Diagnostic Enzymes Market (By Type: Taq Polymerase, MMLV RT, HIV RT; By Application: Diabetes, Oncology, Cardiology; By Product Type) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2023-2032

The global diagnostic enzymes market was surpassed at USD 5.08 billion in 2022 and is expected to hit around USD 6.70 billion by 2032, growing at a CAGR of 2.8% from 2023 to 2032.

Growth of the diagnostic enzymes market is attributed to rising demand for the enzymes in diagnostics with wide applications in pathology. Moreover, advancements in diagnostic techniques for viral infection are anticipated to propel the market growth.

Diagnostic enzymes are widely adopted owing to the higher sensitivity and accuracy offered by enzyme activity. The enzyme activities can be earlier than clinical signs and other diagnostic indicators. Biosensors are becoming a popular potential tool for medical diagnostics, pathogen detection, and monitoring. Biosensors have gained popularity owing to the accuracy, sensitivity, selectivity, and rapid detection strategies that can be used routinely. Diagnosis of serum levels of the enzymes has been used as an indicator of the cellular damage that results in the release of the intercellular components into the bloodstream.

Viral infections of the respiratory tract are among the most common disorders in humans, and the ones caused due to the outbreak of emerging viruses, such as COVID-19, have posed a threat to public health. Therefore, detection of the viral pathogens is vital to stop the occurrence of such epidemics and prevent the unnecessary use of antibiotics. Therefore, novel diagnostic strategies have been adopted by the key players. LightMix (Roche Molecular Diagnostics, Switzerland), AccuPower (Bioneer, Korea), PowerChek (Kogene Biotech, Korea), Anyplex (Seegene, Korea), UltraFast kits (Nanobiosys, Korea), and DiaPlexQ (SolGent, Korea) are some of the commercially available RT-PCR kits for MERS-CoV RNA detection with sensitivities as high as 99.03%.

An increase in the number of diagnostic enzyme tests has led to a boost in recommendations and guidelines with a number of publications on their performance. Moreover, reimbursement pathways lack clear guidelines and systematic Health Technology Assessment (HTA). Various factors influencing payer decisions for diagnostic enzyme tests include FDA clearance, physician support & clinical guidelines, competitor coverage policies, cost/benefit analyses, results of HTAs, and employer or advocacy group demands.

Furthermore, key players operating in the market are focusing on expanding and launching products that can be used for a wide range of applications. For instance, in March 2022, Meridian Bioscience, Inc. launched two master mixes, which can be used in non-invasive liquid biopsy. The launch of such breakthrough technologies enables better analysis of the performance levels as compared to traditional qPCR from the purified nucleic acid.

Type Insights

The glucose oxidase/glucose dehydrogenase segment accounted for the largest revenue share of 10.89% in 2022. An abundant endogenous oxidoreductase found in all living things is glucose oxidase (GOx). Due to its intrinsic biocompatibility, lack of toxicity, and distinctive catalysis against -d-glucose, GOx has gained interest in the biomedical field in recent years.

A variety of biosensors can use GOx to effectively accelerate the oxidation of glucose into gluconic acid and hydrogen peroxide (H2O2), which can be used to detect cancer biomarkers. The crucial role of glucose oxidase in the detection of diabetes is projected to boost demand for the enzyme.

The lactate oxidase segment is expected to show the fastest growth during the forecast period. This can be attributed to the rising adoption of molecular devices for the management of diabetes. Lactate Dehydrogenase (LDH), which catalyzes the interconversion of lactate and pyruvate with the NAD+/NADH coenzyme system, is widely distributed in the cells of diverse living systems.

The LDH isoenzymes found in blood plasma and serum of both humans and animals are directly derived from cells and tissues and produce a distinctive profile. This profile is dependent on the concentration of intracellular isoenzymes in all tissues that contribute to the pool of LDH present in plasma and serum as a result of normal cell deterioration. LDH can be used for the diagnosis of certain types of cancer. Moreover, it can also be used in the diagnosis and monitoring of the diseases that cause cell damage, for assessing the severity of certain cancers and monitoring patients during treatment, and evaluating collections of fluids in the body abnormally.

