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