Infectious Disease Molecular Diagnostics Market (Hepatitis, HIV/CT/NG/HPV and Other Tests)

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Published Apr 6, 2017 | 200 Pages | Pub ID: KLI15310689

What is the Size of the Infectious Disease Molecular Diagnostics Market?

Infectious disease testing using molecular testing technologies exceeded 3.8 billion dollars in 2016.  Growth is expected to be higher than the overall molecular testing market for the next five years.  This is according to Kalorama Information's latest study on the molecular microbiology/virology markets.  This category is projected to account for 60% of the global molecular diagnostics market by 2021.The market segment is defined by test decentralization with the introduction of NAAT platforms able to be operated in hospital labs and near-patient points of care such as physician office labs (POLs) and outpatient clinics. Integrated design from sample preparation to results analysis and user friendly features are just as appealing to larger clinical labs to free up personnel. Menu expansion on integrated analyzers has been the predominant focus of competitors in molecular infectious disease diagnostics. Market share and client retention depend on the ability of one platform to perform all routine infectious disease tests. 

The Molecular diagnostics market is unrivaled among the IVD markets because of its superior technologies in terms of its performance and applicability. Microarray, next-generation sequencing and development-stage isothermal amplification methods represent promising contributions to the market space. For the time being, PCR and isothermal amplification tests represent the bulk of the market with assay development proceeding faster than ever using genomic science tools, microfluidics, machine automation, and novel forms of results detection. Primer and probe design for reagent mixes are assisted by research lab next-generation sequencing. Microfluidics technology is a pervasive feature to many of the newest molecular platforms and has enabled integrated or the hands-off performance of molecular assays including the steps of extraction, amplification, and analysis.

Types of Infectious Disease Molecular Diagnostic Testing

Respiratory Molecular Diagnostic Testing

Respiratory tract infections are not associated with life-threatening chronic disease as are hepatitis, HIV and STDs, but they are responsible for tremendous morbidity and disease burden throughout the world as well as mortality in vulnerable populations such as children, the elderly, and immunocompromised individuals. The WHO has indicated that respiratory tract infections are among the top four causes of morbidity and mortality worldwide. In the United States, viral respiratory infections are the 7th-leading cause of death costing the lives of 60,000 people each year. Upper respiratory tract infections also represent one of the most common reasons for patients to seek outpatient care. At the height of the influenza or flu season, up to 6% of all U.S. outpatient visits can be for influenza-like illness (ILI).

Hospital-Acquired Infections (HAIs) and Sepsis Molecular Diagnostic Testing  

  New capabilities in molecular testing have profoundly changed the face of testing for hospital-acquired (HAIs) or nosocomial, antimicrobial-resistant, and opportunistic infections. Blood cultures have long been used for the detection of inpatient infections and sepsis, but their effectiveness is limited by long turnaround times and the non-specificity of primary results. Molecular diagnostics were first applied to identify pathogens in positive blood cultures through qualitative fluorescent in situ hybridization (FISH) assays. Without target nucleic acid amplification, FISH assays rely upon the blood culturing step to improve test sensitivity. Today, molecular testing for HAIs and pathogen antimicrobial resistance (AMR) is accomplished using PCR and other molecular assays that amplify target nucleic acid content directly from blood, wound site and respiratory samples or blood cultures. Nucleic acid amplification tests performed on integrated systems provide rapid and reliable multiplex results even outside of traditional molecular labs. Rapid testing – measured in the AMR/HAI space in hours to results – is the primary growth area in the molecular AMR/HAI market as hospitals seek to implement appropriate care as quickly as possible in order to save patient lives and reduce antimicrobial misuse.  

Tuberculosis Molecular Diagnostic Testing

  The current market for molecular TB diagnostics has been defined by Cepheid’s GeneXpert system and its Xpert MTB/RIF assay for the detection of TB and rifampicin resistance in sputum samples. Through the TBXpert Project, Cepheid and its partners have distributed more than 14 million Xpert MTB/RIF cartridges and more than 4,000 GeneXpert systems on concessional pricing to high-TB burden countries in the developing world. Recent TB         The World Market for Molecular Diagnostics, 7th Edition    4: Market for Molecular Infectious Disease Diagnostics    January 2017 © Kalorama Information 106    related sales for Cepheid have totaled more than $60 million through the HBDC program and other $20 million through commercial sales in economically developed countries. Placed in sub-Saharan Africa, India, Southeast Asia and countries elsewhere with significant TB burdens, GeneXpert systems have provided reference and district labs with rapid, high-sensitivity TB and first-line drug resistance testing. Despite its advantages over conventional sputum smear microscopy (SSM) for TB diagnosis, the GeneXpert platform has played a minimal role in decentralized and near-patient settings outside of the lab environment, such as in microscopy centers, clinics and community POCs. The nextgeneration of molecular platforms for POC TB testing will require instrument-free or portable designs and lower assay costs to achieve significant penetration in POC settings in the developing world.   

