Respiratory disposables are used to interface respiratory devices with patients, such as ventilators, nebulizers, and oxygen therapy devices.  The main types of respiratory disposables are masks, tubes, inhalers, and others. A mask is a piece of cloth or other material that is personal protective equipment intended for medical purposes. These are used for disease indications such as asthma, a chronic obstructive pulmonary disorder, tuberculosis, lung cancer, and other chronic respiratory diseases. The applications involved in adult, pediatric, and neonatal. The various end-users are hospitals, clinics, ambulatory care centres, and others. The respiratory disposables market research report is one of a series of new reports from The Business Research Company that provides respiratory disposables market statistics, including respiratory disposables industry global market size, regional shares, competitors with a respiratory disposables market share, detailed respiratory disposables market segments, market trends and opportunities, and any further data you may need to thrive in the respiratory disposables industry. This respiratory disposables market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry. The global respiratory disposables market size will grow from $2.77 billion in 2022 to $3.07 billion in 2023 at a compound annual growth rate (CAGR) of 10.5%. The Russia-Ukraine war disrupted the chances of global economic recovery from the COVID-19 pandemic, at least in the short term. The war between these two countries has led to economic sanctions on multiple countries, a surge in commodity prices, and supply chain disruptions, causing inflation across goods and services and affecting many markets across the globe. The respiratory disposables market size is expected to grow to $4.41 billion in 2027 at a CAGR of 9.5%. The high prevalence rate of respiratory diseases globally is driving the respiratory disposables market. Excessive smoking, exposure to toxic materials, adverse climate conditions, and air pollution are some of the main causes which are leading to a rise in respiratory diseases such as asthma, lung cancer, Chronic Obstructive Pulmonary Disease (COPD), and obstructive sleep apnea (OSA). According to a study, around 65 million people suffer from chronic obstructive pulmonary disease (COPD) and around 3 million people die every year because of this disease. It was also reported that around 334 million people suffer from asthma diseases caused by air pollution as well as tobacco smoke, toxic disposable devices. These factors are increasing the demand for the treatment of respiratory ailments, thus driving the respiratory diseases market. The respiratory disposables market is being restrained due to stringent regulatory policies. Regulatory agencies and governments across various countries are imposing stringent restrictions on product approval and launch, this is limiting the market growth. For instance, FDA banned Amphastar Pharmaceutical’s Primatene product, an albuterol CFC inhaler for asthma because ozone-depleting chlorofluorocarbon (CFC) propellants have depleted the ozone layer. The FDA rejected Amphastar’s first attempt to bring a reformulated version of Primatene mist to market. The FDA rejected another application for Primatene Mist. Which resulted in a rise in development costs and potential sales loss due to delays in product launch, thus restraining the Respiratory disposables market. Rapid advances in technology are driving innovation in respiratory disposable manufacturing. Areas of particular development are likely to be AIR gel technology, wearable technologies, and 3D printing technology. These technologies are being used in the manufacturing of respiratory disposables, resulting in higher productivity, lower costs, and higher margins. Companies in this market are increasingly focusing on AIR gel technology, in which gel is incorporated into the bag on the edges of the mask which helps to the protection of the skin and creates a bridge to minimize the irritation of the skin and for effective sealing. For example, Vyair medical prepared Veraseal 2 disposable mask, used for acute care with AIR gel technology and advantage of vented and non-vented versions. Similarly, Sleepnet prepared Mojo ventilation masks with Airgel technology. In the USA, occupational safety and health administration (OSHA) regulates all respiratory medical equipment, guidelines for which are specified in 29 CFR 1910. 134. Under OSHA, the national institute for occupational safety and health/national personal protective technology laboratory (NIOSH/ NPPTL) provides a market approval certificate and FDA approves the product for marketing. Before market approval, all the medical devices should be analyzed appropriately by performing a compatibility test within a hospital environment. They are tested on an Electrical bench and Non-clinical performance testing is also required. Moreover, proper software verification, validation, and hazard analysis must be performed. Labels on the devices are required to include the purpose of the device. In 2021, Medline a Netherland-based medical device company acquired the Hudson RCI brand of respiratory consumables from Teleflex. The acquisition helps Medline's offerings, enlarging the respiratory environment with the highly regarded Hudson RCI products and opening extra opportunities for development and help to customers. Teleflex is a US-based company global provider of medical technologies designed to develop the health and quality of people's lives. Major players in the respiratory disposables