Immunohistochemistry Market Size, Share & Trends

Updated on : September 24, 2024

Overview of the Immunohistochemistry Market

Immunohistochemistry market forecasted to transform from $3.7 billion in 2024 to $5.2 billion by 2029, driven by a CAGR of 7.2%. The increasing number of cancer cases is one of the key factors driving the uptake of IHC products, which, in turn, leads to a greater need for accurate and efficient diagnostic tools such as IHC tests. Additionally, market players have increasingly focused on innovation, including developing new antibodies and manufacturing automated equipment, which enhances the accuracy and efficiency of cancer detection and treatment. Moreover, the adoption of personalized treatment plans is also rising, making it a significant opportunity for market players. However, in situ hybridization, NGS, and RNA sequencing are a few of the alternative technologies challenging the market growth of IHC products, which can limit market growth to some extent.

Immunohistochemistry Market Trends

To know about the assumptions considered for the study, Request for Free Sample Report

Global Immunohistochemistry Market Dynamics

Driver: Adoption of Digital Pathology

Digital pathology uses digital aids to capture images of IHC slides and store and use them for analysis; this helps in observation and interpretation, which results in diagnosis. Digital slides are digital images captured using a slide scanner; these can be remotely analyzed and interpreted by pathologists. Additionally, new algorithms are being developed to automate and speed up the analysis of digital slides. The significant advantages offered are reduced turnaround time, increased archive availability for future reference without the need to maintain physical slides, improvised workflow, and increased focus of pathologists on specialized requirements. The major players offering digital IHC are F. Hoffmann-La Roche AG (Switzerland), Leica Biosystems (Danaher Corporation) (Germany), and Agilent Technologies, Inc. (US).

Governments and industry players globally have focused on various strategies in the field of digital pathology to provide a highly advanced, fast, and accurate diagnosis. Some key developments in this regard have been listed below:

• In June 2024, F. Hoffman La-Roche received 510(k) clearance from the US FDA for the Digital Pathology Dx (VENTANA DP 200) solution. The system helps review and interpret the digital images of scanned pathology slides for disease diagnosis.
• In January 2023, Agilent Technologies, Inc. entered into a strategic partnership with Akoya Biosciences, Inc. to develop end-to-end multiplex IHC diagnostic solutions and commercialized workflow solutions for multiplex assays aiding in biomarker clinical research utilizing digital pathology.
• In June 2022, Roche launched its digital pathology slide scanner system—VENTANA DP 600—to develop digital images of stained tissue samples.

Restraint: Adoption of Alternative Technologies

IHC is a laboratory technique that utilizes antibodies to identify disease-specific antigens (markers) in tissue samples employed in diagnostic and research applications. However, the availability of alternative technologies such as FISH, RNA Sequencing, and NGS for diagnostic and research purposes restrain the growth of the IHC market to a certain extent.

• FISH is a cytogenetic technique that helps identify and visualize specific DNA sequences or chromosomal abnormalities within cells. This method also provides valuable data on DNA amplification at a genetic level for which IHC tests are inconclusive, as while IHC tests help detect protein expression, a direct measurement of gene copy number or gene amplification is not possible with these tests. This technique helps diagnose genetic diseases, map genes, and identify genetic abnormalities, particularly in cancer diagnoses, where IHC alone may be insufficient.
• RNA sequencing, or transcriptome sequencing, is another alternative method to IHC. This method is used to determine the presence and quantity of RNA molecules within a cell, allowing the assessment of gene expression profiles.
• Next Generation Sequencing (NGS) is a parallel sequencing technology that enables high-throughput sequencing of DNA, aiding in a detailed analysis of the genetic composition (nucleotide order) and expression patterns in tissue samples. The technology combined with RNA sequencing methods is used to discover novel RNA variants and splice sites or quantify mRNAs for gene expression analysis. NGS is used for molecular profiling and identifying genetic alterations in tissue samples; it is an alternative to IHC for diagnosing and researching complex genetic conditions.

Thus, the available alternative techniques are expected to restrain the growth of the IHC market to a certain extent.

Opportunity: Growing adoption of companion diagnostics

Companion diagnostics is a test that matches a patient with appropriate therapy using a personalized approach. This test helps identify specific genes or biomarkers for a disease targeted by an associated drug in patients. The co-development of companion diagnostics with therapeutic products can significantly alter the drug development process and commercialize drug candidates by developing safer drugs with enhanced therapeutic efficacy faster and more cost-effectively. The increasing demand for high-priced specialist therapies and safer drugs has led to the growth of the companion diagnostics market. The growing importance of companion diagnostics has also provided growth opportunities for the diagnostics segment and, in turn, the IHC market.

