According to the latest research by Nova one advisor, the global RNA therapy clinical trials market is valued at USD 2.85 Billion in 2024, and it is expected to reach USD 4.16 Billion by 2034, with a CAGR of 3.85% during the forecast period of 2024-2034.
RNA Therapy Clinical Trials Market Key Takeaways:
· The rare diseases segment dominated the global market with a revenue share of more than 21.0% in 2024.
· The anticancer segment is expected to grow at the fastest CAGR during the forecast period.
· The messenger RNA segment held a major revenue share of over 35% in 2024.
· The phase II segment held a major revenue share of over 42% in 2024.
· North America dominated the RNA therapy clinical trials market with a share of 36.58% in 2024.
· Asia Pacific is expected to experience maximum growth over the forecast period with a CAGR of 4.51%.
The Complete Study is Now Available for Immediate Access | Download the Sample Pages of this Report@ https://www.novaoneadvisor.com/report/sample/8994
RNA therapeutics has shown a promising future in clinical therapeutics owing to its high target specificity, versatility, ease of production and safety with minimal side effects. The global surge in a multitude of preclinical and clinical trials for RNA-based therapies, huge investments in R&D, rising participation of volunteers, advancements in gene editing technologies and therapies, use of genomic tools for mapping demographic data, demand for novel therapies and increasing support from government bodies are majorly driving the growth of RNA therapy clinical trials market.
RNA is a genetic material similar to DNA which plays an essential role various cellular processes such as transcription and translation of genetic information, delivery of genetic instructions, protein synthesis, regulation of cellular activities and many more. RNA therapies utilize pieces of RNA for interacting with messenger RNA (mRNA) in cells thereby influence the genetic processes ultimately making them a key player in compensating effects of genetic alteration. Some of the RNA therapies under clinical investigation include mRNA vaccines, antisense oligonucleotides (ASO), small interfering RNA (siRNA), aptamers and RNAi.
One of the major promoters of the RNA-based therapies is the COVID-19 pandemic which paved way for the RNA therapy clinical trials market after the launch of mRNA vaccines for COVID-19 prevention. The success of these mRNA vaccines intrigued researchers and industries worldwide to step into the RNA therapy clinical trials market which boosted the growth of this market.
Furthermore, the integration of artificial intelligence (AI) and machine learning tools has significantly accelerated the development process of RNA therapies by analysing vast genomic and transcriptomic data for identifying optimal RNA targets, for predicting suitable delivery mechanisms, developing personalized RNA therapies, patient stratification, real-time data monitoring and optimizing vaccine designs ultimately improving patient life outcomes and fuelling the market growth of RNA-based therapies.
· For instance, in April 2023, Moderna Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, entered into an agreement with IBM. This collaboration will aid Moderna to explore next generation technologies including quantum computing skills and artificial intelligence to advance and accelerate future mRNA medicines.
RNA Therapy Clinical Trials Market Trends
· Rise in Clinical Trials Across the Globe: The increasing number of registration cohorts in RNA therapy clinical trials, accelerated approvals from regulatory agencies and rising awareness about the safety, efficacy and advancements in RNA technology across the globe is expanding the market for RNA-based therapeutics.
· Technological Innovations and Support from Regulatory Bodies: The rapid advancements in RNA-based therapies are transforming the healthcare landscape. The development of novel techniques for effectively delivering bioactive RNA molecules effectively for treatment for rare diseases and the rising support from regulatory agencies worldwide with fast track designation and accelerated approvals for new therapies associated with RNA are helping to improve patient life outcomes.
RNA Therapy Clinical Trials Market Report Scope
|
Report Attribute |
Details |
|
Market size value in 2025 |
USD 2.67 billion |
|
Revenue forecast in 2034 |
USD 3.5 billion |
|
Growth rate |
CAGR of 3.84% from 2024 to 2034 |
|
Base year for estimation |
2024 |
|
Historical data |
2019 - 2023 |
|
Forecast period |
2024 - 2034 |
|
Quantitative units |
Revenue in USD million/billion and CAGR from 2024 to 2034 |
|
Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
|
Segments covered |
Modality, Phase, Therapeutic Areas, Region |
|
Regional scope |
North America; Europe; Asia Pacific; Latin America; MEA |
|
Country scope |
U.S.; Canada; UK; Germany; France; Italy; Spain; Sweden; Norway; Denmark; India, Japan, China, Australia, South Korea, Thailand; Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE; Kuwait |
|
Key companies profiled |
IQVIA; ICON Plc; Laboratory Corporation of America Holdings; Charles River Laboratories International, Inc.; PAREXEL International Corp.; Syneos Health; Medpace Holdings, Inc.; PPD Inc.; Novotech; Veristat, LLC. |
|
Customization scope |
Free report customization (equivalent up to 8 analyst’s working days) with purchase. Addition or alteration to country, regional & segment scope. |
Advantages of RNA Therapy Clinical
Trials RNA therapy represents a groundbreaking
advancement in medical science, offering unique approaches to treating a
variety of diseases. Clinical trials for RNA therapies provide numerous
benefits, highlighting their potential to revolutionize healthcare. One of the primary advantages of RNA
therapy is its precision targeting. These therapies can be designed to
interact with specific genes or molecular pathways, making them highly
effective for treating genetic disorders, cancers, and infectious diseases.
