Market Outlook:

The pharmaceutical filtration market size is poised to reach USD 11,657.39 Million by 2024, with a projected escalation to USD 31,746.21 Million by 2032, reflecting a compound annual growth rate (CAGR) of 18.6% during the forecast period (2024-2032). 

Filtration in the pharmaceutical industry has been used to purify or separate components and also to maintain sterile conditions during the process in order to prevent contamination. Various methods are used for filtration depending on the component that needs to be filtered. Major factors such as the growing growth of the pharmaceutical industry and the fast expansion of generic drug production are the major drivers of growth in the pharmaceutical filtration devices market. On the other hand, high capital required to open new production facilities and the rigid government regulations on the legalizing of the filtration process will limit the market growth by a certain percentage. This can be attributed to the increasing prevalence of chronic diseases, the increasing investments in biopharmaceutical research and development activities, and the growing technological advancements in the sterilization processes employed by various biopharmaceuticals. Moreover, the COVID-19 pandemic has created a multi-faceted impact on the pharmaceutical filtration market. The demand for vaccines and biologics increased at the onset of the pandemic, and most of the relevant vaccine development biopharmaceutical manufacturing applies pharmaceutical filtration techniques, which has had a positive impact on the market.

Market Dynamics:

Driver:

The COVID-19 outbreak has significantly increased the focus on all safety parameters and quality requirements in the pharmaceutical industry, which has further increased the demand for advanced types of pharmaceutical filtration products. The pandemic has also increased the usage of single-use filtration technologies specifically in pharmaceutical manufacturing due to their exceptional ability to prevent cross-contamination, and this change has positively impacted the market for pharmaceutical filtration as a whole. For example, in September of the year 2022, Pall Corporation announced several significant developments regarding the new three Allegro Connect Systems, the latest further development and progression in their existing portfolio of single-use filtration systems. These newly launched products feature the latest advanced automation control capabilities and effectively manage to mitigate various risks, making this complex process of pharmaceutical production highly valuable, mainly when it comes to producing therapeutic drugs and developing vaccines. But on the other hand, the supply chain disruptions have adversely affected the market for pharmaceutical filtration products to some extent. These supply chain disruptions have caused manufacturing lags that have led to substantial delays in the pre-planned drug commercialization processes. The exemplary and outstanding growth of the biopharmaceutical industry has largely pushed the market for filtration technologies as this process plays a vital and crucial role in the manufacture and research purposes. Pharmaceutical-based large-molecule pharmaceuticals have been undergoing tremendous and steady growth with accelerated rates over the recent years mainly due to its powerful and great medicinal features. To adequately complement the huge research and commercialization efforts related to large molecule-based biopharma manufacturing, membrane separation becomes a critical and indispensable process, thereby adding up the overall demand and requirements for pharmaceutical filtration solutions.

Restraint:

Membrane filters are commonly applied in pharmaceutical filtration, though they face the challenges of fouling and fiber breakage. Fouling occurs when there is an excessive accumulation of biological, organic, or colloidal materials from source water, usually a result of inadequate pretreatment. Fouling can occur from the buildup of proteins inside the membrane or from residue on its surface. Membrane filters have relatively moderate initial costs but operating costs are higher, primarily due to fouling and maintenance problems. Pharmaceutical filters should pass set standards, and to guarantee their reliability, these products must be subjected to demanding lot-release testing so as to confirm their performance. For sterilizing filters, manufacturers always conduct 100% integrity by involving a comprehensive validation procedure to ascertain that these filters totally satisfy any regulatory requirement or quality assurance practice. These advanced filters involve the processes which require the use of expensive, costly, and highly technical equipment and highly trained scientists; all these increase the general cost of the filtration systems. Additionally, the manufacturers of filters are investing heavily to enhance the technology on thermal and mechanical resistances; this has consequently resulted in high costs of producing these filters. Therefore, increased cost of the filters coupled with lower speed of processing could present the greatest challenge to pharmaceutical filtration market growth and development.

Opportunity:

Market players operating in the biopharmaceutical space are constantly expanding and adding cGMP-approved clean rooms for drug discovery that has been extrapolating the market for pharmaceutical filter products. For example, in February 2023, RoslinCT and Lykan Bioscience announced a capacity expansion of six cGMP suites to meet the growing demand for cell therapies. Besides its other capabilities, the facility is designed to accommodate and manage both allogenic and autologous therapy processes. This requires the implementation of several important filtration methods, including depth filtration, sterile filtration, tangential flow filtration (TFF), and virus filtration, which are widely recognized as standard pharmaceutical filtration techniques in the industry. These advancements in single-use filtration have significantly contributed to the expansion and growth of the overall market for the pharmaceutical industry, and there is a significant increase and adaptation of single-use filtration products being adopted. The innovative technology of single-use filtration aids in minimizing bioburden, which is important for product safety and quality. It also allows viruses to be captured effectively in the development of gene therapies and vaccines, so that vital medical breakthroughs can safely be produced. 

