Dublin, Aug. 05, 2025 (GLOBE NEWSWIRE) -- The "New Drug Approvals and Their Contract Manufacture: 2025 Edition" report has been added to ResearchAndMarkets.com's offering.
This report is the 15th edition of the 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.
Report Scope
- 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 analyst'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
This report gives important, expert insight you won't find in any other source. 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.
Key Topics Covered:
- 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
- Sponsor trends
- 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
- Biosimilar approvals hit record high
- Increased outsourcing of special product categories
- High levels of innovation in 2024's approvals
- Trump's tariffs and the Biosecure Act effect on trade with US
- FDA hit by DOGE layoffs
- Biotech investor confidence in 2025
- A few large CMOs gain majority of dose contracts
- Value Chain
- Companies
Company Coverage:
- Fresenius Kabi USA LLC
- Sandoz Inc
- Alvotech SA
- Madrigal Pharmaceuticals
- Verona Pharma Inc
- ImmunityBio
- Geron Corporation
- Iovance Biotherapeutics Inc
- F. Hoffmann-La Roche Ltd
- Samsung Bioepis Co Ltd
- Thermo Fisher Scientific Inc
- Vetter Pharma
- Almac Group Ltd
- Catalent Inc
- Helix Biotech
- Minaris Advanced Therapies LLC
- National Resilience
- WuXi Advanced Therapies Inc
- The National Institute of Allergy and Infectious Diseases (NIAID)
- Stanford Medicine
- Garvan Institute of Medical Research
- Altaris Capital Partners LLC
- Mubadala Investment Company PJSC
For more information about this report visit https://www.researchandmarkets.com/r/wid39g
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