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세계의 희귀질환 임상시험 시장 보고서(2025년)
Rare Disease Clinical Trials Global Market Report 2025
상품코드 : 1855965
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

희귀질환 임상시험 시장 규모는 최근 급속히 확대되고 있습니다. 2024년 120억 6,000만 달러로 평가되었고, 2025년에는 133억 달러에 달하고, CAGR 10.3%로 성장할 전망입니다. 과거 조사 기간 동안 발생한 성장은 건강 관리 제공업체의 유전성 질환에 대한 의식 증가, 임상시험 중 전문 환자 모니터링에 대한 수요 증가, 개인화된 의료 접근법의 개발 진전, 환자 중심의 임상시험 방법의 광범위한 채택, 세계 다시설 임상시험에 대한 요구 증가와 관련이 있습니다.

희귀질환 임상시험 시장 규모는 향후 수년간 급성장할 것으로 전망됩니다. 2029년에는 CAGR 10.0%로 194억 5,000만 달러로 성장할 전망입니다. 예측기간에 예측되는 성장은 임상시험에 진입하는 희소질환 치료제의 수 증가, 희소의약품 승인에 대한 규제당국의 지원 강화, 질병별 환자 등록과 데이터베이스 확대, 국경을 넘은 임상시험과 다시설 연구 증가, 희소질환 연구 인프라에 대한 자금 조달 이니셔티브의 강화에 기인할 것으로 예측됩니다. 예측 기간 동안 주요 동향으로는 분산형 임상시험 모델의 활용 확대, 환자 모집 전략의 혁신, 임상시험 설계에 대한 실제 임상 증거 통합, 정밀의료 접근법 개발, 디지털 건강 기술의 광범위한 채택 등이 있습니다.

희귀질환 임상시험 시장의 성장은 맞춤형 의료의 상승에 의해 견인될 것으로 예측됩니다. 이 접근법은 유전, 라이프 스타일, 환경 등 환자 각자의 특성에 맞는 치료를합니다. 맞춤형 의료는 각 환자에게 보다 효과적이고 안전한 치료를 제공함으로써 치료 결과를 개선할 수 있기 때문에 기세가 증가하고 있습니다. 희귀질환 임상시험은 환자 고유의 유전적 및 분자적 프로파일에 기초한 표적 요법의 창출을 이끌어내는 지견을 제공함으로써 이 분야의 발전에 중요한 역할을 하고 있습니다. 예를 들어 맞춤형 의료연합(PMC)은 2022년에는 FDA 승인의 34%를 개별화 의약품이 차지하고 2023년에는 38%로 상승한다고 보고합니다. 그 결과, 맞춤형 의료의 채택 확대가 희귀질환의 임상시험의 성장을 가속하고 있습니다.

희귀질환 임상시험 시장의 주요 기업은 생명공학 및 제약기업의 고객 특유의 요구와 선호도를 충족하는 데 중점을 둔 고객 중심 모델을 채택하여 혁신을 중시하고 있습니다. 이 접근법은 개별화된 임상시험 솔루션의 개발을 가능하게 하고 환자 참여도를 향상시키고 희귀질환의 치료법 개발을 가속화합니다. 그 두드러진 예는 2025년 3월 EMAS Pharma의 새로운 브랜드 아이덴티티로 도입된 Evestia Clinical Limited입니다. 이 브랜드 이름 변경은 회사의 세계 배포로의 전략적 전환과 희귀질환의 치료법 개발에 대한 약속을 보여줍니다. 에베스티아 클리니컬은 희귀질환 특유의 과제에 대응하는 개별화된 임상시험 솔루션의 제공에 중점을 두고, 이것을 서비스 제공과 브랜드 아이덴티티의 핵심으로 하고 있습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역전쟁과 관세, 그리고 코로나 및 회복이 시장에 미치는 영향을 포함한 거시경제 시나리오

