RNA Therapeutics Market

The size of global RNA therapeutics market in terms of revenue was estimated to be worth $13.7 billion in 2023 and is poised to reach $18.0 billion by 2028, growing at a CAGR of 5.6% from 2023 to 2028. The research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market.

Growth in this market is largely driven by factors such as the increasing number of partnerships and collaborations among market players and RNA technology manufacturers, expanding modalities for RNA therapeutics, and the rising number of emergency use authorizations and approvals for COVID-19 booster vaccines. On the other hand, the discontinuation/recalls of RNA therapeutic products is expected to hinder market growth. Higher progress in the development of RNA aptamer-based products is expected to offer lucrative opportunities to the market players. Contrarily, challenges associated with the manufacturing of RNA therapeutics are expected to impact the market growth to a certain extent.

Attractive Opportunities in the RNA Therapeutics Market

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Global RNA Therapeutics Market Dynamics

DRIVER: Increasing partnerships and collaborations among market players and RNA technology manufacturers

RNA therapeutics is a rapidly growing field that can revolutionize the treatment of a wide range of diseases. The rapid growth of this market has been fueled by strategic partnerships and collaborations, both among market players and RNA technology manufacturers. Partnerships and collaborations between market players accelerate the development and commercialization of RNA therapeutics. By pooling their resources and expertise, companies can share the costs and risks of drug development and gain access to new technologies and markets. For instance, in January 2022, Pfizer Inc. and Beam Therapeutics Inc. entered a four-year exclusive research collaboration focused on in vivo base editing programs aimed at three targets for rare genetic diseases of the liver, muscle, and central nervous system. This collaboration can produce novel therapeutics for patients with rare diseases by combining Beam Therapeutics's in vivo delivery technologies, which deliver base editors to target organs via messenger RNA (mRNA) and lipid nanoparticles (LNPs), with Pfizer's expertise in the development of drugs and vaccines.

RESTRAINT: Discontinuation or recalls of RNA therapeutic products

Instances of discontinuation or recalls can arise due to various reasons, including unexpected adverse effects, safety concerns, efficacy issues, or regulatory non-compliance. These events can lead to a loss of consumer and healthcare provider confidence in RNA therapeutic products, resulting in reduced demand and adoption. Furthermore, discontinuations or recalls can affect the reputation of the companies involved in the process and the broader perception of RNA therapeutics as a viable treatment avenue. Investors can also become cautious, decreasing the funding for R&D in the concerned field. Regulatory authorities can also intensify regulations, potentially resulting in more stringent approval processes.

OPPORTUNITY: Higher progress in the development of RNA aptamer-based therapeutics

RNA aptamers are single-stranded nucleic acid molecules that can bind to specific targets with high affinity and specificity. They have been investigated for a variety of therapeutic applications, including cancer, cardiovascular diseases, and infectious diseases. The progress in the development of RNA aptamer-based therapeutics is a major market opportunity for the market. This is because RNA aptamers have a number of potential advantages over traditional drug therapies. The field of RNA therapeutics has undergone a significant transformation with the emergence of RNA aptamer-based therapeutics. There are currently more pipeline products than approved products. One such example includes pegaptanib sodium (Macugen), discovered by Nexstar Pharmaceuticals, which is an anti-vascular endothelial growth factor (anti-VEGF) RNA aptamer to treat all types of neovascular age-related macular degeneration (AMD).

CHALLENGE: Rapid degradation by ubiquitous RNases in environment and tissues with strong immunogenicity of exogenous RNA

The progress of RNA therapeutics faces significant challenges that have led to the need for innovative solutions in their development and manufacturing. One of the primary obstacles pertains to the inherent susceptibility of exogenous RNA to rapid degradation by ubiquitous RNases present in both the environment and tissues. Another critical challenge involves effectively delivering negatively charged RNA molecules across the hydrophobic cytoplasmic membrane of target cells. Additionally, the strong immunogenicity of exogenous RNA posed a significant obstacle, leading to cell toxicity and hampering the translation of RNA into therapeutic proteins.

RNA Therapeutics Market Ecosystem

R&D is the initial stage in the value chain of the market. Extensive R&D is required to develop these products. R&D activities are divided into in-house and outsourced tasks. In-house tasks focus on critical activities that deal with fundamental analysis and the electronic interpretation of testing parameters. Prominent companies offer RNA drugs and vaccines (including companies with pipeline candidates in phase 3/ 4) and SMEs (companies with pipeline candidates in phase 1 to phase 4). End customers (pharmaceutical & biotechnology companies, academic & research institutions, and diagnostic companies) are the key stakeholders in the supply chain of the market. Investors/funders are the major influencers in the market.

The prominent players in the global RNA therapeutics market are Moderna, Inc. (US), Alnylam Pharmaceuticals, Inc. (US), Pfizer Inc. (US), Novartis AG (Switzerland), Ionis Pharmaceuticals, Inc. (US), Sarepta Therapeutics, Inc. (US), Sanofi (France), Arrowhead Pharmaceuticals, Inc. (US), BioNtech SE (Germany), Orna Therapeutics (US), CRISPR Therapeutics (Switzerland), Silence Therapeutics (UK), Astellas Pharma Inc. (Japan), CureVac SE (Germany), Sirnaomics (US), Arcturus Therapeutics Inc. (US) and Arbutus Biopharma (US).

Ecosystem Analysis: RNA Therapeutics Market

Source: Annual Reports, SEC Filings, Investor Presentations, Expert Interviews, and MarketsandMarkets Analysis

The vaccines segment accounted for the largest share of the RNA therapeutics industry in 2022.

