The leukapheresis market is expected to register a CAGR of nearly 7.5% during the forecast period.
The COVID-19 pandemic positively impacted the market as leukapheresis is a laboratory procedure in which white blood cells, including leukemia cells, are separated from the blood. One symptom of COVID-19 is a reduction in the number of cells called lymphocytes in the blood. Lymphocytes are a type of white blood cell that fights infections. With fewer lymphocytes, the body cannot effectively fight back against SARS CoV-2, the virus that causes COVID-19. In May 2020, the National Institutes of Health Clinical Center (CC) (National Institute of Allergy and Infectious Diseases (NIAID) initiated a clinical study to identify how SARS-CoV-2 affects lymphocytes, the immune, and the blood clotting system using the leukapheresis technique by collecting white blood cells from the patients who recovered from COVID-19. Currently, the study is enrolling participants and being conducted at MedStar Georgetown University Hospital and the National Institutes of Health Clinical Center. Also, in April 2020, the combination of Terumo Blood and Cell Technologies’ centrifugal apheresis system and the adsorption cartridge of partner company Marker Therapeutics (Switzerland) received Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) for treating COVID-19. Thus, considering the significant use of leukapheresis in COVID-19, the market is expected to have steady growth during the forecast period.
The rising incidence of leukemia disorders is expected to boost the demand by increasing the usage rates of leukapheresis machines and kits. Incidence of leukemia is the highest among white people and the lowest among Chinese, Japanese, and Koreans in both men and women. It is the highest among men than women. Some of the signs and symptoms of leukemia are fatigue and weakness, bleeding from gums, trauma, bruising, fever, and weight loss.
According to the Leukemia and Lymphoma Society (2020), every 3 minutes, one person in the United States is diagnosed with blood cancer. According to the North American Association of Central Cancer Registries (NAACCR), in 2022, the country is estimated to record 6,660 cases of acute lymphocytic leukemia. According to the American Cancer Society, 60,530 were diagnosed with leukemia in 2020. In addition, according to Cancer Australia (August 2020), by the end of 2020, 4,527 new cases of leukemia were diagnosed in Australia, including 2,734 men and 1,793 women, compared to 1,958 total diagnosed cases in 2019. Hence, the rising burden of leukemia is creating the need for advanced therapeutics based on leukapheresis for treatment, which is expected to drive the market’s growth over the forecast period.
However, the high cost of therapeutic leukapheresis and stringent regulatory issues for donor recruitment are expected to hinder the growth of the market during the forecast period.
Apheresis devices are used to collect and separate blood components for therapeutic and donation procedures. The devices are inbuilt with some safety units, such as an optical fluid level detector, ultrasonic air-bubble detectors, dry heat fluid warmers, and pressure sensors.
COVID-19 is likely to have a profound impact on the segment studied. This technique is now widely used to treat COVID-19 as a plasma therapy. For instance, in June 2020, medical equipment that carries out the apheresis procedure was installed at the Government Medical College Hospital t near Thrissur, Kerala (India) and the technique was used for the first time in India to administer plasma to a 51-year-old man who was suffering from COVID-19.
Additionally, in August 2020, the Drugs Controller General of India (DGCI) approved the use of an apheresis machine to extract blood plasma in Goa for critically ill COVID-19 patients. Furthermore, in April 2020, Terumo BCT Inc. and Marker Therapeutics AG received the United States Food and Drug Administration approval for the Emergency Use Authorization (EUA) of Terumo BCT’s Spectra Optia Apheresis System combined with Marker Therapeutics’ D2000 Adsorption Cartridge to treat COVID-19 patients aged 18 years or above. Hence, such approvals would increase the market growth in the upcoming future.
The expansion of key market players is another reason for the market’s growth. For instance, in January 2020, Fresenius Kabi expanded the transfusion and apheresis disposables plant in the Dominican Republic. Hence, due to such factors, along with rising technological advancements, the apheresis device segment is expected to witness growth during the forecast period.
North America is expected to hold a large market share in the leukapheresis market due to the rising geriatric population and increasing prevalence and incidence of leukemia in the region. According to the North American Association of Central Cancer Registries (NAACCR), in 2022, approximately 60,650 people are expected to be diagnosed with leukemia.
