[111 Pages Report] The global hollow fiber filtration market is valued at an estimated USD 242.0 million in 2018 and is projected to reach USD 517.4 million by 2023, at a CAGR of 13.5% during the forecast period. The rising preference for continuous manufacturing and the increasing demand for biopharmaceuticals are the major factors that are driving the growth of this market. However, the presence of stringent government regulations for ensuring drug safety is expected to restrain the growth of this market during the forecast period.

By Technique, Microfiltration will grow at fastest rate during forecast period

Filtration is a unitary separation process that is used at the industrial and laboratory scale. Based on technique, the hollow fiber filtration market is segmented into microfiltration and ultrafiltration. Microfiltration is a low-pressure method of separating compounds that have a large-molecular-weight from dissolved solids. This process separates most bacteria and suspended solids but not viruses and multivalent ions. Microfiltration membranes are typically classified according to pore size, rejecting particles in the 0.1 to 0.7-micron range.

Microfiltration is a low pressure-driven membrane process in biopharmaceutical filtration. Due to the open structure of hollow fiber filters, they are preferred for microfiltration processes, especially in the recovery of proteins expressed in bacteria. In the biopharmaceutical industry, microfiltration with hollow fiber filters finds applications in processes such as clarification, purification of cell broths, separation of cell debris, and separation of macromolecules. This technique is also used for the harvesting of cells in upstream bioprocessing and for the recovery & purification of biomass during the production of antibiotics.

By Material, Polymer selection segment is expected to grow at fastest CAGR in the forecast period

The hollow fiber filtration market is segmented by material into polymeric and ceramic filters. Polymer selection for the separation process is based on its compatibility with membrane technology and its intended application. Polymeric hollow fiber filters are widely used in many ultrafiltration and microfiltration applications including filtration, desalination, and biochemical reactions. Polymeric membranes used in pharmaceutical applications either have a straight hollow fiber configuration or are in stacks of cross-wound hollow fiber membrane mats. Hollow fiber modules have the highest packing density compared to other modules, such as the spiral wound modules.

Different types of polymeric materials are used to prepare membranes such as PS and PES, PVDF, and others.

By Application, Continuous Cell Perfusion Segment Is Expected to Grow at Highest CAGR During Forecast Period

On the basis of application, the hollow fiber filtration market is segmented into continuous cell perfusion, harvest and clarification, and concentration and diafiltration. Currently, biopharmaceutical manufacturers are under increasing pressure to reduce development times and production costs and are considering various new approaches to processing. The regulatory approval of innovative and advanced technologies, such as single-use systems, in the drug manufacturing process is also supporting this trend.

The biopharmaceutical industry is actively exploring the potential of continuous manufacturing, with a focus on upstream perfusion cell-culture processes that utilize hollow fiber filters. In 2016, Repligen launched the single-use version of its alternate tangential flow (ATF) perfusion system. Due to the advantages of hollow fibers, such as achieving efficient cell separation (with low shear) and allowing robust large-scale manufacturing, they are considered as the most suitable form of membrane filters for TFF and ATF perfusion processes

By End User, Pharmaceutical and Biotechnology Manufacturers Segment Is Expected to Grow At Highest CAGR During Forecast Period

Based on end user, the hollow fiber filtration market is segmented into pharmaceutical and biotechnology manufacturers, contract research and manufacturing organizations, R&D departments, and other end users. Globally, bioprocessing products have gained rapid acceptance among pharmaceutical and biotechnology manufacturers. The adoption of continuous manufacturing techniques in bioproduction, such as perfusion systems (which utilize hollow fiber filters in pharmaceutical and biotechnology industries), has significantly impacted manufacturing process efficiency by improving plant flexibility and reducing start-up times. In addition, this technology has significantly reduced labor costs and validation requirements.

The growing biopharmaceutical industry, increasing biologics research, significant growth in the biologics market, and technological innovations in pharma and biotech research are the major factors that have significantly contributed to the increasing application of hollow fiber filtration in biopharmaceutical companies.

In 2018, North America is expected to account for the largest market share

The hollow fiber filtration market is divided into four major regions-North America, Europe, Asia Pacific, and the Rest of the World (RoW). In 2018, North America is expected to account for the largest share of this market, followed by Europe. Companies in North America mainly focusing on new products such as perfusion systems and the rising demand for biopharmaceuticals are driving the hollow fiber filtration market. On the other hand, stringent government regulations are a major factor restraining the growth of this market.

On the other hand, the market in Asia Pacific is expected to grow at the highest CAGR during the forecast period. This growth can be attributed to the expanding biomanufacturing sector, increasing government support, developing R&D infrastructure, and growing outsourcing to this region from North America and Europe

Market Dynamics

Driver: Rising preference for continuous manufacturing

Continuous manufacturing enables the automation of the entire production process while eliminating the need for external intervention. In this scenario, continuous cell perfusion bioprocessing provides several advantages over traditional fed-batch processing, as it enhances scalability to address the increasing demand for biopharmaceuticals. Such benefits have led to the adoption of continuous perfusion systems in the continuous manufacturing of biopharmaceutical materials, proteins, and vaccines as well as in high-density cell banking.

