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市场调查报告书
商品编码
1753910
反义及 RNAi 治疗市场报告(依技术、给药途径、应用及地区)2025 年至 2033 年Antisense & RNAi Therapeutics Market Report by Technology, Route of Administration, Application, and Region 2025-2033 |
2024年,全球反义及RNAi疗法市场规模达18亿美元。展望未来, IMARC Group预计到2033年,该市场规模将达到33亿美元,2025-2033年期间的复合年增长率(CAGR)为7.03%。全球遗传疾病和慢性病的日益普及推动了该市场稳步增长,这需要创新疗法、各主要市场支持性监管环境以加快新疗法的审批和商业化,以及药物输送系统的持续技术进步。
药物输送系统的技术进步
在这个市场中,主要驱动因素之一是药物输送方法的持续发展。这些技术使RNA分子能够干净且有效率地输送至相关细胞,避免降解,进而提高治疗效果。例如,脂质奈米颗粒和偶联技术使反义寡核苷酸或siRNA的细胞摄取和平衡变得前所未有的微不足道。它提高了输送效率,同时增强了疗法与特定人体物质的相似度,而这些物质对于癌症、疾病和病毒感染等至关重要。反义和RNAi疗法市场预测表明,这些疗法将获得大量的研究关注和资金投入。例如,诺华于2023年7月收购了DTx Pharma,这是一家专注于神经科学领域短干扰RNA疗法的生物技术公司。同样,这些收购也正在创造积极的市场前景。
遗传性疾病和慢性病的盛行率不断上升
群体中遗传性疾病和慢性疾病的发生率不断上升,有力地推动了反义和RNAi疗法市场的成长。亨廷顿氏舞蹈症、某些类型的癌症以及各种遗传性疾病只是少数常见且缺乏有效治疗方法的疾病,这催生了对反义和RNAi疗法的需求。此外,反义和RNAi疗法作为候选致病基因的抑制剂,为疾病的治疗提供了新的途径。一方面,这些新药最有可能应用在临床上。另一方面,由于能够针对特定基因,它们为目前无法透过传统药理学方法治疗的患者提供了一种新的治疗方式。这反过来又催生了对新生物製药研发项目持续投资的明确需求。
支持新疗法的监管环境
反义和RNAi疗法的需求受到有利监管环境的推动。例如,美国食品药物管理局(FDA)孤儿药产品开发办公室于2023年10月宣布,将在2024财年提供资金,用于承担罕见疾病和病症自然史研究的费用。该RFA的既定目标是「提昇科学严谨性,促进合作,造福罕见疾病患者」。此外,FDA和EMA等全球卫生机构正在加快任何新疗法的审查流程,包括RNAi和反义技术。同时,孤儿药资格认定、加速审批和优先审查凭证等监管激励措施也变得更加重要,因为它们将更有动力激励製药公司投入精力开发反义和RNAi疗法。
反义 RNA 占据反义和 RNAi 治疗市场的大部分份额
反义RNA技术凭藉其成熟的方法和悠久的临床应用历史,在反义和RNAi治疗市场中占据领先地位。反义RNA的工作原理是合成RNA分子与特定的mRNA序列结合,进而阻断致病标靶基因。此外,其广泛的应用范围从遗传病理到各种慢性疾病(包括癌症),也奠定了其领先地位。此外,与其他RNAi技术不同,这些领先技术已在长达两年的时间内广泛应用,这使得人们能够投入大量资源用于研究和开发其作用机制和给药方式。此外,一些反义治疗药物已在RNAi技术市场上获得FDA註册,这最终证实了它们的有效性并鼓励了进一步的投资。所有这些因素都有助于确保其在最大市场份额中的稳定发展;此外,在反义子领域,已经提交上市申请的有前景的药物也已上市。因此,这项技术引领着RNA治疗市场,并为该领域的突破奠定了基础。
肺部给药占业界最大份额
在反义和RNAi疗法市场中,肺部给药已成为给药途径的主导。其理由包括直接用于治疗呼吸系统疾病,局部给药可显着提高疗效。因此,能够进入肺部并携带治疗药物,对于治疗呼吸道合胞病毒和肺动脉高压等疾病以及肺癌等疾病都具有显着效果。它能够使溶液在病灶处达到高浓度,减少全身性副作用,从而降低副作用,提高患者依从性并提高整体治疗效果。此外,能够有效地将药物输送至肺部组织的创新吸入器和解决方案也是一个重要方面。由于负荷不断增加,人们面临着尽可能提高治疗有效性和针对性的压力。因此,肺部给药是RNAi技术市场的关键发展重点,并引领整体投资和创新配额。
北美引领市场,占据反义和 RNAi 治疗市场最大份额
该报告还对所有主要区域市场进行了全面分析,包括北美(美国和加拿大);亚太地区(中国、日本、印度、韩国、澳洲、印尼等);欧洲(德国、法国、英国、义大利、西班牙、俄罗斯等);拉丁美洲(巴西、墨西哥等);以及中东和非洲。报告指出,北美是反义和RNAi疗法最大的区域市场。
北美是反义和RNAi疗法市场最大的区域。这项优势主要归功于该地区成熟的生物技术和製药研究基础设施。此外,各国政府和其他全球卫生组织提供的空前支持,为反义和RNAi治疗平台发展所需的研究和先进开发创造了有利环境。根据反义和RNAi疗法市场分析,该地区多家领先的生物技术和製药公司的存在,创造了激烈的竞争并促进了创新,加速了开发机会和产品上市。此外,北美积极的监管环境,例如美国食品药物管理局(FDA)的积极参与,已快速审批多种用于治疗多种遗传和慢性疾病的RNA药物,也为RNA疗法市场提供了支持。此外,该地区癌症和遗传性疾病等目标疾病的高发生率也创造了反义和RNAi疗法的需求。因此,北美引领反义和 RNAi 治疗市场,是技术开发的主导者,也是基于 RNA 的治疗产品的主要市场。
市场研究报告还对市场竞争格局进行了全面分析,并提供了所有主要公司的详细资料。反义和 RNAi 治疗行业的主要市场参与者包括:
市场主要参与者正日益参与研发,以丰富其基因治疗产品组合。他们积极建立策略合作伙伴关係,收购小型生物技术公司,或与学术机构和研发中心合作,以利用新兴颠覆性技术并加速药物开发。同时,考虑到高昂的成本和开发风险,公司在临床试验方面投入了大量资金,以确保其在更广泛的应用组合(尤其是在基因转移性疾病领域)中的有效性和安全性。与监管机构的合作可以提升公司的竞争力,并引导他们更快推出新药。这项措施对于创造竞争优势以及积极的反义和RNAi疗法市场前景至关重要。
