CMO Scorecard – Outsourcing of NDA Approvals and CMO Performance – 2020 PharmSource Edition

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All the vital news, analysis, and commentary curated by our industry experts.

This report is the 10th 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 53-page report gives important, expert insight you won’t find in any other source. 9 tables and 26 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 GlobalData’s 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

Patheon NV
Catalent Inc
Vetter Pharma-Fertigung GmbH & Co KG
PCI Pharma Services
Baxter International Inc
Mylan NV
Pfizer Inc
Almac Group Ltd
Siegfried Holding AG
Ajinomoto Co Inc
Emergent BioSolutions Inc
Fareva SA
Aenova Holding GmbH
Alcami Corp
Renaissance Pharma Inc
Albany Molecular Research Inc
Fujifilm Corp
Jubilant Life Sciences Ltd
Recipharm AB
Boehringer Ingelheim International GmbH
Cenexi SAS
Delpharm SAS
Rottendorf Pharma GmbH
ACS Dobfar SpA
Fresenius Kabi AG
Hovione FarmaCiencia SA
Lonza Group Ltd
Gland Pharma Ltd
Takeda Pharmaceutical Co Ltd
Quotient Sciences Ltd
3M Drug Delivery Systems
Afton Scientific Corp
Cadila Healthcare Ltd
Cipla Ltd
Consort Medical Plc
Rentschler Biopharma SE
Johnson & Johnson
LTS Lohmann Therapie-Systeme AG
Merck & Co Inc
Mikart Inc
Cambrex Corp
Piramal Enterprises Ltd
Sanofi
Unither Pharmaceuticals
Adoh BV
ARx LLC
The Ritedose Corp
Akorn Inc
Alliance Contract Pharma LLC
Alvogen Inc
AstraZeneca Plc
Bausch Health Companies Inc
Bayer AG
Bristol-Myers Squibb Co
Cerovene Inc
Contract Pharmaceuticals Ltd
Galephar Pharmaceutical Research Inc
GlaxoSmithKline Plc
Grunenthal GmbH
Hikma Pharmaceuticals Plc
Instituto Bioclon
Klocke Pharma-Service GmbH
Importfab Inc
MIAS Pharma Ltd
NextPharma Technologies Holding Ltd
Nova Laboratories Ltd
Orion Corp
NMS Group SpA
Perrigo Co Plc
Pharmaceutics International Inc
Sanico NV
Sharp Packaging Services
Alpex Pharma SA
Exelead Inc
Sotera Health LLC
UPM Pharmaceuticals Inc
AbbVie Inc
Groupe Synerlab SAS
3SBio Inc
AlfaSigma SpA
Alkermes Plc
Aquestive Therapeutics Inc
ASM - Aerosol-Service AG
AustarPharma LLC
Avara Pharmaceutical Services Inc
Basic Pharma
Amgen Inc
Sintetica SA
Biogen Inc
BioRamo LLC
BSP Pharmaceuticals SpA
Centre for Probe Development and Commercialization
Therapure Biopharma Inc
Dexcel PT Holdings Ltd
DSM Pharmaceuticals Inc
Ei A Pharmaceutical SolutionWorks (TM)
Eisai Co Ltd
Dongbao Enterprise Group Co Ltd
Exela Pharma Sciences LLC
Famar Health Care Services
Ferndale Pharma Group Inc
Fritz Keller Holding AG
Gilead Sciences Inc
GBA Gesellschaft fur Bioanalytik mbh
Glatt GmbH
Glenmark Pharmaceuticals Ltd
Grifols SA
Torii Pharmaceutical Co Ltd
Holopack Verpackungstechnik GmbH
Institutt for Energiteknikk
Insud Pharma
Intas Pharmaceuticals Ltd
James Alexander Corp.
Kyowa Kirin Co Ltd
Lifecore Biomedical LLC
Laboratoires PANPHARMA SA
Laboratoires Pierre Fabre SA
Laboratorios Farmaceuticos Rovi SA
Les Laboratoires Servier SAS
Lyne Laboratories
Molteni Farmaceutici
Merck KGaA
Neolpharma SA De CV
Napp Pharmaceuticals Ltd
Nexgen Pharma Inc
Nordmark Arzneimittel GmbH & Co KG
Novast Holdings Ltd
OishiKoseido Corp
Stada Arzneimittel AG
Nordic Group BV
Novartis AG
Pharmaceutical Manufacturing Research Services Inc
Pharmascience Inc
Pharmasol Corp
Pierrel Spa
Pillar5 Pharma Inc
PARI Pharma GmbH
Porton Biopharma Ltd
Propak Health Ltd
PYRAMID Laboratories Inc
QPS Holdings LLC
R Pharm
Lyophilization Services of New England Inc
Evonik Industries AG
Rivopharm SA
Recro Pharma Inc
Sawai Pharmaceutical Co Ltd
Steri-Pharma LLC
Swedish Orphan Biovitrum AB
Tapemark Co
Teligent Inc
Adare Pharmaceuticals Inc
University of Iowa
Toyobo Co Ltd
Tris Pharma Inc
UCB SA
Vifor Pharma Ltd
USV Pvt Ltd
Vectura Group Plc
Vianex SA
Woodfield Pharmaceutical LLC
WuXi AppTec Co Ltd
Zymeworks Inc

