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市場調查報告書
商品編碼
1753910
反義及 RNAi 治療市場報告(依技術、給藥途徑、應用及地區)2025 年至 2033 年Antisense & RNAi Therapeutics Market Report by Technology, Route of Administration, Application, and Region 2025-2033 |
2024年,全球反義及RNAi療法市場規模達18億美元。展望未來, IMARC Group預計到2033年,該市場規模將達到33億美元,2025-2033年期間的複合年成長率(CAGR)為7.03%。全球遺傳疾病和慢性病的日益普及推動了該市場穩步成長,這需要創新療法、各主要市場支持性監管環境以加快新療法的核准和商業化,以及藥物輸送系統的持續技術進步。
藥物輸送系統的技術進步
在這個市場中,主要促進因素之一是藥物輸送方法的持續發展。這些技術使RNA分子能夠乾淨且有效率地輸送至相關細胞,避免分解,進而提高治療效果。例如,脂質奈米顆粒和偶聯技術使反義寡核苷酸或siRNA的細胞攝取和平衡變得前所未有的微不足道。它提高了輸送效率,同時增強了療法與特定人體物質的相似度,而這些物質對於癌症、疾病和病毒感染等至關重要。反義和RNAi療法市場預測表明,這些療法將獲得大量的研究關注和資金投入。例如,諾華於2023年7月收購了DTx Pharma,這是一家專注於神經科學領域短干擾RNA療法的生物技術公司。同樣,這些收購也正在創造積極的市場前景。
遺傳性疾病和慢性病的盛行率不斷上升
群體中遺傳性疾病和慢性疾病的發生率不斷上升,有力地推動了反義和RNAi療法市場的成長。亨廷頓氏舞蹈症、某些類型的癌症以及各種遺傳性疾病只是少數常見且缺乏有效治療方法的疾病,這催生了對反義和RNAi療法的需求。此外,反義和RNAi療法作為候選致病基因的抑制劑,為疾病的治療提供了新的途徑。一方面,這些新藥最有可能應用在臨床上。另一方面,由於能夠針對特定基因,它們為目前無法透過傳統藥理學方法治療的患者提供了一種新的治療方式。這反過來又催生了對新生物製藥研發項目持續投資的明確需求。
支持新療法的監管環境
反義和RNAi療法的需求受到有利監管環境的推動。例如,美國食品藥物管理局(FDA)孤兒藥產品開發辦公室於2023年10月宣布,將在2024會計年度提供資金,用於承擔罕見疾病和病症自然史研究的費用。該RFA的既定目標是「提昇科學嚴謹性,促進合作,造福罕見疾病患者」。此外,FDA和EMA等全球衛生機構正在加快任何新療法的審查流程,包括RNAi和反義技術。同時,孤兒藥資格認定、加速核准和優先審查憑證等監管激勵措施也變得更加重要,因為它們將更有動力激勵製藥公司投入精力開發反義和RNAi療法。
反義 RNA 佔據反義和 RNAi 治療市場的大部分佔有率
反義RNA技術憑藉其成熟的方法和悠久的臨床應用歷史,在反義和RNAi治療市場中佔據領先地位。反義RNA的工作原理是合成RNA分子與特定的mRNA序列結合,進而阻斷致病標靶基因。此外,其廣泛的應用範圍從遺傳病理到各種慢性疾病(包括癌症),也奠定了其領先地位。此外,與其他RNAi技術不同,這些領先技術已在長達兩年的時間內廣泛應用,這使得人們能夠投入大量資源用於研究和開發其作用機制和給藥方式。此外,一些反義治療藥物已在RNAi技術市場上獲得FDA註冊,這最終證實了它們的有效性並鼓勵了進一步的投資。所有這些因素都有助於確保其在最大市場佔有率中的穩定發展;此外,在反義子領域,已經提交上市申請的有前景的藥物也已上市。因此,這項技術引領著RNA治療市場,並為該領域的突破奠定了基礎。
肺部給藥佔業界最大佔有率
在反義和RNAi療法市場中,肺部給藥已成為給藥途徑的主導。其理由包括直接用於治療呼吸系統疾病,局部給藥可顯著提高療效。因此,能夠進入肺部並攜帶治療藥物,對於治療呼吸道合胞病毒和肺動脈高壓等疾病以及肺癌等疾病都具有顯著效果。它能夠使溶液在病灶處達到高濃度,減少全身性副作用,從而降低副作用,提高患者依從性並提高整體治療效果。此外,能夠有效地將藥物輸送至肺部組織的創新吸入器和解決方案也是一個重要方面。由於負荷不斷增加,人們面臨著盡可能提高治療有效性和針對性的壓力。因此,肺部給藥是RNAi技術市場的關鍵發展重點,並引領整體投資和創新配額。
北美引領市場,佔據反義和 RNAi 治療市場最大佔有率
該報告還對所有主要區域市場進行了全面分析,包括北美(美國和加拿大);亞太地區(中國、日本、印度、韓國、澳洲、印尼等);歐洲(德國、法國、英國、義大利、西班牙、俄羅斯等);拉丁美洲(巴西、墨西哥等);以及中東和非洲。報告指出,北美是反義和RNAi療法最大的區域市場。
北美是反義和RNAi療法市場最大的區域。這項優勢主要歸功於該地區成熟的生物技術和製藥研究基礎設施。此外,各國政府和其他全球衛生組織提供的空前支持,為反義和RNAi治療平台發展所需的研究和先進開發創造了有利環境。根據反義和RNAi療法市場分析,該地區多家領先的生物技術和製藥公司的存在,創造了激烈的競爭並促進了創新,加速了開發機會和產品上市。此外,北美積極的監管環境,例如美國食品藥物管理局(FDA)的積極參與,已快速核准多種用於治療多種遺傳和慢性疾病的RNA藥物,也為RNA療法市場提供了支持。此外,該地區癌症和遺傳性疾病等目標疾病的高發生率也創造了反義和RNAi療法的需求。因此,北美引領反義和 RNAi 治療市場,是技術開發的主導者,也是基於 RNA 的治療產品的主要市場。
市場研究報告還對市場競爭格局進行了全面分析,並提供了所有主要公司的詳細資料。反義和 RNAi 治療行業的主要市場參與者包括:
市場主要參與者正日益參與研發,以豐富其基因治療產品組合。他們積極建立策略合作夥伴關係,收購小型生物技術公司,或與學術機構和研發中心合作,以利用新興顛覆性技術並加速藥物開發。同時,考慮到高昂的成本和開發風險,公司在臨床試驗方面投入了大量資金,以確保其在更廣泛的應用組合(尤其是在基因轉移性疾病領域)中的有效性和安全性。與監管機構的合作可以提升公司的競爭力,並引導他們更快推出新藥。這項措施對於創造競爭優勢以及積極的反義和RNAi療法市場前景至關重要。
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.