The 2019 16th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production is the most recent study of biotherapeutic developers and contract manufacturing organizations’ current and projected future capacity and production.
This report’s 485 pages of data-rich analysis will help improve your decision-making in biomanufacturing operations, with in-depth analysis of capacity, production trends, benchmarks, and much more.
- In-depth analysis of key data, capacity, production trends, and benchmarks
- Budget trends and impact of current economic environment
- Downstream purification problems and issues
- Current and projected industry bottlenecks
- Capacity utilization and current production levels
- How capacity bottlenecks are being resolved
- Production trends and implications for industry
- Outsourcing trends
- International offshoring through 2025
- Range of titers, growth
- Disposables: Spending growth; downstream uses; L&E’s; reasons for increasing/ restricting; budget increases; vendor satisfaction
- Disposables: Compare innovators vs CMOs & US vs Europe
- Batch failure rates & trends
- Selecting a CMO - Problems & solutions
- Quality management & PAT implementation
- Hiring and employment growth
- Supplier growth rates
- Much more
2. Introduction and Discussion
3. Overview of Critical Issues in Bioprocessing
4. Emerging Issues in Biopharmaceutical Manufacturing
5. Capacity Utilization
6. Current and Future Capacity Constraints
7. Future Capacity Expansions
8. Outsourcing Trends in Biopharmaceutical Manufacturing
9. Disposables and Single-Use Systems in Biopharmaceutical Manufacturing
10. Downstream Purification
11. Quality Issues, Batch Failures, and PAT in Biopharmaceutical Manufacturing
12. Hiring, Employment Growth and Training in Biopharmaceutical Manufacturing
13. Continuous Processing
14. Suppliers to Biopharmaceutical Manufacturing and Life Sciences
This report is the 16th in our annual evaluations of the state of the biopharmaceutical manufacturing industry. The strength of this study’s methodology remains in its breadth of coverage, which yields a composite view from the respondents closest to the industry. This year, the author surveyed 221 qualified and responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations in 24 countries; plus 120 industry vendors and direct suppliers of materials, services and equipment to this industry segment. Using a web-based survey tool, we obtained and evaluated information including regarding respondents’ current capacity, production, novel technology adoption, human resources, quality, and outsourcing issues. We also assessed respondents’ projected reasons for bottlenecks and their perception of how these bottlenecks might be resolved.
We continue to provide additional in-depth analysis of speciﬁc issues affecting the industry, including monographs in Chapter 2. These monographs cover the events and trends that will shape biopharmaceutical manufacturing over the next ﬁve years. We also have included this year a chapter on Continuous Bioprocessing. Over the past few years, advances in technologies, expression systems, and single-use applications have increasingly made this segment an area of interest for innovation.
To ensure comprehensive global coverage, we partnered with worldwide organizations to ensure the most accurate overview of the worldwide biopharmaceutical industry. Our industry partners are cited in our acknowledgments section. In addition, to support this coverage, we also include acknowledgment of our media partners, whose assistance enabled us to reach the many high quality of respondents required in this quantitative analysis.