Global Transplant Diagnostics Market

The microbiology diagnostics devices and equipment market consist of sales of microbiology diagnostics devices and equipment and related services. Microbiology diagnostics devices and equipment are used to diagnose infectious diseases by examining pathogens. These instruments include incubators, autoclave sterilizers, anaerobic culture systems, blood culture systems, gram strainers, microscopes, mass spectrometers, molecular diagnostic instruments, reagents pathogen-specific kits, and general reagents. The main types of microbiology diagnostic devices and equipment are laboratory instruments, microbiology analyzers. Laboratory instruments are types of instruments such as incubators, gram stainers, bacterial colony counters, petri dish fillers, automated culture systems that are needed for operations in the laboratories. The micro-biology analyzers involved are microbiology diagnostics instruments, microscopes. The reagents are pathogen-specific kits, general reagents. The end-users involved are hospitals, diagnostic centers, customer lab service providers, academic institutes, research institutes. The global microbiology diagnostic devices and equipment market size is expected to grow from $3.42 billion in 2021 to $3.98 billion in 2022 at a compound annual growth rate (CAGR) of 16.4%. The global microbiology diagnostic devices market size is expected to grow to $6.85 billion in 2026 at a CAGR of 14.6%. Increasing funding of public and private investments in medical devices is driving the growth of the microbiology diagnostics market. Increasing Investments indicates the rising confidence of various private and public players on microbiology diagnostic devices thereby indicating a progressive increase and stimulating growth. For instance, India introduced ¥544 billion (~$4.90 billion) of medical devices in 2019 & transported ¥178 billion (~$1.60 billion) of medical devices with a market size at retail & institutional sales level of above ¥1500 billion (~$13.52 billion). It has the potential for above ¥ 1000 billion (~$9.02 billion) investment in medical devices over the next 5 years. The increasing investments in digital health technologies, artificial intelligence and non-invasive monitoring capability, delivery of gene therapy and regenerative medicines technologies, customized 3D printing of medical devices are expected to drive the microbiology diagnostic devices market. Unfavorable regulatory scenarios are one of the major restraints in the microbiology diagnosis devices market. In the US, section 510(k) of the Food, Drug, and Cosmetic Act states that every device manufacturer must register with FDA and notify their intent to market a medical device at least 90 days in advance. These pre-market notifications are considered to be lengthy, rigorous, and time-consuming processes for the approval of medical devices. If in case the submission fails due to some uncertainty, the company has to reperform all the tests and resubmit the premarket approval application. For instance, a 'Verticle Autoclave', a microbiology diagnostic device, complies with the strict international directives and standards such as the capacity of 80-120 liter autoclave chamber volume, low sensitivity loads, restrictions on temperature calibration, and a certificate from ISO17025 accreditation lab for temperature, pressure gauges & timer. Next-Generation Sequencing (NGS) technologies are increasing their prevalence in the microbiology diagnostic devices market due to their cost effectiveness, sensitivity to detect low-frequency variants, and comprehensive genomic coverage. Next-Generation Sequencing or high throughput sequencing or Massively Parallel Sequencing (MPS) is a method of sequencing genomes with the ability to sequence hundreds to thousands of genes or gene regions and the capability to detect novel resistance genes (ARG) in bacteria. BioMérieux partnered with Illumina to develop bioMérieux EpiSe, an NGS service that will facilitate epidemiological monitoring of bacterial infections and monitor outbreaks in hospitals. Some of the modern next-generation sequencing technologies that help to sequence DNA and RNA include Illumina (Solexa) sequencing, Roche 454 sequencing, Ion torrent Proton/ PGM sequencing, and SOLiD sequencing. On May 26th, 2022, The IVD Regulation seeks to ensure a high level of public health and patient safety taking into account scientific progress, and smooth operation of the single market for these