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

Recent Clinical Trials for omalizumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
American Lung Association Asthma Clinical Research Centers	PHASE2
American Lung Association	PHASE2
National Institute of Allergy and Infectious Diseases (NIAID)	PHASE2

See all omalizumab clinical trials

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. DrugPatentWatch analysis and 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 DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	10,300,185	2038-10-05	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	10,300,186	2038-10-12	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	10,561,756	2037-05-01	DrugPatentWatch analysis and company disclosures
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	10,561,757	2037-05-01	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for omalizumab 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
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	10,011,584	2035-05-01	Patent claims search
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	10,016,338	2036-12-20	Patent claims search
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	10,028,940	2037-03-16	Patent claims search
Genentech, Inc.	XOLAIR	omalizumab	For Injection	103976	10,086,076	2037-03-13	Patent claims search

International Patents for omalizumab

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	0012148
World Intellectual Property Organization (WIPO)	2014032048
Japan	2003508161
Hungary	P0301740

Supplementary Protection Certificates for omalizumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC/GB06/006	United Kingdom		PRODUCT NAME: OMALIZUMAB AND ITS PHARMACEUTICALLY ACCEPTABLE FORMS; REGISTERED: UK EU/1/05/319/001 20051024; UK EU/1/05/319/002 20051024
C300222	Netherlands		PRODUCT NAME: OMALIZUMAB; REGISTRATION NO/DATE: EU/1/05/319/001- EU/1/05/319/002 20051025
06C0006	France		PRODUCT NAME: OMALIZUMAB ET SES FORMES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/05/319/001 DU 20051025; REGISTRATION NO/DATE AT EEC: E/1/05/319/001 DU 20051025
6/2006	Austria		PRODUCT NAME: OMALIZUMAB; REGISTRATION NO/DATE: EU/1/05//319/001 UND002 20051025

Last updated: September 24, 2025

rket Dynamics and Financial Trajectory for the Biologic Drug: Omalizumab

Introduction

Omalizumab, marketed under the brand name Xolair among others, is a monoclonal antibody developed by Genentech/Roche. Since its approval in 2003 by the U.S. Food and Drug Administration (FDA), it has become a pivotal therapy in allergic asthma and chronic idiopathic urticaria (CIU). The drug’s innovative mechanism—targeting immunoglobulin E (IgE)—positions it as a cornerstone in the biologics segment for allergic diseases. This analysis explores the evolving market landscape, competitive forces, regulatory environment, revenue trajectory, and future growth prospects for omalizumab.

Market Overview

Omalizumab addresses a significant unmet medical need in severe allergic asthma, which afflicts approximately 5-10% of the global asthma population—roughly 25 million individuals worldwide [1]. Additionally, its approval for chronic spontaneous urticaria (CSU) has broadened its therapeutic scope. The global biologics market for allergy and immunology is expanding rapidly, driven by increased asthma prevalence, antibiotic resistance concerns with traditional therapies, and rising adoption of personalized medicine.

Market Drivers

• Increasing Prevalence of Allergic Conditions:
  Population studies project a steady rise in allergic diseases, particularly in urbanized regions, propelled by environmental factors, pollution, and urban lifestyles. The World Allergy Organization estimates that over 30% of the global population suffers from allergic diseases [2].

• Shift Toward Personalized Medicine:
  Biologics like omalizumab offer targeted therapy options with enhanced efficacy and safety profiles, steering clinicians toward their use over traditional systemic corticosteroids.

• Regulatory Approvals and Expanded Labeling:
  In recent years, regulatory agencies in Europe and the U.S. have approved omalizumab for additional indications, including nasal polyps and potentially other allergic conditions, fostering broader market penetration.

• Patent and Market Exclusivity Trains:
  While patent expiry is an ongoing concern, patent protections and exclusivity periods have sustained revenue streams, with biosimilar competition yet to significantly impact omalizumab markets due to regulatory and manufacturing complexities.

Market Challenges

• Biosimilar Threats:
  Potential biosimilar entries in key markets, particularly Europe and emerging economies, threaten to erode market share and reduce pricing power.

• High Treatment Costs:
  Omalizumab's cost—ranging from $5,000 to $20,000 annually—limits access, especially in low- and middle-income countries, pressuring payers and health systems to seek more cost-effective alternatives.

• Administration Route and Dosing:
  Subcutaneous injections administered every 2-4 weeks pose adherence challenges compared to oral therapies, though they remain preferred over steroids for severe cases.

