Global Oligonucleotide API Market Definition
Oligonucleotides are a diverse therapeutic method that has the potential to treat a variety of conditions. Antisense oligonucleotides, small/short interfering RNA, micro-RNA, immunostimulatory oligonucleotides, aptamers, and splice-switching oligonucleotides have received significant attention in the pharmaceutical sector. Oligonucleotide active pharmaceutical ingredients (APIs) are formed by forming the oligonucleotide chain on a solid substrate, one nucleotide at a period. After synthesizing the entire sequence, the oligonucleotide is split from the solid support and purified by chromatographic purification, often reverse phase and or ion exchange chromatography.
From several techniques, including RNA interference (RNAi), target degradation by RNase H-mediated cleavage, splicing modification, non-coding RNA inhibition, gene activation, and programmed gene editing, oligonucleotides can be used to alter the expression of certain genes. As a result, these compounds offer potential therapeutic uses for a variety of conditions, and subsequently, several oligonucleotide medications received approval. Furthermore, since oligonucleotides may theoretically be developed to selectively target any gene with little, or at least predictable, off-target effects, they can be used for precision and customized medical techniques.
The use of oligonucleotide active pharmaceutical ingredients (APIs) by pharmaceutical firms has just been prominent in solid solutions (powdered form) and more recently in solution form. The application of oligonucleotide APIs has been increasing in the treatment of a variety of pathologies. The product development has unlocked the door to innovative effective treatments in a variety of therapies, mainly for ophthalmologic indications, neuromuscular illnesses, and as excipients in the production of vaccines. Oligonucleotide-based therapies are a boon in the healthcare sector. These therapies are very innovative novel approaches used to treat a variety of chronic diseases such as lung cancer, obstructive pulmonary diseases, pulmonary fibrosis, and so on.
Global Oligonucleotide API Market: Key Insights
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Base Year |
2022 |
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Forecast Year |
2023-2035 |
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CAGR |
~10% |
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Base Year Market Size (2022) |
~ USD 2 Billion |
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Forecast Year Market Size (2035) |
~ USD 5 Billion |
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Regional Scope |
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Global Oligonucleotide API Market Size, Forecast, and Trend Highlights Over 2023 - 2035
The global oligonucleotide API market is estimated to garner a revenue of ~USD 5 Billion by the end of 2035 by growing at a CAGR of ~10% over the forecast period, i.e., 2023 – 2035. Further, the market garnered a revenue of ~USD 2 Billion in the year 2022. The growth of the market can be attributed to the rise in laboratory and research institute experiments worldwide. The Increasing use of oligonucleotides for various applications such as gene editing, diagnostics, therapeutics, and so on has driven the surge in interest in APIs across organizations. As per the data by the World Bank, as of 2018, there were 1597 researchers per 1,000,000 people involved in research and development activities across the globe, an increase from 1412 researchers per million in 2015. Further, the growing use of oligonucleotides in the effective treatment of several disorders is another major factor that is estimated to push the market growth further throughout the forecast period.
In addition to these, factors that are believed to fuel the market growth of oligonucleotide API include the worldwide rising proportion of oligonucleotide API in the drug pipeline which is estimated to accelerate the global oligonucleotide API market size in coming years. The oligonucleotide is a new type of therapeutic molecule ideal for treating a variety of diseases. Oligonucleotide base pairs with DNA or RNA to form a structure. In PCR (polymerase chain reaction), oligonucleotides are commonly used as primers. In addition, funding in life science activities, innovative product launches, and drug discovery, along with investments in high-profile big science projects are expected to drive demand for oligonucleotide API during the forecast period. For instance, according to estimates, governments around the world and international organizations are expected to invest a total of more than USD 170 billion on large-scale science projects between 2022 and 2025.
Global Oligonucleotide API Market: Growth Drivers and Challenges
Growth Drivers
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Globally Rising Prevalence of Cancer and Neurodegenerative Diseases - Based on data from the National Cancer Institute, as of 2020, there were 1,806,590 new cancer diagnoses in the United States and 606,520 cancer deaths. The rising number of cancer cases is propelling the demand for advanced testing procedures. Moreover, the treatment of neurodegenerative diseases requires a personalized approach as well. In terms of neurodegenerative conditions, Alzheimer's disease is one of the most common. There are several limitations associated with conventional medicine in this area, so oligonucleotide APIs are being studied extensively. This factor is expected to expand the global oligonucleotide API market size during the forecast period.
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Growth in Percentage of API Manufacturing Facilities - According to the US Food & Drug Administration (FDA), there were more than 28% of API manufacturing facilities based in the United States in 2019 catering to the market in the U.S. Rest of were located in other regions, including 13% in China.
