IMMUNOHISTOCHEMISTRY MARKET ANALYSIS

Market Size and Trends

The immunohistochemistry market is estimated to be valued at USD 2.88 Bn in 2024 and is expected to reach USD 4.49 Bn by 2031, growing at a compound annual growth rate (CAGR) of 6.5% from 2024 to 2031.

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The immunohistochemistry market is expected to witness high growth over the forecast period. The major factor driving the growth of this market includes the increasing prevalence of chronic diseases like cancer and cardiovascular diseases. Immunohistochemistry tests are widely used for cancer diagnosis and prognosis. Moreover, technological advancements in this field such as the development of fully automated immunohistochemistry staining systems and digital pathology are expected to provide new growth opportunities for market players. However, highly complex procedural requirements and expensive instrumentation hamper the growth of this market.

Rising Demand for Personalized Medicine

The field of personalized medicine has made enormous progress in recent years. Scientists are gaining deeper understanding of how a person's genetics can impact diseases and treatment outcomes. By studying biomarkers like proteins, physicians can gain valuable insights into what treatment approach may work best for each individual patient. This momentum toward tailored healthcare is driving strong demand for immunohistochemistry testing. Testing tumor tissue samples through immunohistochemistry (IHC) staining allows doctors to examine the presence of specific biomarkers. This reveals whether certain targeted therapies may be effective or whether a patient is likely to respond poorly to a standard treatment approach. As personalized medicine becomes more prevalent, immunohistochemistry is playing a critical role in helping physicians develop personalized care plans and choose the most appropriate intervention for each patient. The ability to analyze patient samples and identify biomarker expressions is fueling the tailoring of treatments at the molecular level. More healthcare organizations are incorporating IHC into standard practice to facilitate data-driven clinical decision making on a personalized basis.

Market Concentration and Competitive Landscape

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Market players are actively focusing on partnerships and collaborations, which is expected to drive the growth of the global immunohistochemistry market over the forecast period. For instance, in January 2021, Diaceutics PLC, a company that offers diagnostic tracking, laboratory mapping, testing, and other services, announced a strategic partnership with Canadian Pathology Quality Assurance, a non-profit organization, in order to boost the development of Neurotrophic Tropomyosin Receptor Kinase (NTRK) IHC proficiency testing.

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The immunohistochemistry market faces several challenges. Technological advancement in pathology diagnostics has allowed for new techniques like in-situ hybridization to emerge, providing alternatives to IHC. Stringent regulations surrounding tissue sample handling and antibody specificity require extensive validation. This increases costs and regulatory hurdles for new market entrants. Additionally, the high cost of instruments like automated stainers limits their adoption in low resource settings. Stringent reimbursement policies also impact the pricing and uptake of IHC tests in some countries.

Market Opportunities: Aging population prone to age-related diseases

The rising global incidence of cancer and other chronic diseases is driving increased demand for precision diagnostics using IHC biomarkers. Furthermore, an aging population prone to age-related diseases will require more diagnostic testing. Newly discovered protein biomarkers continue to expand the clinical applications of IHC. Automation and multiplex assays promise to increase throughput and lower turn thus, creating lucrative opportunities for market growth over the forecasted period.

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The product segment includes antibodies, reagents, equipment, and kits. Antibodies segment is anticipated to hold 45.9% of the market share in 2024. Antibodies offer exquisite specificity allowing detection of myriad antigens with high sensitivity. Their development has enabled detection of previously unknown biomarkers facilitating new discoveries. Continued focus on generating novel monoclonal and polyclonal antibodies against emerging targets will further empower diagnostics and research. Antibodies maintain dominance through constant refinement. Hybridoma technology and recombinant techniques yield antibodies with improved affinity and specificity. Developments in humanization reduce immunogenicity enhancing applications. Synthetic libraries and platforms like phage display cultivate antibodies against challenging epitopes. Conjugation to labels intensifies detection across multiple techniques from IHC to flow cytometry. Overall, antibodies uphold leading market share through customization meeting evolving needs.

Insights, By Application: Growing Demand for Clinical Purposes drives diagnostics growth

The application segment includes diagnostics, research, and others. Diagnostics contributes the highest share of the immunohistochemistry market and is projected to hold 57.8% of the market share in 2024. IHC aids definitively diagnosing cancers with prognostic and predictive value. It distinguishes tumor subtypes guiding targeted therapies. IHC accurately stages tumors and detects minimal residual disease assessing prognosis and surveillance. These capabilities are crucial for management decisions. Rising cancer incidence amid aging populations intensifies the clinical impetus. IHC conveniently performs on small biopsies or cytology specimens when tissue is limited. It provides definitive results where other techniques may be non-diagnostic. Automation and digital pathology make IHC high-throughput and quantifiable, meeting workload pressures. Standardization of protocols and companion diagnostics have bolstered reliability and regulatory acceptance. Such attributes cement the role of IHC in maximizing patient outcomes fueling the diagnostics segment growth.

