Polymerase Chain Reaction (PCR) for Point-of-Care (POC) Diagnostics
Report Scope:
The scope of this report is broad and covers the components available in the polymerase chain reaction (PCR) for point-of-care (POC) diagnostics market and potential end-users. Revenue forecasts from 2020 to 2025 are given for types of kits and equipment, with estimated value derived from the revenues of manufacturers.
The report also includes a discussion on the major players in each regional market. Further, it explains major drivers and regional dynamics of the global market. The report concludes with a look at the vendor landscape and includes detailed profiles of major vendors in the global PCR for POC diagnostics market.
This report will cover the variety of markets being served by these newly emerging diagnostic kits, the companies that produce them, and the types of end users who are embracing these kits. This study does not cover the existing kit market for molecular diagnostics, either through manual use or through a variety of automation platforms. These kits, which enable processing of samples for PCR without further operator intervention, by definition do not require much in the way of sample preparation or consumables other than what is used to generate results, so there will not be a discussion of that marketplace. However, the appropriate consumables necessary, as well as the cyclers that are paired with these kits, will be covered as a part of this report.
Report Includes:
Polymerase chain reaction for point-of-care diagnostics is being most rapidly deployed for two types of infectious diseases, respiratory infections and sexually transmitted diseases. Respiratory infections such as influenza and respiratory syncytial virus are common targets for point-of-care diagnostics as these tests replace existing lateral flow immunoassays due to improved precision in results. The other area of infectious disease diagnostics where such technology has had strong growth is in the area of sexually transmitted diseases. The integration of such testing with counseling and connection to resources is proving to be a popular combination for healthcare providers.
The growing prevalence of infectious diseases and the ongoing innovation in the development of diagnostics for the novel coronavirus (COVID-19) are the prime factors creating huge potential for the global market. Market players, governments and research organizations are actively looking for the development of innovative treatment and diagnosis for COVID-19 with the adoption of PCR techniques. For instance, in October 2020, Rover Diagnostics (U.S.) and Columbia Engineering (U.S.) announced the development of a new, low-cost, simple-to-use, ultrafast point-of-care test for COVID-19. It reportedly can provide reverse transcription polymerase chain reaction (RT PCR) results in just eight minutes, faster than any other test of its kind, with targeted accuracy to match laboratory-based tests.
The point-of-care PCR market will grow from $REDACTED in 2019 to $REDACTED in 2025, with a compound annual growth rate (CAGR) of REDACTED% during the period of 2020 to 2025. The rapid growth within this marketplace is reflective of the novelty of the technology in this sector, as well as the strong demand for this technology.
The scope of this report is broad and covers the components available in the polymerase chain reaction (PCR) for point-of-care (POC) diagnostics market and potential end-users. Revenue forecasts from 2020 to 2025 are given for types of kits and equipment, with estimated value derived from the revenues of manufacturers.
The report also includes a discussion on the major players in each regional market. Further, it explains major drivers and regional dynamics of the global market. The report concludes with a look at the vendor landscape and includes detailed profiles of major vendors in the global PCR for POC diagnostics market.
This report will cover the variety of markets being served by these newly emerging diagnostic kits, the companies that produce them, and the types of end users who are embracing these kits. This study does not cover the existing kit market for molecular diagnostics, either through manual use or through a variety of automation platforms. These kits, which enable processing of samples for PCR without further operator intervention, by definition do not require much in the way of sample preparation or consumables other than what is used to generate results, so there will not be a discussion of that marketplace. However, the appropriate consumables necessary, as well as the cyclers that are paired with these kits, will be covered as a part of this report.
