PUBLISHER: The Business Research Company | PRODUCT CODE: 1889584
PUBLISHER: The Business Research Company | PRODUCT CODE: 1889584
Specific immunoglobulin G subclass 4 (IgG4) testing measures the concentration of IgG4, one of the antibodies produced by the body as part of its immune response. In this test, a blood sample is examined to determine the amount of IgG4 present, as unusually elevated levels may indicate abnormal immune activity. The results help clinicians assess conditions such as IgG4-related disease and gain insight into certain immune or inflammatory responses.
The key product types of specific immunoglobulin G subclass 4 (IgG4) testing include reagents and kits, instruments, and services. Reagents and kits are pre-packaged chemical or biological components designed to support the accurate detection, measurement, or analysis of specific targets in diagnostic testing. The key applications include allergy diagnosis, autoimmune disease diagnosis, research, and others, and these products are used by various end users, such as hospitals and clinics, diagnostic laboratories, research institutes, and additional healthcare settings.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.
The specific immunoglobulin G subclass 4 (IgG4) testing market research report is one of a series of new reports from The Business Research Company that provides specific immunoglobulin G subclass 4 (IgG4) testing market statistics, including the specific immunoglobulin G subclass 4 (IgG4) testing industry global market size, regional shares, competitors with the specific immunoglobulin G subclass 4 (IgG4) testing market share, detailed specific immunoglobulin G subclass 4 (IgG4) testing market segments, market trends, and opportunities, and any further data you may need to thrive in the specific immunoglobulin G subclass 4 (IgG4) testing industry. This specific immunoglobulin G subclass 4 (IgG4) testing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.
The specific immunoglobulin G subclass 4 (IgG4) testing market size has grown rapidly in recent years. It will grow from $1.22 billion in 2024 to $1.37 billion in 2025 at a compound annual growth rate (CAGR) of 12.6%. The growth in the historic period resulted from the increasing prevalence of food sensitivities, rising awareness of immune-related disorders, growing demand for advanced diagnostic services, a surge in healthcare expenditure, expansion of specialized laboratory testing, and a heightened focus on personalized dietary management.
The specific immunoglobulin G subclass 4 (IgG4) testing market size is expected to see rapid growth in the next few years. It will grow to $2.17 billion in 2029 at a compound annual growth rate (CAGR) of 12.3%. The growth in the forecast period will be driven by increasing screening for chronic inflammatory conditions, rising emphasis on preventive healthcare, growing adoption of advanced immunology testing in hospitals, a surge in patient awareness regarding allergy management, expansion of private diagnostic laboratories, and a growing focus on comprehensive immune profiling. Major trends in the forecast period include technological advancements in multiplex immunoassay platforms, progress in high-sensitivity detection methods, innovations in automated antibody quantification systems, developments in digital reporting and interpretation tools, research and development in biomarker-based immune assessment, and innovations in microfluidics-enabled diagnostic testing.
The rising prevalence of allergic diseases is expected to drive the growth of the specific immunoglobulin G subclass 4 (IgG4) testing market in the coming years. Allergic diseases are immune-mediated hypersensitivity disorders, including food allergies, atopic dermatitis, asthma, and allergic rhinitis, which occur when the immune system reacts abnormally to typically harmless substances. This rise in prevalence is linked to changes in dietary habits, as increased consumption of highly processed foods can alter gut microbiota and increase the risk of developing allergic sensitization. Specific IgG4 testing helps evaluate immune responses associated with repeated allergen exposure, aiding clinicians in understanding tolerance patterns and interpreting complex allergy-related immune activity. For example, in May 2024, the Food Standards Agency (FSA), a UK government body responsible for food safety and public health, reported that approximately 6%, or 2.4 million, of the UK adult population had a clinically confirmed food allergy. As a result, the growing prevalence of allergic diseases is fueling the expansion of the IgG4 testing market.
Leading companies in the IgG4 testing market are focusing on innovations in testing platforms and methodologies, such as high-sensitivity immunoassay technology, to improve assay accuracy, analytical performance, and diagnostic reliability. High-sensitivity immunoassays are advanced detection systems that employ optimized antibodies, enhanced signal-generation chemistries, and refined assay workflows to quantify very low analyte concentrations with precision. These systems offer improved detection limits, superior specificity, and consistent reproducibility. For instance, in September 2025, Alta DiagnoTech, a US-based developer of in vitro diagnostic immunoassay solutions, launched ELISA Kits for IVD Immunology Testing, a high-sensitivity immunoassay product line designed for accurate biomarker quantification across a wide range of immunology applications. The kits offer enhanced assay sensitivity, robust manufacturing stability, and broad applicability, improving test reliability, analytical precision, and overall diagnostic confidence in immunology testing workflows.
In December 2023, Danaher Corporation, a US-based provider of life sciences, diagnostics, and biotechnology solutions, acquired Abcam plc for $5.7 billion. This acquisition allows Danaher to access Abcam's extensive portfolio of antibodies, recombinant proteins, assay kits, and immunoassay reagents, strengthening its specialized immunodiagnostic capabilities, including those supporting IgG4 testing workflows, while expanding its global research infrastructure, operational scale, and customer reach. Abcam plc, a UK-based provider of high-quality biological reagents and research assay solutions, is renowned for its expertise in antibody development and standardized ELISA platforms, including research-grade IgG4-specific tools widely used in immunology and biomarker research.
Major companies operating in the specific immunoglobulin g subclass 4 (igg4) testing market are F Hoffmann La Roche Ltd., Thermo Fisher Scientific Inc., Abbott Laboratories, Siemens Healthineers AG, Mayo Clinic Laboratories, Laboratory Corporation of America Holdings, Quest Diagnostics Incorporated, Eurofins Scientific SE, Revvity, Randox Laboratories Ltd, NeoGenomics Laboratories Inc., ARUP Laboratories, Dr Lal PathLabs Limited, Metropolis Healthcare Ltd, ProSci Incorporated, Leinco Technologies Incorporated, MyBioSource Inc., Boster Biological Technology, PROTIA Inc., Creative Diagnostics LLC.
North America was the largest region in the specific immunoglobulin G subclass 4 (IgG4) testing market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in specific immunoglobulin G subclass 4 (IgG4) testing report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the specific immunoglobulin G subclass 4 (IgG4) testing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The specific immunoglobulin G subclass 4 (IgG4) testing market includes revenues earned by entities by providing services such as sample collection services, specimen transport services, pre-analytical preparation services, data management services, clinical consultation services, and results dissemination services. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Specific Immunoglobulin G Subclass 4 (IgG4) Testing Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on specific immunoglobulin g subclass 4 (igg4) testing market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for specific immunoglobulin g subclass 4 (igg4) testing ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The specific immunoglobulin g subclass 4 (igg4) testing market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.