Global RNA Therapeutics Market

The market size of global RNA therapeutics market is valued at USD 1.2 billion in the year 2020. It is expected to grow at the CAGR of 28.4% within the forecasted time horizon of 2020-2025 because of growing prevalence of chronic diseases & viral infections, rise in development of the mRNA-based vaccines, high target affinity of RNA therapeutics and rising investment in RNA therapeutics.

However, safety issues associated with the use of the RNA therapy and the high cost of the RNA therapeutics might restrain the growth and development of this market. Its market value will reach USD 4.12 billion by the year 2025.

Definition / Scope
Market Overview
Market Risks
Top Market Opportunities
Market Drivers
Market Restraints
Industry Challenges
Technology Trends
Pricing Trends
Regulatory Trends
Market Size and Forecast
Market Outlook
Distribution Chain Analysis
Competitive Landscape
Competitive Factors
Key Market Players
Strategic Conclusion
References
Appendix

Definition / Scope

RNA is the versatile molecule with a capacity to regulate gene expression and is relatively easy to manufacture and can act on undruggable targets. RNA therapeutics is the field of next-generation biological drugs concerned with delivering functional RNA at a target. This type of therapeutics is of fragile nature and large in size. The new concepts applicable in this sector are small activating RNA, self-amplifying RNA, mRNA-based expression of Cas 9 gene editing tool and monoclonal antibodies.

The major benefits of this therapeutics are effective delivery of RNA molecules to targeted cells, activation of RNA molecules and specificity without stimulating immune response. This RNA therapeutics market is concerned with the sale of the antisense and RNA interference therapeutics products and related services.

Based on technology, the global RNA therapeutics market is comprised of RNA interference and Antisense RNA.

As per the application of the global RNA therapeutics market is considered, the global RNA therapeutics market consists of oncology, cardiovascular, respiratory disorders, renal disease, neurodegenerative disorders, genetic disorders, infectious diseases and others.

Based on the route of administration, the global RNA therapeutics market is comprised of pulmonary delivery, intravenous injections, intradermal injections, intraperitoneal injections, topical delivery, and others.

Market Overview

The total market size of the global RNA Therapeutics market is valued at USD 1.2 billion in the year 2020 and is expected to reach USD 1.53 billion in the year 2021. Its market value is expected to grow at a CAGR of 28.4 % within the forecasted time horizon of 2020-2025. Its market value is expected to reach USD 4.12 billion by the end of the year 2025.

Based on geography, the North American region is leading the global RNA Therapeutics market with a market share of almost 38.88% of the total global RNA Therapeutics market. The market size of this region is valued at USD 0.46 billion in the year 2020.

Based on the technology type, the RNA Interference segment is leading the market with a market share of almost 52.94% of the total global RNA therapeutics market. The market size of this segment is valued at USD 0.63 billion in the year 2020.

Based on the type of application, the oncology segment is leading the market with a market share of almost 19.44% of the total global RNA therapeutics market. The market size of this segment is valued at USD 0.23 billion in the year 2020.

Based on the route of administration, the pulmonary delivery is leading the market with a market share of almost 27.5% of the total global RNA therapeutics market. The market size of this segment is valued at USD 0.33 billion in the year 2020.

Growing prevalence of chronic diseases & viral infections, rise in development of the mRNA-based vaccines, high target affinity of RNA therapeutics and rising investment in RNA therapeutics are the factors responsible for the growth and development of the global RNA therapeutics market. However, safety issues associated with the use of the RNA therapy and the high cost of the RNA therapeutics might restrain the growth and development of this market.

The key market players engaged in the operation of this global RNA therapeutics market are Alnylam Pharmaceuticals Inc., Benitec Biopharma Limited, Cenix BioScience GmbH, Dicerna Pharmaceuticals, Genzyme Corporation, ISIS pharmaceuticals, Quark Pharmaceuticals, Silence Therapeutics, etc.

Market Risks

Safety issues associated with the use of RNA therapeutics

The clinical trials involving the application of the RNA interference and anti-sense technology are ongoing for the treatment of the multiple number of the infectious and non-communicable diseases. However, its use has raised the certain number of the concerns regarding its safety.

For instance, a study conducted among the mice has recorded the deaths of the mice after the po1 III promoter expression of shRNAs in their liver. It has been expected that the mortality of the mice has been due to the saturation of the transport factor that conveys miRNAs from the nucleus to cytoplasm. The safety issue associated with the application of the RNA therapeutics might restrain the growth and development of the global RNA therapeutics market.

