This article presents trends and findings from a survey and study of 222 responsible individuals at biopharmaceutical manufacturers and CMOs in 22 countries, as well as over 130 direct suppliers of materials, services, and equipment to this industry.
Testing for evidence of microbial contamination in bioprocessing has a long history — and can be expensive, slow, and burdensome. So suppliers, testing facilities, and regulators have been seeking improvements.
A number of innovative cellular and gene therapies are in development, and R&D and investments in these fields are rapidly growing. Although the number of approvals and markets remain very small — negligible by the standards of the mainstream (bio)pharmaceutical industry — this is likely to change as the first clinical trials are successfully concluded.
Our discussion of biosimilars in this article will center on developed-market GMP biosimilars. In the European market alone, biosimilars already are a multibillion-dollar business, and one that is rapidly growing.