The global antisense & RNAi therapeutics market size reached USD 1.8 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 3.3 Billion by 2033, exhibiting a growth rate (CAGR) of 7.03% during 2025-2033. The market is experiencing steady growth driven by the increasing prevalence of genetic and chronic diseases globally necessitates innovative treatments, supportive regulatory environments across major markets to expedite the approval and commercialization of new therapies, and continuous technological advancements in drug delivery systems.
Technological advancements in drug delivery systems
In this market, one of the major drivers is the continuing developments of drug delivery methods. These technologies allow RNA molecules to be delivered to relevant cells cleanly and efficiently, in a pattern that avoids degradation and hence provided enhanced efficacy in terms of therapy. For example, lipid nanoparticles and conjugate technologies enabled the previously negligible cellular uptake and balance of antisense oligonucleotides or siRNA. It increases delivery while enhancing the degree of similarity in which therapeutics are suitable to target specific human material, which is critical in cancer, disorders, and viral infections, among other things. The antisense & RNAi therapeutics market forecast indicates that these treatments will gain substantial research attention and financial investment. For instance, Novartis acquired DTx Pharma in July 2023, which is a biotechnology company concentrating on short-interfering RNA therapy for neuroscience indications. Similarly, these acquisitions are creating a positive market outlook.
Increasing prevalence of genetic disorders and chronic diseases
The accelerating incidences of genetic and chronic diseases among the masses is significantly supporting the antisense & RNAi therapeutics market growth. Huntington's, certain types of cancer, and a wide range of hereditary genetic conditions are just a few examples of prevalent illnesses with few efficient treatments, which create demand for antisense & RNAi therapeutics. Along with this, Antisense and RNAi treatment options provide a new avenue as candidate disease-predisposing genes' repressors. On one hand, the new drugs have the best prospects of being included in clinical practice. On the other - by having the ability to target specific genes, they represent a new treatment modality for patients with conditions that are currently unmanageable using conventional pharmacological methods. This, in turn, generates a clear need for continued investment in new biopharmaceutical R&D projects.
