新薬承認と受託製造（2024年版）

当レポートでは、CMO産業について調査分析し、インフレと世界の紛争の激化が製薬企業に与えた影響を考察しています。

目次

• エグゼクティブサマリー
• 参入者
• 技術ブリーフィング
• 革新的な医薬品の承認
• 医薬品承認のアウトソーシング
• 動向
• 産業の分析
• イントロダクション
• FDA NDA承認の概要
• 細胞・遺伝子治療
• ファーストインクラス
• 初回承認
• 2024年に予測される医薬品関連イベント
• スポンサーの動向
• FDA：外注投与製造
• 剤形アウトソーシング
• 特殊製品カテゴリ
• 迅速な承認
• 希少疾病用医薬品指定
• ファストトラック指定
• 画期的新薬指定
• 抑制
• CMOの業績
• 剤形
• 外注API承認
• ANDA承認
• 意味すること
• FDAの承認数は過去最高を記録し、2022年の低迷から回復
• 注射剤メーカーにとっての機会
• Catalentの買収は製薬産業とCMO情勢の双方に影響を与える
• 記録的なATMP承認と遺伝子治療の初導入
• 初の局所遺伝子治療
• 最初のCRISPR承認
• 細胞・遺伝子治療の現在の限界
• 少数の主要CMOが投与契約の大半を獲得
• 激化する世界の紛争
• 製造の未来：AI、ESG、医薬品不足、個別化医療
• バリューチェーン
• 企業

付録

List of Tables

• 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• Table 7: FDA and EMA drug filings rejected or withdrawn in 2023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

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.

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 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 GlobalData'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

Table of Contents

• About GlobalData

Table of Contents

• 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 Us