Northbrook, IL 60062 -- (SBWIRE) -- 10/18/2023 -- The RNA therapeutics industry is poised for a transformative surge in the near future. Breakthroughs in mRNA vaccine technology, exemplified by the rapid development of COVID-19 vaccines, have catapulted RNA-based therapies into the spotlight. This momentum is expected to continue, with RNA therapeutics emerging as a promising modality for treating a wide range of diseases, including cancer, genetic disorders, and rare diseases. With ongoing research and investments in RNA delivery systems, safety profiles, and target-specific therapies, the industry is on the cusp of providing innovative, personalized treatments that can revolutionize healthcare. As regulatory pathways become more defined and manufacturing processes more efficient, we can anticipate a flourishing RNA therapeutics landscape that holds the potential to reshape the future of medicine, offering new hope to patients worldwide.

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 according to a new report by MarketsandMarkets™. 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. The emergence of small activating RNAs (saRNAs) and circular RNAs (circRNAs) has expanded the scope of RNA therapeutics. saRNAs are 21-nucleotide long double-stranded RNAs (dsRNAs) complementary to the promoter region of a targeted gene. They can upregulate gene expression, potentially correcting deficiencies associated with genetic disorders and re-activating tumor suppressor genes in multiple types of cancers. On the other hand, the discontinuation/recalls of RNA therapeutic products is expected to hinder market growth.

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Key Market Players:

The prominent players in the global RNA therapeutics market include 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).

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

Based on product, the RNA therapeutics market is segmented into drugs and vaccines. In 2022, vaccines represented majority of the market share and is anticipated to maintain this dominance throughout the forecast period. Two key vaccine products that have showcased majority revenue contribution in this segment, include Spikevax (Moderna, Inc.) and Comirnaty (Pfizer, Inc.) vaccines. Additionally, these COVID-19 vaccines showcased a considerable revenue growth between from 2021 and 2022. On the other hand, the recent recall/discontinuation of Spikevax (Moderna, Inc.) is anticipated to hinder the revenue growth post 2022. Increase in the development of innovative RNA medicine companies in the RNA therapeutics market has rendered it the fastest growing segment during the forecast period.

The RNA interference (RNAi) therapeutics segment is expected to grow at the highest CAGR from 2023 to 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. Factors associated with RNA interference (RNAi) therapeutics such as precision and versatility have increased the potential of RNAi applications in personalized medicine and other clinical applications. On the other hand, the mRNA therapeutics segment accounted for the highest share in the global market in 2022 and is expected to maintain this trend through 2021-2028. The advantages of mRNA over DNA or proteins/peptides coupled with advent of novel vaccine and molecular entities are the key attributive reason to this dominance.

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

Based on the indication, the RNA therapeutics market is segmented into infectious diseases, rare genetic diseases/hereditary diseases, and other indications. The large share of the infectious diseases segment is a result of the rapid developments in RNA vaccine manufacturing capabilities for the treatment of infectious diseases along with the outbreak of COVID-19. Demand for mRNA vaccines grew significantly through 2021-2022, for immunization against SARS-COV-2 infection.

Increase in the use of RNA-based therapeutics for the treatment of rare/genetic disorders contributes to the high share of hospitals & clinics.

The RNA therapeutics market is segmented into hospitals and clinics and research settings. 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.

Europe dominates the global RNA therapeutics market throughout 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 leads the market for RNA vaccines, with highest share of revenue in this segment in 2022. North America has emerged as the fastest growing region from 2023 to 2028. The collective revenue share of Europe, across both RNA vaccines and RNA drugs is highest in 2022, and this is set to continue through the forecast period.

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RNA Therapeutics Market Dynamics:

Drivers:

- Increasing partnerships and collaborations among market players and RNA technology manufacturers

Restraints:

- Discontinuation or recalls of RNA therapeutic products

Opportunities:

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

Challenge:

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

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RNA Therapeutics Market Advantages:

- Precision Medicine: RNA-based therapies can be tailored to target specific genetic mutations or disease pathways, allowing for personalized treatments that are more effective and have fewer side effects.
Speed of Development: The rapid development of RNA-based vaccines during the COVID-19 pandemic demonstrated the agility of this technology, which can potentially accelerate the response to emerging diseases and medical challenges.

- Versatility: RNA can be engineered to address a wide range of diseases, including genetic disorders, cancer, infectious diseases, and rare diseases, making it a versatile platform for therapeutic development.

- Reduced Off-Target Effects: Compared to traditional small molecule drugs, RNA therapies can have a higher degree of specificity, minimizing off-target effects on healthy cells and tissues.

- Lower Manufacturing Costs: Advances in RNA synthesis and production techniques are driving down manufacturing costs, potentially making RNA therapies more accessible and affordable.

- Targeting Undruggable Proteins: RNA therapeutics can target proteins that were previously considered "undruggable" with small molecules, expanding the range of potential drug targets.

- Potential for Gene Editing: RNA-based therapies, such as CRISPR-Cas9, hold promise for precise gene editing and the treatment of genetic diseases at their root cause.

- Immunomodulation: RNA molecules can be designed to stimulate or inhibit immune responses, making them valuable tools in the treatment of autoimmune diseases and for enhancing cancer immunotherapies.

- Reduced Development Risk: The ability to rapidly iterate and optimize RNA therapies in preclinical and clinical stages can reduce the risks associated with drug development.

- Therapeutic Innovation: RNA therapeutics represent a novel class of drugs that can complement existing treatment modalities, offering innovative solutions to unmet medical needs.

These advantages highlight the transformative potential of RNA therapeutics in advancing healthcare and improving patient outcomes in the near future.

Recent Developments:

- 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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