Key Players:

• Danaher Corporation (US)
• Merck KGaA (Germany)
• Sartorius AG (Germany)
• 3M Company (US)
• Repligen Corporation (US)
• Parker Hannifin Corporation (US)
• Eaton Corporation plc (Ireland)
• Thermo Fisher Scientific, Inc. (US)
• Donaldson Company, Inc. (US)
• Porvair PLC (UK)
• Alfa Laval Corporate AB (Sweden)
• Corning Incorporated (US)
• MANN+HUMMEL (Germany)
• Saint-Gobain (France)
• STERIS plc (US)
• Meissner Filtration Products, Inc. (US)
• Amazon Filters Ltd. (UK)
• Graver Technologies, LLC. (US)
• MMS AG (Switzerland)
• ErtelAlsop (US)
• Kasag Swiss AG (Switzerland)
• Freudenberg Filtration Technologies SE & Co. KG (Germany)
• Cole-Parmer Instrument Company, LLC (US)
• Filtrox AG (Switzerland)
• Membrane Solutions (US)

Recent Development:

• A novel product Vivaflow SU has been launched by Sartorius AG, to be launched in September 2024, that will break a new record in the history of tangential flow filtration TFF for lab applications. The innovative product, Vivaflow SU, will allow ultrafiltration and diafiltration processes in an efficient and environmentally friendly way, using feed volumes from 100 mL up to 1,000 mL. 

• In August 2024, Donaldson Company, Inc. acquired Medica S.p.A., a firm that specializes in hollow fibre membrane filtration technology for a variety of medical device application and water purification. Henc e, the acquisition will expand the overall product portfolio of Donaldson. 

• In June 2024, Danaher Corporation was going to enjoy the launch of its newly introduced Supor Prime sterilizing grade filters that aim directly at the diverse needs of customers who manufacture drugs based on very high concentration biologics. Engineered perfectly for drug developers, the Supor Prime filter will yield increased quantities in their processes; it will prevent early blocking which causes stopped production. More importantly, it ensures efficient limitation of costs created by losses during the filtering process.

Segment Insights:

By Technique

The microfiltration segment proved to be a very important and substantial part of the whole market. In the year 2022, it accounted for a share of 34.41%. This particular segment has managed to achieve this enormous dominance majorly due to its great versatility along with the overall capability of its effective removal of all types of impurities from nearly every sort of biopharmaceutical product. Secondly, this microfiltration technique demonstrates an incredible ability to remove both impurities and particles without imposing any inhibitory effect on biological activity or stability of the medium to be filtered. Furthermore, various strategic initiatives are actively being undertaken by manufacturers of microfiltration systems, which will play a significant role in continuing to support and promote the growth of this important segment within the industry. For instance, in April 2023, the Meissner Corporation made a noteworthy announcement regarding its decision to invest a substantial amount of USD 250 million toward the establishment of a new manufacturing facility located in the United States. This facility is intended for the purpose of developing cutting-edge microfiltration technologies and advanced systems specifically designed for therapeutics manufacturing. Nanofiltration is expected to be growing with the highest CAGR at 10.20% during the forecast period as this technique has the benefit of filtering only particles of specific size and charge, thus remitting high usage in separating small molecules and removing endotoxins and pyrogens. Also, as nanofiltration demands less energy compared to ultrafiltration and reverse osmosis, it further propels the growth of the nanofiltration segment.

By Product Type

Impressively, the final product processing segment has managed to preserve its highest share of 41.55% throughout last year 2022 that also means a prominent share of the market. As for this share, several vital issues must be brought into question and the nature of importance will further clarify that this type is most essential and critical from safety and efficacy points as per final product, and accordingly ensures fulfilment according to set regulatory guidelines. All such impurities or contaminates may get thoroughly removed from such impurity existence using appropriate eliminating means and enable the product totally complying with regulatory guidelines based on the final product by providing impurities totally cleared according to these set guidelines. Of these critical features, there are specific regulatory guidelines established by U.S. FDA, EMA, Japanese Ministry of Health, and others have very strict guidelines for biologics and vaccine manufacturing requiring multiple steps in the final product processing for quality, purity, and safety, failing to comply with which can lead to termination of approval or the credibility of the manufacturing facility. An example is the one in which, on October 2020, the firm AuroLife Pharma was issued a formal warning letter by the U.S. FDA. This followed several significant violations observed relating to the cGMPs applicable for their finished pharmaceutical drugs. The violations indicated a failure to meet existing guidelines on the manufacture of final products. Since their practices did not even meet the minimum safety requirements as indicated by the regulatory standards, the firm's products were found adulterated in the long run. During this time interval from 2023 until 2030, the CAGR of the cell separation market is expected to emerge as 8.14%. The growth in the demand for cell separation will happen majorly due to its rise as a treatment for disorders like genetic disorders and several more medical cancer diseases. CAR-T therapy as well as stem cell therapy are those whose market acceptance is more prominently, respectively because of the increasing diseases related to cancer, as well as autoimmune diseases, along with so much more.

