Diagnostic Specialty Enzymes Market – Product (Polymerases and Nucleases, Proteases, Oxidases, Carbohydrase), Application (Clinical Chemistry [Blood Glucose Monitoring, POC Testing], Immunoassay, Molecular Diagnostics) – Global Forecast (2024 – 2032)

Diagnostic Specialty Enzymes Market – Product (Polymerases and Nucleases, Proteases, Oxidases, Carbohydrase), Application (Clinical Chemistry [Blood Glucose Monitoring, POC Testing], Immunoassay, Molecular Diagnostics) – Global Forecast (2024 – 2032)

Diagnostic Specialty Enzymes Market Size

Diagnostic Specialty Enzymes Market size was valued at USD 1.1 billion in 2023 and is anticipated to showcase growth at 8.1% CAGR from 2024 and 2032. Factors such as increasing adoption of molecular diagnostic tests, increasing demand for timely diagnosis of chronic diseases, and rapid adoption of point of care testing technologies are driving the revenue growth in market. Additionally, advances in enzyme production technology are also supporting the revenue growth in the market.

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Diagnostic specialty enzymes are category of enzymes that are specifically intended for use in diagnostic assays and tests to detect, quantify, and analyze biomarkers, pathogens, genetic variations, and other molecules associated with diseases or health conditions. Diagnostic enzymes have high specificity for their respective substrates, which ensures accurate detection and minimal interference from other components in the sample to be diagnosed.

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Diagnostic Specialty Enzymes Market Trends

• Growing research in enzyme production and engineering is leading to the development of new enzymes with enhanced properties, such as improved specificity, stability, and catalytic efficiency, and higher yield of enzymes during production. Vendors are increasingly focusing towards surging the production efficiency of diagnostic specialty enzymes for enabling their commercial production.
• For instance, as part of the Smart Cell Project initiated by the New Energy and Industrial Technology Development Organization (NEDO), Asahi Kasei Pharma collaborated with the National Institute of Advanced Industrial Science and Technology (AIST) to enhance the production efficiency of cholesterol esterase, a specialty diagnostic enzyme.
• Vendors are increasingly focusing towards offering specialty enzymes as an individual product rather than as a part of kit. Availability of individual specialty enzymes has enabled the medical diagnostic settings to customize the assays and workflows as per the requirements.
• The COVID-19 pandemic has accelerated the adoption of point-of-care (POC) testing and rapid diagnostics technologies, to facilitate early diagnosis, and treatment of patients. POC testing has helped in providing rapid results within few minutes to hours, compared to traditional laboratory-based testing, thereby increasing the demand for diagnostic specialty enzymes globally.

Diagnostic Specialty Enzymes Market Analysis

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Based on product, the market is segmented into polymerases and nucleases. proteases, oxidases, carbohydrase, and other products. The polymerase and nucleases segment held the majority of market share in 2023 of about 34.5%.

• The dominating share of polymerase and nucleases segment can be attributed to increasing adoption of molecular diagnostic testing across in-vitro diagnostic testing laboratories. Polymerase and nucleases find extensive applications in molecular diagnostic testing such as polymerase chain reaction (PCR) and Reverse Transcription PCR (RT-PCR). With the growing adoption of PCR, the demand for polymerase and nucleases enzymes is increasing globally.
• Moreover, technological advancements in polymerase and nuclease-based assays have led to the development of highly sensitive, specific, and rapid diagnostic tests. Advent of isothermal amplification methods and CRISPR-based diagnostic platforms further expand the applications of polymerases and nucleases in point-of-care testing, thereby increasing the revenue growth in the segment

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Based on application, the diagnostic specialty enzymes market is classified into molecular diagnostics, immunoassay, clinical chemistry, and other applications. The molecular diagnostics segment dominated the market with a revenue of about USD 389.6 million in 2023.

• Leading share of molecular diagnostics segment can be attributed to their growing approval by regulatory authorities such as U.S. FDA and European Union (EU), post COVID-19. According to the US FDA, by April 2023, about 28 Multi-analyte and 8 Serial screening molecular diagnostic tests were approved for diagnosing COVID-19.
• Moreover, molecular diagnostic tests offer high specificity and sensitivity over other testing methodologies, thereby increasing the trust of diagnostic settings on these tests. Enzymes used in these tests, such as DNA polymerases and nucleases, play critical roles in amplifying and analyzing nucleic acids with exceptional accuracy. This contributes to the dominating share of molecular diagnostic segment in the market.

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North America diagnostic specialty enzymes market accounted for 40.6% of market share in global market in 2023 and is predicted to reach USD 840.4 million by 2032.

