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희귀의약품 시장 규모, 점유율, 성장 분석 : 치료 유형별, 적응증별, 약제 유형별, 판매별, 유통 채널별, 지역별 - 산업 예측(2025-2032년)
Orphan Drug Market Size, Share, and Growth Analysis, By Therapy Type (Oncology, Hematology), By Indication Type (Non-Hodgkin Lymphoma, Acute Myeloid Leukemia), By Drug Type, By Sale, By Distribution Channel, By Region - Industry Forecast 2025-2032
상품코드 : 1663112
리서치사 : SkyQuest
발행일 : 2025년 02월
페이지 정보 : 영문 211 Pages
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한글목차

희귀의약품 시장 규모는 2023년에 1,957억 6,000만 달러에 달하며, 예측 기간(2025-2032년)의 CAGR은 11.8%로, 2024년 2,188억 6,000만 달러에서 2032년에는 5,342억 달러로 성장할 전망입니다.

희귀의약품 시장은 특히 WHO가 1만 명 중 6.5-10명 미만이 앓고 있는 질병으로 정의한 희귀질환의 치료 개발을 촉진하기 위한 2019년 희귀의약품법 제정으로 큰 견인차 역할을 하고 있습니다. 역사적으로 이러한 의약품의 상업화를 위한 길은 길고 비용이 많이 들며, 분자 발견에서 치료 적용까지 성공률은 10%에 불과합니다. 현재 378개 이상의 희귀질환 치료제가 승인되었으며, 미국은 임상시험, 특히 암 분야에서 그 중 30% 이상을 차지하고 있습니다. 미국에서만 약 7,000개의 희귀질환이 2,500만-3,000만 명에게 영향을 미치고 있으며, 매년 약 250개의 새로운 질환이 확인되고 있으며, 희귀질환 치료제 수요는 지속적으로 증가하고 있으며, 시장은 더욱 진화하고 있습니다.

목차

서론

조사 방법

개요

시장 역학과 전망

주요 시장 인사이트

희귀의약품 시장 규모 : 치료 유형별 & CAGR(2025-2032)

희귀의약품 시장 규모 : 적응증별 & CAGR(2025-2032)

희귀의약품 시장 규모 : 약제 유형별 & CAGR(2025-2032)

희귀의약품 시장 규모 : 판매별 & CAGR(2025-2032)

희귀의약품 시장 규모 : 유통 채널별 & CAGR(2025-2032)

희귀의약품 시장 규모 : 지역별 & CAGR(2025-2032)

경쟁 정보

주요 기업 개요

결론과 제안

KSA
영문 목차

영문목차

Orphan Drug Market size was valued at USD 195.76 billion in 2023 and is poised to grow from USD 218.86 billion in 2024 to USD 534.2 billion by 2032, growing at a CAGR of 11.8% during the forecast period (2025-2032).

The orphan drug market has gained significant traction, particularly following the Orphan Drug Act of 2019, which aims to spur the development of treatments for rare diseases, defined by the WHO as those affecting less than 6.5 to 10 out of 10,000 individuals. Historically, the path to commercialization of these drugs is lengthy and costly, with a mere 10% success rate from molecule discovery to therapeutic application. Currently, over 378 orphan drugs have been approved, with the U.S. leading in clinical trials, particularly in oncology, which accounts for over 30% of these efforts. With approximately 7,000 rare diseases impacting 25-30 million people in the U.S. alone-and around 250 new conditions identified annually-the demand for orphan drugs continues to rise, poised for further market evolution.

Top-down and bottom-up approaches were used to estimate and validate the size of the Orphan Drug market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Orphan Drug Market Segments Analysis

Global Orphan Drug Market is segmented by Therapy Type, Indication Type, Drug Type, Sale, Distribution Channel and region. Based on Therapy Type, the market is segmented into Oncology, Hematology, Neurology, Endocrinology, Cardiovascular, Respiratory, Immunotherapy, Infectious Diseases and Others. Based on Indication Type, the market is segmented into Non-Hodgkin Lymphoma, Acute Myeloid Leukemia, Cystic Fibrosis, Glioma, Pancreatic Cancer, Ovarian Cancer, Multiple Myeloma, Duchenne Muscular Dystrophy, Renal Cell Carcinoma, Graft Vs Host Disease and Others. Based on Drug Type, the market is segmented into Biologics and Non-biologics. Based on Sale, the market is segmented into Generics and Prescribed. Based on Distribution Channel, the market is segmented into Hospital Pharmacy, Retail Pharmacy, Online Pharmacy and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Orphan Drug Market

The Orphan Drug market is being significantly driven by advancements in technology, particularly in genomics and gene sequencing, which have facilitated research and development for rare diseases. These innovations have paved the way for novel treatment approaches, including gene therapy and antisense therapy, allowing for targeted interventions that were once deemed unfeasible. Consequently, the combination of these technological breakthroughs has enhanced the capacity for diagnosing and treating uncommon genetic disorders, making them more manageable and attractive to pharmaceutical companies. As a result, the landscape for orphan medications is evolving, ushering in a new era of possibilities for both patients and developers.

Restraints in the Orphan Drug Market

The orphan drug market faces significant constraints primarily due to the inability of many orphan medications to meet established health technology assessment standards, especially regarding cost-effectiveness. These challenges, exacerbated by the high cost of these drugs and insufficient data supporting their value, can limit patient access significantly. The high price tags associated with these treatments often lead to scrutiny from health payers and regulators who seek value for money, making it difficult for healthcare providers to justify their use. Consequently, the combination of cost and data limitations creates substantial barriers within the orphan drug market.

Market Trends of the Orphan Drug Market

The Orphan Drug Market is experiencing a notable upward trend due to the strategic adoption of auxiliary or surrogate endpoints in clinical trials, which allows companies to demonstrate treatment effectiveness with less stringent criteria. This paradigm shift not only streamlines the research and development process but also significantly lowers time and cost investment in bringing orphan drugs to market. Consequently, pharmaceutical companies are increasingly incentivized to develop therapies for rare diseases, further propelling market growth. As regulatory bodies continue to support these innovations, the orphan drug sector is poised for continued expansion, addressing unmet medical needs while driving profitability for developers.

Table of Contents

Introduction

Research Methodology

Executive Summary

Market Dynamics & Outlook

Key Market Insights

Global Orphan Drug Market Size by Therapy Type & CAGR (2025-2032)

Global Orphan Drug Market Size by Indication Type & CAGR (2025-2032)

Global Orphan Drug Market Size by Drug Type & CAGR (2025-2032)

Global Orphan Drug Market Size by Sale & CAGR (2025-2032)

Global Orphan Drug Market Size by Distribution Channel & CAGR (2025-2032)

Global Orphan Drug Market Size & CAGR (2025-2032)

Competitive Intelligence

Key Company Profiles

Conclusion & Recommendations

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