PUBLISHER: The Business Research Company | PRODUCT CODE: 1815777
PUBLISHER: The Business Research Company | PRODUCT CODE: 1815777
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.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sudden escalation of U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the pharmaceutical sector. Companies are grappling with higher costs on imported active pharmaceutical ingredients (APIs), glass vials, and laboratory equipment-many of which have limited alternative sources. Generic drug manufacturers, already operating with minimal profit margins, are particularly affected, with some scaling back production of low-margin medications. Biotech firms are also experiencing delays in clinical trials due to shortages of specialized reagents linked to tariffs. In response, the industry is shifting API production to regions like India and Europe, building up inventory reserves, and advocating for tariff exemptions on essential medicines.
The in vitro diagnostics enzymes market research report is one of a series of new reports from The Business Research Company 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 enzymes market size has grown strongly in recent years. It will grow from $2.14 billion in 2024 to $2.3 billion in 2025 at a compound annual growth rate (CAGR) of 7.5%. 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 $3.06 billion in 2029 at a compound annual growth rate (CAGR) of 7.4%. 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 forecast of 7.4% growth over the next five years reflects a modest reduction of 0.7% from the previous estimate for this market. This reduction is primarily due to the impact of tariffs between the US and other countries. Trade tensions may strain clinical laboratories by inflating costs ofpolymerase chain reaction master mix and reverse transcriptase enzymes imported from Singapore and Finland, resulting in delayed test results and increased molecular diagnostics expenses. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.
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., bioMerieux 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.
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.
In Vitro Diagnostics Enzymes Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on in vitro diagnostics enzymes market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for in vitro diagnostics enzymes ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The in vitro diagnostics enzymes market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.