Oligonucleotide API Market

Oligonucleotide API Market Outlook from 2024 to 2034

Owing to the growing need for new drug classes, demand for oligonucleotide APIs is projected to rise at a high CAGR of 5.60% from 2024 to 2034. As such, the global oligonucleotide API market is projected to increase from a valuation of USD 2.81 billion in 2024 to USD 4.84 billion by the end of 2034.

Attributes	Key Statistics
Expected Base Year Value (2024)	USD 2.81 billion
Anticipated Forecast Value (2034)	USD 4.84 billion
Estimated Growth (2024 to 2034)	5.60% CAGR

Key Market Drivers

The increasing number of oligonucleotide-active pharmaceutical ingredients in medication pipelines around the world is a major driver of market growth. Pharma businesses have benefited from the ongoing trend toward harmonization of oligonucleotide development and marketing over the last 10-15 years. Several other reasons are also leading to the growth of the oligonucleotide API market:

• Expansion of synthetic biology applications due to the demand for custom oligonucleotide synthesis, enabling precise control over gene expression and metabolic pathway
• Emergence of CRISPR-Cas gene editing technology fuelling demand for oligonucleotides as tools for genetic manipulation, facilitating targeted genome modifications with high efficiency
• Rising adoption of RNA-based therapeutics, such as mRNA vaccines and RNA interference therapies, leveraging oligonucleotides for precise modulation of gene expression and protein synthesis
• Growing use of oligonucleotides in molecular diagnostics for detecting genetic mutations and infectious diseases, offering rapid and accurate detection with high specificity
• Increasing research focus on antisense oligonucleotides for treating neurological disorders and cancer, exploiting their ability to target disease-causing genes and protein
• Advancements in oligonucleotide synthesis techniques, enhancing scalability and cost-effectiveness, enabling the production of high-quality oligonucleotides at larger scales
• Demand for oligonucleotide APIs in agricultural biotechnology for crop improvement and pest management, harnessing their potential for enhancing plant traits and controlling agricultural pests
• Expansion of contract manufacturing organizations (CMOs) offering oligonucleotide synthesis services, and providing outsourcing solutions for pharmaceutical companies and research institutions
• Collaborations between academia, pharmaceutical companies, and government institutions to advance oligonucleotide-based therapies, fostering interdisciplinary research and development efforts.
• Heightened interest in oligonucleotide-based therapies targeting rare diseases and oncology indications, addressing unmet medical needs and offering potential breakthrough treatments.

Trends in the Global Oligonucleotide API Market

• mRNA vaccines, including those for COVID-19, have brought attention to the potential of oligonucleotide APIs in vaccine development, leading to increased investment and research in this area.
• ASOs are gaining interest as a treatment option for various genetic disorders, including rare diseases and neurodegenerative conditions. This is also driving the demand for oligonucleotide APIs tailored for ASO therapeutics.
• Innovations in delivery systems, such as lipid nanoparticles and conjugates, are improving the efficacy and safety of oligonucleotide drugs. This is contributing to market growth as these technologies become essential parts of oligonucleotide API development.
• The increasing complexity and specificity required in oligonucleotide-based therapies are also driving the demand for customized synthesis services from CDMOs.
• Oligonucleotide APIs are also playing a crucial role in the advancement of precision medicine, enabling targeted therapies based on individual genetic profiles. As personalized treatment approaches become more widespread, the demand for oligonucleotide APIs is likely to increase.

Complex and Time-consuming Processes to Slow down the Market Growth for Oligonucleotide APIs

• Pharmaceutical companies may be hesitant to invest in areas with smaller patient populations due to the high research and development costs associated with oligonucleotide therapies.
• Oligonucleotide synthesis and purification processes can be complex and time-consuming, leading to challenges in scaling up production and limiting supply, which also impedes market growth.
• Regulatory hurdles related to safety, efficacy, and manufacturing standards also lead to delays in approvals and market entry, particularly for complex oligonucleotide APIs.
• Despite the increasing demand, commercialization of oligonucleotide-based therapies is still relatively new compared to traditional drugs, and companies may lack experience in marketing and distribution, which substantially slows down market growth.
• Oligonucleotide-based therapies face competition from alternative treatment modalities, such as small molecules, biologics, and gene therapies, which significantly limits market penetration.