products. These changes by the EU legislation aids in the development of microbiology diagnostic devices, as they focus on providing transparency of information through EUDAMED (the new European database of medical devices), allowing manufacturers to monitor products, stronger clinical evidence, post-market surveillance, and enhance safety improvements. In February 2019, Biomerieux, a biotechnology company specialized in in vitro diagnostics, acquired Invisible Sentinel, a US-based company, for $75 million. This acquisition enables bioMérieux’s to expand its customer segments, innovative alternatives to deliver accurate results by rare pathogen testing, and challenging food matrices. Invisible Sentinel provides microbial detection tools and devices for food and beverage molecular testing to improve safety, quality, and productivity. These provide bioMérieux’s molecular food testing solution, 'GENE-UP®', an opportunity to adapt Invisible Sentinel assays to process high volumes of samples. Major players in the microbiology diagnostics devices and equipment market are Becton Dickinnson and Company, Biomerieux, Danaher, Thermo Fisher Scientific, Abbott Laboratories, Bio-Rad Laboratories Inc., Bruker Corporation, Neogen Corporation, Merck KGaA, and Charles River Laboratories International Inc. North America was the largest region in the microbiology diagnostics devices and equipment market in 2021. Asia Pacific was the second largest region in the global microbiology diagnostics equipment market. The regions covered in the global microbiology diagnostics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. The countries covered in the microbiology diagnostics devices and equipment market are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, and USA. The global microbiology diagnostic devices and equipment market is segmented - 1) By Type: Laboratory Instruments, Microbiology Analysers 2) By End-User: Hospitals, Diagnostic Centres, Customer Lab Service Providers, Academic Institutes, Research Institutes 3) By Laboratory Instrument: Incubators, Gram Stainers, Bacterial Colony Counters, Petri Dish Fillers, Automated Culture Systems 4) By Microbiology Analyzer: Microbiology Diagnostics Instruments, Microscopes 5) By Reagent: Pathogen-Specific Kits, General Reagents

The molecular diagnostics devices (or) equipment market consists of sales of molecular diagnostics devices and related services. Molecular diagnostics devices are used to diagnose infectious diseases and perform screening by detecting specific sequences in DNA or RNA at the molecular level. It helps doctors to prescribe more accurate therapeutic interventions in the early stages of a disease. The main products of molecular diagnostics devices (or) equipment are instruments, reagents, and consumables. A reagent is a substance that is used for causing a chemical reaction. Reagents are used to indicate the presence of another substance. The technologies involved are DNA (deoxyribonucleic acid) sequencing, polymerase chain reaction, isothermal nucleic acid amplification technology, transcription-mediated amplification (TMA), in situ hybridization, microarrays, mass spectrometry, and others (southern blotting, northern blotting, and electrophoresis). The various applications are cancer, pharmacogenomics, genetic testing, infectious disease, prenatal, neurological disease, and cardiovascular disease that are used by various end-users such as diagnostic laboratories, hospitals, and others (nursing homes, blood banks, point of care). The global molecular diagnostics devices and equipment market size is expected to grow from $24.19 billion in 2021 to $27.91 billion in 2022 at a compound annual growth rate (CAGR) of 15.3%. The global molecular diagnostics devices market is expected to grow to $46.87 billion in 2026 at a CAGR of 13.8%. The growth in the molecular diagnostic devices and equipment market is attributed to factors such as the rapid rise in various bacterial and viral epidemics. The increase in the spread of diseases increases the demand for early and improved diagnostic methods. To improve the technology to enable the early diagnosis of such diseases, the Government and different organizations extend their financial support towards the major key players of the industry. For example, according to the reports from Centres for Disease Control and Prevention (CDC) US, as of March 2019, 72 Zika virus disease cases were reported in U.S state and 148 Zika virus disease cases reported in