In 2022, the FDA approved c100+ new drug applications (NDAs) and biologics license applications (BLAs). This figure represents a decrease over the 2017-21 period. Both small molecule and biologic new molecular entity (NME) approvals declined substantially, causing overall NDA approvals to drop, which meant fewer commercial-scale production contracts for the most innovative products comparative to other recent years.
In June 2021, the FDA granted accelerated approval of Biogen's Aduhelm for Alzheimer's disease, despite there being little to no evidence of clinical benefit and the majority of an FDA advisory panel voting against the drug's approval. This event caused controversy and added to pre-existing claims that the FDA approval process may not be as rigorous as it was in the past, the long-standing push for speed in the FDA approval process having meant a reduced level of certainty and evidence related to a drug. As a result of these issues, there may have been an increased reluctance to authorize innovative drugs for use.
COVID-19 vaccine drives have allowed economies and societies to safely reopen during the pandemic. However, new challenges such as rising inflation will bring uncertainty to the ongoing global recovery. The pharma industry faces increasing cost pressures, shrinking consumer spending power, staff shortages, and geopolitical tensions. Contract Manufacturing Organization's (CMO's) will need to find ways to remain competitive in these difficult conditions while maintaining quality and compliance. High inflation will also impact supply chains and R&D activities, and challenge their feasibility.
New Drug Approvals and Their Contract Manufacture - 2023 Edition; is the 13th edition in the series of 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 Emergency Use Approvals for COVID-19 and how inflation has impacted pharma manufacturers.
In June 2021, the FDA granted accelerated approval of Biogen's Aduhelm for Alzheimer's disease, despite there being little to no evidence of clinical benefit and the majority of an FDA advisory panel voting against the drug's approval. This event caused controversy and added to pre-existing claims that the FDA approval process may not be as rigorous as it was in the past, the long-standing push for speed in the FDA approval process having meant a reduced level of certainty and evidence related to a drug. As a result of these issues, there may have been an increased reluctance to authorize innovative drugs for use.
COVID-19 vaccine drives have allowed economies and societies to safely reopen during the pandemic. However, new challenges such as rising inflation will bring uncertainty to the ongoing global recovery. The pharma industry faces increasing cost pressures, shrinking consumer spending power, staff shortages, and geopolitical tensions. Contract Manufacturing Organization's (CMO's) will need to find ways to remain competitive in these difficult conditions while maintaining quality and compliance. High inflation will also impact supply chains and R&D activities, and challenge their feasibility.
New Drug Approvals and Their Contract Manufacture - 2023 Edition; is the 13th edition in the series of 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 Emergency Use Approvals for COVID-19 and how inflation has impacted pharma manufacturers.
Scope
This report gives important, expert insight you won't find in any other source. 11 tables and 34 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 segments
- 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
- 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
- Executive Summary
- Players
- Technology Briefing
- Innovative drug approvals
- Dose outsourcing of drug approvals
- Trends
- Industry Analysis
- Introduction
- FDA NDA approvals overview
- More biologic NME approvals than small molecule equivalents
- Cell and gene therapies
- First-in-class
- First-time approvals
- Rejected drugs
- Predicted approvals for 2023
- Sponsor trends
- US vs. EU approval performance
- FDA EUAs in 2022 for COVID-19
- FDA: outsourced dose manufacture
- Dosage form outsourcing
- Special product categories
- Accelerated approvals
- Orphan drug designation
- Fast track designation
- Breakthrough therapy designation
- Containment
- Solubility enhancement
- Outsourcing by company market cap
- CMO performance
- Dosage form
- Outsourced API approvals
- ANDA approvals
- What it means
- FDA approvals decline with a large decrease of NMEs approved
- COVID-19 vaccine demand waning but there are still lucrative contracts
- A few large CMOs gain majority of dose contracts
- High inflation and other business conditions
- Record high number of ATMP approvals in 2022
- Value Chain
- Companies
- Appendix
- Methodology
- Bibliography
- Primary research - key opinion leaders
- Further reading
- About the Authors
- Contact the Publisher
Table 1: Drug approval trends, 2022
Table 2: FDA and EMA drug filings rejected or withdrawn in 2022
Table 3: Predicted drug events in 2023
Table 4: Dose outsourcing of therapies and vaccines granted FDA emergency use approval for COVID-19 in 2020-22