Report Includes:
- 18 data tables and 23 additional tables
- A comprehensive overview of the global market for polymerase chain reaction (PCR) for point-of-care (POC) diagnostics, along with future commercial potential for each key market segment
- Analyses of the global market trends, with data from 2019 and 2020, and projections of compound annual growth rates (CAGRs) through 2025
- Estimation of the actual market size and revenue forecasts for the global PCR for POC diagnostics market and potential end-users for types of kits and equipment
- Identification of the emerging market opportunities and future market potential of the PCR for POC diagnostics industry, technology trends and issues, market determinants, and regulatory frameworks pertaining to PCR technology
- Competitive landscape specific to COVID-19 impact analysis, with emphasis on FDA’s contribution to COVID-19 diagnostic testing and key developments within the segment
- Patent review and new developments in POC PCR technologies, by companies or research institutes
- Discussion of the vendor landscape and detailed profiles of major vendors in the global PCR for POC diagnostics market. Major players include Abbott Laboratories, Bio-Rad Laboratories Inc., Cepheid, Roche Diagnostics and Qiagen N.V.
Polymerase chain reaction for point-of-care diagnostics is being most rapidly deployed for two types of infectious diseases, respiratory infections and sexually transmitted diseases. Respiratory infections such as influenza and respiratory syncytial virus are common targets for point-of-care diagnostics as these tests replace existing lateral flow immunoassays due to improved precision in results. The other area of infectious disease diagnostics where such technology has had strong growth is in the area of sexually transmitted diseases. The integration of such testing with counseling and connection to resources is proving to be a popular combination for healthcare providers.
The growing prevalence of infectious diseases and the ongoing innovation in the development of diagnostics for the novel coronavirus (COVID-19) are the prime factors creating huge potential for the global market. Market players, governments and research organizations are actively looking for the development of innovative treatment and diagnosis for COVID-19 with the adoption of PCR techniques. For instance, in October 2020, Rover Diagnostics (U.S.) and Columbia Engineering (U.S.) announced the development of a new, low-cost, simple-to-use, ultrafast point-of-care test for COVID-19. It reportedly can provide reverse transcription polymerase chain reaction (RT PCR) results in just eight minutes, faster than any other test of its kind, with targeted accuracy to match laboratory-based tests.
The point-of-care PCR market will grow from $REDACTED in 2019 to $REDACTED in 2025, with a compound annual growth rate (CAGR) of REDACTED% during the period of 2020 to 2025. The rapid growth within this marketplace is reflective of the novelty of the technology in this sector, as well as the strong demand for this technology.
CHAPTER 1 INTRODUCTION
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Geographic Breakdown
Analyst's Credentials
BCC Custom Research
Related BCC Research Reports
CHAPTER 2 SUMMARY AND HIGHLIGHTS
Trends in Price/Performance
Market Ramp-Up in Equipment
Explosion in Uses
Pushing Molecular to the Patient