US Territories. Thus, the rise of such chronic diseases serves as a prime driver for the players in the industry to develop more accurate and sophisticated diagnostic devices and equipment. Following the increase in demand for early diagnosis of Zika virus, Co-Diagnostics, Inc. in February 2019 launched its first multi-disease molecular diagnostic test for dengue, chikungunya, and Zika. The regulatory process involving the approval of molecular diagnostic tests is often slow. The lack of clear definition coupled with constant changes in the regulations is a challenge for companies developing these kits. In developing nations such as India and China lack of a well-defined regulatory framework negatively impacts the market, irrespective of the presence of a large population. In the US market, because of the changes in the rules and regulations, the products already in the market may also be required to go through Food and Drug Administration (FDA)’s pre-marketing approval process. For example, CLIA (Clinical Laboratory Improvement Amendments Act) in the US certifies the validity of laboratory-based tests but it does not regulate the clinical validity of molecular diagnostic tests. This means that it does not control whether these results are clinically correct. This argument puts a restraint on the industry and opens an argument that FDA should play a greater role in overseeing laboratories. The major players in the molecular diagnostic industry are focusing on developing automated solutions for devices and equipment used for molecular diagnostic processes. Automation of the process will help to enhance the productivity and consistency of the whole diagnostic process. Computerization of the diagnostic process gives reliable and efficient test results that manual testing by various experts does not. The major players of the industry are using nanotechnology-based Oral Fluid Nano Sensor Test (OFNASET). The test uses a microfluidic-based nanosensor for the detection of oral cancer biomarkers in saliva. To keep up with the trend of automation and accuracy, Roche, created cobas connection modules (CCM) to improve scalability and sample-flow efficiency by allowing samples to automatically move between different systems and instruments. Thus, creating a fully automated workflow. The molecular diagnostic devices in the US are approved by Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). These diagnostics devices are generally approved with an accompanying assay, to evaluate their safety and effectiveness or substantial equivalence regarding the assays they run and the assay's defined performance parameters. However, the same instruments do not require FDA approval or clearance when used for basic scientific research purposes. The European regulatory landscape has become more stringent and technically challenging for medical device companies. The introduction of four different risk classes of diagnostic devices i.e. classes A-D. Class A refers to the lowest risk tests and class D refers to the highest risk test such as HIV testing, blood grouping, and prenatal testing. Most of the genetic testing is classed into class C. The products bearing a CE mark, European approved tests, are safe to use, and are in full compliance. In March 2019, Abbott received a CE mark for its Alinity m molecular diagnostic testing machine. This would allow it to sell the product across Europe. Major players in the molecular diagnostics devices (or) equipment market are Roche Ltd, Hologic, QIAGEN, Abbott, Danaher Corporation, Bio-Rad Laboratories, Siemens Healthcare, Becton Dickinson and Company, Cepheid Inc, and bioMerieux S.A. Asia Pacific was the largest region in the molecular diagnostics devices and equipment market in 2021. Western Europe was the second largest market in the global molecular diagnostics equipment market. The regions covered in the global molecular diagnostics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. The countries covered in the molecular diagnostics devices and equipment market are Brazil, China, France, Germany, India, Indonesia, Japan, South Korea, Russia, UK, USA, and Australia. The global molecular diagnostics devices and equipment market is segmented - 1) By Product: Instruments, Reagents, Consumables 2) By End-User: Diagnostic Laboratories, Hospitals, Others (Nursing Home, Blood Banks, Point of Care) 3) By Technology: DNA (Deoxyribonucleic Acid Sequencing), Polymerase Chain Reaction, Isothermal Nucleic Acid Amplification Technology, Transcription Mediated Amplification (TMA), In Situ Hybridization, Microarrays, Mass Spectrometry, Others (Southern Blotting, Northern Blotting, Electrophoresis) 4) By Application: Cancer, Pharmacogenomics, Genetic Testing, Infectious Disease, Prenatal, Neurological Disease, Cardiovascular Disease

