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.
MACIEJ FROLOW/GETTY IMAGES
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:
- increasing number of global biopharma facilities
- more biological products, many with smaller niches
- more multiproduct facilities
- adoption of single-use systems at clinical/commercial scale
- continuous processing, including perfusion
- high-tech expression systems and other genetic engineering advances
- automation, monitoring, and process control
- bioprocess modeling
- modular facilities adaptable to new enabling technologies, with the ability to repurpose spaces.
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:
- 24% downstream process improvements
- 22% single-use implementation and improvements
- 24% analytical methods
- 30% others: product platforms, cost reductions, materials sourcing, supply-chain regulatory compliance, biosimilars.
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.