Apheresis Market - Growth, Trends, COVID-19 Impact, and Forecasts (2022 - 2027)
由於血漿療法在 COVID-19 感染患者的治療中的廣泛應用，預計在 COVID-19 大流行期間血液分離市場將受到積極影響。鑑於單採裝置在 COVID-19 患者治療中的廣泛使用以及 FDA 對產品批准的增加，單採市場正因大流行而積極增長。
The apheresis market was valued at approximately USD 1,639 million in 2020, and it is expected to witness a revenue of USD 2580 million in 2026, with a CAGR of 7.85% over the forecast period, 2021-2026.
The apheresis market is expected to be positively impacted during the COVID-19 pandemic owing to the extensive application of plasma therapy in the treatment of COVID-19 infected patients. Furthermore, in August 2020, the US FDA granted emergency use authorization (EUA) of convalescent plasma (CCP) therapy in hospitalized individuals with COVID-19. Also, in April 2020, Terumo BCT Inc. and Marker Therapeutics AG received the FDA approval for the Emergency Use Authorization (EUA) of Terumo BCT's Spectra Optia Apheresis System combined with Marker Therapeutics' D2000 Adsorption Cartridge to treat patients aged 18 years or above with confirmed COVID-19 disease. Thus, given the wide usage of apheresis units in the treatment of COVID-19 patients and increasing product approvals by the FDA, the apheresis market enjoys a positive growth over the pandemic.
The propelling factors for the growth of the apheresis market include the increasing number of diseases, a rise in the demand for blood components and associated safety, technological advancement in the development of new apheresis techniques, and a rise in the reimbursement policies and funding for apheresis procedures.
The use of apheresis in clinically ill patients is increasing day by day, and it has been widely used as the primary therapy or as an adjunct to other treatments for various diseases, such as thrombotic thrombocytopenic purpura, hemolytic uremic syndrome, drug toxicities, autoimmune disease, sepsis, and fulminant hepatic failure.
Additionally, as per the Centers for Disease Control and Prevention (CDC) 2019 report, it is estimated that about 37 million (15%) adults in the United States had chronic kidney disease (CKD). Apheresis plays a vital role in the purification of blood in patients with kidney disorders and drives the studied market. Along with these factors, the increasing product innovations and approvals have been driving the market growth. For instance, in June 2020, Fresenius Kabi AG and Fresenius Kabi USA received FDA clearance for ALYX Component Collection System, which is intended for use in blood collection establishments to collect and separate whole blood into its components. Thus, owing to the aforementioned factors, the apheresis market is expected to witness healthy growth over the forecast period.
Hematological disorders make a substantial contribution to the morbidity and mortality of individuals across the globe. According to the World Federation of Hemophilia report 2019, the number of people identified with hemophilia increased from 78,629 in 1999 to 324,648 in 2019 globally. Furthermore, about 157,517 people across the world are suffering from hemophilia A, and about 31,997 people are suffering from hemophilia B. Hence, owing to the increasing burden of hematological incidences and growing applications of apheresis as a treatment method for hematological disorders, the apheresis market for hematological disorders is expected to experience growth in the forecast period. The recent years brought about a rise in new options of therapeutic aphereses, such as immunoadsorption, double filtration, and cytapheresis used in the treatment of both primary and secondary autoimmune renal diseases. Additionally, as per ClinicalTrails.gov, as of January 21, 2021, there are about 47 ongoing clinical trials related to apheresis for different hematological disease development across the United States.
According to the research article published in the Journal of Thrombosis and Thrombolysis, 2020, coagulation parameters such as D-dimer, platelet count, fibrinogen, prothrombin time (PT), or activated partial thromboplastin time (aPTT) were found to be often increased in severe COVID-19 cases with an increased risk of thromboembolic complications, and thus, can indirectly impact the studied segment during the pandemic.
Furthermore, apheresis plays a very crucial role in the management of sickle cell anemia disease. As per the study titled, "Role of Emergency Automated Red Cell Exchange in Sickle Cell Crisis: A Case Report", published in November 2020, apheresis equipment was found to provide better management in red cell exchange therapeutic procedures being performed in sickle cell. Thus, owing to the aforementioned factors, the application of apheresis in treating various hematological disorders is expected to grow significantly over the forecast period.
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. An estimated combined total of 178,520 people in the United States were expected to be diagnosed with leukemia, lymphoma, or myeloma in 2020. The new cases of leukemia, lymphoma, and myeloma accounted for 9.9% of the estimated 1,806,590 new cancer cases diagnosed in the United States in 2020. The high incidence of target diseases thus drives the studied market growth.
In May 2020, the Department of Defense in the United States began an effort to collect 8,000 donated units of plasma from patients who have recovered from COVID-19 to support the development of an effective treatment against the disease. This effort has given rise to the adoption of plasmapheresis devices and disposables in the United States.
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 FDA 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.
The market studied is moderately competitive and is dominated by a few major players, and currently, the market is well established in many areas and has shown nascent success history. However, its full potential is yet to be determined in the developing regions. With increasing government initiatives, there is an awareness among people, which is further driving the growth of the market studied. Additionally, the strategic alliances and new product launches by the major companies are expected to drive the market growth. For instance, in January 2020, Fresenius Kabi invested EUR 30 million for the expansion of a transfusion and apheresis disposables plant in the Dominican Republic.