Explore Companies Pioneering Innovations in the Allergy Diagnostics And Therapeutics Market
- R-Biopharm AG
- DASIT Group SPA
- EUROIMMUN Medizinische Labordiagnostika AG (PerkinElmer, Inc.)
- AESKU.GROUP GmbH
- bioMérieux
- Siemens Healthcare GmbH
- Stallergenes Greer
- HYCOR Biomedical
- Minaris Medical America, Inc.
- Omega Diagnostics Group PLC
- Lincoln Diagnostics, Inc.
- HOB Biotech Group Corp., Ltd.
- Danaher
- Alcon
- AbbVie, Inc.
- Sanofi
- Allergy Therapeutics
- Pfizer, Inc.
- Teva Pharmaceutical Industries Ltd.
- GSK plc
- Sun Pharmaceutical Industries Ltd.
- F. Hoffmann-La Roche Ltd.
- Merck & Co., Inc.
- Astellas Pharma Inc.
- Epigenomics AG
What are Allergy Diagnostics and Therapeutics?
The allergy diagnostics and therapeutics market involves the development and use of tests and treatments to identify, manage, and prevent allergic diseases caused by allergens such as pollen, food, or dust. The market is growing due to the rising global prevalence of allergic diseases, increasing environmental pollution, and growing awareness of early diagnosis and treatment. Advancements in diagnostic technologies, such as molecular and component-resolved testing, are enhancing accuracy.
For Instance,
- In February 2024, the U.S. FDA approved Xolair (omalizumab) injection for treating IgE-mediated food allergies in adults and children aged one year and above. The approval aims to reduce allergic reactions, including the risk of anaphylaxis, from accidental exposure to multiple food allergens.
Market Growth
The allergy diagnostics and therapeutics market size stood at US$ 36.55 billion in 2025, grew to US$ 39.75 billion in 2026, and is forecast to reach US$ 84.59 billion by 2035, expanding at a CAGR of 8.76% from 2026 to 2035.
Learn About the Major Players in the Allergy Diagnostics and Therapeutics Market
Thermo Fisher Scientific Inc.
Corporate Information:
- Headquarters: Waltham, Massachusetts, United States
- Year Founded: 2006 (Formed by the merger of Thermo Electron and Fisher Scientific)
- Ownership Type: Public (NYSE: TMO)
History and Background:
- Formed from the merger of Thermo Electron Corporation (founded 1956) and Fisher Scientific International Inc. (founded 1902).
- Became a dominant force in the life sciences, analytical instruments, and specialty diagnostics market through consistent strategic acquisitions.
- The allergy diagnostics business is primarily anchored by the former Phadia AB, a Swedish company acquired in 2011, which pioneered the ImmunoCAP technology.
Key Milestones/Timeline:
- 2006: Thermo Electron and Fisher Scientific complete merger.
- 2011: Acquires Phadia AB, becoming the global leader in specific IgE in-vitro diagnostics.
- 2020: Significant role in COVID-19 testing, reinforcing its diagnostics capabilities.
- 2021: Acquired PPD, a leading clinical research organization (CRO), further expanding its service offerings in drug development, which includes therapeutics.
Business Overview:
- World leader in serving science, providing analytical instruments, reagents and consumables, software, and services for research, diagnostics, and industrial applications.
- Annual Revenue (Latest Statistics): Over $42 Billion (FY 2024 estimate).
Business Segments/Divisions:
- Life Sciences Solutions: Reagents, instruments, and consumables for biological and medical research.
- Analytical Instruments: Instruments, consumables, software, and services for a range of lab applications.
- Specialty Diagnostics: Diagnostic products, including clinical chemistry, immunodiagnostics (where allergy testing falls), and transplant diagnostics.
- Laboratory Products and Biopharma Services: Laboratory equipment, chemicals, supplies, and clinical trial services (PPD).
Geographic Presence:
- Global presence with operations in over 50 countries.
- Strong market position across North America, Europe, and Asia-Pacific.
Key Offerings (Allergy):
- Diagnostics: ImmunoCAP Specific IgE tests (considered the gold standard for in-vitro allergy testing), ImmunoCAP ISAC (multiplex allergen component testing), and Phadia Laboratory Systems (fully automated analyzers like Phadia 250/2500/5000).
- Services: Allergen Encyclopedia, scientific resources, and Phadia Academy for training.
End-Use Industries Served:
- Clinical Diagnostic Laboratories (main end-user for allergy diagnostics)
- Hospitals and Physician Offices
- Academic Research Institutions
- Biotechnology and Pharmaceutical Companies
Key Developments and Strategic Initiatives:
- Mergers & Acquisitions: Continual strategic acquisitions to expand core technology, such as the PPD acquisition to bolster Biopharma Services.
- Partnerships & Collaborations: Partnership with Kroger Health (May 2023) to expand access to ImmunoCAP allergy testing across U.S. Little Clinic locations.
- Product Launches/Innovations: Focus on expanding the menu of allergen components for the ImmunoCAP system and enhancing the automation capabilities of the Phadia instruments.
- Capacity Expansions/Investments: Continuous investment in manufacturing and R&D facilities globally to meet growing demand for diagnostics and biopharma services.
