Immunohistochemistry (IHC) Market

The global immunohistochemistry market in terms of revenue was estimated to be worth $3.2 billion in 2023 and is poised to reach $4.7 billion by 2028, growing at a CAGR of 7.4% from 2023 to 2028. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. Factors such as burgeoning geriatric population and growing prevalence of cancer diseases, technological advancements in IHC providing diagnostic accuracy and precision, the availability of reimbursement for IHC tests, and adoption of digital pathology are the major factors driving the growth of this market. However, the presence of alternative technologies and high degree of consolidation is expected to restrain the market’s growth during the forecast period. The stringent regulatory requirements for IVD equipments and lack of standardization may also pose a challenge to the growth of this market to a certain extent.

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Immunohistochemistry Market Dynamics

Driver: Adoption of Digital Pathology Fueling Market Growth

Digital pathology systems are increasingly being utilized by healthcare professionals across the globe due to the ongoing trend of automation of diagnostic laboratory processes across major healthcare markets. Digital immunohistochemistry (IHC) integrates traditional IHC staining with digital imaging and analysis tools, facilitating the conversion of stained tissue slides into electronic images that can be remotely accessed, analyzed, and stored, eliminating the reliance on physical slides and enabling efficient collaboration among pathologists and researchers. The advantages of digital pathology application in IHC is that it eliminates physical slide handling and storage, facilitates remote collaboration among pathologists for case sharing and second opinions, enables objective and standardized quantitative analysis of staining, and allows efficient archiving and integration of digital images with other data for comprehensive analysis and research. The major players offering digital IHC are F. Hoffmann-La Roche AG, Leica Biosystems (Danaher Corporation), and Agilent Technologies.

Governments and industry players across the globe are focusing on various strategies in the field of digital pathology to provide a highly advanced, fast, and accurate diagnosis. Listed below are some key developments in this regard:

• In January 2023, Agilent Technologies, Inc. announced a partnership with Akoya Biosciences, Inc. to develop multiplex-immunohistochemistry diagnostic solutions and commercialize workflow solutions for multiplex assays. This partnership will deliver an end-to-end multiplex IHC solution for biomarker clinical research enabled by digital pathology.
• In June 2022, Roche launched VENTANA DP 600 a slide scanner, a digital pathology systems for developing digital images of stained tissue samples.

Restraint: Availability of Alternative Technologies

Although Immunohistochemistry is a widely used technology in pathology for identification of proteins or antigens in tissue samples. There is an availability of alternative advanced technologies that are being used for diagnostic and research purposes some of these are listed below:

• RNA sequencing: RNA sequencing, also known as transcriptome sequencing, is an alternative method to immunohistochemistry (IHC) for analyzing gene expression. It involves determining the sequence and abundance of RNA molecules present in the cell. By sequencing the RNA, researchers can obtain data known as the transcriptome, which provides insights into the activity of all genes within the cell. RNA sequencing allows for a comprehensive assessment of gene expression profiles without the limitations associated with IHC.
• Next Generation Sequencing: NGS is a powerful technology that enables high-throughput sequencing of DNA, allowing for detailed analysis of the genetic composition and expression patterns in tissue samples. It serves as a valuable tool for molecular profiling and the identification of genetic alterations in these samples. Thus, NGS is being considered as an alternative for IHC.
• FISH: FISH is used to identify and visualize specific DNA sequences or chromosomal abnormalities within cells. FISH is particularly valuable in confirming DNA amplifications at the gene level when immunohistochemistry (IHC) results are inconclusive or equivocal. While IHC detects protein expression, it may not provide a direct measurement of gene copy number or gene amplification. In cases where IHC results raise suspicions of gene amplification, FISH is employed to verify and quantify the actual gene copy number. In a study survey by, the College of American Pathologists it was reported that FISH was more precise and accurate than IHC.

Such alternative techniques prove to be a restraint to the IHC market.