Evolving from Single-Test to Panels
CHAPTER 3 MARKET AND TECHNOLOGY BACKGROUND
Introduction
Evolution
History of PCR
1950s-1960s
1970s-1980s
1990s-2017
Ultra-fast PCR Technologies for Point-of-Care Testing
Thermal Cycling Limits the Use of Conventional PCR at the POC
Approaches to Manage PCR Thermal Cycling
Novel Approaches for POC
Laser PCR: Expanding the Possibilities at the POC
Conclusions
New Approaches to Tackle Technical Challenges Correlated with Nucleic Acid-based POC Assays
Market Determinants
High Incidence of Infectious Diseases
Increasing Prevalence of COVID-19
Uses of POC PCR
Infectious Disease
Sexually Transmitted Disease
Other Uses
POC PCR Technology
Detection
Isothermic Amplification
Microfluidics
Regulatory Framework
CHAPTER 4 COVID-19 IMPACT ANALYSIS
FDA's Contribution to COVID-19 Diagnostic Testing
Prioritizing of OTC and At-Home Testing Solutions
Synopsis of FDA-Associated Testing Milestones, Since May 2020
Competitive Landscape Specific to COVID-19 Impact Analysis
Developments in COVID-19 Testing
Meridian Introduces Novel Air-Dryable RT-qPCR Mix
FDA Allows Roche's Novel Diagnostic Test for Identifying MRSA Bacteria
Diagnostic Test for Combined Flu/SAR-CoV-2
CHAPTER 5 POC PCR MARKET BREAKDOWN BY EQUIPMENT
CHAPTER 6 POC PCR MARKET BREAKDOWN BY KITS
Infectious Diseases
Multi-analyte Panels
Single Analyte
Sexually Transmitted Diseases
Biomarkers
CHAPTER 7 POC PCR MARKET BREAKDOWN BY REGION
North America
United States
Canada
Europe
Asia-Pacific
Rest of the World
Latin America
CHAPTER 8 PATENT REVIEW/NEW DEVELOPMENTS
CHAPTER 9 TECHNOLOGY ISSUES
Emerging Diseases and POC PCR
Point-of-Care Testing: Not Just at The Patient Bedside
Quality Control of POC PCR
Company Strategies
CHAPTER 10 INDUSTRY STRUCTURE
Public Health
Clinical Diagnostics
Industrial
CHAPTER 11 DIGITAL PCR ADDITIONAL INFORMATION
Case Study: dPCR Offers More Absolute Results Over qPCR
Porter's Five Forces Model
Threat of New Entrants
Bargaining Power of Buyers
Bargaining Power of Suppliers
Threat of Substitutes
Competitive Rivalry Between Existing Players
Droplet Digital PCR
Applications of Digital PCR
Clinical
Research
Forensics
Industry Structure
CHAPTER 12 COMPANY PROFILES
ABBOTT LABORATORIES
ADVANCED THERANOSTICS INC.
AQUILA DIAGNOSTICS SYSTEMS INC.
ATLAS GENETICS
BIO-RAD LABORATORIES INC.
CEPHEID
FLUXERGY
QIAGEN N.V.
ROCHE DIAGNOSTICS
VISBY MEDICAL INC.
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Geographic Breakdown
Analyst's Credentials
BCC Custom Research
Related BCC Research Reports
CHAPTER 2 SUMMARY AND HIGHLIGHTS
Trends in Price/Performance
Market Ramp-Up in Equipment
Explosion in Uses
Pushing Molecular to the Patient
Evolving from Single-Test to Panels
CHAPTER 3 MARKET AND TECHNOLOGY BACKGROUND
Introduction
Evolution
History of PCR
1950s-1960s
1970s-1980s
1990s-2017
Ultra-fast PCR Technologies for Point-of-Care Testing
Thermal Cycling Limits the Use of Conventional PCR at the POC
Approaches to Manage PCR Thermal Cycling
Novel Approaches for POC
Laser PCR: Expanding the Possibilities at the POC
Conclusions
New Approaches to Tackle Technical Challenges Correlated with Nucleic Acid-based POC Assays
Market Determinants
High Incidence of Infectious Diseases
Increasing Prevalence of COVID-19
Uses of POC PCR
Infectious Disease
Sexually Transmitted Disease
Other Uses
POC PCR Technology
Detection
Isothermic Amplification
Microfluidics
