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基因治療學和RNAi

市場調查報告書

商品編碼

1410092

MicroRNA市場：2023年至2028年預測

MicroRNA Market - Forecasts from 2023 to 2028

出版日期: 2023年12月18日 | 出版商:

Knowledge Sourcing Intelligence | 英文 140 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

預計到 2021 年，全球 microRNA 市場規模將達到 1,410,532,000 美元，預測期內複合年成長率為 18.19%。

被稱為 microRNA (miRNA) 的小非編碼 RNA 分子在調節各種生物體的基因表現方面發揮重要作用。 miRNA 是單鏈RNA 分子，通常由 21 至 25 個核苷酸組成。針對 microRNA 的各種疾病的臨床試驗數量不斷增加，以及癌症等慢性疾病病例數的增加，是 microRNA 市場的主要成長動力。此外，個人化醫療的日益轉變以及市場參與者的技術開拓和市場推出預計將進一步促進 microRNA 市場的成長。

microRNA臨床試驗增加

自 microRNA 被發現以來，其分子和細胞作用已被確定。 microRNA 與人類疾病的相關性於 2002 年首次得到證實，此後，針對 microRNA 在人類和其他生物體中的相關性開展了許多研究，推動了 microRNA 市場的發展。例如，最近一項題為「動脈粥斑塊不穩定診斷中的微小RNA」的研究預計由莫斯科國立醫科大學於2022年9月啟動，並於2024年8月完成。本研究的目的是發現無名動脈不穩定動脈粥狀硬化的生物標記。

癌症盛行率上升

癌症發生率的增加推動了對高效診斷和治療技術的需求。由於 MicroRNA 參與疾病過程並具有作為生物標記或治療標靶的潛力，因此它們具有更好的疾病管理和個人化治療的潛力。因此，癌症患者數量的增加是microRNA市場的主要成長要素。例如，根據世界衛生組織的資料，2020年有近1,000萬人（即六分之一的死亡人數）死於癌症，使其成為全球主要死亡原因。此外，根據世界衛生組織的報告，每年有 40 萬名兒童被診斷出患有兒童癌症。

個人化醫療日益受到關注

個體化醫療的理念旨在為特定患者量身定做醫療干預措施，引起了許多人的興趣。 MicroRNA 可以反映疾病狀態和個體差異，使其成為個人化治療的潛在目標，並推動 microRNA 市場的發展。檢查 miRNA表現圖譜並創建基於 miRNA 的療法的能力將有助於制定個人化治療計劃。根據美國癌症協會的說法，當患者患某種特定癌症的風險很高時，精準醫療可能適用。例如，患者可能得知癌症在其家族中遺傳，或者醫生可能會發現患者家族中的癌症模式。

microRNA市場的機會

上述成長要素正在為 microRNA 市場創造巨大的擴張機會。此外，其他因素也為進入 microRNA 市場提供了機會。例如，microRNA 正在作為一種潛在應用進行研究。這包括獸醫、農業和環境監測等領域。研究 microRNA 在各個領域的功能擴大了研究、產品開發和商業化的可能性。此外，microRNA相關公司獲得的資金和投資進一步擴大了成長機會並推動了microRNA市場的發展。例如，InterRNA Technologies 在 2021 年 9 月的 B 輪資金籌措中獲得了總計 1,850 萬歐元的資金。資金用於推進 microRNA 主要候選藥物 INT 0-1B3 在晚期固體癌患者的臨床評估。

市場抑制因素

預計有幾個因素會限制 microRNA 市場。對 miRNA 的生物學理解不足可能會阻礙有效診斷和治療方法的發展。利用miRNA研究進行治療是很困難的。需要嚴格的臨床試驗和廣泛的研究來檢驗miRNA 的診斷和治療價值。完成臨床檢驗、監管核准和融入標準臨床實踐的複雜過程需要時間、金錢和臨床效用證明。此外，miRNA 很脆弱，在體內通常會很快被破壞，這使得將基於 microRNA 的治療方法有效遞送至目標組織和細胞成為一項重大挑戰。

預計北美將大幅成長

據估計，北美地區將佔據 microRNA 市場的主要佔有率。造成這一佔有率的因素包括有利的監管政策、癌症和慢性腎臟病等慢性疾病負擔的增加以及科學研究的增加。例如，美國疾病預防控制中心 (CDC) 估計，到 2022 年，美國將有 3,550 萬成年人（佔人口的 14%）患有 CKD。根據美國腎臟資料系統（USRDS）的數據，2019年美國有超過75萬人患有末期腎病變（ESRD）。此外，Thermo Fisher Scientific 和 BioGenex 等主要市場領導的出現進一步加速了該地區 microRNA 市場的發展。

