The pharmaceutical industry continues to evolve under the pressure of medication affordability, regulatory constraints, and growing environmental expectations. In 2025, drug manufacturers face a major challenge: ensuring laboratories profitability while accelerating innovation and industrial performances.
Lactalis Ingredients Pharma, as a committed lactose pharmaceutical manufacturer, closely follows these transformations to better support its partners and customers’ needs. Most of the insights were gathered during our visit to CPHI, where we attended expert-led conferences on the topic.
1. Geopolitical impacts : between European Initiatives, USA policies and strong dependency in Asia : Where do we stand ?
France and the EU continue to push for strategic autonomy and fair access to medicines. However, the pharmaceutical industry remains fragile, with shortages of certain essential drugs like amoxicillin that is—used in over 50% of European antibiotic prescriptions while production stays concentrated in Asia, and European capacities remain below demand.
The global pharmaceutical landscape is shaped by geopolitical dynamics: U.S. policies under Trump have triggered a major shift in 2025: a 100% tariff on branded drug imports unless companies localize production, combined with aggressive price cuts. In response, leading pharma players—including Pfizer, AstraZeneca, or Sanofi— has recently announced over $350 billion in U.S. investments, reshoring manufacturing and R&D. This “America First” approach risks accelerating Europe’s loss of industrial and innovation capacity, as up to 85% of planned EU investments are now at risk of relocation. Without strong countermeasures, Europe could face deeper dependency and delayed launches, while the U.S. consolidates its position as a global pharma hub. What will be the impact for Excipients that are often manufacture in Europe?
2. Profitability Pressures: Strategic Reorientation of Research
Pharmaceutical companies increasingly tend to focus their research on high-return therapeutic areas such as diabetes, glycemia, and weight management, sometimes at the expense of complex pathologies like cancer or neurological diseases that need long time of research, tests, approval and heavy investment in medical industrial equipment. This strategic shift reflects the need to balance innovation with profitability and financial sustainability, especially as healthcare investments often yield returns only after 20 to 30 years.
3. Continuous Direct Compression: A New Industrial Frontier
Laboratories and medicines producers are driven by the need to low their cost of production as many medications are not always profitable. Efficiency and productivity gains are part of the balance for laboratories reorientation and reducing the number of production step is in many transition plans. Direct compression was a key evolution past decades. What we notice now is the transition from direct compression batch to continuous direct compression. It marks a second major industrial turning point after the first shift of granulation (dry or wet) to direct compression processes. The continuous direct compression process models applied from the mixing stage, as soon as the various ingredients are filled into fillers. Although the investment is costly, some studies have shown that this type of continuous production could yield savings of 30% to 50%, depending on the type of medication.
Despite their strong potential, these innovative production processes come with significant constraints that cannot be overlooked. Regulatory compliance remains one of the most critical hurdles: global frameworks such as ICH Q13 are still evolving, and differences between agencies complicate harmonization, making approvals lengthy and complex. Safety considerations are equally paramount, as continuous manufacturing introduces new paradigms for process validation and real-time quality control, requiring robust monitoring systems to ensure patient protection.
Another major challenge lies in batch segregation in case of non-compliance. Unlike traditional batch processes, isolating defective material in a continuous flow environment demands advanced control strategies and precise traceability. This issue becomes even more pressing given the very high cost of certain active pharmaceutical ingredients (APIs), where a single deviation can result in substantial financial losses.
Beyond regulatory and safety aspects, economic barriers persist. Transitioning to continuous or hybrid manufacturing models involves heavy investment in technology, automation, and skilled personnel. While these approaches promise efficiency gains and reduced waste, the upfront costs and complexity of integration with existing systems remain significant obstacles.
4. AI-Powered Formulation Modeling
Artificial and human intelligence mergery will probably revolutionize pharmaceutical formulation and process monitoring anticipation. From predicting powder interactions to optimizing excipient selection and, AI helps overcome regulatory and technical barriers. It is already present across the entire pharmaceutical value chain: research, production, clinical trials, supply chain, and regulatory compliance. The goal: reformulate legacy drugs that have lost profitability, while ensuring therapeutic efficacy and process reliability.
Like previously mentioned, continuous direct compression processes have many challenges to overcome and formulation adaptation is one of them also. Finding adequate excipients, mastering powder behavior through flowability, compactability, and homogeneity monitoring, are essential. With the help of AI and machine learning, R&D are increasingly able to simulate and predict these behaviors, with players like Siemens investigating the way.
5. Challenges: Solubility and Drug Efficacy
Tablets and capsules remain the most widely used formats due to their practicality and cost. However, nearly 70% of active pharmaceutical ingredients (APIs) exhibit low water solubility, limiting their bioavailability. This could affect their effectiveness in treating patients.
It is important to control the solubility of drugs because the time required for them to dissolve directly impacts the release of the active ingredient in the body —classified as immediate release or extended release. Dissolution problems often stem from the polymorphism of crystalline forms (alpha, beta, or gamma), as well as the size and configuration of the crystals. Linked to the crystalline forms of the API and its surrounding excipients, formulation challenges increasingly involve incorporating amorphous solid forms. Amorphous solid dispersions (ASDs) are known to improve dissolution, enabling lower doses and enhanced efficacy.
Another way to improve dissolution could be the use of, nanoparticulation technologies. Developed for example by Xspray Pharma, nanoparticulation could optimize administration—especially in oncology— and this achieving medication efficiency while enabling dosage reductions of up to 40%.
Finally, injectable formulations of hydrophobic molecules benefit from innovative technologies such as polymeric micelles and lipid vectors, ensuring rapid and reliable absorption. Controlling solubility is essential for designing more effective drugs that are better tolerated and tailored to patients’ needs.
6. Challenges & Limitations
Toward Personalized Medicine to improve medication efficacy
Variability in individual metabolism, genetics, gastric pH, and patient age challenges the one-size-fits-all approach. While formulators are exploring tailored dosages and smarter excipient combinations to ensure consistent therapeutic outcomes across diverse profiles, these solutions remain largely experimental and confined to controlled environments. Current applications are mostly localized, such as adapting care protocols in hospitals or pilot programs for specific patient cohorts, rather than broad industrial-scale deployment. AI is also being tested to predict diseases and personalize treatments, including virtual medical logistics like home-based care—but these remain proof-of-concept initiatives rather than mainstream practice.
7. Sustainability: A Strategic Imperative
Environmental impact is under scrutiny. Carbon emissions, water usage, and more ethical sourcing are now part of the procurement department concerns. Life Cycle Assessment is emerging as a more holistic approach than simple emission metrics. Alternatives to animal-derived ingredients, such as precision fermentation, are also gaining traction especially for some API molecules. Regulatory frameworks like the Corporate Sustainability Reporting Directive and shareholder can in long terms affect laboratories strategy and will require concrete sustainability trajectories and actions.
Conclusion
2025 marks a pivotal year for the pharmaceutical industry. Between profitability and affordability, geopolitical pressures, and environmental accountability, the sector must reinvent itself. Lactalis Ingredients Pharma remains committed to supporting its partners with high-quality of lactose pharmaceutical, technical expertise, and a forward-looking approach to innovation and sustainability.
