The Chinese CMO sector, in particular, is likely to grow rapidly to meet more of China’s domestic market needs for biopharmaceuticals. And we expect them to begin offering commercial GMP manufacturing services to Western clients ( 4– 6). Eventually, we expect Chinese CMOs to grow in size and sophistication. CMOs in Europe and Asia tend to be more involved in commercial manufacturing fewer are supporting R&D. The United States has a much larger number of small-capacity CMOs supporting R&D and early trials, with the United States the overall leader in biopharmaceutical R&D. The United States/North America, Europe, and Asia/rest of world comprise 35%, 37%, and 17% of global CMO capacity, respectively.Īlthough the United States/North America has the most facilities, the average CMO capacity in this region is lower than that in Europe and Asia/rest of world.
Table 2 lists the regional distribution and average capacity of all facilities and CMO bioprocessing facilities. Table 2: Regional distribution of bioprocessing and CMO facilities, total and average capacity The split between mammalian and microbial capacity (both overall and among CMOs) is estimated at ≥66% mammalian, primarily CHO, and ≤33% microbial, primarily classic Escherichia coli. Such scales are the minimum required capacities generally needed to support a small or mid-sized CMO graduating into the CMO major leagues (those providing commercial manufacturing services). Having 5,000 L ± 3,000 L (or more) capacity at GMP now is the entry level for commercial manufacturing. Thus, many mid- and small-scale CMOs currently support early to middle phases of product development.ĬMOs with capacities in the 1,000–2,000 L range generally find these volumes insufficient to handle most late-phase and commercial-product manufacturing needs. Their services typically end before the usual scale-up and finalization of commercial manufacturing that starts at GMP production of supplies for phase 3 testing. Rather, these small CMOs mostly handle only earlier development phases.
#Capacity crunch meaning full#
Nearly two-thirds of CMO facilities at ≤2,000 L generally do not support the full development lifecycle, particularly late-stage or commercial products manufacturing. Nearly all CMO capacity at ≥2,000 L involves fixed stainless-steel equipment. With most larger CMO facilities owned by a few large CMOs or parent companies, the concentration of CMO capacity in terms of ownership is even greater than for capacity overall. The 58 (12%) largest CMO facilities with capacities ≥10,000 L (each) have an average capacity of ~ 50,000 L, and they collectively hold 82.5% of CMO capacity. About 20% of CMO facilities at ≥5,000 L capacity hold 90% of CMO capacity. In our 2018 survey, more than half (56%) of bioprocessing professionals surveyed reported that their facilities outsource at least some bioprocessing, with 19% outsourcing more than half of their manufacturing operations ( 2).įigure 2: Distribution of total and CMO facilities by facility capacity rangesįigure 2 shows that few CMOs are performing primarily commercial manufacturing, but they hold very disproportionate capacity (and revenue, and often many other parameters). We highlight CMO-related results from BioPlan Associates’ 15th annual Report and Survey of Biopharmaceutical Manufacturing, which includes responses from 222 biopharmaceutical developers/ manufacturers and 130 bioprocessing suppliers or vendors. It also evaluates trends over time and assesses differences in major markets in the United States and Europe. The quantitative trend analysis provides details and comparisons of production by biotherapeutic developers and CMOs.
This year’s study covers such issues as new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, trends and budgets in disposables, trends in downstream purification, quality management and control, hiring issues, and employment. The methodology also included more than 130 direct suppliers of materials, services, and equipment to this industry. The 2018 15th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production yields a composite view and trend analysis from 222 responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations (CMOs) in 22 countries. This analysis follows our recent article examining worldwide bioprocessing capacity status and trends ( 1). Here we examine worldwide CMO biopharmaceutical manufacturing (bioprocessing) capacity, concentrating on “mainstream” CMOs - defined as those providing primarily mammalian cell culture or microbial fermentation services for manufacture at any scale of proteins and antibodies. Contract manufacturing organizations (CMOs) are a core part of the biopharmaceutical industry, with commercial manufacturing making up about a third of marketed products.
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