Reflecting on a transformational year for pharma

Throughout the year, G&L Scientific partnered with pharmaceutical and biotech companies to navigate shifting regulatory landscapes, accelerate market access, and ensure compliance in a rapidly evolving global environment.

The trends that defined 2024:

Oncology and rare disease innovation

Oncology remained the fastest-growing therapeutic area, with leading companies such as J&J, Roche, and AstraZeneca advancing targeted treatments.

Rare diseases also dominated regulatory approvals, with more than half of U.S. Food and Drug Administration (FDA) approvals in 2024 falling into this category. The focus on precision medicine and gene therapy continued to accelerate, opening new possibilities for personalized treatments.

Biosimilars reshaped market dynamics

The growing presence of biosimilars had a major impact on established biologics, with Humira’s 32% revenue decline serving as a stark example.

As patents expired, companies faced increased competition and pressure on pricing, prompting a shift toward diversified portfolios and innovative pipeline development.

AI and digital transformation disrupted

AI played a crucial role in accelerating drug discovery, optimizing clinical trials, and enhancing real-world data analysis.

Companies that integrated AI into their R&D strategies were able to streamline processes, reduce costs, and improve patient outcomes. This technological shift marked a turning point in how treatments are developed and approved.

Weight loss drugs boomed

GLP-1 receptor agonists such as Ozempic and Wegovy saw overwhelming demand, reshaping the pharmaceutical landscape.

As obesity and metabolic health gained recognition as major public health priorities, companies ramped up investment in this space. The regulatory landscape for these treatments evolved rapidly, requiring companies to navigate global market expansion while ensuring long-term safety and efficacy.

Sustainability as an imperative

Pharmaceutical companies intensified their focus on Environmental, Social and Governance (ESG) initiatives, prioritizing equitable access to medicines and sustainable business practices.

With regulatory bodies increasing scrutiny on corporate responsibility, organizations had to align their strategies with both compliance requirements and ethical considerations.

Restructuring became the norm

Leading companies such as Novartis, J&J, and Sanofi streamlined operations in 2024, focusing on high-growth therapeutic areas like oncology, immunology, and vaccines.

These strategic shifts were aimed at improving efficiency, maximizing R&D investments, and responding to evolving healthcare demands.

R&D pipelines at record highs

With over 22,800 drugs in development – a 7% increase on 2023 figures - the pharmaceutical industry experienced an unprecedented level of innovation.

However, increased activity also brought greater regulatory complexity, requiring companies to refine their clinical and regulatory strategies to ensure successful market entry.

Looking ahead

The momentum from 2024 has set the stage for continued transformation in 2025.

Companies that prioritize innovation, optimize regulatory strategies, and embrace digital advancements will be best positioned for long-term success. With evolving global regulations and increasing market competition, the ability to adapt will be more critical than ever.

As a trusted partner in regulatory affairs, clinical operations, and quality assurance, G&L Scientific remains committed to supporting pharmaceutical and biotech organizations through these industry shifts with world-class regulatory, quality, and clinical expertise.

To learn more about how we can help navigate the complexities of 2025 and beyond, visit www.gandlscientific.com

Paul Kuiken is Vice President of Advisory Services at G&L Scientific.