체외진단용 효소 시장 규모, 점유율, 동향 분석 보고서 : 효소별, 질병별, 기술별, 최종 용도별, 지역별, 부문별 예측(2025-2030년)

In-vitro Diagnostics Enzymes Market Growth & Trends:

The global in-vitro diagnostics enzymes market size is anticipated to reach USD 3.05 billion by 2030, according to a new report by Grand View Research, Inc. The market is projected to grow at a CAGR of 10.2% from 2025 to 2030. 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 2019. 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 2020, 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.

In-vitro Diagnostics Enzymes Market Report Highlights:

• By enzyme type, polymerase and transcriptase enzymes held the largest share in 2024 owing to their wide applications in molecular diagnostic assays
• Based on disease type, the infectious disease segment is expected to dominate the market throughout the forecast period
• In terms of technology type, the histology assays segment held the largest share in 2024 owing to the utility of histology assays in cancer diagnostics, coupled with a rising incidence of different cancer types
• By end use, hospital and diagnostic labs dominated the market in 2024. They witness a high inflow of biopsy specimens for histopathology and cytopathology because of an increase in hospitalization and rise in the number of hospital admissions for cancer patients
• North America dominated the overall market in 2024 owing to the presence of a substantial number of players in this region including Innovative Research; Bio-Rad Laboratories, Inc.; Rockland Immunochemicals, Inc.; MyBioSource.com; and RayBiotech, Inc.

Table of Contents

Chapter 1. Methodology and Scope

• 1.1. Market Segmentation & Scope
• 1.2. Segment Definitions
  • 1.2.1. Enzyme
  • 1.2.2. Disease
  • 1.2.3. Technology
  • 1.2.4. End Use
  • 1.2.5. Regional scope
  • 1.2.6. Estimates and forecasts timeline
• 1.3. Research Methodology
• 1.4. Information Procurement
  • 1.4.1. Purchased database
  • 1.4.2. GVR's internal database
  • 1.4.3. Secondary sources
  • 1.4.4. Primary research
  • 1.4.5. Details of primary research
    • 1.4.5.1. Data for primary interviews in North America
    • 1.4.5.2. Data for primary interviews in Europe
    • 1.4.5.3. Data for primary interviews in Asia Pacific
    • 1.4.5.4. Data for primary interviews in Latin America
    • 1.4.5.5. Data for Primary interviews in MEA
• 1.5. Information or Data Analysis
  • 1.5.1. Data analysis models
• 1.6. Market Formulation & Validation
• 1.7. Model Details
  • 1.7.1. Commodity flow analysis (Model 1)
  • 1.7.2. Approach 1: Commodity flow approach
  • 1.7.3. Volume price analysis (Model 2)
  • 1.7.4. Approach 2: Volume price analysis
• 1.8. List of Secondary Sources
• 1.9. List of Primary Sources
• 1.10. Objectives

Chapter 2. Executive Summary

• 2.1. Market Outlook
• 2.2. Segment Outlook
  • 2.2.1. Enzyme outlook
  • 2.2.2. Disease outlook
  • 2.2.3. End use outlook
  • 2.2.4. Technology outlook
  • 2.2.5. Regional outlook
• 2.3. Competitive Insights

Chapter 3. In-vitro Diagnostics Enzymes Market Variables, Trends & Scope

• 3.1. Market Lineage Outlook
  • 3.1.1. Parent market outlook
  • 3.1.2. Related/ancillary market outlook
• 3.2. Market Dynamics
  • 3.2.1. Market driver analysis
    • 3.2.1.1. Increasing Prevalence of Chronic Diseases
    • 3.2.1.2. Advancements in Diagnostic Technologies
    • 3.2.1.3. Rising Demand for Personalized Medicine
  • 3.2.2. Market restraint analysis
    • 3.2.2.1. High Cost of Diagnostic Tests
    • 3.2.2.2. Lack of Awareness in Emerging Markets
• 3.3. In-vitro Diagnostics Enzymes Market Analysis Tools
  • 3.3.1. Industry Analysis - Porter's
    • 3.3.1.1. Supplier power
    • 3.3.1.2. Buyer power
    • 3.3.1.3. Substitution threat
    • 3.3.1.4. Threat of new entrant
    • 3.3.1.5. Competitive rivalry
  • 3.3.2. PESTEL Analysis
    • 3.3.2.1. Political landscape
    • 3.3.2.2. Technological landscape
    • 3.3.2.3. Economic landscape

