Therapeutic Plasma Exchange Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Consumables, Devices), By Technology (Centrifugation, Membrane Separation), By Indication (Neurological Disorders, Hematology Disorders, Renal Disorders, Metabolic Disorders, Others), By End User (Blood Collection Centers & Blood Component Providers, Hospitals & Clinics, Blood Transfusion Centers, Others), By Region and Competition 2018-2028

Market Overview

Global Therapeutic Plasma Exchange Market has valued at USD 762.01 Million in 2022 and is anticipated to project robust growth in the forecast period with a CAGR of 6.75% through 2028. Therapeutic plasma exchange (TPE), also known as plasmapheresis, is an endovascular blood technique utilized to separate pathogenic substances from clients' blood and replace them with replacement fluid, such as albumin solution or fresh frozen plasma. These substances encompass infective autoantibodies, immune complexes, cryoglobulins, and cholesterol-containing lipoproteins. TPE is employed in the treatment of various autoimmune conditions, renal disorders, hematological disorders, and more, contributing to market expansion. Additionally, therapeutic plasma exchange (TPE) offers the significant benefit of reducing plasma viscosity. It is widely performed in the management of chronic diseases as a first-line or second-line therapy, or as a supportive treatment. During plasma exchange, a substantial portion of plasma containing toxins and other abnormal matter is extracted from the other blood components and replaced with replacement fluid, such as fresh frozen plasma (FFP) or albumin.

Key Market Drivers

High prevalence of Neurological, Renal, And Hematological Disorders

The high prevalence of chronic diseases, such as nephrological disorders, acute liver failure, Guillain-Barré Syndrome (GBS), and others, contributes to the growth of the overall therapeutic plasma exchange market. Additionally, there has been a surge in the application of therapeutic plasma exchange, accompanied by intensive research and clinical trials to assess its efficacy compared to other treatments. These factors significantly bolster the growth of the therapeutic plasma exchange market. The most common indications for TPE therapy are nephrology-related disorders, as well as its use in the treatment of myasthenia gravis, Guillain Barré syndrome (GBS), and chronic inflammatory demyelinating polyneuropathy. Currently, the trend in therapeutic plasma exchange involves the use of highly permeable filters and standard dialysis equipment, often referred to as membrane plasma separation (MPS). In the US, the "Plasmaflo" membrane from Asahi Medical (Asahi Kasei Kuraray Medical Co., Ltd, Japan) is widely used.

Advances In Therapeutic Plasma Exchange Research and Development

High-precision technologies like continuous-flow centrifugation can effectively separate specific blood components such as plasma, leukocytes, platelets, or cells. Technological advancements, including the development of next-generation apheresis devices with features like screen navigation, GUI displays, automated interfaces, and other improvements, are being observed across various systems. Advanced TPE systems minimize manual intervention and enhance procedure efficiency. Moreover, these technological advancements promote the adoption of such systems for a wide range of conditions. The development of automated and semi-automated TPE systems has improved the efficiency, accuracy, and consistency of the procedure. These systems help reduce the manual labor involved and allow for better control over the exchange process. Advances in membrane technology have led to the development of more efficient and biocompatible membranes for plasma separation. These membranes allow for better separation of plasma components and reduced risk of blood cell damage. Research has expanded the applications of TPE to various medical conditions, including autoimmune disorders, neurological diseases, transplant-related complications, and more. Clinical trials and studies continue to explore the efficacy of TPE in different settings.

The new generation systems offer improved comfort, safety profile during the exchange procedure, enhanced balance control, and other benefits, driving the widespread use of these systems.

Expanding Variety of Therapeutic Plasma Exchange Applications

Applications in the treatment of a wide array of neurological disorders serve as a significant catalyst for the growth of the Global Therapeutic Plasma Exchange Market. Neurological conditions such as acute inflammatory demyelinating polyradiculoneuropathy, chronic inflammatory demyelinating polyradiculoneuropathy, myasthenia gravis (MG), and paraneoplastic encephalopathies regard TPE as the primary treatment, either as a standalone therapy or in combination with other treatments. TPE is also employed as a secondary treatment for various other neurological conditions, including acute disseminated encephalomyelitis, chronic focal encephalitis, Lambert-Eaton myasthenic syndrome, Sydenham’s chorea, natalizumab-associated progressive multifocal leukoencephalopathy, multiple sclerosis, and neuromyelitis Optica (NMO, or Devic’s disease), usually in conjunction with other therapies. The impact of myasthenia gravis is estimated to be prevalent among over 700,000 individuals worldwide, with 36,000 to 60,000 cases reported in the United States. The market is projected to advance as the prevalence of such neurological disorders continues to rise. Furthermore, the surge in research and development activities on a global scale contributes to the progress of the Global Therapeutic Plasma Exchange Market. The extensive range of medical applications offered by the market also serves as a driving force. Therapeutic plasma exchange is considered a promising treatment option in some cases of potentially life-threatening intoxication. Studies have demonstrated that plasma exchange is as effective as hemoperfusion, reducing mortality rates from 30 to 50 percent with standard therapy to less than 20 percent in phylloid mushroom poisoning.

