Molecular Diagnostics Market: Global Industry Analysis and Forecast (2021-2029) Trends, Statistics, Dynamics, Segment Analysis

Molecular Diagnostics Market size was valued at USD 22 Bn. in 2021 and the total Molecular Diagnostics revenue is expected to grow by 7 % from 2022 to 2029, reaching nearly USD 37.8 Bn.

Molecular Diagnostics Market Overview:

Molecular diagnostics involves the identification of genetic polymorphisms with the goal of facilitating detection, diagnosis, subclassification, prognosis, and monitoring response to therapy. It is a set of procedures used to assess biological markers in the genome and proteome, as well as how their cells express their genes as proteins, therefore using molecular biology in medical diagnostics. Molecular diagnostics are widely utilized, powerful, and sensitive approaches for identifying biological markers in the genome and proteome by detecting bacterial genes (through PCR-based techniques) and quantifying expressed bacterial infection-specific proteins. (Using enzyme-linked immunosorbent assay (ELISA) and proteomics). The growing frequency of infectious illnesses and cancers is driving the growth of the molecular diagnostics market. Additionally, increased knowledge and acceptance of tailored treatments, as well as advancements in biomarker discovery, boost the market growth. However, rigorous regulatory criteria for the licensing of novel molecular diagnostic techniques are expected to hamper the growth of the molecular diagnostic market during the forecast period. On the other hand, increased acceptance of molecular diagnostics in emerging economies is likely to create profitable potential for market growth during the forecast period.

Report Scope:

The research includes market characteristics, size, growth, segmentation, geographical breakdowns, market shares, trends, and business plans on both the demand and supply sides. Future market elements are mostly offered based on the factors that firms contribute to market estimation, significant trends, and segmentation analysis. It covers effective company tactics, customer preferences, government restrictions, current competition activities, as well as future business prospects, and market concerns. The Molecular Diagnostics Marketing market report includes detailed financial information about leading manufacturers, such as year-over-year sales, revenue growth, CAGR, manufacturing cost analysis, and value chain structure.Molecular Diagnostics MarketTo know about the Research Methodology :- Request Free Sample Report

Molecular Diagnostics Market Dynamics:

Market Driver: Major Epidemics of the Modern Era Large outbreaks of bacterial and viral epidemics throughout the world, rising need for point-of-care diagnostics, recent advances in pharmacogenomics, and quickly growing technology are some of the reasons driving the market growth. According to the World Health Organization's 2020 report, TB is the world's 13th largest cause of death and the second leading infectious illness, after only COVID-19 (but ahead of HIV/AIDS). Tuberculosis was expected to affect roughly 10.5 million persons worldwide in 2020. There are 5.8 million males, 3.5 million women, and 1.5 million children in this group. Tuberculosis affects individuals of various ages and origins. In 2020, the top 30 tuberculosis-affected nations accounted for 86.5% of new cases. With two-thirds of the total, India leads the pack, followed by China, Indonesia, the Philippines, Pakistan, Nigeria, Bangladesh, and South Africa. As a result of the growing frequency and patient pool, the demand for molecular diagnostics rose with time.Molecular Diagnostics Market Additionally, the global prevalence of cancer is growing, which is boosting the molecular diagnostics market growth. According to GLOBOCAN 2020, there were 19,282,790 new cancer cases globally in 2020, with that figure expected to climb to 28,887,940 by 2040. As a result, the global cancer incidence, as well as advanced healthcare facilities, have been important drivers of market expansion. Molecular diagnostics is often regarded as the most effective tool for identifying and characterizing microorganisms. An efficient test must be exact, quick, and capable of measuring the infectious load. Better testing detects the organism's strain and medication sensitivity more rapidly, minimizing the time it takes to locate the proper antibiotic. Technological advances, such as polymerase chain reaction (PCR), have also enabled the identification of antibiotic resistance genes and the provision of public health information, such as strain characterization via genotyping. As a result of the aforementioned reasons, the market is expected to increase significantly during the forecast period.Molecular Diagnostics Market Understanding Emerging and Re-emerging Infectious Diseases Global epidemics of severe infectious illnesses caused by harmful microorganisms have substantially spurred researchers to create speedy and accurate pathogen detection technologies. Culture-based approaches have traditionally been regarded as gold standards for pathogen detection; however, the lengthy turnaround time associated with these procedures owing to overnight culturing and pathogen isolation limits their use to some extent. The discovery Product & Services of molecular diagnostic tools have sparked a revolution in the diagnosis and surveillance of infectious illnesses in recent years. Market Restraints: Unfavorable reimbursement situation Inadequate reimbursements are a significant impediment to the growth of the molecular diagnostics business. The most difficult obstacle for most diagnostic firms in commercializing their tests is persuading Medicare and private health insurance to pay for them. Medicare updated its funding process for various IVD tests, including molecular diagnostics, in the United States in 2018. Some of these molecular pathology tests lack their own Healthcare Common Procedure Coding System (HCPCS) codes and must be invoiced using unlisted codes. Medicare Administrative Contractors (MACs) determine a payment amount for their local jurisdictions in such circumstances. Market Opportunities: Growth opportunities in developing countries Developing economies such as India, China, South Korea, Brazil, Turkey, Russia, and South Africa are likely to provide significant participants in the molecular diagnostics market with considerable growth prospects. This can be due to these nations' high illness incidence, big patient populations, improved healthcare infrastructure, rising disposable income, and increased medical tourism. Aside from the above-mentioned causes, the Asia Pacific area has developed as an adaptable and business-friendly center due to less severe rules and data requirements. Market Challenges: Alternative technology adoption Alternative technologies, such as those employed in COVID-19 testing, might pose a challenge to the growth of the molecular diagnostics market. The majority of COVID-19 diagnostic tests are classified as polymerase chain reaction (PCR), serological, or antigen assays. PCR tests identify the presence of an antigen rather than the existence of the body's immunological response or antibodies. PCR testing can be time-consuming, with numerous steps where mistakes might arise between sampling and analysis. With PCR, results might take several days to a week or longer. Antibody tests, also known as serological testing, are used to detect the presence of a virus in the body by screening blood for COVID-19 antibodies. Past infections can also be assessed using antibody testing. Antigen testing is generally referred to as quick tests since the results are usually ready in 15 minutes. Because of their simpler design, antigen tests are less expensive to produce than molecular testing. Thanks to the development of alternative technologies pose a threat to the growth of the molecular diagnostics industry.

Competitive Landscape:

The global molecular diagnostics market is quite competitive, with a number of large companies. However, thanks to technical improvements and product breakthroughs, mid-size to small businesses are growing their market presence by offering new, lower-cost gadgets. Abbott Laboratories, F Hoffmann-la Roche Ltd, Hologic Corporation, Danaher Corporation, and Agilent Technology are among the major participants.

Molecular Diagnostics Market Segment Analysis:

Based on Product & Service, In 2021, the reagents & kits category had the most revenue share of the market. It is expected to continue its dominance in the forecast years as a result of its widespread use in research and therapeutic settings. Standard reagents aid in producing efficient and precise outcomes. Standardized outcomes, increased efficiency, and cost-effectiveness are expected to drive market growth. Moreover, the increased usage of devices to detect coronavirus, which was previously developed for other infectious disorders, is expected to drive market growth. For example, Roche Diagnostics expanded its Covid RT-PCR assays offering to the new Cobas 5800 system in countries that obtained the CE mark clearance in February 2022. Based on Test Type, In 2021, the lab tests category held the greatest proportion of the molecular diagnostics market. The growing requirement for automation, as well as the increased occurrence of numerous infectious illnesses, are driving the growth of this category. Control is one of the advantages of laboratory testing. Conducting distribution testing in a laboratory setting allows for managing the test intensity level, as well as ensuring regulatory compliance, repeatability, and impartiality. Cost reductions, real-time monitoring, and a shorter time to market. All these factors are expected to drive the growth of lab tests during the forecast period. Based on Technology, In 2021, the polymerase chain reaction (PCR) category generated the most revenue. This is due to its Test Type in the diagnosis of COVID-19 and other infectious disorders. The growing use of high-throughput PCR technology to diagnose viral and genetic illnesses fuels market growth. Seegene, for example, announced the introduction of their forthcoming Allplex SARS-CoV-2 Fast PCR Assay in January 2022. With a turnaround time of 60 minutes, the test is suited for bulk testing. DNA sequencing methods and new NGS technologies such as sequencing platforms and RNA sequencing are examples of sequencing technologies for the molecular diagnostics sector. Medication discovery, innovative drug development, and customized treatment are all inextricably related to DNA sequencing technology. Companies are developing novel NGS-based assays for early illness detection. For example, Biodesix announced the launch of its GeneStrat NGSTM Test, a blood-based tumor profiling test, in January 2022, to help clinicians treat advanced lung cancer based on mutations.Molecular Diagnostics Market Based on Application, In 2021, the Infectious Disease Diagnostics category had the most revenue share of the molecular diagnostics market. The growing use of molecular, particularly PCR assays, for the diagnosis of COVID-19 is the primary cause of this segment's dominance. Traditional testing's shortcomings, such as long turnaround times, poor in vitro kinetic development, difficulties cultivating organisms in manually produced culture medium, and lack of sensitivity, have been mitigated by technology advances such as PCR and ISH. During the projection period, the oncology segment is predicted to develop at a rapid CAGR. According to WHO, an estimated 19.3 million new cancer cases would be diagnosed globally in 2020, with around 10.0 million cancer deaths. Cancer is predicted to be the second leading cause of mortality in the United States. Furthermore, in January 2021, the British In Vitro Diagnostics Association called for NHS England to create a commissioning framework for molecular diagnostics in cancer. This is done to increase the use and accessibility of cancer molecular diagnostics.Molecular Diagnostics Market Based on the End User, In 2021, the Hospitals & Clinics segment have the highest revenue share. This is owing to the increased penetration of private and governmental hospitals & clinics worldwide. Growing government and corporate sector investments in the establishment of modern hospitals have fueled the growth of this category. The growing number of hospital & clinic admissions as a result of illness burden is supporting the growth of this category globally. The Diagnostic Laboratories segment is expected to grow significantly during the forecast period. The growing frequency of chronic illnesses increased usage of point-of-care diagnostics, and rising healthcare costs all contribute to the diagnostic labs market's growth. Additionally during the forecast period increased advances in diagnostics laboratories are expected to emerge as a prominent future trend in the diagnostic labs market. However, a lack of experienced personnel is impeding overall industry growth. As a result, the health-tech revolution took off and altered the healthcare sector to unthinkable heights. Since then, other start-ups have developed, revolutionizing the business with innovations like telemedicine, teleconsultation, and, in particular, diagnostic solutions. Diagnostic labs are the backbone of healthcare. The adoption of technology is critical in order to fulfill rising customer demand and maintain a competitive edge in the market. In light of this, industry participants are using the power of technology to provide next-generation healthcare solutions. With the aid of the most recent advances in artificial intelligence (AI) and machine learning, diagnostic lab technology is fast transforming (ML). Various forward-thinking R&D teams are already trying to produce better and easier blood analysis and diagnosis procedures, from establishing accurate and efficient diagnostic solutions to responding to technology innovations. Molecular Diagnostics Market

Molecular Diagnostics Market Regional Insights:

North America dominates the market and is expected to continue to do so during the forecast period. Large outbreaks of bacterial and viral epidemics, rising need for point-of-care diagnostics, fast improving technology, and the presence of important market players in the area are some of the factors driving market expansion. During the COVID-19 pandemic, the Centers for Disease Control and Prevention (CDC) in the United States employed a one-step PCR method to diagnose COVID-19. The experiment was performed by extracting RNA from the sample and adding it to a master mix that included forward and reverses primers, nuclease-free water, and the reaction mixture (reverse transcriptase, polymerase, nucleotides, magnesium, and other additives). According to the Centers for Disease Control and Prevention (CDC), antigen tests and nucleic acid amplification tests (NAATs) were utilized as diagnostic procedures in the United States to diagnose SARS-CoV-2 infection. Viral assays were employed as screening tests to decrease SARS-CoV-2 transmission by identifying sick people who needed to be isolated from others. Molecular diagnostics has been essential in transforming the face of illness diagnostics and ensuring timely identification and correct therapy for critically ill patients. The rise in per capita healthcare spending, advancements in healthcare infrastructure, and an increase in the number of infectious illnesses and cancer cases in the United States have resulted in a trend shift away from traditional diagnostic procedures and toward molecular diagnostics. The increasing prevalence of chronic illnesses in all age groups, particularly among the elderly, may increase the demand for molecular diagnostic testing in Canada. According to Canadian government data, 44% of persons aged 20 and above have at least one of ten prevalent chronic disorders in 2019, and the frequency of chronic diseases is increasing. Furthermore, growing technical breakthroughs increased the entrance of new competitors, and the rapid acceptance of sophisticated molecular diagnostics are aiding market expansion in the United States. For example, in March 2020, Abbott announced that the US Food and Drug Administration (FDA) had granted Emergency Use Authorization (EUA) for the fastest available molecular diagnostics test for the detection of novel coronavirus (COVID-19), with positive results available in as little as five minutes and negative results available in 13 minutes.

