This report is the 14th edition of our long-running analysis of the CMO industry, using the FDA's 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 contract manufacturing organization (CMO) industry and the relative performance of major CMOs. This year's edition includes a discussion of how inflation and increasing global conflict has impacted pharma manufacturers.
Detailed view of CDMO performance by number of drug and vaccine approvals
An assessment of pharmaceutical companies' propensity to outsource manufacture, by their market caps, based on the publisher's Contract Service Providers database
Scope
This 87-page report gives important, expert insight you won’t find in any other source. 18 tables and 25 figures throughout the report illustrate major points and trends. This report is required reading for :
- CMO executives who must have deep understanding of drug approvals and outsourcing 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 and vaccine approvals and the levels of outsourcing associated with NDA sub segmentsDetailed view of CDMO performance by number of drug and vaccine approvals
An assessment of pharmaceutical companies' propensity to outsource manufacture, by their market caps, based on the publisher's Contract Service Providers database
- Outsourcing propensity for New Molecular Entities (NMEs), different dosage forms, and other drug attributes.
- Analysis of NME special product approvals such as those with Accelerated Approval, Orphan, Breakthrough or Fast Track designations and assessment of outsourcing
Table of Contents
- About the Publisher
- Executive Summary
- Players
- Technology Briefing
- Innovative drug approvals
- Dose outsourcing of drug approvals
- Trends
- Industry Analysis
- Introduction
- FDA NDA approvals overview
- Cell and gene therapies
- First-in-class
- First-time approvals
- Predicted drug events for 2024
- Sponsor trends
- FDA: outsourced dose manufacture
- Dosage form outsourcing
- Special product categories
- Accelerated approvals
- Orphan drug designation
- Fast track designation
- Breakthrough therapy designation
- Containment
- CMO performance
- Dosage form
- Outsourced API approvals
- ANDA approvals
- What it means
- FDA approvals hit a record high, recovering from a slump in 2022
- Opportunities for injectable manufacturers
- Catalent acquisition shakes up both the pharma and CMO landscape
- Record ATMP approvals and gene therapy firsts
- First topical gene therapy
- First CRISPR approval
- Cell and gene therapy current limitations
- A few large CMOs gain majority of dose contracts
- Increasing global conflict
- The future of manufacturing: AI, ESG, drug shortages, and personalized medicines
- Value Chain
- Companies
- Appendix
- Methodology
- Bibliography
- Primary research - key opinion leaders
- Further reading
- About the Authors
- Contact the Publisher
Table 1: Drug approval trends, 2023
Table 2: Predicted drug events in 2024
Table 3: Outsourced NDA approvals by dosage form
Table 4: Dose outsourcing relationships by sponsor market cap and FDA approval type, 2018-23
Table 5: CMOs with API contracts for NMEs approved in 2023
Table 6: Companies with 2023 CBER approvals
