Oligonucleotide API Market revenue to surpass USD 5 Billion by 2035, says Research Nester

Major Oligonucleotide API Market players include Ionis Pharmaceuticals, Inc., Jazz Pharmaceuticals plc, Biogen Inc., Sarepta Therapeutics, Alnylam Pharmaceuticals, Inc., Corden Pharma GmbH, Dynavax Technologies, GE Healthcare Life Sciences, Nitto Denko Avecia and STA Pharmaceutical Co.,.

New York, Sept. 27, 2023 (GLOBE NEWSWIRE) -- The global oligonucleotide API market size is projected to expand at ~ 10% CAGR between 2023 and 2035. The market is expected to garner a revenue of USD 5 Billion by the end of 2035, up from a revenue of ~USD 2 Billion in the year 2022. With the growing cases of rare diseases globally and the tremendously rising need for a next-generation public health response to rare diseases, where ~80% of the cases occur by inherited gene mutations and infectious and autoimmune diseases, the oligonucleotide API market is expected to escalate in the upcoming years.
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Around 400 million people worldwide suffer from rare diseases, and oligonucleotide therapeutics constitute one of the most flexible platforms for developing drugs for rare diseases. For instance, it was found that as of 2022, 4 oligonucleotide therapeutics, viz., eteplirsen, golodirsen, viltolarsen, and casimersen, were being used to treat Duchenne muscular dystrophy in the United States of America (USA), whereas 15 oligonucleotide therapeutics were approved to treat various rare diseases. Alteration in the expression of certain genes is possible with the use of oligonucleotides in several techniques such as RNA interference (RNAi), splicing modification, target degradation by RNase H-mediated cleavage, non-coding RNA inhibition, gene activation, and programmed gene editing.

Global Oligonucleotide API Market: Key Takeaways

  • Market in North America to elevate the highest growth
  • Pharmaceutical Companies segment to garner the highest growth
  • Market in Europe to grow at the highest rate

Growing Investment in Research & Development by Pharmaceutical Companies to Boost Market Growth

The major factor attributed to the growth of the market is the surge in spending on the pharmaceutical sector by pharma companies and government institutions globally, which is leading to the development of new drug classes that can benefit patients in the treatment of a wide range of ailments. It was found that in 2021, the overall spending on research and development in the pharmaceutical industry amounted to little more than USD 230 billion worldwide. Although, up until now, most of the oligonucleotide therapeutics focused on gene silencing, prominent market players are persistently pursuing other strategies that include splice modulation and gene activation, expanding the range and accessibility of conventional pharmaceutical modalities together with the development of high-quality oligonucleotide APIs that will facilitate new therapeutic strategies as these molecules have potential therapeutic applications for myriad indications, notably in ophthalmologic indications, neuromuscular diseases, and as ancillary for vaccine development. This, as a result, is expected to elevate the global oligonucleotide API market growth over the forecast period.

Global Oligonucleotide API Market: Regional Overview

The global oligonucleotide API market is segmented into five major regions including North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa region. 

Rising Neuro-Degenerative Disease Prevalence to Drive Growth in the North American Region

The oligonucleotide API market in the North America region is estimated to garner the largest revenue by the end of 2035. The strong presence of the required chemical ecosystem for the pharmaceutical and biopharma companies in the region, as well as the increasing R&D investments in drug discovery and their commercialization, is expected to drive the regional market during the forecast period. According to the US Food & Drug Administration (FDA), over 28% of API manufacturing facilities in 2019 were based in the United States, catering to the market in the U.S. and across the world. Moreover, the increasing prevalence of cancer in the region of North America as well as rising concern about neurodegenerative diseases such as Alzheimer's disease, which require a personalized approach, are expected to further expand the size of the regional market over the forecast period. As per data from the National Cancer Institute, over 1,806,590 new cancer cases were diagnosed in the United States in 2020.

