Balance achieved in biomanufacturing capacity

The notion that there is chronic undercapacity in biomanufacturing has become common wisdom, but a new study suggest that for the first time in years, there may actually be a balance between supply and demand.

The study,conducted by HighTech Business Decisions, notes that the biopharmaceutical contract manufacturing market continues to grow as funding returns to the biotechnology sector and new capacity comes online at contract manufacturing sites.

In 2002, the downturn in the economy and numerous biopharmaceutical product failures in clinical trials caused a slight cutback in the number of biotechnology-based drugs being developed and some manufacturing projects were put on hold.

This year, however, more biotechnology products are moving through the pipeline requiring increasingly larger volumes of production.

By 2008 to 2010, commercial-scale production of at least 50 new biotechnology products will be required, the study suggests.

Sandra Fox, president of HighTech, said: "Typically, the industry goes through cycles of too little capacity versus too much.

In the past few years, capacity shortages drove contractors and pharmaceutical and biotechnology companies to build biomanufacturing capacity at an unprecedented rate.

The setbacks to the biotechnology community occurring in 2002, including restricted funding and some clinical trial failures, along with the newly built capacity, have brought the industry back in balance between capacity and needs."

Fox believes that the industry will continue to grow at a measured pace as biopharmaceuticals move through the pipeline to commercial scale and new capacity continues to come online.

However, with the large number of biopharmaceutical products expected to reach the market in the next five to 10 years, however, capacity shortages may again occur, she predicts.

According to the report, biomanufacturing managers at pharmaceutical and biotechnology companies say that the top three reasons they outsource biomanufacturing are: lack of in-house capacity; lack of in-house expertise; and a need for quick production of material.

The market for biopharmaceutical contract manufacturing is expected to grow by almost a third between 2003 and 2004, from $1.3 billion to $1.7 billion, said HighTech.

Major contractors providing mammalian cell culture or microbial fermentation production technologies include Abbott Bioresearch Center, Avecia Biotechnology, BioReliance, Boehringer Ingelheim, Cambrex Biopharmaceutical Services, Dowpharma, GlaxoSmithKline Biopharmaceuticals, Lonza Custom Manufacturing, Diosynth-RTP, Sandoz GmbH and DSM Biologics.

For more information on the 750-page report, called Biopharmaceutical Contract Manufacturing: Serving the Growing Need for Biopharmaceutical Production, contact HighTech.