The global in-vitro diagnostics enzymes market size was exhibited at USD 2.26 billion in 2022 and is projected to hit around USD 5.33 billion by 2032, growing at a CAGR of 8.98% during the forecast period 2023 to 2032.
Key Pointers:
In-vitro Diagnostics Enzymes Market Report Scope
Report Coverage | Details |
Market Size in 2023 | USD 2.46 Billion |
Market Size by 2032 | USD 5.33 Billion |
Growth Rate From 2023 to 2032 | CAGR of 8.98% |
Base Year | 2022 |
Forecast Period | 2023 to 2032 |
Segments Covered | Enzyme type, Disease type, Technology type, End-use |
Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
Regional Scope | North America; Europe; Asia Pacific; Central and South America; the Middle East and Africa |
Key Companies Profiled | Merck KGaA; Codexis, Inc.; F. Hoffmann-La Roche Ltd.; Amano Enzyme Inc.; Advanced Enzymes Technologies Ltd.; Biocatalysts Ltd.; Amicogen; Dyadic International; BBI Solutions; Affymetrix; American Laboratories |
Accurate and rapid diagnosis and treatment of clinical disorders are essential for optimal clinical outcomes. Owing to the noteworthy biocatalytic properties, enzymes are used in the diagnosis of a wide range of diseases.
The development of enzyme biosensors has increased the enzyme utility in clinical diagnostics. Despite the necessity in clinical diagnosis, the commercialization and translation of biosensors from research to clinics are still low. However, with an increase in R&D efforts, lactate, cholesterol, and glucose biosensors have been commercialized for diagnostic use.
Proteases are important signaling proteins that are critical to a few pathological processes, including cancer, neurological, inflammatory, and cardiovascular disorders. Polymerase and transcriptase enzymes are expected to exhibit the fastest CAGR over the forecast period. In addition, the presence of a substantial number of players that offer these enzymes is expected to enhance the growth. Key players such as Kaneka Eurogentec S.A.; Toyobo Co., Ltd.; and Sekisui Diagnostics, LLC manufacture and distribute a wide range of polymerases, including KOD DNA Polymerase, Taq DNA Polymerase, Tth DNA Polymerase, and TTx DNA Polymerase.
The infectious disease segment dominated the market in 2019. An exponential rise in the COVID-19 cases globally drives the adoption rate of diagnostic enzymes for COVID-19 diagnosis. An increase in the availability of qualitative and quantitative molecular assays based on real-time PCR, Loop-mediated Isothermal Amplification- PCR (LAMP-PCR), multiplex PCR, and digital PCR technologies for the diagnosis of infectious diseases drives the demand for enzymes in this segment.
Enzymatic immunohistochemistry (IHC) is preferred for histology owing to a better contrast ratio and the method’s compatibility for use with multiple stains for the detection of target components. IVD enzymes are employed in different end-use settings for the analysis of tissue specimens and bodily fluids. A wide range of end users including large laboratories that conduct multiple analyses in a day and smaller clinics that conduct a few tests use enzymes for in-vitro diagnostics (IVD).
North America emerged as a prominent regional market in 2022. A rise in the number of cancer cases and the adoption of enzymes for histopathology of biopsy samples are some of the other factors expected to propel market growth in the region. The presence of a large target population, improvements in healthcare infrastructure, high unmet clinical needs, increase in government initiatives, and rise in R&D activities for advanced diagnostic techniques are anticipated to drive the Asia Pacific market with the fastest growth rate.
The key players in the market are involved in novel product launches, acquisitions, collaborations, partnerships, and geographical expansions to reinforce their market presence. For instance, in June 2022, Codexis, Inc. signed a collaboration agreement with Alphazyme LLC for the manufacture and co-marketing of high-fidelity DNA polymerase, T7 RNA polymerase, and reverse transcriptase.
Some of the prominent players in the In-vitro Diagnostics Enzymes Market include:
Segments Covered in the Report
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the global In-vitro Diagnostics Enzymes market.
