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医薬品製造受託機関 (SMO) における注射薬の需要・供給バランス

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

出版日: | 発行: GlobalData | ページ情報: 英文 70 Pages | 納期: 即納可能 即納可能とは

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医薬品製造受託機関 (SMO) における注射薬の需要・供給バランス
出版日: 2018年02月14日
発行: GlobalData
ページ情報: 英文 70 Pages
納期: 即納可能 即納可能とは
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  • 概要
  • 図表
  • 目次
概要

当レポートでは、世界の医薬品製造受託機関 (SMO) における注射薬の開発・生産能力の見通しについて分析し、現在の注射薬パイプライン製品の認証状況や、製品別 (細胞障害性薬物など) の詳細動向、CMOへの開発・生産委託の見通し、CMOの治験・認証・生産能力 (キャパシティ)、市場全体での新薬への需要動向や需給バランスの見通し (今後20年間分)、各々の製薬企業・バイオ医薬品企業にとっての意義などについて調査・考察しております。

第1章 エグゼクティブ・サマリー

第2章 分析対象・手法

第3章 注射薬のNDA (新薬承認申請)/BLA (生物製剤承認申請) 認証:昨今の傾向

  • 注射薬の認証状況:概要
  • 注射薬のNDA/BLA認証
  • 注射薬のNDA/BLA認証:スポンサーの種類別
  • 製品の製造プロセス/パッケージングの特徴
  • NDA/BLA認証済み注射薬の製造委託
  • 欧州におけるバイオシミラーの認証状況
  • 細胞障害性薬物の認証状況
  • CMO (医薬品製造受託機関) によるNDA/BLA認証製品の製造受託状況
  • 結論

第4章 注射薬のパイプライン製品

  • パイプライン製品の概要
  • バイオシミラー
  • 細胞障害性のある強力な薬物のパイプライン製品
  • パイプライン製品の保有状況
  • パイプライン製品:投薬経路別
  • 市場規模 (数量ベース)
  • 結論

第5章 CMO (医薬品製造受託機関) のキャパシティの需要予測

  • 新たな標準効力の製品の認証件数の予測
  • モデル分析の結果:標準的効力の治療薬
  • 新たな細胞障害性薬物の認証件数の予測
  • モデル分析の結果:細胞障害性薬物

第6章 CMO業過のキャパシティの分析

  • CMOの注射薬関連のキャパシティ (開発・製造能力)
  • 注射薬のキャパシティ
  • 細胞障害性注射薬のキャパシティ
  • 注射薬のキャパシティ強化の動き
  • 結論

第7章 需給バランスとその影響

  • 標準的効力製品の需給バランス
  • 標準的効力のNME (新規化合物) のキャパシティ
  • 細胞障害性薬物のキャパシティと需給バランス
  • 結論

付録

図表

List of Tables

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

List of Figures

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

目次
Product Code: GDPS0019MAR

This report is the 6th edition of our long-running analysis of the injectables CMO industry. It provides an expert quantitative analysis on the latest trends and plans for outsourcing commercially approved injectable products. It combines the rich data resources of PharmSource and the GlobalData Pharmaceutical Intelligence Center with our 20 years' experience in analyzing the injectables CMO industry to provide the most definitive, trustworthy source of strategic insight on this topic in the bio/pharmaceutical realm.

Scope

  • The report is based on the most recent data on industry capacity, the injectables pipeline and the behaviors of the key biopharmaceutical industry actors.
  • The model and assumptions are fully explained so you can understand how the analysis was driven and how conclusions were reached.

Reasons to buy

This 70-page report gives important, expert insight you won't find in any other source. Over 25 tables and graphs throughout the report illustrate major points and trends. This report is required reading for -

  • CMO executives who must have deep understanding of the injectables marketplace to make strategic planning and investment decisions.
  • Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management.
  • Private equity investors that need a deeper understanding of the market to identify and value potential investment targets.

Table of Contents

Chapter 1: Executive Summary 1

Chapter 2: Objectives and Methodology 3

Methodology 3

Chapter 3: Recent Trends in Injectables NDA/BLA Approvals 5

Injectables approvals overview 5

NDA/BLA approvals of injectable products 6

Injectable NDA/BLA approvals by sponsor type 10

Processing and packaging characteristics 12

Contract manufacturing of injectable NDA/BLA approvals 15

European biosimilar approvals 18

Cytotoxic drug approvals 19

CMOs winning NDA/BLA approvals 20

What it means 21

Chapter 4: Injectables Pipeline 24

Pipeline Overview 24

Biosimilars 27

Cytotoxic and High Potency Pipeline 28

Pipeline Ownership 29

Pipeline by Route of Administration 31

Unit volumes 32

What it means 35

Chapter 5: Demand Forecast for CMO Capacity 36

Forecasting new standard potency approvals 37

Model Results: Standard Potency Therapeutic Products 41

Forecasting new cytotoxic approvals 44

Model Results: Cytotoxic Products 45

Chapter 6: CMO Industry Capacity analysis 47

Injectables CMO Capacity Overview 47

Injectables capacity 48

Cytotoxic Injectables Capacity 52

Injectables Capacity Expansions 53

What it means 55

Chapter 7: Supply-Demand Balance and Implications 57

Standard Potency Supply-Demand Balance 57

Standard Potency NME capacity 60

Cytotoxic Capacity Supply-Demand Balance 62

What It Means 63

Appendix 1 64

Injectables CMOs Manufacturing NDAs /BLAs and Biosimilars Approved 2012 - November 2017 64

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