Accessibility Statement

Supply


Why It Matters


To Lilly:

Access requires availability. Even when a medicine is approved, priced appropriately, and covered by payers, patients cannot benefit if the product is not physically available. Supply disruptions can undermine every other access effort. Manufacturing is a critical link in getting approved medicines to patients.

To the World:

Growing global demand for innovative medicines requires manufacturing infrastructure that can scale rapidly and reliably. Patients cannot wait for capacity to catch up to need. When supply falls short of demand, markets with less established distribution infrastructure and supply chain redundancy face greater disruption — often the same markets where patients have the fewest alternatives. Building capacity ahead of demand and closer to where patients live helps reduce the risk that any patient is left waiting for a medicine.


Approach


The ability to reliably produce and deliver medicines at scale is as fundamental to our mission as the science that creates them. Since 2020, we have announced more than $55 billion in manufacturing investments globally, including 14 sites currently under construction in our 24-site network located in 10 countries. Our approach is built on five principles:

  • building inventory ahead of regulatory approval in certain cases so supply is ready when patients gain access

  • building a global footprint that brings production closer to patients

  • offering multiple forms and formats — including device options and oral presentations — to meet the needs of different patients and markets

  • deploying technology to increase speed and output, and

  • ensuring that growth at this scale is consistent with our environmental responsibilities.

A Global Footprint Built Around Patients

Our U.S. manufacturing investments are the foundation of our supply strategy — and we are building capacity globally to serve patients where they live. Local production reduces supply chain complexity, shortens the distance between factory and pharmacy, and strengthens our ability to serve growing patient populations in major markets. A distributed global footprint supports faster post-approval availability.

In the U.S., we are expanding across multiple sites and capability types — reshoring critical active pharmaceutical ingredient (API) production, extending our parenteral manufacturing network, and building capacity for oral and injectable therapies across our pipeline. In Europe, we maintain an established manufacturing presence with additional capacity announced to serve the region’s growing patient populations across EU markets. In Asia, our expansion is driven by the scale of unmet need — hundreds of millions of people across China, South Korea, and India live with diabetes, obesity and other conditions where our medicines could make a difference. We have announced manufacturing investments across these markets to bring production closer to the patients who need it.

Redundancy by Design

A resilient supply chain requires more than scale — it requires that scale be structured so that no single facility, supplier, or region becomes a point of failure. Across our network, we work to maintain multiple qualified sources for critical manufacturing steps, parallel production capacity across regions, and a deep external partner network that extends our internal capabilities.

For our most critical medicines, we qualify multiple sources for the major steps of manufacturing — from API synthesis through drug product and packaging. Our preparation for Foundayo (orforglipron), our oral GLP-1 medicine approved in the U.S. in April 2026, illustrates this approach: ahead of approval we established two to three qualified sources for each major manufacturing step and built production across three regions. This redundancy is intentional — built so a disruption at any single facility, supplier, or geography is mitigated by the additional sources.

Our internal manufacturing network is augmented by a broad network of external manufacturing partners. We work with a broad network of strategic external partners across active pharmaceutical ingredient production, drug product manufacturing, and packaging — extending our capacity and creating additional pathways through which medicines can reach patients. These partnerships are held to the same quality and safety standards we apply internally, with ongoing oversight detailed on the supply chain management topic page.

Redundancy is reinforced by visibility. We maintain active monitoring across our global network of supply and distribution sites, with real-time sensing of potential disruptions and coordinated response protocols that allow us to act before issues reach patients. In 2025, this combination of multi-sourced capacity, distributed production, and active monitoring supported shortage-free supply across our full U.S. portfolio.

Proactive Inventory Preparation for Key Launches

Our approach is to build capacity ahead of demand rather than react to shortages. This means making manufacturing investments before regulatory approvals are certain — so that when new medicines receive approval and patients want to use them, supply is available. For major programs, we coordinate launch supply readiness with regulatory timelines to prevent a situation where patients are cleared to receive a medicine but cannot access it because supply has not caught up.

For Foundayo, this approach meant building API and finished-dose capacity ahead of FDA approval so that as regulatory authorities in additional markets clear the medicine for use, supply is ready to reach patients without delay.

Meeting Patients with the Right Presentation

Patients do not all need or want the same medicine in the same form. Building reliable supply means offering the right presentation for the right patient — and the right market. For our highest-volume medicines, this means producing across multiple forms and formats: multiple device options for our injectable medicines, and oral presentations where the science allows.

