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Molecular Diagnostics for Infectious Disease By Syndrome, Plex, Place and by Country. With COVID-19 Impact & Forecasting/Analysis, and Executive Guides and Customization 2022-2026

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    Report

  • 574 Pages
  • August 2022
  • Region: Global
  • Howe Sound Research
  • ID: 5441826

Covid-19 has Changed Everything in Diagnostics. How Big are the Changes? What will be the Impact on Infectious Disease Testing as a Whole?

COVID-19 Drives a surge in demand but what is the long term impact? The microbiology lab may disappear while multiplex takes center stage.

The Molecular Diagnostics - Infectious Disease sector of the clinical diagnostics industry is poised for record growth. A market that just keeps on growing but is spiking as an enormous C19Dx demand sweeps over the globe. Find out what the numbers are in this informative report. And find out about the exciting developments in multiplex assays which threaten to change diagnosis and treatment while limiting the threat of anti microbial drug resistance.

Infectious disease testing directly benefits from the explosion in biotechnology, especially genomics. Learn all about it in this report. A range of dynamic trends are pushing market growth and company valuations.

Trends like:

  • Multiplex testing
  • pathogen evolution and pandemics
  • biotechnology advances in genetics
  • climate change
  • globalization
  • the rise of rapid testing
Exciting technical developments especially in the seesaw between nucleic acid testing and immunoassay, hold the promise of a dynamic, growing and evolving world market that holds the promise of diagnostics taking the lead in infectious disease eradication.

The report has hundreds of pages of information including a complete list of Current United States Medicare Fee Payment Schedules to help sharpen your pricing. Again, assistance in using the information is normally provided without additional charges. The report includes detailed breakouts for 15 Countries and 4 Regions. A detailed breakout for any country in the world is available to purchasers of the report.

All report data is available in Excel format on request.

The report includes five year market forecasts.