Table 5: Outsourced NDA approvals by dosage form
Table 6: Dose outsourcing relationships by sponsor market cap and FDA approval type, 2017-22
Table 7: CMOs with API contracts for NMEs approved in 2022
Table 8: Companies with 2022 Center for Biologics Evaluation and Research (CBER) approvals
Table 9: 2022 outsourced dose approvals
Table 10: CMOs receiving dose contracts for FDA approvals in 2013-22
Table 11: 2022 outsourced API approvals
Table 12: CMOs receiving dose contracts for FDA approvals in 2022
Table 13: Further reading
List of Figures
Figure 1: Leading players for US new drug approvals and their manufacturing, 2022
Figure 2: Top drug approval trends, 2022
Figure 3: FDA NDA and BLA approvals, 2013-22
Figure 4: FDA biologic NME approvals, 2013-22
Figure 5: FDA NDA approvals by sponsor type, 2013-22
Figure 6: EMA approvals, 2013-22
Figure 7: FDA EUAs for COVID-19 products, 2020-22
Figure 8: Share of FDA NDA approvals outsourced, 2013-22
Figure 9: NDA approvals outsourced, 2013-22
Figure 10: Dose outsourcing of small molecule and biologic NMEs, 2013-22
Figure 11: Dose outsourcing of FDA NME approvals by sponsor market cap
Figure 12: Dose outsourcing of non-NME NDA approvals by sponsor market cap
Figure 13: Dose outsourcing of accelerated approval NMEs, 2013-22
Figure 14: Dose outsourcing of FDA orphan NMEs, 2013-22
Figure 15: Dose outsourcing of FDA fast track NMEs, 2013-22
Figure 16: Dose outsourcing of breakthrough therapy designation NMEs, 2013-22
Figure 17: NME approvals requiring special handling, 2013-22
Figure 18: FDA approvals and outsourcing of NMEs utilizing solubility enhancement, 2013-22
Figure 19: Small, micro, and nano cap sponsors’ dose outsourcing propensity for NMEs, 2013-22
Figure 20: Small, micro, and nano cap sponsors’ dose outsourcing propensity for non-NMEs, 2013-22
Figure 21: Mid cap sponsors’ dose outsourcing propensity, 2013-22
Figure 22: Large cap dose outsourcing propensity, 2013-22
Figure 23: Mega cap dose outsourcing propensity, 2013-22
Figure 24: Private company dose outsourcing propensity, 2013-22
Figure 25: Breakdown in composition of dose-outsourced NMEs, by sponsor market cap, 2013-22
Figure 26: Dose-outsourced non-NME NDAs, by sponsor market cap, 2013-22
Figure 27: CMO market share of parenteral NME approvals, 2013-22
Figure 28: CMO market share of parenteral non-NME NDA and biosimilar approvals, 2013-22
Figure 29: CMO market share of solid dose NME approvals, 2013-22
Figure 30: CMO market share of solid dose non-NME NDA approvals, 2013-22
Figure 31: API outsourcing of small molecule and biologic NMEs, 2013-22
Figure 32: ANDA approvals by dosage form, 2013-22
Figure 33: ANDA approvals by route of administration, 2013-22
Figure 34: 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
- 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
- Alvogen Inc
- AOP Health
- ARx LLC
- ASM Aerosol-Service AG
- AstraZeneca Plc
- Astrea SA
- AtomVie Global Radiopharma Inc
- Aurobindo Pharma Ltd
- AustarPharma LLC
- Avara Pharmaceutical Services Inc
- Baccinex SA
- Basic Pharma
- Bausch & Lomb Pharmaceuticals Inc
- Baxter Biopharma Solutions
- Bayer AG
- Berkshire Sterile Manufacturing LLC
- 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 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
- Gilead Sciences Inc
- Gland Pharma Ltd
- Glatt GmbH
- Grifols SA
- Groupe Parima Inc
- Grunenthal GmbH
- Hanford Pharmaceuticals
- Hikma Pharmaceuticals Plc
- Holopack Verpackungstechnik GmbH
- Hovione FarmaCiencia SA
- IDT Biologika GmbH
- Importfab Inc
- Institutt for Energiteknikk
- Ipsen SA
- Italfarmaco SpA
- Iwaki Seiyaku Sakura Factory Co Ltd
- James Alexander Corp
- Janssen-Cilag SpA
- Jubilant HollisterStier LLC
- Juzen Chemical Corp
- KP Pharmaceutical Technology Inc
- Kyowa Hakko Bio Co Ltd
- Laboratorios Farmaceuticos Rovi SA
- Lek dd
- LGM Pharma LLC
- Lifecore Biomedical LLC
- Lonza Group Ltd
- LTS Lohmann Therapie-Systeme AG
- Lupin Ltd
- Lyne Laboratories Inc
- Lyophilization Services of New England Inc
- Mawdsley-Brooks & Co Ltd
- MIAS Pharma Ltd
- Mibe GmbH Arzneimittel
- Mikart LLC
- Minaris Regenerative Medicine LLC
- Mipharm SpA
- Molteni Farmaceutici
- National Resilience Inc
- Neolpharma SA De CV
- Nephron Pharmaceuticals Corp
- 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
- Padagis LLC
- PARI Pharma GmbH
- PCI Pharma Services
- Pfizer Inc
- Pharmaceutical Manufacturing Research Services Inc
- Pharmaceutics International Inc
- Pharmascience 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
- Quay Pharmaceuticals Ltd
- 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
- Sharp Packaging Services
- Sichuan Huiyu Pharmaceutical Co Ltd
- Siegfried Holding AG
- Sintetica SA
- Sirton Pharmaceuticals SpA
- Societal CDMO Inc
- Stada Arzneimittel AG
- Sterigenics LLC
- 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
- UI Pharmaceuticals
- Unither Pharmaceuticals SAS
- UPM Pharmaceuticals Inc
- Vetter Pharma-Fertigung GmbH & Co KG
- Vianex SA
- Woodstock Sterile Solutions
- WuXi Biologics Cayman Inc
- Xellia Pharmaceuticals ApS
- Zydus Lifesciences Ltd