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An Upsurge in Medical Approval Programs for Oligonucleotides - It was observed that as of 2019, around 605 oligonucleotide approval programs were in development throughout the world, compared with only 200 in 2010.
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Growing Expenditures on Healthcare Throughout the World - Global healthcare expenditure accounted for 9.83 billion in 2019 according to data provided by the World Bank, an increase from 9.7 billion in 2018.
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Rising per Capita Income Worldwide - The World Bank reported that worldwide annual per capita income increased by 4.8% in 2021, up from 1.5% in 2019.
Challenges
- High Production of Waste Associated with Oligonucleotide - The current state of the art in oligonucleotide synthesis provides a waste and expense burden to firms, with just 12 oligonucleotide pharmaceuticals having reached the market to date and hundreds more being developed in medical studies and preclinical research. So, the waste from the reversed-phase purification process comprises the hazardous waste disposal. For instance, solvent recovery is economically and environmentally advantageous at high production volumes, but around 50% of the waste volume still needs to be disposed of as aqueous-rich hazardous waste.
- Complex Procedure of Manufacturing
- Mandatory GMP Guidelines and Product Licensing
Global Oligonucleotide API Market Segmentation
The global oligonucleotide API market is segmented and analyzed for demand and supply by end-user into pharmaceutical companies and biotechnology companies. Among these two segments, the pharmaceutical companies segment is estimated to gain the largest market share over the projected time frame. The growth of the segment can be attributed to the increasing adoption of innovative technology by pharmaceutical giants for improving drug efficacy and reducing development costs. For instance, a variety of oligonucleotides has become increasingly popular in the pharmaceutical industry, including antisense oligonucleotides, short-interfering RNAs, splice-switching oligonucleotides, microRNAs, immunostimulatory oligonucleotides, aptamers. The capacity to target the illness gene or the messenger RNAs (mRNAs) that are encoded by it has created new therapeutic possibilities. The length of therapeutic antisense oligonucleotides (ASOs) varies from 18 to 30 base pairs (bp).
The global oligonucleotide API market is also segmented and analyzed for demand and supply by type into short interfering RNA (siRNA), antisense oligonucleotides, phosphorodiamidate morpholino oligonucleotides (PMO), aptamers, CpG oligonucleotides, MiRNA API, and others. Amongst these segments, the antisense oligonucleotides segment is expected to garner a significant share. The growth of the segment can be attributed to the rising focus on personalized medicine across the globe, along with the high efficiency of antisense for delivering effective results in the treatment. Besides this, antisense oligonucleotides deliver effective outcomes in Alzheimer’s treatment. Thus, spiking cases of Alzheimer’s is another factor that is projected to boost the growth of the segment in coming years. This, as a result, is anticipated to create numerous opportunities for the growth of the segment in the coming years.
Our in-depth analysis of the global oligonucleotide API market includes the following segments:
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By API Type |
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By Marketing Status |
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By End User |
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Global Oligonucleotide API Market Regional Synopsis
The North American oligonucleotide API market, amongst the market in all the other regions, is projected to hold the largest market share by the end of 2035. The growth of the market can be attributed majorly to the increased healthcare spending, along with the enhanced healthcare facilities anticipated to fuel the oligonucleotide API market in the region over the forecast period. A recent report from the Centers for Medicare & Medicaid Services revealed that approximately 19.7% of GDP in the United States was spent on healthcare services in 2020, amounting to USD 4.1 trillion in total. In addition to this, surging R&D investments in novel drug discovery and commercialization of oligonucleotide therapies are also expected to further drive the regional market during the forecast period.
Furthermore, the European oligonucleotide API market is also estimated to display lucrative market growth by the end of 2035. The growth of the market can be attributed to the escalating investment in research and development activities in the region, followed by the presence of major players in the region. For instance, the biopharma sector in Europe region raised around USD 21 billion investment in 2018, and this amount surged by nearly 26% to USD 28 billion in 2019. Moreover, the rising focus on the development of precision medicine for cancer is another significant factor that is projected to boost the market growth further throughout the forecast period in the region.
Top Featured Companies Dominating the Global Oligonucleotide API Market
- Ionis Pharmaceuticals, Inc.
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
- Jazz Pharmaceuticals plc
- BIOGEN INC.
- Sarepta Therapeutics, Inc.
- Alnylam Pharmaceuticals, Inc.
- Corden Pharma International GmbH
- Nitto Denko Avecia, Inc.
- Merck KGaA
- Ajinomoto Co., Inc.
- Kaneka Eurogentec S.A.
