Global Immunoassay Reagents and Devices Market – Industry Trends and Forecast to 2031

Immunoassay Reagents and Devices Market Analysis and Size

The immunoassay reagents and devices market is the continuous integration of advanced technologies, such as automation and miniaturization, to enhance efficiency and precision in diagnostic processes. These innovations streamline workflow in laboratories, reduce turnaround times, and increase the accuracy of immunoassay tests. The industry's commitment to technological advancements improves diagnostic capabilities and contributes to the growing adoption of these reagents and devices in various healthcare settings worldwide.

Data Bridge Market Research analyses that the global immunoassay reagents and devices market, which was USD 44,49,219.95 million in 2023, is expected to reach USD 67,76,551.81 million by 2031, at a CAGR of 5.4% during the forecast period 2024 to 2031 In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Immunoassay Reagents and Devices Market Scope and Segmentation

Market Definition

The immunoassay reagents and devices market refers to the industry that produces components and tools used in immunoassay techniques for detecting and measuring specific substances, such as antibodies or antigens, in biological samples. These reagents include antibodies, antigens, enzymes, and other biomolecules essential for the immunoassay process. Key players in the market continually innovate and develop new reagents and devices, fostering growth.

Global Immunoassay Reagents and Devices Market Dynamics

Drivers

• Increasing Demand for Diagnostics

The rising prevalence of infectious and chronic diseases worldwide has led to a growing demand for accurate and efficient diagnostic tools. Immunoassay reagents and devices play a crucial role in diagnosing various conditions, contributing to the market's expansion as healthcare systems focus on early detection and monitoring of diseases.

• Increasing Aging Population  

The increasing aging population worldwide is a key demographic trend impacting market dynamics. As people age, there is a rising demand for healthcare services, particularly in the monitoring and diagnosis of age-related diseases. This trend has spurred a notable increase in the need for immunoassay-based diagnostics, which play a crucial role in detecting and managing various health conditions prevalent among the elderly. The immunoassay technology, known for its accuracy and sensitivity, is adept at identifying biomarkers associated with age-related ailments, contributing to effective disease management.

Opportunities

• Point-of-Care Testing

The increasing demand for timely and efficient healthcare solutions, point-of-care testing allows for on-the-spot testing, minimizing the need for centralized laboratories. This trend is driven by the growing prevalence of infectious diseases and chronic conditions, emphasizing the importance of quick and reliable diagnostic results. The immunoassay reagents and devices market is poised to benefit from the adoption of POCT, as it offers healthcare professionals the ability to make informed decisions at the patient's bedside, enhancing patient care and treatment outcomes. This shift towards decentralized testing reflects a key market advantage, addressing the need for accessible and immediate diagnostic solutions on a global scale.

• Biomarker Discovery

Biomarker discovery is a crucial aspect of medical research that involves identifying specific molecules, known as biomarkers, in the body that indicate the presence or progression of a disease. Immunoassay reagents and devices play a vital role in detecting and measuring these biomarkers, aiding in early disease diagnosis and monitoring. The market's growth is driven by the increasing demand for advanced diagnostic tools, rising prevalence of chronic diseases, and the emphasis on personalized medicine. As biomarker discovery continues to advance, the global immunoassay reagents and devices market is positioned for substantial expansion, offering innovative solutions for precise and early disease detection.

Restraints/Challenges

• High Costs

The expenses involved in research, development, and production of immunoassay reagents and devices contribute to elevated costs. This, in turn, hampers market accessibility for both manufacturers and consumers. The intricate nature of immunoassay technology demands sophisticated instrumentation and specialized reagents, further adding to the financial burden. High production costs may limit the affordability of these diagnostic tools, restricting their widespread adoption.

• Regulatory Challenges

The immunoassay industry is subject to rigorous regulatory scrutiny and approval processes. Meeting the stringent standards set by health authorities can be time-consuming and resource-intensive for manufacturers. Delays in regulatory approvals may impede the timely introduction of new products to the market, affecting innovation and competitiveness within the industry.