Table of Contents

1 Market Guides
1.1 Strategic Situation Analysis and Impact of COVID-19.
1.2 Guide for Executives, Marketing, Sales and Business Development Staff
1.3 Guide for Management Consultants and Investment Advisors
2 Introduction and Market Definition
2.1 What are Molecular Diagnostics?
2.2 The Diagnostics Revolution
2.3 Market Definition
2.3.1 Revenues
2.4 Methodology
2.4.1 Authors
2.4.2 Sources
2.5 Perspective: Healthcare, the IVD Industry, and the COVID-19 Pandemic
2.5.1 Global Healthcare Spending
2.5.2 Spending on Diagnostics
2.5.3 Important Role of Insurance for Diagnostics
3 The Infectious Diseases - Market Analysis by Disease
3.1 HIV - Human Immunodeficiency Virus (AIDS)
3.1.1 Virology
3.1.1.1 Classification
3.1.1.2 Structure and genome
3.1.1.3 Tropism
3.1.1.4 Replication cycle
3.1.1.5 Genetic variability
3.1.2 Diagnosis
3.1.3 Testing
3.1.3.1 Antibody tests
3.1.3.2 Point of Care Tests (POCT)
3.1.3.3 Antigen Tests
3.1.3.4 Nucleic acid-based tests (NAT)
3.1.3.5 Other tests used in HIV treatment
3.1.4 Market Opportunity Analysis
3.2 HBV - Hepatitis B
3.2.1 Virology
3.2.1.1 Genome
3.2.1.2 Pathogenesis
3.2.1.3 Hepatitis B virus replication
3.2.1.4 Serotypes and genotypes
3.2.2 Mechanisms
3.2.3 Diagnosis
3.2.4 Market Opportunity Analysis
3.3 HCV - Hepatitis C
3.3.1 Taxonomy
3.3.2 Structure
3.3.2.1 Genome
3.3.3 Molecular biology
3.3.4 Replication
3.3.5 Genotypes
3.3.5.1 Clinical importance
3.3.6 Market Opportunity Analysis
3.4 HPV - Human papillomavirus
3.4.1 Virology
3.4.1.1 E6/E7 proteins
3.4.1.2 Role in cancer
3.4.1.3 E2 research
3.4.1.4 Latency period
3.4.1.5 Clearance
3.4.2 Diagnosis
3.4.2.1 Cervical testing
3.4.2.2 Oral testing
3.4.2.3 Testing men
3.4.2.4 Other testing
3.4.3 Market Opportunity Analysis
3.5 Influenza
3.5.1 Virology
3.5.1.1 Types of virus
3.5.1.2 Influenzavirus A
3.5.1.3 Influenzavirus B
3.5.1.4 Influenzavirus C
3.5.1.5 Structure, properties, and subtype nomenclature
3.5.1.6 Replication
3.5.2 Testing
3.5.2.1 Advantages/Disadvantages of Molecular Assays
3.5.3 Market Opportunity Analysis
3.6 CTGC - Chlamydia/Gonorhea
3.6.1 Gonorrhea
3.6.1.1 Diagnosis
3.6.1.2 Screening
3.6.2 Chlamydia
3.6.2.1 Diagnosis
3.6.2.2 Screening
3.6.3 Testing
3.6.3.1 Nucleic acid amplification tests (NAATs).
3.6.3.2 Performance of NAAT Tests
3.6.4 Market Opportunity Analysis
3.7 Tuberculosis
3.7.1 Mycobacteria
3.7.2 Diagnosis
3.7.2.1 Active tuberculosis
3.7.2.2 Latent tuberculosis
3.7.3 Epidemiology
3.7.4 Molecular Diagnostic Tests
3.7.5 Market Opportunity Analysis
3.8 MRSA - Methicillin-resistant Staphylococcus aureus
3.8.1 Diagnosis
3.8.2 FDA Approved Molecular Tests
3.8.3 Market Opportunity Analysis
3.9 VRE - Vancomycin-resistant Enterococcus
3.9.1 FDA Approved MDx Tests for VRE
3.9.2 Market Opportunity Analysis
3.10 Blood Screening
3.10.1 Collection and Testing
3.10.2 FDA Approved Multiplex Assays
3.10.3 Market Opportunity Analysis
3.11 COVID-19
3.11.1 Signs and symptoms
3.11.2 Transmission
3.11.3 Diagnosis
3.11.4 Prevention
3.11.5 Management
3.11.6 Prognosis
3.12 Pandemic Diagnostics
3.12.1 Risk Management - Spark and Spread
3.12.2 Dx Technology - Nucleic Acid Based
3.12.3 Dx Technology - Immunoassay & Serology
3.12.4 Time to Market and Preparedness Issues
3.12.5 Unrecognized Role of Multiplex in Pandemic Mangement
4 Industry Overview
4.1 Players in a Dynamic Market
4.1.1 Academic Research Lab
4.1.2 Diagnostic Test Developer
4.1.3 Instrumentation Supplier
4.1.4 Distributor and Reagent Supplier
4.1.5 Independent Testing Lab
4.1.6 Public National/regional lab
4.1.7 Hospital lab
4.1.8 Physician Office Labs
4.1.9 Audit Body
4.1.10 Certification Body
4.2 The Clinical Laboratory Market Segments
4.2.1 Traditional Market Segmentation
4.2.2 Laboratory Focus and Segmentation
4.3 Industry Structure
4.3.1 Hospital Testing Share
4.3.2 Economies of Scale
4.3.2.1 Hospital vs. Central Lab
4.3.3 Physician Office Lab’s
4.3.4 Physicians and POCT