market are Fisher & Paykel, Becton Dickinson Company, Ambu A/S, Smiths Medical, Armstrong Medical, Teleflex, Philips Respironics, Besmed, ResMed, and Dynarex. Asia-Pacific was the largest region in the global respiratory disposables and equipment market in 2022. Western Europe was the second-largest region in the respiratory disposables market. The regions covered in the global respiratory disposables market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. The countries covered in the respiratory disposables market include Brazil, China, France, Germany, India, Indonesia, Japan, South Korea, Russia, UK, USA, and Australia. The respiratory disposables market consists of sales of instruments such as disposable resuscitators, disposable masks, nasal cannulas, tracheostomy tubes, and other consumables and accessories. Values in this market are factory gate values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods. The market value is defined as the revenues that enterprises gain from goods and/or services sold within the specified market and geography through sales, grants, or donations in terms of currency (in USD ($) unless otherwise specified). The revenues for a specified geography are consumption values – that is, they are revenues generated by organizations in the specified geography within the specified market, irrespective of where they are produced. It does not include revenues from resales either further along the supply chain or as part of other products. The global respiratory disposables market is segmented - 1) By Type: Masks, Tubes, Inhalers, Other Types 2) By End User: Hospitals, Clinics, Ambulatory Care Centers, Other End Users 3) By Disease Indications: Asthma, Chronic Obstructive Pulmonary Disorder, Tuberculosis, Lung Cancer, Other Chronic Respiratory Diseases 4) By Application: Adult, Pediatric & Neonatal

Respiratory devices and equipment (therapeutic) are used to treat patients with acute or chronic respiratory disorders such as chronic obstructive pulmonary disease (COPD), chronic bronchitis, asthma, sleep disorders, etc. The main products of the respiratory devices and equipment (therapeutic) market are nebulizers, humidifiers, oxygen concentrators, positive airway pressure devices, ventilators, capnographs, and gas analyzers. A nebulizer is a small machine that turns liquid medicine into a mist, sits with the machine, and breathes in by a connected mouthpiece. The various technologies involved in the respiratory devices and equipment are HEPA filter, electrostatic filtration, microsphere separation, hollow fiber filtration, and others. The market covered in this report is segmented by end-users into home care settings and hospitals. The respiratory devices and equipment (therapeutic) market research report is one of a series of new reports from The Business Research Company that provides respiratory devices and equipment (therapeutic) market statistics, including respiratory devices and equipment (therapeutic) industry global market size, regional shares, competitors with a respiratory devices and equipment (therapeutic) market share, detailed respiratory devices and equipment (therapeutic) market segments, market trends and opportunities, and any further data you may need to thrive in the respiratory devices and equipment (therapeutic) industry. This respiratory devices and equipment (therapeutic) market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry. The global respiratory devices and equipment (therapeutic) market size will grow from $18.03 billion in 2022 to $19.90 billion in 2023 at a compound annual growth rate (CAGR) of 10.4%. The Russia-Ukraine war disrupted the chances of global economic recovery from the COVID-19 pandemic, at least in the short term. The war between these two countries has led to economic sanctions on multiple countries, a surge in commodity prices, and supply chain disruptions, causing inflation across goods and services and affecting many markets across the globe. The global respiratory devices and equipment (therapeutic) market size is expected to grow to $29.55 billion in 2027 at a CAGR of 10.4%. The market for respiratory devices and equipment is expected to expand rapidly. The fact that COVID-19 is essentially a respiratory ailment has boosted the use of respiratory monitoring devices, in turn contributing to the growth of this market. Currently, there is a huge demand for respiratory devices including ventilators, especially in developing countries. Companies across the globe are focusing on increasing the availability of ventilators, nebulizers, and other respiratory support devices for patients. The rising prevalence of respiratory diseases such as Chronic Obstructive Pulmonary Disorder (COPD) and sleep apnea contributed to the growth of the therapeutic respiratory devices and equipment market. According to World Health Organization, one million people die due to chronic obstructive pulmonary diseases caused by smoking among the 4.9 million people who die due to tobacco consumption and 65 million people suffer from moderate to severe COPD. As per its estimates, COPD is predicted to be the third leading cause of death worldwide and potentially fatal respiratory diseases. Tuberculosis, COPD, and lung cancer will account for about one in five deaths worldwide by 2030. According to National Health Interview Survey by the Centers for Disease Control and Prevention (CDC), the number of adults with diagnosed chronic bronchitis in the USA was 9.0 million. In the USA, it is estimated that 22 million Americans suffer from sleep apnea, with 80% of the