Diagnostic Enzymes Market Size, Share, Growth | Forecast 2031

Report Description

The global diagnostic enzymes market size was valued at USD 4.89 Billion in 2022 and is likely to reach USD 7.02 Billion by 2031, expanding at a CAGR of 4.1% during 2023–2031. The market growth is driven by the rising prevalence of chronic disease and increasing healthcare expenditures.

The demand for diagnostic enzymes is growing in several sectors due to rising cases of chronic and infectious diseases worldwide. These factors have driven increased interest from companies in leveraging enzymes’ dynamic functions for diagnostic purposes. Furthermore, the rising global geriatric population caters to the demand for diagnostic kits.

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• For instance, The United Nations' World Ageing Report of 2020, projects a substantial increase in the number of people aged 65 and above by 2050. This demographic shift is expected to complement the diagnostics enzyme market's expansion.

Diagnostic enzymes play a crucial role in detecting and quantifying various substances in the body. They are specialized proteins known for their high specificity, making them effective biocatalysts in accelerating biochemical reactions for desired results. These enzymes are increasingly preferred by industry professionals as they are very useful in dealing with limited sample volumes and expensive reagents.

They play a crucial role in monitoring changes in biomolecule concentrations, which can serve as indicators for various conditions. These enzymes are capable of detecting abnormal metabolic activities, infections (both infectious and noninfectious diseases), and inflammatory conditions.

Diagnostics enzymes have gained popularity in detecting various chronic conditions like cardiovascular diseases, cancer, pain, and inflammatory disorders The adoption of advanced enzymes such as immobilized enzymes with enhanced stability brings significant advancements in various fields including medicine and biotechnology.

The market report finds that the COVID-19 pandemic boosted the global diagnostics enzymes market. The pandemic had a significant initial impact on the pharmaceutical and biotechnology sectors during the lockdown period. However, it also helps industries with a unique opportunity to develop and launch new drugs or vaccines to combat the virus. Companies in these sectors mobilized all available resources to develop COVID-19 vaccines and their adjuvants, responding to the urgent global threat posed by the pandemic.

Diagnostic enzyme manufacturing companies shifted their focus to address various aspects related to COVID-19. They have been actively involved in producing COVID-19 diagnostic kits, researching and analyzing spike proteins of the SARS-CoV-2 virus, and exploring new enzyme-based treatment methods.

• For instance, as per the data published by the National Institutes of Health in 2020, the discovery was made after the COVID-19 outbreak, where researchers identified that the SARS-CoV-2 virus binds to a human enzyme called angiotensin-converting enzyme 2, which normally regulates blood pressure. This breakthrough has spurred further research toward finding potential cures for COVID-19.

Diagnostic Enzymes Market Dynamics

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Major Drivers

Increasing adoption of enzyme-based diagnostic tests is one of the factors that drive the diagnostic enzymes market growth. Enzymes are known for their high specificity and sensitivity, enabling them to precisely detect and quantify specific biomolecules or substances in biological samples. This accuracy makes enzyme-based tests reliable and effective in diagnosing various diseases and conditions.

Diagnostic enzymes can be adapted for use in various diagnostic techniques, such as enzyme-linked immunosorbent assays (ELISAs), polymerase chain reactions (PCR), and molecular diagnostics. Their versatility makes them valuable tools for a wide range of medical conditions and research applications.

Existing Restraints

High sensitivity of enzymes towards pH and temperature hampers the global diagnostic enzymes market. Enzymes require specific optimum conditions to remain stable and perform their functions effectively.

Even slight variations in pH and temperature can denature the enzymes leading to unreliable or inadequate results from diagnostic kits. Additionally, in many countries especially in developing regions, logistics and storage conditions are not ideal for maintaining the required conditions for enzyme stability.

Emerging Opportunities

Increasing research and development in the developing region creates lucrative opportunities for the market. The increasing adoption of enzyme-based diagnostic tests, joined with ongoing innovations in diagnostics technologies is fueling the market.

Advancements in the biotechnology domain such as CRISPR technology have opened new avenues for recombinant DNA technology that impact various sectors such as medical and pharmaceutical fields. Technological advancements aimed at producing enzymes with advanced diagnostic features and increased resistance against deterioration offer opportunities for manufacturers in this market.

Scope of Diagnostic Enzymes Market Report

The market report includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Diagnostic Enzymes Market Segment Insights

Type Segment Analysis

Based on type, the global diagnostic enzymes market is divided into proteases, oxidases, polymerases & nucleases, carbohydrates, and others. The proteases segment is expected to expand at a major growth rate during the projection period due to growing advancements in proteomics research and diagnostic test development.

Proteases are enzymes that break down proteins into smaller peptides or amino acids. They play a crucial role in various diagnostic applications, including proteomics research, disease biomarker discovery, and protein analysis. The demand for proteases in diagnostic tests was growing due to their essential role in the study of protein-related diseases and the identification of specific protein targets for diagnostic purposes.

Biomarkers are molecules that indicate the presence or progression of a disease. Proteases are involved in the cleavage and modification of proteins, making them important tools in identifying disease-specific biomarkers. Proteases are utilized in the development of various diagnostic tests that rely on protein analysis. Enzyme-linked immunosorbent assays (ELISAs) and other immunoassays often use proteases in sample preparation steps to facilitate the detection of target proteins.

The polymerases & nuclease segment is expected to expand at a significant growth rate in the coming years due to increasing advancements in molecular diagnostics and rising infectious disease testing. Molecular diagnostics involve the detection and analysis of nucleic acids (DNA and RNA) in patient samples and have revolutionized the field of diagnostic testing.

