한글목차

세계 희귀의약품 시장 규모는 2023년 2,339억 달러에서 예측 기간 동안 12.2%의 CAGR을 기록하며 2028년 말에는 4,152억 달러 규모로 성장할 것으로 예상됩니다.

생물학적 의약품 부문은 2023년 1,721억 달러에서 12.4%의 CAGR로 2028년 말에는 3,087억 달러로 증가할 것으로 예상됩니다. 비생물학적 의약품 부문은 2023년 619억 달러에서 11.5%의 CAGR로 2028년 말 1,065억 달러 규모로 성장할 것으로 예상됩니다.

본 보고서는 세계의 희귀의약품 시장을 조사했으며, 시장 및 기술 배경, 관련 법규 및 정책, 시장 영향요인 분석, 시장 규모 추이 및 예측, 각 부문별·지역별 상세 분석, ESG 전망, 가격 책정 및 상환 환경, 임상시험 동향, 경쟁 상황, 주요 기업 개요 등을 정리하여 전해드립니다.

목차

제1장 서론

제2장 요약과 하이라이트

• 시장 전망
• 시장 요약

제3장 시장 개요

• 시장 및 기술 배경
• 국가/지역별 희귀질환의 정의
• 미국
• EU
• 대만
• 일본
• 호주
• 싱가포르
• 한국
• 스위스
• 브라질

제4장 시장 역학

• 개요
• 성장 촉진요인
• 유리한 Orphan Drug Act와 유사한 법률
• 유전체학의 기술 진보
• 제네릭 의약품과의 경쟁 결여
• 특허 연장
• 희귀의약품의 프리미엄 프라이싱
• 제조 기술 혁신
• 제휴·라이선싱 계약 증가
• 성장 억제요인
• 훈련을 받은 전문가의 부족
• 취약한 타겟 그룹
• 규제상 과제
• 기회
• 새로운 희귀의약품의 방대한 제품 파이프라인
• 규제 상황
• 미국
• 유럽
• 일본
• 대만
• 한국

제5장 세계의 희귀의약품 시장 : 제품 유형별

• 생물학적 희귀의약품
• 비생물학적 희귀의약품

제6장 세계의 희귀의약품 시장 : 치료 용도별

• 종양
• 혈액질환
• 중추신경계
• 호흡기계
• 면역조절제
• 심혈관 치료
• 내분비계
• 근골격계
• 기타

제7장 세계의 희귀의약품 시장 : 지역별

• 세계의 시장 점유율 분석
• 북미
• 유럽
• 아시아태평양
• 기타 지역

제8장 희귀의약품 시장의 ESG 전망

• ESG : 서론
• 희귀의약품 업계에서 ESG의 중요성
• 희귀의약품 업계에서 ESG의 토대
• ESG 평가와 지표 : 데이터 이해
• 희귀의약품 업계에서 ESG의 실천
• BCC에 의한 결론

제9장 희귀의약품 독점권과 가격 설정 정책

• 희귀의약품 상환 가격 : 현재 전략과 개선 가능성
• 종합적인 가치 평가
• 초기 대화
• 혁신적인 상환 접근법
• 희귀의약품 생산의 사회적 참여

제10장 희귀의약품 임상시험

제11장 경쟁 상황

• 세계의 희귀의약품 판매량 Top 10
• 시장 점유율 분석

제12장 기업 개요

• ABBVIE INC.
• ASTELLAS PHARMA INC.
• ASTRAZENECA PLC
• BRISTOL MYERS SQUIBB
• EISAI CO. LTD.
• ELI LILLY AND CO.
• F. HOFFMANN-LA ROCHE LTD.
• MERCK & CO. INC.
• NOVARTIS AG
• PFIZER INC.
• SANOFI S.A.
• TAKEDA PHARMACEUTICAL CO. LTD.

제13장 부록 : 두문자어

영문목차

Highlights:

The global market for orphan drugs is expected to increase from $233.9 billion in 2023 to $415.2 billion by the end of 2028, with a compound annual growth rate (CAGR) of 12.2% during the forecast period of 2023-2028.

Biological orphan drugs market for orphan drugs is expected to increase from $172.1 billion in 2023 to $308.7 billion by the end of 2028, with a CAGR of 12.4% during the forecast period of 2023-2028.

Non-biological orphan drugs market for orphan drugs is expected to increase from $61.9 billion in 2023 to $106.5 billion by the end of 2028, with a CAGR of 11.5% during the forecast period of 2023-2028.

Report Scope:

The scope of this study includes orphan drugs used in the global pharmaceutical markets. This report analyzes the therapeutic applications of orphan drugs in rare and orphan diseases as well as examines the regulatory framework, patents, and recent innovations in the industry. The report also analyzes each submarket and its applications, projections, and market shares. Technological issues include the latest trends and developments.

This report covers the regional segmentation included as North America, Europe, Asia-Pacific, and Rest of the World. This report also analyzes the regulatory framework for the clinical trials of orphan drugs in rare and orphan diseases. The report examines the trends and characteristics of clinical trials conducted on rare diseases from 1999-2018, using information from various sources. In addition, this report provides an overview of the global orphan drugs market and its competitive landscape. This report also examines acquisition strategies and collaborations, discusses the market's strengths and weaknesses considering new technologies, and analyzes the industry's growing competition and changing customer needs.

