Immunoassay Interference Blocker Market

Immunoassay Interference Blocker Market Size, Share and Growth Forecast by Source Type (Human, Murine, Chimeric, Humanized), by Production Type (In-vivo, In-vitro), by Application (Infectious Diseases, Neurological Diseases, Autoimmune Diseases, Oncology, Others), by End User (Hospitals, Specialty Centers, Others), and by Region for 2024-2031

PMR Offers a Detailed Market Study on Immunoassay Interference Blockers Based on Development of Innovative and Novel Interference Blockers for Advancing Diagnostic Accuracy and Reliability

Report ID: PMRREP24343

Number of Pages: 173

Format: PPT*, PDF, EXCEL

Industry: Healthcare

Published Date: June-2024

Report Price

$4900*

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Immunoassay Interference Blocker Market Size and Share Analysis

The global immunoassay interference blocker market is estimated to value at US$480.1 Mn by the end of 2031 from US$308.6 Mn recorded in 2023. The market is expected to secure a CAGR of 5.7% in the forthcoming years from 2024 to 2031.

Key Highlights of the Market

Market Attributes

Key Insights

Immunoassay Interference Blocker Market Size (2024E)

US$324.8 Mn

Projected Market Value (2031F)

US$480.1 Mn

Forecast Growth Rate (CAGR 2024 to 2031)

5.7%

Historical Growth Rate (CAGR 2018 to 2023)

4.9%

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Market Introduction and Trend Analysis

Immunoassay interference blockers are specialized reagents used in immunoassay tests to mitigate the impact of interfering substances on the accuracy and reliability of diagnostic assays.

Immunoassays are analytical techniques that detect the presence and quantify the concentration of specific analytes, such as proteins, hormones, drugs, or infectious agents, by utilizing the specific binding affinity between antigens and antibodies.

However, various factors can interfere with this binding interaction, leading to false-positive or false-negative results and compromising the diagnostic or research utility of the assay.

Immunoassay interference blockers cover a broad range of spectrum of interactions which might occur in complex network between assay components, assay surfaces and target analytes.

Interfering substances can originate from endogenous sources within the sample matrix or external sources introduced during sample processing or assay procedures.

Common interferents include antibodies from host species, heterophilic antibodies, rheumatoid factor, high concentrations of proteins, lipids, and other molecules present in biological samples.

Additionally, environmental contaminants, cross-reactive substances, and assay artifacts can also contribute to assay interference.

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Historical Growth and Course Ahead

Market for immunoassay interference blockers has witnessed substantial historic growth and is poised for continued expansion in the forecast period.

Immunoassay interference blockers have emerged as essential components in molecular diagnostics sector, ensuring the reliability and reproducibility of immunoassays by neutralizing interference from various substances present in biological samples.

Over the years, immunoassay technologies have enabled development of sensitive, high-throughput and specific immunoassay platforms.

The advancements in immunoassay technologies like western blotting, enzyme-linked immunoassay (ELISA), multiplex assays, chemiluminescent immunoassays (CLIA) etc, have propelled the global market for immunoassay interference blockers.

Some of the key factors fueling market growth include innovation and advancement in healthcare infrastructure, especially in emerging economies, integration of AI and ML in immunoassay platforms, and increasing prevalence of chronic and infectious diseases.

The rising demand for precision diagnostics, and personalized medicine, and ongoing R&D efforts aimed at improving the efficacy and specificity of interference blockers also strengthen the growth of market for interference blockers.

Furthermore, regulatory compliance requirements governing medical devices and diagnostics have spurred the development and commercialization of interference blockers.

Over the past decade, several companies have entered the immunoassay interference blockers industry, channelizing their efforts to maximize productivity, flexibility, and throughput capabilities as well as redefine staff productivity.

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Key Growth Drivers

Growing Burden of Chronic Diseases

The market for immunoassay interference blockers is influenced by several factors such as growing incidence of chronic diseases like cancers, autoimmune diseases, and rare diseases.

The increasing clinical applications of interference blockers in the immunoassay-based diagnostic tests to detect specific biomarkers associated with disease progression, treatment response, and prognosis will drive market growth.

  • A population-based study of 22 million people in the UK revealed that autoimmune disorders affect one in every ten individuals, as published in The Lancet (June 2023).

The market for interference blockers is experiencing growth as healthcare providers and researchers seek solutions to mitigate assay interference and improve the diagnostic performance of immunoassays.

By ensuring the specificity and sensitivity of diagnostic tests, interference blockers contribute to more accurate disease diagnosis, better treatment decisions, and improved patient outcomes in the face of the growing burden of chronic diseases.

