Project Insulin: Rebuilding Insulin Access for Patients, Not Profit

While insulin production costs just dollars per vial, patients often pay hundreds — victims of a system engineered to benefit corporations, not the people who need the drug. Project Insulin is reimagining insulin access with a nonprofit model that eliminates markup, maximizes reach, and sets a precedent for patient-centered drug development.

Insulin: From Breakthrough to Bottleneck

Diabetes has reached epidemic proportions in the United States. According to the Centers for Disease Control and Prevention, over 42 million Americans — more than 10% of the population — are living with diabetes as of 2025, including both diagnosed and undiagnosed cases.¹ Nearly one-third are 65 or older, and an estimated 1.2 million new cases are diagnosed each year. An additional 100 million adults are considered prediabetic, placing them at high risk for developing the disease in the coming years.

There are three main forms of diabetes: Type 1, Type 2, and gestational. Type 1 diabetes, typically diagnosed in childhood or adolescence, occurs when the body produces little or no insulin. It is often linked to genetic predisposition or autoimmune triggers, such as viral infections. Type 2 diabetes, which accounts for the vast majority of cases, results from the body’s inability to use insulin effectively and is also associated with genetic predisposition but is often preventable or reversible in early stages with lifestyle modification. Gestational diabetes affects some pregnant individuals, leading to elevated blood sugar levels that usually resolve after delivery but increase the risk of future Type 2 diabetes.

While many individuals with type 2 diabetes can manage the disease through lifestyle changes, such as diet, exercise, and medications like metformin or GLP-1 receptor agonists, those with advanced type 2 or type 1 diabetes require regular insulin therapy. Today, more than one in four people with diabetes in the United States rely on insulin to survive.²

First isolated in the 1920s, insulin transformed diabetes from a fatal illness into a manageable chronic condition.³ Early insulin therapies were derived from the pancreases of pigs and cows and often triggered allergic reactions. The advent of recombinant DNA technology in the early 1980s enabled the development of synthetic human insulin, approved in 1982. Since then, innovation has led to the introduction of long-acting and rapid-acting analogs that offer patients greater flexibility and control in managing blood glucose levels.

Yet, despite being a century-old drug, insulin remains prohibitively expensive for many who need it — an issue driven not by science but by systemic failures in access, affordability, and incentives.

How the System Failed Insulin Users

Despite only costing $3–10 per vial to manufacture, insulin can retail for over $300. This disconnect between cost and price is not due to scientific complexity but rather to structural failures in the U.S. healthcare and pharmaceutical systems.

Insulin list prices rose between 15% and 17% per year from 2012 to 2020.⁴ Behind that growth lies a tangled and opaque supply chain. Before insulin reaches a patient, it may pass through as many as 10 intermediaries, including manufacturers, wholesalers, pharmacy benefit managers (PBMs), insurers, and pharmacies, each adding cost along the way. In this system, patients pay the most while others profit.

The consequences are dire. A 2022 Yale study found that 14% of insulin users spend at least 40% of their disposable income, after housing and food, on insulin alone.⁵ Many patients, even those with insurance, end up paying hundreds out-of-pocket every month. Some have taken on more than $9,000 in debt just to stay alive. Others skip doses or stretch their supply, a dangerous form of self-rationing that, in one 2018 study, affected as many as 1 in 4 patients.⁶ The result is preventable complications, emergency hospitalizations, and death.

Affordability varies widely depending on coverage.^4,7 Roughly half of uninsured patients pay full list prices for insulin; the rest receive limited support through compassionate-use or manufacturer discount programs. Yet 75% of prescriptions filled by uninsured patients cost over $100, pushing many to opt for older, less effective formulations that offer weaker glycemic control. Among those with insurance, costs still fluctuate based on plan type, deductibles, and drug tiers. Commercially insured patients account for about half of all insulin users, but they also shoulder much of the financial burden, often paying out-of-pocket until they meet high deductibles.

Medicare Part D enrollees currently benefit from a $35 monthly cap, but that only applies to those with the right coverage. Many patients on Medicare Advantage (Part C) receive no insulin coverage at all, and proposed changes under the current administration could limit eligibility for both Medicare and Medicaid. Most Medicaid recipients pay little or nothing for insulin, but that could also change depending on future policy shifts.

The three companies that dominate the U.S. insulin market — Eli Lilly, Novo Nordisk, and Sanofi — have introduced savings programs in recent years, but these are voluntary and often riddled with eligibility restrictions. Notably, approximately 20% of Medicare beneficiaries lack Part D coverage and are ineligible for these savings. And with no mandate to continue these programs, access remains unstable.