Top Market Opportunities

The factors creating a significant opportunity for the growth and development of the global RNA therapeutics market are growing prevalence of chronic diseases & viral infections, rising investment in RNA therapeutics, growing interest of pharmaceuticals and biotech companies towards novel delivery technology, and high target affinity of the RNA therapeutics. The major opportunities of the major RNA therapeutics market are discussed as follows:

Growing prevalence of chronic diseases & viral infections

Globally, the incidences and deaths from the chronic diseases are in rising trend. The major chronic diseases are cardio-vascular disease, cancer, COPD, diabetes, and others. For instance, almost 1.8 million deaths were occurred from lung cancer and 17.9 million deaths are occurred from the cardiovascular disease globally. It has been estimated that about 700 million people will be living with diabetes globally by the year 2045.

According to the National Institute of Environmental health Sciences, Alzheimer’s and Parkinson’s disease is the most common neuro-degenerative diseases affecting millions of people globally. In the context of the United States, almost 930,000 people are expected to be suffered from Parkinson’s disease by the end of the year 2020.

The incidences and extend of the novel viral infections have increased drastically. For instance, the respiratory syncytial virus is known to cause respiratory tract infections among almost 300,000 people in the United States annually. Among this, almost 120,000 children are hospitalized from these infections every year. Similarly, the pandemic outbreak of novel corona virus is also prevailing since December 2019. The benefits of the RNA therapeutics for the treatment of the rising chronic diseases and viral infections is creating a significant opportunity for the growth and development of the global RNA therapeutics market.

High target affinity of RNA therapeutics

The RNA-based therapeutics has the capacity to target the nucleic acids rather than protein molecules. Because of this, the scope of the druggable targets can be extended and achieved through the use of the small molecules and biologics. Along with this, they are able to catalyze the peptide bond formation and recognize the small-molecule ligands. As a result, the use of the RNA-based therapeutics for the treatment of the chronic neurogenerative and mental health disorders and for the development of the vaccines is rising. It is creating a significant opportunity for the growth and development of the global RNA therapeutics market.

Market Drivers

Rising investment in RNA therapeutics

The investment from the private and governmental organizations is increasing at the global level. For instance, the National Institute of health provided the funds for research related to the RNA therapeutics. California Institute of Regenerative Medicine and ALS Association are involved in conducting trials by funding the research institutes and pharmaceutical organizations. In 2018, Curamir Therapeutics received the financial aid of almost 10 million from Delos Capital to develop the miRNA-based drugs for chemotherapy-resistant cancer.

The Alnylam Pharmaceuticals and Regeneron Pharmaceuticals has invested almost USD 1 billion to develop the platform for the treatment of the diseases associated with eye, central nervous system and liver. Dicerna Pharmaceuticals receives about USD 25 million annually in collaboration from Novo Nordisk for the product development. So, the rising investment in the sector of RNA therapeutics is creating a significant opportunity for the growth and development of the global RNA therapeutics market.

Rise in development of the mRNA-based vaccines

The pandemic outbreak of novel corona virus has also surged the rollout campaign for the development of the mRNA-based vaccines for its prevention and control. At present, the mRNA based COVID-19 vaccines approved for the emergency use are Pfizer-BioNTech and Modern. Here, more than 95 countries have approved the use of the Pfizer-BioNTech vaccine for the prevention and control of COVID-19 disease.

Similarly, this type of vaccines is used for the prevention and control of other viral diseases such as influenza, Polio, etc. BioNTech AG has collaborated with the Pfizer to conduct the research and development for the development of the Messenger RNA-based influenza vaccines. Thus, the rise in the development of the mRNA-based vaccines is driving the growth and development of the global RNA therapeutics market.

Market Restraints

High cost of therapy

The cost of the development of the RNA therapeutics is quite high. For instance, the cost of the development of the oligo siRNA is about USD 120 each. According to Future Medicine, the price of Onpattro (RNA interference-based drug) is about USD 450,000 per year.

Onpattro is used for the treatment of the polyneuropathy of hereditary transthyretin mediated amyloidosis in adults. It might be due to the strict regulations, long product approval process, high development cost and small number of patients. The high cost of the RNA therapeutics might restrain the growth and development of the global RNA therapeutics market.

Industry Challenges

Highly Fragmented market

Majority of the proportion of the market size of the global RNA Therapeutics market are accounted by the large number of the market players engaged in it. The major market players engaged in this market are Alnylam Pharmaceuticals Inc., Benitec Biopharma Limited, Cenix BioScience GmbH, Dicerna Pharmaceuticals, Genzyme Corporation, ISIS pharmaceuticals, Quark Pharmaceuticals, Silence Therapeutics, etc. Here, the top three key market players account for almost 35% of the total market value of the global RNA therapeutics market. It is quite challenging for the market players to establish their market value in this market.