The blood transfusion diagnostics market consists of sales of blood transfusion diagnostics devices and related services. The related services here include only installation and maintenance services offered by equipment manufacturers. Blood transfusion diagnostics are the devices used to conduct tests before transfusion of blood from donor-recipient such as blood grouping disease screening. The main types of blood transfusion diagnostics are instruments and kits, reagents, and others. The blood transfusion diagnostic kits are used to collect and transfuse blood. The technologies involved in blood transfusion diagnostics are western blot, ELISA, nucleic acid amplification, fluorescence assay, and rapid test that are used for various applications such as blood grouping and disease screening. The end-users involved are hospitals, diagnostic laboratories, blood banks, and plasma fractionation companies. The global blood transfusion diagnostics market size is expected to grow from $3.34 billion in 2021 to $3.65 billion in 2022 at a compound annual growth rate (CAGR) of 9.2%. The global blood transfusion diagnostic market size is then expected to grow to $5.35 billion in 2026 at a CAGR of 10%. Patients undergoing surgical procedures need a blood transfusion to replace the lost blood during the procedure. Blood transfusion diagnostics are used during the procedures to screen the blood before transferring it to the patient, and will otherwise increase the incidence of infectious disease. According to an article published in the US National Library of Medicine, National Institutes of Health, approximately 310 million surgeries are being performed each year. This increase in the number of procedures will thereby drive the need for blood transfusion diagnostics. Developing and underdeveloped countries lack adequate blood banks, proper medical equipment for blood transfusion, adequate conditions for the storage of blood, and low supply for the high demand of blood. Hospitals are not equipped with proper amenities that help provide hygienic and safe transfusions. For example, according to research conducted by India Spend, around 1.18 million units of blood were wasted during storage in the form of discoloration, bacterial contamination, and expiry due to outdating. The poor infrastructure hampers the growth of the blood transfusion diagnostic market. The growing demand for advanced diagnostic measures and growing prevalence of infectious diseases associated with pathogens such as bacteria & viruses increase the preference for nucleic acid amplification testing (NAAT/NAT) to increase blood safety, improve efficiency and reduce the turnaround time of the results. NAT is a technique that helps detect a particular nucleic acid, virus, or bacteria that acts as a pathogen in blood, tissue, or urine. NAT is highly sensitive and specific for viral nucleic acids and amplifies the region of targeted viral DNA and detects them earlier than the other traditional methods and narrows the period of infectious diseases. For example, XCRP Diagnostic Inc. and Luminex Corporations entered into a licensing agreement of XCR Diagnostic's Xtreme Chain Reaction Nucleic Acid Amplification Technology. In this deal, Luminex got the exclusive rights to use the XCR Diagnostic's NAAT technology for their future molecular diagnostic portfolio. The blood transfusion diagnostics market is highly regulated by governing bodies such as USFDA (the USA Food and Drug Administration), and the Medicines and Healthcare products Agency (MHRA). For instance, the manufacturers and service providers in the USA must comply with the Center for Biologics Evaluation and Research (CBER) Regulations that have been published in the first chapter title 21 of the Code of Federal Regulations (CFR). Part 600 of CFR 21 primarily focuses on the established standards like retention samples conditions, temperature to be maintained during shipment, sterilization of equipment, and role and duties of the inspector to inspect the laboratories. The regulation also allows the manufacturer to report any kind of deviation of their product from their intended purpose. Major players in the blood transfusion diagnostics