cases of moderate and severe obstructive sleep apnea undiagnosed. According to a research study published on American Journal of Respiratory and Critical Care Medicine, in 2021, global prevalence of obstructive sleep apnea was found to be around 20% globally. The increased prevalence of COPD and sleep apnea in the geriatric population is driving the market for therapeutic respiratory devices. Lack of awareness regarding the usage of respiratory devices has always been a major challenge in the therapeutic respiratory device market. Outcomes for patients with chronic respiratory diseases remain poor despite the development of novel therapies. An International Survey conducted on Noninvasive Ventilation Use for Acute Respiratory Failure in General Non-Monitored Wards in 51 countries from 5 continents revealed that 44% of the GPs and physicians reported that they had never performed spirometry to make a diagnosis of COPD and the NIV application in general wards was reported by only 66% of respondents. Limited training and human resources were the most common reasons for not using NIV in general wards. The lack of awareness on the use of respiration devices is negatively affecting the respiratory devices and therapeutics market. The companies in the respiratory devices and equipment therapeutic market are increasingly using AI to develop respiratory devices to treat Asthma and COPD. Artificial intelligence supports the development of innovative sensors-equipped inhalers which help patients to track their dosage intake. These sensors are durable and consume less power and help caution the patients by noting the differences or fluctuations in respiration. These are used for both add-on and embedded inhalers. These inhalers with sensors can track data automatically and can alert both the doctors and patients about the health condition of the patients. Also, the companies in developing devices such as AI aided imaging systems and AI aided platforms that will act as voice biomarkers. For instance, in March 2022, Respira Labs, a US-based respiratory technology company, launched AI-powered wearable lung monitor ‘Sylvee’. The new product uses acoustic resonance to assess the lung function and detect any variations in the lung function. In March 2020, Masimo, a global leader in noninvasive monitoring technologies acquired NantHealth, Inc's connected care business for an undisclosed amount. NantHealth is a provider a tablet-optimized application that sits on top of our DCX platform to provide clinicians more convenient and ubiquitous access to capture a wide array of patient vitals such as respiratory rate, blood pressure, and heart rate in addition to performing patient assessments. This move of Masimo will leverage its capabilities with NantHealth’s solutions that can enable a more efficient patient rounding and assessment workflow by providing a near real-time stream of data from the patient's bedside unlike periodic sampling typically entered into an EHR hours later. Major players in the respiratory devices and equipment (therapeutic) market are Hamilton Medical AG, Koninklijke Philips N.V, Smiths Medica, Ge Healthcare, Philips Health Care, Chart Industries, Invacare Corporation, Fisher & Paykel Healthcare Limited, Resmed, and Dragerwerk AG. Asia-Pacific was the largest region in the respiratory devices and equipment (therapeutic) market in 2022. Western Europe was the second-largest region in the global respiratory devices and equipment (therapeutic) market. The regions covered in the global respiratory devices and equipment (therapeutic) market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. The countries covered in the respiratory devices and equipment (therapeutic) market are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, the UK, and the USA. The respiratory devices and equipment (therapeutic) market consist of sales of instruments such as nebulizers, oxygen concentrators, positive airway pressure devices, ventilators, inhalers, and others. Values in this market are factory gate values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods. The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified). The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products. The global respiratory devices and equipment (therapeutic) market is segmented - 1) By Product: Nebulizers, Humidifiers, Oxygen Concentrators, Positive Airway Pressure Devices, Ventilators, Capnographs, Gas Analyzers 2) By End-User: Homecare settings, Hospitals 3) By Technology: HEPA Filter, Electrostatic Filtration, Microsphere Separation, Hollow Fiber Filtration, Other Technologies

Point-of-care diagnostics devices are designed to aid doctors in performing medical diagnostic testing at or near the point of care, for immediate knowledge on diseases or conditions. These devices are used to test glucose and cholesterol levels, do electrolyte and enzyme analysis, test for drugs of abuse and for infectious diseases, and for pregnancy testing. The main types of point-of-care diagnostic devices and equipment are infectious disease testing kits, cardiometabolic monitoring kits, cholesterol testing kits, pregnancy and fertility tests kits, tumor/cancer markers, urinalysis testing kits, hematology testing kits, drugs of abuse testing kits, fecal occult testing kits, and others. Pregnancy and fertility test kits are point-of-care diagnostic devices used to test pregnancy and fertility prior to seeing a doctor. The various prescription modes include prescription-based testing devices, and over-the-counter (OTC) testing devices. These are used by end-users such as