Supportive regulatory environment for novel therapies
The antisense & RNAi therapeutics demand is impelled by the supportive regulatory environment. For instance, in October 2023, The Food and Drug Administration's Office of Orphan Products Development announced the availability of funds for fiscal year (FY) 2024 to help underwrite the costs of conducting natural history studies on rare diseases and conditions. The stated goal of this RFA is "to advance scientific rigor and collaboration for the benefit of patients with rare diseases or conditions." In addition, global health authorities, such as the FDA and EMA, are introducing faster review processes for any new therapies, inclusive of RNAi and antisense technology. Meanwhile, regulatory incentives like orphan drug status, accelerated approval, and priority review vouchers gain even more relevance since they give pharmaceutical companies even more incentive to put effort into the development of antisense and RNAi therapies.
Antisense RNA accounts for the majority of the antisense & RNAi therapeutics market share
Antisense RNA technology is the leader in the Antisense & RNAi Therapeutics market due to its mature methodology and the longest history of clinical application. Antisense RNA acts based on synthetic RNA molecules adhering to specific mRNA sequences, and it results in the blockade of target genes responsible for disease. In addition, the broadest possible range of applications from genetic pathologies to chronic diseases of various origins, including cancer, primarily has ensured its leader position. Apart from this, unlike other RNAi technologies, the leaders have already spent up to two years of widespread use, which allowed the investment of large resources in research and developing mechanisms of action and delivery. Moreover, some antisense therapeutic agents are already on the RNAi technology market with active FDA registration, which ultimately confirms their effectiveness and encourages further investment. All these factors contribute to ensuring a steady drill with the most significant share; even more, promising drugs already filed to proliferation can be observed in the antisense subfield. Thus, this technology leads the RNA based therapeutics market and lays the foundation for breakthroughs in this field.
Pulmonary delivery holds the largest share of the industry
In the Antisense & RNAi therapeutics market, pulmonary delivery has taken the lead in terms of administration channels. There are several justifications, including direct utilization in curing respiratory conditions, in which localized delivery significantly increases the effectiveness. Thus, the ability to access the lungs and carry therapeutic agents is effective in treating diseases such as respiratory syncytial virus and pulmonary arterial hypertension as well as directing to lung cancer. It enabled high concentration of the solution on the site of the disease, limited systemic, hence lower side effects, improved patient adherence, and the overall effectiveness of treatment. Moreover, innovative inhalers and solutions that allow efficient drug delivery to lung tissues are also an important aspect. Due to the increasing load, there is pressure to make therapy as effective and targeted as possible. Therefore, pulmonary delivery serves as a key development focus of the RNAi technology market and directs the overall investment and innovation quotas.
North America leads the market, accounting for the largest antisense & RNAi therapeutics market share
The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represents the largest regional market for antisense & RNAi therapeutics.
North America is the largest regional segment in the Antisense & RNAi therapeutics market. This prominence is primarily due to the region's mature biotechnological and pharmaceutical research infrastructure. Additionally, unprecedented support from various national governments and other global health organizations has created a conducive environment for research and the advanced development required to progress antisense and RNAi therapy platforms. According to the antisense & RNAi therapeutics market analysis, the presence of several leading biotech and pharmaceutical companies in the region, which has created fierce competition and promoting innovation, has accelerated development opportunities as well as product launch. Additionally, North America's proactive regulatory environment, the exceptional participation of the FDA, which has fast-tracked many RNA-based drugs for several genetic and chronic disease conditions, supports the RNA based therapeutics market. Moreover, the high prevalence of target diseases, including cancer and genetic disorders, in the region creates antisense & RNAi therapeutics demand. Thus, North America leads the Antisense & RNAi Therapeutics market, as a dominant player in technology development and also as the primary market for RNA-based therapeutic products.
The market research report has also provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the major market players in the antisense & RNAi therapeutics industry include:
The major players in the market are increasingly involved in research and development to diversify their genetic therapy portfolios. They are actively engaging in strategic partnerships, taking over small biotech companies, or collaborating with academic institutions and R&D centers to capitalize on emerging and disruptive technologies and fast-track drug development. In confluence with this, considering the high costs and development risks, companies make significant investments in clinical trials to guarantee their effectiveness and safety in a wider applications portfolio, especially in AlNM diseases. Collaboration with the regulatory bodies enhances the companies' competitive performance and guides them along the way to bring new drugs faster. This initiative is vital for creating competitive advantages and a positive antisense & RNAi therapeutics market outlook.