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Innovation resulting in improved productivity continues unabated and is a primary driver for many of the current biopharmaceutical trends.
The biopharmaceutical industry continues to evolve with expectations of a positive future. Much of this anticipation is driven by pressure for the next new thing, demand for better bioprocessing technologies, and by concerns about weak development pipelines. In response, most large pharmaceutical companies are now devoting increasing development efforts on biopharmaceuticals rather than small-molecule drugs. Some are now spending 40% or more of their R&D budget on biopharmaceuticals. The author examines the impact of these and other trends on the future direction of biomanufacturing.
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Innovation resulting in improved productivity continues unabated and is a primary driver for many of the current biopharmaceutical trends. Innovation speeds discovery, drives down costs, and improves productivity. The current situation in the biopharmaceutical industry is exciting enough, with biosimilars, new technologies, personalized medicines, and opportunities in emerging markets. The industry, however, believes more opportunities for advancement are coming in the near future. Innovations are driving a number of major industry trends; and many ongoing trends, themselves, are driving innovation.
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Biosimilars (and biobetters) are driving trends as well. With more than 700 biosimilars/biobetters in the development pipeline, there will be many more biopharmaceutical manufacturers and products, perhaps as many as a dozen or more for each emulated reference product. This pipeline will mean a lot more new biopharmaceutical industry players, ranging from virtual and foreign to the largest Big Pharma companies, with many new manufacturers and facilities. These competitors are expected to compete on the basis of price; therefore, low manufacturing costs will be required. This low-cost requirement is driving many companies to seek out and adopt bioprocessing innovations that achieve the most cost-effective manufacturing. Some of the biopharmaceutical trends coming in 2013 support a future vision that includes:
To gain perspectives on these and other trends, BioPlan Associates asked the 425 global subject matter experts and senior participants on its Biotechnology Industry Council to evaluate the current trends in bioprocessing and biopharmaceuticals. The more than 100 trends identified were categorized as follows:
This relatively evenly distributed breakout suggests that the industry expects advancements in virtually all areas (see sidebar, "Key micro trends").
Demand for a better technology evaluation process
Rapid and cost-effective evaluation of new technologies is crucial to the industry achieving this expected progress. Evaluating new technologies in the regulated pharmaceutical environment can be slow and costly to both innovators and to the end-users doing the beta or evaluation testing. To reduce these challenges, BioPlan Associates has implemented a New Technology Evaluation Program (NTEP) to help kick-start innovation in bio/pharmaceutical manufacturing. The program helps ensure that the best technologies are eventually adopted by industry, even when their originators are small or resource constrained. The program benefits suppliers by providing high-value evaluations, rapidly getting new products into the right hands for testing, and coordinating multisite testing with integrated, compiled data and reporting. The program benefits those testing new products by giving them access to the most promising and cutting edge technologies while eliminating the need to deal with multiple contacts from multiple suppliers. This process can provide available data from other commercial evaluations as an unbiased resource and can rapidly integrate, publish, and disseminate these findings to industry.
Analytical methods; assays
Biomanufacturing process improvements
Biomanufacturing downstream process improvements
Supply chain, raw materials; control and sourcing
Eric Langer, is president of BioPlan Associates, tel. 301.921.5979, firstname.lastname@example.org.