LOTS OF SPONSOR ACTIVITY
Investments in biologics facilities by sponsor companies cover all aspects of biologics drug development and manufacturing, including API production, fill-finish and packaging operations. In addition, not only international, big pharma/biotech firms, but also developing start-ups are making these investments. Ireland and Singapore are two hot spots for recent biopharma investment, but dollars are being spent around the globe. Many announcements have been made as recently as December 2015/early 2016.
Recent big pharma/biotech investments include:
• Expenditure of approximately $550 billion by Boehringer Ingelheim to expand its biopharmaceutical production capabilities in Vienna with the construction of a large-scale manufacturing facility for biologic APIs manufactured using cell cultures.
• Bristol-Myers Squibb is planning to build a new state-of-the-art, large-scale biologics manufacturing facility in Dublin at a cost of ~$900 million that will produce multiple therapies. The company is also expanding its recently opened $500 million biologics production site in Devens, MA.
• Novartis has broken ground on a new $500 million biologics plant in Singapore. Its generic pharmaceuticals business, Sandoz, recently inaugurated its new, nearly $165 million, state-of-the-art BioInject biopharmaceutical manufacturing facility in Austria.
• Biogen plans to invest $1 billion to triple its biologics capacity with the construction of a fourth manufacturing plant in northern Switzerland.
• AstraZeneca acquired a high-tech biologics bulk manufacturing facility in Boulder, Colorado, from Amgen in September 2015 that it is refurbishing. The site is expected to be operational in late 2017. The purchase followed announcements that AstraZeneca is investing $285 million in a biologics facility in Sweden and expanding its Frederick, Maryland, site. The new Swedish facility will focus on filling and packaging of protein therapeutics and, from 2018, supplying medicines for the clinical trial programs of AZ and its MedImmune subsidiary.
• Pfizer is spending $100 million to upgrade its biologics plant in Ireland.
Genzyme is investing $80 million at its recently approved facility in Framingham, MA, adding more downstream processing capabilities for Fabrazyme, its treatment for Fabry disease.
• Eli Lilly is completing a $450 million biologics facility in Ireland. In 2013, the company also announced nearly $1 billion in planned plant expansions for the production of its insulin products, including API and cartridge manufacturing capabilities.
• Amgen opened in August 2015 a $300 million facility including a syringe filling facility and a cold chain warehouse in Singapore. The facility uses disposable technology, continuous processing and real-time analytics, has a replicable and flexible modular design with a small footprint for reduced energy and water consumption and waste generation. It was also constructed in half the time required for a conventional plant, according to the company.
• Baxter opened its first biologics facility in Asia in 2014. The $370 million facility in Singapore produces ADVATE and will also manufacture treatments for hemophilia B once a second expansion suite opens in 2017.
• Roche announced in 2013 that it is investing $880 million in biologics manufacturing capabilities, including an ADC manufacturing plant in Switzerland and expansion/upgrades of sites in California and Germany. Its Japan-based subsidiary Chugai Pharma is also investing $310 million in antibody production capacity at a plant in Tokyo. An additional $125M investment in an expansion of a Genentech fill/finish facility in Oregon was announced in March 2015.
Smaller biotech firms have not been idle, either:
• Regeneron will be investing an additional $350 million on top of its initial $300 million investment to create a pharmaceutical plant at a former Dell computer manufacturing site in Ireland.
• Alexion Pharmaceuticals plans to construct the company’s first biologics manufacturing facility outside of the United States. The nearly $500 million investment in Ireland will take four years to complete.
• Allergan is spending $350 million on a new biologics facility in Ireland to expand its manufacturing capacity for Botox and develop a manufacturing base for the next generation of biologic products currently in the Allergan pipeline.
• Jazz Pharmaceuticals is constructing its first plant in Ireland at a cost of $68 million.
• Grifols is investing $85 million in a purification plant for protein albumin at its biologics plant at Grange Castle, Dublin, earlier than planned in order to meet growing demand.
• ShangPharma plans to establish a subsidiary in the Qidong Biopharma Industrial Zone as part of a multistage expansion project for its biologics service portfolio, with $60 million invested in the first phase to build pre-clinical research and biologics manufacturing facilities. The latter should be operational in 2018.
CONTRACT BIOPHARMA MANUFACTURERS SPENDING, TOO
With the high level of in-house investments being made by sponsor companies, it might at first glance be surprising that biopharmaceutical contract manufacturers have also been expanding their capacities. Notably, most of these investments are being made by larger contract development and manufacturing organizations (CDMOs) offering full support to biologic drug manufacturers from discovery to commercial manufacture.
Many of these firms are leaders in the industry and are investing now in order to meet anticipated increased demand for their services. Others are focused on offering contract development and manufacturing services for advanced and next-generation technologies that require highly specialized capabilities, and in some cases the development of new technologies and processes to enable commercialization (such as for cell and gene therapies).