Unlike traditional therapies, RNA-based treatments focus on the underlying
cause of a condition at the molecular level, rather than just managing
symptoms. Another major benefit is the rapid
development process. RNA therapies, such as mRNA vaccines, can be designed,
tested, and produced much faster than conventional treatments. This was demonstrated
during the COVID-19 pandemic, where mRNA vaccines were developed and deployed
in record time, showcasing the agility of RNA-based solutions in addressing
public health crises. RNA therapy also offers broad
therapeutic potential. It can be utilized for various purposes, including
gene silencing, protein replacement, and gene editing. For example, small
interfering RNA (siRNA) and antisense oligonucleotides can inhibit harmful gene
expression, while mRNA therapies can instruct cells to produce missing or
defective proteins. Additionally, RNA delivery systems are advancing rapidly,
enabling precise and effective treatment with minimal side effects. One of the most significant advantages is
the non-permanent nature of RNA therapies. Unlike DNA-based gene
therapies, RNA does not integrate into the genome, reducing the risk of
unintended long-term effects. This transient nature makes RNA therapies safer
and more manageable for many patients. RNA therapies are also highly
customizable, making them ideal for personalized medicine. Treatments can
be tailored to address specific genetic mutations or individual patient needs,
offering hope for rare and previously untreatable diseases. Furthermore, these
therapies are minimally invasive, with many being delivered via
injection or intravenously, enhancing patient comfort and compliance. Finally, the platform technology
underlying RNA therapies allows for scalability and versatility. Once the
foundational delivery systems are in place, they can be adapted to create
treatments for various diseases by altering the RNA sequence. This efficiency
significantly reduces development time and costs for new therapies. In conclusion, RNA therapy clinical trials
represent a transformative leap in medicine. With their precision, versatility,
and scalability, these therapies hold immense promise for addressing complex
diseases and paving the way for personalized and effective treatments. Segment Insights By Modality Insights The messenger RNA segment held a major
revenue share of over 35% in 2024. Owing to its numerous benefits such as
safety, precision, ease of production and versatility to treat a wide range of
diseases has proven mRNA therapy as a promising option for treating rare
genetic disorders. Also the rapid progress in the development of mRNA vaccines
for COVID-19 saving millions has significantly accelerated the development and
applications of mRNA based therapies and vaccines. Furthermore, the rising
investments for R&D of mRNA-based therapies and collaborations among
industries and research organizations are fuelling the market growth of this
segment. ·
For instance, in April 2023, Sanofi, a global
healthcare company announced funding of $25 million for five years to the lab
of MIT Professor Daniel Anderson supporting the lab’s research for developing
next-generation delivery technology for mRNA. The RNA interference (RNAi) segment is
expected to show fast growth over the forecast period. RNAi technique utilizes
double-stranded RNA (ds RNA) for activating cellular pathways which silence
genes with similar homology to the double strand thereby inhibiting gene
expression. Owing to the various advantages of this technique such as high
specificity, targeting any gene in the genome and administration through
multiple routes has made this a popular option for treating viral infections, hepatitis
and cancer. With ongoing R&D for delivering RNAi more effectively
and reducing the risk of mutational escape are factors expected to boost the
market growth of this segment. ·
For instance, in a study published by Taylor
& Francis journal in Dec 2023 demonstrated a Bmi-1 RNAi-based
chemotherapeutic strategy for inhibiting cancer stem cells and showing strong
potential for treating laryngeal cancer patients suffering from chemotherapy
resistance and tumorigenesis. By Phase Insights On the basis of phase trials, the phase II
segment held a major revenue share of over 42.0% in 2024.The increasing success
rates of preclinical and phase I clinical studies, rising investments in
R&D and the growing among patients about safety and efficacy associated
with RNA-based therapies are the major factors contributing to market growth of
this segment. ·
For instance, in Dec 2024, Descartes-08, an
investigational autologous mRNA-engineered chimeric antigen receptor T-cell
(CAR-T) therapy developed by Cartesian Therapeutics for the treatment of
autoimmune disorders such as myasthenia gravis (MG) has shown durable responses
during treatments in the phase 2b clinical trial (NCT04146051) for some
patients with MG. The phase I clinical trials segment is
anticipated to show the fastest growth over the forecast period owing to the
rising regulatory approvals, advancements in therapies, orphan drug designation
grants for rare diseases, increasing registration of cohorts in clinical trials
and sponsorships by public and private sectors for development of RNA-based
