Contract Injectable Packaging Trends in the Bio/Pharma Industry

Table of Contents

Table of Contents

• Executive Summary
• Players
• Technology Briefing
• Injectables and their packaging
• Outsourcing the packaging of injectable drugs
• Trends
• Industry Analysis
• Introduction
• Trends in injectable approvals
• Cell and gene therapies
• The future of ATMPs
• Emerging sponsors and their injectable products
• Special designation products
• ANDA approvals
• Injectable approvals by sponsor type
• Primary packaging of approved injectables
• Trends in innovator injectable approvals - outsourcing
• Contract packagers of injectables by company
• New and promising contract packagers
• Contract packagers of injectables by facility
• Injectable contract packaging universe
• FDA and EMA packaging regulation track and trace regulatory for secondary packaging and drug/device FDA regulation updates
• FDA: track and trace/DSCSA
• EMA: Falsified Medicines Directive
• Injectable packaging contract manufacturing agreements for pipeline drugs
• Trends in the injectable pipeline
• What it means
• Small number of contract packagers dominate innovative contracts
• Biologics drive marketed and pipeline drug packaging trends
• Pandemic shapes contract packaging demand
• Injectables have large/mega cap sponsors
• Future of injectables is self-administration
• Value Chain
• Companies

Appendix

• Methodology
• Bibliography
• Primary research - Key Opinion Leaders
• Further reading
• About the Authors
• Contact Us

List of Tables

List of Tables

• Table 1: Injectable packaging trends, 2021
• Table 2: M&A deals for dedicated contract injectable packagers, 2019-22
• Table 3: New injectable packaging plants opened in 2021
• Table 4: Capital raising deals for dedicated contract injectable packagers, 2019-22
• Table 5: CPOs receiving packaging contracts for FDA approvals in 2012-21
• Table 6: CPOs packaging site numbers and contract business model
• Table 7: Further reading

List of Figures

List of Figures

• Figure 1: Leading contract packaging players, 2021
• Figure 2: Injectable packaging trends, 2021
• Figure 3: FDA NDA and BLA injectable approvals, 2012-21
• Figure 4: EMA injectable non-generic approvals, 2012-21
• Figure 5: Orphan injectable approvals, 2012-21
• Figure 6: Fast track injectable approvals, 2012-21
• Figure 7: Breakthrough injectable approvals, 2012-21
• Figure 8: ANDA injectable approvals, 2012-21
• Figure 9: FDA NDA injectables approvals by sponsor type, 2012-21
• Figure 10: EMA non-generic injectables approvals by sponsor type, 2012-21
• Figure 11: FDA and EMA injectables approvals packaging, 2012-21
• Figure 12: Top contract packagers for injectables approvals packaging (by contract business model), 2012-21
• Figure 13: Top contract packagers for injectables approvals packaging (by focus), 2012-21
• Figure 14: Top sponsors for injectables approvals packaging contracts, 2012-21
• Figure 15: FDA NDA injectables approvals outsourcing propensity, 2012-21
• Figure 16: EMA non-generic injectable packaging approvals outsourcing propensity, 2012-21
• Figure 17: FDA NDA injectable packaging approvals requiring special handling and their outsourcing, 2012-21
• Figure 18: FDA NDA injectables packaging outsourcing by top five molecule type, 2012-21
• Figure 19: Contract packagers by company type
• Figure 20: Contract packagers by contract business model
• Figure 21: Contract packagers by company type and contract business model
• Figure 22: Global map of contract packagers facilities by contract business model
• Figure 23: Global map of contract prefilled syringe packager facilities by contract business model
• Figure 24: Global map of contract blow fill seal packager facilities by contract business model
• Figure 25: Top contract injectable packagers by integrated packaging sites
• Figure 26: Top injectable contract packagers by standalone packaging sites
• Figure 27: Percentage of injectable packaging sites offering specific package types
• Figure 28: Injectable contract packager sites by FDA and/or EMA regulatory approval
• Figure 29: Injectable contract manufacturing agreements by therapy area, 2018-22
• Figure 30: Top nine injectable contract manufacturing agreements by deal country
• Figure 31: Injectable contract manufacturing agreements by sponsor for pipeline drugs (highest stage), 2012-21
• Figure 32: Injectable contract manufacturing agreements by CMO, 2012-21
• Figure 33: US injectables pipeline and marketed drugs by molecule type
• Figure 34: US injectables pipeline and marketed drugs by therapy area
• Figure 35: US injectables pipeline by top 10 RoA
• Figure 36: US injectables pipeline by top 10 US review designations (Phase II-pre-registration)
• Figure 37: The contract manufacturing value chain