Insights, By End User: Increase in the number of retail diagnostics centres

The end user segment includes hospitals, diagnostics laboratories, academic & research institutes, and others. Diagnostics laboratories contributes the highest share of the immunohistochemistry market and is projected to hold 44.2% of the market share in 2024. Laboratories maintain extensive staining platforms and boarded anatomical pathologists for expert sign-out. They process large test volumes economically through automation and efficiency gains. Reference labs additionally offer specialized multiplex assays beyond local hospital capabilities. Research and academic centers utilize IHC but focus lies elsewhere. Cost-containment and lack of reimbursement restrict hospital adoption. Conversely, diagnostic labs thrive on IHC revenues through contracts with pathology groups and payors. Strong reference lab networks ensure global reach. Robust infrastructure and analytics capabilities position labs to develop novel multiplex assays. Their specialization and economies of scale drive consolidation retaining market primacy.

Regional Insights

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North America has established itself as the dominant regional market for immunohistochemistry globally and is anticipated to hold 43.9% of the market share in 2024. The presence of leading life sciences companies and research organizations in the U.S. and Canada is a major factor contributing to North America's prominent position. Several biopharmaceuticals giants have their headquarters in the region and invest heavily in R&D for drug development and diagnostic solutions. This has promoted widespread adoption of immunohistochemistry techniques across academic and industrial laboratories. Moreover, North America has a highly developed healthcare infrastructure and greater accessibility to advanced diagnostic procedures. This has further augmented the demand for immunohistochemistry in the region from hospital-based clinical applications.

Asia Pacific has emerged as the fastest growing regional market for immunohistochemistry in recent years. Nations such as China, India, Japan, and South Korea offer immense opportunities due to their large population bases and improvements in healthcare spending and services. Rising awareness regarding the early detection of cancer and other chronic diseases has increased the uptake of immunohistochemistry testing in Asia Pacific. Additionally, the presence of prominent generic drug manufacturers has attracted immunohistochemistry kit manufacturers to expand their reach in the region through supply agreements. This ensures steady product supply and cost competitiveness, making testing more affordable. Geopolitical relations have also favored technology transfers and localization of kit production in high growth Asian economies. Together, these factors are fueling the Asia Pacific immunohistochemistry market's rapid expansion.

Market Report Scope

Key Developments

• On January 5, 2024, Biocare Medical, a leader in fully open automated instrumentation, announced a collaboration with Molecular Instruments (MI), the inventor of HCR imaging technology. This partnership combines Biocare Medical's expertise in automated bioimaging systems with MI's sophisticated HCR products, establishing a new standard for automated in situ hybridization (ISH) and immunohistochemistry (IHC).
• In November 2023, Biocare Medical announced its latest product, the Antigen Retrieval Chamber (ARC). ARC is designed for Heat-Induced Epitope Retrieval (HIER) with in vitro diagnostic (IVD) labeling, ensuring precision and consistency. Recognizing the importance of precise heat, pressure, and buffer solutions, ARC is critical for reproducible immunohistochemistry (IHC) and in situ hybridization (ISH) labeling.
• In July 2023, ImmunoChemistry Technologies, a privately-held biotechnology company, announced that the company now offers Immunohistochemistry (IHC) reagents. ImmunoChemistry Technologies offers a wide range of IHC products, including antigen retrievers, blocking reagents, buffers, counter stains, chromogens, and mounting media.
• In March 2021, Roche, a multinational healthcare company, announced the launch of the DISCOVERY Green HRP kit, the latest addition to its extensive array of modular-based detection kits for identifying and profiling biomarkers and cell types in tissue-based research. The DISCOVERY Green HRP (horseradish peroxidase) kit can be used in conjunction with other detection kits to increase the multiplexing capabilities of immunohistochemistry (IHC) and in situ hybridization (ISH).

*Definition: The immunohistochemistry market involves medical instruments and reagents used to identify antigens or biomarkers in cells and tissues. Immunohistochemistry utilizes antibodies to target biomarkers and allows pathologists to examine disease progression. This growing market provides antibodies, reagents, equipment like slides, tissue processors, and stains that help researchers and medical professionals detect cancer, autoimmune diseases, infectious diseases, and other biomarkers through staining and visualizing tissues under a microscope. Immunohistochemistry plays a vital role in disease diagnosis and treatment development.

Market Segmentation

•  Product Insights (Revenue, USD BN, 2019 - 2031)
  • Antibodies
    • Primary Antibodies
    • Secondary Antibodies
  • Reagents
    • Proteolytic Enzymes
    • Fixation Reagents
    • Histological Stains
    • Diluents
    • Others
  • Equipment
    • Slide-staining systems
    • Tissue Processing Systems
    • Slide Scanners
    • Other Equipment
  • Kits
•  Application Insights (Revenue, USD BN, 2019 - 2031)
  • Diagnostics
    • Cancer
    • Infectious Diseases
    • Autoimmune Diseases
    • Neurological Diseases
    • Others Diseases
  • Research
  • Others
•  End User Insights (Revenue, USD BN, 2019 - 2031)
  • Hospitals
  • Diagnostics Laboratories
  • Academic & Research Institutes
  • Others
• Regional Insights (Revenue, USD BN, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Merck KGaA
  • Rockland Immunochemicals Inc.
  • F. Hoffmann-La Roche Ltd
  • Thermo Fisher Scientific
  • PerkinElmer Inc.
  • Bio-Rad Laboratories Inc.
  • Cell Signaling Technology Inc.
  • Bio SB
  • Agilent Technologies Inc.
  • Abcam plc.
  • Becton Dickinson and Company
  • Miltenyi Biotec
  • Biocare Medical LLC
  • Eagle Biosciences Inc.
  • Bio-Techne
  • Diagnostic Biosystems Inc.
  • BioGenex.