- Regulatory Approvals: Ongoing pursuit of FDA and international regulatory clearances for new allergen component tests and diagnostic platforms.
Distribution Channel Strategy:
- Direct sales force globally to large hospitals and reference labs.
- Distributor network for smaller labs and emerging markets.
- Direct-to-consumer partnerships for specific diagnostic services (e.g., Kroger Health).
Technological Capabilities/R&D Focus:
- Core Technologies/Patents: ImmunoCAP Technology (fluorescence enzyme immunoassay), which enables quantitative, high-sensitivity detection of allergen-specific IgE. Patents cover the solid-phase allergen carrier and assay methodology.
- Research & Development Infrastructure: Operates numerous R&D centers globally, focusing on assay development, instrument automation, and digital integration.
- Innovation Focus Areas: Molecular diagnostics (Component Resolved Diagnostics - CRD), high-throughput automation (Phadia Prime), and integrating digital solutions for data analysis and clinical decision support.
Competitive Positioning:
- Strengths & Differentiators: ImmunoCAP is the market leader and recognized gold standard for in-vitro allergy testing. Unmatched test menu size and clinical validation. Strong global distribution and installed base of Phadia systems.
- Market Presence & Ecosystem Role: Dominant player in the in-vitro allergy diagnostics segment, serving as a primary supplier to reference laboratories worldwide. Key enabler for personalized allergy management and immunotherapy planning.
SWOT Analysis:
- Strengths: Market-leading ImmunoCAP technology, vast product portfolio, robust global distribution, strong financial position.
- Weaknesses: High cost of ImmunoCAP system/tests compared to some competitors, reliance on strategic acquisitions for growth.
- Opportunities: Expansion of Component Resolved Diagnostics (CRD), growth in emerging markets, integration of AI/digital health for diagnostic insights.
- Threats: Intense competition from major diagnostics players (e.g., Siemens Healthineers, Danaher) and emerging specialized diagnostics companies, and regulatory changes.
Recent News and Updates (2024-2025):
- Press Releases: Focused on launching new specialty tests (e.g., expanded panels for specific autoimmune diseases run on Phadia systems) and digital lab solutions to optimize workflow.
- Industry Recognitions/Awards: Frequently recognized for leadership in diagnostics and life science tools.
Siemens Healthineers AG
Corporate Information:
- Headquarters: Erlangen, Bavaria, Germany
- Year Founded: 2017 (Legally carved out from Siemens AG) / Traces roots back to 1847 (Siemens & Halske)
- Ownership Type: Public (FWB: SHL) (Majority-owned by Siemens AG)
History and Background:
- The healthcare division of Siemens AG for over a century formally established as a separate, publicly listed company (majority owned by Siemens AG) in 2017 to increase strategic focus and flexibility.
- A major global player in medical technology, including imaging, diagnostics, and advanced therapies.
- Its allergy diagnostics offering is based on its extensive immunoassay portfolio, notably the IMMULITE and Atellica systems, featuring the 3gAllergy assay menu.
Key Milestones/Timeline:
- 1896: Siemens first enters the medical technology sector.
- 2007: Acquisition of Dade Behring, significantly expanding its laboratory diagnostics business.
- 2017: Separately listed on the Frankfurt Stock Exchange as Siemens Healthineers.
- 2021: Completed the acquisition of Varian Medical Systems, significantly bolstering its Advanced Therapies and Cancer Care portfolio.
Business Overview:
- A leading medical technology company with expertise in diagnostics, therapeutic interventions, and in-vivo/in-vitro diagnostics.
- Annual Revenue (Latest Statistics): Approximately €22 Billion (FY 2024 estimate).
Business Segments/Divisions:
- Imaging: Medical imaging systems (MRI, CT, X-ray, etc.).
- Diagnostics: In-vitro diagnostic instruments, reagents, and assays (including allergy testing) for laboratories.
- Advanced Therapies: Medical devices and services for minimally invasive procedures and interventional radiology/cardiology, bolstered by the Varian acquisition (cancer care).
Geographic Presence:
- Operates globally in over 70 countries.
- Strong market presence in Europe, North America, and Asia.
Key Offerings (Allergy):
- Diagnostics: 3gAllergy assays for allergen-specific IgE testing, compatible with their high-throughput automated immunoassay systems like the IMMULITE and Atellica Solution platforms.
- Systems: IMMULITE 2000 XPi/1000 and the modular, integrated Atellica Solution.
End-Use Industries Served:
- Clinical Diagnostic Laboratories
- Hospital Laboratories and Healthcare Systems (major focus)
- Reference Laboratories
- Private Physician and Outpatient Clinics
Key Developments and Strategic Initiatives:
- Mergers & Acquisitions: Focus on portfolio optimization and major, transformative acquisitions like Varian. Diagnostics' focus is on integrating acquired technologies (e.g., assays) into the Atellica platform.
- Partnerships & Collaborations: Collaborates with AI firms and digital health specialists to integrate predictive diagnostics and remote monitoring capabilities into its platforms.
- Product Launches/Innovations: Continuous expansion of the 3gAllergy menu for the Atellica Solution to increase test consolidation and workflow efficiency in the lab.