Nucleases play a vital role in various molecular diagnostic techniques such as PCR, DNA sequencing, and nucleic acid-based assays. The increasing adoption of molecular diagnostics for accurate and rapid disease detection has driven the demand for nucleases.

Nucleic acid-based tests have become essential tools in the diagnosis of infectious diseases. Nucleases are used to extract and prepare nucleic acids from patient samples, enabling the detection of specific pathogens such as viruses and bacteria. There has been a surge in the demand for nucleases in infectious disease testing, including COVID-19 helps in driving the segment.

• For instance, Sherlock Biosciences announced a collaboration with Dartmouth-Hitchcock Health (D-HH) to launch a clinical study of the Sherlock CRISPR nuclease-based SARS-CoV-2 kit for the detection of the SARS-CoV-2 virus that causes COVID-19.

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Sources Segment Analysis

On the basis of sources, the global market is segregated into animals, plants, and microorganisms. The plant segment is projected to register a considerable CAGR during the forecast period due to the presence of a broad range of enzymes and growing demand for natural and sustainable solutions.

There is a growing preference for natural and sustainable alternatives in various industries including diagnostics. Plant-derived enzymes offer a renewable and eco-friendly source for enzymatic reactions, reducing the reliance on animal-derived or synthetic enzymes Growing awareness of environmental concerns there is an increasing demand for plant-based sources in the diagnostics enzymes market. 

Companies present in the market are preferring plant-based diagnostics enzymes as industries and consumers seek more sustainable solutions, plant-derived enzymes are becoming increasingly popular due to their renewable and eco-friendly nature.

Plants produce a wide variety of enzymes with diverse functions. Enzymes derived from plants, such as proteases, amylases, lipases, and cellulases. These plant enzymes find applications in diagnostic assays for their ability to break down specific substrates and aid in various diagnostic processes.

Application Segment Analysis

On the basis of applications, the global diagnostic enzymes market is segmented into molecular diagnostics, immunoassays, and clinical chemistry. The clinical chemistry segment is expected to register a robust growth rate during the forecast period due to rising chronic diseases and increasing the use of enzymes.

Enzymes are widely used in various diagnostic tests to facilitate specific reactions that lead to the detection or quantification of target molecules. Clinical enzymes, such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and creatine kinase (CK). These are crucial biomarkers used to assess organ function and diagnose specific diseases.

It is associated with the analysis of body fluids for therapeutics and diagnostics purposes. Even slight changes in the levels of body fluids, such as plasma, blood, or serum indicate the onset of a life-threatening condition. Thus, analytical techniques involved in clinical chemistry need to be rapid, specific, and highly sensitive.

The increasing prevalence of chronic diseases such as liver diseases, cardiovascular diseases, and diabetes. As the global burden of chronic diseases grows, the demand for diagnostic tests utilizing clinical enzymes as biomarkers also increases. Clinical enzymes are used in various diagnostic tests and assays to assess the health status of patients.

End-user Segment Analysis

Based on the end-users, the diagnostic enzymes market is segregated into hospitals, diagnostic center, and research institutes. The hospital segment is expected to hold a significant market share during the forecast period, due to growing demand for diagnostics and chronic disease management.

Hospitals are among the primary users of diagnostic enzymes as they perform a wide range of medical tests to diagnose and monitor various diseases and conditions. The increasing demand for accurate and timely diagnostic results is driving the diagnostic enzymes market in hospitals. Hospitals play a crucial role in managing chronic diseases, such as diabetes, cardiovascular diseases, and cancer. Diagnostic enzymes are essential in monitoring disease progression and assessing treatment effectiveness in these cases.

The diagnostic center's segment is projected to expand at a considerable growth rate during the projection period due to the increasing number of independent diagnostic centers and the rising adoption of advanced diagnostic technologies. The trend of independent diagnostic centers is growing which offers specialized diagnostic services to patients and healthcare providers.

These centers typically use diagnostic enzymes for a wide range of tests including biochemical assays, immunoassays, and molecular diagnostics. They incorporate diagnostic enzymes for various testing purposes. The adoption of automated systems and high-throughput analyzers in diagnostic centers is boosting the demand for diagnostics enzymes in these settings.

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Regional Analysis

In terms of region, the global diagnostic enzymes market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is expected to dominate the market during the projection period due to the growing technological advancements and well-established healthcare infrastructure.

North America is recognized for research and innovation in the biotechnology and healthcare sectors. The region has a strong presence of leading biotech and pharmaceutical companies, which continually invest in research and development to advance diagnostic technologies, including enzyme-based tests.

The healthcare infrastructure in North America is highly developed and provides a conducive environment for the adoption of advanced diagnostic solutions. The availability of developed laboratories and medical facilities allows for the widespread implementation of diagnostic enzymes in clinical practice.

• For instance, in January 2021, Thermo Fisher Scientific made headlines with its acquisition of Mesa Biotech Inc., a San Diego-based molecular diagnostics company. This strategic move signaled its commitment to expanding its presence in the molecular diagnostics market, further strengthening its capabilities in providing advanced diagnostic solutions.

The market in Asia Pacific is projected to grow rapidly during the forecast period, owing to rising population and increasing healthcare expenditure. Asia Pacific is home to a substantial and diverse population that caters to the demand for diagnostic enzyme-based tests.

The rising population also means a higher demand for accurate and efficient diagnostic solutions to address healthcare needs. In the region increasing healthcare expenditure allows for greater investment in advanced diagnostic technologies, including enzyme-based tests, to improve healthcare outcomes.

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