New Drug Approvals and Their Contract Manufacture – 2021 Edition

This report is the 11th edition of our long running analysis of the CMO Industry, using NDA approvals as the primary indicator of performance. New Drug Approvals and Their Contract Manufacture (formerly called CMO Scorecard) is critical for benchmarking the performance of the CMO industry and the relative performance of major CMOs. This year's edition also includes a discussion of Emergency Use Aprrovals for COVID-19.

Scope

This 59-page report gives important, expert insight you won’t find in any other source. 10 tables and 30 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

Thermo Fisher Scientific Inc

Catalent Inc

Vetter Pharma-Fertigung GmbH & Co KG

PCI Pharma Services

Baxter International Inc

Almac Group Ltd

Viatris Inc

Pfizer Inc

Recipharm AB

Fareva SA

Siegfried Holding AG

Ajinomoto Co Inc

Delpharm SAS

Alcami Corp

Emergent BioSolutions Inc

Aenova Holding GmbH

Boehringer Ingelheim International GmbH

Fujifilm Corp

ACS Dobfar SpA

Rentschler Biopharma SE

Cenexi SAS

Albany Molecular Research Inc

Renaissance Lakewood LLC

Piramal Enterprises Ltd

Jubilant Pharma Ltd

Lonza Group Ltd

Rottendorf Pharma GmbH

Hovione FarmaCiencia SA

Quotient Sciences Ltd

Merck & Co Inc

Unither Pharmaceuticals SAS

Eurofins Scientific SE

Gland Pharma Ltd

BSP Pharmaceuticals SpA

CordenPharma International

Afton Scientific Corp

Klocke Pharma-Service GmbH

MIAS Pharma Ltd

Cambrex Corp

Fresenius Kabi AG

Hikma Pharmaceuticals Plc

Takeda Pharmaceutical Co Ltd

Cadila Healthcare Ltd

Cipla Ltd

Kindeva Drug Delivery LP

Exelead Inc

GlaxoSmithKline Plc

Instituto Bioclon SA de CV

NMS Group SpA

Nova Laboratories Ltd

Pharmaceutical Manufacturing Research Services Inc

The Ritedose Corp

Altasciences Co Inc

AstraZeneca Plc

Bausch Health Companies Inc

Bristol Myers Squibb Co

Lyophilization Services of New England Inc

Mikart LLC

Nordic Group BV

Sanofi

WuXi Biologics Cayman Inc

Xellia Pharmaceuticals ApS

Adare Pharma Solutions

Akorn Inc

Alpex Pharma SA

ARx LLC

ASM – Aerosol-Service AG

Cerovene Inc

Contract Pharmaceuticals Ltd

Glatt GmbH

Grunenthal GmbH

Importfab Inc

LTS Lohmann Therapie-Systeme AG

Merck KGaA

NerPharma Srl

NextPharma Technologies Holding Ltd

Pharmaceutics International Inc

ScinoPharm Taiwan Ltd

Sterigenics LLC

UPM Pharmaceuticals Inc

AbbVie Inc

AGC Biologics SpA

Alfasigma SpA

Alkermes Plc

AustarPharma LLC

Avara Pharmaceutical Services Inc

Biogen Inc

Biotechpharma UAB

Bora Pharmaceuticals Co Ltd

Bushu Pharmaceuticals Ltd

CAF-DCF bvba sprl

CoreRx Inc

DSM Pharmaceuticals Inc

Ei LLC (Inactive)