Regulatory Framework
CHAPTER 4 COVID-19 IMPACT ANALYSIS
FDA's Contribution to COVID-19 Diagnostic Testing
Prioritizing of OTC and At-Home Testing Solutions
Synopsis of FDA-Associated Testing Milestones, Since May 2020
Competitive Landscape Specific to COVID-19 Impact Analysis
Developments in COVID-19 Testing
Meridian Introduces Novel Air-Dryable RT-qPCR Mix
FDA Allows Roche's Novel Diagnostic Test for Identifying MRSA Bacteria
Diagnostic Test for Combined Flu/SAR-CoV-2
CHAPTER 5 POC PCR MARKET BREAKDOWN BY EQUIPMENT
CHAPTER 6 POC PCR MARKET BREAKDOWN BY KITS
Infectious Diseases
Multi-analyte Panels
Single Analyte
Sexually Transmitted Diseases
Biomarkers
CHAPTER 7 POC PCR MARKET BREAKDOWN BY REGION
North America
United States
Canada
Europe
Asia-Pacific
Rest of the World
Latin America
CHAPTER 8 PATENT REVIEW/NEW DEVELOPMENTS
CHAPTER 9 TECHNOLOGY ISSUES
Emerging Diseases and POC PCR
Point-of-Care Testing: Not Just at The Patient Bedside
Quality Control of POC PCR
Company Strategies
CHAPTER 10 INDUSTRY STRUCTURE
Public Health
Clinical Diagnostics
Industrial
CHAPTER 11 DIGITAL PCR ADDITIONAL INFORMATION
Case Study: dPCR Offers More Absolute Results Over qPCR
Porter's Five Forces Model
Threat of New Entrants
Bargaining Power of Buyers
Bargaining Power of Suppliers
Threat of Substitutes
Competitive Rivalry Between Existing Players
Droplet Digital PCR
Applications of Digital PCR
Clinical
Research
Forensics
Industry Structure
CHAPTER 12 COMPANY PROFILES
ABBOTT LABORATORIES
ADVANCED THERANOSTICS INC.
AQUILA DIAGNOSTICS SYSTEMS INC.
ATLAS GENETICS
BIO-RAD LABORATORIES INC.
CEPHEID
FLUXERGY
QIAGEN N.V.
ROCHE DIAGNOSTICS
VISBY MEDICAL INC.
LIST OF TABLES
Summary Table : Global Market for PCR Technology-based POC Diagnostics, by Segment, Through 2025
Table 1 : Generations of PCR Technology
Table 2 : Commercial Systems for Near-Patient Testing
Table 3 : Global Prevalence of HIV Infections, 2000-2020
Table 4 : Global Mortality Cases Due to COVID-19, by Country, as of December 4, 2020
Table 5 : Global Estimates of New Cases of Curable STIs, 2016
Table 6 : Types of Detection for POC PCR Technologies
Table 7 : Types of Isothermic Amplification
Table 8 : Types of Microfluidics
Table 9 : Regulatory Frameworks Pertaining to PCR Technology
Table 10 : Competitive Landscape of PCR Technique for COVID-19
Table 11 : Global Market for PCR Equipment for POC Diagnostics, by Equipment Type, Through 2025
Table 12 : Global Market for PCR Kits for POC Diagnostics, by Kit Type, Through 2025
Table 13 : Number of New Cases of Sexually Transmitted Diseases in the United States, 1950-2017
Table 14 : Global Market for PCR for POC Diagnostics, by Region, Through 2025
Table 15 : North American Market for PCR for POC Diagnostics, by Country, Through 2025
Table 16 : COVID-19 Confirmed Cases and Deaths in the U.S., by State, as of December 11, 2020
Table 17 : Share of New Cancer Cases in Males Across the U.S., by Cancer Site, 2019
Table 18 : STI Cases Across Canada, by Age Group and Disease Type,* 2017
Table 19 : European Market for PCR for POC Diagnostics, by Country, Through 2025
Table 20 : COVID-19 Confirmed Cases in Europe, by Country, as of December 11, 2020
Table 21 : Asia-Pacific Market for PCR for POC Diagnostics, by Country, Through 2025
Table 22 : Rest of the World Market for PCR for POC Diagnostics, by Sub-Region, Through 2025
