Figure 3.1: FDA injectables NDA/BLA approvals 2012‒2016 ……………………………………………………………………………6
Figure 3.10: Manufacturing of BLA Approvals for Global Bio/Pharma 2012‒2017 ………………………………………….. 17
Figure 3.11: Manufacturing of EU-approved biosimilars 2006-2017 ……………………………………………………………… 19
Figure 3.12: CMOs manufacturing NMEs approved 2012‒2017 ……………………………………………………………………. 20
Figure 3.13: CMOs manufacturing Non-NMEs approved 2012‒2017 …………………………………………………………….. 21
Figure 3.2: Injectables share of all NDA/BLA approvals …………………………………………………………………………………..7
Figure 3.3: Injectables NDA/BLA approvals by API type …………………………………………………………………………………..8
Figure 3.4: Injectable NME approvals receiving special consideration ………………………………………………………………9
Figure 3.5: Injectables NME approvals by sponsor type ………………………………………………………………………………. 11
Figure 3.6: Injectables Non-NME approvals by sponsor type ……………………………………………………………………….. 12
Figure 3.7: Lyophilized injectable NME approvals ……………………………………………………………………………………….. 13
Figure 3.8: Packaging of Products Delivered Subcutaneous or Intramuscular ………………………………………………… 14
Figure 3.9: Contract Manufactured NDA Approvals 2006-2017 ……………………………………………………………………. 15
Figure 4.1: Injectable NME Pipeline by Nature of API and Development Phase ………………………………………………. 24
Figure 4.2: Pipeline by Indication Category ………………………………………………………………………………………………… 27
Figure 4.3: Pipeline Candidates Requiring Special Handling …………………………………………………………………………. 28
Figure 4.4: Breakdown of Cytotoxic Pipeline by Phase ………………………………………………………………………………… 29
Figure 4.5: Injectables Pipeline by Sponsor Type ………………………………………………………………………………………… 29
Figure 4.6: Breakdown of Traditional Injectable NME Pipeline by Sponsor …………………………………………………….. 30
Figure 4.7: Pipeline by Mode of Administration ………………………………………………………………………………………….. 31
Figure 4.8: Pipeline by Expected Product Unit Volume (in millions of units) …………………………………………………… 34
Figure 5.1: Projected Demand for CMO Standard Potency Prefilled Device Capacity ………………………………………. 42
Figure 5.2: Projected Demand for CMO Standard Potency Aseptic Vial Fill Capacity ……………………………………….. 42
Figure 5.3: Projected Demand for CMO Standard Potency Capacity by Product Type ……………………………………… 42
Figure 5.4: Projected Demand for CMO Standard Potency Lyophilization Capacity …………………………………………. 43
Figure 5.5: Projected Demand for CMO Cytotoxic Vial Capacity ……………………………………………………………………. 45
Figure 5.6: Projected Demand for CMO Cytotoxic Lyophilization Capacity …………………………………………………….. 46
Figure 6.1: Current and Planned CMO Capacity 2017-2023 ………………………………………………………………………….. 50
Figure 6.1: Injectable CMO Universe …………………………………………………………………………………………………………. 47
Figure 6.3: Distribution of CMO Aseptic Vial Fill Capacity …………………………………………………………………………….. 50
Figure 6.4: Distribution of CMO Lyophilization Capacity ………………………………………………………………………………. 51
Figure 6.5: Distribution of CMO Prefilled Syringe Capacity …………………………………………………………………………… 51
Figure 6.6: Cytotoxic Vial Fill Capacity ……………………………………………………………………………………………………….. 52
Figure 6.7: Cytotoxic Lyophilization Capacity ……………………………………………………………………………………………… 53
Figure 7.1 Aseptic Vial Fill and Prefilled Syringe Supply/Demand Balance in 2023 ………………………………………….. 57
Figure 7.2 Lyophilization Supply/Demand Balance in 2023 ………………………………………………………………………….. 58
Figure 7.3 Composition of Incremental Aseptic Vial Fill Demand in 2023 ………………………………………………………. 59
Figure 7.4 Composition of Incremental Lyophilization Demand in 2023 ………………………………………………………… 59
Figure 7.5 Cytotoxic Aseptic Vial Fill Supply/Demand Balance in 2023 ………………………………………………………….. 62
Figure 7.6 Cytotoxic Lyophilization Supply/Demand Balance in 2023 ……………………………………………………………. 62
