Antisense and RNAi Therapeutics Market – Technology (RNA Interference, Antisense RNA), Route of Administration (Intrathecal, Intravenous, Subcutaneous), Application (Neurodegenerative, Cancer, Skin, Genetic Disorders) – Global Forecast (2024 – 2032)

Antisense and RNAi Therapeutics Market Size

Antisense And RNAi Therapeutics Market size was valued at USD 4.4 billion in 2023 and is anticipated to showcase growth at 18.2% CAGR from 2024 and 2032. Increasing prevalence of neurodegenerative and genetic disorders, growing investments in research related to gene expression and delivery technologies, growth in regulatory approvals for RNAi and antisense therapeutics is driving the market.
 

Additionally, rising awareness towards RNA-based therapeutics is also adding to the revenue growth in the market. Initiatives from patient advocacy groups and campaigns to raise disease awareness are advocating access to innovative treatments and expediting their integration into clinical practice thereby contributing to rise in awareness for advanced RNA-based therapies.
 

Antisense therapy utilizes short synthetic nucleic acid sequences known as antisense oligonucleotides to selectively target and regulate the expression of genes responsible for diseases. RNA interference is an intrinsic cellular mechanism that controls gene expression. In this process, small RNA molecules like small interfering RNAs (siRNAs) or microRNAs (miRNAs) hinder the translation or trigger the degradation of particular mRNA molecules.

Antisense and RNAi therapeutics Market Trends

• Vendors are establishing strategic partnerships and collaborations to enable the exchange of technology, intellectual property, to expediate the development in RNA therapeutics such as antisense and RNAi therapeutics. Vendors are directing their efforts toward addressing the primary hurdles in RNAi and antisense therapeutics related to efficient delivery of therapeutics to target cells or tissues.
   
• Advances in nanoparticle technology, lipid-based carriers, and other delivery systems have improved the stability, specificity, and uptake of RNA-based therapeutics, allowing them to reach their intended targets more effectively. For instance, in 2021, US FDA approved Leqvio (inclisiran) injection that uses lipid nanoparticle ALN-PCS, for SiRNA delivery.
   
• Moreover, recent advances in antisense oligonucleotides technology have enabled the development of therapies for genetic disorders, neurological diseases, and cancer. For instance, four antisense oligonucleotides were approved by US FDA in 2023, intended for the treatment of neurological and genetic disorders. These included Qalsody for amyotrophic lateral sclerosis, Izervay for geographic atrophy, Rivfloza injection for primary hyperoxaluria, and WAINUA for polyneuropathy of hereditary amyloidosis.
   
• Furthermore, vendors are also targeting the potential for combining RNAi/antisense therapeutics with other treatment modalities to improve patient outcomes. These combination therapies, including the combination vaccines and drugs, aims to overcome challenges related to drug resistance through targeting multiple disease mechanisms concurrently.
   

Antisense and RNAi Therapeutics Market Analysis

Based on technology, the market is segmented into RNA interference and antisense RNA. The RNA interference segment held the majority of market share in 2023 of about 62.4%.
 

• RNA interference segment dominates the market owing to its broader application spectrum compared to antisense RNA, making it more versatile and applicable across a wider range of therapeutic targets including viral infections, cancer, and certain genetic disorders.
   
• Increasing approval for RNA interference-based therapeutics by regulatory authorities has also made it more accessible for patients and health practitioners. For instance, US FDA approved Rivfloza in October 2023, an siRNA-based therapeutic for treating primary hyperoxaluria in adults.
   

Based on route of administration, the antisense and RNAi therapeutics market is classified into intravenous injections, intrathecal injections, subcutaneous injections, and other routes of administration. The intravenous injections segment dominated the market with a revenue of about USD 1.9 billion in 2023.
 

• Leading share of intravenous injections segment can be attributed to their significant use in delivering RNA interference-based therapeutics such as CALAA-01, MRX34, APN401, and siRNA-EphA2-DOPC.
   
• Furthermore, intravenous injections find widespread applications in the treatment of inaccessible targets such as systematic genetic disorders and certain types of cancers.
   
• Administering RNAi or antisense therapeutics through intravenous injections enables their systemic distribution throughout the body. This method of delivery allows the therapeutic agents to circulate in the bloodstream, enabling them to reach target tissues and cells located in various parts of the body.
   

Based on application, the antisense and RNAi therapeutics market is classified into cardiometabolic & renal disorders, cancer, neurodegenerative disorders, genetic disorders, infectious diseases, ophthalmic diseases, skin diseases, and other applications. The cardiometabolic & renal disorders segment secured a leading share of about 31.7% in 2023 and is anticipated to grow at 18.3% CAGR during the forecast period.
 

• Increasing prevalence of cardiometabolic and renal disorders such as liver fibrosis, diabetes, dyslipidemia, and chronic kidney disease are driving the demand for antisense and RNAi therapeutics in this segment, contributing to its leading share.
   

For instance, according to the International Diabetes Federation, about 537 million patients (20-79 years) had type -1 diabetes in 2021, which is expected to increase to 643 million by 2030.
 

• Increasing growth in approval of RNAi and antisense therapeutics targeted to treat liver related disorders has also contributed to dominating share of cardiometabolic & renal disorders segment. Liver's distinctive features make it an appealing target for RNA therapies, as they enhance the effective delivery and metabolism of medications.
   

North America antisense and RNAi therapeutics market accounted for 42.1% of market share in global market in 2023 and is predicted to reach USD 8.2 billion by 2032.
 

• Presence of large number of pharmaceutical manufacturers in the country offering advanced treatment options such as RNA therapies is driving the revenue growth in the region. Antisense and RNAi therapeutics manufacturers are leveraging their manufacturing expertise, research and development capabilities, and marketing strategies to maintain dominance in the regional market, which has eased the availability of advanced antisense and RNAi therapeutics-based treatment formulations in the region.
   
• Large number of approvals for RNA therapeutics by regulatory authorities such as U.S. FDA and Health Canada has eased the availability of advanced antisense and RNAi therapeutics covering wide range of diseases. For instance, in 2023, four therapeutic oligonucleotides received approval from U.S. FDA, including two antisense molecules, one RNA aptamer, and one siRNA.
   

The U.S. antisense and RNAi therapeutics market was valued at USD 1.6 billion in 2023 and is anticipated to grow at a CAGR of 18.1% over the forecast period.
 

• Increasing investments in RNA therapeutics-based clinical research and growing demand for personalized drug development is driving the revenue growth in the U.S. market. For instance, according to the American Society of Gene & Cell Therapy, in the first quarter of 2023, companies in the US signed 110 deals to promote advancements in gene and RNA therapies.  
   
• Availability of reimbursement and coverage for RNA-based therapeutics such as antisense and RNAi therapeutics is contributing to their increasing adoption in the country. The availability of reimbursement helps to reduce the out-of-pocket costs for patients which increases their access to treatment.
   

Germany antisense and RNAi therapeutics market is expected to show significant growth during the forecast period.
 

• Germany boasts one of the largest pharmaceutical markets in Europe, fostering a favorable environment for the advancement of Antisense and RNAi therapeutics research and development. According to Germany Trade & Invest (GTI), Germany stands out as a top contender in the European pharmaceutical market, evidenced by its significant investments in R&D, innovative initiatives, and patent applications. The availability of substantial investments for research and development in RNA therapeutics is propelling progress within the market in Germany.
   
• Moreover, the presence of advanced healthcare infrastructure in Germany, along with a rising healthcare expenditure, is also facilitating convenient access to medications like Antisense and RNAi therapeutics. As per the Federal Statistical Office of Germany (FSOG), healthcare spending in the nation reached approximately 13.2% of its GDP in 2021, which was 0.2% higher than 2020.
   

India antisense and RNAi therapeutics market is anticipated to grow remarkably over the coming years.
 

• Increasing growth in genetic disorders and chronic illnesses such as diabetes, cancer, and liver fibrosis, along with improved access to advanced treatment modalities such as antisense and RNAi therapeutics due to significant investments for expanding and modernizing healthcare infrastructure is driving the revenue growth in market in India.
   
• Moreover, owing to its large population, India has become one of the key destinations for clinical trials. Since the approval of first siRNA-based drug trial in 2016, RNA-based therapeutics are gaining increasing attention in the country leading to increased investments from both domestic and global pharmaceutical manufacturers for the development of advanced antisense and RNAi therapeutics.
   

Antisense and RNAi Therapeutics Market Share

The antisense and RNAi therapeutics industry is fragmented. Although major market players hold significant influence, smaller companies and research institutions also play a vital role in advancing and bringing these therapies to market. Established players have extensive pipelines, substantial research capabilities, and established partnerships with other biotechnology and pharmaceutical companies. Small companies are majorly involved in the researching and developing RNAi and antisense therapeutics focusing on niche areas or specific diseases, which has contributed to the overall diversity in the market.
 

Antisense and RNAi Therapeutics Market Companies

Prominent players operating in the antisense and RNAi therapeutics industry include:

• Alnylam Pharmaceuticals, Inc.
• Arbutus Biopharma
• Arrowhead Pharmaceuticals, Inc.
• Benitec Biopharma Inc.
• BioNTech SE.
• CRISPR Therapeutics
• GlaxoSmithKline plc
• Ionis Pharmaceuticals, Inc.
• Novartis AG
• OliX Pharmaceuticals, Inc.
• Orna Therapeutics, Inc.
• Percheron Therapeutics Ltd.
• Sanofi 
• Sarepta Therapeutics, Inc.
• Silence Therapeutics
   

Antisense and RNAi Therapeutics Industry News:

• In April 2024, Alnylam Pharmaceuticals, Inc. and Medison Pharma announced an expansion of their existing partnership in Central & Eastern Europe and Israel, to include certain territories in LATAM and APAC regions, as well as other global markets. The partnership will ensure expansion and commercialization of RNA-based therapeutics such as ONPATTRO (patisiran), AMVUTTRA (vutrisiran), GIVLAARI (givosiran), and OXLUMO (lumasiran) globally.
   
• In April 2024, Chugai Pharmaceutical Co., Ltd. announced a license agreement with Alnylam Pharmaceuticals, Inc. and F. Hoffmann-La Roche AG to obtain commercialization rights in Japan for zilebesiran, an investigational RNAi therapeutic indicated for hypertension.
   

 The antisense and RNAi therapeutics market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 – 2032 for the following segments:

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Market, By Technology

• RNA interference
• Antisense RNA

Market, By Route of administration

• Intravenous injections
• Intrathecal injections
• Subcutaneous injections
• Other routes of administration

Market, By Application

• Cardiometabolic & renal disorders
• Cancer
• Neurodegenerative disorders
• Genetic disorders
• Infectious diseases
• Ophthalmic diseases
• Skin diseases
• Other applications

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Netherlands
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East and Africa