Based on product, the RNA therapeutics market is segmented into drugs and vaccines. Increasing investments in R&D, advancements in RNA synthesis and delivery technologies, and a growing understanding of RNA-based therapeutics have propelled the growth of the market. The R&D departments of the major companies have focused on new vaccines due to the increasing investments in this market. For instance, in August 2023, CureVac announced that the first participant was dosed in the Phase 2 study of monovalent and bivalent modified mRNA COVID-19 vaccine candidates, developed in collaboration with GSK. Moreover, in March 2022, Moderna announced it had begun its second phase 1 HIV vaccine trial. This latest phase 1 trial is a multicenter, open-label, randomized study (HVTN 302), which evaluates the safety and immunogenicity of their experimental HIV trimer mRNA vaccine (mRNA-1574).

The mRNA therapeutics is anticipated to dominate the RNA therapeutics industry through 2021-2028.

Based on the type, the RNA therapeutics market is segmented into RNA interference (RNAi) therapeutics, mRNA therapeutics, antisense oligonucleotide (ASO) therapeutics, and other therapeutics. mRNA therapeutics showcases a broad potential for treating diseases that necessitate protein expression, thereby offering heightened therapeutic efficacy due to its sustained translation into encoded proteins and peptides and enduring expression compared to conventional transient protein or peptide drugs. Evidently, these advantages of mRNA over DNA or protein/peptide introduce mRNA-based technology and products across various biomedical applications. Major industry players such as Moderna, Inc. (US), CureVac SE (Germany), BioNTech SE (Germany), Argos Therapeutics Inc. (US), Ethris GmbH (Germany), Arcturus Therapeutics (US), and Acuitas Therapeutics (Canada) develop novel mRNA therapy for a variety of indications.

The infectious diseases segment accounted for the largest share of the RNA therapeutics industry in 2022.

Based on the indication, the RNA therapeutics market is segmented into infectious diseases, rare genetic diseases/hereditary diseases, and other indications. Rapid developments in the RNA vaccine manufacturing capabilities have led to dominant share of the infectious diseases segment in the global market. mRNA vaccines offer a compelling alternative to traditional vaccine strategies due to their remarkable potency, rapid development capabilities, cost-effective manufacturing potential, and safe administration.

Hospitals & clinics generated the highest revenue in 2022 in the RNA therapeutics industry.

The RNA therapeutics market is segmented into hospitals, clinics, and research settings. An increase in the use of RNA-based therapeutics for the treatment of rare/genetic disorders contributes to the high share of hospitals & clinics. The growing use of RNA therapeutics across hospitals and clinics is driven by factors such as the increasing understanding and advancements of RNA-based therapeutics, the growing number of trends in personalized medicine, the increasing prevalence of chronic diseases, and the rising research investments by governments, private foundations, and industry stakeholders.

The North American RNA therapeutics industry is projected to grow at the fastest pace through the forecast period.

The global RNA therapeutics market is segmented into four major regions, namely, North America, Europe, the Asia Pacific, and the Rest of the World. Europe is the largest regional market for RNA therapeutics. The US has emerged as the key revenue contributor to the North American market. The gene editing space has attracted significant investments and funding from venture capitalists, government agencies, and private entities in the US. This funding has fueled R&D efforts and the translation of gene editing technologies into commercial applications. The availability of capital has facilitated the growth of RNA therapeutic manufacturers, rendering the fastest growth to this region.

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The global RNA therapeutics market is consolidated, with Moderna, Inc. (US), Alnylam Pharmaceuticals, Inc.(US), and Pfizer Inc.  (US) emerging as the top 3 players of the global market. Players such as Novartis AG(Switzerland), Ionis Pharmaceuticals, Inc.(US), Sarepta Therapeutics, Inc.(US), Sanofi(France), Arrowhead Pharmaceuticals, Inc.(US), BioNTech SE (Germany), Orna Therapeutics (US), CRISPR Therapeutics(Switzerland), Silence Therapeutics (UK), Astellas Pharma Inc. (Japan), CureVac SE  (Germany), Sirnaomics  (US), Arcturus Therapeutics Inc. (US) and Arbutus Biopharma  (US) are some of the prominent players in the market.

Scope of the RNA Therapeutics Industry:

This research report categorizes the RNA therapeutics market to forecast revenue and analyze trends in each of the following submarkets:

By Product

• Vaccines
• Drugs

By Type

• mRNA Therapeutics
• RNA Interference (RNAi) Therapeutics
• Antisense Oligonucleotide (ASO) Therapeutics
• Other Therapeutics

By Indication

• Infectious Diseases
• Rare Genetic Diseases/Hereditary Diseases
• Other Indications

By End User

• Hospitals and Clinics
• Research Settings

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • UK
  • France
  • RoE
• Asia Pacific
  • China
  • South Korea
  • Japan
  • RoAPAC
• Rest of the World

Recent Developments of RNA Therapeutics Industry

• In February 2023, Moderna, Inc. received authorization from Health Canada for its COVID-19 booster vaccine, mRNA-1273.214 (SpikevaxBivalent Original/Omicron). This vaccine is designed for immunization against COVID-19 in children and adolescents between 6 to 17 years.
• In January 2023, the US FDA granted Breakthrough Therapy Designation for Moderna’s investigational mRNA vaccine candidate—mRNA-1345. This vaccine was developed to prevent RSV-associated lower respiratory tract disease (RSV-LRTD) in adults aged 60 years or older.
• In September 2022, Alnylam Pharmaceuticals, Inc. received marketing authorization from the European Commission for its RNAi therapy—AMVUTTRA. This treatment is developed for adult patients with stage 1 or stage 2 polyneuropathy, which is hereditary transthyretin-mediated (hATTR).

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