세계의 리보핵산(RNA) 요법 임상시험 시장 보고서(2025년)
Ribonucleic Acid (RNA) Therapy Clinical Trials Global Market Report 2025
상품코드 : 1811021
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

리보핵산(RNA) 요법 임상시험 시장 규모는 향후 수년간 안정된 성장이 전망됩니다. 2029년에는 연평균 성장률(CAGR) 4.8%로 32억 5,000만 달러로 성장합니다. 예측 기간 중 예상되는 성장은 희귀질환 유병률 증가, 규제 당국의 승인 증가, 임상연구 투자 증가, 환자 참여 증가, 맞춤형 의료에 대한 관심 증가에 기인할 것으로 보입니다. 이 기간의 주요 동향으로는 RNA 전달 시스템의 발전, 바이오마커 기반 시험 설계의 발전, 시험 설계에 인공지능의 통합, 분산형 임상시험의 기술 채택, 규제 당국의 신속한 임상시험 경로 개발 등을 들 수 있습니다.

감염성 질환의 부담 증가는 향후 수년간 리보핵산(RNA) 치료제 임상시험 시장의 확대를 촉진할 것으로 예측됩니다. 감염은 세균, 바이러스, 곰팡이, 기생충 등 병원성 미생물이 체내에 침입하여 증식하여 건강장애를 일으키는 것을 말합니다. 감염증 증가는 전 세계 여행객 증가로 인한 것으로, 서로 다른 지역과 집단 간 병원체 확산이 가속화되고 있습니다. RNA 치료 임상시험은 새로운 병원체에 빠르게 적응할 수 있는 표적 치료제의 개발 및 시험을 촉진함으로써 감염성 질환에 대처하는 데 중요한 역할을 하고 있습니다. 예를 들어 2025년 4월 미국 미네소타 주정부 기관인 미네소타주 보건국의 보고서에 따르면 35-39세 남성의 HIV 감염자 비율은 2023년 10%에서 2024년 17%로 상승했습니다. 따라서 감염성 질환 부담 증가는 RNA 치료 임상시험 시장의 성장을 가속하고 있습니다.

RNA 치료 임상시험 시장의 주요 기업은 RNA 기반 안티센스 올리고뉴클레오티드 치료 임상시험과 같은 혁신적인 접근법을 개발하는 데 주력하고 있습니다. 이 임상시험은 특정 유전자 염기서열을 표적으로 유전자 발현을 조절하여 유전성 질환 및 희귀질환에 대한 고정밀 치료제를 제공합니다. RNA 기반 안티센스 올리고뉴클레오티드 치료 임상시험은 유전자 발현을 조절하고 유전성 질환을 치료하기 위해 특정 메신저 RNA 표적에 결합하도록 설계된 짧은 합성 RNA 사슬의 사용을 조사하는 것입니다. 예를 들어 2024년 12월 프랑스 생명공학 기업 Sepul Bio는 망막색소변성증(RP)과 어셔 증후군 2a형의 원인인 USH2A 유전자의 엑손 13 변이를 대상으로 한 RNA 기반 안티센스 올리고뉴클레오티드 치료제인 ultevursen을 평가하는 LUNA 2b상 임상시험을 시작했습니다. 2년 동안 진행되는 이번 이중 마스크 무작위 위약 대조 시험은 전 세계 여러 기관에서 8세 이상의 성인 및 소아 81명을 등록할 예정입니다. 이 치료의 대상은 유전자 검사로 확인된 USH2A의 엑손13 변이 관련 RP 또는 비증후군성 RP입니다. LUNA 임상은 시력, 망막 민감도, 망막 구조 개선 효과를 보인 앞선 1/2상 임상시험의 유망 결과에 이은 후속 연구입니다.

목차

제1장 개요

제2장 시장의 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역 전쟁과 관세 및 Covid와 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 개요

제31장 기타 대기업과 혁신적 기업

제32장 세계의 시장 경쟁 벤치마킹과 대시보드

제33장 주요 합병과 인수

제34장 최근 시장 동향

제35장 시장 잠재력이 높은 국가, 부문, 전략

제36장 부록

KSA
영문 목차

영문목차

Ribonucleic acid (RNA) therapy clinical trials are research studies conducted to assess the safety, efficacy, and optimal application of therapies using RNA-based molecules to treat or prevent diseases. These trials focus on developing innovative medical treatments that work by modulating gene expression, correcting genetic defects, or enabling the body to produce beneficial proteins to address various health conditions.

