Testing is still an important step in combating the pandemic.
Blood transfusions were once performed without any precautions, which could result in mismatched blood groups, the spread of infectious diseases, and other life-threatening problems. Mismatch in blood group during transfusion, transfer of infectious diseases, trauma, and discomfort caused by repeated needle pricks have all been minimized, thanks to advancements in a new type of transfusion technology, as well as collection and processing devices used in blood sample analysis. The rise in chronic diseases and surgical procedure volumes is driving up demand for pathogen-free blood and its components, causing market players to shift their focus to research, approvals, and product launches in order to develop new technically advanced collection and processing devices and consumables.
Most collection devices are now fully automated and are normally operated by experienced users, reducing the need for human intervention, and processing is handled by a built-in software interface.
Medical experts and their assistants use a variety of devices and consumables during blood collection, processing, and management procedures to thoroughly analyze and diagnose infection-causing agents, such as bacteria, viruses, and other pathogens, and then segregate different blood components for treating patients who are missing a specific blood component. Most collection devices are now fully automated and are normally operated by experienced users, reducing the need for human intervention, and processing is handled by a built-in software interface.
Automated systems have emerged as a useful tool in the blood collection and processing industry as these devices reduce the total number of steps needed for the processing of whole blood and also it has minimized the total number of operating procedures, the hands-on times needed, and the amount of equipment too. Among the automated series of devices, next-generation systems provide faster, better, and more advanced methods of blood processing and utilize centrifuges for the separation of whole blood into its components. These next-generation systems also consist of features like a touch-screen graphical interface for easy handling of the system.
Technological advancements, such as automated blood collection and processing devices, portable blood collection and processing devices, customized blood collection and processing devices, 3D-printed blood collection devices, microfluidic blood collection devices, RFID technology, and robotics in blood management are expected to rule the blood collection and processing devices market through their special features.
The global blood collection devices market is projected to reach USD 7.8 billion by 2026 from USD 5.7 billion in 2021, at a CAGR of 6 percent during 2021–2026. The major factors driving the growth of this market include the increasing incidence of infectious diseases, the rising number of accidents and trauma cases, the emergence of liquid biopsy tests, and the rising demand for blood donations and blood components.
The Covid-19 outbreak is an unprecedented global public health challenge and is expected to have a significant impact on the blood collection devices market. Both hospitals and independent laboratories are generally reviewing each test to decide whether to recommend consultations with laboratory hematologists for tests with a higher risk profile or not offer tests that could not be performed safely. This affected the market negatively in the first few months of the pandemic, reducing the use of blood collection devices. However, increasing caution and the rising testing volumes, along with the need for regular health and body checkups ensured market growth in the later phase.
Results now take an average of four to six days for the general population, much longer than the two to three days required before. This is because tests for hospital patients and symptomatic healthcare workers are prioritized and take one day on average, which has resulted in a delayed cycle. While it has affected market growth to some extent, the situation is expected to change for the better.
Rising prevalence of infectious diseases with the emergence of newer pathogens and chronic and lifestyle diseases. The rising prevalence of infectious diseases, such as hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV), malaria, syphilis, and brucellosis is a major factor driving the demand for effective blood collection (due to the risk of disease transmission during blood transfusion). According to the WHO (July 2021), there were an estimated 37.7 million people living with HIV at the end of 2020, over two-thirds of whom (25.4 million) are in the WHO African Region. In 2020, 680,000 (480,000–1.0 million) people died from HIV-related causes, and 1.5 million (1.0–2.0 million) people acquired HIV. In addition, globally, there were more than 7 million new syphilis infections in 2021.
The burden of chronic diseases is rapidly increasing worldwide. Almost half of the total chronic disease deaths are attributable to cardiovascular disease (CVD). In the US alone, as per the American Heart Association, the prevalence of CVD is projected to increase from 36.9 percent in 2010 to 38.7 percent by 2020 and 40.5 percent by 2030. Obesity and diabetes are also showing worrying trends, not only because they already affect a large proportion of the population but also because they have started to appear earlier in life. The prevalence of lifestyle diseases is also growing across the globe, and particularly in emerging countries.