By Enzyme Type
By Disease Type
By Technology Type
By End-use
By Region
Chapter 1 Research Methodology
1.1 Information Procurement
1.2 Information or Data Analysis
1.3 Market Model
1.3.1 Parent market Study
1.3.1.1 Global enzymes market
1.3.1.2 Global IVD market
1.3.1.3 Market study, by region
1.4 Objectives
1.4.1 Objective 1:
1.4.2 Objective 2:
Chapter 2 Executive Summary
2.1 Market Outlook
2.2 Segment Outlook
2.3 Competitive Insights
2.4 Market Summary
Chapter 3 Market Variables, Trends & Scope
3.1 Market Trends and Outlook
3.2 Market Segmentation and Scope
3.3 Market Lineage Outlook
3.3.1 Parent Market Analysis
3.3.1.1 IVD market
3.3.1.2 MOLECULAR Biology Enzymes And Kits market
3.4 Pricing Analysis
3.4.1 Pricing for Proteases: Bulk Orders
3.4.2 Pricing for Proteases: General Orders
3.4.3 Pricing for IVD Grade Proteases: General Orders
3.5 Impact of COVID-19
3.6 Business Environment Analysis
3.6.1 SWOT Analysis; By factor (Political & Legal, Economic and Technological)
3.6.2 Porter’s Five Forces Analysis
3.7 Penetration and Growth Prospect Mapping for technology type, 2023
Chapter 4 Market Dynamics
4.1 Market driver analysis
4.1.1 Rise in demand for enzyme biosensors for point of care testing
4.1.2 Wide applications of enzymes in pathology
4.1.3 Advancements in diagnostic testing of viral infections
4.2 Market Restraint Analysis
4.2.1 Regulatory & reimbursement hurdles for in-vitro diagnostics
4.2.2 High cost of enzyme-based diagnostic test
4.3 Market Opportunity Analysis
4.3.1 Advances in Molecular Diagnostics Technologies
4.4 Market Challenge Analysis
4.4.1 Challenges associated with clinical chemistry testing
Chapter 5 IVD Enzymes Market: Enzyme Type Estimates & Trend Analysis
5.1 Segment Definition
5.2 Market Formulation and Modelling
5.3 IVD Enzymes Market: Enzyme Type Movement Analysis
5.4 Proteases
5.4.1 IVD proteases market, 2020 - 2032
5.4.2 By Therapeutic Area
5.4.2.1 Segment Definition
5.4.2.2 Infectious diseases
5.4.2.2.1 IVD proteases market for infectious diseases, 2020 - 2032
5.4.2.3 Diabetes
5.4.2.3.1 IVD proteases market for diabetes, 2020 - 2032
5.4.2.4 Oncology
5.4.2.4.1 IVD proteases market for oncology, 2020 - 2032
5.4.2.5 Cardiology
5.4.2.5.1 IVD proteases market for cardiology, 2020 - 2032
5.4.2.6 Nephrology
5.4.2.6.1 IVD proteases market for nephrology, 2020 - 2032
5.4.2.7 Autoimmune Diseases
5.4.2.7.1 IVD proteases market for autoimmune diseases, 2020 - 2032
5.4.2.8 Others
5.4.2.8.1 IVD proteases market for other diseases, 2020 - 2032
5.4.3 By Technology type Use
5.4.3.1 Segment Definition
5.4.3.2 Histology Assays
5.4.3.2.1 IVD proteases market for histology assays, 2020 - 2032
5.4.3.3 Molecular Diagnostics
5.4.3.3.1 IVD proteases market for molecular diagnostics, 2020 - 2032
5.4.3.3.2 PCR Assays
5.4.3.3.2.1 IVD proteases market for PCR assays, 2020 - 2032
5.4.3.3.3 NGS Assays
5.4.3.3.3.1 IVD proteases market for NGS assays, 2020 - 2032
5.4.3.3.4 Others
5.4.3.3.4.1 IVD proteases market for other assays, 2020 - 2032
5.4.3.4 Clinical chemistry
5.4.3.4.1 IVD proteases market for clinical chemistry, 2020 - 2032
5.4.4 By Physical Form
5.4.4.1 Segment Definition
5.4.4.2 Powder
5.4.4.2.1 Powder IVD proteases market, 2020 - 2032
