"PharmSource - CMO Scorecard: Outsourcing of NDA Approvals and CMO Performance - 2018 Edition", Edition analyzes the performance of the drug product CMO industry using NDA approvals as the primary indicator of performance. The report examines 118 drugs approved by the FDA Center for Drug Evaluation and Research (CDER) in 2017 along with four therapeutic drugs approved by the FDA Center for Biologics Evaluation and Research (CBER) under the BLA process (Table 4). NDA and BLA approvals include New Molecular Entities (NMEs), as well as new formulations of previously approved APIs. In addition, the report also includes drugs examined by the European Medicines Agency (EMA). The centralized procedure is mandatory for all New Active Substances (NASs), as well as biosimilar and certain generics.
This report analyzes propensity to outsource by dosage form, sponsor type, nature of API, and special handling requirements. It includes information on products that have used formulation technologies such as amorphous solid dispersion (ASD), hot melt extrusion (HME), and jet milling. This year, we have added two new elements to our analysis: injectable market share by dose form and an enhanced examination into the behavior of the global bio/pharma sector.
The data on which this report is based comes from the PharmSource products database, which includes manufacturing details on all NDA approvals from the past decade or more. The data is compiled from a broad array of public sources including product regulatory filings, financial regulatory filings, investor relations, and press releases. Subscribers can use the databases in PharmSource to do their own customized analyses of product and contract manufacturing service data. A more detailed description of our methodology is contained in an Appendix to this report.
Companies mentioned in this report: 3M, Abbvie, ACS Dobfar, Actavis, Adare Pharmaceuticals, Aenova Group, Aesica Pharmaceuticals, Afton Scientific Corp., Ajinomoto Althea, Ajinomoto Co., Akorn, Albany Molecular Research Inc., Alcami, Alkermes, Alliance Medical Products, Almac Group, Alpex Pharma, APL, ARx LLC, ASM Aerosol-Service AG, AstraZeneca, Avara Pharmaceutical Services, Aveva Drug Delivery Systems, B. Braun Melsungen AG, Banner Life Sciences, Bausch & Lomb Pharmaceuticals, Baxter BioPharma Solutions, Baxter International, Bayer Healthcare, BioRamo LLC, BioReliance, Boehringer Ingelheim BioXcellence, Boehringer Ingelheim GmbH, Bristol-Myers Squibb, BSP Pharmaceuticals, Bushu Pharmaceuticals, CAF-DCF, Capsugel, Catalent Pharma Solutions, Cenexi, Cerovene, Chemo, Cipla, Colep, Confab Laboratories, Cook Pharmica LLC, CPL Contract Pharmaceuticals Limited, Debiopharm Research & Manufacturing SA, Delpharm, DPT Laboratories, Ei Inc., Emergent BioSolutions, Excella Pharma Source, Exela Pharma Sciences, Exelead, Famar, Fareva Holding, Ferndale Labs &Contract Manufacturing, Ferrer Internacional, Fresenius Kabi, Frike Group, Galephar SA, Gedeon Richter, Gilead Sciences, Gland Pharma Limited, GlaxoSmithKline, Glenmark, Grifols, Groupe Panpharma, Halo Pharmaceutical, Hameln Pharmaceuticals GmbH, Holopack Verpackungstechnik GmbH, IDT Biologika GmbH, Importfab Inc., Instituto Bioclon S.A. de C.V., Intas Pharmaceuticals Ltd., James Alexander Corporation, Japan Tobacco Inc., Jetpharma SA, Jubilant HollisterStier Contract Manufacturing & Services, Kemwell Biopharma, KP Pharmaceutical Technology, Kremers Urban Pharmaceuticals, Laboratoires