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市場調査レポート
商品コード
1753910
アンチセンスとRNAi治療薬の市場レポート:技術、投与経路、用途、地域別、2025年~2033年Antisense & RNAi Therapeutics Market Report by Technology, Route of Administration, Application, and Region 2025-2033 |
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アンチセンスとRNAi治療薬の市場レポート:技術、投与経路、用途、地域別、2025年~2033年 |
出版日: 2025年06月02日
発行: IMARC
ページ情報: 英文 135 Pages
納期: 2~3営業日
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世界のアンチセンスとRNAi治療薬市場規模は2024年に18億米ドルに達しました。今後、IMARC Groupは、同市場が2033年までに33億米ドルに達し、2025年から2033年にかけて7.03%の成長率(CAGR)を示すと予測しています。同市場は、革新的な治療法を必要とする遺伝性疾患や慢性疾患の世界の蔓延の増加、新治療法の承認と商業化を促進するための主要市場全体での支持的な規制環境、ドラッグデリバリーシステムにおける継続的な技術進歩に牽引され、着実な成長を遂げています。
ドラッグデリバリーシステムの技術進歩
この市場において、主要促進要因のひとつはドラッグデリバリー法の開発が続いていることです。これらの技術により、RNA分子をクリーンかつ効率的に、分解を回避するパターンで関連細胞に送達できるようになり、その結果、治療効果が向上しました。例えば、脂質ナノ粒子とコンジュゲート技術により、アンチセンス・オリゴヌクレオチドやsiRNAの、以前はごくわずかだった細胞への取り込みとバランスが可能になりました。これは、特にがん、疾患、ウイルス感染において重要である、治療薬が特定のヒト物質を標的とするのに適している類似性の程度を高めながら、送達を増加させる。アンチセンスとRNAi治療薬の市場予測によると、これらの治療法は相当な研究的注目と財政的投資を得ることになります。例えば、ノバルティスは2023年7月にDTx Pharma社を買収したが、同社は神経科学を適応症とする短鎖干渉性RNA療法に注力しているバイオテクノロジー企業です。同様に、こうした買収は市場の見通しを明るいものにしています。
遺伝性疾患と慢性疾患の増加
大衆の間で遺伝性疾患や慢性疾患の発生が加速していることが、アンチセンスとRNAi治療薬市場の成長を大きく後押ししています。ハンチントン病、ある種のがん、広範な遺伝性遺伝性疾患は、アンチセンスとRNAi治療薬の需要を生み出す、効率的な治療法がほとんどない蔓延病のほんの一例に過ぎないです。これとともに、アンチセンスやRNAi治療法は、病気の原因遺伝子の抑制剤の候補として新しい道を提供します。一方では、この新薬は臨床に取り入れられる可能性が高いです。もう一方では、特定の遺伝子を標的とする能力を持つことで、従来の薬理学的手法では対処不可能な状態の患者に対する新たな治療手段となります。このことは、新たなバイオ医薬品研究開発プロジェクトへの継続的な投資の必要性を明確にします。
新規治療薬に対する支援的な規制環境
アンチセンスとRNAi治療薬の需要は、支援的な規制環境に後押しされています。例えば、2023年10月、米国食品医薬品局(FDA)の希少製品開発室は、希少疾患や病態に関する自然史研究の実施費用を支援するための2024会計年度の資金が利用可能であることを発表しました。このRFAは、「希少疾患や病態を持つ患者の利益のために、科学的厳密性と協力を促進する」ことを目的としています。さらに、FDAやEMAのような世界の保健当局は、RNAiやアンチセンス技術を含むあらゆる新しい治療法に対して、より迅速な審査プロセスを導入しています。一方、希少疾病用医薬品(オーファンドラッグ)ステータス、早期承認、優先審査バウチャーといった規制上の優遇措置は、製薬会社にアンチセンスとRNAi治療薬の開発に力を入れるインセンティブを与えるため、さらに重要性を増しています。
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.