Eisai Co Ltd

Evonik Industries AG

Fuji Yakuhin Co Ltd

GBA Gesellschaft fur Bioanalytik mbh

Groupe Parima Inc

Institutt for Energiteknikk

Ipsen SA

Johnson & Johnson

Laboratoires Pierre Fabre SA

Laboratorios Farmaceuticos Rovi SA

Lyocontract GmbH

Minaris Regenerative Medicine LLC

Novartis AG

Pharmstandard

Porton Biopharma Ltd

Praxis Pharmaceutical SAU

QPS Holdings LLC

Rosemont Pharmaceuticals Ltd

Sanico NV

Sawai Pharmaceutical Co Ltd

Steri-Pharma LLC

Swedish Orphan Biovitrum AB

Teligent Inc

Teva Pharmaceutical Industries Ltd

Toyobo Co Ltd

Vifor Pharma Ltd

3SBio Inc

Alvogen Inc

Amgen Inc

Apotex Inc

Baccinex SA

Basic Pharma

Bayer AG

BioRamo LLC

Center Pharmaceutical Specialties

Centre for Probe Development and Commercialization

Confab Laboratories Inc

Corium Inc

DAU Laboratory

Dexcel PT Israel Ltd

Exela Pharma Sciences LLC

Ferndale Pharma Group Inc

Fritz Keller Holding AG

Galephar Pharmaceutical Research Inc

Gilead Sciences Inc

Glenmark Pharmaceuticals Ltd

Grifols SA

Holopack Verpackungstechnik GmbH

Intas Pharmaceuticals Ltd

James Alexander Corp

Kirin Holdings Co Ltd

KP Pharmaceutical Technology Inc

Lifecore Biomedical LLC

Lupin Ltd

Lyne Laboratories

Mawdsley-Brooks & Co Ltd

Metrics Contract Services

Molteni Farmaceutici

Neolpharma SA De CV

Nephron Pharmaceuticals Corp

Nexgen Pharma Inc

Novast Holdings Ltd

OishiKoseido Corp

Orion Corp

Panpharma SA

PARI Pharma GmbH

Perrigo Co Plc

Pharmascience Inc

Pharmaserve NW Ltd

Pharmasol Corp

Pierrel Spa

Pillar5 Pharma Inc

Polfarmex SA

Propak Health Ltd

PYRAMID Laboratories Inc

R Pharm

Rechon Life Science AB

Recro Pharma Inc

Rivopharm SA

Sharp Packaging Services

Sintetica SA

Stada Arzneimittel AG

Summit Biosciences Inc

Sun Pharmaceutical Industries Ltd

Tapemark Co

Therapure Biopharma Inc

Torii Pharmaceutical Co Ltd

University of Iowa Pharmaceuticals

USV Pvt Ltd

Vectura Group Plc

Vianex SA

Wockhardt UK Holdings Ltd

Woodfield Pharmaceutical LLC

Table of Contents

About GlobalData

1 Executive Summary

2 Players

3 Technology Briefing

3.1 Innovative Drug Approvals

3.2 Dose Outsourcing of Drug Approvals

4 Trends

5 Industry Analysis

5.1 Introduction

5.2 FDA NDA Approvals Overview

5.3 US vs. EU Approval Performance

5.4 FDA EUA Approvals in 2020 for COVID-19

5.5 FDA: Outsourced Dose Manufacture

5.5.1 Dosage Form Outsourcing

5.6 Special Product Categories

5.7 Outsourcing by Company Market Cap

5.8 CMO Performance

5.9 Outsourced API Approvals

5.10 ANDA Approvals

5.11 What It Means

5.11.1 Increased Innovative Approvals and Number of Outsourced Products

5.11.2 Drivers and Barriers

6 Value Chain

7 Companies

8 Appendix

8.1 Methodology

8.2 Bibliography

8.3 Primary Research – Key Opinion Leaders

8.4 Further Reading

9 About the Authors

Contact Us

List of Tables

Table 1: Drug Approval Trends, 2020

Table 2: Outsourced NDA Approvals by Dosage Form

Table 3: Dose Outsourcing Relationships by Sponsor Market Cap and FDA Approval Type, 2015-2020

Table 4: CMOs With API Contracts for NMEs Approved in 2020

Table 5: Companies with 2020 CBER Approvals

Table 6: 2020 Outsourced Dose Approvals by Company

Table 7: CMOs Receiving Dose Contracts for FDA Approvals in 2011-2020

Table 8: CMOs With API Contracts For Drug Approvals in 2020

Table 9: Dose CMOs Manufacturing NDAs Approved in 2020

Table 10: Further Reading

List of Figures

Figure 1: Leading Players for US New Drug Approvals and Their Manufacturing, 2020

Figure 2: Top Drug Approval Trends, 2020

Figure 3: FDA NDA and BLA Approvals, 2011-2020

Figure 4: FDA NDA Approvals by Sponsor Type, 2011-2020

Figure 5: EMA Approvals, 2012-2020

Figure 6: FDA Emergency Use Approvals for COVID-19 Contract Service Agreements, 2020

Figure 7: Share of FDA NDA Approvals Outsourced 2011-2020

Figure 8: NDA Approvals Outsourced 2011-2020

Figure 9: Dose Outsourcing of Small Molecule and Biologic NMEs, 2011-2020

Figure 10: Dose Outsourcing of FDA NME Approvals by Sponsor Market Cap

Figure 11: Dose Outsourcing of Non-NME NDA Approvals by Sponsor Market Cap

Figure 12: Outsourcing of FDA Orphan NMEs, 2011-2020

Figure 13: Dose Outsourcing of FDA Fast Track NMEs, 2011-2020

Figure 14: Dose Outsourcing of Breakthrough Therapy Designation NMEs, 2013-2020

Figure 15: NME Approvals Requiring Special Handling, 2011-2020

Figure 16: FDA Approvals and Outsourcing of NMEs Utilizing Solubility Enhancement, 2011-2020

Figure 17: Small Cap Sponsors’ Dose Outsourcing Propensity, 2011-2020

Figure 18: Mid Cap Sponsors’ Dose Outsourcing Propensity, 2011-2020

Figure 19: Large Cap Dose Outsourcing Propensity, 2011-2020

Figure 20: Mega Cap Dose Outsourcing Propensity, 2011-2020

Figure 21: Private Company Dose Outsourcing Propensity, 2011-2020

Figure 22: Breakdown in Composition of Dose-Outsourced NMEs, by Sponsor Market Cap, 2011-2020

Figure 23: Dose-Outsourced Non-NME NDAs, by Sponsor Market Cap, 2011-2020

Figure 24: CMO Market Share of Parenteral NME Approvals, 2011-2020

Figure 25: CMO Market Share of Parenteral Non-NME NDA Approvals, 2011-2020

Figure 26: CMO Market Share of Solid Dose NME Approvals, 2011-2020

Figure 27: CMO Market Share of Solid Dose Non-NME NDA Approvals, 2011-2020

Figure 28: API Outsourcing of Small Molecule and Biologic NMEs, 2011-2020

Figure 29: ANDA Approvals 2011-2020

Figure 30: The Contract Manufacturing Value Chain

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