PharmSource – Demand and Supply for Contract Manufacturing of Injectable Drugs Through 2023

Chapter 1

Executive Summary

Chapter 2: Objectives and Methodology

Methodology

Chapter 3: Recent Trends in Injectables NDA/BLA Approvals

Injectables approvals overview

NDA/BLA approvals of injectable products

Injectable NDA/BLA approvals by sponsor type

Processing and packaging characteristics

Contract manufacturing of injectable NDA/BLA approvals

European biosimilar approvals

Cytotoxic drug approvals

CMOs winning NDA/BLA approvals

What it means

Chapter 4: Injectables Pipeline

Pipeline Overview

Biosimilars

Cytotoxic and High Potency Pipeline

Pipeline Ownership

Pipeline by Route of Administration

Unit volumes

What it means

Chapter 5: Demand Forecast for CMO Capacity

Forecasting new standard potency approvals

Model Results: Standard Potency Therapeutic Products

Forecasting new cytotoxic approvals

Model Results: Cytotoxic Products

Chapter 6: CMO Industry Capacity analysis

Injectables CMO Capacity Overview

Injectables capacity

Cytotoxic Injectables Capacity

Injectables Capacity Expansions

What it means

Chapter 7: Supply-Demand Balance and Implications

Standard Potency Supply-Demand Balance

Standard Potency NME capacity

Cytotoxic Capacity Supply-Demand Balance

What It Means

Appendix

Injectables CMOs Manufacturing NDAs /BLAs and Biosimilars Approved 2012 – November 2017

Table 2.1 Abbreviations Used in this Report ………………………………………………………………………………………………….4

Table 3.1: Injectable NDA/BLA approvals by sponsor type 2012‒2017 ………………………………………………………….. 10

Table 3.2: Packaging of New NDA/BLA Approvals ……………………………………………………………………………………….. 14

Table 3.3: Manufacturing Source of NDA Approvals by Approval and Company Type 2012‒2017 ……………………. 16

Table 4.1: Unit Volume Categories Used in Demand Model …………………………………………………………………………. 33

Table 4.2: Products Used to Calibrate Demand Model ………………………………………………………………………………… 33

Table 5.1: Modeling Assumptions for Standard Potency Products ………………………………………………………………… 39

Table 5.2: Modeling Assumptions for Cytotoxic Products ……………………………………………………………………………. 44

Table 6.1: Preferred Injectable CMOs for Capacity Analysis …………………………………………………………………………. 49

Table 6.2: Cytotoxic Injectable CMOs for Capacity Analysis …………………………………………………………………………. 52

Table 6.2: Injectable CMO Capacity Expansions ………………………………………………………………………………………….. 54

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