The World Molecular Diagnostics Market - 7th Edition (HIV Testing, Hepatitis Testing, Molecular Cancer Tests, Blood Screening, Hospital-Acquired Tests, RSV, CT/NG, HPV, Inherited Diseases, ISH)

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Published Jan 30, 2017 | 353 Pages | Pub ID: KLI15232978

What is the Size of the Molecular Diagnostic Market?

The World Molecular Diagnostics Market

According to the seventh edition of Kalorama Information's report on the molecular diagnostics market, the total market for clinical molecular testing products (includes molecular testing instruments, molecular reagents, and related supplies) is $7.3 billion.  DNA-based diagnostics now represents more than one-tenth of the global IVD market with a growth trajectory secured through platform innovation in lower-cost nucleic acid amplification tests (NAATs) and clinical next-generation sequencing (NGS).

“Molecular diagnostics industry is demonstrating revenue growth at more than twice the rest of the IVD market… While not matching its explosive market growth in years past, clinical molecular diagnostics has delivered on its promise in healthcare “

 -Emil Salazar, IVD Industry Analyst and Author

The complexity of the market - there are different kinds of molecular assay technologies depending on the medical condition it is serving -requires a reference that covers hundreds of companies activities.

The World Molecular Diagnostics Market, now in its 7th Edition,is such a resource, providing an independent and authoritative view of this market segment in clinical testing.As part of its coverage, the following molecular testing market analysis is included in this report:

  •  Infectious Disease Market, 2016-2021
  •  Cancer Testing 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
  •  in situ hybridization (ISH) Market by Application: Genetic, Cancer, Other, 2016 to 2021
  •  Other Histology Molecular Diagnostics Market, 2016 to 2021
  •  Inherited Diseases Molecular Diagnostics Market, 2016 to 2021
  •  Transplant Diagnostics Molecular Diagnostics Market, 2016 to 2021

 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; Histology / cytology diagnostics , which is largely synonymous with in situ hybridization (ISH) methods that use direct hybridization of chromogenic (CISH) or fluorescent (FISH) nucleic acid probes within slided tissue or suspended cell samples viewed under microscopy;Molecular Cancer Diagnostics, which are tissue, blood and urine samples can be assayed using nucleic acid amplification tests (NAATs) or sequencing to diagnose, prognose and identify key mutations for targeted therapies; future; Transplant diagnostics - various PCR-based methodologies, Sanger sequencing and NGS used to type HLA alleles in low to high resolution in order to match donors and recipients for solid organ and hematopoietic stem cell (HSCT) or bone marrow transplants, as well as post-transplant monitoring. The report also covers Inherited disease diagnostics - diagnosis of rare genetic diseases andother inherited traits including pharmacodiagnostic (pharmacokinetic) traits;major area of application is thrombophilia markers and anticoagulant response markers

Infectious disease 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 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.

Molecular Diagnostics Market Share Analysis: Who's in the Lead?

Roche Diagnostics has been an unmovable leader. The company’s resources and history in the market have allowed it to adapt and diversify as needed, most recently with its Liat system for CLIA-waived molecular infectious disease testing, HPV assay FDA-approved for primary screening, and new viral load assays for its cobas6800/8800 core lab virology systems. There are a great number of companies participating in these segments of molecular diagnostics, from molecular specialists to the top-tier IVD companies.

The report identifies market share not only for the overall molecular diagnostics market but for molecular test categories, including:

  •  Blood Testing Market Share Analysis
  • Cancer Testing Market Share Analysis
  • Transplantation Market Share Analysis
  • Infectious Disease Market Share Analysis
  • Disease Testing Market Share Analysis

The segmented market share allows competitors and interested market-watchers to see not only how a company is performing in the overall molecular diagnostics market, but also in their specialty area. To assist in global business planning efforts, this report contains market sizing and forecasts to 2021 for major world regions including the United States, Europe,Japan, China and Latin America.

The future of the molecular diagnostics market lies with nucleic acid amplification tests and sequencing-based tests. Time to results for real-time PCR and isothermal amplification are crucial for several infectious disease testing applications including respiratory testing,hospital-acquired infections, bloodstream infections, and molecular point-of-care tests. These trends are discussed in the report.

What Companies Participate in the Molecular Diagnostics Industry?