Opportunity: Growing significance of companion diagnostics

Companion diagnostics include tests or assays intended to assist healthcare providers in making treatment decisions for patients based on the best response to therapy. The co-development of companion diagnostics with therapeutic products has the potential to significantly alter the drug development process and commercialize drug candidates by yielding safer drugs with enhanced therapeutic efficacy quickly and cost-effectively. With an increase in the demand for high-priced specialist therapies and safer drugs, the market for companion diagnostics has a high growth potential. The growing importance of companion diagnostics is also providing growth opportunities for the diagnostics segment and, in turn, the IHC market. Recently, In October 2022, Roche received approval by US FDA for first IHC based companion diagnostic for PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify metastatic breast cancer patients with low HER2 expression for whom Enhertu (fam-trastuzumab deruxtecan-nxki). Pharmaceutical companies are increasingly collaborating with diagnostic companies to make safer and more effective drugs. For instance, in January 2023, Thermo partnered with AstraZeneca to Develop Solid Tissue and Blood-Based Companion Diagnostic Test for Tagrisso. Also, in January 2020, Amgen entered into strategic collaborations with Guardant Health, Inc. (US) and QIAGEN (Germany) to develop blood- and tissue e-based companion diagnostics (CDx), for investigational cancer treatment AMG 510. Such development for companion diagnostics and the integration of companion diagnostics with IHC is facilitating personalized medicine, supporting drug development and approval processes, expanding market potential, improves patient outcomes, encouraging research collaboration, and providing growth opportunities for Immunohistochemistry Market.

Challenge: Stringent regulatory requirements

The current FDA approval process for tissue diagnostic instruments and consumables is very lengthy and complex. This is a major challenge faced by companies in terms of launching new and innovative products. Some products used for tissue diagnostics belong to Class III (under FDA classification) and require Premarket Approval (PMA) before they can be successfully marketed. PMA evaluates the safety and effectiveness of products and is considered the most rigorous marketing application. Similarly, in April 2017, the European Parliament and the Council of the European Union issued the new Regulation (EU) 2017/746 for in vitro diagnostic medical devices. This resolution will replace the existing In Vitro Diagnostic Devices Directive (IVDD) 98/79/EC, and companies will have 5 years to comply with the new regulations (which are more complex and stringent). Considering these stringent regulations, market players in the Immunohistochemistry will find it challenging to align their processes with stringent requirements, which could temporarily impact the time to market for new products, especially in the US and Europe.

Immunohistochemistry Market Ecosystem

The market ecosystem comprises of product providers and end users such as Hospital and Diagnostic Centers, Academic and Research Institutes, and Other end users such as Pharmaceutical & Biotechnology companies, and CROs. The supplier of IHC products develop, manufacture, and distribute IHC products such as antibodies, reagents, kits, and instruments for applications such as diagnosis, and research. Overall, the market ecosystem for IHC is a complex and dynamic network of different players, all working together to advance diagnosis, treatment, and research for different diseases.

The prominent players of this market are F. Hoffmann-LA-Roche AG (Switzerland), Danaher Corporation (US), Agilent Technologies Inc. (US), Merck KGAA (Germany), Bio-Rad Laboratories Inc.(US), Eagle Biosciences Inc. (US), Biocare Medical LLC. (US), Elabscience Biotechnology Inc. (China), Bio-Genex Laboratories (US), Diagnostic Biosystem (US), Histo-Line Laboratories (Italy), Rockland Immunochemicals Inc. (US), Genemed Biotechnologies Inc.(US), Candoor Bioscience GMBH (Germany), Bio-Techne Corporation (US), Abcam PLC (UK), Becton, Dickinson and Company (US), Perkinelmer Inc. (US), Takara Bio, Inc. (Japan), Thermo Fisher Scientific Inc. (US), PHC Holdings Corporation (Japan), Cell Signaling Technology Inc. (US), Bio SB Inc. (US), Miltenyi Biotech (Germany), Sakura finetek Japan Co., Ltd.(Japan), Enzo Biochem, Inc.(US), and Origene Technologies Inc.(US).