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별/국가별 분석

제8장 아시아태평양 시장

제9장 중국 시장

제10장 인도 시장

제11장 일본 시장

제12장 호주 시장

제13장 인도네시아 시장

제14장 한국 시장

제15장 서유럽 시장

제16장 영국 시장

제17장 독일 시장

제18장 프랑스 시장

제19장 이탈리아 시장

제20장 스페인 시장

제21장 동유럽 시장

제22장 러시아 시장

제23장 북미 시장

제24장 미국 시장

제25장 캐나다 시장

제26장 남미 시장

제27장 브라질 시장

제28장 중동 시장

제29장 아프리카 시장

제30장 경쟁 구도와 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹과 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문, 전략

제36장 부록

SHW
영문 목차

영문목차

Rare disease clinical trials are carefully structured medical studies aimed at assessing the safety, efficacy, and potential treatments for rare or orphan diseases that affect a small number of patients. These trials are designed to generate essential clinical evidence to support regulatory approval and enhance patient outcomes. They often face unique challenges, including limited patient availability, specialized trial protocols, and higher costs compared to trials for more common conditions.

The primary phases of rare disease clinical trials include phase I, phase II, phase III, and phase IV. Phase I trials are early-stage studies that evaluate safety, dosage, and preliminary efficacy of investigational therapies in patients with rare diseases. Therapeutic areas covered include oncology, cardiovascular disorders, neurological disorders, infectious diseases, genetic disorders, autoimmune and inflammatory conditions, hematologic disorders, musculoskeletal disorders, and others. Study designs include interventional, observational, and expanded access trials, serving end users such as pharmaceutical companies, biotechnology firms, research institutions, and other stakeholders.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.

The rare disease clinical trials market research report is one of a series of new reports from The Business Research Company that provides rare disease clinical trials market statistics, including the rare disease clinical trials industry global market size, regional shares, competitors with the rare disease clinical trials market share, detailed rare disease clinical trials market segments, market trends, and opportunities, and any further data you may need to thrive in the rare disease clinical trials industry. This rare disease clinical trials market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The rare disease clinical trials market size has grown rapidly in recent years. It will grow from $12.06 billion in 2024 to $13.30 billion in 2025 at a compound annual growth rate (CAGR) of 10.3%. The growth observed during the historic period can be linked to increasing awareness of genetic disorders among healthcare providers, higher demand for specialized patient monitoring during trials, growing development of personalized medicine approaches, wider adoption of patient-centric trial methodologies, and rising need for global multi-center clinical studies.

The rare disease clinical trials market size is expected to see rapid growth in the next few years. It will grow to $19.45 billion in 2029 at a compound annual growth rate (CAGR) of 10.0%. The growth projected for the forecast period can be attributed to a rise in the number of rare disease therapies entering clinical trials, greater regulatory support for orphan drug approvals, expansion of disease-specific patient registries and databases, increasing cross-border clinical trials and multi-center studies, and enhanced funding initiatives for rare disease research infrastructure. Key trends during the forecast period include expanded use of decentralized trial models, innovations in patient recruitment strategies, integration of real-world evidence into trial designs, development of precision medicine approaches, and broader adoption of digital health technologies.

The growth of the rare disease clinical trials market is expected to be driven by the rise of personalized medicine. This approach involves tailoring medical treatments to the individual characteristics of each patient, including their genetics, lifestyle, and environment. Personalized medicine is gaining momentum due to its ability to improve treatment outcomes by offering therapies designed to be more effective and safer for each patient. Rare disease clinical trials play a vital role in advancing this field by providing insights that guide the creation of targeted therapies based on a patient's unique genetic and molecular profile. For example, the Personalized Medicine Coalition (PMC) reported that personalized medicines accounted for 34% of FDA approvals in 2022 and rose to 38% in 2023. As a result, the increased adoption of personalized medicine is driving the growth of clinical trials for rare diseases.

