Immunohistochemistry Market Size: Global Industry Analysis, Trends, Growth, Market Share and Forecast to 2029

Immunohistochemistry (IHC) is a technique used in biological research and diagnostics to visualize the presence, localization, and abundance of specific proteins within tissue samples. IHC is an invaluable tool in the field of pathology for diagnosing diseases (e.g., cancer, infections), understanding cellular functions, and developing targeted therapies. The key products commonly used in IHC are primary & secondary antibodies, detection kits, blocking reagents, antigen retrieval solutions, mounting media, control tissues, and slide stainers & imaging systems. IHC has a wide range of applications across various fields of research, diagnostics, and drug development. Some of these applications include biomarker discovery, cellular localization, neuroscience research, infectious disease research, and clinical trials, among others. Further, its ability to provide spatial and qualitative information on protein expression make it an essential tool in biomedical research and clinical practice.

Launch of novel IHC reagents and platforms to fuel its demand

Continuous advances in IHC have enabled to develop efficient and easy-to-use tests with advanced features such as AI-powered solutions, increased reproducibility, high throughput capability, ability to identify patients for targeted therapies, quick turnaround time, and improved accuracy. Such advancements tend to provide competitive edge to manufacturers and therefore, major players are continuously focusing on new product development to strengthen their positions in this high growth market. Some of the technological advancements are listed below:

• In October 2023, Bio SB, Inc., a cancer diagnostics company launched its new robotic and automated platform to process cancer biopsies using IHC. Featuring its patented sweeping cap gap reagent motion technology, the platform helps to predict how to treat cancer using personalized medicine
• In September 2023, Ibex Medical Analytics launched its Galen Breast HER2, an AI-powered HER2 IHC scoring solution. Developed in collaboration with AstraZeneca and Daiichi Sankyo, Galen Breast HER2 enables detection of invasive tumor areas and quantifies HER2 expression into four standard categories supporting patient identification for targeted therapies
• In September 2023, Cell Signaling Technology (CST), a provider of antibodies, kits, and services launched its SignalStar Multiplex IHC technology, a new tool for spatial biology research. The new tool uses mid-plex and high-throughput IHC assays, to amplify the antibody signals and detect targets with low expression levels
• In March 2023, Aptamer Group launched a new reagent, Optimer-Fc, an antibody alternative, for use in automated IHC workflows. This reagent enables life science researchers to pursue novel and existing disease biomarkers, offering increased accuracy in detection
• In November 2022, F. Hoffmann-La Roche Ltd received the US Food and Drug Administration (FDA) approval for the first IHC companion diagnostic test- VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, to identify epithelial ovarian cancer (EOC) patients eligible for targeted treatment with ELAHERE, an antibody-drug conjugate (ADC) therapy
• In January 2021, Biocare Medical, LLC, unveiled its fully automated and in vitro diagnostic (IVD) labeled staining platform ONCORE Pro for IHC and ISH applications. Having the ability to processes up to 36 slides in a single run, the platform enables diagnostic laboratories to maximize their throughput of sample processing with optimum turn-around-time

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Increasing partnerships to develop novel technologies to boost adoption

High growth of the IHC market has attracted a lot of interest among market players to undertake research partnerships for the development of novel technologies as well as increase the applications further enhancing the adoption of this technology for research as well as clinical applications. Some of the these are listed below:

• In August 2023, Visiopharm and Boston Cell Standards entered into a partnership to co-develop IHC technology by integrating IHC calibration standards with AI-driven image analysis software for quality assurance. This development is intended to meet regulatory guidelines and protocols by diagnostic laboratories including reference standards, assay calibration, and quantitative controls
• In June 2023, Mindpeak, a provider of AI for pathology, partnered with Proscia, a provider of digital and computational pathology solutions to broaden access to advanced cancer diagnostic technologies by integrating CE-IVD algorithms for IHC quantification with Proscia’s CE-IVDR Concentriq Dx software platform, further delivering tightly integrated AI-powered workflows for more efficient, informed, and reproducible clinical decisions
• In June 2023, Lunaphore and Cell Signaling Technology (CST) entered in a partnership to use CST’s over 1,700 IHC-validated antibodies on Lunaphore’s COMET platform, allowing researchers to develop antibody panels within limited timelines
• In February 2023, F. Hoffmann-La Roche Ltd expanded its collaboration with Janssen Biotech Inc. to strengthen research and innovation activities by creating companion diagnostics for targeted therapies including tissue and blood-based biomarkers, sequencing, and digital pathology. The collaboration is aimed at advancing personalized healthcare with multiple companion diagnostics technologies, including IHC
• In January 2023, Agilent Technologies, Inc. entered into a partnership with Akoya Biosciences, Inc. for the development and commercialization of multiplex-IHC diagnostic solutions for tissue analysis. This partnership is aimed at integrating its Dako Omnis (autostaining instrument) with Akoya’s PhenoImager HT (imaging platform) to develop end-to-end commercial solution, including reagents, staining, imaging, and analysis

North America expected to hold a major share in the IHC market

From a geographical perspective, North America holds a major market share of the IHC market. This can be mainly attributed to the increased adoption of advanced IHC instruments, growing number of clinical studies in the region, well-established healthcare infrastructure, presence of major market players supporting development of novel technologies, and increased prevalence of chronic diseases. According to American Cancer Society, in 2024, over 2 million new cancer cases and 611,720 cancer deaths are projected to occur in the US as compared to 1.9 million new cases and 609,360 cancer deaths in 2022, reflecting a considerable increase in the prevalence of cancer. Additionally, launch of advanced IHC instruments and reagents by manufacturers and expanding customer reach by laboratories has further resulted in the high adoption of IHC in the region.

Irrespective of the challenges such as stringent regulatory requirements, lack of standardization, presence of alternative technologies, and high cost of instruments; the global IHC market has high potential to grow at a steady rate and is expected to gain further momentum in the coming years due to a strong emphasis on developing novel technologies such as AI integration & multiplexed IHC, ongoing trend of laboratory automation, high growth of the companion diagnostics market, and rising research activities, among others.

Competitive Landscape

Some of the key players operating in the market are Thermo Fisher Scientific, Inc.; F. Hoffmann-La Roche Ltd.; Merck KGaA; Bio-Rad Laboratories, Inc.; Danaher Corporation; PerkinElmer, Inc.; Becton, Dickinson and Company; among others.

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Key Strategic Questions Addressed

• What is the market size & forecast of the immunohistochemistry (IHC) market?

• What are historical, present, and forecasted market shares and growth rates of various segments and sub-segments of the immunohistochemistry (IHC) market?

• What are the key trends defining the market?

• What are the major factors impacting the market?

• What are the opportunities prevailing in the market?

• Which region has the highest share in the global market? Which region is expected to witness the highest growth rate in the next 5 years?

• Who are the major players operating in the market?

• What are the key strategies adopted by players?