5.4.4.3 Liquid
5.4.4.3.1 Liquid IVD proteases market, 2020 - 2032
5.4.5 By Type
5.4.5.1 Segment Definition
5.4.5.2 Natural
5.4.5.2.1 Natural IVD proteases market, 2020 - 2032
5.4.5.3 Recombinant
5.4.5.3.1 Recombinant IVD proteases market, 2020 - 2032
5.4.6 By End Use
5.4.6.1 Segment Definition
5.4.6.2 Pharma & Biotech
5.4.6.2.1 IVD proteases market for pharma & biotech companies, 2020 - 2032
5.4.6.3 Hospital & Diagnostic Labs
5.4.6.3.1 IVD proteases market for hospital & diagnostic labs, 2020 - 2032
5.4.6.4 CROs
5.4.6.4.1 IVD proteases market for CROs, 2020 - 2032
5.4.6.5 Academic labs
5.4.6.5.1 IVD proteases market for academic labs, 2020 - 2032
5.5 Polymerase & Transcriptase
5.5.1 IVD polymerase & transcriptase market, 2020 - 2032
5.6 Ribonuclease
5.6.1 IVD ribonuclease market, 2020 - 2032
5.7 Others
5.7.1 Other IVD enzymes market, 2020 - 2032
Chapter 6 IVD Enzymes Market: Therapeutic Area Estimates & Trend Analysis
6.1 Segment Definition
6.2 Market Formulation and Modelling
6.3 IVD Enzymes Market: Therapeutic Area Movement Analysis
6.4 Infectious Disease
6.4.1 IVD enzymes market for infectious disease, 2020 - 2032
6.4.2 COVID-19 Testing
6.4.2.1 IVD enzymes market for COVID-19 testing, 2020 - 2032
6.4.3 Hepatitis
6.4.3.1 IVD enzymes market for hepatitis, 2020 - 2032
6.4.4 HIV
6.4.4.1 IVD enzymes market for HIV, 2020 - 2032
6.4.5 Other infectious diseases
6.4.5.1 IVD enzymes market for other infectious diseases, 2020 - 2032
6.5 Diabetes
6.5.1 IVD enzymes market for diabetes, 2020 - 2032
6.6 Oncology
6.6.1 IVD enzymes market for oncology, 2020 - 2032
6.7 Cardiology
6.7.1 IVD enzymes market for cardiology, 2020 - 2032
6.8 Nephrology
6.8.1 IVD enzymes market for nephrology, 2020 - 2032
6.9 Autoimmune Diseases
6.9.1 IVD enzymes market for autoimmune diseases, 2020 - 2032
6.10 Others
6.10.1 IVD enzymes market for other diseases, 2020 - 2032
Chapter 7 IVD Enzymes Market: Technology Type Estimates & Trend Analysis
7.1 Segment Definition
7.2 Market Formulation and Modelling
7.3 IVD Enzymes Market: Technology Type Movement Analysis
7.4 Histology Assays
7.4.1 IVD enzymes market for histology assays, 2020 - 2032
7.5 Molecular Diagnostics
7.5.1 IVD enzymes market for molecular diagnostics, 2020 - 2032
7.5.2 PCR Assays
7.5.2.1 IVD enzymes market for PCR assays, 2020 - 2032
7.5.3 NGS Assays
7.5.3.1 IVD enzymes market for NGS assays, 2020 - 2032
7.5.4 Others
7.5.4.1 IVD enzymes market for other molecular biology assays, 2020 - 2032
7.6 Clinical Chemistry
7.6.1 IVD enzymes market for clinical chemistry, 2020 - 2032
Chapter 8 IVD Enzymes Market: End-use Estimates & Trend Analysis
8.1 Segment Definition
8.2 Market Formulation and Modelling
8.3 IVD Enzymes Market: End-use Movement Analysis
8.4 Pharma & Biotech
8.4.1 IVD enzymes market for pharma & biotech, 2020 - 2032
8.5 Hospital & Diagnostic Labs
8.5.1 IVD enzymes market for hospital & diagnostic labs, 2020 - 2032
8.6 CROs
8.6.1 IVD enzymes market for CROs, 2020 - 2032
8.7 Academic Labs
8.7.1 IVD enzymes market for academic labs, 2020 - 2032
Chapter 9 IVD Enzymes Market: Regional Estimates & Trend Analysis
9.1 Market: Regional Movement Analysis
9.2 North America
