The Biopharmaceutical Contract Manufacturing Market
The production of biopharmaceuticals often requires a far more complex manufacturing process than a traditional small molecule drug. Biopharmaceuticals tend to be large-molecule proteins made using microbial fermentation, mammalian cell culture, insect cell culture, and/or transgenic technologies. Viral production is needed for gene therapy products. The construction of a biomanufacturing facility requires four to five years to complete and validate, and can cost between $250M to $400M per facility. Given the unpredictability of whether or not a product will win FDA approval, pharmaceutical and biotechnology companies have been reluctant to build capacity and biomanufacturing expertise until the success of the product is known. Contract biomanufacturers have been available to produce products for clinical trials and commercial markets, allowing time for the decision-making process regarding the building of in-house capacity and expertise.
However, demand for microbial fermentation and mammalian cell culture production capacity is expected to soar in the next few years as multiple biotechnology drugs in the pipeline make it to commercial markets. Between 2002 and 2006, the size of the biopharmaceutical contract manufacturing market is expected to double, reaching more than US$2B in 2006, with revenues rising in tandem with contractors' new capacity coming online. To keep up with the increasing demand, which could reach a total level of one million liters of tank space required for contract manufacturing services, contractors are building, acquiring, and expanding capacity while making better use of existing capacity.
>> Biopharmaceutical Contract Manufacturers Directory
High-Throughput Screening For Drug Discovery
HTS has become the workhorse of pharmaceutical and biotechnology companies' drug discovery efforts, with expanding responsibilities and increasing pressure to screen more targets with better compound libraries to find high-quality leads.
How drug discovery efforts are managed within HTS laboratories worldwide varies, with different approaches, tools, and strategies being applied. A significant number of HTS laboratories have been in existence for 10 years or more, and expectations are high that successes (drugs that make it to the market) are imminent.
There is a concerted effort to improve the quality of compound libraries, increase throughput to accommodate more compounds and more targets, and find more leads that become clinical candidates. The G-protein coupled receptors (GPCRs) and kinase enzymes are the most often used targets and the average number of targets screened in 2002 per HTS laboratory is 20. Throughput is expected to double between 2001 and 2003.
Suppliers provide (1) compounds and diverse combinatorial chemistry libraries or equipment to synthesize and handle these compounds, (2) validated disease targets or services to generate targets, (3) reagents, dyes, platforms, and kits for assays and assay development, (4) robotics, liquid handlers, and software for laboratory automation, (5) microplates, coated microplates, microfluidics, microarrays and other consumables (6) detection and imaging equipment, (7) sophisticated software programs for data management and data sharing, storage, analysis and data mining, virtual screening, computational chemistry, and (8) services that range from biological reagent labeling to primary screening and lead optimization.
Those companies providing technologies, tools and services for
high-throughput screening for drug discovery are listed in our
complimentary directory of suppliers.
>> High-Throughput Screening Supplier Directory
Articles and Presentations
Sandra Fox and associates have produced more than 100 trade journal articles and conference presentations regarding pharmaceutical, biotechnology, and electronics industry topics since 1990.
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