In-Vitro Diagnostics Enzymes Market Size to Surpass USD 4.10 Bn by 2033

The global in-vitro diagnostics enzymes market size was estimated at USD 2.34 billion in 2024 and is projected to surpass around USD 4.10 billion by 2033, expanding at a CAGR of 6.42% from 2024 to 2033. The North America in-vitro diagnostics enzymes market size is predicted to increase from USD 920 million in 2023 to approximately USD 1,720 million by 2033.           

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Market Overview and Industry Potential

In-vitro diagnostic tests diagnose and detect certain diseases and infections by taking blood or tissue samples from patients inside laboratories. These tests are performed in test tubes or the respective reaction assembly and apparatus following standard reaction protocols. Researchers and clinicians prefer different reaction components including enzymes, reaction buffers, reagents, etc. for achieving precision and accuracy in their test performance. These in-vitro diagnostics enzymes offer reliability and adaptability as they are manufactured by maintaining quality management systems (QMS) and careful documentation of production processes according to ISO standards.

The regulatory guidelines are also followed in the in-vitro diagnostics manufacturing to keep the final test product sellable and compliant. The audit inspection of in-vitro diagnostics manufacturing facilities is conducted by governing bodies to verify safety and quality compliance. Thermo Fisher Scientific, Sigma-Aldrich, QIAGEN, EKF Diagnostics, etc. are some dedicated diagnostics manufacturing companies that provide several enzymes and enzyme master mix solutions to conduct immunobiological assays.   

·         The Department of Biotechnology supported more than 80 R&D projects on genome editing technologies including CRISPR-Cas-Based gene editing technologies, genetic engineering, and other cutting-edge, high-throughput tools and their healthcare applications. During the COVID-19 pandemic, one of the most reliable enzymes used for RT-PCR, q-PCR, and LAMP assays is Moloney Murine Leukemia Virus Reverse Transcriptase (M-MLV).

·         The rise in the adoption of in-vitro diagnostics tests is the key driving force for the growth of the in-vitro diagnostics enzymes market along with the innovations by the leading market players like F.Hoffmann-La Roche Ltd, Biocatalysts Ltd, etc. 

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In-Vitro Diagnostics Enzymes Market Major Trends

·         Development and Implementation of Molecular Tests: In-vitro diagnostics tests are performed with the help of standardized instruments, standard procedures, and appropriate training. A clinical validation, data analytics, and bioinformatics play major roles in developing tests for sale to health clinics, diagnostic laboratories, or consumers. These tests offer technical support from suppliers for troubleshooting and replacement of faulty products and they require less time and effort to maintain in-house IVD inventories.

·         Enzyme Engineering to Improve Catalytic Properties of Enzymes: Protein engineering is an effective approach to optimize the biochemical properties of biocatalysts which include thermos stability, kinetic properties, substrate specificity, shelf-life, solvent stability, etc. These enzymes with enhanced properties have a wide range of applications in industries like cosmetics, dairy, beverage, baking, detergent, food, pharmaceutical, paper and pulp, textile, etc.

·         Emergence of Activity-based Diagnostics: The efforts from molecular biology diagnostics sector, bioengineering, and chemical biology introduced a smart diagnostics approach that utilizes enzymatic activity to measure or produce biomarkers of a particular disease. These tests reduce the dependence on specialized substrate recognition and signal amplification properties of enzymes to achieve specific and sensitive detection of diseases. Molecular and chemical probes contribute to the monitoring of dysregulated enzyme activity as a functional biomarker of disease. Molecular and biological tools utilize enzymatic activity for sensing, measuring, and reporting a diseased state.

In-vitro Diagnostics Enzymes Market Report Coverage

Report Attributes

Key Statistics

Market Size in 2024

USD 2.34 Billion

Market Size in 2025

USD 2.49 Billion

Market Size by 2033

USD 4.10 Billion

Growth Rate from 2024 to 2033

6.42%

Base Year

2023

Forecast Period

2024 to 2033

Dominating Region

North America

Fastest Growing Region

Asia Pacific

Segments Covered

By Enzyme Type, By Disease Type, By Technology Type, By End-use, and Region

Regions Covered

North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa

Key Players

Biocatalysts Ltd., Amicogen, Dyadic International, BBI Solutions, Affymetrix, American Laboratories, Merck KGaA, Codexis, Inc., F. Hoffmann-La Roche Ltd., Amano Enzyme Inc., Advanced Enzymes Technologies Ltd., and Others.

