Apheresis technology – Increasing horizons
Apheresis technology has made great strides in the last decade. The fourth iteration and the seventh edition of American Society for Apheresis guidelines for therapeutic apheresis (TA) have listed 87 diseases with 179 indications for TA, which include 14 new diseases and two new indications for previously listed diseases. The range of indications for TA covers a large number of specialties. The global scenario is dominated by neurology, followed by autoimmune diseases, renal diseases, cancer, and cardiovascular diseases. The global apheresis market was valued at USD 1.42 billion in 2016 with a forecast of a compound annual growth rate (CAGR) of 7.7 percent during the period from 2016 to 2021.
Donor apheresis is also a major component in the above growth and plateletpheresis (single-donor apheresis platelets) still constitutes the major share of apheresis procedures in India. All major centers have this facility as it is a necessity in the centers treating leukemias and other blood disorders. The dengue outbreaks, with resultant spikes in platelet requirements, have contributed immensely to the outreach of this technology beyond the metros and Tier-II cities.
Hematopoietic stem cell (HSC) collection by apheresis through peripheral access is much more convenient than the traditional method of HSC collection from bone marrow, and has a lower complication rate. This is done by peripheral mobilization of HSCs by administering G-CSF (granulocyte colony-stimulating factor)/chemotherapy. The HSCs are released into the peripheral circulation and collected by apheresis technology. Thus harvested, they are used for the reconstitution of hematopoietic system in patients.
Solid organ transplant, predominantly kidney and liver transplants across the ABO blood groups, have been initiated in most of the advanced medical centers. In this area, apheresis plays a central role in desensitization protocols. Rituximab along with plasmapheresis, with or without a selective immunoadsorption column, is used to bring down anti-A and anti-B titers to levels (usually ≤8), acceptable for ABO-incompatible transplant.
Traditionally TA was non-selective and all components of the patient plasma were removed and replaced with donor plasma; with advances in technology, many selective adsorption columns/selective filters have become available and have begun to enter the Indian market. These include columns/filters, which remove pathogenic substances, such as ammonia, bile salts, immunoglobulins, and LDL (low-density lipoproteins), and have a therapeutic/supportive role in many disorders.
In addition to these prevalent uses of apheresis technology, newer applications such as donor granulocyte collection for transfusion to neutropenic patients have also been initiated at a few centers. Therapeutic leukocytapheresis and thrombocytapheresis in patients with excess counts form a part of the therapeutic strategy in patients with very high WBC and platelet counts respectively.
Photopheresis is another newer technology, which is yet to make a major foray into the Indian market. This technology is based on the separation of leucocytes by apheresis, followed by their treatment with ultra-violet light in the presence of 8-methoxypsoralen and then re-transfusion to the patient. This has an immunomodulatory effect and is used in a variety of diseases including, but not limited, to auto-immune diseases, graft versus host disease, and transplant-rejection cutaneous T-cell lymphoma.
The major apheresis providers in India are Haemonetics Corporation, Terumo BCT, and Fresenius Medical Care. For filters, Kawasumi Laboratories, Japan, is a major provider. Adsorption columns for ABO antibody removal are marketed by Glycorex, Sweden, and Pocard, Russia. Jafron Biomedical Co. Ltd., China, has recently entered the Indian market and introduced a slew of adsorption columns, including columns for removal of bilirubin, ammonia, inflammatory mediators, and for poisonous substances, such as rodenticides, herbicides, organ phosphorus pesticides, and the like.
The future of apheresis technology in India is bright and the growth in this sector may exceed the global growth predictions.
