Global Capillary Blood Collection and Sampling Devices Market

Blood collection has been around for decades. When it began, the technique was used to obtain blood from infants for genetic screening. But now, in today's world, with advancements in the capillary blood collection technique, it is used for a wide variety of the hematology test profiles such as blood smears for manual white blood cell count, complete blood count (CBC), hemoglobin & hematocrit (H&H), electrolytes, neonatal blood gasses, neonatal bilirubin, neonatal screening, and glucose tests.

The global capillary blood collection and sampling devices market is expected to witness its worth around USD 2,539.66 million in 2022 due to increased demand for safe blood collection technologies, increased prevalence of chronic diseases, and rising availability of POC diagnostics, favorable medical devices regulations, among others.

Capillary blood collection devices are defined as devices that are used for capillary blood withdrawal. Capillary blood can be obtained by puncturing in finger, earlobe, or heel. It can also be performed by giving an incision to the skin. Capillary blood collection and sampling procedure have gained wide attention as it withdraws an accurate amount of blood and reduces the chances of anemia. Nowadays, the volumetric microsampling technique has gained attention for capillary blood collection. Moreover, new technological advancements are taking place to fulfill the need of physicians and consumers.

Various companies are introducing new products and forming partnerships with local vendors and manufacturers to expand their business in the global capillary blood collection and sampling devices market.

For Instance,

• In March 2020, BD and BioMedomics, a privately held, North Carolina-based clinical diagnostics company, announced that they had developed a rapid test to check the current exposure to COVID 19 within 15 minutes at home. This is a novel testing device and will lead to increased revenue generation

Major Impact of COVID-19 on Global Capillary Blood Collection and Sampling Devices Market

The COVID-19 pandemic has posed challenges and several opportunities within the global market. During the pandemic, supply chain disruptions of medical devices/equipment and essential medical supplies were prominent due to travel and trade restrictions all over the globe.

But, the point-of-care (POC) testing devices segment sees prominent growth due to the virus outbreak. As the virus was spreading, the number of infected patients increased rapidly, resulting in increased blood collection through different safety measures for antibody testing.

Global Capillary Blood Collection and Sampling Devices Market Segments

Global Capillary Blood Collection and Sampling Devices Market DROC Analysis

Drivers-

Increased prevalence of chronic diseases-

Chronic diseases are a global healthcare problem. The change in lifestyle along with unhealthy diet, physical inactivity, and tobacco use is increasing the burden of chronic diseases worldwide.

For instance,

• According to the centers for disease control and prevention, 6 in 10 adults in the U.S. are suffering from a chronic disease, and it is the leading driver of USD 3.5 trillion in annual health care costs in the U.S.
• According to a study, every fifth person in India suffers from chronic disease, and more than 6 out of 10 people die from non-communicable diseases. According to National Health Systems Resource Centre (NHSRC), the burden of non-communicable diseases is 53%
• According to WHO, 85% of the deaths in the U.K are due to chronic diseases, and the number of deaths was 4, 88,000

Global distribution of chronic diseases death (in %)-

Source- WHO

The lower-middle-income countries are the worst hit by chronic diseases; therefore, the disease also becomes a financial burden for developing countries. The disease must be diagnosed accurately for early detection and timely treatment of the disease. For this, efficient blood collection and sampling are necessary, creating a demand for technologically advanced capillary blood testing devices. Thus, the increased prevalence of infectious and chronic diseases acts as a driver for the market.      

Rising number of geriatric population-

The older adult population is expanding, living longer but with multiple chronic conditions. The pace of aging population expansion is dramatic.

For instance,

• According to WHO, by 2050, the population of people who are 60 and above is expected to be 2 billion from 900 million in 2015
• According to Japan's Internal Affairs and Communications Ministry, the population of people aged 65 years and above were 35.88 million in 2019, up by 3,20,000 from the previous year
• According to a demography study of Italy, there were 21.69% of the population in 2019 was 65 years and above and the ratio of elderly dependency was 35

Increase in demand for safe blood collection technologies-

Clinical diagnostics are fundamental to various medical fields and form an important part of healthcare delivery. Blood sample collection is critical to laboratory activities as millions of blood samples are collected for chemical and hematological testing every year to diagnose diseases.

The unsafe practice of blood collection or phlebotomy can cause severe adverse effects in patients, such as fainting, pain at the site of puncture, nerve damage, and in extreme cases, hematoma. Due to the lack of skilled professionals, the poor venipuncture practice has injured anatomical structures in the vicinity of the point of needle entry.

