Diagnostic Enzymes Market Size, Share & Trends Analysis Report By Type (Taq Polymerase, MMLV RT, HIV RT), By Application (Diabetes, Oncology, Cardiology), By Product, By End Use, By Region, And Segment Forecasts, 2024 - 2030

Diagnostic Enzymes Market Size & Trends

The global diagnostic enzymes market size was estimated at USD 4.60 billion in 2023 and is expected to grow at a CAGR of 5.18% from 2024 to 2030. The market is witnessing growth due to the factors such as the increasing prevalence of infectious disorders, high demand for enzymes, innovations in diagnostics technologies, and the rising awareness among patients.

Enzymes used for diagnosis play a crucial role in detecting and measuring various substances, indicating abnormal metabolic activities, infections, diseases, and inflammatory conditions. Swift and accurate identification of serious conditions is vital for optimal clinical outcomes and public health.

Enzymes are widely employed in the diagnosis of many diseases because of their exceptional bio catalytic characteristics. For instance, enzymes such as glucose oxidase (GOx) and glucose dehydrogenase are crucial in diagnosing conditions such as diabetes by detecting glucose levels in the body. They play a vital role in the metabolic activity of living organisms, including plants, microorganisms, animals, and humans. Enzyme abnormality can lead to multiple metabolic disorders. Therefore, components of the enzyme metabolism systems have been incorporated as special markers for disease diagnostics.

Continuous innovations in diagnostics technologies have been driving the growth of diagnostic enzyme market. Advancements in technology have led to the development of more efficient and sensitive diagnostic tests that rely on enzymes for accurate results. For example, nuclease enzymes are increasingly used in DNA sequencing and amplification techniques for various applications, including infectious disease detection.

Rising patient awareness about preventive healthcare measures and early disease detection has increased the demand for enzyme diagnostic tests. Patients are becoming more proactive about monitoring their health status, leading to a higher uptake of enzyme-based diagnostic tests for cardiovascular diseases, diabetes, and cancer. This trend toward proactive healthcare management further fuels the diagnostic enzyme market growth.

Market Concentration & Characteristics

The degree of innovation in the diagnostic enzymes market is high, driven by advancements in diagnostic techniques, government support, increasing prevalence of infectious diseases, growing demand for point-of-care testing, and increasing use of artificial intelligence and machine learning.

The market experiences high M&A activities. For instance, in July 2023, the global joint marketing agreement between INOVIQ and Promega. This collaboration allows for the co-marketing of INOVIQ’s EXO-NET exosome capture technology and Promega’s Nucleic Acid purification systems, aiming to provide comprehensive exosome solutions on a global scale.

This market is heavily influenced by regulations, which significantly impact the industry. For instance, the FDA has approved COVID-19 diagnostic tests for emergency use, which utilize RT-PCR and enzyme-linked immunosorbent assays to detect SARS-CoV-2.

The market for diagnostic enzymes is experiencing significant product expansion. For instance, in February 2022, Takara Bio Inc. expanded its Center for Gene and Cell Processing (CGCP) facility in Shiga, Japan. This expansion began operations in 2020 and includes new equipment such as 200 L bioreactors, 2,000 L fermenters, and large flow centrifuge and purification systems (Takara Bio Inc., 2021). This investment will increase the company’s production capacity to meet the growing demand for diagnostic enzymes.

The level of regional expansion is high in this market. This is evident from the numerous regional expansions and market entries by key players such as Takara Bio, Inc. and Promega Corporation. Takara Bio, Inc. expanded its GMP facility to accommodate a variety of modalities and strengthen its supply chain, while Promega Corporation expanded its presence in Asia Pacific by establishing a new facility in China. In October 2022, Enzo Life Sciences, Inc. expanded its operations in the U.S. by opening office facilities in Farmingdale, New York.