9.2.1 Market estimates and forecast, 2020-2032
9.2.2 U.S.
9.2.2.1 Market estimates and forecast, 2020 - 2032
9.2.2.2 Market estimates and forecast, by enzyme type 2020 - 2032
9.2.2.3 Market estimates and forecast, by therapeutic area 2020 - 2032
9.2.2.4 Market estimates and forecast, by technology type 2020 - 2032
9.2.2.5 Market estimates and forecast, by end-use 2020 - 2032
9.2.3 Canada
9.2.3.1 Market estimates and forecast, 2020 - 2032
9.2.3.2 Market estimates and forecast, by enzyme type 2020 - 2032
9.2.3.3 Market estimates and forecast, by therapeutic area 2020 - 2032
9.2.3.4 Market estimates and forecast, by technology type 2020 - 2032
9.2.3.5 Market estimates and forecast, by end-use 2020 - 2032
9.3 Europe
9.3.1 Market estimates and forecast, 2020 - 2032
9.3.2 Germany
9.3.2.1 Market estimates and forecast, 2020 - 2032
9.3.2.2 Market estimates and forecast, by enzyme type 2020 - 2032
9.3.2.3 Market estimates and forecast, by therapeutic area 2020 - 2032
9.3.2.4 Market estimates and forecast, by technology type 2020 - 2032
9.3.2.5 Market estimates and forecast, by end-use 2020 - 2032
9.3.3 France
9.3.3.1 Market estimates and forecast, 2020 - 2032
9.3.3.2 Market estimates and forecast, by enzyme type 2020 - 2032
9.3.3.3 Market estimates and forecast, by therapeutic area 2020 - 2032
9.3.3.4 Market estimates and forecast, by technology type 2020 - 2032
9.3.3.5 Market estimates and forecast, by end-use 2020 - 2032
9.3.4 U.K.
9.3.4.1 Market estimates and forecast, 2020 - 2032
9.3.4.2 Market estimates and forecast, by enzyme type 2020 - 2032
9.3.4.3 Market estimates and forecast, by therapeutic area 2020 - 2032
9.3.4.4 Market estimates and forecast, by technology type 2020 - 2032
9.3.4.5 Market estimates and forecast, by end-use 2020 - 2032
9.3.5 Italy
9.3.5.1 Market estimates and forecast, 2020 - 2032
9.3.5.2 Market estimates and forecast, by enzyme type 2020 - 2032
9.3.5.3 Market estimates and forecast, by therapeutic area 2020 - 2032
9.3.5.4 Market estimates and forecast, by technology type 2020 - 2032
9.3.5.5 Market estimates and forecast, by end-use 2020 - 2032
9.3.6 Spain
9.3.6.1 Market estimates and forecast, 2020 - 2032
9.3.6.2 Market estimates and forecast, by enzyme type 2020 - 2032
9.3.6.3 Market estimates and forecast, by therapeutic area 2020 - 2032
9.3.6.4 Market estimates and forecast, by technology type 2020 - 2032
9.3.6.5 Market estimates and forecast, by end-use 2020 - 2032
9.4 Asia Pacific
9.4.1 Market estimates and forecast, 2020 - 2032
9.4.2 Japan
9.4.2.1 Market estimates and forecast, 2020 - 2032
9.4.2.2 Market estimates and forecast, by enzyme type 2020 - 2032
9.4.2.3 Market estimates and forecast, by therapeutic area 2020 - 2032
9.4.2.4 Market estimates and forecast, by technology type 2020 - 2032
9.4.2.5 Market estimates and forecast, by end-use 2020 - 2032
9.4.3 China
9.4.3.1 Market estimates and forecast, 2020 - 2032
9.4.3.2 Market estimates and forecast, by enzyme type 2020 - 2032
9.4.3.3 Market estimates and forecast, by therapeutic area 2020 - 2032
9.4.3.4 Market estimates and forecast, by technology type 2020 - 2032
9.4.3.5 Market estimates and forecast, by end-use 2020 - 2032
9.4.4 India
9.4.4.1 Market estimates and forecast, 2020 - 2032