• Increasing adoption of new and advanced diagnostic tests such as digital PCR, Homogenous EIA, and point of care glucose monitoring tests in the region is also driving the demand for diagnostic specialty enzymes.
• Moreover, North America is a hub for prominent players in the market, encompassing manufacturers, suppliers, and distributors of enzyme-based reagents and diagnostic assays. These companies capitalize on their extensive knowledge, resources, and established market position, contributing to the revenue growth in the region.

The U.S. diagnostic specialty enzymes market was valued at USD 386.2 million in 2023 and is anticipated to grow at a CAGR of 7.6% over the forecast period.

• Presence of well-established infrastructure in diagnostic sector in the country supports the adoption and utilization of advanced diagnostic technologies in the U.S, which aids the revenue growth in the market.
• Moreover, significant rise in awareness among patients for early disease diagnosis and treatment has fueled the demand for diagnostic testing in the U.S. This has catered to an increasing demand for diagnostic specialty enzymes among enzyme manufacturers.
• Furthermore, to cater to an increasing demand of diagnostic tests, the diagnostic specialty enzyme manufacturers are increasingly focusing towards expanding their existing enzyme production facilities to meet the growing demand in the country. For instance, in April 2024, EKF Diagnostics Holdings plc announced the opening of their new state-of-the-art Life Sciences manufacturing site in Indiana, United States.

Germany diagnostic specialty enzymes market is expected to show significant growth opportunities during the forecast period.

• Increasing availability of investments for developing advanced diagnostic testing platforms in the country is expected to raise the demand for diagnostic specialty enzymes that are part of the kits suitable for performing advanced diagnostic tests. For instance, in October 2022, European Investment Bank (EIB) announced to offer USD 16.2 million to Spindiag GmbH for the development and commercialization of rapid PCR testing platform.
• Growing adoption for advanced blood glucose monitoring and point of care diagnostic testing in Germany is driving the demand for diagnostic specialty enzymes in the country. According to the Robert Kosch Institute, about 70% of adolescents and children with type 1 diabetes in Germany used continuous glucose monitoring in 2019.

India diagnostic specialty enzymes market is anticipated to grow remarkably over the coming years.

• Increasing burden of chronic diseases in the country is driving the demand for diagnostic testing in the country. Presence of large number of public and private diagnostic settings (about 100,000-110,000 as per 2023 study from Healthcare Federation of India).
• Moreover, high healthcare expenditure on diagnostic testing is also supporting the significant revenue in market in India. For instance, according to the 2023 study from Healthcare Federation of India, about 5% of healthcare expenditure is spend on diagnostics in India.

Diagnostic Specialty Enzymes Market Share

The market is fragmented owing to the presence of large number of established and small-scale vendors globally. Established players in the market have substantial financial resources to invest in research and development, acquisition, and expansion of existing enzyme production capacities. This offers them competitive edge over their rivals. Small companies are majorly involved in the researching and developing new diagnostic specialty enzymes focusing on niche areas or specific type of diagnostic testing technologies, which has contributed to the overall diversity in the market.

Diagnostic Specialty Enzymes Market Companies

Prominent players operating in the market include

• Agilent Technologies, Inc.
• Amano Enzymes Inc.
• American Laboratories, Inc.
• BBI Solutions
• Biocatalysts Ltd. (BRAIN Biotech Group)
• Bio-Rad Laboratories, Inc.
• Codexis, Inc.
• F. Hoffmann-La Roche Ltd.
• Merck KGaA
• New England Biolabs
• Novozymes A/S
• QIAGEN NV
• SEKISUI Diagnostics
• Takara Bio Inc. 
• Thermo Fisher Scientific Inc.

Diagnostic Specialty Enzymes Industry News

• In January 2024, Novozymes A/S announced its merger with Chr. Hansen to establish new company, Novonesis. The merger aims to create a leading global biosolutions provider featuring a broad biological toolbox and a diversified product portfolio.
• In November 2022, Amano Enzyme, Inc. announced an establishment of its new Europe, Middle East and Africa (EMEA) hub at Milton Park (UK) to serve the company’s growing customer base efficiently.

The diagnostic specialty enzymes market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 - 2032 for the following segments

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Market, By Product

• Polymerases and nucleases
• Proteases
• Oxidases
• Carbohydrase
• Other products

Market, By Application

• Molecular diagnostics
• Immunoassay
• Clinical chemistry
  • Blood glucose monitoring
  • POC testing
  • Other clinical chemistry tests
• Other applications

The above information is provided for the following regions and countries

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa