세계 안티센스 및 RNAi 치료제 시장 규모는 2024년 18억 달러에 달했습니다. 향후 IMARC Group은 이 시장이 2033년까지 33억 달러에 달할 것으로 예상하며, 2025년부터 2033년까지 7.03%의 연평균 성장률(CAGR)을 보일 것으로 전망하고 있습니다. 이 시장은 혁신적인 치료법을 필요로 하는 유전성 및 만성질환의 전 세계적 확산, 새로운 치료법의 승인 및 상용화를 촉진하는 주요 시장 전반의 우호적인 규제 환경, 약물전달 시스템의 지속적인 기술 발전에 힘입어 꾸준한 성장세를 보이고 있습니다.
약물전달 시스템의 기술 발전
이 시장에서 주요 촉진요인 중 하나는 약물전달 방법의 지속적인 개발입니다. 이러한 기술을 통해 RNA 분자를 깨끗하고 효율적으로 분해되지 않는 패턴으로 관련 세포에 전달할 수 있게 되었으며, 그 결과 치료 효과가 향상되었습니다. 예를 들어, 지질 나노입자와 컨쥬게이트 기술을 통해 이전에는 극히 미미했던 안티센스 올리고뉴클레오티드와 siRNA의 세포 내로의 흡수와 균형이 가능해졌습니다. 이는 특히 암, 질병, 바이러스 감염에서 중요한 치료제가 특정 인간 물질을 표적으로 삼기에 적합한 유사성을 증가시키면서 전달을 증가시킵니다. 안티센스 및 RNAi 치료제의 시장 예측에 따르면, 이러한 치료법은 상당한 연구 관심과 재정적 투자를 받게 될 것입니다. 예를 들어, 노바티스는 2023년 7월에 DTx Pharma를 인수했는데, 이 회사는 신경과학을 적응증으로 하는 단쇄 간섭성 RNA 치료제에 주력하는 생명공학 기업입니다. 마찬가지로, 이러한 인수는 시장 전망을 밝게 하고 있습니다.
유전성 질환과 만성질환 증가
대중들 사이에서 유전성 질환과 만성질환의 발생이 가속화되면서 안티센스 및 RNAi 치료제 시장의 성장을 크게 촉진하고 있습니다. 헌팅턴병, 일부 암, 광범위한 유전성 유전질환은 안티센스 및 RNAi 치료제에 대한 수요를 창출하는 효율적인 치료법이 거의 없는 만연성 질환의 한 예일 뿐입니다. 이와 함께 안티센스 및 RNAi 치료법은 질병을 일으키는 유전자의 억제제 후보로서 새로운 길을 제시합니다. 한편으로, 이 신약은 임상으로 도입될 가능성이 높습니다. 다른 한편으로, 특정 유전자를 표적으로 삼을 수 있는 능력은 기존의 약리학적인 방법으로 치료할 수 없는 질환을 가진 환자들에게 새로운 치료 수단이 될 수 있습니다. 이는 새로운 바이오의약품 연구개발 프로젝트에 대한 지속적인 투자의 필요성을 분명히 합니다.
신규 치료제에 대한 지원적인 규제 환경
안티센스 및 RNAi 치료제에 대한 수요는 우호적인 규제 환경에 의해 촉진되고 있습니다. 예를 들어, 2023년 10월 미국 식품의약국(FDA) 희귀제품개발실은 2024 회계연도에 희귀질환 및 질환에 대한 자연사 연구 수행 비용을 지원하기 위해 2024 회계연도에 자금을 사용할 수 있다고 발표했습니다. 이 RFA는 "희귀 질환 및 질환을 앓고 있는 환자들의 이익을 위해 과학적 엄격성과 협력을 촉진하는 것"을 목표로 하고 있습니다. 또한, FDA 및 EMA와 같은 세계 보건 당국은 RNAi 및 안티센스 기술을 포함한 모든 새로운 치료법에 대해 보다 신속한 심사 프로세스를 도입하고 있습니다. 한편, 희귀의약품(Orphan Drug) 지위, 조기 승인, 우선 심사 바우처와 같은 규제 혜택은 제약사들이 안티센스 및 RNAi 치료제 개발에 집중할 수 있는 인센티브를 제공하기 때문에 그 중요성이 더욱 커지고 있습니다.
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.