Regional Insights:

In 2022, North America was a very critical and market leading position in the industry with the impressive revenue share of 43.23%. Several reasons which proved very decisive contributed to this spectacular dominance; among them is the existence of a number of large pharmaceutical and biopharmaceutical companies. The existence of a well-developed healthcare infrastructure, in addition to the accessibility of advanced medical products to this region, has really fueled growth and development in the healthcare sector. Moreover, the policies related to healthcare coverage in the United States allow patients to receive the treatments they need, which therefore compels biopharma manufacturing companies and academic institutions to exert further efforts for the advancement of drugs. For instance, according to a Congressional Research Service report in 2021, close to 91.4% of the American population receives protection of some form of medical insurance.

Segmentation:

By Product 

• Membrane Filters
• Prefilters and Depth Media Filters
• Single-use Systems
• Cartridge & Capsule Filters
• Filter Holders
• Filtration Accessories
• Other Products

By Technique

• Microfiltration
• Ultrafiltration
• Cross Flow Filtration 
• Nano filtration
• Others

By Application

• Active Pharmaceutical Ingredient Filtration
• Vaccines and Antibody Processing
• Formulation and Filling Solutions
• Viral Clearance
• Media Buffer
• Cell Separation
• Water Purification
• Air Purification

By Scale of Operation

• Manufacturing Scale
• Pilot Scale
• Research & Development Scale

By Region

North America

• USA

• Canada

• Mexico

Europe

• France

• UK

• Spain

• Germany

• Italy

• Rest of Europe

Asia Pacific

• China

• Japan

• India

• South Korea

• Rest of Asia Pacific

Middle East & Africa

• GCC

• South Africa

• Rest of the Middle East & Africa

South America

• Brazil

• Argentina

• Rest of South America

What to Expect from Industry Profile?

1. Save time carrying out entry-level research by identifying the size, growth, major segments, and leading players in the Pharmaceutical Filtration market in the world.

2. Use the PORTER’s Five Forces analysis to determine the competitive intensity and therefore market attractiveness of the Global Pharmaceutical Filtration market.

3. Leading company profiles reveal details of key Pharmaceutical Filtration market players’ global operations, strategies, financial performance & recent developments.

4. Add weight to presentations and pitches by understanding the future growth prospects of the Global Pharmaceutical Filtration market with forecast for the decade by both market share (%) & revenue (USD Million).

FAQ’s

1) What are the major factors driving the growth of the Global Pharmaceutical Filtration Market?

• The Rising Demand for Biopharmaceuticals are the major factors driving the growth of the Global Pharmaceutical Filtration Market

2) What would be the CAGR of the Global Pharmaceutical Filtration Market over the forecast period?

• The Global Pharmaceutical Filtration Market is poised to grow at a CAGR of 18.6% from 2024 to 2032.

3) Which region will provide more business opportunities for the growth of the Global Pharmaceutical Filtration Market in the future?

• The North America region is expected to create more opportunities in the market.

4) Who are the major players dominating the Global Pharmaceutical Filtration Market?

• Danaher Corporation (US), Merck KGaA (Germany), Sartorius AG (Germany), 3M Company (US), Repligen Corporation (US), Parker Hannifin Corporation (US), Eaton Corporation plc (Ireland), Thermo Fisher Scientific, Inc. (US), Donaldson Company, Inc. (US), Porvair PLC (UK), Alfa Laval Corporate AB (Sweden), Corning Incorporated (US), MANN+HUMMEL (Germany), Saint-Gobain (France), STERIS plc (US), Meissner Filtration Products, Inc. (US), Amazon Filters Ltd. (UK), Graver Technologies,  LLC. (US), MMS AG (Switzerland), ErtelAlsop (US), Kasag Swiss AG (Switzerland), Freudenberg Filtration Technologies SE & Co. KG (Germany), Cole-Parmer Instrument Company, LLC (US), Filtrox AG (Switzerland), Membrane Solutions (US).

5) What are the segments in the Global Pharmaceutical Filtration Market?

• By Product, By Technique, By Application, By Scale of Operation are the industry key segments considered for research study.

6) What is the estimated market revenue for the Global Pharmaceutical Filtration Market in 2032?

The estimated revenue for the Global Pharmaceutical Filtration Market in 2032 is USD 31,746.21 Million.