In October 2022, Roche’s PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody received approval from the US FDA; this is the first IHC-based companion diagnostic used to identify metastatic breast cancer patients with low HER2 expression for whom Enhertu (fam-trastuzumab deruxtecan-nxki) can be a viable treatment option. Also, there has been an increasing number of collaborations among diagnostic and pharmaceutical companies for IHC companion diagnostics for improved diagnosis and personalized therapeutic approaches. For instance, in January 2023, AstraZeneca partnered with Thermo Fisher to develop Solid Tissue and Blood-Based companion diagnostic tests for Tagrissio. Such developments support the drug development and approval processes, improve patient outcomes, encourage research collaborations, and drive the growth of the IHC market.

Challenge: Lack of standardization

The IHC technique is mainly used as a diagnostic method and for some research applications. There is a growing demand for IHC products for the diagnosis of chronic indications, especially cancer, due to the increasing adoption of targeted or personalized approaches to cancer therapeutics and an ever-growing incidence of the disease. This increase in cancer incidence has led to a rising need to standardize diagnostic procedures and the products used in these procedures. Standardization in IHC helps achieve consistent, reliable, and reproducible results across laboratories and improves inter-laboratory comparability and clinical utility. It helps compare research, enhance quality control, and ensure regulatory compliance. However, there is an observed lack of standardization in IHC. For instance, IHC equipment used for diagnostic applications requires particular consumables for particular equipment, which need to be bought from specific vendors only. Thus, a lack of standardization restricts the use of any consumable available and could result in less cost-effectiveness or inconvenience for the end user. However, the growing demand for IHC products for diagnostic and research applications is encouraging the market players to standardize their offerings and make them more standardized; this is expected to lower the effect of this challenge.

Immunohistochemistry: Market Ecosystem

The ecosystem of the IHC market includes product providers and end users such as hospitals and diagnostic laboratories, academic & research institutes and contract research organizations, and other end users such as pharmaceutical & biotechnology companies and forensic laboratories. The product suppliers develop, manufacture, and distribute IHC products such as antibodies, reagents, kits, and instruments for diagnosis and research. The market ecosystem for IHC is a complex and dynamic network of players, all working together to advance diagnosis, treatment, and research for various diseases.

The key players in the IHC market are F. Hoffmann-La-Roche Ltd. (Switzerland), Danaher Corporation (US), Agilent Technologies, Inc. (US), Merck KGaA (Germany), Bio-Rad Laboratories Inc. (US), Bio-Techne (US), Thermo Fisher Scientific Inc. (US), and PHC Holdings Corporation (Japan), among others.

Immunohistochemistry Market: Ecosystem Analysis

Source: Annual Reports, SEC Filings, Investor Presentations, Expert Interviews, and MarketsandMarkets Analysis

Based on application, the diagnostic applications segment accounted for the largest market share of the immunohistochemistry industry.

Based on application, the immunohistochemistry market is segmented into diagnostic, research, and forensic applications.

The diagnostic applications segment held the largest market share of the IHC market in 2023 and is projected to register the highest growth rate during the forecast period. Factors such as an increasing incidence of chronic diseases, such as cancer, autoimmune conditions, and neurological disorders, drive the demand for IHC tests for disease diagnosis. IHC tests enable pathologists to differentiate two disease processes by determining the presence or absence of specific proteins, aiding in reliable decision-making; these advantages offered by IHC methods support market growth.

Antibodies accounted for the largest share of the immunohistochemistry industry based on products.

The immunohistochemistry market is segmented into antibodies, reagents, equipment, and kits based on product. In 2023, the antibodies segment accounted for the largest share of the IHC market; this large share can be attributed to the availability of a wide range of catalogs and custom antibodies. Players operating in the IHC market have also focused on innovation and launched novel antibodies offering higher sensitivity, specificity, and accurate outcomes. Moreover, the significance of primary and secondary antibodies in diagnostic applications is also expected to support the segment growth.

Based on end users, the hospitals and diagnostic laboratories segment accounted for the largest market share of the immunohistochemistry industry in 2023.

Based on end users, the immunohistochemistry market is divided into hospitals and diagnostic laboratories, academic & research institutions and contract research organizations, and other end users. In 2023, the hospitals and diagnostic laboratories segment commanded the largest market share; this growth is attributed to a trend toward developing in-house diagnostic capabilities in hospitals, which allows for quicker diagnostics and is supported by improved reimbursement policies. The rising incidence of cancer, autoimmune disorders, and infectious diseases has substantially increased diagnostic testing volumes, further driving the segment growth.