Based on application, diagnostic segment accounted for the largest market share of the Immunohistochemistry market

Based on application, the IHC market is segmented into diagnostic, research, and forensic applications. The Diagnostic application segment dominated this market in 2022 and is estimated to register the highest growth during the forecast period. The growth of this segment is majorly attributed to factors such as the increasing prevalence of chronic diseases, such as cancer, neurological disorders, and autoimmune conditions, has also fueled the demand for diagnostic applications of IHC. Also, the advantages of development of IHC technology over traditional techniques that utilize special enzyme staining techniques that identifies only a limited number of proteins, tissue structures, and enzymes. Due to such reasons IHC has become a crucial technique and is being widely used for medical research as.

Based on product, antibodies segment accounted for the largest market share of the Immunohistochemistry market

Based on product, the IHC market is segmented into antibodies, reagents, equipment, and kits. In 2022, the antibodies segment accounted for the largest share of the IHC market. The large market share of Antibodies product segment can be attributed to the advancements in antibody development and manufacturing techniques which have significantly enhanced the product quality, sensitivity and specificity for application in IHC. There are also multiple product launches and approvals in this segment promoting market growth.

Based on end users, hospitals & diagnostic laboratories segment accounted for the largest market share of the Immunohistochemistry market

Based on end user, the IHC market is segmented into hospitals & diagnostic laboratories, academic & research institutes, and other end users. The hospitals & diagnostic laboratories segment accounted for the largest share of the IHC market in 2022. Factors such as the rising number of in-house diagnostic procedures in hospitals, the growing trend of establishing in-house diagnostic capabilities in hospitals to provide time-bound and affordable patient services, availability of reimbursement, significant increase in the volume of diagnostic testing performed in hospitals and diagnostic labs due to the rising incidence of diseases such as cancer, autoimmune disorders, and infectious diseases.

The Asia Pacific market is projected to register the fastest growth rate for the Immunohistochemistry market

The global immunohistochemistry market is broadly segmented into five major regions—North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. APAC is expected to register the fastest growth rate during the forecast period owing to several factors, including growing disposable income, increasing demand for quality medical care, and expanding investments by pharmaceutical and biopharmaceutical companies. The rising prevalence of chronic ailments, rapidly increasing geriatric population, growing academic and government investments in diagnostic research, and the presence of many market players are the other major factors driving the growth of the immunohistochemistry market in APAC.

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The Immunohistochemistry market is dominated by a few globally established players such as F. Hoffman-La Roche AG (Switzerland), Danaher Corporation (US), and Agilent Technologies, Inc. (US), among others. Major focus was given to the deals, expansions, and new product launches due to the changing requirements of end users across the world.

Immunohistochemistry Market Report Scope

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

By Product

• Antibodies
  • Primary antibodies
  • Secondary 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 (automated cover slippers, visualization equipment, microtomes, paraffin dispensers, slide labelers, and tissue microarrays)
• Kits
  • IHC Kits for Human tissue
  • IHC Kits for Animal tissue

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 & research Institutes
• Other end users (CROs, pharma & 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
  • Rest of Asia Pacific (RoAPAC)
• Rest of the World (RoW)
  • Latin America
  • Middle East and Africa

Recent Developments

• In February 2023, F. Hoffman-La Roche AG (Switzerland) launched IDH1 R132H (MRQ-67) Rabbit Monoclonal Antibody and the ATRX Rabbit Polyclonal Antibody for use in BenchMark series of instrument for detection of brain cancer.
• In October 2022, F. Hoffman-La Roche AG (Switzerland) received US FDA approval for PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody use as companion diagnostic test to identify metastatic breast cancer patients with low HER2 expression.
• In April 2023, Danaher Corporation (US), subsidiary Leica Biosystems received FDA clearance for BOND MMR Antibody Panel, for detection of colorectal cancer.
• In November 2022, Danaher Corporation (US), subsidiary Leica Biosystems Nussloch GmbH acquired Cell IDx, Inc. an immunodiagnostic company offering chromogenic and fluorescent multiplex IHC biomarker profiling products.
• In January 2023, Agilent Technologies, Inc. (US) signed a partnership deal with Akoya Biosciences for developing chromogenic and immunofluorescent multiplex assays. These assays will be used for immunohistochemistry diagnostic solutions.

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