Chapter 4. In-vitro Diagnostics Enzymes Market: Enzyme Estimates & Trend Analysis

• 4.1. Enzyme Market Share, 2024 & 2030
• 4.2. Segment Dashboard
• 4.3. Global In-vitro Diagnostics Enzymes Market by Enzyme Outlook
• 4.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
  • 4.4.1. Proteases
    • 4.4.1.1. Market estimates and forecasts 2018 to 2030 (USD million)
  • 4.4.2. Polymerase & Transcriptase
    • 4.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.4.3. Ribonuclease
    • 4.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
  • 4.4.4. Others
    • 4.4.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 5. In-vitro Diagnostics Enzymes Market: Disease Estimates & Trend Analysis

• 5.1. Disease Market Share, 2024 & 2030
• 5.2. Segment Dashboard
• 5.3. Global In-vitro Diagnostics Enzymes Market by Disease Outlook
• 5.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
  • 5.4.1. Infectious Disease
    • 5.4.1.1. Market estimates and forecasts 2018 to 2030 (USD million)
    • 5.4.1.2. COVID -19 Testing
      • 5.4.1.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.1.3. Hepatitis
      • 5.4.1.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.1.4. HIV
      • 5.4.1.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 5.4.1.5. Others
      • 5.4.1.5.1. Market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4.2. Diabetes
    • 5.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4.3. Oncology
    • 5.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4.4. Cardiology
    • 5.4.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4.5. Nephrology
    • 5.4.5.1. Market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4.6. Autoimmune Diseases
    • 5.4.6.1. Market estimates and forecasts 2018 to 2030 (USD Million)
  • 5.4.7. Others
    • 5.4.7.1. Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 6. In-vitro Diagnostics Enzymes Market: Technology Estimates & Trend Analysis

• 6.1. Technology Market Share, 2024 & 2030
• 6.2. Segment Dashboard
• 6.3. Global In-vitro Diagnostics Enzymes Market by Technology Outlook
• 6.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
  • 6.4.1. Histology Assays
    • 6.4.1.1. Market estimates and forecasts 2018 to 2030 (USD million)
  • 6.4.2. Molecular Diagnostics
    • 6.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.4.2.2. PCR Assays
      • 6.4.2.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.4.2.3. NGS Assays
      • 6.4.2.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)
    • 6.4.2.4. Others
      • 6.4.2.4.1. Market estimates and forecasts 2018 to 2030 (USD Million)
  • 6.4.3. Clinical Chemistry
    • 6.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 7. In-vitro Diagnostics Enzymes Market: End Use Estimates & Trend Analysis

• 7.1. End Use Market Share, 2024 & 2030
• 7.2. Segment Dashboard
• 7.3. Global In-vitro Diagnostics Enzymes Market by End Use Outlook
• 7.4. Market Size & Forecasts and Trend Analyses, 2018 to 2030 for the following
  • 7.4.1. Pharma & Biotech
    • 7.4.1.1. Market estimates and forecasts 2018 to 2030 (USD million)
  • 7.4.2. Hospital & Diagnostic Labs
    • 7.4.2.1. Market estimates and forecasts 2018 to 2030 (USD Million)
  • 7.4.3. Academic Labs
    • 7.4.3.1. Market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 8. In-vitro Diagnostics Enzymes Market: Regional Estimates & Trend Analysis

