市场调查报告书
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2030年反义疗法/RNAi疗法市场预测:按给药途径、适应症、技术、应用和地区进行全球分析Antisense & RNAi Therapeutics Market Forecasts to 2030 - Global Analysis By Route of Administration, Indication, Technology, Application and By Geography |
根据 Stratistics MRC 的数据,到 2023 年,全球反义/RNAi 疗法市场规模将达到 16.6 亿美元,预计在预测期内将以 13.0% 的复合年增长率增长,到 2030 年达到 39 亿美元。
反义疗法是用单链DNA寡核苷酸基因表现进行选择性和序列特异性抑制。它用于治疗肌萎缩侧索硬化症、亨廷顿病和阿兹海默症。另一方面, RNA干扰(RNAi)疗法由双链RNA(dsRNA)触发,并响应dsRNA而导致单链标靶RNA的序列特异性核糖核酸(mRNA)降解。 RNAi已被应用于治疗多种疾病,包括病毒感染、神经退化性疾病和某些癌症。
根据美国科学促进会 2023 年 7 月发表的一篇论文,麻省大学陈医学院和 RUSH 大学医学中心开发的一种反义疗法表明, X染色体脆折症候群被发现有助于恢復一种名为
遗传性疾病增加
遗传性疾病是由个体 DNA 异常引起的,这些疾病的传统治疗方法往往效果有限。反义和 RNAi 疗法透过在分子层面上针对这些疾病的潜在遗传原因提供了一种有前途的方法。此外,遗传病患病率的不断上升导致反义和 RNAi 疗法的临床试验和研究工作激增。成功的临床试验和监管核准进一步证明了这些治疗方法的潜力并支持市场成长。
基于 RNAi 的药物价格高成本
复杂的开发过程涉及先进技术和严格的监管要求,导致製造成本更高。这些成本通常反映在 RNAi 疗法的定价中,限制了患者和医疗保健系统对这些疗法的可及性。负担能力的挑战可能会阻碍普及并限制市场成长。结果,市场成长受到阻碍。
新药物传递的快速普及和 RNA 疗法的推出
先进药物递送技术的出现提高了反义和RNAi疗法的功效和标靶递送,促进了它们的普及。此外,基于RNA的药物的监管核准和成功进入市场增强了投资者的信心并活性化了研究和开发工作。这些技术进步和监管里程碑的融合正在创造一个有利的环境,推动反义和 RNAi 治疗市场的发展。
免疫反应
当外源性 RNA 分子(例如反义和 RNAi 疗法中使用的分子)被引入体内时,它们可以激活免疫系统。这可以触发先天免疫反应,包括发炎细胞激素的释放和免疫细胞的活化。身体的适应性免疫系统也有可能将外源性RNA辨识为威胁,导致产生针对治疗分子的抗体。
COVID-19 的影响
COVID-19 大流行对反义疗法和 RNAi 疗法市场产生了多种影响。一方面,对 mRNA 疫苗开发的关注加速了基于 RNA 的技术的接受度。然而,临床试验、供应链和研究活动的中断推迟了反义和 RNAi 疗法的开发和商业化。虽然人们对 RNA 技术的认识不断提高是一个积极的结果,但该行业在适应不断变化的环境方面面临着挑战,而韧性和适应性对于疫情后时代的持续成长至关重要。
RNA反义片段预计在预测期内是最大的
据估计,RNA 反义片段所占比重最大。这种创新的治疗方法旨在透过抑製或改变疾病相关蛋白质的产生来在基因层面上治疗疾病。 RNA反义技术预计将有多种应用,包括治疗遗传性疾病、癌症和病毒感染。 RNA反义具有精确干预基因表现的能力,是广泛市场中的重要组成部分,有助于开发针对各种病理的标靶化和个人化治疗解决方案。
预计癌症领域在预测期内复合年增长率最高
预计癌症领域在预测期内将出现良好的成长。反义疗法/RNAi疗法旨在选择性地靶向癌症相关基因并调节其表达,抑制肿瘤进展或促进癌细胞死亡。此部分包括多种方法,包括根据个人遗传特征量身定制的个人化 RNA 疗法。由于这些治疗方法具有针对性和精确性,因此它们有可能透过解决特定的生物学途径并提高治疗效果,同时最大限度地减少副作用来改变肿瘤学。
由于研发投资的增加、慢性病盛行率的上升以及支持性的法规环境,亚太地区在预测期内占据了最大的市场占有率。中国、日本和印度等主要国家处于前沿,专注于基于RNA的新型治疗方法的开发和商业化。此外,随着个人化医疗意识的不断增强,本地和全球生物技术公司之间的合作研究正在推动进步。
预计北美在预测期内将实现盈利成长。以美国为首,该地区在製药和生物技术研究上投入巨资,刺激了基于 RNA 的新型药物的研究和开发。有利的监管环境、行业相关人员之间的策略联盟以及慢性病的高盛行率正在促进市场扩张。此外,北美拥有完善的医疗基础设施、积极的个人化医疗方法以及强大的市场参与者。北美处于反义和 RNAi 疗法开发的前沿,使其成为全球市场上充满活力的重要参与者。
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)