MicroRNA市場參與者

Horizon Discovery Ltd 是一家總部位於英國的生物技術公司，專注於利用基因編輯和基因調控技術來加速新藥物、治療方法和細胞研究工具的發現、開發和生產。 Horizon Discovery 提供基於 CRISPR-Cas9 的基因編輯工具，包括嚮導 RNA 文庫、敲除細胞株和專門的細胞株工程服務。 BioGenex 專注於癌症研究和診斷的自動化系統和分子病理學解決方案。顯色 ISH (CISH) 和螢光ISH (FISH) 測試能夠識別和定位組織樣本中的特定核酸標靶，這是 BioGenex 提供的多種 ISH 解決方案中的兩種。 QIAGEN 是一家全球領先的醫療相關企業，專注於分子診斷、應用測試、學術研究和藥物研究的樣本和檢測技術。 QIAGEN 開發並銷售各種診斷平台和檢測方法，用於診斷遺傳異常、腫瘤相關突變、感染疾病和其他治療應用。

新興市場的主要發展

2022 年 9 月，Craif 推出了乳癌測試，作為 miSignal® 系列的一部分。此測試可以利用尿液中的 microRNA 早期檢測癌症。這種新的乳癌檢測可以同時檢測兩種類型的癌症（乳癌和卵巢）。 2022年7月，MiRXES啟動了全球首個名為「CADENCE」的多種癌症篩檢測試研究計劃。該計劃旨在開發一種多癌症早期檢測測試，可檢測多達九種癌症，包括乳癌和肝癌。該計劃的重點是發現和檢驗血源性 microRNA 和 DNA 生物標記的新組合，以測試多種癌症。

Small non-coding RNA molecules known as microRNAs (miRNAs) play a critical function in the control of gene expression in a range of organisms. It is normally made up of 21 to 25 nucleotides and is a single-stranded RNA molecule. The increasing number of clinical trials for various diseases focusing on microRNA along with the rising cases of chronic illnesses such as cancer is a major growth driver in the microRNA market. Moreover, the increasing shift towards personalized medicine coupled with technological developments and launches by the market players are further contemplated to augment the microRNA market growth.

Increasing Clinical Trials of MicroRNA

The molecular and cellular roles of microRNA have been identified since their discovery. The first proof of microRNAs' involvement in human disease was published in 2002 and after that numerous studies have been conducted on the relevance of microRNA in humans as well as other organisms thereby boosting the microRNA market. For instance, a recent study titled microRNAs in the Diagnosis of atherosclerotic plaque instability was started in September 2022 by Moscow State Medical University and it is estimated to be complete by August 2024. Finding biomarkers of unstable atherosclerosis in the brachiocephalic arteries is the goal of the research.

Rising Prevalence of Cancer

The demand for efficient diagnostic and therapeutic technologies is being driven by the increasing incidence of cancer. MicroRNAs offer chances for better illness management and individualized treatments due to their participation in disease processes and potential as biomarkers or therapeutic targets. Therefore, the rising cancer cases are a major growth factor in the microRNA market. For instance, nearly 10 million deaths, or one in six deaths, were caused by cancer in 2020, making it the top cause of mortality worldwide as per the WHO data. Moreover, 400 000 kids are diagnosed with cancer in children every year according to the WHO report.

Growing Focus on Personalized Medicine

The idea of personalized medicine, which tries to customize medical interventions for specific patients, has drawn a lot of interest. Because of their capacity to reflect both disease states and individual differences, microRNAs are potential targets for personalized treatment thereby propelling the microRNA market. The development of individualized treatment plans is aided by the capacity to examine miRNA expression profiles and create miRNA-based therapeutics. According to the American Cancer Society, in cases where a patient's chance of developing a particular cancer is higher, precision medicine may be applied. For instance, a patient might learn that cancer runs in their family, for instance, or a doctor might see a pattern of cancer in the patient's family.

Opportunities in the MicroRNA market

The growth factors mentioned above provide an immense expansion opportunity for the microRNA market. Moreover, other factors are also offering entrance opportunities into the microRNA market. For example, microRNAs are being researched for possible applications. These include disciplines like veterinary medicine, agriculture, and environmental monitoring. Research, product development, and commercialization potential are expanded as a result of studying the function of microRNAs in various sectors. Additionally, the funding and investments received by the companies involved in the microRNA further extend the growth opportunity thereby propelling the microRNA market. For instance, InteRNA Technologies received a total of € 18.5 million in a series B financing round held in September 2021. This money was utilized to advance the clinical assessment of the microRNA lead candidate INT 0-1B3 in patients with solid tumors that were progressed.

Restraints in the Market

There are a few factors that are expected to limit the microRNA market. The creation of efficient diagnostic and therapeutic approaches may be hampered by a lack of a thorough understanding of miRNA biology. It is difficult to translate microRNA research into therapeutically useful uses. Rigorous clinical trials and extensive research are needed to validate the diagnostic or therapeutic value of miRNAs. It takes time, money, and proof of clinical utility to complete complex processes including clinical validation, regulatory approval, and incorporation into standard clinical practice. Moreover, efficient delivery of microRNA-based therapies to target tissues or cells is a major challenge because miRNAs are often fragile and can be swiftly destroyed in vivo.