Table 7: FDA and EMA drug filings rejected or withdrawn in 2023
Table 8: 2023 outsourced dose approvals
Table 9: CMOs receiving dose contracts for FDA approvals in 2014-23
Table 10: 2023 outsourced API approvals
Table 11: CMOs receiving dose contracts for FDA approvals in 2023
Table 12: Small, micro, and nano cap sponsors’ dose outsourcing propensity for NMEs, 2014-23
Table 13: Small, micro, and nano cap sponsors’ dose outsourcing propensity for non-NMEs, 2014-23
Table 14: Mid cap sponsors’ dose outsourcing propensity, 2014-23
Table 15: Large cap dose outsourcing propensity, 2014-23
Table 16: Mega cap dose outsourcing propensity, 2014-23
Table 17: Private company dose outsourcing propensity, 2014-23
Table 18: Further reading
List of Figures
Figure 1: Leading players for US new drug approvals and their manufacturing, 2023
Figure 2: Top drug approval trends, 2023
Figure 3: FDA NDA and BLA approvals, 2014-23
Figure 4: FDA biologic NME approvals, 2014-23
Figure 5: FDA NDA approvals by sponsor type, 2014-23
Figure 6: Share of FDA NDA approvals outsourced, 2014-23
Figure 7: FDA NDA approvals outsourced, 2014-23
Figure 8: Dose outsourcing of small molecule and biologic NMEs, 2014-23
Figure 9: Dose outsourcing of FDA NME approvals by sponsor market cap
Figure 10: Dose outsourcing of FDA non-NME approvals by sponsor market cap
Figure 11: Dose outsourcing of accelerated approval NMEs, 2014-23
Figure 12: Dose outsourcing of FDA orphan NMEs, 2014-23
Figure 13: Dose outsourcing of FDA fast track NMEs, 2014-23
Figure 14: Dose outsourcing of breakthrough therapy designation NMEs, 2014-23
Figure 15: NME approvals requiring special handling, 2014-23
Figure 16: Breakdown in composition of dose-outsourced NMEs, by sponsor market cap, 2014-23
Figure 17: Breakdown in composition of dose-outsourced non-NMEs NDAs, by sponsor market cap, 2014-23
Figure 18: CMO market share of parenteral NME approvals, 2014-23
Figure 19: CMO market share of parenteral non-NME NDA and biosimilar approvals, 2014-23
Figure 20: CMO market share of solid dose NME approvals, 2014-23
Figure 21: CMO market share of solid dose non-NME NDA approvals, 2014-23
Figure 22: API outsourcing of small molecule and biologic NMEs, 2014-23
Figure 23: ANDA approvals by dosage form, 2014-23
Figure 24: ANDA approvals by route of administration, 2014-23
Figure 25: The contract manufacturing value chain
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- AbbVie Inc
- ACS Dobfar SpA
- AdhexPharma
- Aenova Holding GmbH
- Afton Scientific Corp
- AGC Biologics Inc
- Ajinomoto Bio-Pharma Services
- Akorn Operating Company LLC
- Alcami Corp
- Alfasigma SpA
- Allergopharma GmbH & Co KG
- Almac Group Ltd
- Alpex Pharma SA
- Altasciences Co Inc
- AqVida GmbH
- Arx LLC
- ASM Aerosol-Service AG
- AstraZeneca Plc
- AtomVie Global Radiopharma Inc
- Aurobindo Pharma Ltd
- AustarPharma LLC
- Avara Pharmaceutical Services Inc
- Baccinex SA
- Basic Pharma
- Bausch & Lomb Pharmaceuticals Inc
- Bayer AG
- Berkshire Sterile Manufacturing LLC
- Biogen Inc
- BioRamo LLC
- BioReliance Corp
- Boehringer Ingelheim Biopharmaceuticals GmbH
- Boehringer Ingelheim RCV GmbH & Co KG
- Bora Pharmaceuticals Co Ltd