Kalorama Information reports are designed to be focused on real world industry activities, rather than mere hypothetical business models.This makes company profiles important, as they provide a foundation for understanding what is happening in a market, and what has changed recently.This report contains profiles of major companies competing in molecular diagnostics. For each company, revenues, market share, products on the market and acquisitions and other deals are detailed. The following companies are profiled in the report:

  •  Abbott Diagnostics
  •  Advanced Cell Diagnostics
  •  Affymetrix (Thermo Fisher Scientific)
  •  Agilent Technologies
  •  Alere
  •  Amoy Diagnostics
  •  Applied Spectral Imaging
  •  Beckman Coulter (Danaher)
  •  Becton, Dickinson & Co. (BD)
  •  Beijing Genomics Institute (BGI)
  •  Berry Genomics
  •  Biocartis
  •  bioMérieux
  •  Bio-Rad Laboratories
  •  Cepheid (Danaher)
  •  Covaris
  •  Dako (Agilent Technologies)
  •  Eiken Chemical
  •  Epigenomics
  •  Exosome Diagnostics
  •  Genmark Diagnostics
  •  Grifols
  •  Hologic
  •  Illumina
  •  Immucor
  •  Janssen Diagnostics (Johnson & Johnson)
  •  Leica Biosystems (Danaher)
  •  Luminex Corporation
  •  Meridian Bioscience
  •  Nanosphere (Luminex)
  •  Nanostring Technologies
  •  Qiagen
  •  Quidel
  •  Roche Diagnostics
  •  Siemens Healthcare Diagnostics
  •  Thermo Fisher Scientific
  •  Vela Diagnostics
  •  Ventana Medical Systems (Roche)

PCR and Beyond: Molecular IVD Technologies

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. Real-time PCR provides quantitative molecular results and has been integral to expanding molecular testing capabilities beyond high-complexity labs. The technology reduces “hands on” time or user requirements, improves test sensitivity, and speeds up the time to results. 

In clinical molecular diagnostics, nucleic acid amplification tests are most commonly performed using qPCR (and related qPCR from RNA analytes known as reverse transcriptase-PCR [qRT-PCR]) followed by isothermal amplification methods. In general, NAATs are performed by the following steps: 

Sample Isolation/Extraction – sample preparation for NAATs may include cell lysis, enzymatic clean-up of debris and contaminants, and isolation of target nucleic acids (such as RNA from remaining genomic DNA)  Amplification – primer reagents hybridize at specific short nucleotide sequences located near the sequence of interest; a polymerase or other nucleic acid synthesizing enzyme then replicates the target sequence using the primer as a starting point; thermal cycling or another input is used to repeat the process resulting in a chain reaction of target synthesis (“amplification”)  Detection – colorimetric, fluorescent or chemiluminescent labels are commonly used on target-specific nucleic acid probes to enable detection after hybridization with the amplified target; real-time detection (during amplification) is most common though some popular clinical molecular analyzers use endpoint detection (after amplification) by array or other device component 

Microarrays and Molecular Testing

Nucleic acid microarrays are surfaces with dozens to thousands of microscopic spots each populated by probes specific to one target sequence within the sample. Multiple amplified targets, potentially thousands, are often detected on a microarray with the addition of chromogenic, fluorogenic or other signaling dyes and labels that bind with hybridized probe-target pairs. Alternatively, microarray probes can be connected to electrodes to provide an electrochemical means of target hybridization. High-density microarrays have been used for gene expression profiling by detecting and quantifying specific RNA or protein associated with target genes. Expression microarrays have gradually been replaced with RNA sequencing in research applications. The more clinically relevant application of microarrays – also key to their continued role in research markets – is genotyping. Microarray products are used for non-invasive prenatal testing (NIPT), postnatal testing, tissue typing, select infectious disease tests and patient genotyping related to pharmacogenomics or rare diseases.