Increasing Demand for Source Plasma from Biopharmaceutical Companies

There is a growing demand for source plasma from biopharmaceutical companies due to its utilization in the treatment of an expanding range of debilitating, chronic, and life-threatening disorders. Plasmapheresis procedures are employed to separate plasma from whole blood. Biopharmaceutical companies utilize source plasma to produce plasma-derived therapies through plasma fractionation techniques and various innovative processes. Plasma-derived therapies play a crucial role in the treatment of a broad spectrum of chronic and life-threatening diseases. For example, immunoglobulin (IG) is used to assist patients suffering from primary and secondary immunodeficiency disorders, as well as to combat viral and bacterial infections. The demand for source plasma from biopharmaceutical companies, facilitated by plasmapheresis procedures, remains high. Furthermore, the increasing prevalence of various rare diseases such as hereditary angioedema, hemophilia A & B, Von Willebrand disease, primary immunodeficiency disease (PID), chronic inflammatory demyelinating polyneuropathy (CIDP), and idiopathic thrombocytopenic purpura (ITP) is also contributing to the demand for plasma-derived products, thereby driving the growth of the plasmapheresis market.

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Key Market Challenges

Risk Associated with Plasmapheresis Procedures

During the plasmapheresis procedure, a portion of blood is extracted from the human body, and specific replacement fluids like albumin, fresh frozen plasma (FFP), electrolyte solutions, purified protein products, and starches are administered intravenously to maintain intravascular osmotic pressure. Although generally considered safe, there are still several associated risks. Risk factors include infection, allergic reactions, hypotension, internal bleeding, electrolyte imbalance, and others. One of the most frequent side effects of plasmapheresis is hypotension, characterized by symptoms such as faintness, blurred vision, dizziness, sweating, or abdominal cramps. However, prompt treatment can effectively manage these symptoms. Some patients may experience numbness or tingling around the mouth or nose due to the effect of the anticoagulant citrate on calcium levels in the body. In rare cases, bleeding may occur during the procedure as a result of anticoagulants added to the blood, potentially leading to irregular heartbeat and cardiac arrest if not promptly addressed. Allergic reactions, itching, and rash may also occur as a response to the replacement fluids, but these can be easily treated with intravenous medication. These side effects may impede the widespread adoption of plasmapheresis, thereby limiting market growth to some extent.

High Cost of For Therapeutic Plasma Exchange Products

The cost of equipment significantly impacts the adoption of plasma exchange by medical professionals and, consequently, patients. Apheresis equipment is utilized by blood banks for collecting blood components, while hospitals rely on it for therapeutic plasma exchange procedures. TPE requires specialized equipment, such as apheresis machines, centrifuges, and membrane separation systems. The development, manufacturing, maintenance, and calibration of these machines contribute to their high cost. TPE involves single-use disposable components, such as tubing, filters, and collection bags. Ensuring the quality and safety of TPE products involves rigorous testing, quality control processes, and compliance with industry standards. TPE products might have a relatively limited market demand compared to more widely used medical products. This limited scale of production can contribute to higher per-unit costs. The production and quality control of these components contribute to the overall cost of the procedure. High-quality, biocompatible membrane filters are essential for effective plasma separation. Developing and manufacturing these filters to meet medical standards can be expensive. The overall cost of apheresis treatments is further escalated by the expensive equipment and disposable items.

Key Market Trends

Continuous Advancement

Continuous technological advancements have significantly enhanced and refined high-precision methods. These advancements not only improve patient satisfaction but also enhance the processing of goods derived from blood and plasma. In comparison to other techniques such as membrane separation methods, this method requires minimal blood flow, making it a more advanced approach for facilitating blood collection through the patient's antecubital or radial veins. Moreover, these technological advancements allow for more precise control of hydration status, resulting in greater hemodynamic stability during treatment. Additionally, patients benefit from improved comfort and safety during therapeutic plasma exchange (TPE) procedures. These remarkable technological developments create lucrative opportunities within the market.

