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2030年反義療法/RNAi療法市場預測:按給藥途徑、適應症、技術、應用和地區進行全球分析Antisense & RNAi Therapeutics Market Forecasts to 2030 - Global Analysis By Route of Administration, Indication, Technology, Application and By Geography |
根據 Stratistics MRC 的數據,到 2023 年,全球反義/RNAi 療法市場規模將達到 16.6 億美元,預計在預測期內將以 13.0% 的複合年成長率成長,到 2030 年達到 39 億美元。
反義療法是用單鏈DNA寡核苷酸基因表現進行選擇性和序列特異性抑制。它用於治療肌萎縮側索硬化症、亨廷頓病和阿茲海默症。另一方面, RNA干擾(RNAi)療法由雙鏈RNA(dsRNA)觸發,並響應dsRNA而導致單鏈標靶RNA的序列特異性核糖核酸(mRNA)分解。 RNAi已被應用於治療多種疾病,包括病毒感染、神經退化性疾病和某些癌症。
根據美國科學促進會 2023 年 7 月發表的一篇論文,麻省大學陳醫學院和 RUSH 大學醫學中心開發的一種反義療法表明, X染色體脆折症候群被發現有助於恢復一種名為
遺傳性疾病增加
遺傳性疾病是由個體 DNA 異常引起的,這些疾病的傳統治療方法往往效果有限。反義和 RNAi 療法透過在分子層面上針對這些疾病的潛在遺傳原因提供了一種有前途的方法。此外,遺傳病患病率的不斷上升導致反義和 RNAi 療法的臨床試驗和研究工作激增。成功的臨床試驗和監管核准進一步證明了這些治療方法的潛力並支持市場成長。
基於 RNAi 的藥物價格高成本
複雜的開發過程涉及先進技術和嚴格的監管要求,導致製造成本更高。這些成本通常反映在 RNAi 療法的定價中,限制了患者和醫療保健系統對這些療法的可及性。負擔能力的挑戰可能會阻礙普及並限制市場成長。結果,市場成長受到阻礙。
新藥物傳遞的快速普及和 RNA 療法的推出
先進藥物遞送技術的出現提高了反義和RNAi療法的功效和標靶遞送,促進了它們的普及。此外,基於RNA的藥物的監管核准和成功進入市場增強了投資者的信心並活性化了研究和開發工作。這些技術進步和監管里程碑的融合正在創造一個有利的環境,推動反義和 RNAi 治療市場的發展。
免疫反應
當外源性 RNA 分子(例如反義和 RNAi 療法中使用的分子)被引入體內時,它們可以激活免疫系統。這可以觸發先天免疫反應,包括發炎細胞激素的釋放和免疫細胞的活化。身體的適應性免疫系統也有可能將外源性RNA辨識為威脅,導致產生針對治療分子的抗體。
COVID-19 的影響
COVID-19 大流行對反義療法和 RNAi 療法市場產生了多種影響。一方面,對 mRNA 疫苗開發的關注加速了基於 RNA 的技術的接受度。然而,臨床試驗、供應鏈和研究活動的中斷推遲了反義和 RNAi 療法的開發和商業化。雖然人們對 RNA 技術的認知不斷提高是一個積極的結果,但該行業在適應不斷變化的環境方面面臨著挑戰,而韌性和適應性對於疫情後時代的持續成長至關重要。
RNA反義片段預計在預測期內是最大的
據估計,RNA 反義片段所佔比重最大。這種創新的治療方法旨在透過抑製或改變疾病相關蛋白質的產生來在基因層面上治療疾病。 RNA反義技術預計將有多種應用,包括治療遺傳性疾病、癌症和病毒感染。 RNA反義具有精確干預基因表現的能力,是廣泛市場中的重要組成部分,有助於開發針對各種病理的標靶化和個人化治療解決方案。
預計癌症領域在預測期內複合年成長率最高
預計癌症領域在預測期內將出現良好的成長。反義療法/RNAi療法旨在選擇性地靶向癌症相關基因並調節其表達,抑制腫瘤進展或促進癌細胞死亡。此部分包括多種方法,包括根據個人遺傳特徵量身定做的個人化 RNA 療法。由於這些治療方法具有針對性和精確性,因此它們有可能透過解決特定的生物學途徑並提高治療效果,同時最大限度地減少副作用來改變腫瘤學。
由於研發投資的增加、慢性病盛行率的上升以及支持性的法規環境,亞太地區在預測期內佔據了最大的市場佔有率。中國、日本和印度等主要國家處於前沿,專注於基於RNA的新型治療方法的開發和商業化。此外,隨著個人化醫療意識的不斷增強,本地和全球生物技術公司之間的合作研究正在推動進步。
預計北美在預測期內將實現盈利成長。以美國為首,該地區在製藥和生物技術研究上投入巨資,刺激了基於 RNA 的新型藥物的研究和開發。有利的監管環境、行業相關人員之間的策略聯盟以及慢性病的高盛行率正在促進市場擴張。此外,北美擁有完善的醫療基礎設施、積極的個人化醫療方法以及強大的市場參與者。北美處於反義和 RNAi 療法開發的前沿,使其成為全球市場上充滿活力的重要參與者。
According to Stratistics MRC, the Global Antisense & RNAi Therapeutics Market is accounted for $1.66 billion in 2023 and is expected to reach $3.90 billion by 2030 growing at a CAGR of 13.0% during the forecast period. Antisense therapy is the selective and sequence-specific inhibition of gene expression by single-stranded DNA oligonucleotides. It is used to treat amyotrophic lateral sclerosis and Huntington's and Alzheimer's disease. On the other hand, RNA interference (RNAi) therapy is triggered by double-stranded RNA (dsRNA) and causes sequence-specific ribonucleic acid (mRNA) degradation of single-stranded target RNAs in response to dsRNA. RNAi has applications in treating a wide range of conditions, including viral infections, neurodegenerative diseases, and certain cancers.