Owing to their advantages, regulatory authorities in some countries such as the US are encouraging continuous manufacturing practices among drug manufacturers. For instance, in July 2015, the FDA approved the continuous manufacturing of cystic fibrosis drug Orkambi by Vertex Pharmaceuticals Incorporated (US). Similarly, in April 2016, Janssen Global Services, LLC (Belgium) received approval for the continuous manufacturing of its HIV-1 drug-Prezista. The growing adoption of continuous manufacturing by biopharmaceutical companies, coupled with the rising support from regulatory bodies such as the FDA, is one of the major factors that is expected to drive the growth of the hollow fiber filtration market in the coming years.

Restraint: Stringent government regulations for ensuring drug safety

Owing to the presence of a stringent regulatory framework, pharmaceutical and biotechnology companies face various challenges in obtaining regulatory approvals for the launch of new and innovative products.

The main objective of the validation of filtration processes is to prove that a filtration process can perform consistently without any failure. The FDA provides Quality by Design (QbD) principles in the US, through which the filtration process is designed. This validates the use of pharmaceutical filters. In Canada, Health Canada regulates the use of tangential flow filters with the help of GMP guidelines. Similarly, the Parenteral Drug Association (PDA) compiles validations or equipment qualification, process development, process validation, and cleaning validation for tangential flow filtration equipment.

The presence of stringent regulatory procedures favors the adoption and usage of established technologies and products, including filtration products such as cassettes and flat-sheet filters, as the validation process using these products and technologies has been established. As a result, manufacturers are reluctant to adopt new technologies such as hollow fiber filtration over established technologies.

Opportunity: Emerging markets to offer lucrative growth opportunities

China, India, and Brazil are expected to offer major growth opportunities for the players operating in the hollow fiber filtration market. China is estimated to be a high-growth market for bioprocessing products due to the growing government support and private investments in the country. Companies in China are increasingly making biologics-related investments and hiring a skilled workforce for their operations. Also, R&D investments in markets such as India and Brazil have increased significantly over the last few years. To capitalize on the available growth opportunities, key players are establishing new facilities, R&D centers, and innovation centers in these emerging countries. For instance, in 2015, Singapore Amgen completed its USD 200-million biomanufacturing facility, which uses single-use technologies in 90% of its operations.

Despite the undermined global economy, the Indian pharmaceutical industry is experiencing unprecedented growth. The country is the largest provider of generic medicines globally and is expected to be the third-largest generic active pharmaceutical ingredient (API) provider globally. Rising income levels, expansion of pharmaceutical companies, and the presence of advanced medical infrastructure have led to the growth of the pharmaceutical market in India. This growth in the target industries in emerging countries is expected to create potential growth opportunities for market players in the coming years.

Challenge: Slow adoption of advanced technologies in biopharmaceutical manufacturing

Biopharmaceutical manufacturing directly supports the USD 240-billion biologics industry, and small improvements in manufacturing costs can result in very significant savings (Source: American Pharmaceutical Review). However, the adoption of new technologies in the bioprocessing industry is slower as compared to other industries. This can primarily be attributed to the stringent regulations governing this industry. For instance, manufacturers and contract manufacturing organizations (CMOs) are required to gain regulatory approval for any changes in technologies or processes. As a result, once a manufacturing process has been established and approved, the cost of changes is significant, and the incentives for changing established processes are limited. Thus, even though continuous manufacturing or perfusion technologies offer several advantages to manufacturers, their adoption has been limited. It is also improbable that established processes will be switched from batch/fed-batch to perfusion cell culture given the extensive work that must be completed to demonstrate equivalency. This slow adoption of new and efficient technologies is a challenge for the greater uptake of hollow fiber filters in biopharmaceutical filtration processes.

Scope of the Report

Report Metric Details Market size available for years 2016�2023 Base year considered 2018 Forecast period 2018�2022 Forecast units Million (USD) Segments covered By Material, By Technology, By Application, By End User, By Geography Geographies covered North America (U.S., Canada), Europe, Asia Pacific (Japan, China, India, RoAPAC), Rest of the World Companies covered Asahi Kasei Corporation, Repligen Corporation, GE Healthcare, Danaher Corporation, Parker-Hannifin Corporation, Koch Membrane Systems, Inc., Watersep Bioseparation Corporation, Toyobo Co., Ltd., Microdyn-Nadir GmbH, Cantel Medical Corporation, Coorstek, Inc.

Key Market Players

Asahi Kasei Corporation, Repligen Corporation, GE Healthcare, Danaher Corporation, Parker-Hannifin Corporation, Koch Membrane Systems, Inc., Watersep Bioseparation Corporation, Toyobo Co., Ltd., Microdyn-Nadir GmbH, Cantel Medical Corporation, Coorstek, Inc.

Critical questions the report answers:

Who are the major market players in the hollow fiber filtration market?

What are the growth trends and the largest revenue-generating region for hollow fiber filtration?

How are hollow fiber filtration products sold to customers?

What are the major major material, technologies and applications in hollow fiber filtration?

What are the driving, restraining, opportunistic, and challenging factors for this market?

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