Eric Langer

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.

Figure 1: Average change in biomanufacturers’ budgets (2009–2012).

MACRO TRENDS

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.