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Oligonucleotide Therapy Market Overview
The global oligonucleotide therapy market size was valued US$ XX billion in 2022 and is estimated to reach US$ XX billion by 2030, growing at a CAGR of XX % during the forecast period (2023-2030).
Oligonucleotides are short-chain RNA, or DNA typically generated using automated synthesizers. Oligonucleotides therapy inhibits the expression of certain genes and their development with the raw chemical modified artificial nucleus acids.
Oligonucleotide Therapy Market Dynamics
Technological advancements in antisense technology are expected to drive the growth of the market.
According to the Journal of Biological Chemistry, antisense technology is undertaking to deliver on the broad promise of the technology. Ten RNA-targeted drugs, including eight single-strand antisense drugs (ASOs) and two double-strand ASOs (siRNAs), have now been approved for commercial use. The ASOs in phase 2/3 trials are innovative, delivered by multiple administration routes, and focused on rare and common diseases. Two ASOs are used in cardiovascular outcome studies and several others in very large trials. Interest in the technology continues to grow, and the field has been subject to a significant number of reviews. Thus, from the above statements, the technological advancements in antisense technology are expected to drive the market's growth.
The growing incidence of cancer is expected to drive the growth of the market
According to the American Cancer Society, in 2020, the number of new cancer cases and deaths is estimated at 1.8 million new cancer cases diagnosed and 606,520 cancer deaths in the United States. The rise in cancer cases leads to the demand for novel diagnostics, which is one of the major factors driving the market growth. Moreover, several factors, such as increased pollution and the adoption of a sedentary lifestyle, cause cancer, CVD, diabetes, and autoimmune diseases. The cancer rate has increased drastically in the last few years, and the need for novel therapeutics has increased simultaneously. Oligonucleotide therapeutics are gaining traction as they can produce a new class of nucleic acid probes known as aptamers, which are better probes than monoclonal antibodies. Thus, from the above statements, the growing incidence of cancer is expected to drive the market's growth.
The low number of drug approvals by the FDA is expected to hamper the growth of the market.
Due to the strict standards for manufacturing and high drug efficacy standards set by the regulatory bodies for approval of this therapy and thus increasing the time required for approval and limiting the market's growth. For instance, in January 2020, the market only had 11 drugs approved.
Oligonucleotide Therapy Market Industry Analysis
COVID-19 Impact Analysis
The COVID-19 pandemic has caused overwhelming challenges in healthcare worldwide. During such an outbreak, some high-risk groups who require regular follow-ups and long-term management are not met. Many biomedical companies are rising to the challenge and developing COVID-19 diagnostics. Some of these diagnostics have become commercially available for healthcare workers and clinical laboratories in the last few months. However, diagnostic technologies have specific limitations. Oligonucleotide-based therapies are advanced novel interventions to manage various respiratory diseases such as asthma and Chronic Obstructive Pulmonary Disease (COPD). Moreover, during this pandemic, substituting unnecessary clinic visits with virtual clinic services was highly recommended, if possible, without compromising clinical outcomes.
Additionally, it is expected that the market for Oligonucleotide therapy market will undergo impetus growth during the forecast period and continue to witness an excellent growth rate after the end of the pandemic.
Oligonucleotide Therapy Market Segment Analysis
Antisense Oligonucleotide is expected to hold the largest market share in this market segment.
The antisense oligonucleotide segment is expected to account for the largest share of the market in 2020. This segment's benefit is due to the optimization of enhanced delivery, specificity, affinity, and nuclease resistance with reduced toxicity. Antisense oligonucleotide (ASO) therapies have developed into a prominent class of therapeutics. Moreover, based on such molecules commercially available to the seven drugs, around 160 candidates are under development. For instance, recently approved antisense therapeutics include Viltepso, Vyondys 53 and Waylivra. They target the root cause of diseases at the protein expression level. These disease-modifying invasions have possible applications across a wide spectrum of therapeutic areas, including oncological disorders, neurodegenerative disorders, respiratory disorders, and certain rare genetic disorders.
