Single-use bioprocessing technologies:
In 2011, single-use/disposable bioprocessing systems further increased their dominance for the manufacture of biopharmaceuticals
for preclinical R&D and clinical testing. Single-use systems dominate noncommercial-scale biopharmaceutical manufacturing
in most regions. Single-use systems are increasingly being adopted for upstream manufacturing, such as adoption of single-use
bioreactors and other upstream equipment. Despite dominance within precommercialization manufacturing segments, single-use
systems remain a relatively small market compared with fixed stainless-steel equipment, capturing only approximately 10% of
the overall bioreactor market. Stainless steel remains the preference for commercial GMP manufacturing. In as short as 10
years (approximately about how long it takes a biopharmaceutical to reach the market), half or even more of new commercial
biopharmaceutical manufacturing systems can be expected to be largely or fully single-use based.
Most industry attention in recent years, including blockbuster products and manufacturing technology development, has concentrated
on recombinant proteins produced by mammalian cell culture. Mammalian cell-culture capacity and facilities continue to dominate
worldwide biopharmaceutical manufacturing (2). Microbial manufacturing remains relatively stable with few new technologies,
and few major bioprocessing equipment developers announcing novel devices. A confluence of trends, however, is contributing
to increased use of microbial (i.e., bacteria, yeasts, and other fungi) host cells for recombinant-protein manufacture.
Companies of all sizes worldwide continue to increase their outsourcing, particularly R&D and manufacturing. These activities
include increasing the use of CROs, particularly for high-throughput screening, lead identification, toxicological studies
as well as greater use of CMOs for commercial manufacturing. Based on the BioPlan annual survey that evaluates 24 outsourced
activities, the primary outsourced activities include product-characterization testing, with 70% of biopharmaceutical companies
outsourcing at least some of this activity. Other tasks routinely outsourced include validation services (69% of biomanufacturers
cited), toxicity testing (65%), analytical testing/bioassays (61.1%), and fill–finish operations (60.0%). Relatively few companies
have outsourced all of their manufacturing, but nearly one-half of surveyed manufacturers expect to increase their budgets
for biopharmaceutical CMO outsourcing.
Overall bio/pharmaceutical trends
These trends are, in large part, resulting from global shifts that continue to drive the bio/pharmaceutical industry. Below
are broad industry trends we project in 2012.
The worldwide market for biopharmaceuticals continues to expand and at a more rapid rate than for pharmaceuticals in general.
The world market for biopharmaceuticals is approximately $140 billion, with approximately $100 billion involving recombinant
proteins and antibodies (2). The market includes over 430 biopharmaceuticals, including over 300 recombinant proteins and
antibodies that are approved in the US and/or Europe. The biopharmaceutical market has been and is expected to continue to
grow about 15–18% annually, well above overall economic growth rates. This steady overall growth rate is driving much current
investment in biopharmaceutical R&D.
Despite increasing biopharmaceutical sales, the number and rate of biopharmaceutical approvals in the US has been relatively
poor in the past few years (12 biopharmaceuticals entered the US market in 2011). The 2011 approvals were even fewer in number
than the relatively poor results in 2010 and 2009 (4). This weak showing for biopharmaceuticals is in contrast with FDA reporting
in November 2011 near record overall pharmaceutical approvals. The 2011 FDA biopharmaceutical approvals are listed in Table
Table I: FDA full biopharmaceutical approvals in 2011.**