Diagnostic Enzymes: Trends And Competitive Analysis

Report Overview

Diagnostic enzymes play a pivotal role in clinical diagnostics, aiding in the early detection and monitoring of numerous diseases. In 2024, the global burden of chronic and infectious diseases continued to escalate, fueling the demand for enzymatic diagnostic tools. In 2024, it's estimated that over 589 million adults are living with diabetes worldwide. This number is projected to rise to 853 million by 2050, with millions relying on glucose oxidase-based diagnostics for daily monitoring. Cardiovascular diseases, which claim approximately 17.9 million lives annually, frequently depend on enzyme-based tests such as creatine kinase and troponin assays for rapid and accurate diagnosis.

Enzymes are extensively used in disease diagnosis due to their remarkable biocatalytic properties. For example, enzymes like glucose oxidase (GOx) and glucose dehydrogenase are essential for diagnosing diabetes by measuring glucose levels in the body. They are vital for the metabolic functions of various organisms, including plants, microorganisms, animals, and humans. Abnormal enzyme activity can lead to various metabolic disorders, making components of enzyme metabolism significant markers for disease diagnostics. Key players are focusing on collaborations to launch new products in the market. For instance, in July 2023, INOVIQ and Promega collaborated for a global joint marketing agreement. 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.

The trends and competitive analysis report, compiled by Grand View Research, is a collection of the trends and competitive scenario in more than 20 countries. Qualitative information regarding the trends, government initiatives, funding landscape, competitive strategies, existing competition, and pipeline analysis will be provided in the report. Within the purview of the database, such information is systematically analyzed and provided in the form of outlook reports and summary presentations on individual areas of research.

Disease Burden Driving Enzyme Usage (2023-2024) Scope

The WHO estimated that in 2023, there were approximately 20 million new cancer cases and 10 million related deaths. This number is expected to exceed 30 million annually by 2040, driven by an aging global population and growing exposure to risk factors. Timely and precise cancer diagnosis remains critical.

In addition, as the prevalence of kidney disease increases, alongside the rising rates of diabetes and hypertension, the need for accurate, non-invasive, and cost-effective diagnostic tools is more pressing than ever. This heightened awareness, coupled with advancements in enzyme-based diagnostic technologies, is propelling the growth of the nephrology segment within the diagnostic enzyme market, ensuring better outcomes for patients through earlier detection and personalized treatment strategies. 

Disorder/Disease-wise Enzymes Used in Diagnostic Assays:

Enzyme Biomarkers for Rheumatoid Arthritis

In rheumatoid arthritis (RA), specific enzyme biomarkers are indicative of disease activity and tissue degradation. Lysosomal enzymes such as cathepsin D and lysozyme are elevated due to increased macrophage activation. Gelatinase B (Matrix Metalloproteinase-9 or MMP-9) plays a role in autoimmune inflammation and joint destruction, making it a relevant biomarker for RA progression. Additionally, increased levels of tartrate-resistant acid phosphatase (TRAP), commonly associated with bone resorption, have been linked to RA-related bone pathology.

Role of Diagnostic Enzymes in Liver Disease

Liver diseases ranging from hepatitis and fatty liver disease to cirrhosis and liver cancer often progress without early symptoms, making prompt diagnosis essential. Enzymes serve as vital indicators of liver damage and dysfunction. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are released into the bloodstream when liver cells are damaged. At the same time, alkaline phosphatase (ALP) levels rise in conditions involving bile duct obstruction or liver inflammation. Monitoring these enzymes enables clinicians to detect liver abnormalities early, allowing for timely intervention.

Diagnostic Enzymes In Cardiovascular Disease

Cardiovascular disorders, including coronary artery disease, cerebrovascular disease, and heart failure, remain the leading cause of global mortality, with an estimated 17.9 million cases reported annually. Traditional diagnostic methods, such as clinical history and ECG, often fall short in early detection. Enzyme biomarkers offer a more sensitive and specific diagnostic approach. Key enzymes like creatine kinase-MB (CK-MB), lactate dehydrogenase (LDH), and cardiac troponins are released during myocardial injury. They are critical in diagnosing acute myocardial infarction and other cardiac conditions.

Recent market trends and advancements:

1. Rising Prevalence of Chronic and Infectious Diseases

The increasing burden of chronic and infectious diseases is a major driver of POCT adoption. Enzymes are essential for the development of rapid and accurate diagnostic tests for conditions such as diabetes, cardiovascular diseases, and infectious outbreaks.

• Diabetes: With over 20 million residents in the U.S. affected by diabetes, glucose monitoring has become a cornerstone of POCT.

• Infectious Diseases: The COVID-19 pandemic accelerated the adoption of POCT, with rapid antigen tests becoming a critical tool for managing the crisis. For instance, Roche’s SARS-CoV-2 Rapid Antibody Test 2.0, launched in October 2022, offers a sensitivity of 95.83% and specificity of 100%, making it a reliable solution for rapid testing in non-clinical settings. 

