Therapeutic Apheresis Market Size, Share, Industry, Forecast and outlook (2024-2031)

Therapeutic Apheresis Market is segmented By Procedure (Leukapheresis, Plasmapheresis, Plateletpheresis, Erythrocytapheresis, Others), By Application (Hematology, Neurology, Oncology, Nephrology, Others), By Technology (Centrifugation, Membrane filtration), By End-user (Blood banks, Hospitals, Specialty clinics), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023- 2030

Therapeutic Apheresis Market

Therapeutic Apheresis Market size was valued at USD 1,847.30 million in 2021 and is estimated to reach at a compound annual growth rate (CAGR) of 8.50% over the forecast period 2023- 2030. Therapeutic apheresis is an extracorporeal treatment that removes blood components (plasma and cellular components) from a patient's blood to treat conditions where a pathogenic substance in the blood is causing morbidity.

Therapeutic Apheresis Market Summary

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Therapeutic Apheresis Market Dynamics and Trends

The global therapeutic apheresis market growth is driven by the rising technological advancements, growing demand for blood plasma in biopharmaceutical companies, increasing incidence of hematological disorders, and increasing FDA approvals are among the key factors driving the growth of the global therapeutic apheresis market.

The rising technological advancements is expected to drive the global therapeutic apheresis market during the forecast period.

Advances in apheresis device technology have led to the development of customized devices based on the needs of the patient. The major manufacturers are investing in research and development to create innovative apheresis systems that are automated, patient-friendly, and provide accurate results. Blood collection systems now include automated cell processors and blood collection devices. These devices help to optimize blood usage by separating the required blood components rather than the entire blood. Vendors are selling a variety of cell separators that separate blood components using microfiltration and centrifugation technologies.

Blood cell separators of the next generation are also available on the market. The Spectra Optia apheresis system from Terumo BCT, for instance, is a popular next-generation cell separator. An automated interface management system and ready-to-use tubing sets make up the equipment. These two features aid in the reduction of blood component processing and separation time, as well as making the donation process more comfortable for blood donors. Cell separator technology has advanced to the point where it can now control the anticoagulant volume, change the blood volume on the fly, and collect blood from multiple donors in one sitting.

For instance, on 11th March 2022, the new plasma collection system developed by Terumo Blood and Cell Technologies (Terumo BCT), was approved by the US Food and Drug Administration (FDA). Rika is a next-generation automated technology that focuses on plasma center employees and donors' experiences. It has safety features to reduce operator error and collects plasma in under 35 minutes. Also, on March 28th, 2019, Kaneka Pharma America received the FDA approval for the modification of the indications for the use (IFU) of Kaneka’s LIPOSORBER LA-15 system. This approval will allow more US patients to use the apheresis treatment to lower low-density lipoprotein cholesterol (LDL-C) levels.

High cost of apheresis devices & procedures are likely to hinder the market growth

The high cost of apheresis devices and procedure is one of the major factors hindering the growth of the therapeutic apheresis. Efficiency issues must be addressed in addition to issues of health status or other health outcome-related effects (i.e., safety, efficacy, and effectiveness) of apheresis.

The cost of providing apheresis therapy is a topic that almost everyone is concerned about. The costs of providing this therapy are a concern by almost any standard. The cost issue has sparked the most debate about the technology, and it is the most obvious reason why apheresis is being scrutinized by a growing number of health care professionals.

The cost of a single treatment session has been a source of concern, as has the dramatically increased use of apheresis for therapeutic purposes in recent years.

Cost estimates for individual apheresis treatments are widely available but range from $400 to $1,200. The initial cost of a blood cell separator will vary from $19,000 to $32,000, and disposable sets produced by manufacturers will cost between $40 and $90 per treatment. A physician-director, trained staff, and space (overhead expense) are also required ($27 to $300).

Plateletpheresis is preferred over platelets pooled from multiple donors because it yields more platelets from a single donor and reduces the risk of infections, alloimmunization, and refractoriness associated with multiple random donors. However, the high cost of the machine and the unit cost of the procedure have limited the use of this technology. As a result, the high capital investment and costs associated with devices and procedures are a major stumbling block to the market's growth.

Industry Analysis

The global therapeutic apheresis market provides in-depth analysis of the market based on various industry factors such as porter’s five force analysis, supply chain analysis, regulatory analysis, technological advancements, and therapeutic apheresis services, etc.

Therapeutic Apheresis Market Segmentation Analysis

The apheresis devices segment is expected to grow at the fastest CAGR during the forecast period (2022-2029) 

An apheresis machine is a device that takes blood from a patient or a donor and separates it into its constituent parts plasma, platelets, white blood cells, and red blood cells.

The growing demand for apheresis machines is attributed to the segment's growth due to their durability and widespread use in transfusion treatment. Furthermore, the availability of higher-class machines for the efficient separation of various blood and plasma components will boost segment growth. The presence of key players who manufacture apheresis devices is expected to drive market growth. Process leukoreduction is the ability of modern apheresis devices to collect concentrates of platelets or RBCs that are leukoreduced during collection. Several devices have been granted permission to collect one or more components.

