Biopharmaceutical contract manufacturing organizations (CMOs) are set for rapid growth, thanks to the upcoming expiration of pharmaceutical patents over the next six years.
The global biosimilars market is projected to grow at a robust compound annual growth rate (CAGR) of 60.4 percent between 2012 and 2019, according to a market report from Frost & Sullivan. A biosimilar is a product that is highly similar to a U.S.-licensed reference biological product. As patents expire, the market for biosimilar products expands significantly as non-patent holders begin to compete.
"Due to the steep cost and long time needed to build, equip and validate a biomanufacturing facility, the majority of biopharmaceutical companies prefer leveraging the expertise of CMOs," explained Frost & Sullivan Healthcare Senior Research Analyst Aiswariya Chidambaram.
"CMOs have made substantial investments in infrastructure, technology, and personnel in recent years, and are capable of providing uncomplicated, timely, and cost-effective services,” she continued. “They are also well versed with regulatory compliances and work closely with regulatory agencies, thereby reducing time-to-market."
Other areas that are priming the industry for growth are advances in bioprocessing technologies as well as innovation in biopharmaceuticals production with transgenic plants and animals, stem cells and cloning.
One such advance is disposable technology, which helps minimize production costs. Disposable equipment and single use bioreactors are alternatives to conventional stainless steel equipment, offering the advantages of flexibility, short start-up time, quick changeover between production campaigns, and absence of Clean in Place, Steam in Place, and large volumes of Water for Injection.
As big pharma companies increasingly adopt the Large Molecules model, CMOs also will likely see a boost in business. The big pharma shift to large molecules will likely be led by monoclonal antibodies (mAbs) and is projected to grow at a CAGR of 10.8 percent from 2012 to 2017.
The trend toward outsourcing shows no signs of slowing, and, as such, companies will seek to adopt an integrated/risk-sharing business model. CMOs are looking to provide a "one-stop-shop" option for the biopharmaceutical companies where they can use the resources and expertise of the CMOs, while the pharma companies concentrate on their core capabilities and R&D activities.
"As biopharmaceutical companies continue to focus on improving efficiency and productivity at lower costs, CMOs are required to achieve the same internally through better integration of services and remaining at the forefront of technology," Chidambaram said.
Edited by
Alisen Downey