Table of Contents

1 Table of Contents

2 List of Tables

3 List of Figures

4 Executive Summary

5 Introduction

6 FDA NDA Approvals Overview

7 US vs. EU Approval Performance

8 FDA: Outsourced Dose Manufacture

9 Special Product Categories

10 Outsourcing by Company Market Cap

11 CMO Performance

11.1 Catalent

11.2 Patheon

11.3 Other Prominent CMOs

12 Outsourced API Approvals

13 What It Means

13.1 FDA Approvals Have Fallen but Are Still Strong Compared to Historical Standards

13.2 Drivers and Barriers for Outsourcing

13.2.1 Niche Technology

13.2.2 Small Volumes, Special Designations

13.2.3 Sponsor Market Cap Relationships to Outsourcing

14 Notes on Methodology

15 Appendix

15.1 Appendix Tables

15.2 Bibliography

15.3 Primary Research – Key Opinion Leaders in this Report

15.4 About the Authors

15.5 Contact Us

15.6 Disclaimer

Table

Table 1: Outsourced NDA Approvals by Dosage Form

Table 2: Dose Outsourcing Relationships by Sponsor Market Cap and FDA Approval Type, 2014–2019

Table 3: API CMOs Obtaining Contracts for NME Approvals in 2019

Table 4: 2019 CBER Approvals Included in the Analysis

Table 5: 2019 Outsourced Dose Approvals

Table 6: Dose CMOs Receiving Contracts for FDA Approvals in 2010–2019

Table 7: API CMOs Receiving Approvals in 2019

Table 8: Dose CMOs’ Manufacturing NDAs Approved in 2019

Table 9: MHRA Approvals in 2019

Figures

Figure 1: FDA NDA and BLA Approvals, 2010–2019

Figure 2: FDA NDA Approvals by Sponsor Type, 2010–2019

Figure 3: EMA Approvals, 2012–2019

Figure 4: Share of FDA NDA Approvals Outsourced 2010–2019

Figure 5: NDA Approvals Outsourced 2010–2019

Figure 6: Dose Outsourcing of Small Molecule and Biologic NMEs, 2010–2019

Figure 7: Dose Outsourcing of FDA NME Approvals by Sponsor Market Cap

Figure 8: Dose Outsourcing of Non-NME NDA Approvals by Sponsor Market Cap

Figure 9: Outsourcing of FDA Orphan NMEs, 2010–2019

Figure 10: Dose Outsourcing of FDA Fast Track NMEs, 2011–2019

Figure 11: Dose Outsourcing of Breakthrough Therapy Designation NMEs, 2013–2019

Figure 12: NMEs Requiring Special Handling, 2010–2019

Figure 13: FDA Approval and Outsourcing of NMEs Utilizing Solubility Enhancement, 2011–2019

Figure 14: Small Cap Dose Outsourcing Propensity, 2010–2019

Figure 15: Mid Cap Outsourcing Propensity, 2010–2019

Figure 16: Large Cap Outsourcing Propensity, 2010–2019

Figure 17: Mega Cap Outsourcing Propensity, 2010–2019

Figure 18: Private Company Dose Outsourcing Propensity, 2010–2019

Figure 19: Breakdown in Composition of Dose-Outsourced NMEs, by Sponsor Market Cap, 2010–2019

Figure 20: Breakdown in Composition of Outsourced Non-NME NDAs, by Sponsor Market Cap, 2010–2019

Figure 21: CMO Market Share of Parenteral NME Approvals, 2010–2019

Figure 22: CMO Market Share of Parenteral Non-NME NDA Approvals, 2010–2019

Figure 23: CMO Market Share of Solid NME Approvals, 2010–2019

Figure 24: CMO Market Share of Solid Non-NME NDA Approvals, 2010–2019

Figure 25: API Outsourcing of Small Molecule and Biologic NMEs, 2010–2019

Figure 26: ANDA Approvals 2010–2019

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