Report Includes:

• 33 data tables and 46 additional tables
• Overview and an up-to-date analysis of the global markets for orphan drugs (ODs) for rare diseases treatment
• Analyses of the global market trends, with historical market revenue data (sales figures) from 2021 to 2022, estimates for 2023, forecasts for 2024, and projections of compound annual growth rates (CAGRs) through 2028
• Highlights of the current and future market potential of orphan drugs, along with a detailed analysis of the market drivers, restraints, and opportunities
• Estimate of the actual market size and revenue forecast for the global orphan drugs market, and its corresponding market share analysis based on the product type, therapeutic area, and region
• Analysis of market growth opportunities with a holistic review of Porter's five forces model and PESTLE analyses considering the micro- and macroeconomic factors prevailing in the marketplace
• Discussion of sustainability trends and factors in the orphan drugs market, with emphasis on consumer attitudes, ESG score analysis, future of ESG, case study, and the ESG practices followed
• Analyses of the novel therapeutic applications of orphan drugs in rare and orphan diseases as well as examination of the regulatory framework, patents, and recent innovations in the industry
• Review of the current status and trends in clinical trials for the development of drugs in rare diseases among the three registries from the U.S., EU and Japan
• Discussion of successful orphan medicinal products, rising influence of pharmacogenomics in the ODs market, information on specific rare diseases for which orphan drugs exist
• Assessment of the most promising therapeutic areas in the industry and leading orphan drugs in these areas
• Overview of the industry structure for orphan drugs, pricing and reimbursement policies, COVID-19 impact, and market share analysis of the leading manufacturers of orphan drugs along with their SWOT analyses
• Company profiles of major players within the industry, including AstraZeneca Plc, Eisai Co. Ltd., Bristol Myers Squibb and Pfizer Inc.

Table of Contents

Chapter 1 Introduction

• Study Goals and Objectives
• Reasons for Doing This Study
• Scope of Report
• What's New in this Update?
• Methodology
• Information Sources
• Geographic Breakdown
• Segmentation Breakdown

Chapter 2 Summary and Highlights

• Market Outlook
• Market Summary

Chapter 3 Market Overview

• Market and Technology Background
• Global Definitions of Rare Diseases by Country/Region
• U.S.
• EU
• Taiwan
• Japan
• Australia
• Singapore
• South Korea
• Switzerland
• Brazil

Chapter 4 Market Dynamics

• Overview
• Drivers
• Favorable Orphan Drug Act and Similar Legislation
• Technological Advances in Genomics
• Lack of Competition from Generic Drugs
• Patent Extensions
• Premium Pricing of Orphan Drugs
• Innovations in Manufacturing Technologies
• Increasing Collaborations and Licensing Agreements
• Restraints
• Lack of Trained Professionals
• Vulnerable Target Groups
• Regulatory Challenges
• Opportunities
• Huge Product Pipeline of New Orphan Drugs
• Regulatory Landscape
• U.S.
• Europe
• Japan
• Taiwan
• South Korea

Chapter 5 Global Market for Orphan Drugs by Product Type

• Biological Orphan Drugs
• Non-biological Orphan Drugs

Chapter 6 Global Market for Orphan Drugs by Therapeutic Application

• Oncology
• Blood Disorders
• Central Nervous System
• Respiratory System
• Immunomodulators
• Cardiovascular Therapies
• Endocrine System
• Musculoskeletal System
• Others

Chapter 7 Global Market for Orphan Drugs by Region

• Global Market Share Analysis
• North America
• Europe
• Asia-Pacific
• Rest of the World (RoW)

Chapter 8 ESG Outlook in the Orphan Drugs Market

• Introduction to ESG
• Importance of ESG in the Orphan Drug Industry
• ESG Pillars in the Orphan Drugs Industry
• ESG Ratings and Metrics: Understanding the Data
• ESG practices in the Orphan Drug Industry
• Concluding Remarks from BCC Research

Chapter 9 Orphan Drugs Exclusivity and Pricing Policies

• Reimbursed Price of ODs: Current Strategies and Potential Improvements
• Comprehensive Value Assessment
• Early Dialogues
• Innovative Reimbursement Approaches
• Societal Participation in Producing ODs

Chapter 10 Clinical Trials on Drugs for Rare Diseases

• List of Clinical Trials on Drugs for Rare Diseases

Chapter 11 Competitive Landscape

• Top 10 Selling Orphan Drugs Globally
• Market Share Analysis

Chapter 12 Company Profiles

• ABBVIE INC.
• ASTELLAS PHARMA INC.
• ASTRAZENECA PLC
• BRISTOL MYERS SQUIBB
• EISAI CO. LTD.
• ELI LILLY AND CO.
• F. HOFFMANN-LA ROCHE LTD.
• MERCK & CO. INC.
• NOVARTIS AG
• PFIZER INC.
• SANOFI S.A.
• TAKEDA PHARMACEUTICAL CO. LTD.

Chapter 13 Appendix: Acronyms

• Acronyms