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PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2019 Edition

  • ID: 4791372
  • Report
  • 50 pages
  • GlobalData
1h Free Analyst Time

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FEATURED COMPANIES

  • 3M Drug Delivery Systems
  • AstraZeneca Plc
  • Excella GmbH & Co KG
  • Kyowa Hakko Kirin Co Ltd
  • Patheon NV
  • Sanofi
  • MORE
PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2019 Edition

Summary

This report is the 9th edition of our long running analysis of the CMO Industry, using NDA approvals as the primary indicator of performance. CMO Scorecard is critical for benchmarking the performance of the CMO industry and the relative performance of major CMOs.

Scope
  • This 50-page report gives important, expert insight you won't find in any other source. 32 tables and figures 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.
Reasons to buy
  • Overview of NDA drug approvals and the levels of outsourcing associated with NDA sub segments
  • Detailed view of CDMO performance by number of approvals and an assessment of their sponsors market caps from the PharmSource Contract Service Providers database
  • Outsourcing propensity for NMEs, different dosage forms and by sponsor company cap have all been assessed.
  • Analysis of NME special products approvals such as those with Orphan, Breakthrough or Fast Track designations and assessment of outsourcing
Note: Product cover images may vary from those shown
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FEATURED COMPANIES

  • 3M Drug Delivery Systems
  • AstraZeneca Plc
  • Excella GmbH & Co KG
  • Kyowa Hakko Kirin Co Ltd
  • Patheon NV
  • Sanofi
  • MORE
1 Table of Contents 2

2 List of Tables 3

3 List of Figures 3

4 Executive Summary 4

5 Introduction 5

6 NDA Approvals Overview 5

7 US vs. EU Approval Performance 7

8 Outsourced Dose Manufacture 8

9 Special Product Categories 14

10 Outsourcing by Mega Cap Companies 19

11 CMO Performance 20
11.1 Catalent 26
11.2 Patheon 26
11.3 Other Prominent CMOs 26

12 Outsourced API Approvals 27

13 What it Means 28
13.1 Approvals Have Risen 28
13.2 Drivers for Outsourcing 30
13.2.1 Niche Technology 31
13.2.2 Small Volumes, Special Designations 31

14 Notes on Methodology 33

15 Appendix 34
15.1 Appendix Tables 34
15.2 Bibliography 46
15.3 Primary Research - Key Opinion Leaders in this Report 47
15.4 About the Authors 48
15.5 Contact Us 50
15.6 Disclaimer 50

List of Tables
Table 1: Outsourced NDA Approvals by Dosage Form 12
Table 2: Outsourcing by Sponsor Market Cap and FDA Approval Type, 2012-2018 13
Table 3: API CMOs Receiving NME Approvals in 2018 28
Table 4: 2018 CBER Approvals Included in the Analysis 34
Table 5: 2018 Outsourced Dose Approvals 35
Table 6: Dose CMOs Receiving Contracts for FDA Approvals in 2009-2018 38
Table 7: API CMOs Receiving NME Approvals in 2018 42
Table 8: Dose CMOs' Manufacturing NDAs Approved in 2018 44
Table 9: MHRA Approvals in 2018 45