market are BAG Health Care GmbH, Grifols, Bio-Rad Laboratories Inc., Abbott Laboratories, Immucor Inc, Ortho Clinical Diagnostics, DiaSorin S.p.A, Siemens Healthcare Private Limited, Thermo Fisher Scientific Inc., and Beckman Coulter Inc. The regions covered in the global blood transfusion diagnostics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. The countries covered in the blood transfusion diagnostics market are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, and USA. The global blood transfusion diagnostics market is segmented - 1) By Type: Instruments and Kits, Reagents, Others 2) By End-User: Hospitals, Diagnostic Laboratories, Blood Banks, Plasma Fractionation Companies 3) By Technology: Western Blot, ELISA, Nucleic Acid Amplification, Fluorescence Assay, Rapid Test 4) By Application: Blood Grouping, Disease Screening

The medical and diagnostic laboratory services market consists of sales of medical and diagnostic laboratory services and related goods by entities (organizations, sole traders and partnerships) that provide diagnostics tests for various diseases. This industry includes CT scan centers, X-ray centers and other clinics that undertake disease diagnosis. The main types of medical and diagnostic laboratory services are diagnostic imaging centers, and medical laboratory services. A diagnostic imaging center is a service provider that offers technical or comprehensive diagnostic imaging services. The different expenditure types include public and private that are used in various applications such as cardiology, oncology, neurology, orthopedics, gastroenterology, gynecology, and others. The services are used by male and female. The global medical and diagnostic laboratory services market size is expected to grow from $152.68 billion in 2021 to $170.17 billion in 2022 at a compound annual growth rate (CAGR) of 11.5%. The growth in the market is mainly due to the companies rearranging their operations and recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The medical and diagnostic laboratory services market is expected to reach $248.64 billion in 2026 at a CAGR of 9.9%. The rise in sedentary jobs, busy lifestyles and changing consumer preferences are affecting the disease profile of the world population, especially non-communicable diseases such as cancer, diabetes and cardiovascular diseases. Long working hours, less physical activity, and unhealthy eating and drinking habits are major causes of chronic diseases such as diabetes. According to the World Health Organization, chronic disease prevalence rose by 57% globally, in 2020. Tests to diagnose these diseases include HbA1c tests for monitoring diabetes, biopsies, tumor marker tests, bone scans, MRI and CT scans for diagnosis of various cancers, electrocardiograms, chest X-rays, cardiac CT scans and stress tests for detection of cardiovascular diseases. The increase in the prevalence of lifestyle diseases will increase the demand for tests to diagnose these diseases and thus will drive the medical and diagnostic laboratory services market during the forecast period. The medical and diagnostic laboratory services market is expected to limit by the rising prevalence of self-care diagnostic equipment. These tools can be used by patients without assistance from medical personnel, to diagnose particular disabilities or disorders. Common self-care diagnostic devices include glucose monitoring devices, blood pressure monitoring devices, sleep apnea monitors and temperature monitors. The ease of use of self-care devices has increased demand for them during the last decade and is expected to increase it further during the forecast period. Some virtual applications are also aiding in diagnosis of certain health conditions. For instance, iPhone is working on an IOS accessory called Cue, which can be used as a home diagnostic kit. Self-care diagnostics is expected to have a negative impact on traditional medical and diagnostic laboratory services market during the forecast period by reducing the need for laboratory testing for some basic tests. Medical and diagnostic laboratories are using biomarkers to measure health parameters associated with individual wellness. The health and wellbeing of individuals can be measured by using biomarkers to assess factors behind sleep disorders and symptoms of stress. Biomarkers such as cortisol, testosterone, and secretory IgA can indicate changes in immune system relating to physical and mental conditions. This can be used by