Molecular Diagnostics Market Scope: Inquire before buying

Molecular Diagnostics Market
Report Coverage Details
Base Year: 2021 Forecast Period: 2022-2029
Historical Data: 2017 to 2021 Market Size in 2021: US $ 22 Bn.
Forecast Period 2022 to 2029 CAGR: 7% Market Size in 2029: US $ 37.8 Bn.
Segments Covered: by Product & Service • Reagents & Kits • Instruments • Services & Software
by Test Type • Lab Tests • PoC Tests
by Technology • Polymerase Chain Reaction (PCR) • Isothermal Nucleic Acid Amplification Technology (INAAT) • DNA Sequencing & Next- generation Sequencing (NGS) • In Situ Hybridization (ISH) • DNA Microarrays • Other Technologies
by Application • Infectious Diseases Diagnostics

o COVID-19 o Hepatitis o HIV o CT/NG o HAI o HPV o Tuberculosis o Influenza o Other Infectious Diseases

• Oncology Testing

o Breast Cancer o Colorectal Cancer o Lung Cancer o Prostate Cancer o Other Cancers

• Genetic Testing • Other Test Types
by End User • Diagnostic Laboratories • Hospitals & Clinics • Other

Molecular Diagnostics Market by Region

North America (United States, Canada and Mexico) • Europe (UK, France, Germany, Italy, Spain, Sweden, Austria, Turkey, Russia and Rest of Europe) • Asia Pacific (China, India, Japan, South Korea, Australia, ASEAN and Rest of APAC) • Middle East and Africa (South Africa, GCC, Egypt, Nigeria and Rest of ME&A) • South America (Brazil, Argentina, Columbia and Rest of South America)

Molecular Diagnostics Market Key Players are:

•F. Hoffmann-La Roche Ltd.(Switzerland) • Hologic, Inc.(US) • HTG Molecular Diagnostics, Inc.(US) • Thermo Fisher Scientific, Inc.(US) • Myriad Genetics, Inc.(US) • PerkinElmer, Inc.(US) • Abbott Laboratories(US) • Quidel Corporation(US) • Exact Sciences Corporation(US) • Danaher Corporation(US) • Illumina, Inc.(US) • Becton(US) • Dickinson and Company(US) • Agilent Technologies, Inc.(US) • bioMérieux SA(France) • ELITechGroup (France) • QIAGEN N.V.(Germany) • Siemens Healthineers AG(Germany) • Grifols, S.A.(Spain) • DiaSorin S.p.a.(Italy) • Genetic Signatures(Australia) • TBG Diagnostics Limited(Australia) • MDx Health(Belgium) • Biocartis NV (Belgium) • Vela Diagnostics (Singapore) • Amoy Diagnostics Co., Ltd.(China) • Molbio Diagnostics Pvt. Ltd.(India) • geneOmbio Technologies Pvt. Ltd(India) • Savyon Diagnostics (Israel) • Abacus Diagnostica Oy (Finland) Frequently Asked Questions: 1] What segments are covered in the Global Molecular Diagnostics Market report? Ans. The segments covered in the Molecular Diagnostics Market report are based on Product & Service, Test Type, Technology, Application, End User and Region. 2] Which region is expected to hold the highest share in the Global Molecular Diagnostics Market? Ans. The North America region is expected to hold the highest share in the Molecular Diagnostics Market. 3] What is the market size of the Global Molecular Diagnostics Market by 2029? Ans. The market size of the Molecular Diagnostics Market by 2029 is expected to reach US$ 37.8 Bn. 4] What is the forecast period for the Global Molecular Diagnostics Market? Ans. The forecast period for the Molecular Diagnostics Market is 2021-2029. 5] What was the market size of the Global Molecular Diagnostics Market in 2021? Ans. The market size of the Molecular Diagnostics Market in 2021 was valued at US$ 22 Bn.
1. Global Molecular Diagnostics Market Size: Research Methodology 2. Global Molecular Diagnostics Market Size: Executive Summary 2.1. Market Overview and Definitions 2.1.1. Introduction to Global Molecular Diagnostics Market Size 2.2. Summary 2.2.1. Key Findings 2.2.2. Recommendations for Investors 2.2.3. Recommendations for Market Leaders 2.2.4. Recommendations for New Market Entry 3. Global Molecular Diagnostics Market Size: Competitive Analysis 3.1. MMR Competition Matrix 3.1.1. Market Structure by region 3.1.2. Competitive Benchmarking of Key Players 3.2. Consolidation in the Market 3.2.1 M&A by region 3.3. Key Developments by Companies 3.4. Market Drivers 3.5. Market Restraints 3.6. Market Opportunities 3.7. Market Challenges 3.8. Market Dynamics 3.9. PORTERS Five Forces Analysis 3.10. PESTLE 3.11. Regulatory Landscape by region • North America • Europe • Asia Pacific • Middle East and Africa • South America 3.12. COVID-19 Impact 4. Global Molecular Diagnostics Market Size Segmentation 4.1. Global Molecular Diagnostics Market Size, by Product & Service (2021-2029) • Reagents & Kits • Instruments • Services & Software 4.2. Global Molecular Diagnostics Market Size, by Test Type (2021-2029) • Lab Tests • PoC Tests 4.3. Global Molecular Diagnostics Market Size, by Technology (2021-2029) • Polymerase Chain Reaction (PCR) • Isothermal Nucleic Acid Amplification Technology (INAAT) • DNA Sequencing & Next-generation Sequencing (NGS) • In Situ Hybridization (ISH) • DNA Microarrays • Other Technologies 4.4. Global Molecular Diagnostics Market Size, by Application (2021-2029) • Infectious o COVID-19 o Hepatitis o HIV o CT/NG o HAI o HPV o Tuberculosis o Influenza o Other • Oncology Testing o Breast Cancer o Colorectal Cancer o Lung Cancer o Prostate Cancer o Other Cancers • Genetic Testing • Other 4.5. Global Molecular Diagnostics Market Size, by End User (2021-2029) • Hospitals & Clinics • Diagnostic Laboratories • Other 5. North America Molecular Diagnostics Market (2021-2029) 5.1. North America Molecular Diagnostics Market Size, by Product & Service (2021-2029) • Reagents & Kits • Instruments • Services & Software 5.2. North America Molecular Diagnostics Market Size, by Test Type (2021-2029) • Lab Tests • PoC Tests 5.3. North America Molecular Diagnostics Market Size, by Technology (2021-2029) • Polymerase Chain Reaction (PCR) • Isothermal