5 Profiles of Key MDx Companies
5.1 1928 Diagnostics
5.2 Abacus Diagnostica
5.3 Abbott Laboratories
5.4 Accelerate Diagnostics
5.5 Access Bio
5.6 Ador Diagnostics
5.7 ADT Biotech
5.8 Akonni Biosystems
5.9 Altona Diagnostics
5.10 Alveo Technologies
5.11 Anatolia Geneworks
5.12 Antelope Dx
5.13 Applied BioCode
5.14 Assurance Scientific Laboratories
5.15 Aureum Diagnostics
5.16 Aus Diagnostics
5.17 Beckman Coulter Diagnostics
5.18 Becton, Dickinson and Company
5.19 Binx Health
5.20 Biocartis
5.21 BioFire Diagnostics (bioMérieux)
5.22 bioMérieux Diagnostics
5.23 Bio-Rad Laboratories, Inc
5.24 Bosch Healthcare Solutions GmbH
5.25 Celemics
5.26 Cepheid (Danaher)
5.27 Chembio
5.28 Co Diagnostics
5.29 Credo Diagnostics Biomedical
5.30 Cue Health
5.31 Curetis N.V./Curetis GmbH
5.32 Detect
5.33 Diagenode Diagnostics
5.34 Diascopic
5.35 Diasorin S.p.A.
5.36 Eiken Chemical
5.37 Enzo Biochem
5.38 Eurofins Scientific
5.39 Fluxergy
5.40 Fulgent Genetics
5.41 Fusion Genomics.
5.42 Genedrive
5.43 Genetic Signatures
5.44 GenMark Dx (Roche)
5.45 Grifols
5.46 Grip Molecular Technologies
5.47 Hibergene Diagnostics
5.48 Hologic
5.49 Illumina
5.50 Immunexpress
5.51 Inflammatix
5.52 Invetech
5.53 Janssen Diagnostics
5.54 Karius
5.55 Lexagene
5.56 LightDeck Diagnostics
5.57 Lucira Health
5.58 Luminex Corp
5.59 LumiraDx
5.60 Lumos Diagnostics
5.61 Mammoth Biosciences
5.62 Maxim Biomedical
5.63 Meridian Bioscience
5.64 Mesa Biotech (Thermo Fisher)
5.65 Millipore Sigma
5.66 Mindray
5.67 Mobidiag (Hologic)
5.68 Molbio Diagnostics
5.69 Nanomix
5.70 Novacyt
5.71 Novel Microdevices
5.72 Operon
5.73 Oxford Nanopore Technologies
5.74 Panagene
5.75 Pathogenomix
5.76 Perkin Elmer
5.77 Prenetics
5.78 Primerdesign (Novacyt)
5.79 Prominex
5.80 Qiagen
5.81 QuantuMDx
5.82 Quest Diagnostics
5.83 Quidel
5.84 Randox Toxicology
5.85 Roche Molecular Diagnostics
5.86 Saw Diagnostics
5.87 SD Biosensor
5.88 Seegene
5.89 Siemens Healthineers
5.90 SomaLogic
5.91 Sona Nanotech
5.92 SpeeDx
5.93 T2 Biosystems
5.94 Talis Biomedical
5.95 Thermo Fisher Scientific Inc.
5.96 Veramarx
5.97 Veredus Laboratories
5.98 Vir
5.99 Vircell
5.100 Visby Medical
5.101 XCR Diagnostics
5.102 YD Diagnostics
5.103 Zhejiang Orient Gene Biotech
6 Market Trends
6.1 Factors Driving Growth
6.1.1 New Genotypes Creating New Markets
6.1.2 Aging Population a Boon for All Diagnostics
6.1.3 Developing World Driving ID Dx Growth
6.1.4 Point of Care - Why Centralization is Losing Steam
6.1.5 Self Testing
6.1.6 The Need for Speed
6.1.7 The COVID Pandemic
6.2 Factors Limiting Growth
6.2.1 Lower Costs
6.2.2 Infectious Disease is Declining
6.2.3 Wellness Hurts
6.2.4 Economic Growth improves Living Standards
6.3 Instrumentation and Automation
6.3.1 Instruments Key to Market Share
6.3.2 The Shrinking Machine
6.3.3 Multiplex, Point of Care and The Speed Factor
6.4 Diagnostic Technology Development
6.4.1 The Sepsis Testing Market - A New Direction?
6.4.2 POCT/Self Testing as a Disruptive Force
6.4.3 The Genetics Play - One Test for All Known Infections
6.4.4 Antibiotic Resistance Genes - Simplifying Diagnostics
7 Molecular Dx - Infectious Disease Recent Developments
7.1 Recent Developments - Importance and How to Use This Section
7.1.1 Importance of These Developments
7.1.2 How to Use This Section
7.2 BioMérieux Invests in Sepsis Dx Startup Weezion
7.3 Domus Diagnostics to Launch POC MDx Test System
7.4 Proof Dx Plans Infectious Disease, Oncology Tests for CRISPR-Based POC
7.5 Oxford Nanopore Diagnostics to Develop Clinical Tools
7.6 Pathogenomix Developing Infectious Disease Platform Using NGS
7.7 COVID-19 Accelerating Trend Toward Pharmacy-Based Testing
7.8 Co-Diagnostics Seeks FDA EUA for At-Home PCR Diagnostic
7.9 Sense Biodetection to Debut Instrument-Free Point-of-Care MDx
7.10 Home Test Company Prenetics to go Public
7.11 Roche to Acquire TIB Molbiol to Expand Infectious Disease Portfolio
7.12 Lucira Health Posts Revenue Growth on OTC C19 Test