In-vitro Diagnostics Enzymes Market Geographical Analysis

U.S. In-vitro Diagnostics Enzymes Market Size and Growth 2024 to 2033

The U.S. in-vitro diagnostics enzymes market size was valued at USD 790 million in 2024 and is estimated to be worth around USD 1,380 million by 2033, growing at a solid CAGR of 6.60% from 2024 to 2033.

A graph showing the growth of the us in vitro

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North America dominated the in-vitro diagnostics enzymes market in 2023 due to favorable government initiatives and funding support from healthcare organizations. The Advanced Research Projects Agency for Health promotes the mission of the National Institute of Health to achieve the knowledge of healthcare and living systems for its applications in enhancing health and life by reducing illnesses.

With continued efforts, scientists in the United States have successfully developed several vaccines to save the nation. The adoption of precision medicine greatly increased due to its potential to identify patients’ adaptability to certain treatments and medications. The healthcare systems also adopted next-generation sequencing tests that are ideal in the scanning of a person’s DNA to detect genomic variations.

The convenience of performing tests in laboratories, healthcare settings, or at home increased the rate of adoption of these molecular or immunological techniques. Sigma-Aldrich offers several enzyme products like proteinase K, G6P-DH, etc. The National Human Genome Research Institute supports research projects by providing funding opportunities in fields like bioinformatics and computational biology, ethical, legal, and social implications, science and effectiveness of medicine, etc.  

·         In November 2024, the National Human Genome Research Institute initiated the Protein Capture Reagents program which aims to develop a community resource of renewable, high-quality protein capture reagents such as antibodies, transcription factor reagents, and tests for next-generation capture technologies.

·         The National Institute of Health supports research and development of innovative healthcare solutions by focusing on two important threats such as drug-resistant infections, and diseases impacted by environmental change.

Asia Pacific is anticipated to be the fastest-growing region during the forecast period due to support from charitable trusts, and government organizations to a broad array of scientific and interdisciplinary research. Scientists are conducting vast experiments related to HIV infection, kidney disease, rheumatic heart disease, etc. which require an extensive network of reaction components including enzymes and reagents.

Industry leadership, leading businesses, practical process improvement business systems, and outstanding financial performance are some of the key factors to drive the success of the in-vitro diagnostics enzymes market. Industries like Thermo Fisher Scientific are offering enzymes that allow flexible assay designs, compatibility with microfluidics solutions, point-of-care testing, and assurance of ISO 13485 quality.

·         In January 2024, QIAGEN announced a strategic investment plan in its QIAGEN Digital Insights business (QDI) to offer the best insights to customers performing clinical research and molecular testing. The QDI, one of the leading bioinformatics players having sales of around $100 million in 2023 will get support from these investments.   

·         Thermo Fisher Scientific offers new-generation enzymes for molecular diagnostics that are present in lyophilized forms. These enzymes are portable, room-temperature stable, and suitable for molecular assays.

Market Segments Analysis:

Enzyme Analysis

The polymerase and transcriptase segment dominated the in-vitro diagnostics enzymes market due to the wide adoption and applications of these enzymes for PCR techniques, medical diagnostics, medicine and biology, molecular biology research, etc. These enzymes offer high precision in PCR testing by detecting mutations or low-abundant genes. PCR reactions are usually performed by using enzymes like DNA polymerase, ligase, reverse transcriptase, and RNA polymerase.

However, the protease segment is expected to grow during the forecast period due to their properties like a breakdown of proteins which is an essential step in many molecular diagnostic tests. These proteases play major roles in ELISA, protein sequencing, amino acid detection, etc.   

Disease Analysis

The infectious disease segment dominated the in-vitro diagnostics enzymes market due to the rising prevalence of infectious disorders caused by bacteria, fungi, parasites, and viruses. A wide range of communicable or non-communicable diseases like HIV, flu, measles, and COVID-19 are growing and their testing requires high-throughput enzymes which drives the need for the in-vitro diagnostics enzymes.

The oncology segment is anticipated to grow in the coming years due to an increased shift toward cancer diagnosis, treatment, and prevention. Researchers and healthcare professionals are continuously making efforts to cancer diagnostics with the help of in-vitro diagnostics enzymes. The detection tests include PCR, ELISA, DNA sequencing, RNA sequencing, etc.

Technology Analysis

The histology assays segment dominated the in-vitro diagnostics enzymes market due to the importance of histological assays in medical diagnosis. The visualization of tissue structures and cell characteristic changes is possible with the help of this technology. These techniques offer exciting work outcomes like improvements in process work-flows, effective patient outcomes, flexible work schedules, and remote accessibility.

