PCR Molecular Diagnostics Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)

The PCR Molecular Diagnostics Market is segmented by Product Type (Instrument, Reagents and Consumables and Software) Application (Infectious Disease Testing, Oncology Testing, Other Applications), End Users (Hospitals, Diagnostics Laboratories, Others) and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report offers the value (in USD million) for the above segments.

Market Snapshot

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Study Period: 2018-2026
Base Year: 2021
Fastest Growing Market: Asia-Pacific
Largest Market: North America
CAGR: 3.5 %

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Market Overview

The PCR Molecular Diagnostics market is expected to grow with an estimated CAGR of 3.5%, over the forecast period.

PCR are most widely used diagnostic tests for detecting pathogens, including viruses. It Is considered as one of the best tests to identify the COVID 19 virus in the human body. Additionally, a study titled 'Molecular diagnostic technologies for COVID-19: Limitations and challenges', published on Aug 2020 at NCBI stated that PCR Molecular Diagnostics are used to identify symptomatic or asymptomatic SARS-CoV-2 carriers and is safe and accurate as they have a high clinical sensitivity and avoid false-negative results. Moreover, rising technological advancement and growing public awareness of preventive care are propelling the market growth. Though COVID 19 has a major impact on the medical industry, the PCR Molecular Diagnostics market is on a positive trend.

The rising prevalence of cancer and infectious diseases is also a major factor that drives PCR molecular diagnostics market. The Infectious Diseases Society of America has stated that every year there is a probability of new, potentially dangerous bacteria, viruses, fungi such as severe acute respiratory syndrome (SARS). World Health Organization in March 2020 stated that more than 17% of all infectious diseases are vector born. In addition to this the Global Cancer facts and figures, 4th edition, published at American Cancer Society reported that according to International Agency for Research on Cancer (IARC), the cancer cases are rising and it is expected to reach 27.5 million by 2040, aging is also a supporting factor for the rise in new cancer’s.

Adoption and implementation of software associated to molecular diagnostics at respective diagnostics centers is expected to boost the market growth. Aditionally PCR molecular diagnostics also played a crucial role in cancer diseases. For instance, in March 2020, a review made on Important Diagnostic Methods of Cancer Biomarkers related Diagnosis and Treatment reported that Polymerase chain reaction (PCR) & Real Time PCR plays a vital role in cancer diagnostics. 

Furthermore, in June 2020, Mobidiag Ltd., announced that it has received CE-IVD markings for its Novodiag COVID-19 and Amplidiag COVID-19 molecular diagnostic tests for the early detection of the SARS-CoV-2 virus, responsible for novel coronavirus infection (COVID-19). Based on well-established high-throughput qualitative PCR technology, 48 samples can be processed in less than three hours while running on Mobidiag’s Amplidiag Easy platform. Hence, owing to above mentioned factors, the market is expected to witness significant growth in the future.

Scope of the Report

PCR, or the polymerase chain reaction, is a chemical reaction, which is considered to be a molecular technique that is used to amplify the DNA sequences. Short DNA sequences called primers are used to amplify the selected part of the genome. It involves three steps denaturation, Annealing, extension, during which the temperature is raised and lowered which helps the DNA replication enzyme to copy the target DNA sequence, this helps to produce billions of target/desired sequences in few hours. 

The PCR Molecular Diagnostics Market is segmented by Product Type (Instrument, Reagents and Consumables and Software) Application (Infectious Disease Testing, Oncology Testing, Other Applications), End Users (Hospitals, Diagnostics Laboratories, Others) and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The report offers the value (in USD million) for the above segments.

By Product
Instrument
Standard PCR Systems
Digital PCR Systems
Real-time PCR Systems
Reagents and Consumables
Software
By Application
Infectious Disease Testing
Oncology Testing
Other Applications
By End User
Hospitals
Diagnostic Laboratories
Others
Geography
North America
United States
Canada
Mexico
Europe
Germany
United Kingdom
France
Italy
Spain
Rest of Europe
Asia-Pacific
China
Japan
India
Australia
South Korea
Rest of Asia-Pacific
Middle East and Africa
GCC
South Africa
Rest of Middle East and Africa
South America
Brazil
Argentina
Rest of South America