This global immunoassay reagents and devices market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the global immunoassay reagents and devices market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Developments

• In November 2022, Getein unveiled the MAGICL 6000 CLIA analyzer at MEDICA 2022, catering to mid to high-workflow laboratories with its compact design. This innovative one-step CLIA solution provides optimal efficiency for such laboratory settings
• In November 2022, LumiraDx launched a rapid microfluidic immunoassay HbA1c test across Europe, parts of the Middle East, Asia, Latin America, and Africa. This expansion signifies a strategic move to make this diagnostic tool widely available in diverse regions
• In April 2022, Bio-Techne Corporation and Cygnus Technologies introduced the Simple Plex HEK 293 HCP 3G assay for automated process impurity detection on the Ella immunoassay platform. Addressing the vital need for impurity clearance in Gene and Cell Therapy applications, this assay facilitates accurate quantification of host cell proteins (HCP) throughout viral production phases, aligning with regulatory criteria for ensuring product purity
• In February 2022, Hycor Biomedical Inc secured additional FDA 510(k) clearance for the NOVEOS Immunoassay Analyzer, a chemiluminescent diagnostic tool designed to measure analyte concentrations in human samples. The device, specializing in allergy diagnosis, enhances the capabilities of in-vitro diagnostic equipment
• In January 2021, Abbott's Panbio COVID-19 Ag Rapid Test Device received the CE Mark for asymptomatic SARS-CoV-2 virus diagnosis. This test, equipped with self-swabbing capabilities, offers an efficient and accessible solution for detecting the virus in diverse settings

Global Immunoassay Reagents and Devices Market Scope

The global immunoassay reagents and devices market is segmented on the basis of product, platform, technique, specimen type, application and end user. The growth amongst these segments will help you analyse meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Product

• Reagents and Kits
• Analyzers

Platform                                                                                               

• Chemiluminescence Immunoassays
• Fluorescence Immunoassays
• Enzyme Immunoassay
• Radioimmunoassays
• Others

Technique

• Enzyme-Linked Immunosorbent Assays
• Rapid Tests
• Enzyme-Linked Immunospot
• Western Blotting
• Immuno-PCR
• Other Techniques

Specimen Type

• Blood
• Urine
• Saliva
• Others

Application

• Infectious Diseases
• Oncology And Endocrinology
• Bone and Mineral Disorders
• Cardiology
• Hematology and Blood Screening
• Autoimmune Disorders
• Toxicology
• Neonatal Screening
• Other Applications

End User

• Hospitals
• Clinical Laboratories
• Pharmaceutical And Biotechnology Companies
• Blood Banks
• Research and Academic Laboratories
• Others

Global Immunoassay Reagents and Devices Market Regional Analysis/Insights

The global immunoassay reagents and devices market are analysed and market size insights and trends are provided by country, product, platform, technique, specimen type, application and end user as referenced above.

The countries covered in the global immunoassay reagents and devices market report are U.S., Canada and Mexico, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E., South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America

North America dominates in the global immunoassay reagents and devices market, both in terms of market share and revenue. This dominance is expected to persist from 2024 to 2031, driven by heightened investments in research and development, growing government initiatives, and enhanced healthcare infrastructure across the region. The increased focus on these factors contributes to the flourishing market presence of North America in the field of immunoassay technologies.

The Asia-Pacific is expected to experience the most rapid growth in the global immunoassay reagents and devices market from 2024 to 2031. This can be attributed to heightened government investments in the healthcare sector and a surge in technological advancements. The region's commitment to healthcare initiatives further propels its position as a key player in driving market expansion during the forecast period.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Healthcare Infrastructure Growth Installed base and New Technology Penetration

The global immunoassay reagents and devices market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for global immunoassay reagents and devices market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the global immunoassay reagents and devices market. The data is available for historic period 2016-2021.

Competitive Landscape and Global Immunoassay Reagents and Devices Market Share Analysis

The global immunoassay reagents and devices market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to global immunoassay reagents and devices market.

Some of the major players operating in the global immunoassay reagents and devices market are:

• F. Hoffmann-La Roche Ltd (Switzerland)
• Siemens (Germany)
• Randox Laboratories Ltd. (U.K.)
• Abbott (U.S.)
• Bio-Rad Laboratories, Inc. (U.S.)
• Merck KGaA (Germany)
• Beckman Coulter, Inc. (U.S.)
• BIOMÉRIEUX (France)
• Thermo Fisher Scientific Inc. (U.S.)
• BD (U.S.)
• Mindray Bio-Medical Electronics Co., Ltd. (China)
• DiaSorin S.p.A (Italy)
• Ortho Clinical Diagnostics (U.S.)
• QIAGEN (Germany)
• QuidelOrtho Corporation (U.S.)
• BioCheck (U.S.)
• Bio-Techne (U.S.)
• PerkinElmer Inc. (U.S.)
• Agilent Technologies, Inc. (U.S.)
• MESO SCALE DIAGNOSTICS, LLC (U.S.)

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