한글목차

CMO 산업에 대해 조사분석했으며, 인플레이션과 세계의 분쟁 격화가 제약기업에게 미친 영향을 분석하여 전해드립니다.

목차

• 주요 요약
• 참여자
• 기술 브리핑
• 혁신적인 의약품 승인
• 의약품 승인의 아웃소싱
• 동향
• 산업의 분석
• 서론
• FDA NDA 승인의 개요
• 세포·유전자 치료
• 퍼스트 인 클래스
• 초회 승인
• 2024년에 예측되는 의약품 관련 이벤트
• 스폰서의 동향
• FDA : 외주 투여 제조
• 제형 아웃소싱
• 특수 제품 카테고리
• 신속한 승인
• 희귀의약품 지정
• 패스트트랙 지정
• 획기적 신약 지정
• 억제
• CMO 실적
• 제형
• 외주 API 승인
• ANDA 승인
• 의미하는 것
• FDA 승인 수는 과거 최고를 기록하며, 2022년의 침체로부터 회복
• 주사제 제조업체에게 기회
• Catalent 인수는 제약 산업과 CMO 상황 양측에 영향을 미친다.
• 기록적인 ATMP 승인과 유전자 치료의 첫 도입
• 첫 국소 유전자 치료
• 최초의 CRISPR 승인
• 세포·유전자 치료의 현재 한계
• 소수의 주요 CMO가 투여 계약의 대부분을 획득
• 격화하는 세계의 분쟁
• 제조의 미래 : AI, ESG, 의약품 부족, 맞춤형 의료
• 밸류체인
• 기업

부록

영문목차

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