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Key Market Trends

The Oncology Testing Segment is Expected to Grow Over the Forecast Period

Polymer Chain Reaction (PCR) is widely used in diagnostics of oncology. Real-time PCR technology is best used for cancer diagnostics. In addition to this, there are several PCR techniques that help in cancer diagnosis and prognosis. In Jan 2020, a group of scientists in cancer research during a Bio-Rad workshop at the Precision Medicine World Conference (PMWC) in Santa Clara, California, has showcased that the Integrated Use of Next-Generation Sequencing and Droplet Digital PCR (ddPCR) in Cancer Monitoring in which they have concluded that droplet digital PCR (ddPCR) technology quantifies genetic material from tumor cells that have been entered to the bloodstream through a liquid biopsy approach. Using droplet digital PCR (ddPCR), 1,000 or even 10,000 wild-type copies with cancer-associated mutations can be detected within a few days. This data gives insights regarding when to add new therapies or discontinue existing treatments that are not working with this data valuable for clinicians.

Along with that, the companies are merging, engaging in partnerships and acquisitions to increase their manufacturing capacities, improve their product portfolio and to provide a competitive diversity. For instance, In Septemebr 2020, Qiagen announced the acquisition of the remaining 80.1% of diagnostics instruments company NeuMoDx Molecular, Inc. for USD 248 million in cash. The move rounds out QIAGEN’s portfolio of automated molecular testing solutions based on the proven PCR technology. The above conditions show that the PCR Molecular Diagnostics market is expected to have a promising growth rate over the forecast period.

CAGR

North America Dominates the Market and Expected to do Same in the Forecast Period.

North America holds the major market share in the PCR Molecular Diagnostics market. Rising incidence of diseases, the elderly population (aging), and technological advancements are attributed to the market growth. Especially in recent times, pandemics have also boosted the PCR molecular diagnostics market.

American Cancer Society estimated that in 2020, around 1,806,590 new cancer cases and 606,520 cancer deaths are projected to occur in the United States. In 2020, according to an article published in Cancer Journal for Clinicians, estimated that 43% of all cancers diagnosed in men are colorectal, lung, and prostate cancers. The most common cancers in women are breast, lung, and colorectal which accounts for 50% of new cancers diagnosed in 2020. With the early diagnosis and rising awareness on preventive care especially with the technological development of PCR techniques in recent times, the rate of cancer survivors has increased potentially. According to National Cancer Institute, it is estimated that there were 16.9 million cancer survivors in 2019 and by 2030 it is projected to increase to 22.2 million.

A study on PCR past, present, and future, published in Aug 2020 declared that PCR is one of the most valuable techniques used in diagnostics, bioscience and forensics. A study conducted on important diagnostics methods for cancer biomarkers in March 2020, published at Journal of Critical Review stated that RT-PCR was used to screen her-2 biomarkers in breast cancer which will have a vital effect in the progression and pathogenesis of cancer. Her-2 gene is considered to be a significant biomarker and target of therapy. Adding to this the use of PCR in COVID 19 diagnostics has given a wide opportunity to top players of PCR molecular diagnostics market, one such is Abbott Real-time SARS-CoV-2-Assay is an Emergency Use Authorization (EUA) test authorized by the U.S. FDA which uses polymerase chain reaction (PCR) technology for diagnosis of SARS-CoV-2 virus infection. Hence, considering to above mentioned factors, the market is expected to witness significant growth in the future.

Geo

Competitive Landscape

The PCR Molecular Diagnostics market is moderately competitive with several players across the globe. In terms of market share, few of the major players currently dominate the market.  With the rising patient awareness levels and high prevalence of infectious and cancer diseases, especially the COVID 19, many regional players are expected to grow their presence in the market.  Some of the major players of the market are Abbott Laboratories, Thermo Fisher Scientific, Inc., Bio-Rad Laboratories, Inc., Takara Bio, Inc., Qiagen N.V, etc

Recent Developments

In March 2020, Abbott has received emergency use authorization (EUA) from the FDA for the product m2000 Real-Time System for identification of SARS-CoV-2. The platform uses polymerase chain reaction (PCR) technology, which amplifies a single piece (or few copies of a piece) of DNA to quickly and accurately diagnose a patient. The m2000 is currently used in labs around the world.

In April 2021, Thermo Fisher Scientific Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the Thermo Fisher Scientific Amplitude Solution with the TaqPath COVID-19 High-Throughput Combo Kit. The Amplitude Solution enables clinical and public health laboratories to scale gold standard PCR testing and process up to 8,000 samples in a single day with minimal staffing resources and a secured supply of kits, reagents and consumables to meet their testing needs.