Théa, Lehigh Valley Technologies Inc., Lifecore Biomedical, Lonza Netherlands, LTS Lohmann, LTS Lohmann Therapie-Systeme AG, Lyne Laboratories, Lyophilization Services of New England, Medimmune, Mikart, Mipharm, Mitsubishi Tanabe Pharma Corporation, MonoSol Rx, Mustafa Nevzat Pharmaceuticals, Mylan, Nerviano Medical Sciences, Nexgen Pharma, NextPharma Technologies, Nipro Pharma Corp., Nordmark Arzneimittel GmbH & Co. KG, Norwich Pharma Services, Nova Laboratories Ltd, Nuvo Research, Orion Corporation, Pari Pharma, Patheon, PCI Pharma Services, Perrigo, Pfizer, Pharmaceutical Manufacturing Research Services Inc., Pharmaceutics International, Pharmaceutics International Inc, Pharmascience Inc., Pierre Fabre, Pierrel SpA, Pillar5 Pharma Inc., Piramal Pharma Solutions, Porton Biopharma Limited, QS Pharma, Rechon Life Science, Recipharm, Recro Pharma Inc., Renaissance, Rentschler Biopharma SE, Rivopharm S.A., Rosemont Pharmaceuticals, Rottendorf, Rottendorf Pharma GmbH, Sanico NV., Sanofi, Sanquin Blood Supply Foundation, Siegfried, Sintetica, Sirton Pharmaceuticals SpA, Steri-pharma LLC, Sterigenics, Swedish Orphan Biovitrum AB, Synerlab Group, Tapemark, Teligent, The Ritedose Corporation, Tris Pharma, Unither Pharmaceuticals, University of Iowa Pharmaceuticals, UPM Pharmaceuticals, Valeant Pharmaceuticals International, Vectura, Vetter Pharma International, Vifor Pharma, Wockhardt Contract Manufacturing, Woodfield Pharmaceutical and Zydus Cadila
Reasons to buy
This 43-page report gives important, expert insight you won’t find in any other source. 28 tables and 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.
3. NDA Approvals Overview
4. US Versus EU Approval Performance
5. Outsourced Dose Manufacture
6. Special Product Categories
7. Outsourcing by Global Bio/Pharma Companies
8. CMO Performance
9. Outsourced API Approvals
10. What It Means
11. Notes on Methodology
List of Tables
Table 1: Outsourced NDA Approvals by Dosage Form
Table 2: Outsourcing by Sponsor Type and FDA Approval Type 2012-2017
Table 3: API CMOs Receiving NME Approvals in 2017
Table 4: 2017 CBER Approvals Included in the Analysis
Table 5: 2017 Outsourced Dose Approvals
Table 6: Dose CMOs Receiving Contracts for FDA Approvals in 2008-2017
Table 7: 2017 Outsourced API Approvals
Table 8: Dose CMOs Manufacturing NDAs Approved 2017
Table 9: MHRA Approvals in 2017
List of Figures
Figure 1: NDA Approvals 2008-2017
Figure 2: NDA Approvals by Sponsor Type 2008-2017
Figure 3: EMA Approvals 2012-2017
Figure 4: Share of NDA Approvals Outsourced 2008-2017
Figure 5: NDA Approvals Outsourced 2008-2017
Figure 6: Dose Outsourcing of Small and Large Molecule APIs 2008-2017
Figure 7: Outsourcing of NME Approvals by Sponsor Type
Figure 8: Outsourcing of Non-NME NDA Approvals by Sponsor Type
Figure 9: Outsourcing of Orphan NMEs 2008-2017
Figure 10: Outsourcing of Fast Track NMEs 2011-2017
Figure 11: Outsourcing of Breakthrough NMEs 2013-2017
Figure 12: NMEs Requiring Special Handling 2008-2017
Figure 13: Approval and Outsourcing of NMEs Utilizing Advanced Formulation Technologies 2011-2016
Figure 14: Global Bio/Pharma Outsourcing Propensity 2008-2017
Figure 15: Trends in Global Bio/Pharma NDA Outsourcing 2008-2017
Figure 16: Breakdown in Composition of Outsourced NMEs 2008-2017 by Sponsor Type
Figure 17: Breakdown in Composition of Outsourced Non-NME NDAs 2008-2017 by Sponsor Type
Figure 18: Outsourcing of API for NME Approvals 2008-2017
Figure 19: ANDA Approvals 2008-2017