Additionally, recent advances in antisense oligonucleotide chemistry have enabled the development and synthesis of specialized oligonucleotides, improving safety profiles and better cell targeting capabilities. These advanced variants of antisense oligonucleotide-based therapeutic competitors are assumed to possess the potential to provide to the unmet demand for effective treatment options for diseases that were previously considered difficult to treat. Thus, from the above statements antisense oligonucleotide segment is expected to hold the largest market share.
Neurodegenerative disorders segment is expected to hold the largest market share in this market segment.
The neurodegenerative disorders segment is expected to account for the largest share of the market in 2020. The aged population has an enhanced risk for degenerated nerves, which worsen with time. Alzheimer's disease is the most common neurodegenerative disorder. According to the article(frontiers), in 2020. Alzheimer's disease (AD) is a growing neurodegenerative disease characterized by memory loss, dramatic changes in character and behavior, and difficulty carrying out normal daily activities in the latter stages of the disease.
Moreover, Alzheimer's disease (AD) incidence increases with age and is shown to affect ~10% of people aged 65–75 and 32% of the elderly aged 80 and above. According to the World Health Organization (WHO) incidence of AD is worsening every year. Thus it is assumed that there could be a threefold increase in AD patients by 2050.
Additionally, AD is driven by collecting different forms of amyloid beta-peptide (Aß) in the brain leading to neuroinflammation, oxidative stress, mitochondrial dysfunction, dysregulation of enzyme systems, and neuronal death. Therefore, the growth in the aged population increases the number of individuals with Alzheimer's disease. Thus, from the above statements, the neurodegenerative disorders segment is expected to hold the largest market share.
Oligonucleotide Therapy Market Geographical Analysis
North America region holds the largest market share in the global oligonucleotide therapy market.
North America region is dominating the oligonucleotide therapy market accounted for the largest market share in 2020. The growth is attributed to the presence of the main market leaders, market consolidation, and commercialization of new molecules is expected to boost the market in the forecast period. For instance, Miragen Therapeutics, Inc. agreed to merge with Signal Genetics, Inc for an initial investment of USD 40 million. Through this merger, both the companies expect to develop micro RNA-targeted oligonucleotide clinical products. New molecule application is another strategy the market players use to mark their presence in the oligonucleotide therapy market.
Moreover, Biogen recently received FDA approval for a new drug application for nusinersen. If approved, the antisense oligonucleotides molecule would be the first of its kind to be used for treating spinal muscular atrophy. Thus, the North American region is expected to hold the largest market segment in the forecast period from the above statements.
Oligonucleotide Therapy Market Competitive Landscape
The oligonucleotide therapy market is moderately competitive with presence of local as well as global companies. Some of the key players which are contributing to the growth of the market include Kastle Therapeutics, Sarepta Therapeutics, Pfizer Inc., InteRNA Technologies B.V., Santaris, Akcea Therapeutics, Miragen Therapeuutics Inc., Alnylam Pharmaceuticals Inc.,, Biogen Inc., Ionis Pharmaceuticals Inc. The major players are adopting several growth strategies such as product launches, acquisitions, and collaborations, which are contributing to the growth of the oligonucleotide therapy market globally.
Oligonucleotide Therapy Market Key Companies to Watch
Alnylam Pharmaceuticals:
Overview:
Alnylam Pharmaceuticals Inc. is a biopharmaceutical company headquartered in Cambridge, Massachusetts. The company was founded in 2002, and the company has 18 potential treatments in various development stages in genetic medicine, cardiometabolic disease and infectious hepatic disease. Moreover, the company is focused on discovering, developing, and commercialization of RNA interference (RNAi) therapeutics for genetically defined diseases.
Product Portfolio:
Alnylam Pharmaceuticals Inc. on October 15, 2019. announced today that Muthiah (Mano) Manoharan, Ph.D., Senior Vice President of Drug Innovation Chemistry at Alnylam, has been awarded the 2019 Lifetime Achievement Award from the Oligonucleotide Therapeutics Society (OTS).
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