therapies are fuelling the growth of this segment. ·
For instance, in Dec 2024, Huida Gene
Therapeutics, a global clinical-stage biotechnology company developing
programmable genome medicines declared its initiation of the world’s first clinical
evaluation of a RNA-editing therapy by administering dose to the first patient
in the HERO clinical trial evaluating HG2024 for the treatment of MECP2
duplication syndrome (MDS) thereby making a breakthrough for this rare
neurodevelopmental disorder. By Therapeutic Areas Insights The rare diseases segment dominated the
global market with a revenue share of more than 21.0% in 2024. The rising
prevalence of rare diseases across the globe with no potential treatments and
cure for these diseases has captivated researchers and biopharmaceutical
industries worldwide to develop promising therapies using RNA technology for
improving patient life outcomes. Furthermore, the accelerated initiation of
registration cohorts in clinical
trials, numerous pipeline drugs and therapies and the recent
technological advancements are fuelling the market growth of this segment. ·
For instance, in June 2024, Avidity Biosciences
experimental RNA therapy for Facioscapulohumeral muscular dystrophy (FSHD)
which is rare, progressive, life-long muscle weakening condition has shown
promising results in reducing the expression of DUX4 mRNA and DUX4 protein in
muscles that causes this rare disease. Their proprietary monoclonal antibody
delpacibart braxlosiran or del-brax (AOC 1020) binds to the transferrin
receptor 1 (TfR1) conjugated with a siRNA targeting DUX4 mRNA. The U.S. Food
and Drug Administration (FDA) and the European Medicines Agency (EMA) have
granted orphan designation for del-brax and the FDA has granted del-brax fast
track designation. The anticancer segment is anticipated to
grow rapidly during the forecast period. With the recent developments in
RNA-based therapies for cancer treatment which utilize various types of RNAs
such as small interfering RNA (siRNA), micro RNA (miRNA) and mRNA for targeting
and inhibiting the expression, cell proliferation, invasion and metastasis of
specific genes vital for cancer cell growth and survival as well as blocking
tumour development by selectively silencing oncogenes or activating tumour
suppressor genes thereby significantly surpassing the traditional chemotherapy
treatments and minimizing the adverse effects associated with chemotherapy.
Additionally, the specificity, potential for tailoring personalized treatments
and the ability to target multiple pathways with RNA-based therapy is expected
to fuel the market growth of this segment over the forecast period. By Region North America dominated the RNA therapy
clinical trials market with a share of 36.58% in 2024. The presence of advanced
healthcare infrastructure, fast track designation and regulatory approvals from
the U.S. FDA for RNA therapies, ongoing R&D in various biopharmaceutical
industries, research institutions and the rising investments from public and
private sectors for developing a potential cure for rare disorders are the
factors promoting the market growth of this region. Furthermore, the rise in
success rates in clinical trials and increased participation of volunteers in
the trials are expanding the market for RNA-based therapeutics in this region. ·
For instance, in Sep 2024, Ractigen Therapeutics
received orphan drug designation (ODD) from the FDA for its investigational
small activating RNA (saRNA) which is currently under preclinical development
and will be used for treatment of Duchenne muscular dystrophy (DMD) and Becker
muscular dystrophy (BMD) caused by any mutation in the DMD gene. The Asia Pacific is anticipated to
experience maximum growth over the forecast period with a CAGR of 4.51%. Due to
the large demographic presence in this region and the increasing cases of rare
diseases, genetic disorders and chronic illnesses has been demanding the development
of safe and effective therapies for treatment which is leading the shift of the
biotech companies, academic institutes and research organizations towards
RNA-based therapies for improving patient life quality. Furthermore, the technological advancements,
rising investments in healthcare expenditure and growing support from
government bodies has shown a significant rise in conducting RNA therapy
clinical trials in this region which is expected to boost the market growth in
the upcoming years. Immediate Delivery is Available | Get
Full Report Access@ https://www.novaoneadvisor.com/report/checkout/8994
Related Report HIV Clinical Trials Market- The HIV
clinical trials market size was exhibited at USD 1.30 billion in 2024
and is projected to hit around USD 2.42 billion by 2034, growing at a CAGR of
6.4% during the forecast period 2024 to 2034. Europe Clinical Trials Market- The Europe
clinical trials market size was exhibited at USD 22.25 billion in 2024
and is projected to hit around USD 43.00 billion by 2034, growing at a CAGR of
6.81% during the forecast period 2024 to 2034. Pediatric
Clinical Trials Market- The pediatric
clinical trials market size was exhibited at USD 16.50 billion in 2023
and is projected to hit around USD 27.65 billion by 2033, growing at a CAGR of
5.3% during the forecast period 2024 to 2033. U.S. Clinical Trials Market- The U.S.
