市場調查報告書
商品編碼
1540902
2024-2032 年反義和 RNAi 治療市場報告(按技術、給藥途徑、應用和地區)Antisense & RNAi Therapeutics Market Report by Technology, Route of Administration, Application, and Region 2024-2032 |
IMARC Group年,全球反義和RNAi治療市場規模達17億美元。全球遺傳疾病和慢性病盛行率不斷上升,推動該市場正在經歷穩定成長,這需要創新的治療方法、主要市場的支持性監管環境以加速新療法的批准和商業化,以及藥物輸送系統的持續技術進步。
主要市場促進因素:市場由強大的技術促進因素驅動,例如藥物傳輸系統的快速進步,增加了對細胞的治療影響和靶向特異性,以及遺傳性疾病和慢性疾病的高發病率,這需要使用尖端技術治療方式。
主要市場趨勢:反義和 RNAi 治療行業的主要趨勢之一是其與基於獨特基因譜並旨在改善患者治療結果的個人化醫療緊密相關。
地理趨勢:根據反義和RNAi治療市場分析,北美由於其優良的醫療基礎設施、高醫療支出和友善的監管環境,在反義和RNAi治療市場佔據主導地位。
競爭格局:這是一個充滿活力的市場,擁有許多傳統藥品市場參與者,例如頂級製藥公司和已經確立地位的創新者。競爭空間必須決定自有技術的專利之爭、獲得監管機構的批准以及進行新的合作。
挑戰與機會:反義和RNAi療法市場研究報告顯示,該產業的主要挑戰是開發和管理RNAi和反義療法的高成本和複雜性。後者也是一個機會,因為它將將該行業轉變為創新和低成本藥物發現的場所,從而在未經治療的遺傳疾病方面取得突破。
藥物輸送系統的技術進步
在這個市場中,主要驅動力之一是藥物傳遞方法的持續發展。這些技術使 RNA 分子能夠以避免分解的方式乾淨且有效地遞送到相關細胞,從而提高治療效果。例如,脂質奈米顆粒和綴合物技術使以前可以忽略不計的細胞攝取和反義寡核苷酸或 siRNA 的平衡成為可能。它增加了遞送,同時增強了治療方法適合針對特定人體物質的相似程度,這對於癌症、疾病和病毒感染等至關重要。反義和 RNAi 療法市場預測顯示這些療法將獲得大量研究關注和財務投資。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適應症的短干擾 RNA 療法的生物技術公司。同樣,這些收購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增加
遺傳疾病和慢性病在大眾中發病率的不斷上升極大地支持了反義和 RNAi 治療市場的成長。亨廷頓氏舞蹈症、某些類型的癌症和廣泛的遺傳性疾病只是缺乏有效治療方法的流行疾病的幾個例子,這創造了對反義和 RNAi 療法的需求。除此之外,反義和 RNAi 治療方案作為候選疾病易感基因的抑制因子提供了一條新途徑。一方面,新藥最有可能進入臨床。另一方面,它們具有針對特定基因的能力,為目前使用傳統藥理學方法無法控制的患者提供了一種新的治療方式。這反過來又明確需要持續投資新的生物製藥研發項目。
新療法的支持性監管環境
支持性監管環境推動了反義和 RNAi 療法的需求。例如,2023 年 10 月,美國食品藥物管理局孤兒產品開發辦公室宣佈為 2024 會計年度 (FY) 提供資金,以幫助承擔對罕見疾病和病症進行自然史研究的費用。該 RFA 的既定目標是「提高科學嚴謹性和合作,造福罕見疾病或病症患者」。此外,FDA 和 EMA 等全球衛生當局正在為任何新療法引入更快的審查流程,包括 RNAi 和反義技術。同時,孤兒藥地位、加速核准和優先審評券等監管激勵措施變得更加重要,因為它們讓製藥公司更有動力致力於反義和 RNAi 療法的開發。
IMARC Group提供了每個細分市場的主要趨勢分析,以及 2024-2032 年全球、區域和國家層面的預測。我們的報告根據技術、給藥途徑和應用對市場進行了分類。
RNA干擾
siRNA
miRNA
反義RNA
反義RNA佔反義和RNAi治療市場的大部分佔有率
該報告基於該技術對市場進行了詳細的細分和分析。這包括 RNA 干擾(siRNA 和 miRNA)和反義 RNA。根據反義和 RNAi 治療市場報告,反義 RNA 代表了最大的部分。
反義RNA技術因其成熟的方法論和最長的臨床應用歷史而成為反義和RNAi治療市場的領導者。反義 RNA 是基於附著於特定 mRNA 序列的合成 RNA 分子發揮作用,並導致對導致疾病的目標基因的封鎖。此外,從遺傳病理學到包括癌症在內的各種來源的慢性疾病的最廣泛的應用範圍主要確保了其領先地位。除此之外,與其他 RNAi 技術不同的是,這些領先技術已經花費了長達兩年的廣泛使用時間,這使得在研究和開發行動和交付機制方面投入了大量資源。此外,一些反義治療劑已進入RNAi技術市場,並已在FDA積極註冊,最終證實了它們的有效性並鼓勵進一步投資。所有這些因素都有助於確保鑽探的穩定性和最重要的佔有率;更重要的是,在反義子領域可以觀察到已經申請擴散的有前途的藥物。因此,該技術引領了基於RNA的治療市場,並為該領域的突破奠定了基礎。
靜脈途徑
皮下途徑
鞘內途徑
肺部輸送
腹腔注射
其他
肺部輸送佔產業最大佔有率
反義和 RNAi 療法市場報告還提供了基於給藥途徑的詳細市場細分和分析。這包括靜脈途徑、皮下途徑、鞘內途徑、肺部遞送、腹膜內注射等。根據該報告,肺部遞送佔據最大的反義和 RNAi 治療市場。
在反義和RNAi治療市場中,肺部遞送在給藥管道方面處於領先地位。有幾個理由,包括直接用於治療呼吸系統疾病,其中局部輸送顯著提高了有效性。因此,進入肺部並攜帶治療劑的能力可有效治療呼吸道合胞病毒和肺動脈高壓等疾病以及針對肺癌。它使疾病部位的溶液濃度高,限制了全身性,因此副作用較低,提高了患者的依從性和治療的整體有效性。此外,能夠將藥物有效輸送到肺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,我們面臨著使治療盡可能有效和有針對性的壓力。因此,肺部遞送成為RNAi技術市場的重點發展重點,並主導著整體投資和創新佔有率。
腫瘤學
心血管疾病 (CVD)
呼吸系統疾病
腎臟疾病
神經退化性疾病
遺傳性疾病
傳染病
其他
該報告根據應用程式提供了詳細的市場細分和分析。這包括腫瘤學、心血管疾病 (CVD)、呼吸系統疾病、腎臟疾病、神經退化性疾病、遺傳性疾病、傳染病等。
北美洲
美國
加拿大
亞太
中國
日本
印度
韓國
澳洲
印尼
其他
歐洲
德國
法國
英國
義大利
西班牙
俄羅斯
其他
拉丁美洲
巴西
墨西哥
其他
中東和非洲
北美市場領先,佔據最大的反義和RNAi治療市場佔有率
該報告還對所有主要區域市場進行了全面分析,其中包括北美(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。根據該報告,北美是反義和 RNAi 治療藥物最大的區域市場。
北美是反義和 RNAi 治療市場最大的區域市場。這一突出地位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前所未有的支持為反義和 RNAi 治療平台所需的研究和先進開發創造了有利的環境。根據反義和RNAi治療市場分析,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,加速了發展機會和產品的推出。此外,北美積極主動的監管環境以及 FDA 的特殊參與(FDA 已快速追蹤許多用於治療多種遺傳和慢性疾病的 RNA 藥物)為 RNA 治療市場提供了支持。此外,該地區目標疾病(包括癌症和遺傳性疾病)的高盛行率創造了反義和 RNAi 療法的需求。因此,北美作為技術開發的主導者以及基於 RNA 的治療產品的主要市場,引領著反義和 RNAi 治療市場。
The global antisense & RNAi therapeutics market size reached US$ 1.7 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 3.2 Billion by 2032, exhibiting a growth rate (CAGR) of 7.25% during 2024-2032. 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.
Major Market Drivers: The market is driven by powerful technological drivers such as rapid advancements in drug delivery systems, which increased therapeutic impact on cells and targeting specificity, and a high incidence of genetic disorders and chronic diseases, which requires the use of cutting-edge therapeutic modalities.
Key Market Trends: One of the major antisense & RNAi therapeutics industry trends is its tight association with the personalization of medicine based on unique genetic profiles and aimed at improving patient outcomes.
Geographical Trends: According to the antisense & RNAi therapeutics market analysis, North America dominates the market for Antisense & RNAi Therapeutics due to its excellent healthcare infrastructure, high healthcare spending, and friendly regulatory environment.
Competitive Landscape: This is a dynamic market with a pool of traditional drug market players such as top pharmaceutical companies and innovators that have established themselves. The competitive space will have to determine the battle for patents of owned technologies, achieving the green light from the regulatory authorities, and making new collaborations.
Challenges and Opportunities: The antisense & RNAi therapeutics market research report shows that the industry's major challenge is the high cost and complexity of developing and managing RNAi and antisense-based therapies. The latter is also an opportunity since it will transform the sector into loci of innovation and low-cost drug discovery resulting in breakthroughs in untreated genetic diseases.
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.
IMARC Group provides an analysis of the key trends in each segment of the market, along with forecasts at the global, regional, and country levels for 2024-2032. Our report has categorized the market based on technology, route of administration and application.
RNA Interference
siRNA
miRNA
Antisense RNA
Antisense RNA accounts for the majority of the antisense & RNAi therapeutics market share
The report has provided a detailed breakup and analysis of the market based on the technology. This includes RNA Interference(siRNA, and miRNA), and Antisense RNA. According to the antisense & RNAi therapeutics market report, Antisense RNA represented the largest segment.
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.
Intravenous Route
Subcutaneous Route
Intrathecal Route
Pulmonary Delivery
Intraperitoneal Injection
Others
Pulmonary delivery holds the largest share of the industry
A detailed breakup and analysis of the market based on the route of administration have also been provided in the antisense & RNAi therapeutics market report. This includes intravenous route, subcutaneous route, intrathecal route, pulmonary delivery, intraperitoneal injection, and others. According to the report, pulmonary delivery accounted for the largest antisense & RNAi therapeutics market share.
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.
Oncology
Cardiovascular Diseases (CVDs)
Respiratory Disorders
Renal Diseases
Neurodegenerative Disorders
Genetic Disorders
Infectious Diseases
Others
The report has provided a detailed breakup and analysis of the market based on the application. This includes oncology, cardiovascular diseases (CVDs), respiratory disorders, renal diseases, neurodegenerative disorders, genetic disorders, infectious diseases, and others.
North America
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
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.
Alnylam Pharmaceuticals Inc.
Arbutus Biopharma Corporation
Arrowhead Pharmaceuticals Inc.
Benitec Biopharma Ltd.
Bio-Path Holdings Inc.
Dicerna Pharmaceuticals Inc. (Novo Nordisk A/S)
Ionis Pharmaceuticals Inc.
OliX Pharmaceuticals Inc.
Phio Pharmaceuticals Corp.
Sarepta Therapeutics Inc.
Silence Therapeutics
Sirnaomics Inc.
(Please note that this is only a partial list of the key players, and the complete list is provided in the report.)
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.
April 08, 2024: OliX Pharmaceuticals Inc., a leading developer of RNA interfering therapeutics in the treatment area of severe diseases including fibro-inflammatory and metabolic diseases, disclosed that the Company has gotten approval from the Alfred Human Research Ethics Committee to commence the Phase 1 clinical trial of drug candidate OLX75016 (candidate of OLX702A for NASH treatment).
June 21, 2023: Arbutus Biopharma Corporation provided the first data from the empirical study on RNA interference therapy, nucleos(t)ide analogue (NA), and pegylated interferon alfa-2a therapy in patients with chronic hepatitis B virus at the EASL Conference 2023.