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2025 – The year ahead

It’s that time of year again when we take stock of the advances the biopharma industry has made and look ahead to the evolving client requirements that will shape 2025 and beyond. Subodh Deshmukh, CEO of Aragen Bioscience discusses.

Crucially, from a CDMO perspective, the question remains: are we investing in the right skills, manufacturing equipment, and cutting-edge technologies to empower the newer drugs entering the development pipeline?

Reflecting on the past year, it is clear that the industry has seen a mix of resilience and transformation. Small molecules, as the most mature and stable segment, have remained robust and steady. Meanwhile, biologics have continued to demonstrate significant innovation, with manufacturing capabilities increasingly democratised to newer regions across the globe. In contrast, advanced therapies such as cell and gene therapies have faced a more challenging year, grappling with affordability issues, funding pressures, and persistent scalability concerns.

When we dig deeper, the trends emerging within these broader categories paint a compelling picture. In biologics, for example, the focus is shifting beyond simply achieving therapy approvals to addressing the urgent need to reduce production costs and improve access. Not long ago, manufacturing costs in the region of $100 per gram were considered a mark of efficiency for biologics production. Today, we see growing momentum toward achieving a cost per gram closer to $50, as both CDMOs and their clients drive efficiencies to remain competitive.

In tandem, we are witnessing the rapid emergence of increasingly targeted and efficient biologics, such as third-generation ADCs and the growing field of bispecific and trispecific antibodies. These novel technologies are improving therapeutic precision by enhancing disease targeting and minimising off-target effects, offering substantial clinical benefits.

It would be remiss to reflect on recent industry successes without highlighting the transformative impact of GLP-1 drugs. While they have rightfully earned attention for their role in addressing weight management, perhaps even more noteworthy is the parallel rise of peptides and oligonucleotides. These molecules are demonstrating extraordinary promise across a broad spectrum of serious medical indications, from oncology and cardiovascular diseases to rare genetic disorders. This widening therapeutic scope positions these modalities as key drivers of innovation in the years ahead.

So if we break this down even further and explore the newer types of technologies and manufacturing techniques, we see that bioreactor technology is evolving. For example, the traditional fed-batch processes for mAbs are increasingly being replaced by intensified processes like N-1 perfusion and continuous manufacturing. These approaches reduce cycle times significantly (e.g., from 14-17 days to 9-12 days) while enhancing yield and maintaining product quality.

By 2025, intensified manufacturing is expected to become the norm for most biologics production. N-1 perfusion is being widely used to increase titers while for newer biospecific antibodies we are seeing tailored reactors with chromatography systems, resins, new materials, membranes specific for mAb of interest. Technologies such as single-use bioreactors, membrane chromatography, and hybrid upstream-downstream systems will contribute to cost reductions.

For emerging formats such as bispecific and trispecific antibodies, tailored bioreactor systems are playing an increasingly pivotal role. These systems incorporate advanced chromatography techniques, next-generation resins, and specialised membranes to optimise yields and purity for complex molecules. Simultaneously, technologies such as single-use bioreactors, membrane chromatography, and hybrid upstream-downstream systems are continuing to reduce costs and enhance production efficiency.

Similarly, in ADCs 2025 will continue to see newer manufacturing approaches help create the next generation of therapies with cleavable linkers and site specific conjugations that help improve drug-to-antibody ratio (DAR) uniformity. Companies are building facilities that integrate payload development, conjugation, and bioassay validation under one roof. By consolidating these critical processes within a single site, organisations are enhancing operational efficiency, minimising delays, and accelerating time-to-market while ensuring seamless and consistent production.

Tangential flow filtration (TFF) and advanced chromatography will also see further refinement. These methods are critical for separating ADCs from impurities, such as unbound payloads or aggregated species and are critical to ensuring product consistency, quality, and patient safety.

Sustainability is becoming another defining theme for the industry. Environmental considerations are increasingly influencing biopharma operations, with companies actively pursuing energy-efficient manufacturing processes, reducing plastic consumption in single-use technologies, and adopting green chemistry principles in synthesis. By 2025, regulatory requirements and growing consumer demand are expected to accelerate the push toward carbon-neutral operations, particularly among organisations engaged in large-scale biologics production. Sustainability is no longer just a matter of environmental responsibility—it is becoming a competitive differentiator that aligns business success with societal impact. Many organisations are investing in renewable energy and energy-efficient manufacturing processes to minimise environmental impact and crafting compelling narratives to attract investors.

The renewed focus on supply chain resilience has been one of the defining lessons of the past few years. Geopolitical tensions, trade restrictions, and pandemic-like disruptions have exposed vulnerabilities within global supply networks. In response, companies are diversifying their supply chains, implementing dual-site production models, and balancing innovation hubs in developed markets with cost-efficient manufacturing capabilities in emerging economies. This strategic shift not only mitigates risks but also enhances business continuity and ensures organisations are better prepared to navigate an unpredictable geopolitical landscape.

While the biopharma industry has seen remarkable success with mAbs and other biologics, challenges remain for newer modalities like cell and gene therapies. Eight years after the first CAR-T therapy approval, manufacturing costs and scalability issues continue to hinder widespread adoption. This reflects the reality that not all innovations achieve immediate commercial viability, and further advancements—both technological and regulatory—are needed to unlock their full potential. In 2025, the industry will likely reach a pivotal juncture where only the most efficient and innovative CGT players thrive, setting the stage for broader adoption of advanced therapies by 2030.

Overall, speeding up development timelines will remain a top priority for CDMOs and their partners as we move into 2025. The adoption of integrated manufacturing sites or facilities located in close geographic proximity is proving to be a game-changer in this regard. By minimising the transfer of materials, personnel, and data between dispersed locations, companies can expedite clinical development timelines, reduce operational costs, and de-risk supply chain complexities. This integrated approach is especially valuable for complex therapies, where each manufacturing step requires precise coordination to maintain product integrity and compliance.

As we move into 2025, it is clear that the biopharma industry stands at a transformative crossroads. The convergence of intensified manufacturing processes, next-generation biologics, integrated workflows, and sustainability initiatives is driving unprecedented progress. At the same time, challenges persist in areas such as advanced therapies and supply chain resilience, requiring continued innovation and collaboration across the value chain.

Source – European pharmaceutical manufacturer