• 8.1. Regional Market Share Analysis, 2024 & 2030
• 8.2. Regional Market Dashboard
• 8.3. Global Regional Market Snapshot
• 8.4. Market Size & Forecasts Trend Analysis, 2018 to 2030:
• 8.5. North America
  • 8.5.1. U.S.
    • 8.5.1.1. Key country dynamics
    • 8.5.1.2. Regulatory framework/ reimbursement structure
    • 8.5.1.3. Competitive scenario
    • 8.5.1.4. Target disease prevalence
    • 8.5.1.5. U.S. market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.5.2. Canada
    • 8.5.2.1. Key country dynamics
    • 8.5.2.2. Regulatory framework/ reimbursement structure
    • 8.5.2.3. Competitive scenario
    • 8.5.2.4. Target disease prevalence
    • 8.5.2.5. Canada market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.5.3. Mexico
    • 8.5.3.1. Key country dynamics
    • 8.5.3.2. Regulatory framework/ reimbursement structure
    • 8.5.3.3. Competitive scenario
    • 8.5.3.4. Target disease prevalence
    • 8.5.3.5. Mexico market estimates and forecasts 2018 to 2030 (USD Million
• 8.6. Europe
  • 8.6.1. UK
    • 8.6.1.1. Key country dynamics
    • 8.6.1.2. Regulatory framework/ reimbursement structure
    • 8.6.1.3. Competitive scenario
    • 8.6.1.4. Target disease prevalence
    • 8.6.1.5. UK market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.6.2. Germany
    • 8.6.2.1. Key country dynamics
    • 8.6.2.2. Regulatory framework/ reimbursement structure
    • 8.6.2.3. Competitive scenario
    • 8.6.2.4. Target disease prevalence
    • 8.6.2.5. Germany market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.6.3. France
    • 8.6.3.1. Key country dynamics
    • 8.6.3.2. Regulatory framework/ reimbursement structure
    • 8.6.3.3. Competitive scenario
    • 8.6.3.4. Target disease prevalence
    • 8.6.3.5. France market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.6.4. Italy
    • 8.6.4.1. Key country dynamics
    • 8.6.4.2. Regulatory framework/ reimbursement structure
    • 8.6.4.3. Competitive scenario
    • 8.6.4.4. Target disease prevalence
    • 8.6.4.5. Italy market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.6.5. Spain
    • 8.6.5.1. Key country dynamics
    • 8.6.5.2. Regulatory framework/ reimbursement structure
    • 8.6.5.3. Competitive scenario
    • 8.6.5.4. Target disease prevalence
    • 8.6.5.5. Spain market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.6.6. Norway
    • 8.6.6.1. Key country dynamics
    • 8.6.6.2. Regulatory framework/ reimbursement structure
    • 8.6.6.3. Competitive scenario
    • 8.6.6.4. Target disease prevalence
    • 8.6.6.5. Norway market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.6.7. Sweden
    • 8.6.7.1. Key country dynamics
    • 8.6.7.2. Regulatory framework/ reimbursement structure
    • 8.6.7.3. Competitive scenario
    • 8.6.7.4. Target disease prevalence
    • 8.6.7.5. Sweden market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.6.8. Denmark
    • 8.6.8.1. Key country dynamics
    • 8.6.8.2. Regulatory framework/ reimbursement structure
    • 8.6.8.3. Competitive scenario
    • 8.6.8.4. Target disease prevalence
    • 8.6.8.5. Denmark market estimates and forecasts 2018 to 2030 (USD Million)
• 8.7. Asia Pacific
  • 8.7.1. Japan
    • 8.7.1.1. Key country dynamics
    • 8.7.1.2. Regulatory framework/ reimbursement structure
    • 8.7.1.3. Competitive scenario
    • 8.7.1.4. Target disease prevalence
    • 8.7.1.5. Japan market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.7.2. China
    • 8.7.2.1. Key country dynamics
    • 8.7.2.2. Regulatory framework/ reimbursement structure
    • 8.7.2.3. Competitive scenario
    • 8.7.2.4. Target disease prevalence
    • 8.7.2.5. China market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.7.3. India
    • 8.7.3.1. Key country dynamics
    • 8.7.3.2. Regulatory framework/ reimbursement structure
    • 8.7.3.3. Competitive scenario
    • 8.7.3.4. Target disease prevalence
    • 8.7.3.5. India market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.7.4. Australia
    • 8.7.4.1. Key country dynamics
    • 8.7.4.2. Regulatory framework/ reimbursement structure
    • 8.7.4.3. Competitive scenario
    • 8.7.4.4. Target disease prevalence
    • 8.7.4.5. Australia market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.7.5. South Korea
    • 8.7.5.1. Key country dynamics
    • 8.7.5.2. Regulatory framework/ reimbursement structure
    • 8.7.5.3. Competitive scenario
    • 8.7.5.4. Target disease prevalence
    • 8.7.5.5. South Korea market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.7.6. Thailand
    • 8.7.6.1. Key country dynamics
    • 8.7.6.2. Regulatory framework/ reimbursement structure
    • 8.7.6.3. Competitive scenario
    • 8.7.6.4. Target disease prevalence
    • 8.7.6.5. Thailand market estimates and forecasts 2018 to 2030 (USD Million)
• 8.8. Latin America
  • 8.8.1. Brazil
    • 8.8.1.1. Key country dynamics
    • 8.8.1.2. Regulatory framework/ reimbursement structure
    • 8.8.1.3. Competitive scenario
    • 8.8.1.4. Target disease prevalence
    • 8.8.1.5. Brazil market estimates and forecasts 2018 to 2030 (USD Million)
    • 8.8.1.6. )
  • 8.8.2. Argentina
    • 8.8.2.1. Key country dynamics
    • 8.8.2.2. Regulatory framework/ reimbursement structure
    • 8.8.2.3. Competitive scenario
    • 8.8.2.4. Target disease prevalence
    • 8.8.2.5. Argentina market estimates and forecasts 2018 to 2030 (USD Million)
• 8.9. MEA
  • 8.9.1. South Africa
    • 8.9.1.1. Key country dynamics
    • 8.9.1.2. Regulatory framework/ reimbursement structure
    • 8.9.1.3. Competitive scenario
    • 8.9.1.4. Target disease prevalence
    • 8.9.1.5. South Africa market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.9.2. Saudi Arabia
    • 8.9.2.1. Key country dynamics
    • 8.9.2.2. Regulatory framework/ reimbursement structure
    • 8.9.2.3. Competitive scenario
    • 8.9.2.4. Target disease prevalence
    • 8.9.2.5. Saudi Arabia market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.9.3. UAE
    • 8.9.3.1. Key country dynamics
    • 8.9.3.2. Regulatory framework/ reimbursement structure
    • 8.9.3.3. Competitive scenario
    • 8.9.3.4. Target disease prevalence
    • 8.9.3.5. UAE market estimates and forecasts 2018 to 2030 (USD Million)
  • 8.9.4. Kuwait
    • 8.9.4.1. Key country dynamics
    • 8.9.4.2. Regulatory framework/ reimbursement structure
    • 8.9.4.3. Competitive scenario
    • 8.9.4.4. Target disease prevalence
    • 8.9.4.5. Kuwait market estimates and forecasts 2018 to 2030 (USD Million)

