[pullquote]Passing the second quarter of 2017, there seems to be little evidence that the biologics sector of pharma will slow down. Robust growth and expansion of the biologics market over the last few years has led to a highly competitive sector in manufacturing new biologic entities (NBEs) and biosimilars. Analysis from the 2017 Nice Insight Contract Development and Manufacturing Survey found 51% of respondents were engaged in the development of NBEs, and 33% were engaged in the development of biosimilars.
BCC research finds the global biologics market is expected to grow 46.7% from 2014-2021, grossing an estimated $72.7 billion over the seven-year period, with monoclonal antibodies owning 53.4% of the market. Drivers for projected market increases said BCC include big brand-name drug patent expirations, growing incidence of chronic diseases globally, and increased availability of advanced diagnostics.
The 2017 Nice Insight CDMO Outsourcing survey offers similar insight; the respondent product pipeline for biologics revealed vaccines are the most common product at 51%, followed by blood factors (46%), hormones (44%) and antibody drug conjugates (42%).
Industry watchers such as BioPlan Associates echo the sentiment. BioPlan’s 13th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production revealed robust market stats and growing capacity capabilities not only in established global markets, but also in emerging markets.
Capital continues to flood the sector, which continues to fuel tremendous growth. Eric Langer, president and managing partner for BioPlan Associates reports annual sales of biopharmaceuticals are now more than $200 billion globally, and industry revenue continues to grow at a rather steady ≤15% annually. This includes confirming an increasing number and percentage of pharmaceuticals entering the market are biopharmaceuticals, with about 40% of Big Pharma and overall pharmaceutical R&D/pipelines now involving biopharmaceuticals, not drugs (chemical substances).
Lastly, the sector is winning. In 2015, the Center for Drug Evaluation and Research (CDER) approved 45 new molecular entity (NME) and new Biologics License Applications (BLAs), a peak number. In 2016, CDER approved 22 novel drugs, approved either as NMEs under New Drug Applications (NDAs) or as new therapeutic biologics under BLAs. But again, pipelines are full, so the pace, though moderating a bit of late, will stay steady.
Top companies are announcing significant expansions of capacity and technical ability. For instance, last fall, Catalent celebrated a new $34 million extension to its advanced Madison, Wisconsin, biologics manufacturing facility. Catalent announced that the additional 22,000 sq. ft. of space will accommodate a new 2 x 2,000-liter single-use bioreactor system. This will allow the company to accommodate late-phase clinical and commercial production of up to 4,000-liter batches. The new footprint will also support the expansion of analytical and process development laboratories, as well as additional office space. This expansion follows activity announced in 2015, including major expansion of its bioassay and protein characterization capabilities at its Kansas City facility and new integrated analytical capabilities at the Madison facility.
Similarly, German CDMO Rentschler Biotechnologie announced the opening of a 6,000-liter-capacity facility at the company’s site in Laupheim. Revealing their confidence in the market’s potential, the system increases Rentschler’s manufacturing capacity for the second time within a year; a new 2,000-liter, single-use bioreactor was put into operation in 2015.
Earlier this year, Fujifilm Corp. announced the expansion of its BioCDMO division to increase production capacity and meet growing demand. The company revealed it has invested $130 million in its facilities in the United States and UK, including a $93 million cGMP production facility — built in part with funding from BARDA (Biomedical Advanced Research and Development Authority). According to Fujifilm, it has plans to invest an additional $28 million to outfit the facility with mammalian cell culture bioreactors and on 2018 projects. Fujifilm said the facility will manufacture the company’s Saturn monoclonal antibody platform with an initial cell culture capacity of 6,000L.
Development and investment continue to flow into the biopharmaceutical sector, and 2017 will most likely end as another year marking the segment’s trajectory.
