| Study Period | 2019 - 2030 |
| Market Size (2025) | USD 1.50 Billion |
| Market Size (2030) | USD 2.22 Billion |
| CAGR (2025 - 2030) | 8.12 % |
| Fastest Growing Market | Asia-Pacific |
| Largest Market | North America |
| Market Concentration | Low |
Major Players*Disclaimer: Major Players sorted in no particular order |
Diagnostic Enzymes Market Analysis
The Global Diagnostics Enzyme Market size is estimated at USD 1.50 billion in 2025, and is expected to reach USD 2.22 billion by 2030, at a CAGR of 8.12% during the forecast period (2025-2030).
While COVID-19 severely impacted the pharmaceutical and biotechnology sectors for a brief time due to the lockdown scenario, it eventually helped them by an opportunity to make and launch new drugs or vaccines against COVID-19. Many companies are developing COVID-19 vaccines and their adjuvants in a very short time by putting every resource available on their disposable as an imminent threat of COVID-19 looms over the world. The same goes for the diagnostics enzyme manufacturing companies, as they are now busy with several things related to COVID-19, such as COVID-19 diagnostic kits, identification and analysis of the spike proteins, development of new enzyme-based treatment methods, and many other things. For example, after the COVID-19 outbreak, researchers identified SARS-CoV-2 virus binds to an enzyme present in the human body, called angiotensin-converting enzyme 2, which normally regulates blood pressure in the human body (PubMed, July 2020), and now researchers are working on this breakthrough to get the cure for COVID-19. Apart from this, other studies are going on as well.
The major growth factors for the diagnostics enzyme market are the increasing adoption of enzyme-based diagnostic tests, the innovations in diagnostics technologies, new innovations and development in the biotechnology domain, increasing chronic and infectious diseases, and huge funding in R&D for the same. Over the years, the biotechnology sector became one of the fastest-growing markets because of new R&D. For example, clustered regularly interspaced short palindromic repeats (CRISPR) technology opened new gates for recombinant DNA technology in the medical, pharmaceutical, and other sectors. Other factors responsible for the growth of the diagnostic enzyme market are the rise in infectious and other chronic diseases, increasing interest of companies toward the enzyme because of its dynamic functions, and the growing geriatric population, worldwide. As per the United Nation's World Ageing Highlight of 2020, about 727 million people were aged 65 and above, living all over the world, and this number is expected to reach 1.5 billion people by 2050, which may also complement the growth of the diagnostics enzyme market.
The major restraining factor for the growth of the diagnostic enzyme market is the high sensitivity of enzymes toward pH and temperature. Enzymes are proteins that require an optimum condition to be stable and perform their function in two important factors: optimum pH and temperature. A slight difference in these two factors may denature the enzyme leading to no or very poor results from the diagnostic kit. Moreover, in most of the countries except developed countries, the logistics and storage conditions are not as good as they should be to maintain the optimum condition for the enzyme. Another factor is the cost of the enzyme, which is usually very high due to the high cost associated with the production and isolation of the enzyme.
Diagnostic Enzymes Market Trends
Nuclease Enzymes are Expected to Dominate the Diagnostic Enzyme Market During the Forecast Period
The nuclease enzymes are two of the most necessary and crucial enzymes with a wide array of applications in pharmaceuticals and R&D in biotechnology, clinical diagnostics, and others. Therefore, these enzymes are essential for all pharmaceutical and biotechnology companies and molecular biology research institutes.
The use of nuclease enzymes is expected to increase manifolds during the forecast period due to new ongoing research in DNA sequencing and DNA amplification, RNA sequencing and RNA amplification, and the development of nucleases-based diagnostic kits for the detection of infectious diseases and some other applications. For example, in May 2020, Co-Diagnostics successfully tests a nuclease-based testing kit to identify COVID-19 in cancer cells known as Logix Smart. Similarly, in August 2020, Sherlock Biosciences entered 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. Additionally, the rising demand and acceptance of personal and precision medicine for various chronic and genetic diseases is expected to increase the demand for nuclease enzymes in the forecast period.
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North America is Expected to Dominate the Market of Diagnostics Enzyme During the Forecast Period
The North American region includes the United States, Canada, and Mexico. Due to huge funding in the R&D by the government as well as private players and the presence of key market players in North America, there is expected to be significant growth in North America in the market studied and occupy a major share in the diagnostics enzyme market during the forecast period.