HIV Molecular Diagnostic Testing   

  Molecular HIV testing is fairly mature with most innovation and growth relating to antiviral therapy including testing for viral load, viral tropism, and drug resistance. Outside of developed markets, HIV screening and diagnosis remains an ongoing challenge. Clinical approaches to HIV in the United States, Europe and other developed countries emphasize molecular testing as a tool for the management of chronic infection and achieving viral suppression. The long-term development of the molecular HIV test market will depend upon improved availability of antiretroviral therapy and in the developing world. Rapid tests for HIV screening and other more advanced lab tests for diagnosis are already widely distributed at concessional or discounted prices through centralized procurement programs. Molecular HIV diagnostics for viral load testing will require similar concessional pricing in order to implement antiretroviral treatment (ART) worldwide.   

Hepatitis Molecular Diagnostic Testing

  Novartis (previously Chiron Corporation) owned intellectual property (IP) for molecular hepatitis C diagnostics that was subsequently acquired along with the Novartis Diagnostics business by Grifols in 2013. Companies such as Abbott Diagnostics, Hologic, Siemens Healthcare Diagnostics and Roche Diagnostics have licensed and marketed hepatitis C virus (HCV) tests based on Novartis IP. Core lab leaders Abbott, Siemens and Roche have unsurprisingly maintained their majority share of the molecular HCV diagnostics market. Core lab virology offers relatively little room for new competitors, but molecular diagnostics companies like Cepheid that established themselves in hospital lab markets have begun to target virology opportunities by offering HCV viral load assays. Decentralized and near-patient viral load testing is expected by Kalorama Information to develop to a limited extent so that providers can more quickly and consistently implement care, but the majority of the market will remain in centralized labs where molecular HCV viral load testing is performed on high-throughput analyzers. 

 -New Report from Kalorama Information Infectious Disease Testing Markets -

Kalorama's Infectious Disease Molecular Diagnostic Test Markets provides the following information:  
  •  Infectious Disease Market, 2016-2021
  •  NAT Blood Screening Market 2016-2012
  •  Hepatitis Test Market
  •  HIV Diagnostics Market, 2016 to 2021
  •  HAIs/Sepsis Diagnostics Market, 2016 to 2021
  •  CT/NG Diagnostics Market, 2016 to 2021
  •  HPV Diagnostics Market, 2016 to 2021
  •  RSV Diagnostics Market, 2016 to 2021
  •  Mycobacteria/TB Molecular Diagnostics Market, 2016 to 2021
  •  Other Infectious Disease Molecular Diagnostics Market, 2016 to 2021
  • Overall Molecular Diagnostic Market, 2016 to 2021 
  • Trends in the Market
  • Market Share for Infectious Disease Molecular Testing Market

Molecular diagnostics are not only a fixture in centralized labs, but are becoming more common in near-patient settings and in smaller labs such as in hospitals. Integrated assay designs and small-footprint analyzers are also opening markets for molecular infectious disease diagnostics where they are badly needed in the developing world. Consequently, molecular infectious disease diagnostics feature the best growth prospects (projected market growth of over 9% annually) out of the three primary infectious disease test segments – microbiological ID/AST, immunoassays, and molecular diagnostics. 
Applications of Clinical Molecular Diagnostics  The major applications of clinical molecular diagnostics include: Infectious disease diagnostics such as molecular microbiology and virology, including the detection, identification, quantification and nucleic-acid based resistance or susceptibility profiling of pathogens; Blood Transfusion Diagnostics, nucleic acid screening (NAT) of donated blood, often pooled samples, for the detection of active infections responsible for transfusion transmitted infections (TTIs); ancillary market for molecular immunohematology or blood typing.  The development of molecular tests has been prioritized for all recent disease threats, notably Ebola and Zika virus. While immunoassays are preferred for routine screening and by cost-constrained labs, molecular tests offer optimal sensitivity and specificity key to public health response,diagnosis, and targeted treatment. Infectious diseases range from the common flu to antimicrobial resistant inpatient infections and engage all levels of healthcare and thus represent the largest market for molecular diagnostics. 
The following companies are involved in infectious disease molecular testing, and are profiled in the report: 

  • Abbott Diagnostics  
  • Alere   
  • Beckman Coulter (Danaher)
  • Becton, Dickinson & Co. (BD)   
  • Biomérieux
  • Bio-Rad Laboratories
  • Cepheid (Danaher)   
  • Eiken Chemical   
  • Grifols   
  • Hologic   
  • Illumina   
  • Immucor   
  • Janssen Diagnostics (Johnson & Johnson)   
  • Luminex Corporation   
  • Meridian Bioscience
  • Qiagen   
  • Quidel  
  • Roche Diagnostics   
  • Siemens Healthcare Diagnostics  
  • Thermo Fisher Scientific    