In Situ Hybridization (ISH) and the Molecular Diagnostics Market

In situ hybridization (ISH) refers to the direct probing without enzymatic amplification of nucleic acid targets within sample cells or tissue. Molecular probes for ISH may incorporate chromogenic labels (CISH) or fluorescent labels (FISH). Multiplex tests can be conducted on the same slide using a combination of probes or combo - immunohistochemical (IHC) probes. In situ hybridization probes feature sequences complementary to the target sequence. The most common samples used with ISH tests include formalin-fixed paraffin-embedded (FFPE) tissue, fresh frozen tissue sections, blood cultures and cytological samples (cells brushed or scraped away rather than intact tissue or cells suspended in biological fluid). Nucleic acid targets for this type of testing may include DNA or RNA, including messenger (mRNA) associated with protein encoding. Viral infections can be assayed using these techniques from cytological samples or tissue. Bacterial infections can be identified using ISH from cultured blood samples. The most common application of ISH testing is for cancer testing, or the characterization of tumors to inform targeted therapy. Viral infections in tissue such as human papillomavirus (HPV) or Epstein-Barr Virus (EBV) are also associated with oncogenic activity and the development of proliferative disease.

Sequencing and its Role in the Molecular Diagnostics Market

Clinical nucleic acid sequencing diagnostics stand apart from NAATs or tests based on qPCR, isothermal amplification, or microarrays. Sequencing uses a variety of methods to signal the types of individual nucleotides (adenine, cytosine, guanine, or thymine) in a target genetic sequence. While both NAATs and clinical sequencing interrogate target nucleic acid sequences, clinical sequencing results are not limited by probe specificity and permit reading of the sequence (probe hybridization can be thought of as providing a “yes/no” result). Aberrant sequences containing SNPs may go unrecognized as such by specific NAAT probes, but still function as an etiological agent or biomarker of clinical significance. Software-driven, open interpretation of clinical sequencing results enables a more flexible determination of pathogenic biomarkers, significant pathogenic traits, patient genetic traits, and oncogenes. Rapid and significant improvements in nucleic acid sequencing in terms of cost and speed have been realized with the launch of nextgeneration (NGS) or post-Sanger sequencing platforms. Clinical sequencing is present in the areas of prenatal testing, cancer testing, pharmacogenetics, and infectious diseases (drug resistance testing). However, the footprint and complexity of many currently available NGS systems do not yet permit decentralized and POC testing applications. 

With NGS technology, sequencing has progressed from a discovery tool in genomics and systems biology to a translational research tool and, within the last five or so years, an instrument of the clinical laboratory.

Microbiology Molecular Testing Market Demonstrates Innovation

Microbiology is a key area to watch in molecular, though it has many applications.  The  infectious diagnostics market was traditionally dominated by virology or HIV and hepatitis testing including infection diagnosis, virus genotyping, and viral load testing. Together, HIV and hepatitis still represent roughly 40% of the entire molecular diagnostics market in microbiologys. healtchare facility-acquired infections and bloodstream infections now represent the largest market segment due to the threat of antimicrobial resistance (AMR) in healtchare facilitys and rising complexity of testing deployed in cases of inpatient infections. Molecular tests have been highly successful in healtchare facility markets due to their unique ability to identify the infection and characterize resistance within actionable timelines. 

There is no surprise in terms of undetermined market share in the infectious disease diagnostics industry.   Eight companies are estimated to account for over eighty-five percent of the global market (Figure accompanying). Roche Diagnostics has been an unmovable leader with a market share estimated at 21%. The company’s resources and history in the market have allowed it to adapt and diversify as needed, most recently with its Liat system for CLIA-waived molecular Microbiology testing, HPV test FDA-approved for primary screening, and new viral load tests for its cobas 6800/8800 core lab virology systems. Hologic claims a large market share through its leadership in the molecular CT/NG and HPV testing space. Cepheid and bioMérieux have significantly increased market share in molecular Microbiology diagnostics over the past few years through respective placements of GeneXpert and FilmArray systems in healtchare facility labs. 

The success of  bioMérieux and Cephied confirms the strategies of competitors in the same space of decentralized molecular testing. Remaining market leaders – Becton, Dickinson & Co. (BD), Abbott Diagnostics, Siemens Healthcare Diagnostics – are perhaps less active  in molecular microbiology testing (though BD has been dynamic in more fully addressing its markets in HAI and women’s health/sexual health).

 Abbott and Siemens have stuck more to core molecular Microbiology markets in virology (HIV/hepatitis).

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, healtchare facility labs, other centralized clinical labs and near-patient testing sites such as clinics and physician offices.

The primary technologies for clinical molecular diagnostics include nucleic acid amplification tests (NAATs) based on real-time PCR (qPCR) and other amplification-detection 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. 

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