Table 23 : COVID-19 Confirmed Cases in Latin America, by Country, December 3, 2020
Table 24 : Middle East and North Africa HIV and AIDS Briefly, 2019
Table 25 : Patents in POC PCR, by Companies or Research Institutes
Table 26 : Threat of New Entrants Analysis, 2019 and 2025
Table 27 : Bargaining Power of Buyers Analysis, 2019 and 2025
Table 28 : Bargaining Power of Suppliers Analysis, 2019 and 2025
Table 29 : Threat of Substitutes Analysis, 2019 and 2025
Table 30 : Competitive Rivalry Between Existing Players, 2019 and 2025
Table 31 : Global Market for Digital PCR, by Type, Through 2025
Table 32 : Abbott Laboratories: Product Portfolio
Table 33 : Bio-Rad Laboratories: Product Portfolio
Table 34 : Cepheid: Product Portfolio
Table 35 : FluxErgy: Product Portfolio
Table 36 : FluxErgy: Recent Developments
Table 37 : Qiagen N.V.: Product Portfolio
Table 38 : Roche Diagnostics: Product Portfolio
Table 39 : Visby Medical Inc.: Product Portfolio
Table 40 : Visby Medical Inc.: Recent Developments
Summary Table : Global Market for PCR Technology-based POC Diagnostics, by Segment, Through 2025
Table 1 : Generations of PCR Technology
Table 2 : Commercial Systems for Near-Patient Testing
Table 3 : Global Prevalence of HIV Infections, 2000-2020
Table 4 : Global Mortality Cases Due to COVID-19, by Country, as of December 4, 2020
Table 5 : Global Estimates of New Cases of Curable STIs, 2016
Table 6 : Types of Detection for POC PCR Technologies
Table 7 : Types of Isothermic Amplification
Table 8 : Types of Microfluidics
Table 9 : Regulatory Frameworks Pertaining to PCR Technology
Table 10 : Competitive Landscape of PCR Technique for COVID-19
Table 11 : Global Market for PCR Equipment for POC Diagnostics, by Equipment Type, Through 2025
Table 12 : Global Market for PCR Kits for POC Diagnostics, by Kit Type, Through 2025
Table 13 : Number of New Cases of Sexually Transmitted Diseases in the United States, 1950-2017
Table 14 : Global Market for PCR for POC Diagnostics, by Region, Through 2025
Table 15 : North American Market for PCR for POC Diagnostics, by Country, Through 2025
Table 16 : COVID-19 Confirmed Cases and Deaths in the U.S., by State, as of December 11, 2020
Table 17 : Share of New Cancer Cases in Males Across the U.S., by Cancer Site, 2019
Table 18 : STI Cases Across Canada, by Age Group and Disease Type,* 2017
Table 19 : European Market for PCR for POC Diagnostics, by Country, Through 2025
Table 20 : COVID-19 Confirmed Cases in Europe, by Country, as of December 11, 2020
Table 21 : Asia-Pacific Market for PCR for POC Diagnostics, by Country, Through 2025
Table 22 : Rest of the World Market for PCR for POC Diagnostics, by Sub-Region, Through 2025
Table 23 : COVID-19 Confirmed Cases in Latin America, by Country, December 3, 2020
Table 24 : Middle East and North Africa HIV and AIDS Briefly, 2019
Table 25 : Patents in POC PCR, by Companies or Research Institutes
Table 26 : Threat of New Entrants Analysis, 2019 and 2025
Table 27 : Bargaining Power of Buyers Analysis, 2019 and 2025
Table 28 : Bargaining Power of Suppliers Analysis, 2019 and 2025
Table 29 : Threat of Substitutes Analysis, 2019 and 2025
Table 30 : Competitive Rivalry Between Existing Players, 2019 and 2025
Table 31 : Global Market for Digital PCR, by Type, Through 2025
Table 32 : Abbott Laboratories: Product Portfolio
Table 33 : Bio-Rad Laboratories: Product Portfolio
Table 34 : Cepheid: Product Portfolio