- Capacity Expansions/Investments: Significant investments in the Diagnostics division to digitize and automate laboratory workflows via the Atellica platform.
- Regulatory Approvals: Ongoing regulatory clearances in major markets (FDA, CE-IVDR) for new assays and system enhancements.
Distribution Channel Strategy:
- A strong, centralized global direct sales and service network, particularly focused on large hospital systems and integrated delivery networks.
- Leverages its broad portfolio (imaging, diagnostics, therapy) to secure bundled solutions and long-term contracts.
Technological Capabilities/R&D Focus:
- Core Technologies/Patents: 3gAllergy technology for quantitative IgE testing and advanced immunoassay technologies (chemiluminescence) on the IMMULITE and Atellica platforms. Patents focus on immunoassay automation and integrated workflow solutions.
- Research & Development Infrastructure: Global R&D centers focusing on integrating lab diagnostics with clinical workflow and molecular techniques.
- Innovation Focus Areas: Integration of Artificial Intelligence (AI) for predictive diagnostics, development of high-throughput and consolidated systems (Atellica), and expanding the menu of high-value assays.
Competitive Positioning:
- Strengths & Differentiators: Comprehensive, integrated portfolio across the entire patient pathway (Imaging, Diagnostics, Therapy). Strong footprint in hospital labs due to the integrated nature of the Atellica platform. Competitive, automated allergy testing menu (3gAllergy).
- Market Presence & Ecosystem Role: A key competitor in in-vitro diagnostics, challenging the diagnostics leader through workflow automation and system consolidation. A primary technology provider for large-scale, automated clinical laboratories worldwide.
SWOT Analysis:
- Strengths: Global brand recognition, strong financial backing from Siemens AG, integrated in-vitro and in-vivo portfolio, advanced automation platforms (Atellica).
- Weaknesses: Intense competition in the allergy diagnostics segment from the market leader, complexity of platform migration for some users.
- Opportunities: Adoption of the Atellica platform driving assay consolidation, growth in value-based healthcare models favoring integrated solutions, and expansion into digital and predictive diagnostics.
- Threats: Pricing pressure in the diagnostics market, rapid innovation cycles by competitors, and global economic volatility impacting capital equipment sales.
Recent News and Updates (2024-2025):
- Press Releases: Announcements related to new AI-powered applications for imaging and diagnostics, and continued global installations of the Atellica Solution platform.
- Industry Recognitions/Awards: Regularly receives awards for its imaging and diagnostic equipment design and technological advancements.
Allergy Diagnostics And Therapeutics Market Value Chain Analysis
Clinical Trials
- Ongoing clinical trials in allergy diagnostics and therapeutics are exploring advanced and more effective approaches beyond traditional methods like skin prick tests and allergen avoidance.
- Research focuses on innovative treatments such as oral immunotherapy (OIT), sublingual immunotherapy (SLIT), and biologic therapies.
- These trials aim to enhance the safety and effectiveness of treatments for food allergies, allergic asthma, and rhinoconjunctivitis.
Regulatory Approvals
- Regulatory approvals for allergy diagnostics and therapeutics involve detailed evaluation by agencies like the U.S. FDA and the European Medicines Agency (EMA).
- The approval process varies based on the type of product diagnostic or therapeutic, its innovation level, and target market.
- Each product must meet strict safety, quality, and efficacy standards before receiving market authorization.
Patient Support and Services
- Patient support programs for allergy diagnostics and therapeutics guide individuals from diagnosis through long-term treatment management.
- These services provide assistance across medical, financial, and emotional aspects to improve patient outcomes and quality of life.
- They aim to enhance treatment adherence, offer education on allergy management, and connect patients with expert care resources.
Company and Its Offerings in the Allergy Diagnostics and Therapeutics Market
- Danaher Corporation: Offers advanced diagnostic solutions through its subsidiaries, like Beckman Coulter and Cepheid, supporting accurate allergy testing and laboratory automation.
- Alcon: Provides therapeutic eye care solutions for allergic conjunctivitis and other ocular allergies through its range of antihistamine and anti-inflammatory eye drops.
- AbbVie Inc.: Focuses on developing biologic therapies and immunomodulators for allergic and inflammatory conditions.
- Sanofi: Offers a wide portfolio of allergy treatments, including antihistamines and biologics like Dupixent for asthma and atopic dermatitis.
- Pfizer Inc.: Develops and markets innovative therapies targeting allergic and inflammatory diseases, supported by strong R&D in immunology and respiratory care.
Recent Developments in the Allergy Diagnostics And Therapeutics Market
- In August 2025, Sanofi introduced Allegra-D in India, a non-drowsy tablet for allergy and nasal congestion relief. The drug combines Fexofenadine Hydrochloride (60 mg) and Pseudoephedrine Hydrochloride (120 mg) and has been approved by the Drug Controller General of India (DCGI) for use in adults and children aged 12 and above.
- In January 2024, ALK received FDA approval to extend the use of its sublingual immunotherapy tablet, ODACTRA, for treating house dust mite-induced allergic rhinitis in adolescents aged 12 to 17 years.
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