$5.1 Billion Histology and Cytology In Vitro Diagnostics (IVD) Market, reports Kalorama Information

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The global histology IVD market grew 23.5% from 2020 to 2021 reflecting strong rebounding after the market experienced negative effects from the COVID-19 pandemic during 2020. Further growth is estimated in 2022.

2021 was a fast growth year for the histology and cytology IVD market.

The market for the testing of tissues and cells, histology and cytology in vitro diagnostics reached $4.9 billion in 2021 per market research firm Kalorama Information and is expected to grow to $5.1 billion in 2022. Last year, 2021 was a fast growth year for the market. The global histology IVD market grew 23.5% from 2020 to 2021 reflecting strong rebounding after the market experienced negative effects from the COVID-19 pandemic during 2020. The market stabilized from COVID and now Kalorama Information analysts expect a 4.2% CAGR.

Kalorama Information made the finding in its report Histology and Cytology IVD Market Update.

Histology and cytology are the study of tissue (and cells, respectively). Histological or tissue analysis involves a two-step procedure: preanalytical sample preparation and advanced staining. Sputum, cervical and synovial fluids, and bits of tissue that have been biopsied or surgically removed are processed, placed on glass slides, and stained to characterize targeted cellular constructions, tissue morphology and cell components. Trained technologists perform a first pass screen of the stained slides. Pathologists further investigate tumor section slides and others that are found to have suspicious or aberrant cells. The tests are used primarily to detect cancer and infectious agents in tissue and cervical fluid, but the reader is reminded that every organ or piece of tissue removed from a patient during surgery is also processed and analyzed in this two-step procedure.

Physicians diagnose the majority of cancer cases through identification of a tumor’s source, be it cancer of the liver, lungs, or kidney and so on. However, in many cases, the pathologist may confirm a patient’s cancer diagnosis while being unable yet to find a source. They will then use a battery of test techniques including in situ hybridization (ISH), immunohistochemistry (IHC), immunofluorescence (IF), and molecular analysis of tumor cells, a toolkit of strategies to improve diagnosis in difficult cases.

Histology reagents and instruments can be segmented in the main categories shown below. All of these techniques involve analyzing cells either in surgical and biopsied tissue (histology) or body fluids (cytology). This includes traditional tissue stains, Pap tests, immunohistochemical stains, in situ hybridization staining (ISH), HPV tests.

Immunohistochemical (IHC) stains, initially the primary technique in histological diagnosis and analysis, use fluorescent and colorimetric labeled antibodies to detect enzymes, proteins and other analytes in tissue; over time, new, improved methodologies were developed, such as in situ hybridization and more specifically fluorescent in situ hybridization (FISH) techniques, which use DNA probes to detect pathogens and molecular structures in cells. These techniques provide pathologists and clinicians with gene and protein patterns to aid in distinguishing cell attributes that demonstrate their virulence for disease progression and sensitivity to specific therapeutics.

Traditional stains used on all types of formalin fixed, paraffin embedded tissues and fluids make up the most mature area in this market. The most widely used stain is the hematoxylin & eosin (H&E) stain used to provide a general overview of tissue structures and cells. Hematoxylin, a basic dye, stains nuclei blue due to an affinity to nucleic acids in the cell nucleus; eosin, an acidic dye, stains the cytoplasm pink. There are hundreds of various other techniques that have been used to selectively stain cells and cellular components. The most widely used special stains include Congo red, elastin, Feulgen, giemsa, Gomori, iron, Masson, PAS (periodic acid schiff) and reticulin.

Vendors in the space include:

  • BioMeda
  • Biosource
  • Dako/Agilent
  • Immunon
  • Ortho Clinical Diagnostics
  • Roche/Ventana
  • Siemens Healthcare
  • Sigma Aldrich
  • Spectrum

About Kalorama Information:
Kalorama Information, part of Science and Medicine Group, is the leading publisher of market research in healthcare areas, including in vitro diagnostics (IVD), biotechnology, medical devices, and pharmaceuticals. Science and Medicine Group supports companies seeking to commercialize the rapidly changing marketplace at the intersection of science, medicine, and technology. Comprised of industry-leading brands, Science and Medicine Group serves analytical instrument, life science, imaging, and clinical diagnostic companies by helping them create strategies and products to win markets and provide platforms to digitally engage their markets through a variety of innovative solutions. Kalorama Information produces 30 reports a year. The firm offers a Knowledge Center, which provides access to all published reports.

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