Table 35 : FluxErgy: Product Portfolio
Table 36 : FluxErgy: Recent Developments
Table 37 : Qiagen N.V.: Product Portfolio
Table 38 : Roche Diagnostics: Product Portfolio
Table 39 : Visby Medical Inc.: Product Portfolio
Table 40 : Visby Medical Inc.: Recent Developments
LIST OF FIGURES
Summary Figure : Global Market for PCR Technology-based POC Diagnostics, by Segment, 2019-2025
Figure 1 : Shares of Global Prevalence of Malaria Cases, by Country, 2018
Figure 2 : Rise in Number of Cancer Patients, Projections and Trends, 2012 and 2030
Figure 3 : Incidences of Diagnosed Infectious Disease, by Country, 2019
Figure 4 : Global Market for PCR Equipment for POC Diagnostics, by Equipment Type, 2019-2025
Figure 5 : Global Market for PCR Kits for POC Diagnostics, by Kit Type, 2019-2025
Figure 6 : Funders for Malaria R&D Globally, 2018
Figure 7 : Donated Funds for R&D, by Diseases, 2018
Figure 8 : Number of Clinical Trial Studies Globally, 2010-2018
Figure 9 : Venture Investment in Infectious Disease Companies Across the U.S., 2006-2018
Figure 10 : Deaths Due to Infectious and Parasitic Diseases in Spain, by Age Group, 2018
Figure 11 : Trend in Geriatric Population in Germany, 2000-2030
Figure 12 : Allocation of Diagnosed Infectious Diseases in Selected Countries, by Gender, as of 2019
Figure 13 : Infectious Disease Treatments in China, by Disease Incidence, 2019
Figure 14 : Trends in Aging Population (Aged 65 Years and Above) in Japan, 2010-2040
Figure 15 : STD Incidence in China, by Disease, 2019
Figure 16 : Value Chain Analysis of PCR-based POC Market
Figure 17 : Global Market for Digital PCR, by Type, 2019-2025
COMPANIES MENTIONED
ABBOTT LABORATORIES
ADVANCED THERANOSTICS INC.
AQUILA DIAGNOSTICS SYSTEMS INC.
ATLAS GENETICS
BIO-RAD LABORATORIES INC.
CEPHEID
FLUXERGY
QIAGEN N.V.
ROCHE DIAGNOSTICS
VISBY MEDICAL INC.
Summary Figure : Global Market for PCR Technology-based POC Diagnostics, by Segment, 2019-2025
Figure 1 : Shares of Global Prevalence of Malaria Cases, by Country, 2018
Figure 2 : Rise in Number of Cancer Patients, Projections and Trends, 2012 and 2030
Figure 3 : Incidences of Diagnosed Infectious Disease, by Country, 2019
Figure 4 : Global Market for PCR Equipment for POC Diagnostics, by Equipment Type, 2019-2025
Figure 5 : Global Market for PCR Kits for POC Diagnostics, by Kit Type, 2019-2025
Figure 6 : Funders for Malaria R&D Globally, 2018
Figure 7 : Donated Funds for R&D, by Diseases, 2018
Figure 8 : Number of Clinical Trial Studies Globally, 2010-2018
Figure 9 : Venture Investment in Infectious Disease Companies Across the U.S., 2006-2018
Figure 10 : Deaths Due to Infectious and Parasitic Diseases in Spain, by Age Group, 2018
Figure 11 : Trend in Geriatric Population in Germany, 2000-2030
Figure 12 : Allocation of Diagnosed Infectious Diseases in Selected Countries, by Gender, as of 2019
Figure 13 : Infectious Disease Treatments in China, by Disease Incidence, 2019
Figure 14 : Trends in Aging Population (Aged 65 Years and Above) in Japan, 2010-2040
Figure 15 : STD Incidence in China, by Disease, 2019
Figure 16 : Value Chain Analysis of PCR-based POC Market
Figure 17 : Global Market for Digital PCR, by Type, 2019-2025
COMPANIES MENTIONED
ABBOTT LABORATORIES
ADVANCED THERANOSTICS INC.
AQUILA DIAGNOSTICS SYSTEMS INC.
ATLAS GENETICS
BIO-RAD LABORATORIES INC.
CEPHEID
FLUXERGY
QIAGEN N.V.
ROCHE DIAGNOSTICS
VISBY MEDICAL INC.
