Axplora, an expert in small molecule API manufacturing and a partner to over 900 of the world’s leading pharmaceutical and biotech companies, initiated over €100 million in total investments across its global network in 2025, underscoring its commitment to accelerating growth, strengthening capabilities and reinforcing its position at the forefront of pharmaceutical manufacturing worldwide. The total investment included €60 million allocated to the expansion of its Mourenx, France site, €35 million at Gropello, Italy, and €8.5 million at Vizag, India. In addition, March of 2025 saw the expansion of Axplora’s ADC (antibody-drug conjugate) manufacturing capabilities at is site in Le Mans, France. But, the company isn’t stopping there.

In February 2026, Axplora announced a multi-million-euro investment to expand lyophilization (freeze-drying) capabilities at its Le Mans, France Site, and in March, the company reached a milestone in its $60 million investment program at its Farmabios site in Gropello Cairoli. The latest phase includes construction of a new 4,500 m², three-story R&D and laboratory hub, designed to accelerate development, expand execution capacity and deliver cost-efficient high-potency manufacturing at scale. Once operational, the new HPAPI facility will increase development and analytical throughput, reduce technology transfer complexity and compress timelines from early development to commercial production.

Contract Pharma caught up with Arul Ramadurai, Chief Commercial Officer, Axplora, at DCAT Week to discuss the company’s investment in expanding its HPAPI development and manufacturing capabilities, including the drivers behind the investment, market trends, challenges, regulatory factors and sustainability initiatives.

The State of the HPAPI Market

“The highly potent molecule space is expanding rapidly—especially in oncology, where the standard of care is continuously improving,” explains Ramadurai. “HPAPIs have evolved into their own category, with both small and large molecule modalities growing substantially.”

On the small molecule side, Ramadurai sees compounds such as “-tinibs” delivering excellent clinical outcomes at reasonable volumes. Meanwhile, large molecule innovation is being driven by antibody–drug conjugates (ADCs), which combine a potent small molecule payload with an antibody for targeted delivery. Overall, there are more than 1,000 highly potent molecules currently in development.

Oncology remains the largest segment associated with HPAPIs, but Ramadurai says he increasingly sees HPAPIs in immunology and other disease areas as well. For example, he says another emerging area is steroid conjugates—a completely new category, but one where Axplora sees significant potential due to potency and targeted delivery.

While Axplora may be expanding in the HPAPI space, it is not a new player. In fact, Ramadurai emphasizes that Axplora was early in the space—over 30 years ago.

He says, “We supported the first ADCs and many early HPAPIs, and today we contribute to the supply chains for 6 of the 14 FDA approved ADCs. Because we’ve been in this space for decades, we understand customer needs and can provide tailored, expert services. That demand, and our longstanding expertise, are the main drivers behind our expansion in Gropello and Le Mans.”

Ensuring Speed and Efficiency

Axplora has structured its investment strategy around three key pillars:

• Cycle time – delivering projects faster, especially important for clinical timelines.
• Yield – improving efficiency and reducing waste.
• Asset fit – ensuring facilities and equipment are suited to a molecule’s needs for efficient scale-up.

“Our investments are designed to enable faster, more efficient tech transfers and scale ups aligned with these three metrics,” says Ramadurai.

Bottlenecks in HPAPI development and manufacturing frequently occur before and after production.

According to Ramadurai, “R&D is critical—some organizations lack the process development expertise needed to establish robust, scalable processes. Without strong R&D and industrialization, you end up with processes that don’t behave well during scale up.”

“QC and analytics are another common bottleneck,” he adds. “It doesn’t help if production is fast but QC takes two months to release product.”

To address this, Axplora’s investment includes additional R&D capacity, more labs, and strengthened QC resources so the entire value chain—R&D, production, QC—is aligned to the same cycle time goals.

Supply Chain Resilience

Another major concern today is supply chain resilience. The Covid-19 pandemic exposed vulnerabilities in global supply chains, and the subsequent rebound in oncology and targeted therapies has significantly accelerated outsourcing. As a result, there has been a trend amongst pharmaceutical companies to diversify their supply chains to minimize geopolitical, raw material and tariff-related risks.

For early phase materials, Ramadurai admits that outsourcing still often leans toward Asia for speed and cost, however, to manage risk, the company utilizes dual sourcing and strategic stockpiling and employs a global purchasing team that proactively assesses risks and plans ahead based on the project pipeline.

“When a raw material becomes high-risk, Axplora employs either a dual sourcing or inventory strategy,” says Ramadurai. “If a second source exists—even if both sources are in China—we qualify it. If no second source exists, we build stock or work with customers on long term supply agreements.”

As a result of this proactive approach, Ramadurai claims the company experienced no supply chain disruptions during the pandemic.

Regulatory and ESG Considerations

Regulatory expertise is integrated from the start at Axplora. The company has a global regulatory group that covers all sites and closely monitors developments in areas like Annex 1, solvent regulations, and emerging guidelines. Because many of Axplora’s customers are large pharma companies, Ramadurai says the company often learns from their regulatory experiences as well and incorporates those learnings across Axplora.

“The goal is to stay aligned with evolving expectations so that new facilities, processes, and technologies are designed with regulatory requirements built in from day one,” Ramadurai remarks.

Sustainability is also essential—for ethical reasons and because major pharma companies increasingly require it. Axplora is aligned with the Science Based Targets initiative (SBTi) for Scope 1, 2, and 3, and has clear 2030 goals. Plus, its Italian site is Ecovadis 2025 Gold-certified for sustainability.

“Across Axplora, we’re improving solvent recycling, energy efficiency, and waste management, and we have an ESG leader on our executive team. We also collaborate with customers to align sustainability expectations and targets,” says Ramadurai.

Looking Ahead

With over 1,000 highly potent molecules in development—more than double the number from five years ago—Ramadurai expects strong growth.

“Many companies are investing in HPAPI capacity, but our strategy is not to build speculative capacity. We invest based on clear signals from customers and the market,” Ramadurai explains.

He adds, “Axplora’s strategy is to stay ahead of what customers will need—not just respond to what they need today. The more we understand their future requirements, the more value we can create.

“Our 30 years in HPAPIs help us guide customers through challenges like scalability, process robustness, and asset fit. Customers often bring us processes developed elsewhere, and we can tell from experience whether those processes will succeed at commercial scale. Helping customers resolve these issues early is how we ultimately deliver for patients.”