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. 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. * Interested in Company Profiles?
Connect with Us for Detailed Profiles 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
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