According to the Terry Fox Research Institute, an estimated 21,700 people were diagnosed with blood cancers in Canada in 2019. These cancers affect people of all ages, and survival rates are highly dependent on the type of blood cancer. It is estimated that 7,500 Canadians die from blood cancers, making them the third leading cause of cancer-related deaths in the country.
Moreover, recent developments by market players are increasing market growth. For instance, in January 2019, Key Biologics LLC and Cascade Regional Blood Services (CRBS) entered into a multi-year agreement to provide researchers in academia, pharma, and biotech with vital blood products and materials for the research and product manufacturing efforts. The partnership focuses on the collection of mononuclear cells (MNCs) by leukapheresis and includes joint donor recruitment, product distribution, and marketing in the United States. The renovation project will include a new 8,000 square foot blood donation center with 12 whole blood donor beds, 15 apheresis donor beds (used for platelet and plasma donations), two leukapheresis donor beds (used for white blood cell donations) and ten health history rooms. The apheresis donor room, where platelets are collected, will house the most apheresis machines of any of the more than 170 Red Cross donation centers in the nation.
Thus, such factors are likely to boost the North American leukapheresis market substantially during the forecast period.
The leukapheresis market is consolidated, competitive, and consists of a few major players. A few major players are currently dominating the market in terms of market share. New product developments, acquisitions, and strategic alliances are some strategies adopted by industry players. Some companies currently dominating the market are Asahi Kasei Medical Co. Ltd, Haemonetics Corporation, Terumo BCT Inc., STEMCELL Technologies Inc., Macopharma, Fresenius SE & Co. KGaA, HemaCare, Key Biologics LLC, AllCells, and StemExpress.
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The COVID-19 pandemic positively impacted the market as leukapheresis is a laboratory procedure in which white blood cells, including leukemia cells, are separated from the blood. One symptom of COVID-19 is a reduction in the number of cells called lymphocytes in the blood. Lymphocytes are a type of white blood cell that fights infections. With fewer lymphocytes, the body cannot effectively fight back against SARS CoV-2, the virus that causes COVID-19. In May 2020, the National Institutes of Health Clinical Center (CC) (National Institute of Allergy and Infectious Diseases (NIAID) initiated a clinical study to identify how SARS-CoV-2 affects lymphocytes, the immune, and the blood clotting system using the leukapheresis technique by collecting white blood cells from the patients who recovered from COVID-19. Currently, the study is enrolling participants and being conducted at MedStar Georgetown University Hospital and the National Institutes of Health Clinical Center. Also, in April 2020, the combination of Terumo Blood and Cell Technologies’ centrifugal apheresis system and the adsorption cartridge of partner company Marker Therapeutics (Switzerland) received Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) for treating COVID-19. Thus, considering the significant use of leukapheresis in COVID-19, the market is expected to have steady growth during the forecast period.
The rising incidence of leukemia disorders is expected to boost the demand by increasing the usage rates of leukapheresis machines and kits. Incidence of leukemia is the highest among white people and the lowest among Chinese, Japanese, and Koreans in both men and women. It is the highest among men than women. Some of the signs and symptoms of leukemia are fatigue and weakness, bleeding from gums, trauma, bruising, fever, and weight loss.
According to the Leukemia and Lymphoma Society (2020), every 3 minutes, one person in the United States is diagnosed with blood cancer. According to the North American Association of Central Cancer Registries (NAACCR), in 2022, the country is estimated to record 6,660 cases of acute lymphocytic leukemia. According to the American Cancer Society, 60,530 were diagnosed with leukemia in 2020. In addition, according to Cancer Australia (August 2020), by the end of 2020, 4,527 new cases of leukemia were diagnosed in Australia, including 2,734 men and 1,793 women, compared to 1,958 total diagnosed cases in 2019. Hence, the rising burden of leukemia is creating the need for advanced therapeutics based on leukapheresis for treatment, which is expected to drive the market’s growth over the forecast period.
However, the high cost of therapeutic leukapheresis and stringent regulatory issues for donor recruitment are expected to hinder the growth of the market during the forecast period.
