Growth in research activities targeting cell therapies, increase in usage of cell isolation in cancer research, expanding biotechnology and biopharmaceutical industries, and growth in government investments are propelling the global cell-separation market to reach USD 6.3 billion by 2020 from USD 2.9 billion in 2015, at a CAGR of 16.8 percent. Over the next five years, the growth in the relatively untapped Asian region is likely to be centered in China, Japan, Malaysia, and India at the highest CAGR owing to the public-private partnerships with international players to enter into the domestic market and rising focus of prominent players on the Indian cell-separation instruments market.

Performance of indigenous equipment at par with global counterparts is leading to a sharp shift in user preference. This is quite evident from the increasing trends in the market share of indigenous players. Increasing export of indigenous blood bank equipment is also adding to the credentials. Continuous upgradation in indigenous equipment and reducing the technological gap is playing a pivotal role in making quality products available at affordable cost. The trend is shifting toward hospitals that are upgrading their blood component separation units to meet the demand for blood components among patients admitted and other needy persons from the cooperation between blood bankers and clinicians to provide better care for the patient. For instance, Stanley Hospital has recently acquired a blood component separator for its blood bank at a cost of '25 lakh. The Government Wenlock Hospital is also among the few hospitals that no longer depend on other blood banks to separate platelets, red blood cells, and plasma from the whole blood.

Taking into consideration the growth opportunities in the Asian market, major companies are expanding their presence in this region. Public-private organizations are increasingly providing numerous grants and funds to researchers and research institutes for their stem cell-related projects. India and China have a large number of contract research organizations (CROs) that offer drug discovery services for pharmaceutical and biotechnology companies. As a result, the demand for cell-separation techniques is expected to increase and will present an array of opportunities for the cell-separation market to flourish.

Emerging Trends

The most promising areas of translational medical research, including CAR-T cancer therapies and stem cell-based regenerative medicine, require the isolation and purification of large numbers of viable, functional cells. There is growing demand from researchers and clinicians for technologies that provide high viability, enhanced efficiency, and scalability to optimize conventional cell-separation techniques. Several companies operating in the cell-separation technology market are shifting focus from research laboratories to clinical research and translation laboratories, to offer their products such as reagents, instruments, and other tools used in cell-separation process.

Data from a dedicated online market survey conducted to identify the most relevant technologies show that fluorescence-activated cell sorting (FACS), respectively flow cytometry (33 percent usage), laser micro dissection (17 percent), manual cell picking (17 percent), random seeding/dilution (15 percent), and microfluidics/lab-on-a-chip devices (12 percent) are currently the most frequently used technologies for cell separation.

Recently, the trend is shifting toward the use of microfluidics in cell separation. Advancement in microfluidic technology has provided robust solutions for separation of cells which are present in low quantity in the body. Citing the potential of microfluidic technology in cell isolation, various research studies are being performed for evaluating the performance of microfluidic chips in isolating other types of cells. The increasing application of microfluidics in cell separation will help in overcoming the present challenges in this market, which in turn will present significant opportunities for the cell-separation market growth.

Researchers at University of California, Los Angeles, have developed a new way to separate and organize cells suspended in fluid samples by their subtle biochemical differences. The system sorts cells more quickly and accurately than the current methods, and could lead to a simple, rapid automation of cell analysis, as well as an easier way to separate therapeutic cells from non-therapeutic, or contaminating cells. The new magnetic ratcheting technology is an approach to an automated system that could fit in a lab-on-a-chip, where samples such as blood could be rapidly analyzed with resolutions as fine as single cells.

Roadblocks

The isolation of highly purified cells in high quantity from low-volume sample, high cost of instruments, and ability of magnetic tagging and isolation to identify only two types of cells are major challenges faced by researchers and clinicians. Due to budget constraints and dearth of technical know-how, users in emerging countries are relatively reluctant to adopt new techniques such as automated magnetic cell separators and flow cytometers. Moreover, the survival of small players and new entrants in the market is another challenge. This market demands continuous improvement of existing products and technologies as well as the launch of novel products. Thus, to remain competitive, companies have to invest heavily in R&D which is very difficult for small players and new entrants.

Future Outlook

Most separation methods have room to increase throughput. Among them, field-flow fractionation (FFF), dielectrophoresis (DEP), and density-gradient centrifugation show great potential in future large-scale production. FACS can achieve an impressive >95 percent purity, while MACS is portable. With growing knowledge on better stem cell markers, and the generation of more specific aptamers by systematic evolution of ligands by exponential enrichment, affinity-based techniques will still be very powerful in the future for stem cell separation. As a method to isolate cells in an automated, miniaturized, multiplex, and portable fashion, microfluidics offer exciting solutions to many challenges. Although the purity of cell separation by microfluidic devices needs to be substantially improved, merging conventional technologies onto microfluidic platform will be extremely beneficial in the coming years.

Dr Rajesh Deshpande, Manager-Medical Affairs, Medical Devices, Regional Business Centre-NESEA, Fresenius Kabi India Pvt. Ltd.
Second Opinion
Advancements and Emerging Trends

Technological advancements in the field of transfusion medicine have led to the advent of automated blood cell collection and separation, which can provide individual blood components with consistent high- quality yield and purity. This is primarily performed with the help of blood cell separator. The blood cell separators are either based on the centrifugation principle or the membrane-based filtration principle. Blood cell separators based on centrifugation principle use two types of separation methods − intermittent flow separation and continuous flow separation.

{mosimage}In intermittent flow separation, the blood is pumped into a rotating centrifuge bowl in the form of cycles. Each cycle consists of drawing blood into the bowl, separation of required components, and the return of remaining blood. Cycles are repeated until desired quantity obtained.

The main advantage of this method is single-arm-access portable machines. However, the longer procedure time and high extracorporeal volume are the main deterrents in utilizing this technique for therapeutic procedures, which need to process larger blood volumes in a definite time frame.

The new-generation cell separator use continuous-separation technique with a single-arm access with high collection efficiency and shorter procedure time.

Filtration technology is also used in some apheresis processes, such as membrane filtration. Membranes with specific pore sizes allow plasma to pass through, while retaining cellular components. Filtration method is essentially used for plasma collection procedures - donor as well as therapeutic.

Increasing awareness of the therapeutic benefits of apheresis as well as the definite advantages of centrifugal technique over filtration has led to a steady rise of centrifugal therapeutic apheresis procedures on apheresis machines.

Technology has made it easy to connect columns, filters, and other accessories to these machines to support new protocols such as immunoadsorption aimed at specific indications.

Dr Rajesh Deshpande
Consultant Hematopathologist,
Regional Business Centre-NESEA,
Fresenius Kabi India Pvt. Ltd.


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