physicians to know the causative factors behind such conditions. This is a premium service primarily targeted at wealthy individuals and senior employees of corporations. Major companies in the medical and diagnostic laboratory services market include Laboratory Corporation of America, Eurofins, Quest Diagnostics Incorporated, Sonic Healthcare Limited, Kaiser Permanente, RadNet, OPKO Health, Myriad Genetics, Charles River Laboratories, Inc., and NeoGenomics Laboratories, Inc. North America was the largest region in the medical and diagnostic laboratory services market in 2021. Asia Pacific was the second largest region in the medical and diagnostic laboratory services market. The regions covered in the medical and diagnostic laboratory services market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the medical and diagnostic laboratory services market are Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, USA, Venezuela, and Vietnam. The global medical and diagnostic laboratory services market is segmented - 1) By Type: Diagnostic Imaging Centers, Medical Laboratory Services 2) By Application: Cardiology, Oncology, Neurology, Orthopedics, Gastroenterology, Gynecology, Others 3) By End-User Sex: Male, Female 4) By Type of Expenditure: Public, Private Subsegments Covered: Computer Tomography (CT-Scan) Centers, Medical Radiological Laboratories, Dental or Medical X-Ray Laboratories, Ultrasound Imaging Centers, Magnetic Resonance Imaging (MRI) Centers

The influenza diagnostic market consists of sales of diagnostic tests used to diagnose influenza including viral culture, serology, rapid antigen testing, Reverse Transcription-Polymerase Chain Reaction (RT-PCR), immunofluorescence assays, and rapid molecular assays. Influenza, commonly known as flu, is a contagious illness caused by the influenza virus. Three varieties of this virus affect people: type A, type B, and type C. Common symptoms include fever, sore throat, cough, body ache, fatigue, and headache. The market consists of revenues generated by establishments conducting the diagnostics tests for influenza virus detection. The main traditional diagnostic test types of influenza diagnostics are Rapid Influenza Diagnostic Tests (RIDT), viral culture, DFA, serological assays and others. Rapid influenza diagnostic tests (RIDTs) are immunoassays that can detect the presence of influenza A and B viral nucleoprotein antigens in respiratory specimens and provide a qualitative result (positive vs. negative). The various molecular diagnostic tests include Reverse Transcription Polymerase Chain Reaction (RT-PCR), Isothermal Nucleic Acid Amplification Tests (INAAT), loop mediated isothermal based amplification assays, transcription mediated isothermal based amplification assays, transcription mediated isothermal based amplification assays, other isothermal nucleic acid amplification tests and are used by hospitals and clinical laboratories, diagnostic reference laboratories, academic/research institutes, other end users. The global influenza diagnostic market size is expected to grow from $1.75 billion in 2021 to $1.89 billion in 2022 at a compound annual growth rate (CAGR) of 8.4%. The change in the influenza diagnostic market growth trend is mainly due to the companies stabilizing their output after catering to the demand that grew exponentially during the COVID-19 pandemic in 2021. The influenza diagnostic market is expected to reach $2.53 billion in 2026 at a CAGR of 7.6%. The major factor driving the market is increasing funding for research on influenza diagnostics. Addressing the public health impact of influenza disease requires a proper understanding of the virus and its effect on individuals and populations. Therefore, it is important to accelerate the pace of scientific research progress that can have the greatest public health impact. Many public and private health organizations, researchers, health professionals, biopharmaceutical companies have maximized the spending for research funds or grants to reduce the risk of the emergence of pandemic influenza. For instance, in 2019, the National Institute of Allergy and Infectious Disease (NIAID), part of the National Institutes of Health, has initiated the Collaborative Influenza Vaccine Innovation Centers (CIVICs) program, a new network of research centers that will work together to develop influenza vaccines. NIAID will provide up to approximately $51 million in total first-year funding for the program, which is designed to support the