7.13 BforCure Preparing Multiple Panels for Point-of-Care qPCR Platform
7.14 Talis Biomedical Discusses Point-of-Care
7.15 Roche to Acquire GenMark Diagnostics for $1.8B
7.16 Pandemic Pushes Handheld qPCR Devices Closer to Commercialization
7.17 Hologic to Acquire Mobidiag
7.18 Lucira Health Focuses on User Friendly Approach to Home Testing
7.19 Infectious Disease Dx Firm Talis Biomedical Raises $254M in IPO
7.20 Fluidigm Plans 'Durable' Diagnostics, Clinical Business
7.21 Thermo Fisher Scientific to Acquire Mesa Biotech for Up to $550M
7.22 Mammoth Biosciences Developing Pathogen Detection Tech
7.23 Illumina, IDbyDNA Developing Sequencing-Based Respiratory Tests
7.24 Scanogen Developing 90 Minute Infection Test
7.25 Malaria Assays Use CRISPR for Point-of-Care Multispecies Detection
7.26 FDA Provides Self Testing SARS-CoV-2 EAU Guidance
7.27 Mammoth Biosciences Announces Rapid, CRISPR-Based COVID-19 Diagnostic
7.28 Genetic Signatures Gets CE Mark for Coronavirus Molecular Test
7.29 Qiagen Respiratory Panel with Coronavirus Receives CE Mark
7.30 Lumos Diagnostics Closes $15M Series A Funding
7.31 Fusion Genomics to Assess NGS-Based Respiratory Tract Infection Assay
8 The Global Market for Molecular Diagnostics Infectious Disease
8.1 Global Market Overview by Country
8.1.1 Table - Global Market by Country
8.1.2 Chart - Global Market by Country
8.2 Global Market by Syndrome - Overview
8.2.1 Table - Global Market by Syndrome
8.2.2 Chart - Global Market by Syndrome - Base/Final Year Comparison
8.2.3 Chart - Global Market by Syndrome - Base Year
8.2.4 Chart - Global Market by Syndrome - End Year
8.2.5 Chart - Global Market by Syndrome - Share by Year
8.2.6 Chart - Global Market by Syndrome - Segments Growth
8.3 Global Market by Plex - Overview
8.3.1 Table - Global Market by Plex
8.3.2 Chart - Global Market by Plex - Base/Final Year Comparison
8.3.3 Chart - Global Market by Plex - Base Year
8.3.4 Chart - Global Market by Plex - End Year
8.3.5 Chart - Global Market by Plex - Share by Year
8.3.6 Chart - Global Market by Plex - Segments Growth
8.4 Global Market by Place - Overview
8.4.1 Table - Global Market by Place
8.4.2 Chart - Global Market by Place - Base/Final Year Comparison
8.4.3 Chart - Global Market by Place - Base Year
8.4.4 Chart - Global Market by Place - End Year
8.4.5 Chart - Global Market by Place - Share by Year
8.4.6 Chart - Global Market by Place - Segments Growth
9 Global MDx Infectious Disease Markets - By Syndrome
9.1 Respiratory
9.1.1 Table Respiratory - by Country
9.1.2 Chart - Respiratory Growth
9.2 Gastrointestinal
9.2.1 Table Gastrointestinal - by Country
9.2.2 Chart - Gastrointestinal Growth
9.3 Blood
9.3.1 Table Blood - by Country
9.3.2 Chart - Blood Growth
9.4 Meningitis/Encephalitis
9.4.1 Table Meningitis/Encephalitis - by Country
9.4.2 Chart - Meningitis/Encephalitis Growth
9.5 Sexually Transmitted Disease
9.5.1 Table Sexually Transmitted Disease - by Country
9.5.2 Chart - Sexually Transmitted Disease Growth
9.6 Other
9.6.1 Table Other - by Country
9.6.2 Chart - Other Growth
10 Global MDx Markets for Infectious Disease - by Plex
10.1 Single Plex
10.1.1 Table Single Plex - by Country
10.1.2 Chart - Single Plex Growth
10.2 Duplex
10.2.1 Table Duplex - by Country
10.2.2 Chart - Duplex Growth
10.3 Triplex
10.3.1 Table Triplex - by Country
10.3.2 Chart - Triplex Growth
10.4 Multiplex Technology
10.4.1 Table Multiplex - by Country
10.4.2 Chart - Multiplex Growth
11 Global MDx Infectious Disease Markets - by Place
11.1 Hospital Lab
11.1.1 Table Hospital Lab - by Country
11.1.2 Chart - Hospital Lab Growth
11.2 Outpatient Lab
11.2.1 Table Outpatient Lab - by Country
11.2.2 Chart - Outpatient Lab Growth
11.3 POC
11.3.1 Table POC - by Country
11.3.2 Chart - POC Growth
11.4 Other Place
11.4.1 Table Other Place- by Country
11.4.2 Chart - Other Place Growth
12 Appendices
12.1 United States Medicare System: 2022 Clinical Laboratory Fees Schedule

