In-vitro Diagnostics Enzymes Market Size, Share & Trends Analysis Report By Enzyme (Polymerase & Transcriptase, Proteases), By Disease (Infectious Disease, Diabetes), By Technology, By End-use, By Region, And Segment Forecasts, 2025 - 2030

In-vitro Diagnostics Enzymes Market Size, Share & Trends Analysis Report By Enzyme (Polymerase & Transcriptase, Proteases), By Disease (Infectious Disease, Diabetes), By Technology, By End-use, By Region, And Segment Forecasts, 2025 - 2030

In-vitro Diagnostics Enzymes Market Growth & Trends

The global in-vitro diagnostics enzymes market size is anticipated to reach USD 3.05 billion by 2030, according to a new report by Grand View Research, Inc. The market is projected to grow at a CAGR of 10.2% from 2025 to 2030. 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 2019. 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 2020, 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.

In-vitro Diagnostics Enzymes Market Report Highlights

• By enzyme type, polymerase and transcriptase enzymes held the largest share in 2024 owing to their wide applications in molecular diagnostic assays
• Based on disease type, the infectious disease segment is expected to dominate the market throughout the forecast period
• In terms of technology type, the histology assays segment held the largest share in 2024 owing to the utility of histology assays in cancer diagnostics, coupled with a rising incidence of different cancer types
• By end use, hospital and diagnostic labs dominated the market in 2024. They witness a high inflow of biopsy specimens for histopathology and cytopathology because of an increase in hospitalization and rise in the number of hospital admissions for cancer patients
• North America dominated the overall market in 2024 owing to the presence of a substantial number of players in this region including Innovative Research; Bio-Rad Laboratories, Inc.; Rockland Immunochemicals, Inc.; MyBioSource.com; and RayBiotech, Inc.

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