professional diagnostic centers, hospitals/critical care centres, outpatient healthcare settings, ambulatory care settings, research laboratories, and homes. The point-of-care diagnostics devices and equipment market research report is one of a series of new reports from The Business Research Company that provides point-of-care diagnostics devices and equipment market statistics, including point-of-care diagnostics devices and equipment industry global market size, regional shares, competitors with a point-of-care diagnostics devices and equipment market share, detailed point-of-care diagnostics devices and equipment market segments, market trends and opportunities, and any further data you may need to thrive in the point-of-care diagnostics devices and equipment industry. This point-of-care diagnostics devices and equipment market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry. The global point-of-care diagnostics devices and equipment market size will grow from $28.47 billion in 2022 to $32.34 billion in 2023 at a compound annual growth rate (CAGR) of 13.6%. The Russia-Ukraine war disrupted the chances of global economic recovery from the COVID-19 pandemic, at least in the short term. The war between these two countries has led to economic sanctions on multiple countries, a surge in commodity prices, and supply chain disruptions, causing inflation across goods and services and affecting many markets across the globe. The global point-of-care diagnostics devices and equipment market size is expected to grow to $48.35 billion in 2027 at a CAGR of 10.6%. An increase in the incidence of target diseases is driving the POC devices and equipment market globally. The rising incidence of chronic diseases, like diabetes, rheumatism, or cancer is increasing steadily worldwide due to poor lifestyle choices and increasing obesity, thus driving the growth of the POC devices and equipment market. For example, according to the Centers for Disease Control and Prevention, In 2020, about 697,000 people in the US died due to heart disease. The POC diagnostics devices and equipment market is expected to slow down due to stringent regulatory policies, which increase the gestational period before the product enters the market. POC devices and equipment manufacturers are required to obtain multiple FDA clearances before launching their product into the market. The entire process of approval consumes a lot of time, thereby restraining the market growth. Over-the-Counter (OTC) testing is being termed as an important trend driving the growth of the point of care diagnostics market. FDA has approved OTC test kits for cholesterol, fecal occult blood, pregnancy, and HIV/HCV. This method would improve the access to testing and early detection of the disease. These testing kits may generate more revenue than prescription tests over the forecast period due to ease of using the kits, increased home care and self-testing, and a rise in availability and adoption rate. Point of care devices is regulated by the U.S. Food and Drug Administration (FDA) and all the diagnostic laboratory tests are regulated by the clinical laboratory improvement amendments of 1988 (CLIA) that are administered by the Centers for Medicare & Medicaid Services (CMS). As these devices measure the biomarker levels in the body they are classified as class II (requiring 510[k] approval), or III devices (requiring the more tedious premarket approval). On the contrary, to the stringent approvals by FDA, China has a moderately lenient approval mechanism. Therefore, the top companies are using a partnership approach with local vendors and distributors to expand their market share. Major players in the point-of-care diagnostic devices and equipment market are Abbott, F. Hoffmann-La Roche, Siemens Healthineers, Danaher, Beckman Coulter, Becton Dickinson and Company, QIAGEN N.V., Johnson & Johnson, Alere Inc., and BioMerieux. North America was the largest region in the point-of-care diagnostic devices and equipment market in 2022. Asia-Pacific was the second-largest region in the global point-of-care diagnostics devices and equipment market. The regions covered in global point-of-care diagnostics devices and equipment market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. The countries covered in the point-of-care diagnostic devices and equipment market are Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, the UK, and USA. The point-of-care diagnostics market consists of sales of instruments such as pregnancy and fertility testing kits, cholesterol test strips, drug abuse testing kits, and others that are used in point-of-care diagnostics. Values in this market are factory gate values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified). The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products. The global point-of-care diagnostics devices and equipment market is segmented - 1) By Type: Infectious disease testing kits, Cardio metabolic monitoring kits,, Cholesterol testing kits, Pregnancy and fertility tests kits, Tumor/Cancer markers, Urinalysis testing kits, Hematology testing kits, Drugs of abuse testing kits, Fecal occult testing kits, Other Types 2) By End User: Professional diagnostic centers, Hospitals/critical care centers, Outpatient healthcare Setting, Ambulatory care settings, Research laboratories, Home 3) By Prescription Mode: Prescription-based Testing Devices, Over-The-Counter (OTC) Testing Devices