Category-wise Insights

ASOs to Gain Popularity in the Global Healthcare Sector

The antisense oligonucleotide APIs category is projected to hold the largest share of the market in the year 2024. This segment holds 78% of the global oligonucleotide API market.

• The demand for ASOs in the healthcare sector is experiencing a tremendous surge as they offer precise targeting of specific RNA sequences implicated in disease pathways. This allows for highly targeted therapeutic interventions with potentially fewer off-target effects.
• ASOs have demonstrated therapeutic potential across a wide range of diseases, including rare genetic disorders, neurodegenerative diseases, and various types of cancer. This is also one of the main reasons for their popularity in the healthcare sector.

Attributes	Details
API	Antisense Oligonucleotides API
Market Share	78%

Oligonucleotide APIs to find their place in Pharmaceutical and Biopharmaceutical Companies

The oligonucleotide API market is also categorized by end-users into CMOs, pharmaceutical and biopharmaceutical companies, and contract development & manufacturing organizations. The pharmaceutical and biopharmaceutical companies segment dominates the market with a share of 49% in 2024.

• Oligonucleotide APIs are being increasingly preferred by pharmaceutical and biopharmaceutical companies as they enable the development of targeted therapies that can specifically modulate gene expression or protein function.
• The promising clinical prospects and market potential of oligonucleotide-based therapies have attracted significant investor interest, providing funding and support for pharmaceutical and biopharmaceutical companies. This has also increased their acceptance in the international marketplace.

Attributes	Details
End User	Pharmaceutical and Biopharmaceutical Companies
Market Share	49%

Country-wise Insights

This section offers a comprehensive analysis of the oligonucleotide APIs market across various countries, including India, Thailand, Malaysia, Indonesia, and France. The table presents the Compound Annual Growth Rate (CAGR) for each country, depicting the estimated market growth in these regions until 2034.

Countries	CAGR
India	7.80%
Thailand	6.20%
Malaysia	5.90%
Indonesia	5.40%
France	4.20%

Thriving Pharma Manufacturing Capability to Drive Market Growth in India

India is expected to exhibit significant market growth over the forecast period. The Indian market for oligonucleotide APIs is anticipated to grow at a CAGR of 7.80%.

• India has a thriving pharmaceutical manufacturing industry that specializes in producing oligonucleotide APIs. The country's well-established infrastructure and highly skilled workforce make it a desirable destination for oligonucleotide API production.
• Indian manufacturers also offer cost-competitive solutions due to lower production costs, making oligonucleotide APIs more affordable for global markets.

Government Support Boosts Thai Oligonucleotide API Market

Thailand is also one of the lucrative markets in the oligonucleotide APIs industry. The Thai market for oligonucleotide APIs is anticipated to grow at a CAGR of 6.20%.

• The Thai government has implemented innovative policies to promote the biotechnology and pharmaceutical industries, providing incentives for research, development, and manufacturing of oligonucleotide APIs.
• Thailand's strategic location in Southeast Asia also provides access to regional markets and supply chains, enhancing its competitiveness in the oligonucleotide APIs market.

Significant Investments by Public and Private Entities to Bolster Market Growth in Malaysia

Malaysia also is a promising market in the global oligonucleotide APIs industry. Over the next ten years, the Malaysian demand for oligonucleotide APIs is projected to rise at a 5.90% CAGR.

• Malaysia has made significant investments in biotechnology infrastructure and research capabilities. This has positioned itself as a hub for biopharmaceutical development of oligonucleotide APIs.
• Malaysia also boasts a skilled and educated workforce in the biotechnology and pharmaceutical sectors, supporting the development and manufacturing of complex oligonucleotides.

Collaborative Partnerships to Fuel Market Growth in Indonesia

Indonesia is also one of the countries that is filled with potential in this market. The Indonesian oligonucleotide API market is anticipated to retain its dominance by progressing at a growth rate of 5.40% till 2034.

• Indonesia's large and growing population presents a significant market opportunity for oligonucleotide APIs. This has increased the adoption of oligonucleotide APIs in the country.
• Collaborations between Indonesian companies and international partners are also enhancing technology transfer and knowledge exchange in oligonucleotide API production.

