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

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

Companies mentioned

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

List of Tables

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

List of 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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