The molecular diagnostics segment is expected to grow during the forecast period due to its applications in the early diagnosis and detection of diseases like cancer, congenital abnormalities, and infectious diseases. Molecular diagnostic laboratories effectively perform various test methods like nucleic acid purification, protein purification, DNA isolation, RNA isolation, etc.

End User Analysis

The hospitals and diagnostic segment dominated the in-vitro diagnostics enzymes market due to the involvement of potential end users like hospitals, pharmaceutical and biotechnology companies, molecular diagnostic laboratories, and contract research organizations. Several life science industries are involved in the manufacturing, quality control, distribution, sales, and marketing of enzyme products and diagnostic services all over the world.

The academic segment is expected to grow in the coming years due to the adoption of IVD enzymes by research institutes, small diagnostic centers, and government agencies for performing diagnostic tests for a variety of purposes. IVD kits are launched through thorough research and understanding of the need which includes all reaction assembly components. 

Discover Additional Market Growth with Our Related Reports:

·         The U.S. in vitro diagnostics market size was valued at USD 37.17 billion in 2023 and is anticipated to hit around USD 41.62 billion by 2033, poised to grow at a CAGR of 2% from 2024 to 2033.

·         The global enzyme-linked immunosorbent assay (ELISA) testing market size accounted for USD 2.27 billion in 2024 and is predicted to reach around USD 4.19 billion by 2034, growing at a CAGR of 6.32% from 2024 to 2034.

·         The global artificial intelligence in diagnostics market size is estimated for USD 1.33 billion in 2023 and it is predicted to hit around USD 8.54 billion by 2033, registering a compound annual growth rate (CAGR) of around 20.37% during the forecast period 2024 to 2033.

·         The global point-of-care molecular diagnostics market size accounted for USD 8.1 billion in 2022 and is expected to hit around USD 11.70 billion by 2032, poised to grow at a CAGR of 3.8% during the forecast period from 2023 to 2032.

·         The global next generation cancer diagnostics market size is estimated at USD 17.74 billion in 2024 and is anticipated to reach around USD 38.36 billion by 2034, growing at a CAGR of 8.02% between 2024 and 2034.

Competitive Landscape and Major Breakthroughs in the In-Vitro Diagnostics Enzymes Market

The in-vitro diagnostics enzymes market continues to evolve rapidly and witnessing significant advancements in the years 2023 and 2024 with a dynamic competitive landscape. Major players such as Abbott, Hoffmann-La-Roche, Bio-Rad, EKF Diagnostics, Thermo Fisher Scientific, etc. maintain a dominant position in the in-vitro diagnostics enzymes market. These companies are leveraging their vast resources and expertise to drive innovation and expand their molecular testing capabilities.

In-vitro Diagnostics Enzymes Market Top Companies

·         Biocatalysts Ltd.

·         Amicogen

·         Dyadic International

·         BBI Solutions

·         Affymetrix

·         American Laboratories

·         Merck KGaA

·         Codexis, Inc.

·         F. Hoffmann-La Roche Ltd.

·         Amano Enzyme Inc.

·         Advanced Enzymes Technologies Ltd.

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In September 2024, Roche celebrated Roche Pharma Day 2024 and reported that innovative diagnostics technologies enabled research and development opportunities through collaborations with pharmaceutical and biotechnology companies.  

What is Going Around the Globe?

·         In September 2024, QIAGEN announced that it had received the European IVDR certification for QIAstat-Dx syndrome testing systems and related assays under the In-Vitro Diagnostic Medical Devices Regulation (IVDR) of the European Union.

·         In October 2024, Bio-Rad announced its financial results for the third quarter of 2024 in which the company reached a total net sales of $649.7 million which is a 2.8% increase from the third quarter of 2023.   

The research report categorizes the in-vitro diagnostics enzymes market into the following segments and subsegments:

By Enzyme Type

·         Protease

·         Polymerase and Transcriptase

·         Ribonuclease

·         Others

By Disease Type

·         Infectious Disease

o   COVID-19 Testing

o   Hepatitis

o   HIV

o   Others

·         Diabetes

·         Oncology

·         Cardiology

·         Nephrology

·         Autoimmune diseases

·         Others

By Technology Type

·         Histology Assays

·         Clinical Chemistry

·         Molecular Diagnostics

o   PCR Assay

o   NGS Assay

o   Others

By End User

·         Pharma & Biotech

·         Hospital and Diagnostic Labs

·         Contract Research Organizations (CROs)

·         Academic Labs

By Region

·         North America

·         Europe

·         Asia Pacific

·         Latin America

·         Middle East and Africa

Thanks for reading you can also get individual chapter-wise sections or region-wise report versions such as North America, Europe, or Asia Pacific.

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