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

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