clinical trials market size was valued at USD 25.81 billion in 2023 and
is projected to surpass around USD 41.57 billion by 2033, registering a CAGR of
4.88% over the forecast period of 2024 to 2033. AI-based Clinical Trials Solution
Provider Market- The global AI-based
clinical trials solution provider market size was exhibited at USD 2.60
billion in 2023 and is projected to hit around USD 19.16 billion by 2033,
growing at a CAGR of 22.11% during the forecast period 2024 to 2033. Some of the prominent players in the RNA
therapy clinical trials market include: ·
IQVIA ·
ICON Plc ·
Laboratory Corporation of America Holdings ·
Charles River Laboratories International, Inc. ·
PAREXEL International Corp. ·
Medpace Holdings, Inc. ·
PPD Inc. ·
Novotech RNA Therapy Clinical Trials Market
Recent Developments ·
On 17 Dec 2024, Silexion Therapeutics Corp., a
clinical-stage biotech developing RNAi therapies for KRAS-driven cancers
declared its ongoing collaboration with Evonik, a global leader in specialty
chemicals. This collaboration aims at developing an advanced long-acting siRNA
PLGA microparticle formulation which has shown high potency for KRAS-mutated
cancers in preclinical models. ·
In Nov 2024, HuidaGene Therapeutics received the
first-ever FDA clearance of CRISPR/Cas13 RNA-Editing HG202 investigational new
drug (IND) application for neovascular age-related macular degeneration (nAMD)
which is the only clinical-stage RNA-targeting therapy for nAMD. ·
In Sep 2024, Carisma Therapeutics, a clinical
stage biopharmaceutical company developing innovative immunotherapies declared
the expansions of its in vivo chimeric antigen receptor macrophage and monocyte
(CAR-M) therapy collaboration with Moderna Inc., for developing therapies for
autoimmune diseases. ·
In June 2024, Ascidian Therapeutics, a company
developing RNA rewriting (or RNA exon editing) technology declared a research
collaboration and licensing agreement with Roche in which Ascidian will receive
$ 42 million in initial payment, and up to $ 1.8 billion in research, clinical
and commercial milestones. The collaboration aims using RNA Exon Editors with
Roche’s CNS delivery capabilities to developing novel therapies targeting
neurological diseases. Segments Covered in the Report By Modality ·
RNA interference ·
Antisense therapy ·
Messenger RNA ·
Oligonucleotide, non-antisense, non-RNAi By Clinical Trials Phase ·
Phase I ·
Phase II ·
Phase III ·
Phase IV By Therapeutic Areas ·
Rare Diseases ·
Anti-infective ·
Anticancer ·
Neurological ·
Alimentary/Metabolic ·
Musculoskeletal ·
Cardiovascular Respiratory ·
Sensory ·
Others By Regional ·
North America ·
Europe ·
Asia Pacific ·
Latin America ·
Middle East and Africa (MEA) Immediate Delivery Available | Buy This
Premium Research https://www.novaoneadvisor.com/report/checkout/8994
USA: +1 804 441 9344 APAC: +61 485 981 310 or +91 87933 22019 Europe: +44 7383 092 044 Email: sales@novaoneadvisor.com Web: https://www.novaoneadvisor.com/
You can place an order or ask any
questions, please feel free to contact at sales@novaoneadvisor.com |
+1 804 441 9344
