DUBLIN–(BUSINESS WIRE)–The “New Drug Approvals and Their Contract Manufacture – 2023 Edition” report has been added to ResearchAndMarkets.com’s offering.
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.
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
Key Topics Covered:
- 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
Companies Mentioned
- 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
- And Many More Companies!
For more information about this report visit https://www.researchandmarkets.com/r/a0j1ls
Source: GlobalData
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