Eric S. S. Langer President and Managing Partner BioPlan Associates
BioPlan Associates presents the results of its latest annual survey.
The biopharmaceutical industry is in good health, with total annual sales now approaching $200 billion and growing at ~15% annually—as it has over the past decade. This doubling every five years means that biopharmaceuticals (vs. small molecule drugs) have proven themselves to be profitable segment, including for suppliers to the industry. Most biopharmaceuticals, such as antibodies and replacement enzymes, have clearly understood biological activities related to disease processes, with this making development, approvals, and marketing in some cases easier than many small molecule drugs.
And according to this year’s 11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production,1 which includes thousands of key data points covering bioprocessing and biopharmaceuticals, overall industry growth of suppliers to the industry remains steady at around 15%. In addition, productivity efficiency has become the #1 objective of biomanufacturers in U.S. and Europe. In BioPlan’s 11th annual survey, responses from 238 global biomanufacturers in 30 countries, and 158 suppliers to the industry provides 11 years of biopharma trends and analysis, including 12 critical areas of growth, processing, single-use systems, outsourcing, capacity, and quality management. We provide a few of the highlights below.
Industry is Planning Better (or More): Companies are continuing to build their organizations, but are doing so more strategically than before recent years’ economic difficulties hit. About three quarters of respondents, the largest percentage for any area in 2014, are focusing on productivity to a “Much Greater” or “Somewhat Greater” extent. There continues to be a strong focus on “quality,” with over half indicating it will be an area of current and future focus.
Efficiency the Top Concern: Again, this year’s survey respondents identified the single most important trend or operational area that the industry must focus on in 2014 being manufacturing efficiency. Over 20% of the industry believes that they and their suppliers need to increase their efforts to produce more, do it more quickly, and do so with fewer resources.
Single-Use Applications in Biomanufacturing: This year, the ongoing growth in adoption of disposable systems has slightly slowed. With potential applications increasingly already using single-use systems, we are starting to see market saturation. Almost all respondents, approximately 90%, are currently using one or more common single-use devices such as disposable filter cartridges (89.9%), tubing (89.0%), and depth filters (84.4%). Other common disposables reportedly being used include buffer containers, connectors, clamps, tangential flow filtration devices, and sampling systems.
Cutting Operating Costs: This year again the most commonly reported cost-cutting action taken in the past 12 months was focused on reducing operating costs, with over 70%, having implemented programs to cut costs; followed by “Negotiating harder with vendors” (39%).
Countries for Outsourcing: The U.S. ranked highest overall as a potential outsourcing destination, with 27% of respondents indicating that there was a “Likelihood” or “Strong likelihood” that they would outsource production to facilities there. Following were China (24%), and Germany (16%), with India and Singapore rounding out the top five. When asked about future five-year foreign outsourcing destinations, the top pick by U.S. respondents was Singapore. For Western European companies, the U.S. is still the primary destination for outsourcing over the next five years, cited by 47%, followed closely by China.
Outsourcing/CMO Use: Our survey showed a significant shift toward outsourcing across all platforms, other than for mammalian culture, which remains relatively steady from last year. Among respondents producing in mammalian cell culture, 50% indicated they performed all their production “in-house,” (i.e., do no outsourcing of these tasks), while 42% do no outsourcing of their microbial bioprocesses. Only a small portion, 5%, outsourced all of their mammalian bioprocessing, indicating that there are a few virtual biopharmaceutical companies, those operating without any bioprocessing facilities.
Capacity Utilization: Our survey respondents reported capacity utilization remains rather overall constant, particularly for the most used systems. For mammalian cell culture systems, survey respondents reported average capacity utilization was at 67%. Microbial systems were at 56%. Capacity utilization rates for the expression systems that currently dominate bioprocessing appear to be in a healthy steady-state, with no major industry-disruptive excesses or shortages of manufacturing capacity.
Average Titer for New mAb Bioprocesses: The average titer for new mAb bioprocesses being implemented, i.e., at clinical scale, is now 3.21 g/L and for commercial manufacture is now 2.56 g/L, with both showing a rather continuous trend for increasing. However, 44% of commercial manufacturing respondents reported titer ranges between 0.5 and 2 g/L, likely reflecting that most current established mAb manufacturing was implemented years ago. Clinical supply yields more reflect the state-of-the-art, while commercial yields more reflect dated historical levels. The percentage indicating they are operating at productivities of over 5 g/L is very low for commercial scale and while higher at clinical scale, are still low. This indicates that few are seeking to attain the very highest yields, with most likely preferring increasingly standardized and proven platform expression and production systems.
Activities Outsourced: It is significant that respondents now expect to off-shore activities in the next five years for about 10% of operations in all areas queried. So even though off-shoring will likely increase, this will likely remain just a small percentage of company operations in any of these and other specific areas. Analytical and toxicology testing services are still the leaders in terms of any outsourcing, followed by fill-finish and validation services.
Summary: The biopharma industry continues to mature, and the data this year confirm 11-year trends as companies and their suppliers build organizations more strategically than ever before. Productivity, efficiency, globalization of operations, services, and markets are likely to ensure growth and evolution as costs decrease, and global demand for biologics escalates.
1 11th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production: A Survey of Biotherapeutic Developers and Contract Manufacturing Organizations, BioPlan Associates, April 2014.