Transplant diagnostics are the tests conducted before relocation/ transplantation of the donor organ to the recipient patient. Histocompatibility and immunogenetics are the main topics of transplantation diagnostics in the context of organ transplantation and hematopoietic stem cell transplantation. The main types of transplant diagnostics are reagents and consumables, instruments, and software and services. The transplant diagnostics instruments are products that are designed to speed up and improve the quality of transplant diagnostics. The technologies used in transplant diagnostics are non-molecular assay, and molecular assay to transplant various organs such as kidney, liver, heart, lung, and pancreas. The transplant types included are solid organ and stem cells that are used by end-users such as hospitals and transplant centres, research laboratories and transplant centres, and commercial service providers. The transplant diagnostics market research report is one of a series of new reports from The Business Research Company that provides transplant diagnostics market statistics, including transplant diagnostics industry global market size, regional shares, competitors with a transplant diagnostics market share, detailed transplant diagnostics market segments, market trends and opportunities, and any further data you may need to thrive in the transplant diagnostics industry. This transplant diagnostics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry. The global transplant diagnostics market grew from $1.66 billion in 2022 to $1.82 billion in 2023 at a compound annual growth rate (CAGR) of 9.6%. The Russia-Ukraine war disrupted the chances of global economic recovery from the COVID-19 pandemic, at least in the short term. The war between these two countries has led to economic sanctions on multiple countries, a surge in commodity prices, and supply chain disruptions, causing inflation across goods and services and affecting many markets across the globe. The transplant diagnostics market is expected to grow from $2.4 billion in 2027 at a CAGR of 7.2%. Rising incidents of acute diseases are leading to an increase in organ failure rates, thus increasing the demand for transplant procedures driving the transplant diagnostics market. Organ transplant is a complex process and the success of the procedure depends on the acceptance of the donor's organ by the recipient's body system. To check whether the organ transplant can be successful, transplant diagnostic tests are performed. According to the United Network for Organ Sharing, a US-based non-private organization that manages organ transplantation in the US, in the year 2021, The U.S. saw a record-setting number of organ transplants. 24,669 kidney transplants, 9,236 liver transplants, and 3,817 heart transplantation procedures were performed in 2021. This high demand for diagnostic tests is driving the transplant diagnostics market. A huge gap between organ donation and demand for organ transplantation is restraining the growth of the transplant diagnostics market. The number of organ donors is increasingly falling short of the number of people requiring organ transplantation. According to Health Resources and Services Administration in 2021, 106,090 people were on the waiting list for receiving organ donation. This is creating a huge deficit between the supply and demand of organ donors, with the number of people on the waiting list for organ transplants growing increasing with each passing year. This low number of organ donors is limiting the need for transplant diagnostic tests and devices, thus restraining the market growth. Companies in the transplant diagnostics market are using Next Generation Sequencing (NGS) for conducting tests to match organ donors and recipients. NGS technology allows the sequencing of an entire human genome, i.e. millions of DNA molecules within a single day. In Next-generation sequencing (NSG), genes are matched between the donor and recipient and depending on the extent of the match, a decision to perform organ transplantation is made. Nearly all transplant diagnostic tests and devices currently use this technology to decide on organ transplantation. For example, Castle Biosciences launched the Decision Dx-CMSeq Test that used NGS (Next Generation Sequencing) to identify somatic mutations in genes. The transplant diagnostics market is regulated by authorities such as the US Food and Drug Administration (FDA). For instance, companies in the transplant diagnostics market must comply with the Good Laboratories Practices (GLP) Part 58 directed by the FDA Title 21. According to this regulation, all the clinical instruments used to diagnose specimens must be maintained under specified conditions and should be properly calibrated, so that there should be minimal distortion in the result. The testing facility must be equipped with a quality assurance unit to monitor each piece of equipment, personnel, methods, practices, record, and controls. In August 2022, Eurobio Scientific, a France-based biotechnology company, acquired GenDx for $134.3 million(€135 million). The acquisition would help Eurobio to expand its research in the areas of transplantation. Genome Dx is a Netherlands-based molecular diagnostics startup. Major players in the transplant diagnostics market are Thermo Fisher ScientificInc., Illumina Inc., F. Hoffmann La-Roche AG., Abbott Laboratories Inc., Qiagen N.V., Immucor Transplant Diagnostics Inc., Bio-rad Laboratories Inc., Omixon Ltd., CareDx, Affymetrix Inc., and GenDx. North America was the largest region in the transplant diagnostics market in 2022. Western Europe was the second largest region in the global transplant diagnostics market report. The regions covered in global transplant diagnostics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. The countries covered in the transplant diagnostics market are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, and USA. The transplant diagnostics market includes revenues earned by entities by PCR-based molecular assays, sequencing-based molecular assays, and non-molecular assay technologies. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included. The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified). The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products. The global transplant diagnostics market is segmented - 1) By Type: Reagent & Consumables, Instrument, Software & Services 2) By Transplant Type: Solid Organ, Stem Cell 3) By End User: Hospitals and Transplant Centers, Research Laboratories & Transplant Centers, Commercial Service Providers 4) By Technology: Non Molecular Assay, Molecular Assay 5) By Organ: Kidney, Liver, Heart, Lung, Pancreas

Molecular diagnostics devices are used to diagnose infectious diseases and perform screening by detecting specific sequences in DNA or RNA. It helps doctors 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 to cause 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, which are used by various end-users such as diagnostic laboratories, hospitals, and others (nursing homes, blood banks, point of care). The molecular diagnostics devices (or) equipment market research report is one of a series of new reports from The Business Research Company that provides molecular diagnostics devices (or) equipment market statistics, including molecular diagnostics devices (or) equipment industry global market size, regional shares, competitors with a molecular diagnostics devices (or) equipment market share, detailed molecular diagnostics devices (or) equipment market segments, market trends and opportunities, and any further data you may need to thrive in the molecular diagnostics devices (or) equipment industry. This molecular diagnostics devices (or) equipment market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry. The global molecular diagnostics devices and equipment market size will grow from $27.65 billion in 2022 to $30.82 billion in 2023 at a compound annual growth rate (CAGR) of 11.5%. The Russia-Ukraine war disrupted the chances of global economic recovery from the COVID-19 pandemic, at least in the short term. The war between these two countries has led to economic sanctions on multiple countries, a surge in commodity prices, and supply chain disruptions, causing inflation across goods and services and affecting many markets across the globe. The molecular diagnostics devices and equipment market size is expected to grow from $43.28 billion in 2027 at a CAGR of 8.9%. 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 in October 2021, melioidosis was declared as a multistate epidemic. 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 B. pseudomallei, InBios, launched Active Meliodosis Detect™ point of care diagnostic test for the detection of B. pseudomallei. 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 2021, BioFire Diagnostics receive first marketing authorization from U.S. FDA for its BioFire Respiratory Panel 2.1. The product is a diagnostic product for simultaneous detection of multiple respiratory viral and bacterial nucleic acids in nasopharyngeal swabs obtained from patients. 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 global molecular diagnostics devices (or) equipment market in 2022. Western Europe was the second largest market in molecular diagnostics devices (or) equipment market. The regions covered in the global molecular diagnostics devices (or) equipment 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 (or) equipment market are Brazil, China, France, Germany, India, Indonesia, Japan, South Korea, Russia, UK, USA, and Australia. The molecular diagnostics devices and equipment market consits of sales of thermocycler, single particle mass spectrometers, time-of-flight mass spectrometer (TOF) and others that are used to to detect pathogen and infectious diseases. Values in this market are factory gate values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. This market is segmented into instruments, reagents, and consumables. The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified). The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products. 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

In-vitro diagnostics devices and equipment is a gadget that tests human samples collected from the human body such as tissues and blood, with the goal of using the results to help with clinical diagnosis or management. The main types of in-vitro diagnostics equipment are point-of-care diagnostics devices and equipment, immunochemistry diagnostic devices and equipment, clinical chemistry diagnostics devices and equipment, molecular diagnostics devices and equipment, microbiology diagnostic devices and equipment, hemostasis diagnostic devices and equipment, hematology diagnostic devices, and equipment, and immunohematology diagnostic devices, and equipment. Hematology instruments are machines that analyze blood. The hematology instruments perform blood counts, detect proteins or enzymes, and help to diagnose illnesses or genetic defects. The type of expenditure is public and private. The products used are instruments/equipment and disposables. The end-users are hospitals and clinics, diagnostic laboratories, and others. The in-vitro diagnostics devices and equipment market research report is one of a series of new