The strategic role of CDMOs in the development of oligonucleotide-based therapies

The advancement of oligonucleotide-based therapies has marked a turning point in modern medicine. In this context of accelerated innovation, contract development and manufacturing organisations, known as CDMOs, have taken on an increasingly prominent role. This is highlighted in a recent analysis published by MarketsandMarkets (July 2025), which emphasises how these players are taking on an increasingly important role in global pharmaceutical development strategy.

The role of CDMOs specialising in oligonucleotides has evolved significantly in recent years. Their contribution is no longer limited to the technical capacity to synthesise or purify molecules, but also encompasses key aspects such as adaptation to international regulatory requirements, especially GMP, the development of robust and scalable processes, and direct collaboration with scientific teams in the early stages of preclinical development. This has made it possible to shorten timelines, reduce technical risks, and facilitate access to capabilities that often exceed the internal resources of laboratories and biotechnology start-ups.

The growth of the global market in this area reflects this transformation. Forecasts point to significant expansion, with estimates placing its value at more than $6.7 billion in 2029 and potentially up to $18.4 billion by 2034. This growth is driven not only by the increase in oligonucleotide-based clinical programmes, but also by the pharmaceutical industry’s interest in outsourcing complex processes to partners that combine technical expertise with operational agility.

Geographically, the picture is diverse. North America maintains its leadership in terms of ecosystem volume and maturity, thanks to its consolidated infrastructure network and regulatory experience. However, the Asia-Pacific region is showing rapid growth, driven by public and private investment, as well as policies that encourage the development of local biotechnology capabilities. This trend reflects not only market globalisation, but also a decentralisation of technical knowledge and manufacturing capacity. And what about Europe? Take Sylentis, for example.

The progress made by these organisations is also linked to their commitment to technological innovation. The implementation of modular facilities, automated synthesis systems, high-performance purification platforms and digital solutions is redefining the way processes are designed and scaled.

In this new scenario, the relationship between therapy developers and CDMOs is becoming increasingly strategic. Decisions are no longer made solely on the basis of production capacity or cost, but also on technical expertise, regulatory flexibility, operational quality and adaptability throughout the product lifecycle. For many management teams, choosing the right partner can mean the difference between the success and stagnation of a clinical programme.

This evolution has direct implications for initiatives such as SYOLIGO in a field where speed, quality, and regulatory viability are determining factors. Understanding the strategic role of CDMOs and establishing strong partnerships with those that add value beyond manufacturing is essential.

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