The main modalities in RNA therapy clinical trials include RNA interference, antisense therapy, messenger RNA (mRNA), oligonucleotides, non-antisense, and non-RNA interference (RNAi) approaches. RNA interference is a natural cellular mechanism where small RNA molecules suppress gene expression or translation by neutralizing specific messenger RNA molecules. These trials cover multiple clinical phases-phase I, phase II, phase III, and phase IV-and target a broad range of therapeutic areas such as rare diseases, anti-infectives, cancer, neurological disorders, metabolic and alimentary conditions, musculoskeletal diseases, cardiovascular and respiratory ailments, sensory disorders, and more.

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 pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

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

The ribonucleic acid (RNA) therapy clinical trials market size has grown strongly in recent years. It will grow from $2.57 billion in 2024 to $2.70 billion in 2025 at a compound annual growth rate (CAGR) of 5.0%. The growth during the historic period can be attributed to the increasing demand for novel therapies, the rising success of mRNA vaccines, growing research funding, increased clinical trial activity, and heightened demand for comparative genomics.

The ribonucleic acid (RNA) therapy clinical trials market size is expected to see steady growth in the next few years. It will grow to $3.25 billion in 2029 at a compound annual growth rate (CAGR) of 4.8%. The growth expected in the forecast period can be attributed to the increasing prevalence of rare diseases, rising regulatory approvals, growing investment in clinical research, increased patient participation, and a heightened focus on personalized medicine. Key trends during this period include advancements in RNA delivery systems, progress in biomarker-driven trial designs, integration of artificial intelligence in trial design, adoption of technology in decentralized clinical trials, and developments in regulatory fast-track pathways.

The growing burden of infectious diseases is expected to drive the expansion of the ribonucleic acid (RNA) therapy clinical trials market in the coming years. Infectious diseases result from pathogenic microorganisms such as bacteria, viruses, fungi, or parasites that invade the body, multiply, and cause health problems. The increase in infectious diseases is largely attributed to the rise in global travel, which accelerates the spread of pathogens across different regions and populations. RNA therapy clinical trials play a crucial role in addressing infectious diseases by facilitating the development and testing of targeted treatments that can quickly adapt to new pathogens. For example, in April 2025, a report by the Minnesota Department of Health, a US-based state agency, indicated that the proportion of HIV cases among males aged 35 to 39 rose from 10% in 2023 to 17% in 2024. Hence, the increasing burden of infectious diseases is propelling the growth of the RNA therapy clinical trials market.

Leading companies in the RNA therapy clinical trials market are concentrating on developing innovative approaches, such as RNA-based antisense oligonucleotide therapy clinical trials, which target specific genetic sequences to regulate gene expression and provide highly precise treatments for genetic and rare diseases. RNA-based antisense oligonucleotide therapy clinical trials investigate the use of short synthetic RNA strands designed to bind specific messenger RNA targets to modulate gene expression and treat genetic disorders. For instance, in December 2024, Sepul Bio, a biotechnology company based in France, started the LUNA Phase 2b clinical trial to assess ultevursen, an RNA-based antisense oligonucleotide therapy aimed at mutations in exon 13 of the USH2A gene responsible for retinitis pigmentosa (RP) and Usher syndrome type 2a. This two-year, double-masked, randomized, sham-controlled trial plans to enroll 81 adults and children aged eight and older at multiple sites worldwide. The therapy targets individuals with RP or non-syndromic RP linked to exon 13 mutations in USH2A, confirmed through genetic testing. The LUNA trial follows encouraging outcomes from earlier Phase 1/2 studies where ultevursen demonstrated improvements in visual acuity, retinal sensitivity, and retinal structure.

In July 2023, Novartis AG, a pharmaceutical company based in Switzerland, acquired DTx Pharma for $1 billion. This acquisition is intended to enhance Novartis's neuroscience pipeline and broaden its expertise in RNA-based therapeutics by incorporating DTx Pharma's FALCON platform and advancing innovative small interfering RNA (siRNA) programs targeting neuromuscular and neurological disorders. DTx Pharma is a US-based company specializing in RNA-based therapeutic clinical trials for neuromuscular and neurological diseases.

