Improving Diabetes Care with GLP-1 Drugs: Charting the Course for Change in Asia Pacific

The global pharmaceutical landscape is experiencing a major shift with the rapid rise of Glucagon-like peptide-1(GLP-1) drugs. Market projections estimate the value of this sector will reach $150 billion by 2030¹, underscoring the scale and significance of this innovation in medical care.

GLP‑1 receptor agonists are a class of drugs used to treat Type 2 diabetes mellitus (T2DM) and obesity. These therapies, primarily administered as subcutaneous injectables for ease of at-home use, act by mimicking the native GLP‑1 hormone, enhancing glucose-dependent insulin secretion, suppressing glucagon release, lowering HbA1c levels, and promoting weight loss - all while carrying a minimal risk of hypoglycemia when used alone. Due to their large molecular weight and hydrophilic nature, GLP‑1 agonists face challenges with oral delivery, including poor and variable gastrointestinal absorption, leading to low bioavailability.

GLP‑1 therapies have become central to the management of type 2 diabetes and chronic weight conditions linked to obesity. In the Asia Pacific region - where over 60% of global diabetes cases are found - the demand for these treatments is expected to surge. Forecasts suggest a 68% increase in disease prevalence by 2045, potentially affecting more than 200 million individuals². These trends underscore a rising need for advancements in GLP‑1 delivery systems and broader patient access initiatives.

Packaging and Delivery: Critical Enablers of GLP‑1 Therapy Success

As demand for GLP‑1 therapies continue to surge, innovation in delivery systems will be critical to ensuring patient convenience, safety, and adherence. Current GLP‑1 treatments are peptide‑based injectables typically administered once weekly. Advancements in self‑injection devices are rapidly expanding treatment options, enhancing outcomes, and broadening patient access.

However, the unique molecular characteristics of GLP‑1 peptides present distinct challenges for both packaging and delivery that can directly affect drug stability and therapeutic efficacy. These large, complex molecules are inherently unstable and prone to degradation through pathways such as aggregation, deamidation, and oxidation³. Their sensitivity to temperature fluctuations, pH variations, and interactions with packaging materials can compromise potency and safety if not precisely controlled.

Furthermore, the biological fragility of GLP‑1 compounds necessitates highly engineered containment solutions that extend far beyond traditional small‑molecule packaging. To maintain therapeutic integrity, primary packaging must ensure exceptional protection against oxygen and moisture while maintaining chemical compatibility with the drug. This helps prevent adverse interactions or contamination from leachables compounds. Every material in contact with the drug - such as elastomeric closures, syringe barrels, and needle shields - requires carefully selected materials and surface treatments to minimize protein adsorption and preserve drug stability throughout its intended shelf life.

For pharmaceutical developers in Asia Pacific, this evolution highlights the importance of early investment in innovative, patient‑centric packaging and scalable, risk‑mitigated delivery systems - particularly given the region’s increasingly compressed development timelines. Packaging and delivery are no longer peripheral considerations; they are integral decisions impacting therapeutic success. Pre‑filled syringes and cartridge-based pen systems must combine safety and reliability with intuitive, user‑friendly design, empowering patients to confidently self‑manage their treatments at home.

Evolving Regulations and Compliance Challenges

Delivering safe and effective GLP-1 therapies requires a keen understanding of evolving global regulations. As USP <382> takes effect from 1 December 2025, there will be clear guidelines in place for drug manufacturers to demonstrate suitability of intended use of packaging materials and delivery systems through comprehensive system-based functional testing.

Simultaneously, EU GMP Annex 1 has introduced stringent requirements for sterile manufacturing. These updated good manufacturing practice (GMP) requirements emphasize enhanced environmental monitoring, improved contamination control strategies, and more robust quality systems for sterile injectable drug products.

Compliance requires substantial investment in advanced cleanroom facilities, skilled personnel, and thorough validation processes. To succeed in this complex environment, pharmaceutical companies should collaborate with trusted industry partners who can deliver proven innovations under rigorous quality standards. Ensuring patient safety and therapeutic effectiveness depends on strong supplier quality agreements, proactive change‑control management, and meticulous documentation across all sterile manufacturing and packaging operations.

Key Considerations for Entering the GLP-1 Market

Large pharmaceutical companies have already set the global standard by demonstrating how scientific innovation, robust partnerships, and reliable delivery systems can drive both patient impact and market leadership.

Several critical considerations stand out for pharmaceutical companies investing in the GLP-1 space in Asia Pacific:

• Technical excellence in delivery system innovation is paramount. As demand for GLP-1 therapies grows, the need for safer, more convenient, and patient-friendly packaging and delivery technologies will expand in parallel. The unique requirements of GLP-1 peptides demand advanced containment technologies including low-tungsten syringes to minimize metal-induced degradation, and specialized elastomer formulations with reduced extractables profiles. Delivery devices should also consider precise dose mechanisms, temperature-stable lubricant systems and ergonomic designs.
• Strategic partnerships and supply chain resilience will be essential. Success in GLP-1 and beyond depends on the ability to forge long-term collaborations with suppliers who possess deep technical expertise and global manufacturing capabilities. Partners must demonstrate proven track records in peptide drug packaging, regulatory compliance across multiple markets and ability to scale production rapidly to meet market demand. A local presence in Asia combined with global resources and innovation capabilities enables delivery of not just containment and delivery solutions, but also the strategic support needed to navigate complex regulatory landscapes and scale globally.
• Ensuring quality manufacturing is pivotal. Companies must implement robust quality systems that encompass supplier qualification, incoming material testing, process validation and post market surveillance. This includes establishing extractables databases for all packaging components, conducting comprehensive compatibility studies and maintaining real-time stability programs that support global registration strategies. Advanced manufacturing capabilities including automated assembly under ISO Class 5 conditions and 100% inspection systems for critical quality are also essential for ensuring consistent product standards.
• Regulatory readiness is key to bringing the finished product-to-market. Beyond USP <382> and EU GMP Annex 1, successful GLP-1 commercialization requires comprehensive understanding of International Council for Harmonization (ICH) guidelines forquality management and risk management, U.S. Food and Drug Administration (FDA) guidance on combination products, and regional variations in medical device regulations.

The GLP-1 revolution presents a unique opportunity for Asia-Pacific i .drug developers. The industry stands at a critical juncture where technical innovation, regulatory compliance and strategic partnerships will determine market success.

With over a century of expertise in pharmaceutical packaging and delivery systems—particularly in diabetes care—partners such as West are uniquely positioned to support drug manufacturers in navigating the complexities of this evolving landscape. West enables drug developers to address regulatory requirements while delivering safe, effective, and patient‑centric therapies worldwide. Through an integrated portfolio spanning early‑stage development, regulatory submission, and commercialization, West offers end‑to‑end solutions supported by extensive technical expertise, strong global infrastructure, and a proven record of regulatory compliance.