 Clinical molecular diagnostics refer to in vitro diagnostic (IVD) tests used in patient health care that detect, quantify or characterize nucleic acid analytes, whether pathogenic nucleic acid, patient DNA or patient RNA. As an IVD market, molecular diagnostics refer to the relevant test kits, other reagents and instruments that are used for clinical testing in settings that include reference laboratories, independent labs, hospital labs, other centralized clinical labs and near-patient testing sites such as clinics and physician offices. Various diseases and conditions are diagnosed, confirmed or monitored using molecular diagnostics including infections, inherited diseases, developmental disorders, cancer, and patient traits related to the metabolism and efficacy of certain drugs. Molecular diagnostics can also be used to determine a patient risk or susceptibility for disease; tissue compatibility for transplant; and the safety of donated blood for transfusion.  

The primary technologies for clinical molecular diagnostics include nucleic acid amplification tests (NAATs) based on real-time PCR (qPCR) and other amplificationdetection protocols; direct nucleic acid probe tests such as in situ hybridization (ISH) and its fluorescent ISH (FISH); next-generation sequencing (NGS); amplification followed by probe-based hybridization on arrays (or microarrays); and other related methods.  The report introduces the core technologies behind clinical molecular diagnostics and reviews market trends in product features and molecular diagnostic capabilities.  Nucleic Acid Amplification Test (NAAT) Technologies  Since its inception, clinical molecular diagnostics has progressed from research-emergent, highly complex procedures performed in few labs to analyzer-integrated and -automated steps covering sample preparation through results analysis. In its earliest stages, clinical molecular diagnostics consisted of polymerase chain reaction (PCR) amplification of target sequences followed by detection of target amplicons from bands on gel electrophoresis    

The development of real-time PCR profoundly expanded the role of molecular diagnostics in healthcare; the technology registers amplification-generated fluorescence or other optically detected changes in real time to determine positive results and the relative sample amount of analyte. 


  • Introduction
  • Overall Molecular Diagnostics Market
  • Molecular Diagnostic Technologies
  • Molecular Diagnostics In Healthcare
  • Global Molecular Diagnostics Market
  • Table 1-1: Global Molecular Diagnostics Market (2016-2021) – Infectious Disease, Blood Screening, Histology, Cancer Assays, Transplant, Inherited Diseases ($ Millions)
  • Figure 1-1: Global Molecular Infectious Disease Diagnostics Market (2016-2021) – United States, Europe, Japan, China, Latin America, Rest Of World ($ Millions)
  • Conclusions
  • Introduction
  • Nucleic Acid Amplification Test (NAAT) Technologies
  • Real-Time Pcr (Qpcr)
  • Isothermal Amplification
  • Table 2-1: Selected Isothermal Amplification Methods And Platform Examples
  • Trends In Nucleic Acid Amplification Testing And Emerging Technologies
  • Microarrays
  • Table 2-2: Selected Clinical Array Component And Microarray Systems
  • Introduction
  • Reimbursement Environment for Molecular Diagnostics
  • Molecular Diagnostics And The Clinical Utility Standard
  • Laboratory-Developed Tests Are Here To Stay Conclusions

  • Market Size and Forecast by Category
  • Table 4-1: Market-Available Molecular Diagnostic Platforms - POC, Hospital And Developing World (Vendor, Assay Menu, Planned Assays, Regulatory Status, Procedure Integration, Test PrincipleMarket Analysis
  • Table 4-2: Global Molecular Infectious Disease Diagnostics Market (2016-2021) – Hepatitis, HIV, HAIs/Sepsis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other ($ Millions)
  • Figure 4-1 Global Molecular Infectious Disease Diagnostics Market (2016) - Hepatitis, HIV, HAIs/Sepsis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other ($ Millions)
  • Figure 4-2 Global Molecular Infectious Disease Diagnostics Market (2016-2021) – Hepatitis, HIV, HAIs/Sepsis, CT/NG, HPV, Respiratory, Mycobacteria/TB, Other ($ Millions)
  • Table 4-3: Global Molecular Infectious Disease Diagnostics Market (2016-2021) – United States, Europe, Japan, China, Latin America, Rest Of World ($ Millions)
  • Figure 4-3: Global Molecular Infectious Disease Diagnostics Market (2016) - United States, Europe, Japan, China, Latin America, Rest Of World ($ Millions)
  • Figure 4-4: Global Molecular Infectious Disease Diagnostics Market (2016-2021) – United States, Europe, Japan, China, Latin America, Rest Of World ($ Millions)
  • Figure 4-5: Global Molecular Infectious Disease Diagnostics Market Share - Abbott Diagnostics, BD, Biomérieux, Cepheid, Hologic, Qiagen, Roche Diagnostics, Siemens Healthcare Diagnostics, Others (%)
  • CT/NG, HPV And Women’s Health
  • Hepatitis
  • HIV
  • Hospital-Acquired Infections (HAIs) And Sepsis
  • Respiratory
  • Tuberculosis
  • Market for Molecular Blood Transfusion Diagnostics
    • Introduction
    • Market Analysis
    • Table 4-4: Global NAT Blood Screening (2016-2021) – United States, Europe, Japan, China, Latin America, Rest Of World ($ Millions)
    • Figure 4-6: Global NAT Blood Screening Market (2016) - United States, Europe, Japan, China, Latin America, Rest Of World ($ Millions)
    • Figure 4-7 Global NAT Blood Screening Market (2016-2021) – United States, Europe, Japan, China, Latin America, Rest Of World ($ Millions)
    • Table 4-5: Commonly Tested Pathogens In Blood Screening
    • Figure 4-8: Global NAT Blood Screening Share - Grifols, Roche Diagnostics, Others (%)
    • New Infectious Disease Threats And Assay Introduction
    • Conclusions