2. Technological Advancements in POCT Devices

Innovations in POCT technology are driving demand for high-performance enzymes that enable accurate and efficient diagnostics.

• HbA1c Testing: Strategic collaborations, such as the partnership between HemoCue and Novo Nordisk, are improving access to POCT for diabetes management. In February 2024, HemoCue’s HbA1c 501 Systems were deployed in over 400 clinics across 30 countries, targeting underserved regions. This initiative highlights the role of enzymes in enabling precise and accessible HbA1c testing.

• Non-Invasive Testing: Breakthrough products like Qvin’s Q-Pad A1c Test System, approved by the FDA in January 2024, demonstrate the potential of enzyme-based diagnostics in non-invasive testing. This system uses menstrual blood to measure hemoglobin A1c, offering a novel approach to diabetes care. 

3. Expanding Applications of POCT

POCT is finding applications beyond traditional healthcare settings, including home healthcare, fertility testing, and infectious disease management.

• Pregnancy and Fertility Testing: The demand for easy-to-use and effective POCT solutions is driving innovation in fertility and pregnancy testing.

• Infectious Disease Testing: The high prevalence of diseases like Clostridium difficile (C. diff) and hepatitis B is fueling demand for rapid diagnostic solutions. Roche’s cobas Cdiff nucleic acid test, which delivers results in 20 minutes, exemplifies the role of enzymes in enabling rapid and accurate infectious disease testing. 

4. Strategic Collaborations and Product Launches

Collaborations between industry players and continuous product innovation are driving market growth.

• Hepatitis B Testing: In July 2023, Brii Biosciences expanded its hepatitis B virus portfolio through a partnership with VBI Vaccines, gaining exclusive rights to develop and market PreHevbri in Greater China and the Asia Pacific region. Similarly, GSK plc received Fast Track designation from the FDA for bepirovirsen, an investigational treatment for chronic hepatitis B, in February 2024.

• HPV Testing: Roche’s FDA-approved HPV self-testing kit, launched in May 2024, enables women to collect their own vaginal samples for cervical cancer screening. This innovation aligns with the growing emphasis on early detection and prevention 

The CRISPR Breakthrough In Diagnostics

As of 2024, CRISPR technology has made major progress in diagnostics, especially in rapidly detecting viral pathogens during outbreaks. Tools like the advanced SHERLOCK platform now enable direct virus detection in fluids like saliva or blood without the need for traditional lab-based nucleic acid extraction. CRISPR-Cas12 and Cas13 enzymes support fast, accurate point-of-care testing delivering results in under an hour and can differentiate between closely related viruses, which is essential in clinical settings.

Moreover, researchers have identified nearly 200 new CRISPR systems through advanced algorithms. These discoveries are expanding both gene-editing and diagnostic possibilities, with early lab tests showing reduced off-target effects and improved precision. Enzyme engineering efforts also continue to improve recombinant protein stability and function across various conditions, broadening global usability.

Moreover, in January 2025, researchers from the Broad Institute of MIT and Harvard, in collaboration with Cyrus Biotechnology, engineered two CRISPR nucleases, Cas12 and Cas9, to evade detection by the immune system. By identifying protein sequences on each nuclease that trigger immune responses, the team utilized computational modeling to design new versions that avoid immune recognition. Engineered enzymes demonstrated similar gene-editing efficiency while significantly reducing immune responses when tested in mice. This breakthrough marks a significant advancement in improving the safety and effectiveness of CRISPR-based therapies.

Additionally, in January 2025, AstraZeneca and Synthego signed a licensing agreement with AstraZeneca, to manufacture and distribute eSpOT-ON, a CRISPR gene-editing enzyme developed by AstraZeneca, to the worldwide research community. This advanced nuclease, developed by AstraZeneca, will be paired with Synthego's top-tier guide RNA (gRNA) to enhance gene-editing precision, aiming to improve health outcomes across various therapeutic applications.

These developments underscore CRISPR’s evolving role in diagnostics and its growing potential to revolutionize healthcare response and disease management.

Innovations And Key Competitors In The Diagnostic Enzymes Market:

The market is witnessing considerable product expansion. A notable instance occurred in February 2022, when Takara Bio Inc. expanded its Center for Gene and Cell Processing (CGCP) facility in Shiga, Japan. This expansion, which commenced operations in 2020, includes the addition of advanced equipment such as 200 L bioreactors, 2,000 L fermenters, and large-flow centrifuge and purification systems. This investment is expected to enhance the company’s production capacity, enabling it to meet the increasing demand for Diagnostic Enzymes. The key players operating in the market are further 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.

In addition to innovative product launches and partnerships, strategic activities by key market players and the launch of technologically advanced products will create lucrative opportunities in the diagnostics enzymes market.

The global diagnostics enzyme market is experiencing significant growth, driven by the rising demand for point-of-care testing (POCT). This trend is transforming healthcare delivery by decentralizing diagnostics, reducing turnaround times, and improving patient outcomes. Enzymes, as critical components of POCT devices, are playing a pivotal role in enabling this transformation. Below, we explore the key drivers, market trends, and innovations fueling the demand for POCT and its impact on the diagnostics enzyme market.

