GlobalData
GlobalData

Pharma

FDA-awarded RMAT designations continue to surge in 2025, reveals GlobalData

Since the FDA first awarded a regenerative medicine advanced therapeutic (RMAT) designation in 2017, activity in this space remained relatively modest until 2023. However, the number of RMAT designations increased sharply in 2024, reaching a record of 48 RMAT designations in 2025, reflecting the expanding regenerative medicine landscape and suggesting that a larger number of […]
Read more

Europe–US new drug manufacturing outsourcing gap widens, reveals GlobalData

Contract manufacturing facilities located in the US and Europe provide biopharma companies with strategic options to diversify supply chains, access specialized technologies, and speed time-to-market for new drugs. Outsourced dose manufacturing for innovator drugs and biosimilars approved in the US and Europe (the EU and UK) has traditionally oscillated between the two geographies, but there […]
Read more

MSCopilot Detect emerges as early contender for scalable remote MS monitoring, says GlobalData

Digital biomarkers are gaining momentum in multiple sclerosis (MS) care, with new findings highlighting the potential of smartphone-based assessments to transform disability monitoring. Early evidence supporting MSCopilot Detect use underscores growing industry efforts to enable scalable, remote, and standardized disease assessment, a shift that could reshape clinical  patient monitoring, and the evaluation of MS disease […]
Read more

Real-world data point to patient experience as next battleground for anti-CD20 therapies in RMS, says GlobalData

As real-world evidence (RWE) increasingly shapes competition in the relapsing multiple sclerosis (RMS) market, TG Therapeutics is leaning on patient-reported outcomes to carve out space for Briumvi (ublituximab) in a crowded anti-CD20 monoclonal antibody (mAb) field. There is growing importance on patient-centered outcomes as manufacturers seek competitive advantage beyond comparable clinical efficacy in MS treatment, […]
Read more

Produodopa’s positive RWE for Parkinson’s disease to boost clinician confidence in crowded levodopa market, says GlobalData

At the European Academy of Neurology (EAN) 2026 virtual congress, AbbVie presented new 12-month interim data from the ROSSINI study, supporting the real-world safety and effectiveness of Produodopa in patients with advanced Parkinson’s disease. Sustained improvements were observed across motor fluctuations, non-motor symptoms, and selected quality-of-life outcomes. Positive real-world evidence (RWE) for Produodopa could boost […]
Read more

China’s first dual BAFF/APRIL therapy approval signals new phase of competition in IgA nephropathy market, says GlobalData

China’s approval of the first dual BAFF/APRIL-targeting therapy for IgA nephropathy marks a significant shift in a treatment landscape long constrained by limited disease-modifying options and reliance on corticosteroids. The milestone highlights the growing role of innovative biologics in addressing persistent unmet needs, while underscoring the increasing influence of Chinese biopharma innovation in a competitive […]
Read more

Takeda’s oveporexton among key value-driving biopharma catalysts in Q3 2026, reveals GlobalData

Regulatory catalysts are set to shape biopharma sentiment in Q3 2026, with a selective pipeline of approval decisions and clinical milestones highlighting where innovation is most likely to create value. Foremost among them is Takeda Pharmaceutical’s oveporexton, whose anticipated FDA decision could validate a disease-modifying approach in narcolepsy type 1 (NT1), while pivotal readouts across […]
Read more

Biotech funding recovery favors late-stage, lower-risk assets, reveals GlobalData

The biopharmaceutical industry has seen a recovery in funding through 2026, following a prolonged downturn that limited access to capital across the sector. This recovery includes investment increasingly concentrated in later-stage, lower risk assets rather than early-stage innovation, according to GlobalData, a leading intelligence and productivity platform. According to GlobalData’s State of the Biopharmaceutical Industry […]
Read more

GLP1-RAs emerge as biopharma’s most influential platform drug class, reveals GlobalData

GLP-1 receptor agonists (GLP-1RAs) have contributed significantly to the therapeutic landscape, evolving from a primarily diabetes treatment into leading weight-loss assets with multi-indication capabilities across global pharmaceutical markets. What changed is not just awareness but the convergence of unmet need, a step change in efficacy, and expanding proof of value, turning GLP-1RAs from a diabetes […]
Read more

Biopharma confidence reaches four-year high as dealmaking and innovation gather pace, finds GlobalData

Confidence in the biopharmaceutical industry has climbed to its highest point since 2022, signaling a sector that is regaining momentum despite persistent regulatory and market pressures. The rebound reflects the impact of strategic restructuring, disciplined capital allocation, and renewed investment in innovation. As dealmaking accelerates and funding sentiment improves, the industry appears increasingly positioned to […]
Read more

AI integration in pharmaceutical processes remains focused on high-impact functions, says GlobalData

Artificial Intelligence (AI) has shifted from an experimental technology to an industry-wide operational tool across the pharmaceutical value chain. Companies are prioritizing AI deployment in high-impact areas such as drug discovery, clinical trials, and medical writing, where returns are most tangible. As confidence in AI’s commercial value strengthens, the technology is reshaping R&D economics, accelerating […]
Read more

US drug approvals surpass 10-year average in 2025, reveals GlobalData

The US FDA approved 131 drugs last year through its New Drug Application (NDA), Biologics License Application (BLA), and biosimilar pathways, leading to a steady 4.8% year-on-year increase in approvals. After an uneven decade in which new drug approvals fluctuated widely, the number approved by US regulators in 2025 exceeded the 10-year average, according to […]
Read more

Immunology and neurology drug development enters transformational era, says GlobalData

The landscape of both immunology and neurology therapeutics is currently undergoing a paradigm shift. Immunology therapeutics are moving beyond conventional tumor necrosis factor (TNF)-alpha inhibitors, Janus kinase (JAK) inhibitors, and interleukin (IL)-6 antagonists toward precision-targeted modalities that address fundamental immune dysregulation. Meanwhile, in neurology, precision biologics, gene therapies, and psychedelic-assisted modalities are converging toward a […]
Read more

China poised to launch first stand-alone opioid-induced constipation treatment, says GlobalData

China is confronting a rising oncology burden alongside the challenge of opioid-induced constipation (OIC), a common and debilitating side effect of opioid-based pain treatment. The National Medical Products Administration (NMPA) recently approved Shionogi’s Symproic (naldemedine), the first peripherally acting μ-opioid receptor antagonist (PAMORA) for OIC, marking an important step forward in supportive care and pain […]
Read more

Male infertility market growth to be driven by increased awareness and population growth, says GlobalData

The male infertility pharmaceutical market across the seven major markets (7MM: US, 5EU, and Japan) is projected to grow at a compound annual growth rate (CAGR) of 2.9% between 2025 and 2035, driven primarily by rising awareness of male reproductive health and continued population growth, according to GlobalData, a leading intelligence and productivity platform. GlobalData’s […]
Read more

DPP1 inhibitors reinforced with long-term phase II pooled data from verducatib, says GlobalData

Positive pooled long-term data from Phase II interim results for Boehringer Ingelheim’s verducatib, presented at the recent ATS 2026 International Conference, demonstrated the pipeline asset’s potential to reduce the risk of pulmonary exacerbations (PEx) in non-cystic fibrosis bronchiectasis (NCFB) patients. The results provide validation of the dipeptidyl peptidase 1 (DPP1)/cathepsin C inhibition in NCFB and […]
Read more
1 2 3 108