Type Insights

The glucose oxidase/dehydrogenase segment accounted for the largest revenue share of 10.61 % in 2023. Glucose oxidase (GOx), a naturally occurring oxidoreductase present universally in living organisms, has gained significant attention in biomedical applications due to its biocompatibility, non-toxic nature, and unique ability to catalyze d-glucose. GOx is utilized in various biosensors to accelerate glucose oxidation into gluconic acid and hydrogen peroxide (H2O2), enabling the detection of cancer biomarkers. Its pivotal role in diabetes detection is expected to drive demand for this enzyme.

The lactate dehydrogenase (LDH) segment is expected to grow significantly during the forecast period due to the increasing adoption of molecular devices for managing diabetes. The LDH profile depends on the concentration of intracellular isoenzymes in all tissues, contributing to the pool of LDH in plasma and serum due to normal cell deterioration. LDH can diagnose specific types of cancer, monitor diseases that cause cell damage, assess the severity of certain types of cancer, and monitor patients during treatment.

Application Insights

The infectious diseases segment held the largest market share in 2023. Early identification and treatment of infectious diseases have been made possible by the widespread application of PCR technology. Organisms that are difficult to detect can now be identified with better precision and sensitivity. Atypical pneumonia, TB, streptococcal pharyngitis, ulcerative urogenital infections, and several persistent illnesses are all detected by PCR in the diagnosis of infectious diseases. The Thermus thermophilus Escherichia coli's DNA polymerase gene expression enables effective reverse transcriptase activity for one-step detection of cellular mRNA expression.

The oncology segment is most likely to experience the swiftest expansion among all segments in the diagnostic enzymes market during the forecast period. This growth can be attributed to several factors. For instance, the U.S. government’s Cancer Moonshot initiative, launched in February 2022, focuses on improving cancer screening rates and identifying undetected cases that may have been missed due to the COVID-19 pandemic. Over the next quarter-century, the objective is to decrease cancer deaths by 50% through early detection and treatment.

Product Insights

The clinical enzyme segment accounted for the largest revenue share of 50.43 % in 2023. Due to the rising application of enzymes in clinical chemistry, they are crucial for analyzing bodily fluids to detect and manage health conditions. Even slight plasma, serum, or blood level changes can indicate severe potential health issues. Hence, clinical chemistry requires rapid, precise, and susceptible analytical methods. Enzyme properties such as selectivity and speed are critical in these diagnostic procedures. Enzymes can accurately detect specific substrates in assays and eliminate interfering substances from reactions. Moreover, enzymes are utilized to measure cofactors, inhibitors, and activators. Their catalytic activity makes enzymes particularly suitable as labels in immunoassays.

The molecular segment is expected to grow substantially, driven by the rising use of enzymes in molecular diagnostics. Enzymes are integral to PCR assays, NGS assays, and similar techniques. PCR, a widely adopted molecular biology method, finds application in diagnostics, sequencing, forensics, and cloning. Other assays using enzymes include Isothermal Nucleic Acid Amplification Technology (INAAT) and Transcription-Mediated Amplification (TMA). INAAT enables rapid detection of specific nucleic acid sequences without the need for traditional thermal cycling, effectively addressing associated limitations.

End Use Insights

The clinical laboratories segment held the largest market share of 47.44 % in 2023. The growth of clinical laboratories can be attributed to several factors, including the increasing adoption of point-of-care testing, the growing demand for molecular diagnostics, and the rising need for personalized medicine. Additionally, the development of advanced diagnostic technologies, such as next-generation sequencing and digital PCR, is further fueling the growth of clinical laboratories.

The other end users segment is expected to grow at the fastest rate during the forecast period. This segment includes various applications such as the food industry, pharmaceuticals, and research institutions. The primary drivers for the growth of this market segment are increasing demand for rapid and accurate diagnostic tests, rising awareness about early disease detection, and growing research activities in the field of molecular diagnostics.