Key Market Trends
Apheresis Device Segment is Expected to Hold a Significant Share in the Leukapheresis Market
Apheresis devices are used to collect and separate blood components for therapeutic and donation procedures. The devices are inbuilt with some safety units, such as an optical fluid level detector, ultrasonic air-bubble detectors, dry heat fluid warmers, and pressure sensors.
COVID-19 is likely to have a profound impact on the segment studied. This technique is now widely used to treat COVID-19 as a plasma therapy. For instance, in June 2020, medical equipment that carries out the apheresis procedure was installed at the Government Medical College Hospital t near Thrissur, Kerala (India) and the technique was used for the first time in India to administer plasma to a 51-year-old man who was suffering from COVID-19.
Additionally, in August 2020, the Drugs Controller General of India (DGCI) approved the use of an apheresis machine to extract blood plasma in Goa for critically ill COVID-19 patients. Furthermore, in April 2020, Terumo BCT Inc. and Marker Therapeutics AG received the United States Food and Drug Administration approval for the Emergency Use Authorization (EUA) of Terumo BCT’s Spectra Optia Apheresis System combined with Marker Therapeutics’ D2000 Adsorption Cartridge to treat COVID-19 patients aged 18 years or above. Hence, such approvals would increase the market growth in the upcoming future.
The expansion of key market players is another reason for the market’s growth. For instance, in January 2020, Fresenius Kabi expanded the transfusion and apheresis disposables plant in the Dominican Republic. Hence, due to such factors, along with rising technological advancements, the apheresis device segment is expected to witness growth during the forecast period.
North America is Expected to Hold a Significant Share in the Market During the Forecast Period
North America is expected to hold a large market share in the leukapheresis market due to the rising geriatric population and increasing prevalence and incidence of leukemia in the region. According to the North American Association of Central Cancer Registries (NAACCR), in 2022, approximately 60,650 people are expected to be diagnosed with leukemia.
According to the Terry Fox Research Institute, an estimated 21,700 people were diagnosed with blood cancers in Canada in 2019. These cancers affect people of all ages, and survival rates are highly dependent on the type of blood cancer. It is estimated that 7,500 Canadians die from blood cancers, making them the third leading cause of cancer-related deaths in the country.
Moreover, recent developments by market players are increasing market growth. For instance, in January 2019, Key Biologics LLC and Cascade Regional Blood Services (CRBS) entered into a multi-year agreement to provide researchers in academia, pharma, and biotech with vital blood products and materials for the research and product manufacturing efforts. The partnership focuses on the collection of mononuclear cells (MNCs) by leukapheresis and includes joint donor recruitment, product distribution, and marketing in the United States. The renovation project will include a new 8,000 square foot blood donation center with 12 whole blood donor beds, 15 apheresis donor beds (used for platelet and plasma donations), two leukapheresis donor beds (used for white blood cell donations) and ten health history rooms. The apheresis donor room, where platelets are collected, will house the most apheresis machines of any of the more than 170 Red Cross donation centers in the nation.
Thus, such factors are likely to boost the North American leukapheresis market substantially during the forecast period.
Competitive Landscape
The leukapheresis market is consolidated, competitive, and consists of a few major players. A few major players are currently dominating the market in terms of market share. New product developments, acquisitions, and strategic alliances are some strategies adopted by industry players. Some companies currently dominating the market are Asahi Kasei Medical Co. Ltd, Haemonetics Corporation, Terumo BCT Inc., STEMCELL Technologies Inc., Macopharma, Fresenius SE & Co. KGaA, HemaCare, Key Biologics LLC, AllCells, and StemExpress.
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Table of Contents
1 INTRODUCTION
4 MARKET DYNAMICS
5 MARKET SEGMENTATION (Market Size by Value - USD million)
6 COMPETITIVE LANDSCAPE
Companies Mentioned
A selection of companies mentioned in this report includes:
- Asahi Kasei Medical Co. Ltd
- B. Braun Melsungen AG
- BioIVT LLC
- Fresenius SE & Co. KGaA
- Haemonetics Corporation
- Kaneka Corporation
- Cellero LLC
- Macopharma
- Medica SPA
- Miltenyi Biotec
- STEMCELL Technologies Inc.
- StemExpress
- Sumitomo Bakelite Company Limited (Kawasumi Laboratories Inc.)
- Terumo BCT Inc.
Methodology
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