A good early indication of where the global bioprocessing market will go is that bioprocessing companies are generally in good shape performance-wise. In the latest financial releases, Eppendorf, Sartorius, Thermo Fisher, and other key players reported 2019 revenues in the high single-digit to low double-digit range.

Bruce Carlson of Kalorama Information.

Along with the major pharmaceutical companies, bioprocessors are ramping up their research and development efforts in the area of oncology. This area will represent a major effort for the immediate future.

One of the more interesting trends that have evolved involves how biopharmaceutical manufacturers have been collaborating and partnering with healthcare companies and other stakeholders to form collaborations that attempt to solve scientific and technological issues, speed up the commercial delivery of new therapeutics, and generally make research more efficient.

Overall, SDI and KI expect the following:

• Growth in high single digits for the market overall
• A continuing trend toward single-use components and improved productivity of cell culture/line productivity
• Improvements in purification membranes and resins
• A move toward continuous bioprocessing from batch methods, with the general goal of streamlining processes to cut costs and processing time and be more competitive
• The development of more biologic drugs
• Demand from healthcare systems for increased volumes of drugs at decreased prices, forcing manufacturers to develop novel processes that cut their capital investments
• The continued popularity of outsourcing, in spite of the complexity of bioprocessing steps
• The introduction of new therapeutics, such as CAR-T cells and gene therapy, which will drive bioprocessing

The last several years have experienced an important shift in the nature of the products produced and marketed by the biopharma industry. Today's biopharmaceutical portfolio shows more therapeutic competition, a greater prevalence of large molecule drugs, more personalized or targeted products, and an increase in the types of treatments for many orphan diseases. These trends have given rise to biopharmaceutical products with highly specific manufacturing requirements.

Biotechnology companies, bioprocessors, and biotherapeutics producers face a number of issues and challenges to their continued success and the development of future therapeutics. Most recently, a key challenge has involved productivity. To be successful, it is necessary to straighten out any operational challenges. The downstream bioprocessing segment is playing a more important role in therapeutic production as companies attempt to optimize the segment to avoid bottlenecks and speed up processing so they can deliver product to market more efficiently.

For many bioprocessors, the biggest challenge has been to produce enough products to sell. As a result of successes, many large drug manufacturers are shifting their research to large-molecule products. Bioprocessing will inherently become a more complicated, intertwined production process thanks to the implementation of continuous manufacturing, single-use, and other technologies downstream. Bioprocessors must innovate to be able to continue to command premium prices. For them, speed, process innovation, and operational excellence are must-win battles.

The companies which are located in emerging markets will have to find their own niches with the right operational and quality performance to make the best use of access to, and knowledge about, their local markets. Contract manufacturers will have to spur process innovation and operational efficiency while retaining an excellent reputation for service and performance.

In many instances now, bioprocessors are outsourcing a variety of functions, such as process development, research, testing, validation, and bioprocessing design, among others. Manufacturers harness outsourcing to eliminate the need to construct expensive specialized facilities or hiring and training staff.

There may be instances of reductions in outsourcing capabilities and capacity. Although some contract manufacturers have been investing in large-scale capacity, they have only kept pace with existing needs for the most part. Many have not made any further expansions of any significance; however, these expansions are being planned. The expected strong market for biosimilars should help contractors learn the ropes when it involves cGMP manufacturing. This, in turn, will generate more competition among commercial-scale-capable biopharmaceutical contractors.

Bruce Carlson is the publisher of market research firm Kalorama Information, part of Science and Medicine Group.

Disclosure: Strategic Directions International and Kalorama Information are sister companies of The Science Advisory Board.