Chapter 9. Competitive Landscape

• 9.1. Recent Developments & Impact Analysis, By Key Market Participants
• 9.2. Company/Competition Categorization
• 9.3. Vendor Landscape
  • 9.3.1. Key company market share analysis, 2024
  • 9.3.2. Merck KGaA
    • 9.3.2.1. Company overview
    • 9.3.2.2. Financial performance
    • 9.3.2.3. Product benchmarking
    • 9.3.2.4. Strategic initiatives
  • 9.3.3. Codexis, Inc
    • 9.3.3.1. Company overview
    • 9.3.3.2. Financial performance
    • 9.3.3.3. Product benchmarking
    • 9.3.3.4. Strategic initiatives
  • 9.3.4. F. Hoffmann-La Roche Ltd
    • 9.3.4.1. Company overview
    • 9.3.4.2. Financial performance
    • 9.3.4.3. Product benchmarking
    • 9.3.4.4. Strategic initiatives
  • 9.3.5. Amano Enzymes Inc
    • 9.3.5.1. Company overview
    • 9.3.5.2. Financial performance
    • 9.3.5.3. Product benchmarking
    • 9.3.5.4. Strategic initiatives
  • 9.3.6. Advanced Enzymes Technologies Ltd.
    • 9.3.6.1. Company overview
    • 9.3.6.2. Financial performance
    • 9.3.6.3. Product benchmarking
    • 9.3.6.4. Strategic initiatives
  • 9.3.7. Biocatalysts Ltd
    • 9.3.7.1. Company overview
    • 9.3.7.2. Financial performance
    • 9.3.7.3. Product benchmarking
    • 9.3.7.4. Strategic initiatives
  • 9.3.8. Amicogen
    • 9.3.8.1. Company overview
    • 9.3.8.2. Financial performance
    • 9.3.8.3. Product benchmarking
    • 9.3.8.4. Strategic initiatives
  • 9.3.9. Dyadic International
    • 9.3.9.1. Company overview
    • 9.3.9.2. Financial performance
    • 9.3.9.3. Product benchmarking
    • 9.3.9.4. Strategic initiatives
  • 9.3.10. BBI Solutions
    • 9.3.10.1. Company overview
    • 9.3.10.2. Financial performance
    • 9.3.10.3. Product benchmarking
    • 9.3.10.4. Strategic initiatives
  • 9.3.11. Affymetrix
    • 9.3.11.1. Company overview
    • 9.3.11.2. Financial performance
    • 9.3.11.3. Product benchmarking
    • 9.3.11.4. Strategic initiatives