacology for omalizumab

Mechanism of Action	IgE-directed Antibody Interactions
Physiological Effect	Decreased IgE Activity
Established Pharmacologic Class	Anti-IgE

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 omalizumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for the Biologic Drug: Omalizumab

Introduction

Omalizumab, marketed under the brand name Xolair, is a revolutionary biologic drug that has significantly impacted the treatment of various allergic and immune system disorders. This article delves into the market dynamics and financial trajectory of omalizumab, highlighting its impact, growth prospects, and the challenges it faces.

Mechanism of Action

Omalizumab is a recombinant DNA-derived humanized IgG1-kappa monoclonal antibody that targets the IgE molecule, a key player in allergic reactions. By binding to IgE, omalizumab reduces the amount of free IgE available to bind to mast cells and basophils, thereby reducing the release of mediators involved in allergic responses[4].

Market Size and Growth

The global sales of Xolair (omalizumab) have shown significant growth. As of 2023, the global drug sales of Xolair stood at USD 3,885.14 million, with a historical growth rate (CAGR) of 5.81% between 2020 and 2023[4].

Global Asthma Drugs Market

The broader asthma drugs market, in which omalizumab plays a crucial role, is also experiencing substantial growth. The global asthma drugs market was valued at USD 25.69 billion in 2024 and is expected to reach around USD 40.17 billion by 2033, growing at a CAGR of 5.09% from 2024 to 2033[3].

U.S. Asthma Drugs Market

In the U.S., the asthma drugs market was valued at USD 8.95 billion in 2023 and is projected to surpass USD 14.75 billion by 2033, with a CAGR of 5.12% over the forecast period[3].

Key Applications

Omalizumab is used in the treatment of several conditions, including:

Asthma

Omalizumab is particularly effective in treating severe asthma that is not adequately controlled by inhaled corticosteroids and other treatments. It targets specific pathways in the immune system involved in asthma, offering more targeted and effective treatment for severe cases[3].

Chronic Urticaria

Omalizumab has demonstrated efficacy in managing chronic urticaria (CU) by exerting effective symptom control and facilitating the regression of skin lesions. Its therapeutic efficacy typically requires a 12-week treatment period[5].

Other Allergic Conditions

Omalizumab is also used off-label for conditions such as food allergies and nasal polyps, further expanding its market reach[2].

Market Drivers

Several factors are driving the growth of the omalizumab market:

Rising Prevalence of Asthma

The increasing prevalence of asthma, affecting approximately 25 million individuals in the United States alone, presents a significant growth factor. The annual cost of asthma in the U.S., estimated at around $56 billion, highlights the financial burden and the need for effective treatments[3].

Technological Advances

Advancements in inhaler technology, such as smart inhalers that track medication usage, and personalized medicine approaches are enhancing the overall management of asthma and other allergic conditions. These innovations complement the use of biologics like omalizumab[3].

Regulatory Approvals

Recent approvals of new drugs and delivery methods, such as the FDA approval of TEZSPIRE for severe asthma, indicate a favorable regulatory environment that supports the growth of biologic treatments[3].

Market Challenges

Despite its growth, the omalizumab market faces several challenges:

High Costs

The high cost of omalizumab and other biologic drugs can make them unaffordable for many patients, limiting access to these life-saving treatments. However, as demand grows, prices are expected to drop[2].

Side Effects and Immunogenicity

Patients receiving omalizumab must be monitored for potential side effects, such as allergic reactions and infections. Additionally, some biologic drugs can stimulate the immune system to produce antibodies against the drug, reducing its effectiveness over time[2].

Generic Competition

The market is facing increasing competition from generic versions of traditional asthma medications, driven by patent expirations and efforts to reduce healthcare costs. This competition could impact the market share of biologic drugs like omalizumab[3].

Competitive Landscape

The omalizumab biosimilars market is becoming increasingly competitive with several key players:

Major Players

Companies such as Roche, Novartis, Glenmark Pharmaceuticals, Selexis, Generium, CuraTeQ, Celltrion Healthcare, Alvotech, BiosanaPharma, Mabpharm, CSPC Pharmaceutical Group, Biomabs, and HisunPharm are actively involved in the development and marketing of omalizumab biosimilars[1].

Financial Trajectory

The financial trajectory of omalizumab is marked by significant growth and investment:

Revenue Growth

The global sales of Xolair have consistently shown growth, with a CAGR of 5.81% between 2020 and 2023. This growth is expected to continue as the demand for effective biologic treatments increases[4].

Investment in R&D

The development of biologic drugs like omalizumab requires high investment in research and development. This investment is crucial for maintaining market leadership and driving innovation in the pharmaceutical industry[2].

Real-World Effectiveness

Studies have shown that omalizumab is highly effective in real-world settings. For example, in the management of chronic urticaria, omalizumab has demonstrated effective symptom control and facilitated the regression of skin lesions among Chinese patients[5].

Conclusion

Omalizumab has revolutionized the treatment of allergic and immune system disorders, particularly in the management of severe asthma and chronic urticaria. The market dynamics are driven by the rising prevalence of asthma, technological advances, and favorable regulatory approvals. However, the market also faces challenges such as high costs, potential side effects, and increasing generic competition.

Key Takeaways

• Market Growth: The global omalizumab market is expected to grow significantly, driven by the increasing prevalence of asthma and other allergic conditions.
• Technological Advances: Innovations in inhaler technology and personalized medicine are enhancing the effectiveness of omalizumab.
• High Costs: Despite its effectiveness, the high cost of omalizumab limits access for many patients.
• Competitive Landscape: The market is highly competitive with several major players involved in the development of omalizumab biosimilars.
• Real-World Effectiveness: Omalizumab has shown significant efficacy in real-world settings, particularly in managing chronic urticaria.

FAQs

What is the primary mechanism of action of omalizumab?

Omalizumab works by binding to the IgE molecule, reducing the amount of free IgE available to bind to mast cells and basophils, thereby reducing the release of mediators involved in allergic responses[4].

Which conditions is omalizumab primarily used to treat?

Omalizumab is primarily used to treat severe asthma, chronic urticaria, and other allergic conditions such as nasal polyps and food allergies[2][5].

What are the main drivers of the omalizumab market?

The main drivers include the rising prevalence of asthma, technological advances in inhaler technology and personalized medicine, and favorable regulatory approvals[3].

What are the major challenges facing the omalizumab market?

The major challenges include high costs, potential side effects, immunogenicity, and increasing competition from generic versions of traditional asthma medications[2][3].

Who are the key players in the omalizumab biosimilars market?

Key players include Roche, Novartis, Glenmark Pharmaceuticals, Selexis, Generium, CuraTeQ, Celltrion Healthcare, Alvotech, BiosanaPharma, Mabpharm, CSPC Pharmaceutical Group, Biomabs, and HisunPharm[1].

Sources

1. Global Omalizumab Biosimilars Market Research Report 2024. Valuates Reports.
2. Omalizumab, the innovative biologic that disrupted the market of the .... Irene Pérez Herranz.
3. U.S. Asthma Drugs Market Size to Surpass USD 14.75 Bn by 2033. BioSpace.
4. The Global Drug sales of Xolair (2020 - 2026, USD Millions). GlobalData.
5. Real-World Effectiveness of Omalizumab in Chronic Urticaria. Karger.