According to the article published by the American Association for the Advancement of Science in July 2023, an antisense therapy developed by UMass Chan Medical School and RUSH University Medical Center is found useful in restoring production of the protein FMRP in cell specimens taken from individuals suffering from fragile X syndrome.
Rising incidence of genetic disorders
Genetic disorders result from abnormalities in an individual's DNA, and traditional treatment options for these conditions are often limited. Antisense and RNA interference (RNAi) therapies offer a promising approach by targeting the underlying genetic causes of these disorders at the molecular level. Furthermore, the increasing prevalence of genetic disorders has prompted a surge in clinical trials and research efforts focusing on antisense and RNAi therapies. Successful trials and regulatory approvals further validate the potential of these treatments, driving market growth.
High cost of RNAi based drugs
The complex development process, involving advanced technologies and stringent regulatory requirements, contributes to elevated production costs. These expenses are often reflected in the pricing of RNAi therapeutics, limiting accessibility for patients and healthcare systems. Affordability challenges can impede widespread adoption, hindering the market's growth potential. As a result, it will hamper market growth.
Rapid adoption of novel drug delivery and launch of RNA therapeutics
The advent of advanced drug delivery technologies has enhanced the efficacy and targeted delivery of antisense and RNA interference (RNAi) therapeutics, fostering their widespread adoption. Furthermore, the regulatory approval and successful market entry of RNA-based treatments have bolstered investor confidence and fuelled research and development initiatives. This convergence of technological advancements and regulatory milestones has created a favourable environment, propelling the Antisense & RNAi Therapeutics Market.
Immune responses
When exogenous RNA molecules, such as those used in antisense and RNA interference (RNAi) therapies, are introduced into the body, they may activate the immune system. This can trigger innate immune responses, including the release of pro-inflammatory cytokines and the activation of immune cells. Also, the body's adaptive immune system may recognize the foreign RNA as a threat, leading to the production of antibodies against the therapeutic molecules.
Covid-19 Impact
The COVID-19 pandemic has had a mixed impact on the antisense and RNAi therapeutics markets. On one hand, the focus on mRNA vaccine development has accelerated RNA-based technology acceptance. However, disruptions in clinical trials, supply chains, and research activities have caused delays in the development and commercialization of anti-sense and RNAi therapies. While increased recognition of RNA technologies is a positive outcome, the industry faces challenges in adapting to the changing landscape, emphasising the importance of resilience and adaptability for continued growth in a post-pandemic era.
The RNA antisense segment is expected to be the largest during the forecast period
The RNA antisense segment is estimated to hold the largest share. This innovative therapeutic approach aims to treat diseases at the genetic level by inhibiting or modifying the production of disease-related proteins. RNA antisense technology holds promise for various applications, including treating genetic disorders, cancers, and viral infections. With its ability to precisely intervene in gene expression, RNA antisense represents a pivotal segment within the broader market, contributing to the development of targeted and personalised therapeutic solutions for a range of medical conditions.
The cancer segment is expected to have the highest CAGR during the forecast period
The cancer segment is anticipated to have lucrative growth during the forecast period. Antisense and RNA interference (RNAi) therapies are designed to selectively target and modulate the expression of genes associated with cancer, inhibiting tumour progression or promoting cancer cell death. This segment encompasses a diverse range of approaches, including personalised RNA treatments tailored to individual genetic profiles. Because of their targeted and precise nature, these treatments have the potential to alter oncology by tackling certain biological pathways and improving therapeutic efficacy while minimising side effects.
Asia Pacific commanded the largest market share during the extrapolated period owing to increased investment in research and development, the rising prevalence of chronic diseases, and a supportive regulatory environment. Key countries such as China, Japan, and India are at the forefront, with a focus on developing and commercialising novel RNA-based therapies. Furthermore, collaborations between local and global biotech firms, along with a growing awareness of personalised medicine, drive advancements.
North America is expected to witness profitable growth over the projection period. The region, lead by the US, has made significant expenditures in pharmaceutical and biotechnology research, which has stimulated the development of novel RNA-based medicines. Favourable regulatory landscapes, strategic collaborations between industry stakeholders and a high prevalence of chronic diseases contribute to market expansion. It also has a well-established healthcare infrastructure, a proactive approach to personalised medicine, and prominent market players. North America is at the forefront of the development of antisense and RNAi treatments, making it a dynamic and significant player in the worldwide market.
Key players in the market
Some of the key players in the Antisense & RNAi Therapeutics Market include Alnylam Pharmaceuticals, Inc., Ionis Pharmaceuticals (Akcea Therapeutics, Inc.), Biogen Inc, Sarepta Therapeutics, Inc, Arbutus Biopharma, Silence Therapeutics, Isarna Therapeutics GmbH, Arrowhead Pharmaceuticals, Inc, Gene Signal International SA, Benitec Biopharma Ltd, Olix Pharmaceuticals, GSK plc, Sanofi, Bio-Path Holdings Inc, Antisense Therapeutics Limited., Quark Pharmaceuticals, Merck, Astellas Pharma Inc, Marina Biosciences and Dicerna Pharmaceuticals.
In July 2023, Alnylam Pharmaceuticals, Inc. partnered with Roche; to develop and market, zilebesiran, investigational ribonucleic acid interference (RNAi) therapeutic to treat hypertension
In March 2023, OliX Pharmaceuticals, Inc. dosed the first patient in a Phase 1 clinical trial of an investigational RNAi therapeutic designed to treat age-related macular degeneration (AMD)