The Future of Biopharma

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.

Eric S. Langer

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.

PHOTO CREDIT: DAN WARD/MARIA TOUTOUDAKI/BUENA VISTA IMAGES/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 multi-product facilities

• adoption of single-use systems at clinical and 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.

TREND ANALYTICS

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, etc.

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 multi-site 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.

CONCLUSION

The key trends in this industry are being driven by the need for new efficiencies, greater quality, and cost reductions in manufacturing processes. To remain competitive, especially as biosimilars and biobetters evolve, better ways of evaluating new technologies are needed that cut down on time to market and streamline the overall testing process. There is an increasing demand in the industry today for improved productivity, cost reductions, and higher quality, as companies continue to struggle to do more with fewer resources. Many are relying on suppliers' innovations to advance production processes for current biologics, emerging biosimilars products, and for the production of biologics in emerging markets using flexible processes. The industry's suppliers/innovators continue to demonstrate their commitment by investing in development of new technologies. Concurrently, end-users' demand for improved productivity continues to fund these improvements. More streamlined new product and technology evaluation programs, coordinating trial users throughout the industry, promise to facilitate innovation and its dissemination.

Eric S. Langer is president and managing partner at BioPlan Associates, Inc., elanger@bioplanassociates.com, www.bioplanassociates.com