Increasing Adoption of Immunoassay Techniques

Immunoassays are essential tools in the detection of biomarkers, infectious agents, hormones, and other molecules, making them invaluable in medical diagnosis, drug development, and basic research.

In clinical diagnostics, immunoassays are routinely used for the diagnosis and monitoring of various diseases, including infectious diseases, autoimmune disorders, and hormonal imbalances.

They offer advantages such as rapid turnaround times, ease of use, and scalability, making them ideal for high-throughput screening and routine testing in clinical laboratories.

As immunoassay technologies continue to evolve and expand, the role of interference blockers becomes increasingly critical in supporting the integrity and validity of immunoassay-based assays in diverse scientific and clinical settings.

Factors Impeding the Market

Complexity of Interference Mechanisms

Various endogenous substances like proteins, hormones, and lipids present in biological samples, exogenous medications and assay components interfere with the immunoassay detection methods.

The composition and concentration of these endogenous substances can vary widely among individuals and even within the same individual over time, adding a layer of complexity to interference management.

Further, wide variety of medications available, each with its chemical composition and pharmacological effects, complicates efforts to identify and mitigate potential interference effects.

Such interferences exhibit cross-reactivity with assay components, leading to false positive or false negative results if not adequately addressed.

Addressing these challenges requires a multifaceted approach encompassing rigorous assay design, validation studies, and the development of interference blockers tailored to specific interference mechanisms.

Low FDA Approvals, and High Costs of Molecular Testing

FDA approvals for immunoassay interference blocker kits and reagents are severely deterring the expansion of the global market of immunoassay interference blockers.

Molecular diagnostic reagents including immunoassay interference blocker kits do not have any clinical results on medical usage, thus delays in FDA approvals for the immunoassay interference blockers have created potential complications.

Cost of molecular testing, on the other hand, are unaffordable for various laboratories outside extremely industrialized Western Countries.

Apart from this, consumables and hardware investments are the major cost factors restricting the dissemination of molecular diagnosis in clinical diagnostic laboratories.

The prohibitive cost associated with diagnostic reagents and blocking reagents has played a key role in increasing the usage of immunoassay interference blocker kits.

However, with this high adoption rate, the pricing of molecular testing and blocking reagents must go down to accommodate deficits in the healthcare.

Future Opportunities for Market Players

Rising Demand for Point-of-Care Testing

Interference blockers play a crucial role in ensuring the reliability and accuracy of point-of-care tests by minimizing the impact of interfering substances or factors that may compromise assay performance.

Point-of-care testing offers several advantages over traditional laboratory-based testing, including reduced turnaround times, improved patient satisfaction, and enhanced clinical decision-making.

In POCT environments, where testing is often conducted in less controlled conditions compared to centralized laboratories, the risk of interference from endogenous substances, medications, or environmental factors is heightened.

Interference blockers designed for POCT applications thus must be highly effective in mitigating these interferences while maintaining assay sensitivity and specificity.

As the adoption of POCT continues to expand across various healthcare settings, there arises a corresponding need for interference blockers tailored specifically to these settings, presenting a compelling opportunity for innovation and market growth.

Development of Novel Interference Blockers

Companies around the globe are investing significantly in the research and development activities to undertake innovative approaches to leverage advancements in biotechnology and molecular biology.

The use of monoclonal antibodies and recombinant proteins to develop highly specific blockers or the employment of genetic engineering and nanotechnology to produce blockers with tailored binding affinities and enhanced stability, offers exciting possibilities for interference blockers.

Investments in high-throughput screening technologies, computational modelling and machine learning algorithms is further accelerating the discovery of novel blockers.

This not only enhances diagnostic precision but also builds confidence among healthcare providers and patients, driving the adoption of advanced diagnostic technologies and contributing to better healthcare outcomes.

Category-wise Analysis

Category

Projected CAGR through 2031

Product Category - Antibody Interference Blockers

6.1%

Technique - ELISA

6.0%

Antibody Interference Blockers Represent the Spearheading Segment

The antibody interference blockers segment accounted for more than 45% of the global market revenue in 2023 and is likely to maintain its dominance during in the forthcoming years recording a CAGR of 6.1%.

The targeted approach of antibody interference blockers in ensuring specificity in blocking interference without affecting the binding of the analyte of interest to its capture or detection antibodies makes them the most preferred blockers amongst all the other types.

Further, these blockers provide wide spectrum of interference including endogenous antibodies and exogenous substances, without impacting the sensitivity of the assay.