List of Figures
Figure 1: NDA and BLA Approvals 2009-2018 6
Figure 2: NDA Approvals by Sponsor Type, 2009-2018 7
Figure 3: EMA Approvals, 2012-2018 8
Figure 4: Share of NDA Approvals Outsourced 2009-2018 9
Figure 5: NDA Approvals Outsourced 2009-2018 10
Figure 6: Dose Outsourcing of Small Molecule and Biologic NMEs 2009-2018 11
Figure 7: Outsourcing of NME Approvals by Sponsor Market Cap 13
Figure 8: Outsourcing of Non-NME NDA Approvals by Sponsor Market Cap 14
Figure 9: Outsourcing of Orphan NMEs 2009-2018 15
Figure 10: Outsourcing of Fast Track NMEs 2011-2018 16
Figure 11: Outsourcing of Breakthrough Therapy Designation NMEs, 2013-2018 17
Figure 12: NMEs Requiring Special Handling 2008-2018 18
Figure 13: Approval and Outsourcing of NMEs Utilizing Solubility Enhancement 2011-2018 19
Figure 14: Mega Cap Outsourcing Propensity 2008-2018 20
Figure 15: Breakdown in Composition of Outsourced NMEs, by Sponsor Market Cap, 2008-2018 21
Figure 16: Breakdown in Composition of Outsourced Non-NME NDAs, by Sponsor Market Cap, 2008-2018 22
Figure 17: CMO Market Share of Parenteral NME Approvals, 2009-2018 23
Figure 18: CMO Market Share of Parenteral Non-NME NDA Approvals, 2009-2018 24
Figure 19: CMO Market Share of Solid NME Approvals, 2009-2018 25
Figure 20: CMO Market Share of Solid Non-NME NDA Approvals, 2009-2018 25
Figure 21: API Outsourcing of Chemical and Biologic NMEs, 2008-2018 27
Figure 22: Innovator Drug Clinical Trials Versus FDA NDA/BLA Approvals, 2009-2018 29
Figure 23: ANDA Approvals 2009-2018 46
Note: Product cover images may vary from those shown
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  • 3M Drug Delivery Systems
  • AbbVie Inc
  • ABF Pharmaceutical Services GmbH
  • ACS Dobfar SPA
  • Adare Pharmaceuticals Inc
  • Adoh BV
  • Aenova Holding GmbH
  • Aesica Pharmaceuticals Ltd
  • Afton Scientific Corp
  • Ajinomoto Althea Inc
  • Ajinomoto Co Inc
  • Akorn Inc
  • Albany Molecular Research Inc
  • Alcami Corp
  • Alkermes Plc
  • Allergan Plc
  • Alliance Contract Pharma LLC
  • Almac Group Ltd
  • Alpex Pharma SA
  • Apotex Inc
  • Aquestive Therapeutics Inc
  • ARx LLC
  • ASM - Aerosol-Service AG
  • AstraZeneca Plc
  • AustarPharma LLC
  • Avara Pharmaceutical Services Inc
  • Bausch & Lomb Pharmaceuticals Inc
  • Bausch Health Companies
  • Baxter Biopharma Solutions
  • Bayer AG
  • BioRamo LLC
  • Boehringer Ingelheim Bioxcellence
  • Boehringer Ingelheim GmbH
  • Cadila Healthcare Ltd
  • Capsugel Inc
  • Catalent Inc
  • Cenexi SAS
  • Centre for Probe Development and Commercialization
  • Cerovene Inc
  • Cipla Ltd
  • Confab Laboratories Inc
  • Contract Pharmaceuticals Ltd
  • Delpharm SAS
  • Dexcel PT Israel Ltd
  • DPT Laboratories Ltd
  • Ei A Pharmaceutical SolutionWorks (TM)
  • Eisai Co Ltd
  • Emergent BioSolutions Inc
  • Excella GmbH & Co KG
  • Exela Pharma Sciences LLC
  • Fareva SA
  • Fresenius Kabi Product Partnering
  • Fritz Keller Holding AG
  • Galephar Pharmaceutical Research Inc
  • Gilead Sciences Inc
  • Gland Pharma Ltd
  • GlaxoSmithKline Plc
  • Glenmark Pharmaceuticals Ltd
  • Grifols SA
  • Groupe Synerlab SAS
  • Grunenthal GmbH
  • Halo Pharma Inc
  • Hameln Pharmaceuticals GmbH
  • Hikma Pharmaceuticals Plc
  • Holopack Verpackungstechnik GmbH
  • Hovione FarmaCiencia SA
  • Importfab Inc
  • Institutt for Energiteknikk
  • Insud Pharma
  • Intas Pharmaceuticals Ltd
  • James Alexander Corp.
  • Jubilant HollisterStier Contract Manufacturing & Services
  • Kemwell Biopharma Pvt Ltd
  • KP Pharmaceutical Technology Inc
  • Kyowa Hakko Kirin Co Ltd
  • Laboratoires PANPHARMA SA
  • Laboratoires Pierre Fabre SA
  • Laboratoires Thea SA
  • Lifecore Biomedical LLC
  • LTS Lohmann Therapie-Systeme AG
  • Lyne Laboratories
  • Lyophilization Services of New England Inc
  • Merck & Co Inc
  • Mikart Inc
  • Mipharm SpA
  • Mitsubishi Tanabe Pharma Corp
  • Mylan NV
  • Napp Pharmaceuticals Ltd
  • Neolpharma SA De CV
  • Nexgen Pharma Inc
  • NextPharma Technologies Holding Ltd
  • Nordmark Arzneimittel GmbH & Co KG
  • Norwich Pharma Services
  • Novast Holdings Ltd
  • Nuvo Pharmaceuticals Inc
  • OishiKoseido Corp
  • Orion Corp
  • OSO BioPharmaceuticals Manufacturing LLC
  • Paras Biopharmaceuticals Finland Oy
  • PARI Pharma GmbH
  • Patheon NV
  • PCI Pharma Services
  • Perrigo Co Plc
  • Pfizer Inc
  • Pharmaceutical Manufacturing Research Services Inc
  • Pharmaceutics International Inc
  • Pharmascience Inc
  • Pharmasol Corp
  • Pierrel Spa
  • Pillar5 Pharma Inc
  • Propak Health Ltd
  • QPharma AB
  • Quotient Sciences Ltd
  • Rechon Life Science AB
  • Recipharm AB
  • Recro Pharma Inc
  • Renaissance Pharma Inc
  • Rentschler Biotechnologie GmbH
  • Rivopharm SA
  • Rosemont Pharmaceuticals Ltd
  • Rottendorf Pharma GmbH
  • Sanico NV
  • Sanofi
  • Sharp Packaging Services
  • Shire Plc
  • Siegfried Holding AG
  • Sintetica SA
  • Sirton Pharmaceuticals SpA
  • Sterigenics International
  • Steri-Pharma LLC
  • Synergy Health Ltd
  • Tapemark Co
  • Teligent Inc
  • Teva Pharmaceutical Industries Ltd
  • The Ritedose Corp
  • Therapure Biopharma Inc
  • Torii Pharmaceutical Co Ltd
  • Tris Pharma Inc
  • UCB SA
  • Unither Pharmaceuticals
  • University of Iowa Pharmaceuticals
  • UPM Pharmaceuticals Inc
  • USV Pvt Ltd
  • Vectura Group Plc
  • Vetter Pharma-Fertigung GmbH & Co KG
  • Vianex SA
  • Vifor Pharma AG
  • Woodfield Pharmaceutical LLC
  • Zymeworks Inc
Note: Product cover images may vary from those shown
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