Major players in the ribonucleic acid (rna) therapy clinical trials market are Pfizer Inc., AstraZeneca plc, Novartis AG, GlaxoSmithKline plc, Moderna Inc., BioNTech SE, Biogen Inc., Daiichi Sankyo Company Limited, Charles River Laboratories International Inc., Alnylam Pharmaceuticals Inc., Sarepta Therapeutics Inc., Ionis Pharmaceuticals Inc., Arrowhead Pharmaceuticals Inc., Arcturus Therapeutics Holdings Inc., Cartesian Therapeutics Inc., CureVac N.V., Orna Therapeutics Inc., Silence Therapeutics plc, ETHRIS GmbH, ProQR Therapeutics N.V., Lexeo Therapeutics Inc., Avidity Biosciences Inc., Aro Biotherapeutics Company, Wave Life Sciences Ltd.

North America was the largest region in the ribonucleic acid (RNA) therapy clinical trials market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in ribonucleic acid (RNA) therapy clinical trials report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the ribonucleic acid (RNA) therapy clinical trials market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The ribonucleic acid (RNA) therapy clinical trials market includes revenues earned by entities by providing services, such as RNA therapeutic administration, biological sample collection and analysis, long-term follow-up, genetic and molecular testing, and patient screening and enrollment. 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.

Ribonucleic Acid (RNA) Therapy 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 ribonucleic acid (rna) therapy 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 ribonucleic acid (rna) therapy 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 ribonucleic acid (rna) therapy 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. Ribonucleic Acid (RNA) Therapy Clinical Trials Market Characteristics

3. Ribonucleic Acid (RNA) Therapy Clinical Trials Market Trends And Strategies

4. Ribonucleic Acid (RNA) Therapy 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 Ribonucleic Acid (RNA) Therapy Clinical Trials Growth Analysis And Strategic Analysis Framework

6. Ribonucleic Acid (RNA) Therapy Clinical Trials Market Segmentation

7. Ribonucleic Acid (RNA) Therapy Clinical Trials Market Regional And Country Analysis

8. Asia-Pacific Ribonucleic Acid (RNA) Therapy Clinical Trials Market

9. China Ribonucleic Acid (RNA) Therapy Clinical Trials Market

10. India Ribonucleic Acid (RNA) Therapy Clinical Trials Market

11. Japan Ribonucleic Acid (RNA) Therapy Clinical Trials Market

12. Australia Ribonucleic Acid (RNA) Therapy Clinical Trials Market

13. Indonesia Ribonucleic Acid (RNA) Therapy Clinical Trials Market

14. South Korea Ribonucleic Acid (RNA) Therapy Clinical Trials Market

15. Western Europe Ribonucleic Acid (RNA) Therapy Clinical Trials Market

16. UK Ribonucleic Acid (RNA) Therapy Clinical Trials Market

17. Germany Ribonucleic Acid (RNA) Therapy Clinical Trials Market

18. France Ribonucleic Acid (RNA) Therapy Clinical Trials Market

19. Italy Ribonucleic Acid (RNA) Therapy Clinical Trials Market

20. Spain Ribonucleic Acid (RNA) Therapy Clinical Trials Market

21. Eastern Europe Ribonucleic Acid (RNA) Therapy Clinical Trials Market

22. Russia Ribonucleic Acid (RNA) Therapy Clinical Trials Market

23. North America Ribonucleic Acid (RNA) Therapy Clinical Trials Market

24. USA Ribonucleic Acid (RNA) Therapy Clinical Trials Market

25. Canada Ribonucleic Acid (RNA) Therapy Clinical Trials Market

26. South America Ribonucleic Acid (RNA) Therapy Clinical Trials Market

27. Brazil Ribonucleic Acid (RNA) Therapy Clinical Trials Market

28. Middle East Ribonucleic Acid (RNA) Therapy Clinical Trials Market

29. Africa Ribonucleic Acid (RNA) Therapy Clinical Trials Market

30. Ribonucleic Acid (RNA) Therapy Clinical Trials Market Competitive Landscape And Company Profiles

31. Ribonucleic Acid (RNA) Therapy Clinical Trials Market Other Major And Innovative Companies

32. Global Ribonucleic Acid (RNA) Therapy Clinical Trials Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Ribonucleic Acid (RNA) Therapy Clinical Trials Market

34. Recent Developments In The Ribonucleic Acid (RNA) Therapy Clinical Trials Market

35. Ribonucleic Acid (RNA) Therapy Clinical Trials Market High Potential Countries, Segments and Strategies

36. Appendix

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