Table of Contents

  1. 1. INTRODUCTION

    1. 1.1 Study Assumptions and Market Definition

    2. 1.2 Scope of the Study

  2. 2. RESEARCH METHODOLOGY

  3. 3. EXECUTIVE SUMMARY

  4. 4. MARKET DYNAMICS

    1. 4.1 Market Overview

    2. 4.2 Market Drivers

      1. 4.2.1 Rising Prevalance of Cancer and Infectious Diseases

      2. 4.2.2 Technological Advancements in PCR Devices

      3. 4.2.3 Increasing Demand For Rapid Diagnostic Tests And Growing Adoption of PCR

    3. 4.3 Market Restraints

      1. 4.3.1 High Cost of PCR Instrument/Devices

      2. 4.3.2 Stringent Regulatory Policies

    4. 4.4 Porter's Five Force Analysis

      1. 4.4.1 Threat of New Entrants

      2. 4.4.2 Bargaining Power of Buyers/Consumers

      3. 4.4.3 Bargaining Power of Suppliers

      4. 4.4.4 Threat of Substitute Products

      5. 4.4.5 Intensity of Competitive Rivalry

  5. 5. MARKET SEGMENTATION

    1. 5.1 By Product

      1. 5.1.1 Instrument

        1. 5.1.1.1 Standard PCR Systems

        2. 5.1.1.2 Digital PCR Systems

        3. 5.1.1.3 Real-time PCR Systems

      2. 5.1.2 Reagents and Consumables

      3. 5.1.3 Software

    2. 5.2 By Application

      1. 5.2.1 Infectious Disease Testing

      2. 5.2.2 Oncology Testing

      3. 5.2.3 Other Applications

    3. 5.3 By End User

      1. 5.3.1 Hospitals

      2. 5.3.2 Diagnostic Laboratories

      3. 5.3.3 Others

    4. 5.4 Geography

      1. 5.4.1 North America

        1. 5.4.1.1 United States

        2. 5.4.1.2 Canada

        3. 5.4.1.3 Mexico

      2. 5.4.2 Europe

        1. 5.4.2.1 Germany

        2. 5.4.2.2 United Kingdom

        3. 5.4.2.3 France

        4. 5.4.2.4 Italy

        5. 5.4.2.5 Spain

        6. 5.4.2.6 Rest of Europe

      3. 5.4.3 Asia-Pacific

        1. 5.4.3.1 China

        2. 5.4.3.2 Japan

        3. 5.4.3.3 India

        4. 5.4.3.4 Australia

        5. 5.4.3.5 South Korea

        6. 5.4.3.6 Rest of Asia-Pacific

      4. 5.4.4 Middle East and Africa

        1. 5.4.4.1 GCC

        2. 5.4.4.2 South Africa

        3. 5.4.4.3 Rest of Middle East and Africa

      5. 5.4.5 South America

        1. 5.4.5.1 Brazil

        2. 5.4.5.2 Argentina

        3. 5.4.5.3 Rest of South America

  6. 6. COMPETITIVE LANDSCAPE

    1. 6.1 Company Profiles

      1. 6.1.1 Abbott Laboratories

      2. 6.1.2 Thermo Fisher Scientific, Inc.

      3. 6.1.3 Bio-Rad Laboratories, Inc.

      4. 6.1.4 Takara Bio, Inc.

      5. 6.1.5 Qiagen N.V.

      6. 6.1.6 Danaher Corporation

      7. 6.1.7 Becton Dickinson and Company

      8. 6.1.8 Agilent Technologies, Inc.

      9. 6.1.9 Eppendorf AG

      10. 6.1.10 F. Hoffman-La Roche Ltd.

    2. *List Not Exhaustive
  7. 7. MARKET OPPORTUNITIES AND FUTURE TRENDS

**Competitive Landscape covers- Business Overview, Financials, Products and Strategies and Recent Developments

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Frequently Asked Questions

The Global PCR Molecular Diagnostics market is studied from 2018 - 2026.

The Global PCR Molecular Diagnostics is growing at a CAGR of 3.5% over the next 5 years.

Asia-Pacific is growing at the highest CAGR over 2021- 2026.

North America holds highest share in 2021.

Abbott Laboratories, Thermo Fisher Scientific, Bio-Rad Laboratories, Inc, Takara Bio, Inc, Qiagen N.V. are the major companies operating in Global PCR Molecular Diagnostics.

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