Abbott Diagnostics
  • Table 5-1: Abbott Diagnostics Revenue (2013-2016) ($ Millions)
  • Infectious Diseases/qPCR
  • Cytogenetics/Oncology/FISH
  • Molecular ID/AST
Agilent Technologies
  • Table 5-2: Agilent Technologies Revenue (Fy 2013-Fy 2016) ($ Millions)
  • Alere
  • Table 5-3: Alere Revenue (2013- 2016) ($ Millions)
Amoy Diagnostics

Beckman Coulter (Danaher)

Becton, Dickinson & Co. (BD)
  • Table 5-4: Becton, Dickinson & Co. (BD) Revenue (Fy 2013-Fy 2016) ($ Millions)
  • Molecular
  • Histology/Cytology
  • Flow Cytometry
  • Table 5-5: Biomérieux Revenue (2013-2016) ($ Millions)
  • Molecular
  • Sequencing
Bio-Rad Laboratories
  • Transplant Diagnostics
  • Molecular Diagnostic Qc Products
  • Sequencing
Cepheid (Danaher)
  • Table 5-6: Cepheid Revenue (2013-2016) ($ Millions)
  • Molecular Hospital-Acquired Infection (HAI) Testing
  • Molecular Sexual Health And Women’s Health Testing
  • Molecular Critical Infectious Disease Testing
  • Molecular Oncology Testing

Eiken Chemical
  • Table 5-7: Eiken Chemical Revenue (Fy 2013-Fy 2016) ($ Millions)
  • Table 5-8: Grifols Diagnostic Revenue (2013-2016) ($ Millions)
  • Molecular Immunohematology And Specialty Testing Services
  • NAT Blood Screening
  • Table 5-9: Hologic Revenue (Fy 2013-Fy 2016) ($ Millions)
  • Molecular Cytology / Histology (HPV)
  • Other Molecular (Stis, HIV, Hcv, TB, Respiratory)
  • Microbiology (Accuprobe Molecular Culture Id Tests)
  • Table 5-10: Illumina Revenue (2013-2016) ($ Millions)
  • Sequencing
  • Translational Research
  • Clinical Assay Development
  • Industry Lab-Developed Tests
  • Arrays
  • Table 5-11:Immucor Revenue (Fy 2013-Fy 2016) ($ Millions)
  • Transfusion Diagnostics
  • Transplant Diagnostics
  • Immucor Dx Laboratory Service
  • Janssen Diagnostics (Johnson & Johnson)
Luminex Corporation
  • Table 5-13: Luminex Corporation Revenue (2013- 2016) ($ Millions)
  • Business Expansion
  • Magpix Multiplexing
  • Aries Molecular System
Meridian Bioscience
  • Table 5-14: Meridian Bioscience Revenue (Fy 2013-Fy 2016) ($ Millions)
  • Table 5-15: Qiagen Revenue (2013-2016) ($ Millions)
  • Molecular Infectious Disease
  • Cancer Diagnostics
  • Transplant Diagnostics
  • Next-Generation Sequencing
  • Circulating Tumor Cells
  • Table 5-16: Quidel Revenue (2013-2016) ($ Millions)
Roche Diagnostics
  • Table 5-17: Roche Diagnostics Revenue (2013-2016) ($ Millions)
  • Molecular Diagnostics
  • Blood Screening
  • Sequencing
  • Liquid Biopsy
  • Microbiology
Siemens Healthcare Diagnostics

Thermo Fisher Scientific
  • Table 5-18: Thermo Fisher Scientific Revenue (2013-2016) ($ Millions)
  • Transplant Diagnostics
  • PCR
  • Sequencing

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