In North America, the major growth is expected to be observed in the United States, as it is more technologically advanced than the rest of the world and R&D spending of the United States is very high. According to the National Center for Science and Engineering Statistics, in 2018, the total R&D cost of the United States was about USD 606.1 billion. Moreover, based on performance reports, it was estimated that in 2019 the total capital investment in R&D will be around USD 656 billion. The other reason for the major share of the United States is the presence of key market players who are innovating and launching new products, world-class research institutes run by some of the most prominent scientists (Nobel laureates too), technologically advanced biotechnology companies, and awareness among the public. For instance, in January 2021, Thermo Fisher Scientific announced the acquisition of a molecular diagnostics company known as Mesa Biotech Inc. based in San Diego.
After the United States, Canada may occupy the second-largest share in the diagnostics enzyme market in North America, followed by Mexico. Canada is following the path of the United States and investing heavily in R&D in the pharmaceutical and biotechnology sector, apart from improving its health infrastructure and awareness among the public.
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Diagnostic Enzymes Industry Overview
The diagnostics enzyme market is expected to be highly competitive due to the huge multinational enzyme companies, new biotechnology companies in the market, and their advanced and critical research and innovations. Some of the major market players of the diagnostics enzyme market are Sanofi Genzyme, F Hoffmann-La Roche Ltd, Codexis Inc., Aldevron, Amano Enzymes, Biocatalysts Ltd, Kaneka Eurogentec, etc.
Diagnostic Enzymes Market Leaders
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Sanofi Genzyme
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ThermoFisher Scientific
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Aldevron
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F Hoffmann-La Roche
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Codexis Inc.
- *Disclaimer: Major Players sorted in no particular order
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Diagnostic Enzymes Market News
- In June 2020, Codexis Inc. and Alphazyme LLC signed a partnership deal for the production and co-marketing of the enzymes used in the diagnostics and life sciences market.
- In May 2020, Co-Diagnostics successfully tested a nuclease-based testing kit, Logix Smart, to identify COVID-19 in cancer cells in the human body.
Diagnostic Enzymes Industry Segmentation
As per the scope of the study, the diagnostics enzymes are specialty enzymes used as a component or directly in the assay systems or kits for the determination of different diseases, medical conditions, or disorders. These enzymes have various applications in the detection and diagnosis of various diseases in a very short period. For example, the ELISA (Enzyme-Linked Immunosorbent Assay) test is commonly used for the detection of antibodies and other proteins for diseases, like hepatitis B and AIDS. The diagnostics enzyme market is segmented by type (polymerases and nucleases, carbohydrases, proteases, oxidases, and other types), application (clinical chemistry, molecular diagnostics, and other applications), end user (hospitals, clinical laboratories, and other end users), and geography (North America, Europe, Asia Pacific, Middle-East and Africa, and South America). The report offers the value (in USD million) for the above segments.
| By Type | Polymerases and Nucleases | ||
| Carbohydrases | |||
| Proteases | |||
| Oxidases | |||
| Other Types | |||
| By Application | Clinical Chemistry | ||
| Molecular Diagnostics | |||
| Other Applications | |||
| By End Users | Hospitals | ||
| Clinical Laboratories | |||
| Other End Users | |||
| By Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Rest of Europe | |||
| Asia Pacific | China | ||
| Japan | |||
| India | |||
| Australia | |||
| South Korea | |||
| Rest of Asia Pacific | |||
| Middle-East and Africa | GCC | ||
| South Africa | |||
| Rest of Middle-East and Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
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Diagnostic Enzymes Market Research FAQs
How big is the Global Diagnostics Enzyme Market?
The Global Diagnostics Enzyme Market size is expected to reach USD 1.50 billion in 2025 and grow at a CAGR of 8.12% to reach USD 2.22 billion by 2030.
What is the current Global Diagnostics Enzyme Market size?
In 2025, the Global Diagnostics Enzyme Market size is expected to reach USD 1.50 billion.
Who are the key players in Global Diagnostics Enzyme Market?
Sanofi Genzyme, ThermoFisher Scientific, Aldevron, F Hoffmann-La Roche and Codexis Inc. are the major companies operating in the Global Diagnostics Enzyme Market.
Which is the fastest growing region in Global Diagnostics Enzyme Market?
Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Global Diagnostics Enzyme Market?
In 2025, the North America accounts for the largest market share in Global Diagnostics Enzyme Market.
What years does this Global Diagnostics Enzyme Market cover, and what was the market size in 2024?
In 2024, the Global Diagnostics Enzyme Market size was estimated at USD 1.38 billion. The report covers the Global Diagnostics Enzyme Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Global Diagnostics Enzyme Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
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Statistics for the 2025 Global Diagnostics Enzyme market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Global Diagnostics Enzyme analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
