In-vitro Diagnostics Enzymes Market Size, Share & Trends Analysis Report By Enzyme Type (Polymerase & Transcriptase, Proteases), By Disease Type, By Technology Type, By End-use, By Region- Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2023-2032

The global in-vitro diagnostics enzymes market size was exhibited at USD 2.26 billion in 2022 and is projected to hit around USD 5.33 billion by 2032, growing at a CAGR of 8.98% during the forecast period 2023 to 2032.

in-vitro diagnostics enzymes market size

Key Pointers:

  • North America occupied the largest share of 43.76% in 2022 
  • Asia Pacific is anticipated to be the fastest-growing regional market over the forecast period
  • Polymerase and transcriptase accounted for the largest revenue share of 32.5% in 2022
  • Infectious disease accounted for the largest revenue share of 30.1% in 2022.
  • Histology assays dominated the IVD enzymes market with a revenue share of 47.1% 
  • The hospitals and diagnostic laboratories segment dominated the market with a share of 41.9% in 2022.
  • The academic labs segment is expected to expand at the fastest CAGR from 2023 to 2032. 

In-vitro Diagnostics Enzymes Market Report Scope

Report Coverage Details
Market Size in 2023 USD 2.46 Billion
Market Size by 2032 USD 5.33 Billion
Growth Rate From 2023 to 2032 CAGR of 8.98%
Base Year 2022
Forecast Period 2023 to 2032
Segments Covered Enzyme type, Disease type, Technology type, End-use
Market Analysis (Terms Used) Value (US$ Million/Billion) or (Volume/Units)
Regional Scope North America; Europe; Asia Pacific; Central and South America; the Middle East and Africa
Key Companies Profiled Merck KGaA; Codexis, Inc.; F. Hoffmann-La Roche Ltd.; Amano Enzyme Inc.; Advanced Enzymes Technologies Ltd.; Biocatalysts Ltd.; Amicogen; Dyadic International; BBI Solutions; Affymetrix; American Laboratories

 

Accurate and rapid diagnosis and treatment of clinical disorders are essential for optimal clinical outcomes. Owing to the noteworthy biocatalytic properties, enzymes are used in the diagnosis of a wide range of diseases.

The development of enzyme biosensors has increased the enzyme utility in clinical diagnostics. Despite the necessity in clinical diagnosis, the commercialization and translation of biosensors from research to clinics are still low. However, with an increase in R&D efforts, lactate, cholesterol, and glucose biosensors have been commercialized for diagnostic use.

Proteases are important signaling proteins that are critical to a few pathological processes, including cancer, neurological, inflammatory, and cardiovascular disorders. Polymerase and transcriptase enzymes are expected to exhibit the fastest CAGR over the forecast period. In addition, the presence of a substantial number of players that offer these enzymes is expected to enhance the growth. Key players such as Kaneka Eurogentec S.A.; Toyobo Co., Ltd.; and Sekisui Diagnostics, LLC manufacture and distribute a wide range of polymerases, including KOD DNA Polymerase, Taq DNA Polymerase, Tth DNA Polymerase, and TTx DNA Polymerase.

The infectious disease segment dominated the market in 2019. An exponential rise in the COVID-19 cases globally drives the adoption rate of diagnostic enzymes for COVID-19 diagnosis. An increase in the availability of qualitative and quantitative molecular assays based on real-time PCR, Loop-mediated Isothermal Amplification- PCR (LAMP-PCR), multiplex PCR, and digital PCR technologies for the diagnosis of infectious diseases drives the demand for enzymes in this segment.

Enzymatic immunohistochemistry (IHC) is preferred for histology owing to a better contrast ratio and the method’s compatibility for use with multiple stains for the detection of target components. IVD enzymes are employed in different end-use settings for the analysis of tissue specimens and bodily fluids. A wide range of end users including large laboratories that conduct multiple analyses in a day and smaller clinics that conduct a few tests use enzymes for in-vitro diagnostics (IVD).

North America emerged as a prominent regional market in 2022. A rise in the number of cancer cases and the adoption of enzymes for histopathology of biopsy samples are some of the other factors expected to propel market growth in the region. The presence of a large target population, improvements in healthcare infrastructure, high unmet clinical needs, increase in government initiatives, and rise in R&D activities for advanced diagnostic techniques are anticipated to drive the Asia Pacific market with the fastest growth rate.

The key players in the market are involved in novel product launches, acquisitions, collaborations, partnerships, and geographical expansions to reinforce their market presence. For instance, in June 2022, Codexis, Inc. signed a collaboration agreement with Alphazyme LLC for the manufacture and co-marketing of high-fidelity DNA polymerase, T7 RNA polymerase, and reverse transcriptase.

Some of the prominent players in the In-vitro Diagnostics Enzymes Market include:

  • Merck KGaA
  • Codexis, Inc.
  • F. Hoffmann-La Roche Ltd.
  • Amano Enzyme Inc.
  • Advanced Enzymes Technologies Ltd.
  • Biocatalysts Ltd.
  • Amicogen
  • Dyadic International
  • BBI Solutions
  • Affymetrix
  • American Laboratories

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the global In-vitro Diagnostics Enzymes market.

By Enzyme Type 

  • Proteases
    • By Disease Type
      • Infectious disease
      • Diabetes
      • Oncology
      • Cardiology
      • Nephrology
      • Autoimmune diseases
      • Others
    • By Technology Use
      • Histology Assays
      • Molecular Diagnostics
      • PCR Assays
      • NGS Assays
      • Others
      • Clinical Chemistry
    • By Physical Form
      • Powder
      • Liquid
      • By Type
      • Natural
      • Recombinant
    • By End-use
      • Pharma & Biotech
      • Hospital & Diagnostic Labs
      • CROs
      • Academic Labs
  • Polymerase & Transcriptase
  • Ribonuclease
  • Others

By Disease Type 

  • Infectious disease
    • COVID-19 Testing
    • Hepatitis
    • HIV
    • Others
  • Diabetes
  • Oncology
  • Cardiology
  • Nephrology
  • Autoimmune diseases
  • Others

By Technology Type 

  • Histology Assays
  • Molecular Diagnostics
    • PCR Assays
    • NGS Assays
    • Others
  • Clinical Chemistry

By End-use 

  • Pharma & Biotech
  • Hospital & Diagnostic Labs
  • Contract Research Organizations (CROs)
  • Academic Labs

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East & Africa (MEA)

Frequently Asked Questions

The global in-vitro diagnostics enzymes market size was exhibited at USD 2.26 billion in 2022 and is projected to hit around USD 5.33 billion by 2032

The global IVD enzymes market is expected to grow at a compound annual growth rate of 8.98% from 2023 to 2032

Some of the key players in the IVD enzymes market include Merck KGaA, Codexis, Inc., F. Hoffmann-La Roche Ltd., Amano Enzyme Inc., Advanced Enzymes Technologies Ltd., Biocatalysts Ltd., Amicogen, Dyadic International, BBI Solutions, Affymetrix, American Laboratories

Key factors driving the IVD enzymes market growth include a rise in the adoption of IVD in clinical diagnostics.

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