CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance -

DUBLIN--()--The "CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2020 Edition" report has been added to's offering.

This report is the 10th edition of the long running analysis of the CMO Industry, using NDA approvals as the primary indicator of performance. The CMO Scorecard is critical for benchmarking the performance of the CMO industry and the relative performance of major CMOs.

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 publisher'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

Key Topics Covered:

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

A selection of the companies mentioned include:

  • Patheon NV
  • Catalent Inc
  • Pfizer Inc
  • Almac Group Ltd
  • Siegfried Holding AG
  • Ajinomoto Co Inc
  • Emergent BioSolutions Inc
  • Fareva SA
  • Aenova Holding GmbH
  • Quotient Sciences Ltd
  • 3M Drug Delivery Systems
  • Afton Scientific Corp
  • Cadila Healthcare Ltd
  • Cipla Ltd
  • Consort Medical Plc
  • Merck & Co Inc
  • Mikart Inc
  • Cambrex Corp
  • Piramal Enterprises Ltd
  • Sanofi
  • Adoh BV
  • ARx LLC
  • Alvogen Inc
  • AstraZeneca Plc
  • GlaxoSmithKline Plc
  • Grunenthal GmbH
  • Hikma Pharmaceuticals Plc
  • Instituto Bioclon
  • Nova Laboratories Ltd
  • Orion Corp
  • NMS Group SpA
  • Perrigo Co Plc
  • Sanico NV
  • Sharp Packaging Services
  • Alpex Pharma SA
  • Exelead Inc
  • Sotera Health LLC
  • 3SBio Inc
  • AlfaSigma SpA
  • Alkermes Plc
  • Aquestive Therapeutics Inc
  • ASM - Aerosol-Service AG
  • Basic Pharma
  • Amgen Inc
  • Sintetica SA
  • Biogen Inc
  • BioRamo LLC
  • BSP Pharmaceuticals SpA
  • Eisai Co Ltd
  • Dongbao Enterprise Group Co Ltd
  • Exela Pharma Sciences LLC
  • Famar Health Care Services
  • Institutt for Energiteknikk
  • Insud Pharma
  • Intas Pharmaceuticals Ltd
  • James Alexander Corp.
  • Kyowa Kirin Co Ltd
  • Les Laboratories Servier SAS
  • Lyne Laboratories
  • Molteni Farmaceutici
  • Merck KGaA
  • Neolpharma SA De CV
  • Napp Pharmaceuticals Ltd
  • Pharmasol Corp
  • Pierrel Spa
  • Pillar5 Pharma Inc
  • PARI Pharma GmbH
  • 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
  • WuXi AppTec Co Ltd
  • Zymeworks Inc

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Laura Wood, Senior Press Manager

For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900