Technology Trends

Adoption of new and advanced technologies is creating a favorable environment for the growth and development of the global RNA therapeutics market. Based on the type of technology, this market consists of enabling technologies and enabled technologies.

Here, the enabling technologies consists of Microarrays, labeling, purification, linear amplication, qRT-PCR & Inhibition while the enabled technologies consist of RNA interference technology, and RNA antisense technology.

Some of the key technological trends in this global RNA therapeutics market are discussed as follows:

RNA Interference Technology: This technology works by causing destruction of specific mRNA molecules and this mechanism is triggered by double stranded RNA causing the gene silencing in a sequence-specific manner.

RNA Antisense Technology: This technology is used for the inhibition of gene expression and prevent the nucleic acid sequence base pairs from being translated into a protein.

SMART Technology: It is the emerging technology used to recode a specific pre-mRNA by suppressing cis-splicing. It enables the gene expression repair in skin gene therapy.

Pricing Trends

The price of the products of this RNA therapeutics market depends upon the type of technology, product type, application, unit of RNA molecules and others. For instance, the cost of the development of the oligo siRNA is about USD 120 each while the cost of the development of the 21-mer siRNA duplex is about USD 130.

According to Future Medicine, the price of Onpattro, RNA interference-based drug, is about USD 450,000 per year for the treatment of the polyneuropathy of hereditary transthyretin mediated amyloidosis in adults.

Regulatory Trends

Some of the regulations directly or indirectly related to the global RNA therapeutics market are discussed as follows:

Human Gene Therapy for Rare Diseases, Guidance for industry: The guidance was developed by the FDA in 2020 which provides the recommendations for the development of the human gene therapy-based products to treat a rare disease in adults and pediatric patients to the sponsors.

Manufacturing considerations for Licensed & Investigational Cellular & gene therapy products: This guidance was developed in January 2020 to provide the risk-based recommendations to minimize the transmission of the novel corona virus for the manufacturers of the licensed and investigational cellular and gene therapy.

Market Size and Forecast

Based on geography

The North American region is leading the global RNA Therapeutics market with a market share of almost 38.88% of the total global RNA Therapeutics market. The market size of this region is valued at USD 0.46 billion in the year 2020.
The European segment accounts for a market share of almost 27.77% of the total market size of Global RNA Therapeutics Market. The market size of this region is valued at USD 0.33 billion in the year 2020.
The APAC segment accounts for a market share of almost 16.66% of the total market size of Global RNA Therapeutics Market. The market size of this region is valued at USD 0.2 billion in the year 2020.

Based on the technology type

The RNA Interference segment is leading the market with a market share of almost 52.94% of the total global RNA therapeutics market. The market size of this segment is valued at USD 0.63 billion in the year 2020.
The segment accounts for the market with a market share of almost % of the total global RNA therapeutics market. The market size of this segment is valued at USD billion in the year 2020.

Based on the type of application

The oncology segment is leading the market with a market share of almost 19.44% of the total global RNA therapeutics market. The market size of this segment is valued at USD 0.23 billion in the year 2020.
The cardiovascular segment accounts for the market with a market share of almost 18.88% of the total global RNA therapeutics market. The market size of this segment is valued at USD 0.22 billion in the year 2020.
The respiratory disorders segment accounts for the market with a market share of almost 16.66% of the total global RNA therapeutics market. The market size of this segment is valued at USD 0.2 billion in the year 2020.
The renal disease segment accounts for the market with a market share of almost 16.94% of the total global RNA therapeutics market. The market size of this segment is valued at USD 0.20 billion in the year 2020.
The neurodegenerative disorders segment accounts for the market with a market share of almost 10.55% of the total global RNA therapeutics market. The market size of this segment is valued at USD 0.12 billion in the year 2020.
The genetic disorders segment accounts for the market with a market share of almost 8.33% of the total global RNA therapeutics market. The market size of this segment is valued at USD 0.1 billion in the year 2020.
The infectious diseases segment accounts for the market with a market share of almost 5% of the total global RNA therapeutics market. The market size of this segment is valued at USD 0.06 billion in the year 2020.