Regional Insights

North America held the largest share in the diagnostic enzymes market of 41.8% in 2023, due to the high demand for enzymes and the region's increasing prevalence of infectious disorders. The Food and Drug Administration (FDA) granted emergency use authorizations for COVID-19 laboratory-developed diagnostics, which led to a surge in enzyme demand. Enzyme-linked immunosorbent assays (ELISA) and reverse transcription polymerase chain reaction (RT-PCR) tests were predominantly used for the detection of SARS-CoV-2 in these emergency use authorizations.

U.S. Diagnostic Enzymes Market Trends

The diagnostic enzymes market in the U.S. is driven by the increasing adoption of enzyme-based diagnostic tests, advancements in diagnostic technologies, the rise in chronic and infectious diseases, growing demand for point-of-care testing, the use of artificial intelligence and machine learning, and the growing demand for enzyme-based diagnostic tests in clinical chemistry. For instance, in October 2023, Thermo Fisher Scientific introduced Gibco CTS Detachable Dynabeads, an innovative platform featuring an active-release mechanism for efficient cell isolation and purification in cell therapy manufacturing. The detachable Dynabeads allow for easy cell release, supporting scalable and high-quality cell therapy production.

Europe Diagnostic Enzymes Market Trends

The European diagnostic specialty enzymes market is expected to grow significantly during the forecast period due to several factors, such as increasing healthcare expenditures, a growing aging population, the rising prevalence of chronic diseases, and increasing government initiatives to improve healthcare infrastructure.

The diagnostic enzymes market in the UK is experiencing significant growth, driven by several factors. One major factor is the increasing adoption of enzyme-based diagnostic tests due to technological innovations. Another factor is the rising burden of chronic and infectious diseases, which has led to a greater demand for accurate and efficient diagnostic tools. According to the data by the National Library of Medicine, Infectious diseases represent a major public health challenge globally, contributing to significant health disparities. In the UK, contagious diseases account for 7% of deaths and 4% of lost life years. The economic burden of infectious diseases in the UK is estimated to be around $38 billion annually, highlighting the substantial impact on the country's healthcare system and economy.

The growth of the France diagnostic enzymes market is driven by the increasing demand for diagnostic enzymes in applications such as clinical chemistry (including point-of-care testing and blood glucose monitoring), molecular diagnostics, and immunoassays. Advancements in diagnostic techniques, government support, and the rising prevalence of infectious diseases are fueling France's market growth.

Asia Pacific Diagnostic Enzymes Market Trends

The Asia Pacific region is expected to exhibit the most rapid growth during the projected period. Factors contributing to this growth include a large population base, increasing healthcare spending, significant unmet medical needs, expanding healthcare infrastructure, rising research and development efforts in advanced diagnostic technologies, government initiatives, and improvements in healthcare facilities. Moreover, the increasing prevalence of diseases like cancer, COVID-19, HIV/AIDS, hepatitis, and other conditions is likely to boost demand for histological, clinical chemistry, and molecular biology techniques in the region.

The China diagnostic enzymes market growth is expected to be driven by the increasing demand for diagnostic enzymes in various applications such as biocatalysts, diagnostics, pharmaceuticals, and research and biotechnology. Key trends influencing the market include the increasing demand for diagnostic enzymes, advancements in diagnostic techniques, government support and regulations, and the increasing prevalence of infectious diseases.

The growth of the diagnostic enzyme market in India can be attributed to the expansion of detergent and chemical industries, increasing awareness regarding declining nutrition levels leading to higher protein consumption, and the growing demand for eco-friendly textiles. Enzymes are increasingly used as natural and sustainable alternatives in personal care products and cosmetics due to their benefits, such as exfoliation and skin rejuvenation.

Latin America Diagnostic Enzymes Market Trends

The diagnostic specialty enzymes market in Latin America is anticipated to grow steadily due to the region’s increasing industrialization and rising consumer demand for high-quality natural products. Specialty enzymes offer multifunctional advantages in various applications and have replaced chemical catalysts due to technological advancements. The growing demand for non-harmful biological catalysts in pharmaceuticals and diagnostics and consumer concerns about product quality drive the market’s expansion. 