Application Insights

The infectious diseases segment held the largest market share in 2022. Early identification and treatment of infectious diseases have been made possible by the widespread application of PCR technology. Organisms that are difficult to be detected can now be identified with better precision and sensitivity. Typical pneumonia, TB, streptococcal pharyngitis, ulcerative urogenital infections, and a number of 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 expected to exhibit the fastest growth during the forecast period. Large-scale adoption of ISH methods as well as the development of high-throughput technologies, such as next-generation DNA sequencing and comparative genomic hybridization, for the diagnosis of human tumors, drives the usage of diagnostic enzymes in this segment.

In February 2022, the U.S. government initiated Cancer Moonshot, which was directed towards enhancing the screening rates for cancer and for identifying the missed cases due to the COVID-19 pandemic. In the next coming 25 years, the government aims to reduce cancer deaths by 50% with early treatment and diagnosis, thereby propelling demand for cancer diagnostic enzyme tests.

Product Type Insights

The clinical segment accounted for the largest revenue share in the diagnostic enzymes market owing to the increasing use of enzymes in clinical chemistry, which is associated with the analysis of body fluids for therapeutic and diagnostic purposes. Minute changes in the levels of body fluids, such as plasma, serum, or blood may indicate the onset of a life-threatening condition. Therefore, analytical techniques involved in clinical chemistry should be rapid, specific, and highly sensitive.

Due to the enzymes selectivity and speed, they are a crucial part of clinical chemistry diagnostic procedures. Enzyme specificity can be used to either assess the substrate in an assay or remove interferents from another reaction. Additionally, enzymes are used to quantify co-factors, inhibitors, and activators. Enzymes are furthermore perfect for usage as labels in immunoassay procedures due to their catalytic activity.

The molecular segment is expected to expand at a lucrative growth rate. Various enzymes are used in molecular diagnostics mainly through the techniques such as PCR assays, NGS assays, and others. PCR is one of the most widely used molecular biology techniques. The technology has been increasingly adopted in multiple fields, including diagnostic testing, sequencing, forensic analysis, and cloning.

Other molecular biology assays that involve the utilization of enzymes include Isothermal Nucleic Acid Amplification Technology (INAAT) and Transcription Mediated Amplification (TMA). INAAT facilitates the detection of a target nucleic acid sequence in an exponential, streamlined manner. This overcomes the limitations associated with thermal cycling.

Regional Insights

North America dominated the diagnostic enzymes market in 2022. The dominance of the region is owing to the high demand for enzymes and the increasing prevalence of infectious disorders in the region. The FDA has authorized COVID-19 laboratory-developed diagnostics for emergency use to address the ongoing pandemic. Enzyme-linked immunosorbent assays and RT-PCR-based tests for the detection of SARS-CoV-2 are also used in the majority of these emergency use authorizations. Owing to the high usability of enzymes during RT-PCR, the development of such tests is expected to generate revenue in the North America market.

Asia Pacific is estimated to show the fastest growth during the forecast period. The presence of a large target population, rising healthcare expenditure, high unmet clinical needs, growing establishment of the healthcare infrastructure, rising R&D activities for advanced diagnostic techniques, increasing government initiatives, and improving healthcare infrastructure are among the factors anticipated to provide a potential growth platform in this region for key diagnostic enzymes manufacturers.

In addition, the growing prevalence of cancer and infectious diseases, such as COVID-19, HIV/AIDS & hepatitis, and other disorders, is anticipated to drive demand for histology, clinical chemistry, and molecular biology techniques during the forecast period.

Key Players

• Takara Bio, Inc.
• Promega Corporation
• Enzo Life Sciences, Inc.
• Merck KGaA
• Thermo Fisher Scientific, Inc.
• Creative Enzyme
• F. Hoffmann-La Roche Ltd.
• Solis BioDyne.
• Ambliqon A/S.

Market Segmentation

• By Type Outlook
• 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
• 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
• By Application Outlook
• Diabetes
• Oncology
• Cardiology
• Infectious Diseases
• Nephrology
• Autoimmune Diseases
• Others
• By Product Type Outlook
• Molecular Enzymes
• Clinical Enzymes
• By Regional Outlook
• North America

• U.S.

• Canada

• Europe

• Germany

• UK

• France

• Italy

• Spain

• Asia Pacific

• Japan

• China

• India

• Australia

• South Korea

• Rest of World

• Brazil

• South Africa