They can also be utilised in variety of immunoassay formats such as ELISA, western blotting, immunohistochemistry, and others.

All these factors support the growing demand for antibody interference blockers in different experimental setups and applications.

ELISA to be the Most Widely Preferred Technique for Immunoassay-Based Assays

Amongst various techniques used in immunoassay assays, ELISA (enzyme-linked immunoassay) is a widely used technique owed to its ease of use, cost-effectiveness, result accuracy, and high sensitivity. ELISA assays have been extensively validated and standardized for use in clinical laboratories.

Accurate detection and quantification of analytes in low concentration and even in the presence of interfering substances like heterophilic antibodies, or rheumatoid factors.

This makes the technique crucial for making clinical decisions and monitoring disease progression. ELISA technique is estimated to expand at a CAGR of 6.0% in terms of value in the forthcoming years.

Region-wise Analysis

Region

CAGR through 2034

North America

5.8%

East Asia

6.4%

North America’s Significant Revenue Share Prevails

North America is the most significant shareholder in the global market and is expected to grow at a CAGR of 5.8% during the forecast period.

North America market accounts for the notable share owing to the factors such as presence of key players in the region and growing adoption of immunoassay interference blockers across various applications like pharmaceutical research, and clinical diagnostics.

North America has a high prevalence of chronic diseases such as cardiovascular diseases, diabetes, and cancer.

Detection and management of these diseases require detecting biomarkers specific to the disease without the interference of endogenous substances, to understand the disease progression, treatment response and its prognosis.

Interference blockers help block the interference of these substances during the assay procedure.

  • According to the Centers for Disease Control and Prevention 2024, an estimated 129 million people in the U.S. have at least 1 major chronic disease. An increasing proportion of people in America are dealing with multiple chronic conditions; 42% have two or more, and 12% have at least five.
  • Besides the personal impact, chronic disease has a substantial effect on the U.S. healthcare system. About 90% of the annual US$4.1 trillion healthcare expenditure is attributed to managing and treating chronic diseases and mental health conditions.

East Asia Set for an Impressive Growth Rate

East Asia Market is projected to secure a CAGR of 6.4% in the forecast period from 2024 to 2031. Rapid industrialization and urbanization in this region contribute significantly to the immunoassay interference blockers industry development.

China market recorded the significant share in terms of revenue in 2023 owed to the rising incidence of diseases like respiratory diseases, and cardiovascular diseases, and significant investment in the healthcare infrastructure and research and development capabilities, thereby, fostering China's medical diagnostics ecosystem.

Likewise, Japan with a well-established biotechnology and pharmaceutical industry has been focussing on developing innovative medical technologies.

The demand for accurate diagnostic tools has led to the growing demand for immunoassay interference blockers across the academic and research sectors.

Several local players offering immunoassay technology-based services and products including interference blockers, have been catering to the demands domestically, as well as competing with leading players at a global level.

Competitive Landscape Analysis

Collaborations, and partnership to develop innovative products and accelerate their launch across nations are the key growth strategies followed by the key players in the market.

Companies are continuously investing in research and development to introduce innovative and novel interference blockers.

The competition landscape is characterized by the increase in product consolidation activities, including sales and service agreements, collaborations, and rising R&D activities.

New product launches, joint ventures, partnerships, patent transfers, and mergers & acquisitions also remain the major strategic moves of both global and regional players.

Recent Industry Developments

June 2024

Meridian Bioscience, Inc., launched two new 100% animal-free immunoassay interference blockers, K-Block™, and Mouse-Free IgG. These innovative blockers have equivalent or superior performance compared to traditional animal-derived blockers.

May 2024

Bio-Rad Laboratories, Inc. launched new StarBright Red Dyes —StarBright Red 715, 775, and 815 — and an expansion of its StarBright Violet Dye series with 29 additional highly validated antibodies conjugated to StarBright Violet 570, 515, 440, 670, 790, and 475 Dyes.

January 2023

Quantum-Si Incorporated entered a partnership with Aviva Systems Biology, a leading provider of antibody, protein, and immunoassay reagent products with an extensive portfolio of over 20,000 antibodies against more than 15,000 human gene targets.

October 2023

Fapon signed a strategic cooperation agreement with Halodoc, the largest telehealth platform in Indonesia.

This partnership brings together Fapon's expertise in in-vitro diagnostics (IVD) technologies and integrated solutions with Halodoc's strong sales channels and local service provisions.

The partnership aims to enhance the healthcare standards in Indonesia, benefit local communities, and propel the country's IVD industry.

February 2022

Rockland Immunochemicals, Inc. (Rockland), acquired antibodies-online GmbH (antibodies-online). The acquisition combines Rockland's excellence in the design, development, and manufacture of antibodies and assays with antibodies-online's trusted e-commerce brand, broad supplier network, and proprietary technology stack.

September 2021

Aviva Systems Biology, a market leader in antibodies, immunoassay kits, and recombinant proteins for life science research, launched the new Protein on Demand semi-custom recombinant protein portfolio for basic research and preclinical studies.

Report Scope

Attributes

Details

Forecast Period

2024 to 2031

Historical Data Available for

2018 to 2023

Market Analysis

US$ Million for Value

Key Regions Covered

  • North America
  • Europe
  • East Asia
  • South Asia & Oceania
  • Latin America
  • Middle East and Africa

Key Market Segments Covered

  • Product
  • Technique
  • End User
  • Region

Key Companies Profiled in the Report

  • F. Hoffmann-La Roche Ltd
  • Thermo Fisher Scientific Inc.
  • Merck KGaA
  • Surmodics, Inc.
  • Scantibodies Laboratory, Inc.
  • Abcam plc
  • Meridian Bioscience, Inc.
  • Candor
  • Creative Biolabs
  • TOYOBO.inc.
  • Aviva Systems Biology Corporation
  • Rockland Immunochemicals, Inc.
  • Fapon Biotech Inc.
  • Molecular Depot LLC
  • Bio-Rad Laboratories Inc.
  • Biopanda Diagnostics
  • Diagnopal
  • Biosensis Pty Ltd.

Report Coverage

  • Market Forecast and Trends
  • Company Share Analysis
  • Competitive Intelligence
  • DROT Analysis
  • Market Dynamics and Challenges
  • Strategic Growth Initiatives  

Customization & Pricing

Available upon request

Market Segmentation

By Product

  • Antibody Interference Blockers
    • Serum Derived Blockers
    • Heterophilic Blocking Reagents
    • Human Immunoglobulin Blockers
    • Animal Monoclonal Antibody IgG Blockers
    • Animal Polyclonal Antibody IgG Blockers
    • Others
  • Detection Interference Blockers
    • Enzyme Blockers
      • Alkaline Phosphatase Blockers
      • B-Galactosidase Blockers
      • Other Enzyme Blockers
    • Others
  • Surface Interference Blockers
    • Bovine Serum Albumin Blockers
    • Peptide Based Blockers
    • Others

By Technique

  • ELISA
    • Sandwich Immunoassay
    • Antibody Detection Assay
    • Competitive Assay
  • Lateral Flow Assay
  • Western Blotting
  • Chemiluminescent Immunoassay (CLIA)
  • Latex Agglutination Turbidimetric Immunoassay (LTIA)
  • Others

By End User

  • Biotechnology Companies
  • Contract Research Organizations
  • Academic & Research Institutes
  • Clinical Labs and Hospitals

By Region

  • North America
  • Europe
  • East Asia
  • South Asia and Oceania
  • Latin America
  • Middle East and Africa

For report customisation and delivery information contact our sales representative.

Companies Covered in This Report

  • F. Hoffmann-La Roche Ltd
  • Thermo Fisher Scientific Inc.
  • Merck KGaA
  • Surmodics, Inc.
  • Scantibodies Laboratory, Inc.
  • Abcam plc
  • Meridian Bioscience, Inc.
  • Candor
  • Creative Biolabs
  • TOYOBO.inc.
  • Aviva Systems Biology Corporation
  • Rockland Immunochemicals, Inc.
  • Fapon Biotech Inc.
  • Molecular Depot LLC
  • Bio-Rad Laboratories Inc.
  • Biopanda Diagnostics
  • Diagnopal
  • Biosensis Pty Ltd.

Frequently Asked Questions

The increasing incidence of chronic diseases, increasing adoption of immunoassay techniques across diverse applications, and growing demand for healthcare services in emerging nations are surging the demand for immunoassay interference blockers.

Some of the key players operating in the market are F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc., Merck KGaA, Surmodics, Inc., Scantibodies Laboratory, Inc., Abcam plc, Meridian Bioscience, Inc., Candor and Creative Biolabs.

The antibody interference blockers segment recorded a significant market share in 2023.

The need for rapid and accurate diagnostic solutions and growing investments in research and development activities to develop novel blockers are estimated to present opportunities for the market players.

North America is set to account for a significant share of the market.

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