The North American market is projected to register the second-highest growth rate in the immunohistochemistry industry after the Asia Pacific market.

The global immunohistochemistry market is broadly segmented into six major regions: North America, Europe, the Asia Pacific, Latin America, the Middle East, and Africa. North America reported the second-highest growth rate and accounted for the largest market size. The key factors supporting the market in the region are the presence of technologically advanced and well-established diagnostic lab infrastructure and a stronghold of the key players in the region. Additionally, the growing incidence of chronic and infectious diseases further supports the adoption of IHC products for diagnostic applications.

To know about the assumptions considered for the study, download the pdf brochure

The immunohistochemistry market is dominated by a few globally established players, such as F. Hoffman-La Roche Ltd. (Switzerland), Danaher Corporation (US), and Agilent Technologies, Inc. (US). Owing to the changing demands of end users globally, companies have focused on organic and inorganic developments, such as partnerships, product launches, and expansions, to sustain their market positions.

Scope of the Immunohistochemistry Industry:

This report categorizes the immunohistochemistry market to forecast revenue and analyze trends in each of the following submarkets:

By Product

• Antibodies
  • By type
    • Primary antibodies
    • Secondary antibodies
  • By clonality
    • Monoclonal antibodies
    • Polyclonal antibodies
  • Reagents
    • Histological Stains
    • Blocking Sera and Reagents
    • Chromogenic Substrates
    • Fixation Reagents
    • Organic Solvents
    • Proteolytic Enzymes
    • Diluents
    • Other Reagents (Antigen Retrieval Solutions, Stabilizers, Controls, And Mounting Solutions)
  • Equipment
    • Slide-staining Systems
    • Tissue Processing Systems
    • Slide Scanners
    • Other Equipment (Digital Pathology Systems And Histology Equipment, Such As Automated Cover Slippers, Visualization Equipment (Bright-Field, Fluorescence Microscopes), Microtomes, Paraffin Dispensers, Slide Labelers, And Tissue Microarrays)
  • Kits
    • Human Immunohistochemistry Kits
    • Animal Immunohistochemistry Kits
  • Immunohistochemistry Market, by Application
  • Diagnostic applications
    • Cancer
    • Infectious diseases
    • Autoimmune diseases
    • Nephrological diseases
    • Neurological diseases
    • Other diseases (Ophthalmic, Cardiovascular, Dermatological, And Dental Diseases)
  • Research applications
    • Drug Development and Testing
    • Other research applications (Stem Cell Research And Developmental Biology)
  • Forensic applications

By End User

• Hospitals & Diagnostic Laboratories
• Academic Institutions & Contract Research Organizations (CROs)
• Other end users (Pharmaceutical & Biopharma Companies, and Forensic Laboratories)

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Rest of Europe (RoE)
• Asia Pacific (APAC)
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific (RoAPAC)
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East
  • Gcc
    • Saudi Arabia (KSA)
    • United Arab Emirates (Uae)
    • Rest Of GCC
  • Rest Of Middle East
• Africa

Recent Developments of Immunohistochemistry Industry

• In April 2023, Leica Biosystems, a subsidiary of Danaher Corporation (US), received clearance from the US FDA for its BOND MMR Antibody Panel to detect colorectal cancer.
• In January 2023, Agilent Technologies, Inc. (US) partnered with Akoya Biosciences to develop chromogenic and immunofluorescent multiplex assays for IHC diagnostic applications.
• In February 2023, F. Hoffman-La Roche AG (Switzerland) launched the IDH1 R132H (MRQ-67) Rabbit Monoclonal Antibody and the ATRX Rabbit Polyclonal Antibody. Danaher’s BenchMark series of instruments utilizes these antibodies to detect brain cancer.
• In October 2022, F. Hoffman-La Roche AG (Switzerland) received approval from the US FDA for its PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody. These antibodies are used as companion diagnostic tests to identify metastatic breast cancer patients with low HER2 expression that can use Enhertu (fam-trastuzumab deruxtecan-nxki) as a viable treatment option.
• In November 2022, Leica Biosystems Nussloch GmbH, a subsidiary of Danaher Corporation (US), acquired Cell IDx, Inc. Cell IDx is an immunodiagnostic company offering chromogenic and fluorescent multiplex IHC biomarker profiling products.

Frequently Asked Questions (FAQ):

To speak to our analyst for a discussion on the above findings, click Speak to Analyst