The biopharmaceutical industry is starting 2012 with good reason for optimism. Based on preliminary results from BioPlan Associates'
9th Annual Report and Survey of Biomanufacturing, biologics manufacturers and their vendors are spending more, demanding better
technologies, and expressing greater optimism than at any time in the nine years we have been assessing this industry. This
year the BioPlan study finds substantial optimism, with a 37.3% of suppliers indicating that their company did either "better"
or "much better" than expected in 2011. Even more relevant, 49.4% expect they will do "better" or "much better" in 2012.
INDUSTRY GROWTH RATES
Sales growth among vendors is a leading indicator of the overall performance of the bio/pharmaceutical industry because vendor
sales are derived from demand for materials biologics production. If vendors are doing welll and are optimistic for the future,
the bio/pharmaceutical industry is likely to follow. Supplier respondents indicated that, on average, sales growth is currently
at approximately 14% annually, up from 13.0% in 2010 and 14.1% in 2007.
BIOPHARMA'S BUDGET TRENDS
Budgets also are a good indicator of industry strength, and budget estimates for 2012 are up strongly in areas such as acquisition
of new technologies, capital equipment, and personnel training and development. Early results from the 2012 BioPlan survey
projects increases in all 12 areas, except for outsourcing (see Figure 1).
Figure 1: Average change in biomanufacturers’ budgets (2009–2012).
These overall trends are in large part resulting from global shifts that continue to drive the bio/pharmaceutical industry.
Below are trends we project in 2012 specifically relating to biomanufacturing.
Internationalization. The bio/pharmaceutical industry continues to expand globally, driven by the need for prudent expansion of infrastructure,
presence in new markets, and cost savings through outsourcing and offshoring, including R&D, which is traditionally performed
in established high-technology regional clusters.
Biomanufacturing capacity also is increasing outside established markets. Although the US and Western Europe remain the leaders
in biopharmaceutical manufacturing capacity, more than 37% of bioreactor capacity is operating in other parts of the world,
including nearly 10% in Japan and the Pacific Rim, 9% in China, and more than 8% in India (2). Western product developers
also are joining with local companies, such as in the local manufacture of vaccines. As more biopharmaceutical manufacturing
is performed worldwide, product developers are working to standardize their products and manufacturing processes, which involves
simplifying their manufacturing processes, so they can be reliably performed with consistent product produced even in facilities
in lesser developed counties.
Single-use manufacturing. The trend toward more global standardized manufacturing is contributing to the adoption of single-use/disposable bioprocessing
equipment, which allow the same manufacturing systems to be shipped and installed at multiple facilities. Some companies,
with major vaccine manufacturers among the leaders, are starting to think more in terms of selling full manufacturing and
technology packages, including all needed equipment and technology transfer, not just finished end-products, to foreign countries
that are seeking local manufacture of vaccines for domestic distribution. Companies, such as GE and Biologics Modular, for
example, are developing fully modular, drop-in-place-type, and equipment preinstalled or simply installed single-use bioprocessing-based
facilities to address the interest for prepackaged biopharmaceutical manufacturing facilities.
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.
Microbial manufacturing. 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.
Outsourcing. 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.