CIVICs program centers over seven years. The variability in sensitivity and specificity among the influenza diagnostic tests is restraining the growth of the market. In most rapid flu tests, there are difficulties in identifying patients with influenza. The sensitivity of rapid flu tests ranges from 10-80% across various patient populations. Most diagnostic tests show an increase in the rate of false-negative results during low influenza virus activity, which often leads to an incorrect diagnosis. Thus, the variability in sensitivity and specificity is restraining the growth of the influenza diagnostic market. Rapid influenza diagnostic tests (RIDTs) are increasingly being implemented in influenza diagnostics. RIDTs are immunoassays which can identify the presence of influenza A and B viral nucleoprotein antigens in respiratory specimens and display the result in a qualitative way (positive vs. negative). It can yield results in a clinically relevant time frame of less than approximately 15 minutes and diagnose patients, who are present with influenza-like illness, mainly if it is performed within the first four days of the onset of symptoms. The rising popularity of RIDT is due to the benefits such as simple to use and rapid diagnosis. In June 2019, Meridian Bioscience Inc., an international producer and distributor of a range of diagnostic test kits, completed its acquisition of GenePoc Inc., a Canadian provider of molecular diagnostic instruments and assays. Meridian will now include GenePOC’s state-of-the-art revogene molecular diagnostics platform, which offers samples to result in testing for single tests, as well as flexible multiplexing capability. GenePOC is a subsidiary of Debiopharm Group. It specializes in the development and commercialization of rapid molecular assays usable on the unique revogene platform for near-patient infectious disease diagnostic. Major players in the influenza diagnostics market are F. Hoffmann-La Roche Ltd, Quidel Corporation, ?h?rm? F??h?r, Abbott Laboratories, Hologic, Becton Dickinson and Company, DiaSorin S.p.A., Luminex Corporation, Meridian Bioscience Inc. and GenMark Diagnostics. The regions covered in the influenza diagnostic market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the influenza diagnostics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, and USA. The global influenza diagnostic market is segmented - 1) By Traditional Diagnostic Tests: Rapid Influenza Diagnostic Tests (RIDT), Viral Culture, DFA, Serological Assays, Others 2) By Molecular Diagnostic Tests: Reverse Transcription Polymerase Chain Reaction (RT-PCR), Isothermal Nucleic Acid Amplification Tests (INAAT), Loop Mediated Isothermal Based Amplification Assays, Transcription Mediated Isothermal Based Amplification Assays, Transcription Mediated Isothermal Based Amplification Assays, Other Isothermal Nucleic Acid Amplification Tests, Others 3) By End User: Hospitals and Clinical Laboratories, Diagnostic Reference Laboratories, Academic/Research Institutes, Others

Diagnostic Equipment Market Characteristics

The diagnostic devices (or) equipment market consists of sales of diagnostic equipment and related services by entities (organizations, sole traders and partnerships) that produce diagnostic equipment used in diagnosis of various diseases. This industry includes establishments that produce diagnosis equipment such as X-ray systems, ultrasound systems, computed tomography (CT) scanners, magnetic resonance imaging systems and other diagnostics equipment.

Diagnostic And Monitoring Ophthalmic Devices And Equipment Market Definition

The diagnostic and monitoring ophthalmic devices and equipment market consists of sales of diagnostic and monitoring ophthalmic devices and equipment and related services by entities (organizations, sole traders and partnerships) that manufacture diagnostic and monitoring ophthalmic devices and equipment. The diagnostic and monitoring ophthalmic devices are used for the diagnosis and monitoring of diseases related to the retina and cornea by measuring affix lenses and refractive errors. These devices also help to identify the power of the intra ocular lens (IOLs) and analyze the visual field. These devices include ultrasound imaging systems, optical coherence tomography scanners, ophthalmoscopes, corneal topographers, specular microscopes, slit lamps, fundus cameras, anomaloscope, haploscope, ophthalmic lens gauge, stereopsis measuring Instrument, retinoscopes, stereoscope and others.

