How Pharma and Medtech Convergence Is Changing DDS Partner Selection in 2026

Evolution of Drug Delivery Systems

The DDS model has shifted markedly over the past five years, as the biologics, biosimilar, and GLP-1 wave pushed volume toward self-administration and displaced the traditional siloed model in favor of closer drug-device integration.

Then: Primary packaging and DDS suppliers focused on components and basic quality control, while pharmaceutical CDMOs handled formulation, stability, and GMP fill and finish. Device documentation and drug product chemistry were often prepared separately and integrated late in development, increasing the risk of costly surprises.

Now: DDS suppliers have started to move upstream, offering pharma-facing analytical labs, formulation and injectability advice, and selective downstream GMP fill and finish. The modern supplier positions the container, device, and drug product as a single engineered system and starts engaging with pharma early in clinical phases, anticipating the compound’s eventual commercial scale-up.

These market dynamics are expanding the DDS value proposition. Rather than supplying containers and delivery devices alone, leading DDS companies are moving both upstream and downstream to help pharmaceutical customers de-risk development, accelerate time to market, and simplify combination-product execution.

This broader role is most evident in three areas of value chain expansion:

• Analytical testing
• Formulation and injectability support
• Selective fill and finish

Value Chain Expansion #1

Analytical testing is a common upstream service extension: suppliers are building or partnering to provide E&L studies, CCI testing, compatibility and stability support, particulate analysis, aged-functionality tests, and combination-product testing. These labs enable early identification of material-drug interactions, seal performance issues, and particulate risks, all of which DDS companies must address well before pivotal studies to avoid bridging studies or late design changes. Companies are also adding device-specific testing, like glide/break-loose, force/profile, visual/mechanical quality assurance, and inhalation performance testing, which provides the integrated evidence regulators expect.

Value Chain Expansion #2

Formulation and injectability support is increasingly offered by DDS firms, particularly inhalation leaders. Typical services include mapping the viscosity or injectability window for a device, advising on silicone or coating strategies, providing handling and process guidance, and running early-stage stability and compatibility studies. These capabilities help lock the drug-device pairing earlier, reducing iterations.

Value Chain Expansion #3

Fill and finish is growing as a selective, site-dependent capability among primary packaging and DDS suppliers. Some suppliers operate in-house GMP fill lines for clinical and targeted commercial volumes; others use partner-enabled or hybrid models that combine ready-to-use/ready-to-fill components, small-batch clinical fills, and outsourced large-scale aseptic production. Strategic partnerships linking autoinjector platforms to CDMO fill and assembly reduce tech transfers and improve supply-chain accountability.

Key Requirements for Value Chain Expansion

Value chain expansion is becoming a competitive differentiator rather than simply a capability upgrade. As pharmaceutical companies consolidate suppliers and seek partners that can support integrated drug-device development, DDS companies must invest in the quality systems, technical expertise, and operating model required to deliver these services credibly.

Key requirements include:

• Quality and regulatory alignment: Align with ISO 13485 QMS, drug-manufacturing GMP, and device GMP expectations (e.g., 21 CFR 820 and combination-product GMP considerations under 21 CFR 4) for combination products. Standards and guidance to reference also include ISO 10993 (biocompatibility), ISO 62366 (usability), and ISO 14971 (risk management).
• People and skills: Hire or partner to secure analytical chemists for E&L, CCI, and particulates testing, alongside materials scientists, formulation and process engineers, device engineers, quality assurance and control, and regulatory affairs experts.
• Make vs. buy decisions: Determine core capabilities to develop in-house or outsource. E&L, CCI, compatibility, and device testing in-house may be strategically combined with selective partnership networks with GMP fill and finish capabilities.
• Positioning: Emphasize validated platforms, documented regulatory-grade evidence, and accountable partnerships.

Drug Delivery System Industry Outlook

As drug delivery firms prepare for the next large-molecule blockbuster or generics opportunity, pharmaceutical companies that seek to evaluate new device partners will prioritize suppliers that can:

• minimize technology transfers and vendor handoffs.
• accelerate development timelines.
• improve first-time success rates.
• deliver cleaner regulatory submissions backed by integrated, risk-based evidence.

In this shifting landscape, to stay competitive, DDS suppliers should invest in capabilities that increase regulatory lock-in, reduce redesigns, and strengthen long-term customer relationships. Strategic partnerships, acquisitions, and targeted capability expansions will remain important levers as companies compete to become the trusted upstream partner for combination products.