Financial Trajectory and Revenue Analysis

Historical Revenue Trends

Since its launch, omalizumab has demonstrated stable growth, with peak global sales surpassing $3 billion annually in the late 2010s. In 2021, Roche reported sales of approximately $2.8 billion, reflecting consistent demand despite biosimilar concerns arriving in some regions [3].

Regional Revenue Breakdown

The U.S. remains the largest market, accounting for approximately 50-55% of total revenues, driven by comprehensive insurance coverage and high disease prevalence. Europe contributes around 25-30%, with significant penetration in the United Kingdom, Germany, and France. The Asia-Pacific region represents an emerging market with expanding adoption, expected to grow at a compound annual growth rate (CAGR) of 8-10% over the next five years.

Growth Drivers

The growth trajectory is sustained by indication expansion, new formulations, and increased clinician awareness. Roche’s strategic partnerships and marketing efforts aim to penetrate primary care settings, broadening access to earlier intervention.

Competitive Landscape

Several monoclonal antibodies offer alternative or adjunctive therapies for allergic conditions, including mepolizumab, reslizumab, benralizumab, and dupilumab, which target different cytokines involved in allergy and asthma pathogenesis. However, omalizumab’s early-market entry and strong clinical track record sustain its dominant position.

Emerging biosimilars are under development, but their commercial viability hinges on regulatory acceptance and payer reimbursement strategies. The complexity of omalizumab’s manufacturing process and the need for a robust biosimilar approval pathway mitigate immediate threats.

Regulatory Environment

Omalizumab’s regulatory journey has seen expansions in indications globally, including approvals for pediatric asthma and chronic spontaneous urticaria. Regulatory agencies continuously evaluate safety post-marketing, particularly concerning rare adverse events such as anaphylaxis, influencing risk management practices and labeling updates.

Price negotiations and reimbursement policies are increasingly scrutinized, especially in the European Union, where healthcare budgets tighten. Value-based pricing models are being explored to balance innovation incentives with affordability.

Future Market Outlook

Projections forecast the omalizumab market to reach approximately $4.5 billion by 2025, primarily driven by:

• Indication Expansion: Approval for nasal polyps in the U.S. and Europe.
• Novel Formulations: Subcutaneous auto-injectors and possibly long-acting formulations to improve adherence.
• Emerging Markets: Increased access and healthcare infrastructure investments expanding patient reach.
• Biomarker-driven Therapy: Improved patient selection based on IgE levels and other biomarkers, optimizing outcomes and cost-effectiveness.

Nonetheless, the landscape may be reshaped by biosimilar entrants, novel biologics with improved efficacy, and evolving healthcare policies aimed at reducing drug costs.

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Key Takeaways

• Omalizumab remains a leading biologic for allergic asthma and urticaria, with a strong existing revenue base and growth potential.
• Market expansion is fueled by indication broadening, regional adoption, and evolving treatment paradigms emphasizing personalized medicine.
• Patent protections and high manufacturing costs defend its market position against biosimilar competition in the near term.
• Cost and administration challenges influence market dynamics, particularly in emerging economies.
• Future growth hinges on indication expansion, innovative formulations, and healthcare system adaptations toward value-based care.

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FAQs

1. What are the primary therapeutic indications for omalizumab?
Omalizumab is approved for moderate to severe persistent allergic asthma in patients aged six and older, chronic spontaneous urticaria in adults and adolescents aged 12 and above, and more recently for nasal polyps in selected regions.

2. How does omalizumab's mechanism of action differ from other biologics in allergy treatment?
It specifically binds to circulating IgE, preventing its interaction with receptors on mast cells and basophils, thereby reducing allergic inflammation. Other biologics target cytokines like IL-5 or IL-4/13 pathways.

3. What is the potential impact of biosimilars on omalizumab’s market share?
Biosimilars could reduce prices and increase access, especially in regions with evolving regulatory pathways. However, manufacturing complexity and patent protections delay immediate market penetration.

4. Are there any significant safety concerns associated with omalizumab?
Rare cases of anaphylaxis have been reported, necessitating post-injection observation. Overall, safety profiles are favorable, with manageable adverse events.

5. What strategic approaches can pharmaceutical companies adopt to sustain omalizumab’s market share?
Investing in indication expansion, developing next-generation formulations, engaging in value-based pricing negotiations, and exploring combination therapies can enhance market resilience.

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References

1. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention, 2022.
2. World Allergy Organization. Allergy Data & Epidemiology, 2021.
3. Roche. Annual Report 2021.