The Brazil diagnostic enzymes market growth trends are influenced by several critical factors, including the increasing demand for diagnostic enzymes in various applications such as clinical chemistry, molecular diagnostics, and immunoassays; advancements in diagnostic techniques; government support; and the rising prevalence of infectious diseases.

MEA Diagnostic Enzymes Market Trends

The MEA region has been witnessing an increase in the prevalence of chronic and infectious diseases, which has led to a higher demand for diagnostic tests. Additionally, governments in the MEA are investing heavily in healthcare infrastructure, further driving the growth of the market.

The South Africa diagnostic enzymes market is expected to grow due to the rising demand for enzymes in clinical chemistry, molecular diagnostics, and immunoassays. The market is driven by advancements in diagnostic techniques, government support, and the increasing prevalence of infectious diseases such as COVID-19, HIV/AIDS, and others.

Key Diagnostic Enzymes Company Insights

The key players operating in the market are focusing on partnerships, strategic collaborations, and geographical expansion, in emerging and economically favorable regions. For Instance, in January 2022, Merck signed a research collaboration with Absci to produce new enzymes. This strategy is expected to enhance Merck’s biomanufacturing applications.

Recent Developments

• In April 2024, BBI Solutions acquired IBEX Technologies to enhance its capabilities in supporting In Vitro Diagnostic (IVD) manufacturers. This strategic move comes amid growing global demand for IVD hemostasis testing, driven by an aging population, chronic diseases, and increased reliance on point-of-care tests. The acquisition positions BBI to cater to evolving IVD industry needs and capitalize on the demand for reliable diagnostic solutions.

• In June 2023, AIST and Asahi Kasei Pharma collaborated on the Smart Cell Project of NEDO to improve cholesterol esterase production efficiency, an enzyme utilized in vitro diagnostic assays enabling the manufacture of a commercial product called CEN II.

• In January 2023, Thermo Fisher Scientific acquired The Binding Site Group, a leading specialty diagnostics company, in a USD 2.84 billion all-cash deal. This acquisition enhances Thermo Fisher's specialty diagnostics portfolio by adding innovative solutions for multiple myeloma diagnostics and monitoring, ultimately aiming to improve patient outcomes.

• In January 2022, Merck entered a research collaboration with Absci to develop new enzymes, which is anticipated to help improve Merck's bio-manufacturing capabilities.

Diagnostic Enzymes Market Report Scope

Global Diagnostic Enzymes Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2018 to 2030. For the purpose of this report, Grand View Research has segmented the global diagnostic enzymes market report based on type, application, product, and region:

• Type Outlook (Revenue, USD Million, 2018 - 2030)

  • Taq Polymerase

  • MMLV RT

  • HIV RT

  • Hot Start Taq Polymerase

  • UNG

  • RNase Inhibitors

  • Bst Polymerase

  • PCR Master Mix

  • Lyophilized Polymerase

  • T7 RNA Polymerase

  • Cas9 Enzyme

  • Acid Phosphatase

  • Alanine Aminotransferase

  • Alkaline phosphatase

  • Amylase

  • Angiotensin Converting Enzyme

  • Aspartate Aminotransferase

  • Cholinesterase

  • Creatinine Kinase

  • Gamma Glutamyl Transferase

  • Lactate Dehydrogenase

  • Renin

  • Glucose Oxidase/Glucose Dehydrogenase

  • Urease

  • Lactate Oxidase

  • Horseradish Peroxide

  • Glutamate Oxidase

  • Others

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Diabetes

  • Oncology

  • Cardiology

  • Infectious Diseases

  • Nephrology

  • Autoimmune Diseases

  • Others

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Molecular Enzymes

  • Clinical Enzymes

• End Use Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospitals

  • Clinical Laboratories

  • Other End Users

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

    • Mexico

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Argentina

  • MEA

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait