Dawn M. Ecker, consultant and bioTRAK database manager, BioProcess Technology Group

Over the past 15 years, the BioProcess Technology Group (BPTG, formerly BioProcess Technology Consultants) has built and maintained the proprietary internal bioTRAK database to track recombinant biopharmaceutical products from preclinical development through US and EU commercialization. In addition, the firm is watching other biopharmaceutical markets, including for gene therapies and modified cell therapies. BPTG also is considering regional products for regional markets and tracking manufacturing capacity required to manufacture biopharmaceuticals for US and EU markets.

The group leverages that information in conjunction with its forecast methodology to evaluate supply and demand for such products and create custom reports. The dataset at the time of Ecker’s presentation covered products with marketing approval (not including biosimilars). Some products (32) have been removed from the market since BPTG started tracking biopharmaceuticals. More such products are in the pipeline than have achieved market approval. Among all phases of development, proteins expressed by mammalian cells are the dominant product type.

In terms of product and indication, BPTG has a rigorous classification system for biopharmaceuticals. The six classes in the bioTRAK database focus on recombinant proteins, including conjugates:

• antibodies (including fragments, bispecifics, and fusion proteins)
• blood proteins
• cytokines
• enzymes
• hormones (including insulin)
• other proteins (including peptides).

For each product, BPTG tracks a single indication. For marketed products, it uses the largest indication. For a product in development, BPTG looks at whichever indication is most advanced or closest to approval.

Ecker presented a cumulative overview of marketed products between 1982 and 2019. In 1982, Humulin insulin was the first recombinant product approved. Currently, antibodies form the largest category of approvals, followed by hormones and enzymes. Half of all marketed biopharmaceutical products target autoimmune diseases and cancer. However, when Ecker and her colleagues started going through the data set, they realized that it was not complete. So they began defining targets based on product function (e.g., as replacements or modulators). Replacement or enhancement products include those for lysosomal storage disorders for which an enzyme is provided; diabetes, for which insulin is provided; and infertility, for which reproductive hormones are provided. Modulators include Remicade (infliximab), which blocks the tumor necrosis factor inflammation cascade for rheumatoid arthritis, and Avonex interferon, which inhibits inflammation that causes multiple sclerosis flare-ups. In such cases, the process is interfered with to cause a blockade or (in some cases) activation. Data from four decades clearly indicate that antibody products have increased significantly, with a decrease in development of cytokines and hormones. Production of blood proteins, enzymes, and proteins have been consistent over that period.

In her conclusion, Eker noted a significant increase in MAb products, which currently dominate the biopharmaceutical market as well as the current pipeline. Cancer and autoimmune disorders are the top indications for today’s biopharmaceuticals. And although replacement/enhancement of proteins was the primary process in early biotechnology approaches, the industry is now making a transition toward modulation functions instead.

In her talk at the CPhI Theater on Tuesday April, 30, 2019, consultant Dawn M. Ecker explained how the BioProcess Technology Group of BDO Global (BPTG, formerly BioProcess Technology Consultants) uses the proprietary internal bioTRAK database to anticipate the supply and demand for recombinant pharmaceutical products. The database traces the development of such products from preclinical development through commercialization in American and European Union markets. Taking the long view on data from products marketed between 1982 and 2019, Ecker reveals that the pipeline indicates continued production of monoclonal antibody therapies.