Table of Tables
Table 1 Classification of HIV Species
Table 2 HIV Tests - CMS Codes & Prices
Table 3 Current HIV Molecular Tests and Instruments Used
Table 4 HBV Tests - CMS Codes & Prices
Table 5 HCV Tests - CMS Codes & Prices
Table 6 HPV Clearance Rates
Table 7 HPV Tests - CMS Codes & Prices
Table 8 HPV Tests, Technology, Types
Table 9 Types of Influenza Tests
Table 10 Influenza Tests - CMS Codes & Prices
Table 11 FDA Cleared Molecular Assays for Influenza
Table 12 FDA Cleared NAAT CTGC Tests
Table 13 CTGC NAAT Target Sequences and Possible False Reactions
Table 14 CTGC Tests - CMS Codes & Prices
Table 15 FDA Approved MDx Tests for Tuberculosis
Table 16 Tuberculosis Tests - CMS Codes & Prices
Table 17 FDA Approved Tests for MRSA
Table 18 MRSA Tests - CMS Codes & Prices
Table 19 FDA Approved Tests for VRE
Table 20 VRE Tests - CMS Codes & Prices
Table 21 FDA Approved Multiplex Assays
Table 22 Characteristics of Coronavirus Pandemic Infections
Table 23 COVID-19 Symptoms
Table 24 Market Players by Type
Table 25 Clinical Laboratory Departments and Segments
Table 26 Laboratory Management Focus - Different Approaches
Table 27 Key Segmentation Variables Going Forward
Table 28 Five Factors Driving Growth
Table 29 Four Factors Limiting Growth
Table 30 Key Diagnostic Laboratory Technology Trends
Table 31 Global Market by Region
Table 32 Global Market by Syndrome
Table 33 Global Market by Plex
Table 34 Global Market by Place
Table 35 Respiratory by Country
Table 36 Gastrointestinal by Country
Table 37 Blood by Country
Table 38 Meningitis/Encephalitis by Country
Table 39 Sexually Transmitted Disease by Country
Table 40 Other by Country
Table 41 Single Plex by Country
Table 42 Duplex by Country
Table 43 Triplex by Country
Table 44 Multiplex by Country
Table 45 Hospital Lab by Country
Table 46 Outpatient Lab by Country
Table 47 POC by Country
Table 48 Other Place by Country
Table 49 2022 Clinical Lab Fee Schedule
Table of Figures
Figure 1 Map - Global Healthcare Spending Per Capita
Figure 2 The Lab Test Pie - Wholesale and Retail
Figure 3 HIV Virion
Figure 4 Diagram of the HIV Replication Cycle
Figure 5 The Structure of the HBV Virus
Figure 6 Hepatitis B Replication
Figure 7 Structure of the HCV Virus
Figure 8 HCV Replication Cycle
Figure 9 Structure of the Influenza Virion
Figure 10 Influenza Replication
Figure 11 Scanning Electronmicrograph of Tuberculosis
Figure 12 Percentage of World Population Over 65
Figure 13 Chart Infectious Disease Decline
Figure 14 Global Market Shares Chart
Figure 15 Global Market by Syndrome - Base vs. Final
Figure 16 Global Market by Syndrome Base Year
Figure 17 Global Market by Syndrome End Year
Figure 18 Syndrome Share by Year
Figure 19 Syndrome Segments Growth
Figure 20 Global Market by Plex - Base vs. Final
Figure 21 Global Market by Plex Base Year
Figure 22 Global Market by Plex End Year
Figure 23 Plex Share by Year
Figure 24 Plex Segments Growth
Figure 25 Global Market by Place - Base vs. Final
Figure 26 Global Market by Place Base Year
Figure 27 Global Market by Place End Year
Figure 28 Place Share by Year
Figure 29 Place Segments Growth
Figure 30 Respiratory Growth
Figure 31 Gastrointestinal Diagnostics Growth
Figure 32 Blood Growth
Figure 33 Meningitis/Encephalitis Growth
Figure 34 Sexually Transmitted Disease Growth
Figure 35 Other Growth
Figure 36 Single Plex Growth
Figure 37 Duplex Growth
Figure 38 Triplex Growth
Figure 39 Multiplex Growth
Figure 40 Hospital Lab Growth
Figure 41 Outpatient Lab Growth
Figure 42 POC Growth
Figure 43 Other Place Growth

