Membrane Technology for Biopharmaceuticals

Report Highlights

• The market for membrane technology used in biopharmaceutical discovery, development and commercial production, estimated at $740 million dollars in 2004, is expected to rise at an average annual growth rate (AAGR) of 10.7% to $1.23 billion in 2009.
• Sales readily can be tied to increases in R&D spending that has grown by an average of 11% annually from 1993 to 2003, the growing number of biotech drugs in the pipeline and skyrocketing sales of approved biopharmaceticals.
• Expanded production capacity for bioprocessing will continue to accelerate growth rates across the spectrum, including membrane-based cell culture systems, microfiltration and ultrafiltration of protein solutions, virus removal, and the production of pharmaceutical-grade makeup water.

INTRODUCTION

To facilitate the identification of tiny molecular variations, or mutations, life science companies developed increasingly advanced and very-high-throughput automated analytical systems. Membranes are an enabling technology in all phases of the process used to bring biotech drugs to market, from laboratory research to large-scale pharmaceutical manufacturing.

Membranes ease the handling of biological samples for microscopic analysis and are used in the laboratory setting for the transfer, immobilization and detection of DNA, RNA and proteins. Other lab-scale applications include sterilization of cell culture media, particulate removal and solution clarification. The generation of ultrapure water, essential to the life science lab, also is made possible by point of use membrane filtration systems.

Large-scale bioprocessing applications for membranes are found in the production of vitamins, vaccines, antibiotics, therapeutic protein drugs and monoclonal antibodies, where filtration systems are used for purification and clarification of various biological solutions. Cells grown in membrane bioreactors secrete valuable products for therapeutic drug manufacture. The removal of potentially harmful viruses encountered in drug production also may be accomplished using membranes.

This BCC technical market report provides an in-depth analysis of the market for membrane technology across a range of life science/biotech applications including gene and protein analysis, drug candidate screening, laboratory separations and water treatment, cell culture, virus removal and drug production, all of which are vital to the pharmaceutical industry’s continued success.

SCOPE OF STUDY

The report contains:

• An overview and history of the industry
• In-depth analysis of the markets for membrane technology vital to bringing drug products to market including:
    - gene and protein analysis
    - drug candidate screening
    - laboratory separations and water treatment
    - cell culture
    - virus removal
    - drug production
• Five-year projections through 2009 for market activity and value
• Industry structure, technological trends, pricing considerations, R&D, government regulations, company profiles and competitive technologies.

METHODOLOGY

A comprehensive literature, patent, and Internet search was undertaken and key industry players were queried. News and current developments in the field are evaluated in BCC's monthly newsletter Membrane & Separation Technology News, which was also used in compiling the report. The related BCC reports C-073N Separation Systems for Commercial Biotechnology and C-232 Ultrafiltration Membrane Industry: Developments and Markets were valuable as information sources. Other information sources are listed below.

Growth rates were calculated based on existing and proposed device and equipment sales during the forecast period. Membrane consumables used in bioprocessing were also taken into account.

For single use devices: syringe filters, centrifuge filters, bottletop filters, transfer membranes, etc., market value is based on estimations of unit sales. Price per unit is based on the median device cost, which is presented in the report section profiling each product type. For example, microarrays can be processed at a rate of up to 600 membrane-topped slides per week. (The National Cancer Institute scans 200 to 400 weekly using three array readers.) However, an average research lab probably processes about 100 microarrays weekly, the figure use to calculate market size.

High throughput drug screening is characterized as an average weekly output of 80,000 wells, or about 160 96-well plates per day. Syringe filter sales relate to multiwell plate sales, as they are used, among other applications, in tandem with the automated workstations that process the plates.

The cell culture market size is based, in part, on the BCC report C-086R-Cell Culture Systems and Conventional Bioreactor Technology, which estimates hollow fiber bioreactor size at no more than 5% of the total cell culture market. The annual reports of public companies manufacturing the systems back up this assumption.

After reviewing biopharmaceutical manufacturers' manufacturing processes, it can be assumed that 90%, or more, of drug producers employ membrane filtration. An "average" plant requires about 100 square meters of membrane area. Installed system costs range from $300 to $1,200 per square meter of membrane; replacement membrane costs average from about $30 to $200 per square meter depending on configuration. Hollow fiber modules are at the low end (>$30/ m2), while plate and frame, and tubular elements are at the high end ($150/m2 and up). For reusable, mostly UF, elements, membrane lifetimes average about one year. Disposable, mostly MF, elements' lifetimes are measured in mere hours; their use can be estimated by batch.

Values are given in U.S. dollars; forecasts are made in constant U.S. dollars, and growth rates are compounded. Calculations do not include design or installation costs, or validation expenses.

INFORMATION SOURCES

Information used in the preparation of this report was gleaned from the monthly BCC newsletters Membrane and Separations Technology News and Analytical Separations News, SEC filings, annual reports, patent literature, , scientific and industry journals, government reports, census information, conference literature, patent documents, online resources and industry participants.

AUTHOR'S CREDENTIALS

During the past 6 years, Susan Hanft has authored numerous BCC technical market reports in the fields of membrane technology and water treatment. Ms. Hanft also serves as editor of the BCC newsletter Membrane & Separations Technology News.