The hemostasis diagnostic devices and equipment market consists of sales of hemostasis diagnostic devices. Hemostasis is a process of slowing and stopping the blood flow to initiate wound healing after a vascular injury. Hemostasis is the first step of healing a wound, it happens in three main stages, blood coagulation, platelet plug formation, and lastly vasoconstriction. Three types of devices help speed up the hemostasis process, vascular closure devices (VCD), compression devices, and there are bandages coated with agents which will speed the clotting process. With the help of hemostasis diagnostic devices, we can predict the cause of bleeding during surgery by identifying any hemostatic defects which patients may have. The main products of hemostasis diagnostic devices and equipment are analyzers, coagulation instruments, other hemostasis instruments, and reagents and kits. A hemostasis diagnostic analyzer is a tool utilized to predict the cause of bleeding during surgery by identifying any hemostatic defects. The hemostasis diagnostic devices and equipment are automated, semi-automated, and manual that is used by hospitals, clinics, independent diagnostic, laboratories, and others. The global hemostasis diagnostic devices and equipment market size is expected to grow from $4.1 billion in 2021 to $4.81 billion in 2022 at a compound annual growth rate (CAGR) of 17.4%. The global hemostasis diagnostic devices market size is expected to grow to $8.57 billion in 2026 at a CAGR of 15.5%. The increased likelihood of older people being diagnosed with a disease is driving the number of surgeries such as cardiovascular diseases (CVD), using hemostasis devices. Due to the higher incidence of diseases with advancing age, there is an increase in the number of surgeries in elderly patients nowadays. These hemostasis devices are very efficient in speeding up the natural process of clotting in the blood and can monitor anticoagulation and transfusion therapy guidance in any surgery. According to the American Heart Association report, Americans older than 80 have a high risk of devolving a cardiovascular disease (CVD), around 83% of men and 87.1% of females will be suffering from any form of CVD, therefore, to improve the comfort of the patient and the success rate of surgeries as a result hemostasis device has been implemented widely. The use of hemostasis devices in hospitals or clinics requires a very lengthy approval procedure which is restraining the market. Before hemostasis devices can enter the market for commercial use they have to clear the regulations set by the Code of Federal Regulations (title 21). The process of approval consists firstly identification of the device, secondly classification of the device and finally, the date of the pre-market approval (PMA) or the notice of completion of prescription drug plan (PDP) is required. It is a very long and time-consuming approval process that discourages new entrants from entering this market. For example, Cardiva medical Inc. had to wait for a processing period of four months before they received approval to change the existing equipment with a newer and modern one. The emergence of new and improved technology in the hemostasis diagnostic device and equipment market. To improve the quality and success rate of operations, new and improved technology such as the collagen vascular hemostasis devices have been implemented. Collagen is the main structural protein found in skin and other connective tissues. It is widely used in purified form for cosmetic surgical treatments and has now emerged in the hemostasis diagnostic devices market. A patient can face immobility right after a femoral surgery leading to increased discomfort, as a result, collagen-based closure devices have been implemented. According to a study conducted by the American Journal of Neuroradiology which they surveyed 698 Angio-Seal closures, using the Angio seal reduced the average time before mobilization by close to 15 minutes with no major complications. Angio seal is a type of collagen hemostasis device which reduces the average time of hemostasis and betters the mobilization of the patient. In 2021, Baxter International Inc., a leading global medical products company, has announced its Baxter Healthcare Corporation subsidiary has completed the acquisition of certain assets related to PerClot Polysaccharide Hemostatic System from CryoLife, Inc for up to $60.8 million, as well as $25 million paid upfront. This acquisition helps the transaction reinforces Baxter’s strategy of acquiring products and technologies that both complement and augment the company’s leading portfolio. CryoLife, Inc. is one of the world's leading contemporary medical device companies. Major players in the hemostasis diagnostic devices and equipment market are C.R. Bard, Baxter International Inc, Pfizer Inc, Johnson & Johnson, Abbott Laboratories, Beckman Coulter Inc, Becton, Dickinson and Company, Chrono-Log Corporation, CSL Behring LLC, and F. Hoffmann-La Roche Ltd. North America was the largest region in the hemostasis diagnostic devices and equipment market in 2021. Asia Pacific was the second-largest region in the global hemostasis diagnostic equipment market. The regions covered in the global hemostasis diagnostics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. The countries covered in the hemostasis diagnostic devices and equipment market are Brazil, China, France, Germany, India, Indonesia, Japan, South Korea, Russia, UK, USA, and Australia. The global hemostasis diagnostic devices and equipment market is segmented - 1) By Product: Analyzers, Coagulation Instrument, Other Hemostasis Instruments, Reagents and Kits 2) By End-User: Hospitals, Clinics, Independent Diagnostic, Laboratories, Others 3) By Device Technology: Automated, Semi-Automated, Manual