Samples

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Companies Mentioned

  • 1928 Diagnostics
  • Abacus Diagnostica
  • Abbott Laboratories
  • Accelerate Diagnostics
  • Access Bio
  • Ador Diagnostics  
  • ADT Biotech  
  • Akonni Biosystems
  • Altona Diagnostics
  • Alveo Technologies  
  • Anatolia Geneworks
  • Antelope Dx  
  • Applied BioCode  
  • Assurance Scientific Laboratories
  • Aureum Diagnostics
  • Aus Diagnostics
  • Beckman Coulter Diagnostics
  • Becton, Dickinson and Company  
  • Binx Health
  • Biocartis
  • BioFire Diagnostics (bioMérieux)
  • bioMérieux Diagnostics
  • Bio-Rad Laboratories, Inc 
  • Bosch Healthcare Solutions GmbH
  • Celemics
  • Cepheid (Danaher)
  • Chembio
  • Co Diagnostics
  • Credo Diagnostics Biomedical
  • Cue Health
  • Curetis N.V./Curetis GmbH
  • Detect
  • Diagenode Diagnostics
  • Diascopic  
  • Diasorin S.p.A.
  • Eiken Chemical
  • Enzo Biochem
  • Eurofins Scientific  
  • Fluxergy
  • Fulgent Genetics  
  • Fusion Genomics.
  • Genedrive
  • Genetic Signatures
  • GenMark Dx (Roche)
  • Grifols
  • Grip Molecular Technologies  
  • Hibergene Diagnostics 
  • Hologic  
  • Illumina  
  • Immunexpress
  • Inflammatix
  • Invetech
  • Janssen Diagnostics
  • Karius
  • Lexagene  
  • LightDeck Diagnostics
  • Lucira Health
  • Luminex Corp
  • LumiraDx
  • Lumos Diagnostics
  • Mammoth Biosciences
  • Maxim Biomedical
  • Meridian Bioscience
  • Mesa Biotech (Thermo Fisher)
  • Millipore Sigma
  • Mindray
  • Mobidiag (Hologic)  
  • Molbio Diagnostics
  • Nanomix
  • Novacyt
  • Novel Microdevices
  • Operon  
  • Oxford Nanopore Technologies
  • Panagene
  • Pathogenomix  
  • Perkin Elmer
  • Prenetics
  • Primerdesign (Novacyt)
  • Prominex
  • Qiagen  
  • QuantuMDx  
  • Quest Diagnostics
  • Quidel
  • Randox Toxicology
  • Roche Molecular Diagnostics
  • Saw Diagnostics
  • SD Biosensor  
  • Seegene
  • Siemens Healthineers
  • SomaLogic
  • Sona Nanotech
  • SpeeDx  
  • T2 Biosystems
  • Talis Biomedical
  • Thermo Fisher Scientific Inc.
  • Veramarx  
  • Veredus Laboratories
  • Vir
  • Vircell
  • Visby Medical
  • XCR Diagnostics
  • YD Diagnostics  
  • Zhejiang Orient Gene Biotech

Methodology

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