Moreover, capillary blood testing requires a smaller amount of blood volume and can be performed easily and quickly. It is preferred over venous sampling in pediatrics to avoid blood volume and reduce the risk of anemia. Therefore, 56% of the invasive procedures performed during the neonatal period are capillary blood sampling. It is also preferred by people who have severe burns or are anxious about blood testing and those who have inaccessible or fragile veins.

Thus, the advantages of capillary blood sampling over venous blood sampling have made this a preferred choice of blood sampling by physicians and patients. Therefore, this creates a demand for better and more efficient capillary collection devices; hence, increased demand for safe blood collection technologies acts as a market driver.

The rising availability of POC diagnostics-

Point of care testing is diagnostic testing performed at patients' bedsides in a home setting. Moreover, it can be performed anywhere at any time. Therefore it is commonly known as bedside testing. Earlier testing was limited to laboratories and hospitals, where the specimen was sent, and it takes hours to days to obtain the sample.

This technique allows physicians to achieve lab-quality diagnostic results within minutes rather than days. Not only is it quick, but it also allows the clinicians to enable quality and effective patient care in the comfort of the patient's home. Due to its advantages, POC diagnostics is on the rise.

For instance,

• According to various reports, the total worth of the global diagnostics market was USD 40-45 billion, out of which the contribution of POC diagnostics is USD 12-13 billion
• The U.S. dominates the POC market, with a share greater than 50%, while 12% of IVDs in the U.S. are POC diagnoses
• According to an investment bank Morgan Stanley review, 37% of the USD 3 billion POC market is dedicated to infectious disease testing

With the rise in health awareness and incidence of infectious disease, there has been a rise in the demand for POC testing. Conventional arterial and venous blood collection methods are painful, invasive, and have a higher risk of needlestick injuries and contamination if not performed by skilled people. Whereas the capillary blood collection method is minimally invasive, causes less pain, and also has very few side effects. Also, it does not require skilled professionals to carry out this procedure; hence it is a point care testing technique. With the rise in POC testing, capillary collection devices have also been advanced.

For instance,

• Neoteryx, LLC has developed a Mitra cartridge device that is used for capillary blood sampling anywhere, anytime, and by anyone
• Elabscience, Inc. is manufacturing and distributing COVID-19 IgG/IgM Rapid Test for testing COVID-19 symptoms

Less time consumption and enhanced efficiency lead to better healthcare performance, resulting in greater economic advantages for healthcare providers and patients. Thus, techniques like capillary blood sampling, which can be used at the point of care, are preferred. Therefore, the rising availability of POC diagnostics acts as a driver for the market.

Increasing demand for single-use lancets-

Lancets are small medical equipment used for capillary blood sampling; they have a double-edged blade or needle for making punctures to take out small blood. These are disposable and cost-effective ways to draw blood for medical testing.

It is used in the medical field to draw blood to test for diabetes, cholesterol, anemia, and other medical conditions. With the increasing urbanization and changed lifestyle, there is an increasing prevalence of diabetes, cholesterol, and anemia, among others.

For instance,

1. WORLD-AGE STANDARDIZED PREVALENCE OF DIABETES AMONG AGES 20–79 YEARS IN INTERNATIONAL DIABETES FEDERATION (IDF) REGIONS, RANKED BY 2019 WORLD-AGE STANDARDIZED PREVALENCE ESTIMATES (IN %)

Source: Diabetes Research and Clinical Practice

This shows an increased prevalence of diabetes worldwide; therefore, there will be a requirement for more single-use lancets. Also, they are very easy to use, and regular blood glucose monitoring can be done at home. Thus, increasing demand for single-use lancets acts as a driver for the market.

Opportunities

Favorable medical device regulations-

The U.S Food and Drug Administration regulates all medical devices in the U.S. Any medical device manufactured, relabelled, imported, or repackaged by any company to sell in the U.S. has to meet FDA regulations.

A three-tiered classification system is followed for the regulation of medical devices. The FDA has around 1700 generic devices, which are further categorized into 16 medical panels, which are additionally assigned to the three regulatory classes.

Blood specimen collection devices like tubes, vials, serum separators, and systems are classified under class 2. These devices have moderate to high risks to patients and users. 43% of the medical devices fall under this category.

The lancets are classified as class 1 devices and do not require a premarket notification application and FDA clearance before marketing into the U.S. markets, according to 21 CFR parts 862- 892. Therefore, they do not have to follow very strict regulations; thus, favorable medical device regulations act as an opportunity for the market.

Product innovation and technological advancements in capillary blood collection devices-

Blood collection is a step of utmost importance for healthcare delivery. 70-80% of the clinical decisions are made on blood sample analysis. With the growing innovation trend in blood collection, many companies are using safe, easy, and more efficient ways to collect blood samples.

