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Leukapheresis is a laboratory procedure to separate white blood cells from a sample of blood which can occur with chronic lymphocytic leukemia (CLL). Leukapheresis is a good treatment option for patients who have very high white blood cell count or to obtain white blood cells for later transplant to treat decrease in white blood cells during chemotherapy. It also helps fightingprostate cancerand other form of cancers.

Earlier, leukapheresis was designed for palliative treatment for leukemia with only limited efficacy. But later as this technique was used for treatment modality for hyperleukocytic acute myeloid leukemia, and now it is also used to collect granulocytes to transfuse into neutropenic patients with bacterial or fungal infections, the growth of adoption of this technique is expected to increase.

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How Leukapheresis is important for CAR or Adaptive Cell Therapy Manufacturing?

Chimeric antigen receptor(CAR) T cell therapymay be offered to people when their cancer comes back. Leukapheresis is the first step in this treatment. Research is going on for this treatment. Researchers want to collect T cells from people who may become eligible for a CAR T-cell study in the future. Leukapheresis is an essential step for CAR therapy or other adaptive cellular therapy products. The procedure is required to develop a streamlined process where patients have to undergo apheresis for development of a CAR cell or other adoptive cell therapy product. Once patient meets the eligibility conditions for one of the NCI CAR clinical cell therapy trials, they will undergo leukapheresis estimated by recipient weight and target cell harvest dose in Department of Transfusion Medicine (DTM). Therefore, need for leukapheresis in CAR therapy is a major factor for the boost in its adoption.

Prevalence of Leukemia Is projected to Boost the Treatment

Cases of leukemia have been increasing significantly. According to American Cancer Society, in 2020, there were 60,530 new cases of all kinds of leukemia which witnessed 23,100 deaths. Acute myeloid leukemia being the most prevalent accounted for 19,940 cases in US. The cancer burden in Europe is estimated to have risen to 2.7 million new cases and 1.3 million deaths in Europe as per the Joint Research Centre in European Union. Therefore, it is expected that the rising cases of leukemia and cancer may pave a way of growth for leukapheresis.

Side Effects of Leukapheresis may restrain the Growth

Like any other medical treatment, leukapheresis also have some risks and side effects which may decline its growth. Hypocalcemia, anemia, local or systematic infections may occur among the patients. Hypocalcemia is an irregular drop of calcium from the body when white blood cells are extracted. The lack of calcium in the body may cause numbness, muscle spasms, etc. Anaemia can also occur due to low count of red blood cells or platelets which may happen during the process. Although, in most of the cases, the effect of anaemia is mild. Local or systematic infections, redness and bruising at the vein puncture may also happen. All these side effects can cause the patients to decline the treatment if it is not very important.

Alternative Technologies may Cause Hindrance in Market Boost

As per the research article by pnas.org, clinical leukapheresis can concentrate mononuclear cells from almost the entire blood volume, but such large numbers and cell concentrations are incompatible with such technology. Therefore, an ultra-high throughput microfluidic chip, CTC-iChip rapidly sorts through an entire leukapheresis product of over 6 billion nucleated cells, increasing the CTC isolation capacity by two orders of magnitude. CTC based liquid biopsies provide cancer diagnostics, treatment selection, and response monitoring. Therefore, these factors may cause restrain to the leukapheresis market during the forecast period.

Competitive Landscape

Prominent players in the market include Caltag Medsystems Limited (UK), BioIVT (US), Asahi Kasei Medical Co. Ltd. (Japan), Terumo BCT, Inc. (US), MEDICA S.p.A (Italy), StemExpress, LLC (US), AllCells, LLC (US), Charles River Laboratories (US), Lonza Group AG (Switzerland), Macopharma SA (France), PuriBlood Medical Co. Ltd. (Taiwan), Miltenyi Biotec (Germany), ZenBio (US), Discovery Life Sciences (US), Intelligent Tissue Group (US), Haemonetics Corporation (US), etc.

AllCells, LLC, a leading provider of prmary cells supporting biomedical research announced in September 2020 about the addition of Cyropreserved Leukppaks to their extensive product portfolio. The primary cells are of high quality due to on-site facilities. These cells are cryopreserved using GE Healthcares GMP-compliant VIA freeze quad controlled rate freezer which is capable of consistently high post recovery and viability. Cryopreserved cells are flexible and thus, experiments on them can be done as per the schedule without waiting on delivery of fresh cells.

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Novartis in October 2020 announced the authorization from Japans Ministry of Health, labour and Welfare for a site for manufacturing of commercial CAR-T cell therapy for patients in Japan. The commercial is the first to get approval in Asia. The companys aim is to being treatment closer to patients. Kymriah is the first ever FDA approved CAR-T cell therapy, and the first ever CAR-T to be approved in two distinct indications. Kymriah is currently approved for the treatment of pediatric and young adults of acute lymhoblastic leukemia.

Haemonetics Corporation, Boston based company have made an agreement to sell its Fajardo, Puerto Rico manufacturing operations to filter GVS. The company will retain all intellectual property rights to its proprietary blood filters which are currently manufactured at their Fajardo facility. The company has offered exclusive rights to manufacture and supply the blood filters. Thus, Fajardo facility will become GVS employees.

Regional Outlook

The major contributors towards the growth of leukapheresis include, increasing incidences of leukemia, growing demand for leukapheresis procedures, research applications, growing demand for leukopaks for research applications, etc.

North America is expected to hold the dominating share owing to rise in geriatric population, increasing cases of leukemia. According to Leukemia and Lymphoma Society, approximately every 3 minutes, one person is diagnosed with leukemia in US and in 9 minutes someone dies. According to American Cancer Society, 60,530 new cases of all kinds of leukemia were diagnosed in 2020 which witnessed 23,100 deaths. Acute myeloid leukemia is the most prevalent and accounted for 19,940 cases in US. North Ameirca is one of the leading countries to record deaths due to cancer and leukemia. Furthermore, research and development and new technological advancements are another factor for the market growth.

European region is also expected to have a significant growth during the forecast period 2021-2031. The acute promyelocytic leukemia which is a rare disease also accounted for 2.5 per million person in Italy, 1.39 per million in Spain, 0.54 per million in Great Britain, 0.4 per million in France according to frontiers.org. Growing AML cases are also the concerning topic, it is expected that the cases will increase by 17% by 2027, therefore increasing the growth of its treatment options. All these factors offer a contribution towards the growth of increasing leukapheresis market.

In Asia, China and Pakistan account for 36.2% and 43.5% in AML cases. Increasing medical infrastructure, emerging technologies, increasing trials and investments due to rising geriatric population, and cases of leukemia is paving the way for market growth. As per Globocan, over 20,000 new cases of childhood blood cancer are detected in India of which almost 15,000 cases are of leukemia. China is expected to witness increase over 14,000 cases of acute lymphocytic leukemia by 2029, therefore, rising incidences are projected to grow the adoption of leukapheresis.

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Leukapheresis Market Dynamic Demand and Drives with Forecast to 2031 - Digital Journal