9.4.4.2 Market estimates and forecast, by enzyme type 2020 - 2032
9.4.4.3 Market estimates and forecast, by therapeutic area 2020 - 2032
9.4.4.4 Market estimates and forecast, by technology type 2020 - 2032
9.4.4.5 Market estimates and forecast, by end-use 2020 - 2032
9.5 Latin America
9.5.1 Market estimates and forecast, 2020 - 2032
9.5.2 Brazil
9.5.2.1 Market estimates and forecast, 2020 - 2032
9.5.2.2 Market estimates and forecast, by enzyme type 2020 - 2032
9.5.2.3 Market estimates and forecast, by therapeutic area 2020 - 2032
9.5.2.4 Market estimates and forecast, by technology type 2020 - 2032
9.5.2.5 Market estimates and forecast, by end-use 2020 - 2032
9.5.3 Mexico
9.5.3.1 Market estimates and forecast, 2020 - 2032
9.5.3.2 Market estimates and forecast, by enzyme type 2020 - 2032
9.5.3.3 Market estimates and forecast, by therapeutic area 2020 - 2032
9.5.3.4 Market estimates and forecast, by technology type 2020 - 2032
9.5.3.5 Market estimates and forecast, by end-use 2020 - 2032
9.6 Middle East & Africa (MEA)
9.6.1 Market estimates and forecast, 2020 - 2032
9.6.2 South Africa
9.6.2.1 Market estimates and forecast, 2020 - 2032
9.6.2.2 Market estimates and forecast, by enzyme type 2020 - 2032
9.6.2.3 Market estimates and forecast, by therapeutic area 2020 - 2032
9.6.2.4 Market estimates and forecast, by technology type 2020 - 2032
9.6.2.5 Market estimates and forecast, by end-use 2020 - 2032
Chapter 10 Competitive Landscape
10.1 Strategy Framework
10.2 Market Participation Categorization
10.3 Company Profiles
10.3.1 Merck KGaA
10.3.1.1 Company overview
10.3.1.2 Sigma-Aldrich Co. LLC
10.3.1.2.1 Company overview
10.3.1.3 Financial performance
10.3.1.4 Product benchmarking
10.3.1.5 Strategic initiatives
10.3.2 Codexis
10.3.2.1 Company overview
10.3.2.2 Financial performance
10.3.2.3 Product benchmarking
10.3.2.4 Strategic initiatives
10.3.3 F. Hoffmann-La Roche Ltd.
10.3.3.1 Company overview
10.3.3.2 Financial performance
10.3.3.3 Product benchmarking
10.3.3.4 Strategic initiatives
10.3.4 Amano Enzymes
10.3.4.1 Company overview
10.3.4.2 Financial performance
10.3.4.3 Product benchmarking
10.3.4.4 Strategic initiatives
10.3.5 Advanced Enzymes Technologies Ltd.
10.3.5.1 Company overview
10.3.5.2 Financial performance
10.3.5.3 Product benchmarking
10.3.5.4 Strategic initiatives
10.3.6 Biocatalysts Ltd.
10.3.6.1 Company overview
10.3.6.2 Financial performance
10.3.6.3 Product benchmarking
10.3.6.4 Strategic initiatives
10.3.7 Amicogen
10.3.7.1 Company overview
10.3.7.2 Financial performance
10.3.7.3 Product benchmarking
10.3.7.4 Strategic initiatives
10.3.8 Dyadic International
10.3.8.1 Company overview
10.3.8.2 Financial performance
10.3.8.3 Product benchmarking
10.3.8.4 Strategic initiatives
10.3.9 BBI Solutions
10.3.9.1 Company overview
10.3.9.2 Financial performance
10.3.9.3 Product benchmarking
10.3.9.4 Strategic initiatives
10.3.10 Affymetrix
10.3.10.1 Company overview
10.3.10.2 Financial performance
10.3.10.3 Product benchmarking
10.3.10.4 Strategic initiatives
10.3.11 American Laboratories
10.3.11.1 Company overview
10.3.11.2 Financial performance
10.3.11.3 Product benchmarking
10.3.11.4 Strategic initiatives