Nucleic Acid Amplification Technology (INAAT) • DNA Sequencing & Next-generation Sequencing (NGS) • In Situ Hybridization (ISH) • DNA Microarrays • Other Technologies 5.4. North America Molecular Diagnostics Market Size, by Application (2021-2029) • Infectious Disease Diagnostics o COVID-19 o Hepatitis o HIV o CT/NG o HAI o HPV o Tuberculosis o Influenza o Other Infectious Diseases • Oncology Testing o Breast Cancer o Colorectal Cancer o Lung Cancer o Prostate Cancer o Other Cancers • Genetic Testing • Other Applications 5.5. North America Molecular Diagnostics Market Size, by End User (2021-2029) • Hospitals & Clinics • Diagnostic Laboratories • Other 5.6. North America Semiconductor Memory Market, by Country (2021-2029) • United States • Canada • Mexico 6. European Molecular Diagnostics Market (2021-2029) 6.1. European Molecular Diagnostics Market, by Product & Service (2021-2029) 6.2. European Molecular Diagnostics Market, by Test Type (2021-2029) 6.3. European Molecular Diagnostics Market, by Technology (2021-2029) 6.4. European Molecular Diagnostics Market, by Application (2021-2029) 6.5. European Molecular Diagnostics Market, by End User (2021-2029) 6.6. European Molecular Diagnostics Market, by Country (2021-2029) • UK • France • Germany • Italy • Spain • Sweden • Austria • Rest Of Europe 7. Asia Pacific Molecular Diagnostics Market (2021-2029) 7.1. Asia Pacific Molecular Diagnostics Market, by Product & Service (2021-2029) 7.2. Asia Pacific Molecular Diagnostics Market, by Test Type (2021-2029) 7.3. Asia Pacific Molecular Diagnostics Market, by Technology (2021-2029) 7.4. Asia Pacific Molecular Diagnostics Market, by Application (2021-2029) 7.5. Asia Pacific Molecular Diagnostics Market, by End User (2021-2029) 7.6. Asia Pacific Molecular Diagnostics Market, by Country (2021-2029) • China • India • Japan • South Korea • Australia • ASEAN • Rest Of APAC 8. Middle East and Africa Molecular Diagnostics Market (2021-2029) 8.1. Middle East and Africa Molecular Diagnostics Market, by Product & Service (2021-2029) 8.2. Middle East and Africa Molecular Diagnostics Market, by Test Type (2021-2029) 8.3. Middle East and Africa Molecular Diagnostics Market, by Technology (2021-2029) 8.4. Middle East and Africa Molecular Diagnostics Market, by Application (2021-2029) 8.5. Middle East and Africa Molecular Diagnostics Market, by End User (2021-2029) 8.6. Middle East and Africa Molecular Diagnostics Market, by Country (2021-2029) • South Africa • GCC • Egypt • Nigeria • Rest Of ME&A 9. South America Molecular Diagnostics Market (2021-2029) 9.1. South America Molecular Diagnostics Market, by Product & Service (2021-2029) 9.2. South America Molecular Diagnostics Market, by Test Type (2021-2029) 9.3. South America Molecular Diagnostics Market, by Technology (2021-2029) 9.4. South America Molecular Diagnostics Market, by Application (2021-2029) 9.5. South America Molecular Diagnostics Market, by End User (2021-2029) 9.6. South America Molecular Diagnostics Market, by Country (2021-2029) • Brazil • Argentina • Rest Of South America 10. Company Profile: Key players 10.1. F. Hoffmann-La Roche Ltd. 10.1.1. Company Overview 10.1.2. Financial Overview 10.1.3. Global Presence 10.1.4. Capacity Portfolio 10.1.5. Business Strategy 10.1.6. Recent Developments 10.2. Hologic, Inc. 10.3. Thermo Fisher Scientific, Inc. 10.4. PerkinElmer, Inc. 10.5. Abbott Laboratories 10.6. bioMérieux SA 10.7. QIAGEN N.V. 10.8. Myriad Genetics, Inc. 10.9. Siemens Healthineers AG 10.10. Danaher Corporation 10.11. Illumina, Inc. 10.12. Becton 10.13. Dickinson and Company 10.14. Grifols, S.A. 10.15. Quidel Corporation 10.16. Agilent Technologies, Inc. 10.17. DiaSorin S.p.a. 10.18. Exact Sciences Corporation 10.19. Genetic Signatures 10.20. MDx Health 10.21. Biocartis NV 10.22. TBG Diagnostics Limited 10.23. HTG Molecular Diagnostics, Inc. 10.24. Vela Diagnostics 10.25. Amoy Diagnostics Co., Ltd. 10.26. ELITechGroup 10.27. Molbio Diagnostics Pvt. Ltd. 10.28. Savyon Diagnostics 10.29. Abacus Diagnostica Oy 10.30. geneOmbio Technologies Pvt. Ltd

About This Report

Report ID 610
Category Healthcare
Published Date Sept 2022
Updated Date
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