Biological applications within the pharmaceutical industry have proven to be one of the primary technological development
areas of the 21st century. Productivity in biological R&D has surpassed returns from conventional small-molecule pharmaceuticals,
and the number of biologic license applications (BLAs) has been rising. Increased capital and labor resource allocation towards
biologically-derived pharmaceuticals and biocatalysts has buoyed the biopharmaceutical research market as the new frontier
in innovative drugs. More specifically, the industry's trajectory towards pharmacogenetics has the potential to provide access
to more powerful personalized medicines. Not only will pharmocogenetics remove guesswork from the drug selection process,
it will also speed recovery time and increase safety by significantly reducing the likelihood of adverse reactions. Moreover,
advance knowledge of susceptibility to particular diseases will allow for careful monitoring so that treatments can be introduced
at the most appropriate stage to maximize their effect.
Some well-known large capitalization pharmaceutical companies have recently made significant investments in biotechnology
through acquisitions, in-licensing, or partnership deals with emerging biotech firms. With conventional R&D yielding below-par
returns and the industry's vulnerability to generic competition, the development of large-molecule biologics is an attractive
option for many pharmaceutical companies. Sanofi-Aventis' $20-billion acquisition of Genzyme, completed in April 2011, was
a clear play for positioning within the biotherapeutics market. Also noteworthy are Roche's $47-billion acquisition of the
remaining stock in US biotech Genentech that it did not already own, and Pfizer's $68-billion merger with Wyeth Pharmaceuticals,
which had one of the strongest biotechnology pipelines among large pharmaceutical players.
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According to S&P industry data, biotechnology products are expected to account for 48% of the top 100 drugs of 2016. Of the
25 drugs approved by FDA through August 2011, 21 were new molecular entities (NMEs). According to the Pharmaceutical Research
and Manufacturers of America (PhRMA), biopharmaceutical companies are currently working on 887 cancer medicines, all of which
are either in clinical trials or under review by FDA. The total includes 98 being developed for lung cancer, 91 for breast
cancer, 80 for prostrate cancer, and 55 for colorectal cancer. Biologic-based products accounted for 12 of the 27 new pharmaceuticals
and biologics approved by FDA in 2010. A move away from vaccines in favor of products such as monoclonal antibodies (mAbs)
was the norm until 2007. However, since then, vaccine development has seen a reinvigoration. For example, in 2008, the number
of candidate vaccines in development rose to 223 from just 62 in 2006. MAbs, which had been by far the biggest pipeline category,
were overtaken, despite the rise of investigational drugs from 160 to 192 over the same period.
Much of the motivation for biomanufacturing research has been based on the belief that it is significantly different from
traditional manufacturing and therefore requires different resources and approaches for both engineers and management. In
many cases, the underlying technology required to support production at scale did not even exist five years ago. In fact,
the manufacturing infrastructure needed to support this market is enormous. While the foundation of the needed capacity is
in place for some segments, the capital expenses and development necessary to support a $600 billion per year market requires
much planning and a comprehensive technology map for execution. The key differences between conventional small-molecule manufacturing
and biomanufacturing include:
Transfer of technology
The transfer of products from the prototype stage to production is a significant task in the developmentof biotechnology
and biomedical products because of the complexity of the products and the regulations established by government agencies such
as FDA. Scalability comprises a large part of the difficulty as well. A test tube of organisms will often react differently
than a vat of organisms.
Biotechnology products comprise complex technology that may not yet exist at the time of product conception and design. Managing
the creation of the technology for concurrent design and manufacturing as required for product advancement, and applying it
to products are extremely difficult, but is usually required in biomanufacturing. This provides significant challenges to
companies because they are often required to invent or acquire untested, leading-edge technology as they develop new products.
Development risk of products in biotechnology is generally high because of the leading-edge nature of the products and their
cost of introduction.
Origination of drug candidates
Historically, traditional pharmaceutical companies have developed new chemical entities within their own drug discovery groups.
In the case of biopharmaceuticals, much of the innovation that occurs is not related to the licensing of new drugs from biotechnology.
To date, the traditional pharmaceutical companies have accounted for the introduction of 70% of the approved biopharmaceuticals;
of which over 50% are originated externally.