French Oligonucleotide API Market to Expand Due to Well-established Regulatory Framework

France also exhibits a promising future in the global oligonucleotide APIs market. The oligonucleotide APIs market in France is anticipated to retain its dominance by progressing at a growth rate of 4.20% till 2034.

• The French government also provides funding and support for biopharmaceutical research and innovation initiatives, such as the French National Research Agency (ANR). This has also driven advancements in oligonucleotide APIs and strengthened France's position in the global market.
• The country also has a well-established regulatory framework for the biopharmaceutical industry, providing a favorable environment for oligonucleotide API development and commercialization.

Competitive Landscape

The global oligonucleotide active pharmaceutical ingredient (API) market is still in its early stages and is dominated by a few key players. These include Jazz Pharmaceuticals, Inc., Sarepta Therapeutics, Biogen, Dynavax Technologies, Akcea Therapeutics, and Alnylam Pharmaceuticals, Inc.

However, the market is expected to grow with strategic partnerships and the introduction of new products by industry leaders. To stay competitive in this market, companies need to have a strong creative and innovative capacity.

Recent Developments

• In September 2023, ST Pharm broke ground on its second oligonucleotide manufacturing plant in Ansan, Gyeonggi Province. The USD830.9 million investment aimed to establish the world's largest oligonucleotide API manufacturer, with projected production capabilities of 14 mol.
• In May 2022, Bachem and Eli Lilly & Co. initiated a strategic collaboration to develop and manufacture oligonucleotide-based active pharmaceutical ingredients. Bachem provided engineering infrastructure and personnel at its Switzerland facilities, with Lilly committing to placing manufacturing projects worth around CHF 100 million over seven years.
• In November 2021, Korea's ST Pharm announced a USD126 million investment to construct its second oligonucleotide manufacturing plant, doubling its capacity to 14 moles per year by 2025, positioning it as the world's largest oligonucleotide CDMO.

Key Companies in the Market

• Jazz Pharmaceuticals, Inc.
• Sarepta Therapeutics
• Biogen
• Dynavax Technologies
• Akcea Therapeutics.
• Alnylam Pharmaceuticals, Inc.

Key Coverage in the Oligonucleotide API Industry Report

• General Insights on the Oligonucleotide GMP Manufacturing
• Antisense Oligonucleotide API Market
• Oligonucleotide API Market in India
• Oligonucleotide API Manufacturers
• Assuring Quality of Oligonucleotide APIs and DPs

Oligonucleotide API Market Segmentation

By API:

• Antisense Oligonucleotides APIs
• Short Interfering RNA (siRNA) APIs
• Phosphorodiamidate Morpholino Oligonucleotides (PMO) APIs
• MiRNA APIs
• Aptamers APIs
• CpG Oligonucleotides APIs
• Others (ON Conjugates (NP), ShRNA, etc.)

By Marketing Status:

• Marketed
• Clinical Trials (Clinical Phases)

By End User:

• Contract Manufacturing Organizations (CMOs)
• Pharmaceutical Companies
• Biopharmaceutical Companies
• Contract Development & Manufacturing Organizations (CDMOs)

By Region:

• North America
• Latin America
• Asia Pacific
• Middle East and Africa (MEA)
• Europe

Frequently Asked Questions

How much is the Oligonucleotide API Market Currently Worth?

The oligonucleotide API market is expected to be worth USD 2810.3 million by 2024.

What is the Sales Forecast for Oligonucleotide API through 2034?

The market for oligonucleotide API is expected to reach USD 4846.1 million by 2034.

At what rate is the Oligonucleotide API Market growing?

The oligonucleotide API market is growing at a CAGR of 5.60% from 2024 to 2034.

Who are the key Companies in the Oligonucleotide API Market?

Jazz Pharmaceuticals, Inc., Sarepta Therapeutics, Biogen, Dynavax Technologies, Akcea Therapeutics, and Alnylam Pharmaceuticals, Inc, etc. are some of the major players in the market for oligonucleotide API.

What was the overall Value of the Oligonucleotide API Market in 2023?

The valuation for the oligonucleotide API market in 2023 was USD 2712.60 million.