As per the estimates of the American National Red Cross, 2021 updated, approximately 36,000 units of red blood cells are needed every day, and nearly 21 million blood components are transfused each year in the United States. Additionally, according to the Globocan 2020 report, Canada had 8506 cases of Non-Hodgkin lymphoma and 313 deaths caused due to it in 2020. The increase in cases of non-Hodgkin lymphoma is expected to boost the demand for the blood collection market.
This scenario has ensured greater adherence to health checkups and the growing importance of markers to find disease conditions, mainly via blood collection. Health checkups are gaining popularity both at a personal level as well as performed at a corporate level for employee well-being. This will be favorable for the market growth and a significant contributor to the blood collection devices market, as blood tests are a primary mode of diagnosing these diseases.
High cost of automated blood collection devices. For blood banks, capital investments in automated blood collection, using apheresis devices, are very high in comparison to that of whole-blood collection. The average price for devices ranges between USD 45,000 and USD 55,000. Hence, smaller blood banks and hospitals do not opt for this type of blood collection. The cost of therapeutic apheresis is also very high, as it includes the additional cost of disposables – between USD 1500 and USD 3000 per patient. Owing to their high costs, the adoption of these automated blood collection products is very low as compared to manual blood collection products in countries like China and India. This is limiting the overall growth of the blood collection devices market.
The cost of providing apheresis therapy is a matter of almost universal concern. Estimates of costs of individual apheresis treatments are very much available but vary widely. For instance, in the US, the cost of an apheresis procedure is approximately USD 2500 per treatment. An investment of USD 19,000 to USD 32,000 for a blood cell separator is the initial cost for setting up the machine, and disposable sets produced by manufacturers will vary between USD 40 and USD 90 per treatment. Replacement fluids (at an average volume of 2.8 liters), such as albumin or fresh frozen plasma, make up the remainder of the costs, running into USD 125 to USD 600 per treatment.
Complexities of storage and shipping. Storing and shipping whole-blood samples poses significant challenges and costs. Once collected, whole blood must be used immediately or stored and maintained under strict temperature and environmental conditions for analysis or other applications. The characteristics of blood samples begin to change within hours of collection, if not refrigerated or frozen. Maintaining their stability is essential since blood components begin to degrade immediately; extended exposure to ambient temperatures can dramatically affect the outcome of any analysis on such samples. Therefore, medical organizations around the world have created guidelines for their storage, packaging, and shipping.
The USFDA recommends that whole-blood samples held in specialized containers should only be kept refrigerated for 42 days. However, it is recognized that some changes in the samples may occur during that time. Another governing body, the National Institute of Health and Welfare in Finland, determined that whole-blood samples refrigerated at 4°C (or about 39°F) should only be held for up to seven days before discarding.
Technological advancements in blood collection procedures and products. Collecting blood samples from patients with difficult venous access (DVA) is challenging or sometimes impossible. In DVA patients, traditionally used blood collection products are often unable to collect adequate samples, which can also lead to repeated attempts to collect blood. This increases the risk of anemia in patients and the risk of transmission of bloodborne pathogens to nurses and phlebotomists.
To overcome this issue, innovative hematology-tube designs have been introduced to support capillary-blood collection for reducing the risks of collection and processing errors in DVA patients. Besides this, a vein illumination and visualization technique – vein finder, a recent addition to safe blood collection procedures – is used to assist healthcare professionals in finding a good vein for venipuncture. The device illuminates the veins beneath the skin using ultrasound or infrared technology and facilitates easy vein access, thus reducing the need for repeated venipuncture.
There is a growing trend toward innovations in blood collection. Two firms won US FDA 510(k) clearances for blood collection devices recently – a push-button device from Seventh Sense called TAP, and a needle-free device from Velano Vascular called Pivo. Meanwhile, other firms, such as Neoteryx, are pursuing microsampling of blood but focusing on dried blood spots.
Companies operating in the global blood collection equipment market are focusing on mergers and acquisitions and new product launches to gain a competitive advantage.
