The global Tuberculosis (TB) molecular diagnostics market was valued at $ 65.4 Million in 2017 and is forecast to grow at a modest 9.26 % CAGR between 2018 and 2025, culminating in 2025 global sales of $ 121.6 Million.
Causal organism for infectious diseases could be bacteria, viruses, parasites or fungi and can be spread, directly or indirectly, from one person to another. Molecular diagnostic is showing promise in the identification of microorganisms as well as evaluation of virulence factors and antibiotic resistance determinants. Molecular infectious diseases diagnosis is moving towards high-throughput, simple, array-type technologies that provide a wealth of data on types of organisms present in a sample and the virulence factors/resistance determinants that influence the severity of disease. Molecular diagnostic helping infectious diseases to be more accurately and effectively treated.
GBS specific gene could be detected from vaginal swab using real-time PCR assay to show the presence of normal flora (Lactobacillus sp.). Else to detect all potential bacteria in a blood sample, a broad-range PCR assay with post amplification analysis using gene sequencing. Global infectious molecular diagnostic market is expected to grow at a faster rate than expected due to rising demand from physicians, failure rate of conventional diagnosis, better and early detection, reducing cost of molecular diagnostic, improvement reimbursement coverage, technological. Moreover, high unmet needs across the developing and emerging nations is also expected to boost the molecular diagnostics over the next few years.
Microbial phenotypic such as protein, bacteriophage, and chromatographic profiles, biotyping and susceptibility testing, are used for identification and differentiation. As per CDC, 2,700 new cases of Hepatitis A in U.S. around 2011 and 19,000 new cases of hepatitis B. According to the National Institute of Allergy and Infectious Diseases, 50,000 new cases of HIV infections occur annually in the U.S., and nearly 33 million people are infected with HIV in the world. Even incidence of Human papillomavirus (HPV), Chlamydia, Gonorrhea, HIV and Syphilis (primary and secondary) is in rise.
“Optimal Price Point (OPP) for Endoscope Equipment”
Estimated Average Molecular Diagnostics product cost – $ xx globally. However, with improving access and availability of options, OPP and range of acceptable Prices (RAP) are going to change. We at Ameri Research continuously track these prices with our proprietary pricing model.
Due to the wide array of products available in the market, pricing, positioning, and sales channel optimization play a vital role in the success of a product. On an average, in the U.S., the molecular diagnostics products are available at USD 3600. However, the high-end products are available at much higher prices. The prices in emerging countries and developed countries vary significantly due to the difference in purchasing power and availability of latest products.
The molecular diagnostics market is broadly segmented by product as Instruments, Reagents & Kits, Software & Services. Instruments like QIAsymphony SP/AS from QIAGEN and ELITe InGenius® from Elitech group are some of the instruments which integrate extraction, amplification and result interpretation with an unprecedented flexibility and assay menu possibility.
Reagents and kits are a large component of the overall market for Oncology Molecular Diagnostic. There are several options in the market for a wide range of usages from Thermo Fisher to Qiagen to Luminous Bioscience.
Today’s demanding business climate, rapid delivery of results from the lab directly to the patient has dramatically increased the informatics integration and workflow challenges in clinical testing and molecular diagnostic labs. Nautilus LIMS™ from Thermo Fisher is such a software solution.
Test Location Insights
Specialty clinics and laboratories constitute primary test locations for molecular diagnostic. Laboratories having high volume capacity are driving the market. However, to facilitate early diagnostic, POC (Pont of Care) diagnostic is increasing. Some of these POCs are retail clinics & pharmacies, student health clinics, neighborhood ambulatory care clinics, physician offices, CLIA waived labs, CLIA moderately complex labs, hospital floor (near-patient bedside), emergency rooms, intensive care units, rural health clinics, nursing homes, assisted living residence. CLIA waived labs are 5% of total POC and used primarily for respiratory testing.
The molecular diagnostics market is broadly segmented by technology as PCR, In Situ Hybridization, Chips and microarrays, Isothermal Nucleic Acid Amplification Technology (INAAT), Mass spectrometry, Sequencing, Transcription Mediated Amplification. In 2017, PCR technology market share was little above 30% of market share. DNA and RNA sequencing expected to grow at a CAGR of 18% during the forecasted period and will provide high throughput analysis.
North America accounted for over 46% revenue share in 2016. The key reasons attributed for the high share include the high prevalence of stomach and GI cancers, strong reimbursement framework, highly skilled medical professionals, technological advancements and government support for R&D and innovation in medical devices sector. Moreover, the presence of high-end hospital and POC and high emphasis on preventive screening is expected to boost the usage rates over the forecast period.
Asia Pacific is expected to register the maximum CAGR of 7.5% through 2017 to 2025. The rapid increase in a number of cancer cases, growing healthcare expenditure and skill training, and improvement in reimbursement scenario are expected to favor the high market growth in the region.
Merger and Acquisition Insight
With the rising investor confidence and positive market trends, several players are actively engaging in merger and acquisition activities. Moreover, the disruption in the global healthcare market due to political factors such as repealing Obama Care Act, changes in the regulatory framework, and other trade barriers, are anticipated to trigger merger and acquisition activities to drive market consolidation and further intensify the market competition. We have identified 4 major deals from 2014 to 2017.
Top Players & Company Share
The Molecular Diagnostic market is highly competitive and some of the key success factors include technology, pricing, and distribution channel. As of 2017, major players in the market include Cepheid, Beckton Dickinson, Gen Probe (Hologic), Qiagen, Roche Diagnostics, Bayer Healthcare, Dako, Abbott Laboratories, Danaher Corporation, Siemens, Sysmex Corporation, Grifols, and Biomérieux Sa.
Tuberculosis (TB) Molecular Diagnostics Market by Products (Revenue, USD Million, 2014 – 2025)
- Reagents & Kits
- Software & Services
Tuberculosis (TB) Molecular Diagnostics Market by Test Location (Revenue, USD Million, 2014- 2025)
- Point of Care
Tuberculosis (TB) Molecular Diagnostics Market by Technology (Revenue, USD Million, 2014- 2025)
- In Situ Hybridization
- Chips and microarrays
- Isothermal Nucleic Acid Amplification Technology (INAAT)
- Mass spectrometry
- Transcription Mediated Amplification
Tuberculosis (TB) Molecular Diagnostics Systems Regional Outlook (Revenue, USD Million, 2014- 2025)
- North America
- Asia Pacific
- Latin America
- Middle East and Africa
- South Africa
- Saudi Arabia