Rising Healthcare Expenditure to Drive Growth in Europe

The oligonucleotide API market in Europe is estimated to garner the highest CAGR by the end of 2035. The growing government expenditure on healthcare with the rising burden of diseases and the increasing geriatric population in the region, besides the increasing focus on building an extensive pipeline for immunology treatment by many giant key players in the region, is projected to boost regional market growth in the estimated time frame. It was found that the general government expenditure on health in the European Union amounted to nearly USD 1,300 billion, or ~8 % of GDP, in 2020. Moreover, as oligonucleotides are perceived as the next large group of therapeutics following biologics and molecules, apart from cancer immunotherapies and cardiovascular and microbial infections, these APIs are also tested for the treatment of neurological disorders, which are also expected to boost market growth in the region in the given assessment years.

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Global Oligonucleotide API, Segmentation by End-User

  • Pharmaceutical Companies
  • Biotechnology Companies

The pharmaceutical companies segment is anticipated to hold the largest revenue by the end of 2035. The rising quest of pharma companies globally to become self-reliant as well as the increasing research and development of drugs to provide efficient, cost-effective, and robust means of preventing and treating major diseases that burden the world are expected to elevate segment growth in the forecasted time frame. For instance, it was found that the FDA had approved 50 novel drugs in 2021, which also included the first KRAS inhibitor for cancer and the first anti-amyloid antibody for Alzheimer’s disease. Besides this, the surge in development and medical approval programs for oligonucleotides, together with the increasing investigation for oligonucleotide drugs by using various methods and technologies, is expected to boost the segment growth in the projected years. In 2019, ~605 oligonucleotide approval programs were in development throughout the world, compared to as few as 200 in 2010. Additionally, a variety of oligonucleotides that include antisense oligonucleotides, short-interfering RNAs, splice-switching oligonucleotides, microRNAs, immunostimulatory oligonucleotides, and aptamers are gaining popularity in the pharmaceutical industry.

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Global Oligonucleotide API, Segmentation by API Type

  • Short Interfering RNA (siRNA)
  • Antisense Oligonucleotides
  • Phosphorodiamidate Morpholino Oligonucleotides (PMO)
  • Aptamers
  • CpG Oligonucleotides
  • Others

Antisense oligonucleotides are anticipated to hold the largest share of revenue by the end of 2035. The factors applicable to the growth of the segment include the rising focus on developing treatments for brain cancer and breast cancer as well as increasing research on human genomics & proteomics, and related biotechnologies worldwide, along with the investigation of the efficiencies of antisense for delivering effective results in the treatment. For instance, in Europe, the biopharma sector raised an investment of ~USD 21 billion in 2018, and this amount hiked by ~26%, amounting to nearly USD 28 billion in 2019. Oligonucleotide API manufacturing typically comprises solid-phase synthesis, deprotection & cleavage, purification & filtration, and the isolation of API from aqueous solutions through the process of lyophilization. This product has a wide range of applications in fields such as biotechnology, molecular biology, diagnosis, and therapy. Moreover, synthetic oligonucleotides and antisense oligonucleotide APIs are used in gene therapy for inactivating genes that help in propagating the disease and for disrupting the faulty gene’s transcription, respectively. This, as a result, is anticipated to create numerous opportunities for the growth of the segment in the coming years.

Global Oligonucleotide API, Segmentation by Marketing Status

  • Marketed
  • Clinical Trials

A few of the well-known market leaders in the global oligonucleotide API market that are profiled by Research Nester are Ionis Pharmaceuticals, Inc., Jazz Pharmaceuticals plc, Biogen Inc., Sarepta Therapeutics, Alnylam Pharmaceuticals, Inc., Corden Pharma GmbH, Dynavax Technologies, GE Healthcare Life Sciences, Nitto Denko Avecia, STA Pharmaceutical Co., Ltd, and other key market players.

Recent Development in the Global Oligonucleotide API Market

  • Ionis Pharmaceuticals, Inc. a biotechnology company together with Biogen Inc., unveiled the results of the investigation of the use of antisense oligonucleotide (ASO) for people with C9orf72-associated amyotrophic lateral sclerosis (ALS).
  • Jazz Pharmaceuticals plc, a biopharmaceutical company based in Ireland announced that its Zepzelca (Lurbinectedin) got approval from the U.S. Food and Drug Administration (FDA), for treating adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.

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