Capillary blood collection is an ideal technique for pharmacy clinics. This method is preferred over venipuncture due to its ease of use and safety; moreover, it eliminates the need for skilled technicians. However, one of the disadvantages of fingersticks is that there are variations between the droplets of blood. This can be overcome by the launch of novel and innovative products.

For instance,

• Seventh Sense Biosystems launched a product named TAP, the world's first device that uses a push button to draw blood. This device is placed on the upper arm, and the blood is withdrawn with a push of a button. This provides an easier and cost-effective way to high quality lab testing

Challenges

Product recalls-

Blood collection devices are instrumental to the healthcare industry. If these products are not safe or are defective, they can lead to harmful effects. Hence, FDA gives out strict regulations regarding the use of these products. Despite the strict laws, there are some cases where the product has been launched in the market and is recalled later for the safety of people from its hazardous effects.

For instance,

•  In 2016, Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 for use with blood collection. Siemens Healthcare Diagnostics Inc has recalled multi-cap glass and Multicap-S plastic capillaries. The product was recalled because capillary caps may not attach to the capillary and result in breakage of glass capillary

Owen Mumford has recalled its disposable single-use lancing systems for taking capillary blood samples. This product was recalled because there was a failure in the retraction of the needle after firing; this could lead to needle stick injuries

BD recalled its Microcontainer collection tubes because they have damaged reservoirs. It may cause an insufficient amount of blood sample collection and disproportional blood-to-additive ratio, hence producing inaccurate results

Product recalls posing an obstacle to the medical device manufacturers as these recalls cost too much to the manufacturers. Moreover, these manufacturers also have to provide some compensation which again costs a lot. Due to the high costs and the defamation of the company name in the market, product recalls can be seen as a challenge for the market

Use of venipuncture, an alternative to capillary blood collection procedure-

Capillary blood collection has gained much attention due to its minimally invasive nature and the appropriate amount of blood collection feature, among others. However, this venipuncture is an alternative that is also used for blood collection. Venipuncture is the process of blood extraction from the vein using a needle or a syringe.

Venipuncture has several advantages over capillary blood collection procedures, which are shown below:

• If multiple tests are needed for diagnosis of a condition, then generally venepuncture is used for blood collection
• Venipuncture allows blood storage for future use, using vacutainer tubes
• Suitable veins can be found at most of the body's sites; however, that is not possible with capillary blood collection

This signifies that the existence of an alternative technique for blood collection acts as a challenge for the growth of the market

Regional market analysis-

• North America is expected to dominate the global capillary blood collection and sampling devices market, and Asia-Pacific is expected to grow with the highest CAGR in the forecast period
• The blood sampling devices segment is expected to account for the largest share of the global capillary blood collection and sampling devices market

Market Players in the Global Capillary Blood Collection and Sampling Devices Market

Some of the major market players operating in this market are Akacia Medical, HTL-STREFA, Sarstedt AG & Co. KG, Thermo Fisher Scientific Inc., BD, B. Braun Melsungen AG, Cardinal Health, Terumo Medical Corporation, Chembio Diagnostic Systems, Inc., Owen Mumford Ltd, Neoteryx, LLC, Greiner Bio-One International Gmbh, Improve Medical, KABE LABORTECHNIK Gmbh, Nipro Europe Group Companies (A Subsidiary Of Nipro Corporation), Radiometer Medical Aps (A Subsidiary Of Danaher), FL MEDICAL S.R.L., Surescreen Diagnostics Ltd, F. Hoffmann-La Roche Ltd, Ypsomed AG, Creative Diagnostics, Elabscience, Inc., Mologic, Tasso, Inc., Abbott, Vitrex Medical A/S, Disera Medical Equipment Logistics Industry And Trade Inc., Accubiotech Co., Ltd., CHENGDU RICH SCIENCE INDUSTRY CO., LTD, And BIOMEDOMICS INC., among Others.

Top Player

Cardinal Health-

Cardinal Health, headquartered in Ohio, U.S. offers services and complementary products to manufacturers and healthcare providers, including healthcare product manufacturing and automated dispensing systems. More than 49,500 employees around the Americas, Asia-Pacific, Europe, Middle East, and Africa. The company was founded in 1971. The company is a distributor of pharmaceuticals, a global manufacturer and distributor of medical and laboratory products, and a provider of performance and data solutions for healthcare facilities. For the fiscal year 2021, Cardinal Health reported annual revenue of $162.9 billion, an increase of 5.1% over the previous fiscal cycle.

The company has subsidiaries like Abilene Nuclear, LLC (Delaware), Allegiance 1, LLC (Delaware), Almus Pharmaceuticals Singapore Pte. Ltd. (Singapore), C. International, Inc (Ohio), among others.