logo
 

In Vitro Diagnostics: Key Statistics

The In Vitro Diagnostics (IVD) industry had an estimated $61B in market revenue in 2016 and grew at a 5-year CAGR of 5% from 2012-2017.[i] This article focuses on the key vocabulary and major statistics of the IVD industry.[ii]


Industry Jargon & Key Terms

  • Reagent: A substance or compound added to a system to cause a chemical reaction or added to test if a reaction occurs.
  • Assays: An investigative (analytic) procedure in laboratory medicine, pharmacology, environmental biology and molecular biology for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a target entity (the analyte).
  • Point of Care Testing (POCT): POCT testing refers to medical diagnostic testing at or near the point of care, or at the time and place of patient care. Seen as more convenient and helpful in making quicker decisions, POC has grown quickly in the past years. Generating about $18B annually in revenue, POC represents about 30% of the IVD market.[iii]
  • Molecular Diagnostics: Using techniques such as DNA (deoxyribonucleic acid) microarray analysis, mass spectrometry and nucleic acid amplification in order to make rapid diagnoses, Molecular Diagnostics is the fastest growing vertical of the IVD industry. Growing at a 3-year CAGR of 14%, Molecular Diagnostics generated $6B in market revenue in 2016.[iv]
  • Immunoassays: A biochemical test that measures the presence or concentration of a macromolecule or a small molecule in a solution through the use of an antibody (usually) or an antigen (sometimes). Representing about 22% of the IVD market, Immunoassay testing and equipment produces about $13B in revenue.[v]
  • Flow Cytometry: A laser-based, biophysical technology employed in cell counting, cell sorting, biomarker detection and protein engineering, by suspending cells in a stream of fluid and passing them through an electronic detection apparatus. A flow cytometer allows simultaneous multiparametric analysis of the physical and chemical characteristics of up to thousands of particles per second.
  • Haematology: The study and analysis of blood to diagnose and treat illnesses
  • Haemostasis: A branch of the Haematology field that focuses on the body’s normal physiological response for the prevention and stopping of bleeding/haemorrhage.
  • Clinical Chemistry: An applied form of biochemistry that analyzes bodily fluids for diagnostic and/or therapeutic purposes.
  • 510(k) Pre-Market Notifications (PMN): A 510(K) is a “premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval.”[vi]

 

  • Premarket Approval Pathway (PMA): Premarket approval (PMA) is the FDA “process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. A PMA application must be submitted if the device cannot be cleared through the 510(k) premarket notification procedures. The PMA process is much more demanding than the 510(k) premarket notification process and is the most stringent type of device marketing application required by FDA.”[vii]
  • Quality System Regulation (QSR): Requires manufacturers to follow design, testing, control, documentation and other quality assurance procedures during the manufacturing process.[viii]
  • Geriatric: Relating to an older or aging person, particularly in reference to their health care.

Key Transaction Data

Key Valuation Multiples

Key Efficiency Ratios

Key Liquidity & Leverage Ratios


Key Profitability Ratios

[i] Abha Thakur, IVD Market by Product Type (Reagents, Instruments and Software & Services), by Technique (Immunodiagnostics, Blood Testing, Molecular Diagnostics, Tissue Diagnostics, Clinical Chemistry, and Other IVD Techniques), by Application (Infectious Diseases, Cancer, Cardiac Diseases, Immune System Disorders, Nephrological Diseases, Gastrointestinal Diseases, and Other Indications), and by End Users (Standalone Laboratory, Hospitals, Academic and Medical Schools, Point of Care Testing, and Others) – Global Opportunity Analysis and Industry Forecast, 2017-2023 Allied Market Research, https://www.alliedmarketresearch.com/ivd-in-vitro-diagnostics-market (last visited Dec 18, 2017).

[ii] In Vitro Diagnostics (IVD) Market Outlook To 2024: In-Depth Market View, Key Product & Service Categories (Reagents & Kits, CT, Instruments, Softwares, Services), Application (Diabetes, Infectious Diseases, Oncology, Cardiology, Nephrology, HIV/Ads, Autoimmune Diseases, Drug Testing/Pharmacogenomics), Regional Segmentation, Top Players & Company Share, Competitive Dynamics, Growth Drivers & Restraints, M&A Insights, Segment Forecast And Key Conclusion, Ameri Research Inc. (2017), https://www.ameriresearch.com/product/vitro-diagnostics-ivd-market-outlook-2024-depth-market-view-key-product-service-categories-reagents-kits-ct-instruments-softwares-services-application-diabetes-infectious-dis/ (last visited Jan 12, 2018).

[iii] Chantal Morel, Overview of the diagnostics market Ensuring innovation in diagnostics for bacterial infection: Implications for policy [Internet]. (2016), https://www.ncbi.nlm.nih.gov/books/NBK447315/ (last visited Dec 18, 2017).

[iv] Chantal Morel, Overview of the diagnostics market Ensuring innovation in diagnostics for bacterial infection: Implications for policy [Internet]. (2016), https://www.ncbi.nlm.nih.gov/books/NBK447315/ (last visited Dec 18, 2017).

[v] Chantal Morel, Overview of the diagnostics market Ensuring innovation in diagnostics for bacterial infection: Implications for policy [Internet]. (2016), https://www.ncbi.nlm.nih.gov/books/NBK447315/ (last visited Dec 18, 2017).

[vi] 510(k) Premarket Notification, accessdata.fda.gov, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm (last visited Feb 8, 2018).

[vii] Center for Devices and Radiological Health, Premarket Approval (PMA) U S Food and Drug Administration Home Page, https://www.fda.gov/medicaldevices/deviceregulationandguidance/howtomarketyourdevice/premarketsubmissions/premarketapprovalpma/ (last visited Feb 8, 2018).

[viii] Jack Curran, IBISWorld Industry Report 33911a Medical Instrument & Supply Manufacturing in the US, IBIS World US 30–35 (2017), http://clients1.ibisworld.com/reports/us/industry/operatingconditions.aspx?entid=881 (last visited Jan 29, 2018).

[ix] PitchBook data found searching the following keywords: “in vitro diagnostics” or “ivd” or “point-of-care testing” or “blood testing device” or “point-of-care diagnostics” or “blood diagnostic” or “point-of-care diagnostic” or “vitro diagnostic” or “point-of-care device” or “diagnostics test” or “cancer diagnostic” or “clinical diagnostic” or “disease detection” or “disease diagnostics” or “blood testing system” or “diagnostic reagents” or “research diagnostics” or “clinical diagnostics” or “molecular detection” or “clinical chemistry” or “molecular diagnostics” or immunoassay or flow cytometry or haemostasis or hematology or coagulation or histology or “research reagents” or “reagent systems”

[x] PitchBook data based on a proxy market composed of the following data: Abbott, Alere, Becton Dickinson, Danaher, Roche, Siemens, Thermo Fisher, Sysmex, Illumina, Myriad Genetics, Qiagen, Luminex, BioMerieux, Diasorin

[xi]PitchBook data based on a proxy market composed of the following data: Abbott, Alere, Becton Dickinson, Danaher, Roche, Siemens, Thermo Fisher, Sysmex, Illumina, Myriad Genetics, Qiagen, Luminex, BioMerieux, Diasorin

[xii]PitchBook data based on a proxy market composed of the following data: Abbott, Alere, Becton Dickinson, Danaher, Roche, Siemens, Thermo Fisher, Sysmex, Illumina, Myriad Genetics, Qiagen, Luminex, BioMerieux, Diasorin

[xiii]PitchBook data based on a proxy market composed of the following data: Abbott, Alere, Becton Dickinson, Danaher, Roche, Siemens, Thermo Fisher, Sysmex, Illumina, Myriad Genetics, Qiagen, Luminex, BioMerieux, Diasorin

William Montgomery contributed to this report.

Nate Nead on LinkedinNate Nead on Twitter
Nate Nead
Nate Nead is a licensed investment banker and Principal at Deal Capital Partners, LLC which includes InvestmentBank.com and Crowdfund.co. Nate works works with middle-market corporate clients looking to acquire, sell, divest or raise growth capital from qualified buyers and institutional investors. He is the chief evangelist of the company's growing digital investment banking platform. Reliance Worldwide Investments, LLC a member of FINRA and SIPC and registered with the SEC and MSRB. Nate resides in Seattle, Washington.