GLP-1 Supply Is Stabilizing—But Injection Pens & Autoinjectors Are the New Bottleneck

Introduction

In many markets, headlines suggest the GLP-1 “shortage era” is ending. In the U.S., regulators have announced that certain GLP-1 injections are no longer considered in national shortage, signaling improved product availability and manufacturing capacity.

But across the industry, a different constraint is becoming more visible: the delivery device—especially injection pens and autoinjectors. Even when drug substance and fill-finish capacity improve, device capacity, component sourcing, and final assembly throughput can still limit how quickly finished, patient-ready products reach pharmacies and clinics.

This article explains why GLP-1 supply is stabilizing in some regions, why the pen/autoinjector supply chain remains tight, and what pharma, clinics, and device partners can do to reduce risk.

1) What “Supply Stabilizing” Really Means

Regulatory updates in the U.S. show meaningful movement:

• The U.S. Food and Drug Administration stated it had determined the shortage of semaglutide injection products was resolved (while still noting that patients may see intermittent localized disruptions as products move through the supply chain).

• The same FDA update series also described determinations that the shortage of tirzepatide injection was resolved, and clarified how enforcement discretion would phase out for compounding as shortages end.

Key takeaway: “Resolved” at a national level does not mean every pharmacy has every dose at all times. It often means manufacturers can meet projected national demand, while distribution timing, local allocation, and presentation-level constraints may still occur.

2) Why Devices Become the Bottleneck After Drug Supply Improves

GLP-1 therapies are typically delivered via high-volume, high-precision self-injection systems. Scaling these devices is not as simple as adding a filling line.

A) Device manufacturing is a multi-step, multi-supplier chain

A finished autoinjector/pen depends on:

• precision molded plastics + tooling capacity

• springs and metal components

• drug-contact materials and elastomers

• automated assembly lines

• functional testing and packaging

• serialization/labeling workflows (depending on market)

When demand jumps, the slowest step—often tooling, molding cavities, or automated assembly—sets the pace.

B) Capacity expansion takes time (and money)

Major device suppliers are investing heavily to expand output—clear evidence that demand is pushing the system:

• SHL Medical opened a new US$220M manufacturing facility in South Carolina specifically to serve growing autoinjector demand, noting cardiometabolic use cases among key drivers.

• Ypsomed reported strong growth driven by autoinjector deliveries and explicitly stated demand for its autoinjector platforms continues to grow—while it expands production across regions (China, Europe, and planned U.S. capacity).

These expansions validate a core point: the industry is still catching up on device capacity.

C) Pharma is increasingly “device-sourcing” at scale

Industry reporting indicates deeper partnerships and outsourcing to secure device throughput:

• A **FUJIFILM Biotechnologies announcement described a partnership with SHL to expand finished-goods autoinjector services (including final assembly capacity) up to 30 million units per year beginning in early 2025.

• A **Gerresheimer executive told **Reuters that weight-loss drug deals (including components like cartridges, syringes, and autoinjectors) are expected to drive meaningful growth—highlighting how device and component capacity is now a strategic battleground.

3) Why “Pens/Autoinjectors” Are Harder to Scale Than Many People Assume

Even sophisticated teams underestimate device ramp complexity. Here are the most common friction points:

1) Tooling lead times and validation

New molds and higher-cavity tooling can take months—then require qualification. Any changes can trigger re-validation and additional documentation.

2) Automated assembly and testing throughput

High-speed assembly lines require:

• stable upstream component supply

• strict tolerances to avoid jam rates

• in-line testing reliability

• robust scrap and rework handling

3) Platform-specific constraints

Many brands rely on platform devices or platform families (for different volumes like 1.0 mL / 2.25 mL). When demand concentrates on a few platforms, capacity tightens quickly. (Ypsomed explicitly referenced growing demand for its 1.0 mL and 2.25 mL autoinjector platforms.)

4) Geographic resiliency and “where it’s made”

To reduce risk, suppliers are diversifying production sites (Europe + China + North America). That helps long-term—yet near-term transitions still require ramp and tech transfer.

4) What This Means for Clinics, Distributors, and Pharma Teams

For clinics and providers

Even if drug availability improves, device presentation availability (pen vs vial, specific strengths, specific packaging) can affect prescribing workflows and patient adherence.

For pharma and program owners

The device is no longer a “packaging detail.” It is a capacity-critical component that can determine:

• launch timing

• market allocation strategy

• cost of goods and supply continuity

• patient experience and persistence

For device partners and OEM/ODM programs

Demand is shifting from “can you make it?” to “can you scale it reliably, globally, with change control and documentation?”

5) Practical Strategies to Reduce Device-Driven Supply Risk

If you’re building or scaling a GLP-1 (or other high-demand self-injection) program, the following approaches are increasingly common:

1. Secure capacity early
   Reserve molding and assembly capacity well ahead of launch scale-up—device lead times can be longer than fill-finish in some scenarios.

2. Design for manufacturability (DFM) from day one
   Avoid features that complicate molding, add manual assembly steps, or increase testing complexity.

3. Build supply chain resiliency
   Multi-site production strategies and second-source components can reduce single-point failures.

4. Use validated platforms where possible
   Platform systems can shorten timelines—but you still need capacity commitments.

5. Integrate final assembly planning with fill-finish planning
   Announcements like FUJIFILM–SHL highlight how pharma teams are aligning CDMO strategy with device final assembly strategy—not treating them separately.

Conclusion

GLP-1 availability is improving in parts of the world, and regulators have signaled that certain national shortages have been resolved.
But the market’s next constraint is increasingly clear: injection pens and autoinjectors—their components, their production lines, and their ability to scale at the pace demand requires.

For brands and partners, the lesson is straightforward: device capacity is now strategic capacity. Organizations that plan device supply early, build resilient sourcing, and scale validated manufacturing networks will be better positioned for stable, long-term growth.