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

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

Who should buy this report?

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

Companies mentioned

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 ...

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

Table of Contents

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 ...

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 ...

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 ...

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

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