Use of Therapeutic Plasma Procedure in Pediatric Applications

The therapeutic plasma exchange (TPE) treatment is extensively studied for the removal of pathogenic materials in various neurologic, hematologic, renal, and autoimmune diseases in children. Thrombotic Thrombocytopenic Purpura (TTP) and Hemolytic-Uremic Syndrome (HUS) is rare disorders primarily affect children and involve abnormal clotting in small blood vessels, leading to platelet destruction and organ damage. TPE is used to remove the antibodies causing the disorder and to replace deficient blood components. TPE is sometimes used in pediatric oncology to manage paraneoplastic syndromes, where cancer cells trigger an autoimmune response against the patient's nervous system. TPE can be used to manage certain pediatric hematologic disorders such as sickle cell disease, where it helps decrease the concentration of abnormal hemoglobin and improve blood flow.

Currently, its utilization among the pediatric population is limited, primarily relying on retrospective, single-center experiences. The market growth is driven by the treatment of autoimmune diseases, Guillain-Barré syndrome (GBS), renal diseases, atherosclerosis, and other related conditions.

Segmental Insights

Indication Insights

Based on indication, the global therapeutic plasma exchange market is categorized into Neurological Disorders, Haematology Disorders, Renal Disorders, Metabolic Disorders, and Others. The neurological disorder segment is expected to dominate this market, driven by the increasing incidence and prevalence of neurological diseases in the geriatric population. Additionally, there is a growing understanding of the use of plasma exchange in treating neurological disorders, and key players are investing more in R&D for new applications in this field. These factors contribute significantly to the market's growth.

Technology Insights

Based on technological aspects, the Therapeutic Plasma Exchange market is categorized into centrifugation and Membrane Separation. By 2023, the centrifugation segment is projected to hold a significant share in the Therapeutic Plasma Exchange market. The substantial market share of this segment can be attributed to the widespread adoption of centrifugation technology in donor apheresis, which offers various advantages including cost-effectiveness in related disposables and more efficient plasma removal.

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Regional Insights

The dominance of North America in the global therapeutics plasma exchange market can be attributed to several factors. Firstly, there has been a significant increase in the incidence of autoimmune diseases worldwide, which has contributed to the region's market growth. Additionally, the utilization of lipoprotein apheresis therapy for cardiac diseases like coronary artery disease (CAD), hypercholesterolemia strokes, and atherosclerosis has witnessed a sharp rise. Furthermore, the region has experienced a recent surge in the number of cardiac deaths. The demand for therapeutic plasma exchange treatments in North America will be primarily driven by the high geriatric population and the continuous rise in healthcare spending in the region. These factors are expected to fuel the expansion of the regional market in the coming years. Notably, North America is projected to generate the highest revenue during the forecast period, owing to its well-established hospital infrastructure and the presence of top global companies. The region also benefits from the existence of numerous biotech enterprises, academic institutions, and research organizations, which further contribute to its dominance in the field of therapeutic plasma exchange. As academic and research organizations continue to expand, the need for therapeutic plasma exchange treatments is expected to grow consistently in these fields.

Recent Developments

• In April 2020, Terumo BCT and Marker Therapeutics obtained the initial FDA emergency use authorization (EUA) for a device aimed at treating COVID-19 patients with acute respiratory failure.
• In May 2020, Ceros Corporation was granted FDA regulatory clearance to produce INTERCEPT plasma utilizing an innovative, single-use plastic kit.
• In December 2019, Haemonetics Corporation inaugurated its new corporate headquarters in Downtown Boston.

Key Market Players

• Asahi Kasei Corporation
• Baxter International Inc
• B. Braun Melsungen AG
• Cerus Corporation
• Fresenius Kabi AG
• Haemonetics Corporation
• Hemacare Corporation
• IncMedica S.p.A.
• Kawasumi Laboratories
• Terumo Corporation

In this report, the Global Therapeutic Plasma Exchange Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Therapeutic Plasma Exchange Market, By Product:

o   Consumables

o   Devices

• Therapeutic Plasma Exchange Market, By Technology:

o   Centrifugation

o   Membrane Separation

• Therapeutic Plasma Exchange Market, By Indication:

o   Neurological Disorders

o   Haematology Disorders

o   Renal Disorders

o   Metabolic Disorders

o   Others

• Therapeutic Plasma Exchange Market, By End User:

o   Blood Collection Centres & Blood Component Providers

o   Hospitals & Clinics

o   Blood Transfusion Centres

o   Others

• Therapeutic Plasma Exchange Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia-Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

§  Kuwait

§  Turkey

§  Egypt

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Therapeutic Plasma Exchange Market.

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Global Therapeutic Plasma Exchange market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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