- Bristol-Myers Squibb Co
- BSP Pharmaceuticals SpA
- Bushu Pharmaceuticals Ltd
- Cambrex Corp
- Catalent Inc
- Cenexi SAS
- Cerovene Inc
- Chia Tai Tianqing Pharmaceutical Group Co Ltd
- Contract Pharmaceuticals Ltd
- Corden Pharma International GmbH
- CoreRx Inc
- Corium Innovations Inc
- Curia Global Inc
- Delpharm SAS
- Dexcel PT Israel Ltd
- DPT Laboratories Ltd
- Eisai Co Ltd
- EMD Serono Inc
- Emergent BioSolutions Inc
- EuroAPI SAS
- Eurofins Scientific SE
- Excella GmbH & Co KG
- Exela Pharma Sciences LLC
- Exelead Inc
- Fareva SA
- Ferndale Pharma Group Inc
- Fidia farmaceutici SpA
- FinVector Oy
- Fresenius Kabi AG
- Fritz Keller Holding AG
- Fuji Yakuhin Co Ltd
- FUJIFILM Diosynth Biotechnologies USA Inc
- Gensenta Ilac Sanayi ve Ticaret AS
- Gland Pharma Ltd
- Glatt GmbH
- Grifols SA
- Groupe Parima Inc
- Grunenthal GmbH
- Hanford Pharmaceuticals
- Hetero Drugs Ltd
- Hikma Pharmaceuticals Plc
- Holopack Verpackungstechnik GmbH
- Hovione FarmaCiencia SA
- IDT Biologika GmbH
- Importfab Inc
- Ipsen SA
- Iwaki Seiyaku Sakura Factory Co Ltd
- James Alexander Corp
- Jubilant HollisterStier LLC
- Juzen Chemical Corp
- Kyowa Hakko Bio Co Ltd
- Laboratorios Farmaceuticos Rovi SA
- Lek Pharmaceuticals dd
- LGM Pharma LLC
- Lichtenheldt GmbH
- Lifecore Biomedical LLC
- Lonza Group Ltd
- LTS Lohmann Therapie-Systeme AG
- Lupin Ltd
- Mawdsley-Brooks & Co Ltd
- MIAS Pharma Ltd
- Mibe GmbH Arzneimittel
- Mikart LLC
- Minaris Regenerative Medicine LLC
- Mipharm SpA
- Mission Pharmacal Co
- Molteni Farmaceutici
- National Resilience Inc
- Neolpharma SA De CV
- NerPharma Srl
- NextPharma Technologies Holding Ltd
- Nova Laboratories Ltd
- Novartis AG
- Novast Holdings Ltd
- NUVISAN Pharma Holding GmbH
- OishiKoseido Corp
- Oncotec Pharma Produktion GmbH
- Organon & Co
- PARI Pharma GmbH
- PCI Pharma Services
- Pfizer Inc
- Pharmaceutics International Inc
- Pharmasol Corp
- Pharmathen Global BV
- Pharmstandard
- Pierrel SpA
- Piramal Pharma Solutions Inc
- Polymun Scientific Immunbiologische Forschung GmbH
- Procaps SAS
- PYRAMID Laboratories Inc
- Qilu Pharmaceutical Co Ltd
- QPS Holdings LLC
- Quotient Sciences Ltd
- Rechon Life Science AB
- Recipharm AB
- Renaissance Lakewood LLC
- Rentschler Biopharma SE
- Rivopharm SA
- Rottendorf Pharma GmbH
- R-Pharm
- Samsung Biologics Co Ltd
- Sandoz International GmbH
- Sanico NV
- Sanofi
- Sawai Pharmaceutical Co Ltd
- Sever Pharma Solutions AB
- SGS Quay Pharmaceuticals Ltd
- Sharp Packaging Services
- Sichuan Huiyu Pharmaceutical Co Ltd
- Siegfried Holding AG
- Simtra BioPharma Solutions
- Sintetica SA
- Sirton Pharmaceuticals SpA
- Skyepharma Production SAS
- SM Farmaceutici Srl
- Stada Arzneimittel AG
- Steri-Pharma LLC
- Takeda Pharmaceutical Co Ltd
- Tapemark Co
- Teikoku Seiyaku Co Ltd
- Teligent Inc
- The Biovac Institute
- The Ritedose Corp
- Thermo Fisher Scientific Inc
- TOYO Pharmaceutical Co Ltd
- Toyobo Co Ltd
- Tulex Pharmaceuticals Inc
- Unither Pharmaceuticals SAS
- UPM Pharmaceuticals Inc
- Vetter Pharma-Fertigung GmbH & Co KG
- Vianex SA
- Woodstock Sterile Solutions
- WuXi Biologics Cayman Inc
- WuXi XDC Cayman Inc
- Xellia Pharmaceuticals ApS
- Zydus Lifesciences Ltd