Key Competitors landscape analysis

Major players utilize inorganic growth strategies to expand their product & service offerings in different regions, which results in increased share and opening up of new revenue streams. This enables the companies to benefit from economies of scale, allowing them to provide competitive prices and top-notch client services. Moreover, by continuing to spend on R&D to enhance the effectiveness and dependability of diagnostic enzymes, these businesses seek to increase their competitiveness even more. 

Recent strategic initiatives by key companies

Company Profile

Thermo Fisher Scientific, Inc. 

Company Overview:

• Headquarters: Waltham, Massachusetts, U.S.

• Founded: 2006 (merger of Thermo Electron and Fisher Scientific)

• Ownership: Public (NYSE: TMO)

• Revenue: 42.88 Billion (2024)

• Specialization: Thermo Fisher is a global leader in scientific instrumentation, reagents, consumables, and software services. In diagnostics, it provides critical enzyme-based reagents and platforms used in clinical chemistry, molecular diagnostics, and infectious disease testing.

• Global Presence: Operations in over 50 countries with manufacturing, R&D, and distribution hubs across North America, Europe, and Asia-Pacific.

Product Benchmarking:

Thermo Scientific Enzyme-Based Diagnostic Reagents

Purpose:
These enzyme reagents are used in automated clinical chemistry analyzers to detect a variety of diseases, including liver dysfunction, myocardial infarction, and metabolic disorders.

Key Enzyme Reagents Include:

• ALT/GPT (Alanine Aminotransferase) - Liver function testing

• AST/GOT (Aspartate Aminotransferase) - Cardiac and liver diagnostics

• ALP (Alkaline Phosphatase) - Liver and bone disease markers

• LDH (Lactate Dehydrogenase) - Myocardial infarction and hemolysis marker

• GGT (Gamma-glutamyl Transferase) - Alcoholic liver disease testing

Features:

• Liquid-stable and ready-to-use formulations

• Optimized for high-throughput clinical chemistry systems (e.g., Indiko, Konelab, and other analyzers)

• High sensitivity and linearity

• Long shelf life and minimal calibration requirements

Clinical Use:

• Hospitals and laboratories use these enzyme reagents for routine and emergency diagnostic testing

• Supports biochemical assessment of liver, heart, pancreas, and metabolic disorders

• Integrated with Thermo Fisher clinical analyzers and middleware for LIS connectivity

Lyo-Ready PCR Enzymes and Reverse Transcriptases

Purpose:
Thermo Fisher Scientific's Lyo-Ready enzymes are designed for molecular diagnostics, enabling the development of lyophilized (freeze-dried) assays suitable for point-of-care (POC) testing. These enzymes maintain high performance while being compatible with lyophilization processes, facilitating the creation of stable, room-temperature assays.

Features:

• Lyophilization-Compatible: Formulated with minimal glycerol content (<0.1-0.5%) to ensure stability during freeze-drying.

• Room-Temperature Stability: Enables storage and transport without the need for cold chains, crucial for POC applications.

• High Performance: Retains sensitivity, specificity, and reproducibility akin to conventional enzymes.

• Versatility: Compatible with various molecular techniques, including RT-qPCR, LAMP, and RPA.

• Quality Assurance: Manufactured under ISO 13485 standards, ensuring consistency and reliability.

Product Portfolio:

• Reverse Transcriptases:

  • Lyo-Ready SuperScript III Flash Reverse Transcriptase: Optimized for 1-step RT-qPCR applications.

  • SuperScript IV Reverse Transcriptase: Suitable for 2-step RT-qPCR, RT-PCR, LAMP, and cDNA synthesis.

  • Maxima H Minus Reverse Transcriptase: Designed for 2-step RT-qPCR and other applications requiring high thermostability.

  • RevertAid H Minus Reverse Transcriptase: Ideal for 2-step RT-qPCR, RT-PCR, and cDNA synthesis.

• DNA Polymerases:

  • Platinum II Taq DNA Polymerase: Hot-start enzyme for high-specificity PCR.

  • AmpliTaq Gold DNA Polymerase: Provides robust performance across various PCR applications.

  • Phusion Hot Start II DNA Polymerase: Offers high fidelity for applications requiring accurate DNA amplification.

• Isothermal Amplification Enzymes:

  • Bst DNA Polymerase: Suitable for LAMP, HAD, EXPAR, RCA, and RPA techniques.

  • EquiPhi29 DNA Polymerase: Designed for MDA, WGA, and RCA applications.

• RNase Inhibitors:

  • RNaseOUT RNase Inhibitor: Protects RNA from degradation during reactions.

  • RiboLock RNase Inhibitor: Ensures RNA integrity across various applications.

Clinical Use

These Lyo-Ready enzymes are integral in developing molecular diagnostic assays, particularly for POC testing. Their stability and performance make them suitable for detecting various pathogens, including viruses and bacteria, in decentralized settings without the need for complex laboratory infrastructure.