Therapeutic plasma exchange (TPE) also referred as “plasmapheresis” highly involved in removal and replacement of patient’s blood plasma. The main goal of TPE is to remove large amounts of disease causing agents, such as antibodies that attack the body and generate symptoms. Therapeutic plasma exchange involves separation of plasma from the whole blood. The removed plasma is then exchanged or replaced with IV fluids, albumin, blood products, or a combination of both.

Pipeline Analysis

Currently, therapeutic plasma exchange (TPE) for patients suffering with severe sepsis is under Phase 1 Clinical Trial. Sepsis is body's extreme response to an infection. It can be considered a life threatening medical emergency. Avoidance of timely treatment sepsis can have adverse reactions that lead to tissue damage, organ failure, and death. According to centre for disease control and prevention (CDC), each year, at least 1.7 million adults in America develop sepsis. Also, nearly 270,000 Americans die from sepsis.

Currently, Alberta Health Services, Calgary has developed interventional therapy for adult patients with vasoplegic shock for 2 organ dysfunction will receive TPE to overcome the cause of sepsis. The therapy developed is "septic shock". The actual study start date was October 2020 and estimated study completion date is December 2021.  

Growth Factors

High prevalence of chronic diseases like nephrological disorders, acute liver failure, Guillain-Barré Syndrome (GBS), and others fuel the growth of overall therapeutic plasma exchange market. In addition, surge in application of therapeutic plasma exchange coupled with intensive research and clinical trials are performed to determine the efficacy of plasma exchange as compared to other treatment. Such factors bolster the growth of therapeutic plasma exchange market. Most common indications for TPE therapy is used in the nephrology related disorders. Also, TPE is majorly used in treatment for myasthenia gravis, Guillain Barré syndrome (GBS), and chronic inflammatory demyelinating polyneuropathy. Considering the potential of therapeutic plasma exchange (TPE) to remove large therapeutic plasma exchange performed with highly permeable filter and standard dialysis equipments is the current trend. It is often referred as membrane plasma separation (MPS). Currently, MPS is popular in US. In US, most common used membrane is the “Plasmaflo” from Asahi Medical (Asahi Kasei Kuraray Medical Co., Ltd, Japan).

Market Trends

Membrane Plasma Separation (MPS) V/S Centrifugation

Many hospitals and other medical facilities contact mobile TPE for the procedure to be performed on patients. Mobile TPE with centrifugal equipment sometimes exceeds reimbursement. TPE performed membrane plasma separation (MPS) is similarly safe and cost effective as compared to centrifugal method and can be performed by haemodialysis machines. Inpatient haemodialysis is a current trend and creates lucrative opportunities to provide MPS over mobile aphresis or TPE. The average charges for mobile TPE services are approx. US$ 1,100 ranging from US$ 980 to US$1,350 in US. The charges exceed than national average medicare reimbursement of about US$ 730. However, direct cost of membrane plasma separation provided by hospital staff in inpatient dialysis unit is approx. US$400. Therefore, it can be projected that membrane plasma separation (MPS) can be more cost effective than mobile TPE with cost saving of approx. US$700 per procedure. According to the statistics released by the Asahi Kasei Kuraray Medical Co., Ltd. it shows that Japan utilize MPS procedure by 100% over centrifugation in hospitals. Moreover, there is high adoption of MPS procedure in Germany of almost 80% over 20% centrifugation methods in hospital.

IVIg Therapy Accelerates Therapeutic Plasma Exchange Market

The cost analysis of GBS therapy involves 5 days of IVIg coupled with 5 plasma exchange treatment. Benefits associated with IVIg therapy is that it can be performed in almost any medical facility and it can be used where TPE is less widely available. Therefore, wide availability of dialysis in all major facilities would appear that providing medical procedure with TPE coupled with dialysis equipment offers excellent opportunity for the patients.  It ultimately helps to lower the cost of treatment and now has gained significant attention with IVIg or TPE.  Therefore, prevailing charges and reimbursement would suggest that providing TPE with dialysis equipment offers excellent option that ultimately lower the costs of treating many of the disease that can now be managed with either IVIg or TPE.

Segmental Outlook

Therapeutic plasma exchange market is segmented based on disease indication and end use. Based on disease indication, the market is segmented as nephrology disorders, renal disorders, hematology disorders, and metabolic disorders.  By end use the market is segmented as hospitals, specialty clinics, and ambulatory surgical centers.  

Based on disease indication, hematology disorder will mark a significant revenue share in the global market for therapeutic plasma exchange. Hematological disorders involve disorders related to blood and blood forming organs that affect millions of Americans. In addition to blood cell cancers, hematological diseases involve rare genetic disorders, conditions related to HIV, anemia, sickle cell disease, and complications related to chemotherapy or transfusion. According to CDC, for all age groups and both the sexes, anemia is decrease by almost 7% in 2016 that is from 40% to 33%. By 2025, World Health Organization (WHO) global nutrition Target for anemia is to reduce it by 50%. Myasthenia gravis (MG) is a well known autoimmune disease associates by antibodies that is considered as a life threatening disorder.  According to Indian Journal of Critical Care Medicine, MG has annual incidence of approx. 30 new cases per million, is expected that approx. 15-20% of these patients will go into MG and 3-8% of all patients will die from this condition. Therapeutic plasma exchange is well established therapy for MG. Moreover, TPE improves short-term outcomes in patients suffering from MG over treatment with steroids and oral and immunosuppressives.  

Regional Overview

North America is anticipated to gain significant market share for therapeutic plasma exchange market whereas Asia Pacific will witness fastest growth in the coming years for therapeutic plasma exchange market. Technological advancement is one of the most prominent factors driving the regional growth of therapeutic plasma exchange market. Other factor that contribute for growth of regional market involves high prevalence of various autoimmune disoders, rise in adoption of lipoprotein aphresis treatment for cardiovascular indications like CAD, hypercholesterolemia strokes and atherosclerosis resulting in cardiac deaths. Therapeutic plasma exchange (TPE) has wide applications in cardiac surgical patients and adoption in cardiac surgical patients suffering from high risk heart and lung transplant patients.

Competitive Landscape

Key companies profiled in this report involve Asahi Kasei Corporation, Baxter International, Inc., Terumo Corporation, B. Braun Melsungen AG, Fresenius Kabi AG, Kawasumi Laboratories, Inc., Haemonetics Corporation, Cerus Corporation, Hemacare Corporation, Medica S.p.A., and among others.

Market Segmentation

Market By Disease Indication

Neurological Disorders

Renal Disorders

Hematology Disorders

Metabolic Disorders

Market By End User

Hospitals

Specialty Clinics

Ambulatory Surgical Centers

Market By Geography

North America

• U.S.
• Canada

Europe

• U.K.
• Germany
• France
• Spain
• Rest of Europe

Asia-Pacific

• China
• Japan
• India
• Australia
• South Korea
• Rest of Asia-Pacific

Latin America

• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC
• South Africa
• Rest of Middle East & Africa