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December 2024
The global RNA based therapeutic market was evaluated at US$ 6.83 billion in 2023 and is expected to attain around US$ 40.81 billion by 2034, growing at a CAGR of 17.64% from 2024 to 2034. RNA based therapeutic market is growing because therapeutic RNA includes vaccines and proteins against infectious diseases and cancer. Synthetic RNA for therapeutics is usually transcribed in vitro (IVT) from DNA plasmids using bacteriophage RNA polymerase.
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RNA based therapeutic market is growing rapidly because in vitro transcribed (IVT) mRNA enters the cytoplasm and can be used for therapeutic protein replacement or immunization after entering the cytoplasm. This technique does not make genomic changes or carry genetic risks like DNA-based therapies. RNA-based therapies can broaden drug targets and are considered the most attractive therapeutic targets. RNA-based therapy was first used in diseases with positive effects, such as cancer, neurological diseases, and infectious diseases.
Recent advances in RNA technology have led to the approval of eight ASO, three siRNA, and two mRNA vaccines for COVID-19 under the Emergency Use Authorization scheme. Other drugs are also currently in preclinical or clinical trials. More advanced RNA-based therapies have also been developed recently. RNA therapeutics is a term used to describe the use of RNA-based molecules to alter biological pathways to treat certain diseases. Generally speaking, RNA sequences are essential for regulating the activity or function of their target molecules. Once the nucleic acid chemistry and delivery methods are established, developing RNA-based drugs targeting new targets can be accomplished quickly using traditional methods. This is expected to contribute to robust growth in the RNA based therapeutic market.
Artificial intelligence is transforming the biotechnology industry with applications in the RNA based therapeutic market as well. AI is being used in the industry to analyze large quantities of data including biological information that helps researchers identify new RNA targets and better predict the effects of different RNA-based therapies and drug applications. Machine learning is also being applied to process genomic and proteomic data to isolate and study genetic mutations and RNA molecules associated with various diseases. These new technologies are used to design and optimize sequences for better stability and efficiency. Predictive modelling is helping researchers identify new drug candidates early during development. The integration of AI technologies in RNA therapeutics has worked to enhance personalized and precision medicine. This can potentially revolutionize the treatment of cancers, viral infections and hereditary diseases.
RNA-based drugs have become a transformative force in the biopharmaceutical industry driven by their ability to target nearly any genetic component within cells, including those considered "undruggable" by traditional therapies such as small molecules and antibodies. This is especially true for non-coding RNAs, especially small ones often different from RNA sequences. Drugs such as antisense RNA and siRNA provide an unprecedented opportunity to target non-coding RNAs by working through specific binding. Given that the human genome contains more non-coding RNAs than proteins, and recent studies have shown that these play an important role in the pathogenesis of many diseases, the demand for RNA-based drugs will increase. The increasing interest and innovation in RNA therapy is causing the RNA based therapeutic market to expand, making it a major growth driver for the biopharmaceutical industry.
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A significant limitation to the growth of the RNA based therapeutic market lies in the problems associated with the delivery of RNA interference (RNAi) drugs, particularly small interfering RNA (siRNA). Similar to older oligonucleotide technologies such as antisense DNA and catalytic RNA, the efficient delivery of siRNA to target cells and tissues remains a major challenge. The negative charge and size of siRNAs hinder their ability to cross cell membranes, limiting their ability to reach the desired site of action in the body. This delivery challenge must be addressed for safe and effective in vivo application of RNAi-based therapies. Until solutions are found, these challenges will limit the widespread use and development of RNA-based therapeutics.
Advances in RNA-based therapeutics offer significant opportunities for treating and curing many human diseases by directly intervening in the underlying disease rather than simply reducing symptoms, as with conventional treatment. Although many therapeutic RNAs have entered clinical trials, a few have received FDA approval, and clinical results have been mixed; some have shown benefits, while others are ineffective or toxic. Despite these challenges, RNA therapeutics continues to gain medical traction, and their ability to revolutionize medicine for many diseases remains strong. Given the significant growth for companies and investors in this rapidly changing environment, there are many opportunities for the RNA based therapeutic market to grow, with the expansion of the RNA-based drug spectrum and the prospect of complementary therapies to come.
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The RNA based therapeutic market is experiencing robust growth globally, with North America leading the market, with North America leading the way by investing heavily in research, leading to new treatments and medical equipment. It also provides medical education that trains specialist physicians who can centrally manage patients as patient’s freedom of choice. As the United States develops policies and implements new healthcare models, health insurance and access to care continue to increase. The aging population will increase enrollment and costs in federal healthcare programs such as Medicare and Medicaid.
The market in the Asia Pacific is growing rapidly due to a number of reasons including recent advancements in the biotechnology and pharmaceutical research space. Countries such as China, Japan, and India are pledging significant investment in the development of innovative medical technologies. The growing prevalence of conditions such as cancer, viral infections and genetic disease is boosting further investment by both private and government entities. Changing regulatory frameworks around biomedical research in countries such as South Korea and Singapore is also leading to the gradual commercialization of RNA-based therapies. These factors are providing a conducive environment for growth of the market in the region.
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The RNA based therapeutic market in Asia Pacific is expected to witness significant growth during the forecast period. Asia Pacific will be the largest region in healthcare spending, and is expected to contribute over 20% of global funding by 2030. Asia’s consumer-driven digital health pool is expected to grow by 22%. Asia is poised for rapid changes in healthcare, driven by changing demographics, rising consumer expectations, and technological innovations. The healthcare sector in Asia Pacific has huge growth potential and innovative drivers. Government policies have also supported this growth. The “Healthy China 2030” initiative aims to expand the scale of the national health industry.
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By application, the RNA antisense segment led the RNA based therapeutic market in 2023. The growing recognition of RNA’s potential in treating diseases at the molecular level has driven momentum for RNA-based therapies overall, with RNA antisense technologies leading the way. The success of mRNA vaccines in the COVID-19 pandemic has also helped accelerate interest in RNA-based therapies.
The RNA interference (RNAi) technologies segment is the fastest growing application type in the RNA based therapeutic market. Such therapies can be tailored to specific targets, such as cancer, while sparing healthy cells. RNAi may provide a tool for the immune response against diseases caused by viruses and transposons by inducing an RNAi response.
By application, the genetic disorders segment held the largest share in the RNA based therapeutic market in 2023. RNA-based therapeutics can specifically target and correct genetic mutations at the RNA level, making them highly effective for treating genetic disorders such as cystic fibrosis, Duchenne muscular dystrophy (DMD), spinal muscular atrophy (SMA), and beta-thalassemia.
The success of mRNA vaccines for COVID-19 has highlighted the potential of RNA-based therapies in genetic medicine. mRNA therapies are being developed to replace defective proteins or correct genetic mutations, while RNAi therapies can silence harmful genes responsible for genetic diseases.
The research institutes segment held a significant share in RNA based therapeutic market in 2023. Increased funding for RNA research from government bodies and academic institutions has bolstered the efforts of research institutes, enabling them to advance their studies in RNA-based therapies. Research institutes play a pivotal role in developing novel RNA delivery systems, which are crucial for the successful therapeutic application of RNA-based treatments. Research institutes are at the forefront of exploring RNA-based therapies for a wide range of diseases, from cancer and genetic disorders to viral infections and rare diseases. Their ability to conduct early-stage research and clinical trials has significantly accelerated the development of RNA therapeutics.
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