North America is Projected to Grow Significantly

The North American region is estimated to hold a significant share of the microRNA market. Various factors attributed to such a share are favorable regulatory policies, the growing burden of chronic diseases such as cancer, and chronic kidney disease, and increasing scientific research studies. For instance, CDC estimated that 35.5 million US adults which equates to 14% of the population, were having CKD in 2022. According to the United States Renal Data System (USRDS), there were more than 750,000 people in the US who had ESRD in 2019. Additionally, the presence of major market leaders such as Thermo Fisher Scientific and BioGenex further accelerates the microRNA market in the region.

MicroRNA Market Players

Horizon Discovery Ltd is a biotechnology business with its headquarters in the UK, It focuses on the use of gene editing and gene modulation technologies to hasten the discovery, development, and production of novel medications, treatments, and cell-based research tools. Horizon Discovery provides CRISPR-Cas9-based gene editing tools such as guide RNA libraries, knockout cell lines, and specialized cell line engineering services.
BioGenex specializes in automated systems and molecular pathology solutions for cancer research and cancer diagnostics. Chromogenic ISH (CISH) and fluorescence ISH (FISH) tests, which enable the identification and localization of certain nucleic acid targets inside tissue samples, are two of the wide variety of ISH solutions offered by BioGenex.
QIAGEN is one of the leading global medical companies with a focus on sample and assay technologies for molecular diagnostics, applied testing, scholarly research, and pharmaceutical studies. QIAGEN creates and sells a variety of diagnostic platforms and assays for the diagnosis of genetic abnormalities, oncology-related mutations, infectious diseases, and other therapeutic applications.

Key Market Developments

In September 2022, Craif launched a breast cancer test as a part of the miSignal® series. This test enables early-stage cancer detection using urinary microRNA. This new breast cancer test can detect two types of cancer (breast and ovary) at once.
In July 2022, MiRXES launched the world's first research project for a multi-cancer screening test titled CADENCE. The project aimed to develop a multi-cancer early detection test for up to nine cancers including breast, and liver. It was focused to discover and validate novel combinations of blood-borne microRNA and DNA biomarkers for multi-cancer tests.

Segmentation:

By Type

Products
Services

By Application

Cancer
Infectious Diseases
Immunological Disorder
Cardiovascular Disease
Neurological Disease
Others

By End-Use

Biotechnology & Pharmaceutical Companies
Academic & Government Research Institutes
Other end-users

By Geography

North America
United States
Canada
Mexico
South America
Brazil
Argentina
Others
Europe
United Kingdom
Germany
France
Spain
Others
Middle East and Africa
Saudi Arabia
UAE
Israel
Others
Asia Pacific
Japan
China
India
South Korea
Indonesia
Thailand
Others

1. INTRODUCTION

1.1. Market Overview
1.2. Market Definition
1.3. Scope of the Study
1.4. Market Segmentation
1.5. Currency
1.6. Assumptions
1.7. Base, and Forecast Years Timeline

2. RESEARCH METHODOLOGY

2.1. Research Data
2.2. Assumptions

3. EXECUTIVE SUMMARY

3.1. Research Highlights

4. MARKET DYNAMICS

4.1. Market Drivers
4.2. Market Restraints
4.3. Porter's Five Force Analysis
- 4.3.1. Bargaining Power of Suppliers
- 4.3.2. Bargaining Power of Buyers
- 4.3.3. Threat of New Entrants
- 4.3.4. Threat of Substitutes
- 4.3.5. Competitive Rivalry in the Industry
4.4. Industry Value Chain Analysis

5. MICRORNA MARKET, BY TYPE

5.1. Introduction
5.2. Products
5.3. Services

6. MICRORNA MARKET, BY APPLICATION

6.1. Introduction
6.2. Cancer
6.3. Infectious Diseases
6.4. Immunological Disorder
6.5. Cardiovascular Disease
6.6. Neurological Disease
6.7. Others

7. MICRORNA MARKET, BY END-USE

7.1. Introduction
7.2. Biotechnology & Pharmaceutical Companies
7.3. Academic & Government Research Institutes
7.4. Other end-users

8. MICRORNA MARKET, BY GEOGRAPHY

8.1. Introduction
8.2. North America
- 8.2.1. United States
- 8.2.2. Canada
- 8.2.3. Mexico
8.3. South America
- 8.3.1. Brazil
- 8.3.2. Argentina
- 8.3.3. Others
8.4. Europe
- 8.4.1. United Kingdom
- 8.4.2. Germany
- 8.4.3. France
- 8.4.4. Spain
- 8.4.5. Others
8.5. The Middle East and Africa
- 8.5.1. Saudi Arabia
- 8.5.2. UAE
- 8.5.3. Israel
- 8.5.4. Others
8.6. Asia Pacific
- 8.6.1. Japan
- 8.6.2. China
- 8.6.3. India
- 8.6.4. South Korea
- 8.6.5. Indonesia
- 8.6.6. Thailand
- 8.6.7. Others