In Vitro Diagnostics Enzymes Market Report 2025

This In Vitro Diagnostics Enzymes market report provides a comprehensive analysis of the market’s characteristics, size, and growth, including segmentation, regional and country-level breakdowns, competitive landscape, market shares, trends, and strategies. It also tracks historical and forecasted market growth across various geographies.

The in vitro diagnostics enzymes market size has grown strongly in recent years. It will grow from $2.14 billion in 2024 to $2.32 billion in 2025 at a compound annual growth rate (CAGR) of 8.5%. The growth in the historic period can be attributed to increasing incidence of diseases such as cancer and HIV/AIDS, growing need for diagnostic testing and monitoring of age-related diseases, shifts in lifestyle factors, including diet and physical activity, rise in approval of new diagnostic assays and products by regulatory authorities, and higher healthcare expenditures globally.

The in vitro diagnostics enzymes market size is expected to see strong growth in the next few years. It will grow to $3.17 billion in 2029 at a compound annual growth rate (CAGR) of 8.1%. The growth in the forecast period can be attributed to increasing focus on personalized healthcare, growing healthcare infrastructure, rising disposable incomes in emerging markets, rise in collaborations between companies and research institutions, and increasing demand for rapid and convenient diagnostic solutions. Major trends in the forecast period include the adoption of microfluidics technologies, development of novel enzyme substrates and detection methods, use of point-of-care molecular diagnostic platforms integrated enzyme-based amplification techniques, integration of CRISPR-based technologies with enzyme assays, use of liquid biopsy techniques, and utilization of advanced data analytics and bioinformatics tools.

The in vitro diagnostics enzymes market is expected to grow significantly due to the rising prevalence of cancer. Cancer refers to a group of diseases characterized by abnormal cell growth and division, posing a threat to healthy tissues. Factors contributing to the increased prevalence of cancer include infectious agents, immune system dysfunctions, and hormonal influences. In vitro diagnostics (IVD) enzymes play a crucial role in various diagnostic and monitoring assays across the cancer care continuum, from early detection and diagnosis to treatment selection, monitoring, and personalized medicine. For example, the World Health Organization (WHO) projects a 77% increase in new cancer cases by 2050 compared to 2022, highlighting the growing need for in vitro diagnostics enzymes in cancer management.

Leading companies in the in vitro diagnostics enzymes market are investing in innovative products such as autoimmune disorder detection kits to maintain their market position. These kits are designed to detect autoimmune diseases, where the immune system mistakenly attacks the body's tissues. For instance, NeoDx Biotech Labs Pvt Ltd. recently launched an IVD kit for detecting autoimmune disorders, incorporating advanced technologies such as immunoassays, molecular diagnostics, and antibody detection methods. This kit offers high sensitivity and specificity, enabling clinicians to swiftly and accurately diagnose autoimmune conditions.

In February 2023, SD Biosensor Inc. and SJL Partners LLC acquired Meridian Bioscience Inc. for $1.53 billion. This acquisition allows SD Biosensor to leverage Meridian's expertise in diagnostic products and raw materials for immunological and molecular tests across various applications. Meridian Bioscience Inc., based in the US, is known for its contributions to in vitro diagnostic enzymes and related technologies.

Major companies operating in the in vitro diagnostics enzymes market are F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc., Danaher Corporation, Merck KGaA, Siemens Healthineers AG, Becton Dickinson and Company, Agilent Technologies Inc., Grifols SA, Hologic Inc., Illumina Inc., Mindray Medical International Limited, PerkinElmer Inc., bioMérieux SA, QuidelOrtho Corporation, Sysmex Corporation, Bio-Rad Laboratories Inc., Qiagen N.V., DiaSorin SpA, Promega Corporation, Randox Laboratories Ltd., Meridian Bioscience Inc., Fujirebio Diagnostics Inc., Sekisui Diagnostics LLC, Trivitron Healthcare, Codexis Inc., Amicogen Inc., EKF Diagnostics Holdings plc, Advanced Enzymes Technologies Ltd., Biocatalysts Ltd., Alpha Laboratories Ltd.

North America was the largest region in the in vitro diagnostics enzymes market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the in vitro diagnostics enzymes market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the in vitro diagnostics enzymes market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

In vitro diagnostics (IVD) enzymes are specialized proteins used in diagnostic tests conducted outside the living organism, typically in a laboratory setting. These enzymes catalyze specific biochemical reactions that help detect, quantify, or monitor the presence of various substances, including pathogens, biomarkers, or other molecules relevant to diagnosing diseases.

The main enzyme types in the in vitro diagnostics enzymes market are proteases, polymerase and transcriptase, ribonuclease, and other enzyme types. Proteases refer to enzymes that catalyze the breakdown of proteins into smaller peptides or amino acids. Various disease types are targeted, including infectious diseases, diabetes, oncology, cardiology, nephrology, autoimmune diseases, and others. These enzymes are utilized in various technologies such as histology assays, molecular diagnostics, clinical chemistry, and others, and are used by end users such as pharmaceutical and biotech companies, hospitals and diagnostic labs, contract research organizations (CROs), and academic labs.

The in vitro diagnostics enzymes market research report is one of a series of new reports that provides in vitro diagnostics enzymes market statistics, including in vitro diagnostics enzymes industry global market size, regional shares, competitors with an in vitro diagnostics enzymes market share, detailed in vitro diagnostics enzymes market segments, market trends, and opportunities, and any further data you may need to thrive in the in vitro diagnostics enzymes industry. This in vitro diagnostics enzymes research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The in vitro diagnostics (IVD) enzymes market consists of revenues earned by entities by providing services such as enzyme engineering, custom enzyme production, validation services, promega custom assay services, and bio-techne enzyme solutions. The market value includes the value of related goods sold by the service provider or included within the service offering. The in vitro diagnostics (IVD) enzymes market also includes sales of Taq DNA polymerase, reverse transcriptase, alkaline phosphatase (ALP), horseradish peroxidase (HRP), DNA ligase, NEB enzyme products, and sigma-Aldrich diagnostic enzymes. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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