reports from The Business Research Company that provides in-vitro diagnostics devices and equipment market statistics, including in-vitro diagnostics devices and equipment industry global market size, regional shares, competitors with a in-vitro diagnostics devices and equipment market share, detailed in-vitro diagnostics devices and equipment market segments, market trends and opportunities, and any further data you may need to thrive in the in-vitro diagnostics devices and equipment industry. This in-vitro diagnostics devices and equipment market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry. The global in-vitro diagnostics market grew from $95.6 billion in 2022 to $106.53 billion in 2023 at a compound annual growth rate (CAGR) of 11.4%. The Russia-Ukraine war disrupted the chances of global economic recovery from the COVID-19 pandemic, at least in the short term. The war between these two countries has led to economic sanctions on multiple countries, a surge in commodity prices, and supply chain disruptions, causing inflation across goods and services and affecting many markets across the globe. The in-vitro diagnostics market is expected to grow to $148.58 billion in 2027 at a CAGR of 8.7%. Demand for point-of-care diagnostic devices is increasing as they provide rapid results, are cost-effective, and have advanced diagnosis features for patients. The number of patients seeking treatments at local physician offices, retail clinics, and in-patient homes is increasing thus boosting the demand for point-of-care testing devices. Companies in this market are focusing on developing more user-friendly, reliable, and efficient point of care devices. For instance, in March 2020, Abbott launched Novel COVID-19 Test. The test will be used on the m2000 RealTime system available in hospitals and molecular labs in the U.S. Philips also launched a new handheld blood test, Handheld Minicare I-20 system used for diagnosing heart attacks in emergency departments which provide results within 10 minutes. IVD devices are being integrated with IoT and data analytics technologies to improve device efficiency and increase device security. IoT refers to a system of interconnected devices via communication technologies such as WIFI and Bluetooth for data transfer and accessing devices remotely. Data analytics refers to qualitative and quantitative techniques, used to infer actionable information from large data sets. These technologies are helping in enhancing IVD device functionality, mainly through remote monitoring, predictive maintenance for decreased downtime, and advanced data processing capabilities. Major companies in the in-vitro diagnostics devices and equipment market include Siemens Healthineers, F. Hoffmann-La Roche Ltd., Danaher (Beckman Coulter Inc), Abbott Laboratories Inc., and Thermo Fisher Scientific Inc. North America was the largest region in the global in-vitro diagnostics market in 2022. Asia-Pacific was the second largest region in the global in-vitro diagnostics market. The regions covered in the in-vitro diagnostics devices and equipment market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa. The countries covered in the in-vitro diagnostics devices and equipment 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 in-vitro diagnostics devices and equipment market consist of sales of kits, reagents, piece of software, system, and instrument. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods. The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified). The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products. The global in-vitro diagnostics market is segmented - 1) By Type: Point-of-Care Diagnostics Devices And Equipment, Immunochemistry Diagnostic Devices And Equipment, Clinical Chemistry Diagnostics Devices And Equipment, Molecular Diagnostics Devices And Equipment, Microbiology Diagnostic Devices And Equipment, Hemostasis Diagnostic Devices And Equipment, Hematology Diagnostic Devices And Equipment, Immunohematology Diagnostic Devices And Equipment 2) By End User: Hospitals And Clinics, Diagnostic Laboratories, Other End Users 3) By Type of Expenditure: Public, Private 4) By Product: Instruments/Equipment, Disposables

Blood transfusion diagnostics are used to conduct tests before the 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 blood transfusion diagnostics market research report is one of a series of new reports from The Business Research Company that provides blood transfusion diagnostics market statistics, including blood transfusion diagnostics industry global market size, regional shares, competitors with a blood transfusion diagnostics market share, detailed blood transfusion diagnostics market segments, market trends and opportunities, and any further data you may need to thrive in the blood transfusion diagnostics industry. This blood transfusion diagnostics market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry. The global blood transfusion diagnostics market grew from $3.65 billion in 2022 to $3.98 billion in 2023 at a compound annual growth rate (CAGR) of 9.0%. The Russia-Ukraine war disrupted the chances of global economic recovery from the COVID-19 pandemic, at least in the short term. The war between these two countries has led to economic sanctions on multiple countries, a surge in commodity prices, and supply chain disruptions, causing inflation across goods and services and affecting many markets across the globe. The blood transfusion diagnostics market is expected to grow from $5.68 billion in 2027 at a CAGR of 9.3%. 