CMO Industry Scorecard 2020: Outsourcing of NDA Approvals and CMO Performance – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance – 2020 Edition” report has been added to ResearchAndMarkets.com’s offering.

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.

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. (Read more…) 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

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

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

For more information about this report visit https://www.researchandmarkets.com/r/9g0dnn

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