Investments in biologic capability are projected to fuel industry innovation.
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 a CAGR of 5.8%, 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 like Eric Langer and 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. Langer reports annual sales of biopharmaceuticals are now over $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 maintain a steady pace.
Top companies are announcing significant expansions of capacity and technical ability. For instance, last October Catalent, celebrated the 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.
More recently, 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 US 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 projects it will start operating in 2018. Fujifilm said the FDBT facility will manufacture the company's Saturn monoclonal antibody platform with an initial cell culture capacity of 6,000L (3X 2,000L bioreactors).
Clearly, development and investment continue to flow into the biopharmaceutical sector and 2017 is shaping up to be just another year marking the segment’s trajectory.