Blood-sample collection is widely considered the most fundamental of procedures in the laboratory setting, remarkable both for its simplicity and its frequency. Blood collection is one of the most high-touch procedures that patients undergo, as clinical laboratory testing influences majority of all medical decisions. Medical device manufacturers offer and continue to improve on a variety of safer products for blood collection.
Recent advances in technology are improving standard of care without requiring either additional manual procedures or a significant investment in staff training or equipment. For instance, launch of a plasma collection card that prevents the change in RBC’s chemical composition at the time of blood collection is an essential development. Glass bottles are now greatly replaced by disposable blood bags for the collection of blood and its components in order to prevent bloodborne pathogen exposure. New devices are using capillary action to draw blood through tiny channels. These disposable devices can replace traditional venipunctures at medical laboratories.
The process of obtaining blood samples has not changed in decades. A skilled health worker has to put a thick needle, which hurts, and patients do not like it. However, recently the FDA has approved a device, which is about the size of a golf ball, to extract blood painlessly. When placed on the upper arm, the device only micro-punctures the upper layers of the skin. It has 30 thin needles that work like a leech to draw blood. As a result, a 100 L of blood is drawn in a matter of two minutes. The company also plans to enhance the capabilities of this device by integrating a digital chip; this could dramatically change how blood is collected. For example, it could time-stamp a blood sample, which would be helpful when patients in remote areas have to mail their samples to a lab.
In 2016, the Indian blood collection equipment and devices market is estimated at Rs. 177.58 crore. Blood bags contributed 63 percent to the market, with 11.53 million bags. Multiple bags are more in demand, and have a 68.3 percent share in value terms, although in quantity terms the share is 40 percent. Triple bags are more popular than their counterparts, double and quadruple in the multiple bag segments. The discerning customer in the metros and large cities is opting for inline filter bags, sales of which in 2016 are estimated at 30,000 units.
The market for blood collection monitors, blood donor couches, and tube sealers is estimated at 1000 units each in 2016. Tube strippers for blood bags and automatic blood component extractors are generally placed at the blood collection facilities by the vendors.
The growth in the market is driven by a host of factors including technological advancements, introduction of innovative products, rise in blood transfusion procedures among the elderly and the chronically ill, and strong promotional campaigns undertaken by various collection agencies for encouraging blood donation. Epidemic rise in cancer and the ensuing spurt in cancer treatment procedures and rapid increase in complex surgical procedures such as open heart and orthopedic surgeries also provide the requisite impetus. Implementation of stringent regulations along with the increased focus of medical devices manufacturers on developing automated, improved solutions to collect, process, and store blood and its components is fueling growth in the market.
The blood collection equipment market is expected to reach Rs. 63,360 crore by 2021 at a CAGR of 5.3 percent from 2016 to 2021, propelled by the increasing number of surgical procedures requiring blood transfusions, growing number of accidental and trauma cases, and rising prevalence of diseases.
Stringent regulations along with the increased focus of medical device manufacturers on developing automated, improved solutions to collect, process, and store blood and its components will continue to fuel growth in the market. Also, emergence of needle free devices and RFID technology and market expansion opportunities in emerging countries are some of the opportunities of this market.
The blood bags segment is estimated to be valued at Rs. 1270 crore by 2016 end, and is expected to reach Rs. 2620 crore by 2024 end. Global consumption of disposable plastic blood bags is expected to exceed 320 million units by 2024 end, increasing at a CAGR of 11.9 percent over the next 5 years.
On the basis of sales channel, the blood bags market is segmented into tender sales and private sales. In 2015, tender sales segment was valued at Rs. 722.56 crore. In terms of volume, tender sales channel segment is expected to expand at a CAGR of 9.9 percent. In 2015, the blood banks end-user segment was pegged at 91 million units of disposable plastic blood bags.
Companies are focusing on developing automated collection devices that minimize the contamination risk associated with blood collection, reduce human intervention, and lower chances of pathogen development. These automated alternatives, which include autologous disposables and devices, have been gaining significant popularity in recent times. Other major technological advancements include development of blood bags with blood collection monitors, integrated filters, as well as tube sealers.
Organic strategies, expansions and acquisitions, and new product launches are some of the strategiesundertaken by key market playersto strengthen and expand their presence in the market. For instance, in 2016, Medtronic established its new Asia Pacific regional headquarter in Singapore. This expansion enabled the company to strengthen its presence in the APAC market. Major global players include AdvaCare Pharmaceuticals, Beckman Coulter, Becton, Dickinson and Company, Fenwal, Grifols International, Medtronic, Haemonetics Corporation, Immucor, Kawasumi Laboratories, MacoPharma, Shanghai Transfusion Technology, Stago, Terumo Corporation, and Terumo BCT.
Most blood collection agencies require a minimum 56-day interval between donations of whole blood to allow hemoglobin levels to return to normal. However, recent studies suggest that the deferral should be lengthened to prevent iron deficiency.
Researchers compared hemoglobin levels and iron parameters over 180 days in 24 new male donors and compared them to 25 regular male donors who had donated more than 10 times. Over the 180-day observation period, regular donors had lower levels of hemoglobin, ferritin, and hepcidin, while erythropoietin and soluble transferrin receptor were higher compared to new donors.
Although hemoglobin indices returned to normal by day 57, both groups of donors had low levels of ferritin at day 57 compared to pre-donation levels. Only 25 percent of new and 32 percent of regular donors had returned to baseline levels. After 180 days, all regular donors and 82 percent of new donors had reached baseline ferritin levels. The study authors suggest ferritin levels may be used to determine personalized donation intervals, or the donation interval should be increased to 180 days to avoid iron deficiency in all donors. More research is needed to confirm these results and investigate trends in female donors.
Since 1947, scientists have successfully tried to improve the experience from the creation of Vacutainer vacuum tubes and standardization of blood collection tubes to dried blood spot sampling. Dried blood sampling ushered in the microsampling technology. This technology has enabled collection of very tiny amounts of blood that are enough to evaluate the drug levels and the biochemistry parameters of blood. A blood micro-sample is a sample of less or equal to 50 l. Samples of 5-20 l are enough for analyzing the blood, plasma, or serum chemical exposure.
Microsampling devices enable accurate and precise collection of a fixed volume of blood while eliminating bias posed by dried blood spotting hematocrit analysis (volumetric blood hematocrit). They require only minimal training and are easier to use. This enables collection of blood from remote locations. Moreover, the blood collected does not require cold storage or biohazard transportation, consequently eliminating associated costs.
In recent future, the market is expected to witness the introduction of the robotic integration in the venipuncture devices. These devices will use a combination of 3-D near-infrared and ultrasound imaging to localize blood vessels under the skin, and a robotic manipulator that orients and inserts the needle into the indicated vessel based on real-time image analysis and force feedback.
What ties together all the new threads in blood collection product design is a desire to minimize pain and discomfort for participants along with prevention of transmission of infectious diseases.
The National AIDS Control Organization (NACO) in collaboration with Government of India has been promoting voluntary blood donation. This will increase the demand for blood collection products such as bags, needles, collection tubes etc. In addition increasing incidence of infectious diseases, accidents, and trauma cases will further lead to an increased demand for these products.