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.
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.KEY CHALLENGES
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.