Leading companies in the rare disease clinical trials market are emphasizing innovation by adopting a client-centric model, which focuses on meeting the specific needs and preferences of biotech and pharmaceutical clients. This approach allows for the development of personalized clinical trial solutions, improving patient engagement and accelerating the creation of therapies for rare conditions. A notable example is Evestia Clinical Limited, which was introduced as the new brand identity for EMAS Pharma in March 2025. This rebranding signals the company's strategic shift towards global expansion and its commitment to advancing therapies for rare diseases. Evestia Clinical is focused on offering personalized clinical trial solutions that address the unique challenges of rare conditions, making this a core aspect of its service offering and brand identity.

In July 2024, AstraZeneca, a UK-based pharmaceutical company, acquired Amolyt Pharma, a French company specializing in rare endocrine disease therapies. The acquisition, the financial details of which were not disclosed, expands AstraZeneca's portfolio in rare disease treatments and supports its commitment to addressing unmet medical needs. Amolyt Pharma focuses on the development of therapies for rare endocrine disorders and the management of related clinical trials.

Major players in the rare disease clinical trials market are F. Hoffmann-La Roche AG, Pfizer Inc., Novartis AG, AstraZeneca plc, Takeda Pharmaceutical Company Limited, IQVIA Holdings Inc., Laboratory Corporation of America Holdings, ICON plc, Moderna Inc., Charles River Laboratories International Inc., Parexel International Corporation, Revvity Inc., Sarepta Therapeutics Inc., TFS HealthScience, Inventiva S.A., Tonix Pharmaceuticals Holding Corp., SpringWorks Therapeutics Inc., OrphAI Therapeutics Inc., BBCR Consulting LLC, and Credevo Inc.

North America was the largest region in the rare disease clinical trials market in 2024. The regions covered in rare disease clinical trials report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the rare disease clinical trials market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The rare disease clinical trials market includes revenues earned by entities through clinical trial design and protocol development, pharmacovigilance and safety services, and laboratory and biomarker services. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Rare Disease Clinical Trials Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on rare disease clinical trials market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for rare disease clinical trials ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The rare disease clinical trials market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. Rare Disease Clinical Trials Market Characteristics

3. Rare Disease Clinical Trials Market Trends And Strategies

4. Rare Disease Clinical Trials Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Rare Disease Clinical Trials Growth Analysis And Strategic Analysis Framework

6. Rare Disease Clinical Trials Market Segmentation

7. Rare Disease Clinical Trials Market Regional And Country Analysis

8. Asia-Pacific Rare Disease Clinical Trials Market

9. China Rare Disease Clinical Trials Market

10. India Rare Disease Clinical Trials Market

11. Japan Rare Disease Clinical Trials Market

12. Australia Rare Disease Clinical Trials Market

13. Indonesia Rare Disease Clinical Trials Market

14. South Korea Rare Disease Clinical Trials Market

15. Western Europe Rare Disease Clinical Trials Market

16. UK Rare Disease Clinical Trials Market

17. Germany Rare Disease Clinical Trials Market

18. France Rare Disease Clinical Trials Market

19. Italy Rare Disease Clinical Trials Market

20. Spain Rare Disease Clinical Trials Market

21. Eastern Europe Rare Disease Clinical Trials Market

22. Russia Rare Disease Clinical Trials Market

23. North America Rare Disease Clinical Trials Market

24. USA Rare Disease Clinical Trials Market

25. Canada Rare Disease Clinical Trials Market

26. South America Rare Disease Clinical Trials Market

27. Brazil Rare Disease Clinical Trials Market

28. Middle East Rare Disease Clinical Trials Market

29. Africa Rare Disease Clinical Trials Market

30. Rare Disease Clinical Trials Market Competitive Landscape And Company Profiles

31. Rare Disease Clinical Trials Market Other Major And Innovative Companies

32. Global Rare Disease Clinical Trials Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Rare Disease Clinical Trials Market

34. Recent Developments In The Rare Disease Clinical Trials Market

35. Rare Disease Clinical Trials Market High Potential Countries, Segments and Strategies

36. Appendix

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