For instance, Fresenius Kabi's Amicus apheresis system is a widely used apheresis system for preparing leukoreduced platelets. The device incorporates active interface control, autoelutriation, and fluid flow dynamics to achieve leukoreduction. An optical interface detector is placed within the separation chamber to monitor changes in the platelet interface. The system recirculates some of the donor plasma into the interface to separate platelets from leukocytes by elutriation. Plasma pumped through the interface dislodges platelets but not leukocytes into the collection path. The platelet collection path runs in the opposite direction as the flow path for returning RBCs and plasma to the donor, allowing for more separation between donor platelets and donor leukocytes.

Therapeutic Apheresis Market Geographical Share

North America region holds the largest market share of the global therapeutic apheresis market

North America accounted for the largest share of the apheresis market. The large share of this region can be attributed to easier access to advanced blood collection technologies, the presence of established healthcare infrastructure, and the increasing presence of leading apheresis companies in the country.

USA is the major market in the region. The market growth in the United States can be attributed to the rising geriatric population. As the population ages, more cancer cases and chronic diseases are likely to be identified.  This factor will boost the growth of the market in the region.

The growing burden of various ailments related to blood such as kidney diseases, metabolic diseases, cancer, and neurological disorders, the presence of established healthcare infrastructure, and high patient awareness levels are the major factors driving the growth of the studied market in North America. According to the Leukemia & Lymphoma Society (LLS), approximately every three minutes, one person in the United States is being diagnosed with blood cancer. Approximately 178,520 people in the United States were diagnosed with leukemia, lymphoma, or myeloma in 2020. The new cases of leukemia, lymphoma, and myeloma accounted for 9.8% of the total 1,898,160 new cancer cases diagnosed in the United States in 2021. The high incidence of target diseases thus drives the studied market growth.

Additionally, the increasing product approvals and presence of most of the major players in the region play a vital role in the growth of the studied market. For instance, in October 2020, Haemonetics Corporation received the Food and Drug Administration approval for its NexSys PCS system with Persona technology for plasma collection based on an individual donor's body composition. Thus, the aforementioned factors are associated with the significant growth of the apheresis market in North America over the forecast period.

COVID-19 Impact on Therapeutic Apheresis Market

In the beginning stage the COVID-19 pandemic significantly disrupted blood collection and usage. Demand for blood products became unpredictable, particularly in the months following the March 2020 lockdown. Blood drives were cancelled in the early months of the pandemic, donors stopped showing up, and hospitals reduced elective surgeries. During the COVID-19 pandemic, blood centres were also challenged to collect COVID-19 convalescent plasma (CCP). In the United States, government agencies national and regional blood centres pooled resources to collect an unprecedented 500,000 units of CCP. Blood centres continued to collect whole blood, platelets, plasma, and red blood cells (RBCs) to meet the medical needs of non-COVID-19 patients while CCP took centre stage. The blood centre saw a 52 percent drop in RBC demand and a 30 percent drop in platelet demand between March and May 2020. At the same time, there was a surge in the number of people wishing to donate blood. During this time, apheresis platelet collections were purposefully kept going to keep donor appointments and engagement up. After the daily platelet goal was met, apheresis collections were limited to single platelet collections. To accommodate the surge of donors, there was a 46 percent increase in turns per bed from pre-COVID-19 to post-COVID-19. The number of apheresis procedures performed increased by 9.3%, and the number of components collected increased by 9.5 percent.

Therapeutic Apheresis Companies and Competitive Landscape

The global therapeutic apheresis market is moderately competitive in nature, with the leading players capturing maximum share in revenues. Fresenius SE & Co. KGaA(Fresenius Kabi AG), Terumo Corporation (Terumo BCT Inc.), Haemonetics Corporation, Cerus Corporation, B. Braun Melsungen AG, Nikkiso Co. Ltd, Medica S.p.A., Sumitomo Bakelite Company Limited (SB-Kawasumi Laboratories, Inc.), Asahi Kasei Corporation(Asahi Kasei Medical Co., Ltd.) and Mallinckrodt Pharmaceuticals(Therakos). The key players are adopting strategies such as mergers and acquisitions, partnerships, and regional expansion to stand out as strong competitors in the market. New product launches along with increased focus on R&D are other ways the leading players improve their market presence.

For instance, On November 24, 2020, The Food and Drug Administration approved Cerus Corporation's INTERCEPT Blood System for Cryoprecipitation and two products, Pathogen Reduced Cryoprecipitated Fibrinogen Complex (PRCFC) pathogen reduced plasma cryoprecipitate reduced, manufactured using the system.

Key Companies to Watch

Cerus Corporation 

Overview: Cerus Corporation operates as a biomedical products company. The company focuses on developing and commercializing the INTERCEPT Blood System to enhance blood safety. The company markets its INTERCEPT platelet and plasma systems in the United States of America, Europe, the Commonwealth of Independent States countries, the Middle East and selected countries in other regions worldwide.

Product Portfolio: The INTERCEPT Blood System- The INTERCEPT Blood System for plasma is intended for the ex vivo pathogen inactivation of whole-blood derived plasma and apheresis plasma. The system is used to inactivate a broad spectrum of viruses, bacteria, protozoa and contaminate donor leukocytes in plasma components.

Key Developments: In November 2020, the Food and Drug Administration approved Cerus Corporation’s INTERCEPT Blood System for Cryoprecipitation and two products, Pathogen Reduced Cryoprecipitated Fibrinogen Complex (PRCFC) and pathogen reduced plasma cryoprecipitate reduced, manufactured using the system.

The global therapeutic apheresis market report would provide an access to an approx. 53 market data table, 43 figures and 180 pages