Based on the route of administration

The pulmonary delivery is leading the market with a market share of almost 27.5% of the total global RNA therapeutics market. The market size of this segment is valued at USD 0.33 billion in the year 2020.
The intravenous injections segment accounts for a market share of almost 18.06% of the total market size of the global RNA therapeutics market. The market size of this segment is valued at USD 0.21 billion in the year 2020.
The Intradermal injections segment accounts for a market share of almost 16.38% of the total market size of the global RNA therapeutics market. The market size of this segment is valued at USD 0.19 billion in the year 2020.
The intraperitoneal injections segment accounts for a market share of almost 11.11% of the total market size of the global RNA therapeutics market. The market size of this segment is valued at USD 0.13 billion in the year 2020.
The topical delivery segment accounts for a market share of almost 5% of the total market size of the global RNA therapeutics market. The market size of this segment is valued at USD 0.06 billion in the year 2020.

Market Outlook

The global RNA therapeutics market is expected to grow at the CAGR of 28.4% within the forecasted time horizon of 2020-2025 because of growing prevalence of chronic diseases & viral infections, rise in development of the mRNA-based vaccines, high target affinity of RNA therapeutics and rising investment in RNA therapeutics. Its market value will reach USD 4.12 billion by the year 2025.

Impact of COVID-19 on Global RNA therapeutics market

The pandemic situation of the COVID-19 disease all across the globe has affected the global RNA Therapeutics market during the preliminary phase of the outbreak in the year 2019 and early 2020 as the social mobility restrictions and lockdown measures were adopted for the prevention & control of its transmission.

However, the situation of the market for the RNA therapeutics is quite different at the later phase of the pandemic outbreak. The focus & investment of the research and development agencies has shifted towards the development of the mRNA-based vaccines for the prevention and control of the novel corona virus, which has flourished the growth and development of the global RNA therapeutics market.

Distribution Chain Analysis

The key stakeholders involved in the operation of this global RNA therapeutics market are research & development organizations, approving authorities, product manufacturers, distributors, sales, and end-users. At first, the research and development activities are conducted for the development of the RNA therapeutics-based products. Once the clinical trails are completed and the product is approved, it is available for the end-users.

Competitive Landscape

The major market players engaged in this market are Alnylam Pharmaceuticals Inc., Benitec Biopharma Limited, Cenix BioScience GmbH, Dicerna Pharmaceuticals, Genzyme Corporation, ISIS pharmaceuticals, Quark Pharmaceuticals, Silence Therapeutics, etc. Here, Calando Pharmaceuticals is leading the global RNA therapeutics market accounting for a market share of almost 14% of the global RNA therapeutics market followed by Bio-path Holdings (11%) and Glaxo Smith (10%).

Competitive Factors

The key market players engaged in this market are competing for the product portfolio expansion, high investment in research and development activities, mergers & acquisitions, geographical expansion, and collaborations.

The Medicines Company (US-based Company) has focused on the development of RNA drug inclisiran for the treatment of Renal impairment and cardiovascular diseases. For instance, ISIS pharmaceuticals Inc has focused its research activities on antisense technology and developed antisense therapeutics entitled Mipromersen and Fomivirsen.

In August 2020, Blackstone Life Sciences (global investment company) has established financial collaboration of almost USD 2 billion with Alnylam Pharmaceuticals Inc (RNAi therapeutics Company) to accelerate the development of RNAi therapeutics. Along with this, Biogen and Lonis has collaborated to develop the antisense drug candidates for neurological diseases.

Key Market Players

Short profile of the key market players engaged in the global RNA therapeutics market are discussed as follows:

Calando Pharmaceuticals: It is the US-based company engaged in the development of the clinical stage nanobiotechnological and nanoparticle therapeutics. It has developed the proprietary technology to create siRNA-based therapeutics.

Alnylam Pharmaceuticals Inc.: It is theUK-based biopharmaceutical company specialized in the development and commercialization of RNA interference therapeutics for genetically defined diseases.

Benitec Biopharma Limited: It is the Australia-based biotechnological company specialized in the development of the gene-silencing therapies for the treatment of the chronic and life-threatening diseases.

Cenix BioScience GmbH: It is the German-based research organization engaged on the discovery and pre-clinical development of the novel therapeutics and RNA interference gene silencing in vitro and vivo environment.

Dicerna Pharmaceuticals: It is the US-based biopharmaceutical company engaged in the development of the medicines based on the RNA interference.

Strategic Conclusion

The global RNA therapeutics market is growing at the CAGR of 28.4% within the forecasted time horizon of 2020-2025 because of growing prevalence of chronic diseases & viral infections, rise in development of the mRNA-based vaccines, high target affinity of RNA therapeutics and rising investment in RNA therapeutics. However, safety issues associated with the use of the RNA therapy and the high cost of the RNA therapeutics might restrain the growth and development of this market.

References

Appendix

COPD= Chronic Obstructive pulmonary disease
USD= United States Dollar
CAGR= Compound Annual Growth Rate