For our injectable medicines, our manufacturing platforms produce single-dose autoinjectors, multi-dose reusable pen devices, and single-dose vials, with additional formats in development. This flexibility serves patients in several ways. Autoinjectors offer convenience and ease of use for patients who prefer a fully prepared, single-step device. Multi-dose pens consolidate multiple weekly doses into one device, reducing the number of devices a patient handles each month. Vials provide a lower-cost presentation that can expand affordability and broaden the patients we are able to reach. Each format also scales differently — vials and multi-dose pens can be produced at higher volumes per unit of manufacturing capacity, which helps us meet demand faster as we bring new lines online.

Oral medicines address access barriers that no injectable device can fully solve. With the approval of Foundayo, we became one of the first companies to bring an oral GLP-1 medicine to patients with obesity — a different access proposition than any injectable. A once-daily pill does not require cold-chain storage, specialized shipping, or device handling, which can make it easier to deliver in markets and settings where those requirements are barriers. Orals also reach patients who may be unwilling to use an injectable medicine, and may support adherence and weight maintenance for patients who began treatment on an injectable. Bringing oral options to the incretin class is one of the most consequential ways we are working to expand the patients our medicines can reach.

Technology Enabling Speed

Advancing technology allows us to produce more medicines from the same infrastructure, reducing the time between production and patient access. Our facilities employ machine learning, AI, digitally integrated monitoring systems, and advanced automation. We have deployed AI-powered digital twins — virtual representations of our factories — that enable us to simulate manufacturing configurations digitally before implementing them physically. For our incretin medicines, this technology has directly increased the volume of doses we can produce, helping us serve more patients at a time of high demand. We have also accelerated the process of replicating manufacturing capabilities across sites, so that new and expanded facilities reach productive output faster — shortening the path from construction to dose availability for patients.

Expansion Without Compromise

As we expand at this scale, we are accountable for how that growth affects the communities and environments where we operate. New facilities incorporate renewable energy, automation, green chemistry principles, and flexible design that allows multi-purpose production under one roof — choices that increase output while reducing environmental impact. Facilities designed for efficiency also produce more doses per unit of energy and raw material, which is why we see growing to meet patient demand and operating responsibly as connected, not competing, priorities.


Progress


In 2025 and early 2026, we finalized the selection of remaining sites for our announced $55 billion manufacturing commitment. In the U.S., we announced four new manufacturing sites and a site expansion: a bioconjugate and monoclonal antibody facility in Virginia; an API facility in both Texas and Alabama; an injectable medicine and delivery device facility in Pennsylvania; and an expansion in Puerto Rico for oral medicines. Together, these investments reshore critical API production capabilities, extend our parenteral manufacturing network, and build capacity for current and future pipeline medicines. Across the portfolio, we maintained on-time delivery of launch supply across priority markets.

We also addressed the U.S. supply shortage for our incretin medicines. After tirzepatide appeared on the FDA shortage list during a period of unprecedented demand in 2023 and 2024, we expanded API and drug product capacity, brought new lines online, and broadened the set of presentations available to patients. By the end of 2025, our incretin medicines were no longer on the FDA shortage list, and we maintained shortage-free supply across our full U.S. portfolio throughout the year. Lilly’s acquired Kenosha site was approved by the FDA ahead of schedule, accelerating availability for patients.

We expanded the pace at which new capacity comes online. Through accelerated replication of manufacturing processes and parallelized site readiness, we have shortened the timeline between groundbreaking and dose availability — moving meaningfully faster than the prior industry pace for new manufacturing builds. New drug product and packaging lines were added in 2025 across our existing network, expanding the volume of doses available to patients without waiting for new facilities to come fully online.

Our deployment of AI in manufacturing also delivered measurable results. Using digital twin technology, we optimized production of our incretin medicines, producing higher volumes than would have been possible through traditional process optimization. We also deployed AI-driven visual inspection systems across our autoinjector production lines. These technologies directly increased the number of patients we can serve at a time of high demand.


What's Next


Our focus for the coming years is on executing the investments we have announced — bringing new sites online, ramping production, and coordinating launch supply readiness so that regulatory approvals translate directly into patient availability. We expect to continue expanding the forms and formats in which patients receive our medicines, including additional device options such as reusable devices and fixed multi-dose delivery, as well as broadening availability of Foundayo as additional regulatory approvals are received. As our global network grows, we intend to continue deploying AI and digital manufacturing tools to increase output and further embed sustainability into new facilities.


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