PharmSource – CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2018 Edition
- Pages: 43
- Published: April 2018
- Report Code: GDPS0020MAR
This report is the 8th 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.
Who should buy this report?
This 43-page report gives important, expert insight you won’t find in any other source. 28 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.
Afton Scientific Corp.
Albany Molecular Research Inc.
Alliance Medical Products
ASM Aerosol-Service AG
Avara Pharmaceutical Services
Aveva Drug Delivery Systems
B. Braun Melsungen AG
Banner Life Sciences
Bausch & Lomb Pharmaceuticals
Baxter BioPharma Solutions
Boehringer Ingelheim BioXcellence
Boehringer Ingelheim GmbH
Catalent Pharma Solutions
Cook Pharmica LLC
CPL Contract Pharmaceuticals Limited
Debiopharm Research & Manufacturing SA
Excella Pharma Source
Exela Pharma Sciences
Ferndale Labs & Contract Manufacturing
Gland Pharma Limited
Hameln Pharmaceuticals GmbH
Holopack Verpackungstechnik GmbH
IDT Biologika GmbH
Instituto Bioclon S.A. de C.V.
Intas Pharmaceuticals Ltd.
James Alexander Corporation
Japan Tobacco Inc.
Jubilant HollisterStier Contract Manufacturing & Services
KP Pharmaceutical Technology
Kremers Urban Pharmaceuticals
Lehigh Valley Technologies Inc.
LTS Lohmann Therapie-Systeme AG
Lyophilization Services of New England
Mitsubishi Tanabe Pharma Corporation
Mustafa Nevzat Pharmaceuticals
Nerviano Medical Sciences
Nipro Pharma Corp.
Nordmark Arzneimittel GmbH & Co. KG
Norwich Pharma Services
Nova Laboratories Ltd
PCI Pharma Services
Pharmaceutical Manufacturing Research Services Inc.
Pharmaceutics International Inc
Pillar5 Pharma Inc.
Piramal Pharma Solutions
Porton Biopharma Limited
Rechon Life Science
Recro Pharma Inc.
Rentschler Biopharma SE
Rottendorf Pharma GmbH
Sanquin Blood Supply Foundation
Sirton Pharmaceuticals SpA
Swedish Orphan Biovitrum AB
The Ritedose Corporation
University of Iowa Pharmaceuticals
Valeant Pharmaceuticals International
Vetter Pharma International
Wockhardt Contract Manufacturing
Table of Contents
1. Executive Summary 5
2. Introduction 6
3. NDA Approvals Overview 6
4. US Versus EU Approval Performance 8
5. Outsourced Dose Manufacture 9
6. Special Product Categories 13
7. Outsourcing by Global Bio/Pharma Companies 17
8. CMO Performance 19
9. Outsourced API Approvals 21
10. What It Means 24
11. Notes on Methodology 25
12. Appendix 27
List of Tables
Table 1: Outsourced NDA Approvals by Dosage Form 12
Table 2: Outsourcing by Sponsor Type and FDA Approval Type 2012–2017 13
Table 3: API CMOs Receiving NME Approvals in 2017 23
Table 4: 2017 CBER Approvals Included in the Analysis 27
Table 5: 2017 Outsourced Dose Approvals 27
Table 6: Dose CMOs Receiving Contracts for FDA Approvals in 2008–2017 31
Table 7: 2017 Outsourced API Approvals 35
Table 8: Dose CMOs Manufacturing NDAs Approved 2017 39
Table 9: MHRA Approvals in 2017 42
List of Figures
Figure 1: NDA Approvals 2008–2017 7
Figure 2: NDA Approvals by Sponsor Type 2008–2017 8
Figure 3: EMA Approvals 2012–2017 9
Figure 4: Share of NDA Approvals Outsourced 2008–2017 10
Figure 5: NDA Approvals Outsourced 2008–2017 10
Figure 6: Dose Outsourcing of Small and Large Molecule APIs 2008–2017 11
Figure 7: Outsourcing of NME Approvals by Sponsor Type 12
Figure 8: Outsourcing of Non-NME NDA Approvals by Sponsor Type 13
Figure 9: Outsourcing of Orphan NMEs 2008–2017 14
Figure 10: Outsourcing of Fast Track NMEs 2011–2017 15
Figure 11: Outsourcing of Breakthrough NMEs 2013–2017 15
Figure 12: NMEs Requiring Special Handling 2008–2017 16
Figure 13: Approval and Outsourcing of NMEs Utilizing Advanced Formulation Technologies 2011–2016 17
Figure 14: Global Bio/Pharma Outsourcing Propensity 2008–2017 18
Figure 15: Trends in Global Bio/Pharma NDA Outsourcing 2008–2017 19
Figure 16: Breakdown in Composition of Outsourced NMEs 2008–2017 by Sponsor Type 20
Figure 17: Breakdown in Composition of Outsourced Non-NME NDAs 2008–2017 by Sponsor Type 21
Figure 18: Outsourcing of API for NME Approvals 2008–2017 22
Figure 19: ANDA Approvals 2008–2017 41