In February 2022, BD (Becton, Dickinson, and Company) released UltraSafe Plus 2.25 mL, a new needle-guard solution that improves the delivery of drugs and other biologic solutions.
In the same month, Abacus dx launched the newest addition to Streck’s trusted blood collection tube portfolio, RNA Complete BCT.
In December 2021, Seattle-based Tasso, a maker of simplified blood collection devices, landed USD 100 million in funding to expand its production and commercial reach for advanced at-home blood collection devices. The new funding brings its total equity investment to USD 131 million.
In December 2021, Ethos Laboratories, a College of American Pathologists-accredited and certified leader in diagnostic testing services, launched Tru-Immune a finger prick, a self-collection kit for its Covid-19 neutralizing antibody test.
In August 2021, Quest Diagnostics acquired Boca Raton-based Nationwide Laboratory Services. With the acquisition, Quest will broaden access to diagnostic innovation and insights, empowering better health for more communities in South Florida.
In June 2021, Greiner Bio-One introduced MiniCollect PIXIE Heel Incision Safety Lancet for expanding its portfolio with a new safety lancet specially designed for heel incision and now has three different lancet types on offer to cover individual needs.
In April 2021, Terumo Blood and Cell Technologies and CSL Plasma announced a collaboration to deliver a new plasma collection platform.
Some of the key players include BD, Terumo BCT, Fresenius Kabi AG, Grifols S.A., Haematonics, Nipro Medical Corporation, Greiner Holding, Quest Diagnostics, Abacus dx, Sarstedt AG & Co., Macopharma, Smiths Medical, Cardinal Health, Tasso, and Retractable Technologies.
In 2021, the US emerged as one of the most lucrative markets, accounting for a market share of over 87.3 percent across North America. Growth in the country is driven by the growing popularity of health checkups due to a rise in lifestyle and chronic disorders. With advancements in biotechnology and ease in sample collection and processing, growth exhibited by the blood collection devices market is expected to improve. The presence of numerous key players in the country is the other factor driving the growth of the market in this region.
Germany is projected to dominate the Europe blood collection devices market, holding over 18.9 percent of the market share in 2021. Growth can be attributed to factors, such as increasing medical applications, growing product launches, technological advancements in the biotechnological industry, and the growing prevalence of chronic diseases in the country.
The market in China for blood collection devices is poised to expand at 9.7 percent CAGR through 2031. Demand is projected to rise due to the increase in the number of diagnoses and physical examinations. Additionally, high disposable incomes, favorable government policies, new product launches, and a rise in government funding for life science research will boost the market. Growing product penetration and health awareness are among the major factors driving market growth in China.
The blood collection devices market in India is likely to grow at a CAGR of 8.2 percent. With a market share of over 69.3 percent in 2021, India is expected to spearhead the growth of South Asia. Key factors aiding growth are the rising prevalence of infectious and chronic diseases in the country, an outbreak of contagious diseases, such as Covid-19, and the rising focus on improving overall healthcare infrastructure.
Safe blood and blood products are required for a variety of modern healthcare services. Maintaining blood supply requires selecting high-performance goods. In an ideal world, India’s over 3000 blood banks and present blood bank density of 2.2 blood banks per million people would be sufficient to meet the country’s blood needs. However, because each blood component is utilized for a different health necessity, failure to effectively process and store blood components independently leads to underutilization of blood. Unplanned distribution and blood bank viability issues exacerbate the problem of unmet blood needs.
The Indian blood transfusion sector is regarded as requiring legal oversight because it is not only fragmented and decentralized but also has a diverse ownership pattern. Despite this, there is no well-defined and strict regulatory framework for blood products. Frailty can result from the government’s incapacity to enforce laws, rules, and policies, as well as the personnel who are unaware of or incapable of following quality assurance and/or good manufacturing standards. While the country’s health sector has achieved significant progress in recent decades, there are certain issues that must be addressed because they may impair the timely availability of safe blood products, necessitating improved planning and monitoring of blood transfusion services.