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. North America was the largest region in the blood transfusion diagnostics market in 2022. Western Europe was the second largest region in the global blood transfusion diagnostics market. The regions covered in 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 blood transfusion diagnostics market consists of revenues earned by entities by providing installation and maintenance services. The market value includes the value of related goods sold by the service provider or included within the service offering. The blood transfusion diagnostics market also includes sales of blood transfusion diagnostics devices. Values in this market are factory gate values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods. The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified). The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products. The global blood transfusion diagnostics market is segmented - 1) By Type: Instruments and Kits, Reagents, Other Types 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 molecular diagnostics market consists of sales of molecular diagnostics services and related products by entities (organizations, sole traders, partnership) that are utilised to direct patient management, from diagnosis to treatment, especially in the treatment of congenital anomalies, infectious diseases, and cancer. Molecular diagnostic is a term used to describe a class of techniques that are used to examine biological markers in the genetic code (genome) of an organism and to determine how its cells express their genes as proteins. The main types of products in molecular diagnostics are instruments, reagents, consumables, software, and services. Instruments refer to a measuring device for determining the present value of a quantity under observation. The technologies include polymerase chain reaction (PCR), DNA sequencing, and next-generation sequencing, and these are used in oncology, pharmacogenomics, infectious diseases, genetic testing, neurological disease, cardiovascular disease, microbiology, and other applications. The various end-users are hospitals, laboratories, and other end-users (blood banks, home health agencies, and nursing homes). The global molecular diagnostics market size is expected to grow from $49.49 billion in 2021 to $49.64 billion in 2022 at a compound annual growth rate (CAGR) of 0.3%. The global molecular diagnostics market size is expected to decline to $47.78 billion in 2026 at a compound annual growth rate (CAGR) of -1.0%. The rising prevalence of infectious diseases and cancers of different forms drives the molecular diagnostics market. To determine whether mutations to a gene or chromosome may raise a person's chance of acquiring cancer or other disorders, molecular testing is employed. The increasing prevalence of infectious diseases and various types of cancer creates a demand for new diagnostic procedures, including fast and specific molecular diagnostic tests. For instance, in 2020, according to the National Cancer Institute, a US-based government agency, an estimated 1,806,590 new cases of cancer would be diagnosed in the United States and 606,520 people would die from the disease. Therefore, the increasing prevalence of cancer is driving the growth of the molecular diagnostic market. The advances in genomics and proteomics are a key trend gaining popularity in the molecular diagnostics market. Polymerase chain reaction (PCR) is a recent development in genomics and helps in discovering new approaches to molecular diagnosis for disease diagnosis and pathogenesis of diseases. This enables better monitoring and a fast diagnosis and major organizations are investing to have a competitive edge. Following the trend, $600 million to support the COVID-19 vaccine and therapy clinical trials led by the private sector and for Canadian bio-manufacturing opportunities. This announcement was part of the $1 billion Plan to Mobilize Science. The growing research in proteomics and genomics will help develop more advanced molecular diagnostic techniques in the forecast period. In April 2021, Hologic, a US-based women’s health technology company, acquired Mobidiag Oy for an undisclosed amount. The acquisition would accelerate the global growth of Mobidiag’s molecular diagnostic test platforms, which offer ease of use, multiplex capability, and rapid turnaround time. Mobidiag Oy is a Finland-based company that develops and provides molecular diagnostics for infectious diseases and antibiotic resistance. The major players in the molecular diagnostics market are Becton, BioMérieux SA, Danaher Corporation, Grifols, Hologic Inc., Novartis AG, QIAGEN, Siemens Healthcare GmbH, Abbott, and Dickinson and Company. North America was the largest region in the molecular diagnostics market in 2021. The regions covered in the global molecular diagnostics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, the Middle East, and Africa. The countries covered in the molecular diagnostics market are Brazil, China, France, Germany, India, Indonesia, Japan, South Korea, Russia, the UK, the USA, and Australia. The global molecular diagnostics market is segmented - 1) By Technology: Polymerase Chain Reaction (PCR), DNA Sequencing, and Next-Generation Sequencing 2) By Product: Instruments, Reagents and Consumables, Software and Services 3) By Application: Oncology, Pharmacogenomics, Infectious Diseases, Genetic Testing, Neurological Disease, Cardiovascular Disease, Microbiology, and Others 4) By End-User: Hospitals, Laboratories, and Others (Blood Banks, Home Health Agencies, and Nursing Homes)