In effect, the U.S. insulin supply chain operates with a short-term profit focus. It’s a model that pushes risk and cost onto patients. especially the uninsured, underinsured, and elderly. Given the rising prevalence of diabetes, growing demand for insulin, and systemic failure to deliver it affordably, the current moment presents both a crisis and an opportunity for reform.

A Biosimilar Solution from Project Insulin

Project Insulin is a nonprofit pharmaceutical company with a mission to make insulin affordable for everyone. Instead of chasing profit, the organization is developing a biosimilar version of insulin glargine modeled after the blockbuster brand Lantus, with plans to distribute it directly to patients at cost.

The idea began with a moment of correction. During Diabetes Awareness Month in 2020, founder and Executive Director Eric Moyal, an experienced nonprofit fundraiser, made a social media post praising the market for its advances in diabetes care. His partner’s sister, who has type 1 diabetes, pointed out the reality: the insulin used today is no different than the insulin from 20 years ago, and the insulin crisis wasn’t the result of innovation; it was a money problem. That realization sparked a bold idea: what if someone tackled it as a nonprofit, free of shareholders?

With a background in fundraising rather than science, Moyal believed the solution wasn’t technical — it was financial. “We’re not trying to disrupt Big Pharma,” he says. “We’re trying to reach the people they don’t.”

“The intent is to cut out multiple middle organizations that add to the final cost per vial, and put those savings back into patients’ pockets,” says Moyal. “By owning our insulin and controlling the supply chain, we not only reduce costs but can prioritize access over profit.” He also observes that Project Insulin has a fiduciary duty to support communities, a long-term focus on sustainability, and a commitment to re-investing in R&D. “We are creating a transparent, replicable model for how generic and biosimilar medicines can be developed and delivered differently,” Moyal adds.

Project Insulin’s model is radically transparent. The price per vial is determined by a simple formula: (operating costs + manufacturing costs) / vials sold. The more insulin the group produces and the more support it receives, the lower the cost for everyone.

Their nonprofit status allows them to first cut out the fiduciary responsibility to shareholders and profit seekers and will then eliminate the profit-seeking intermediaries that inflate prices at every stage of the traditional insulin supply chain. Project Insulin will sell its biosimilar directly through a mail-order pharmacy — either owned or white-labeled — and through partnerships with local, state, and federal healthcare clinics. The nonprofit aims to serve patients who fall through the cracks of commercial programs, government subsidies, and patchwork affordability efforts.

Project Insulin has built a robust volunteer-led team with deep expertise in strain engineering, fermentation, downstream processing, analytics, and scale-up.

Nonprofit Approach Provides Many Benefits

Founding Project Insulin as a nonprofit wasn’t just a strategic decision; it was a matter of principle. Moyal recognized early that trust would be essential in working with a community that had long been underserved.

The nonprofit model offers both moral and practical advantages. Without shareholders to satisfy, Project Insulin can price their insulin biosimilar to match their costs and ensure an enduring supply of cost-effective insulin. In addition, while development and initial production will require funding, once the organization is selling insulin, the sales will provide sustainable funding, with any additional donations and grants reducing prices further.

Donations have a direct benefit on the price patients pay, and such a clear impact can be a powerful incentive for foundations to give because their dollars can affect a large number of people, according to Moyal. “We also are not threatened by competitors. In fact, if another organization wants to use our model, we would be excited, because our mission is to make insulin affordable, not to make money. Our commitment is not to a few hundred thousand shareholders, but to a billion people with diabetes worldwide,” he says. “We are running Project Insulin as a business because of the efficiencies that can be gained, particularly for something as complex as bringing a biosimilar to market. The difference is that our bottom line isn’t profit, but people’s health,” Moyal adds.

That clarity of purpose also opens doors that traditional drug companies can’t access. Foundations and donors are drawn to the ability to make a tangible difference. Each dollar goes further, reducing costs in real-time for people who might otherwise go without.

Importantly, Moyal believes this approach could be extended beyond insulin. Project Insulin may eventually serve as a template for nonprofit biosimilar or generic drug development in other high-need therapeutic areas, such as oncology or cardiovascular disease.

Industry Backing for a Mission-Driven Model

One of the most rewarding surprises in building Project Insulin has been the enthusiastic response from contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), and scientific advisors across the pharmaceutical industry. From the start, Eric Moyal made no attempt to disguise the challenge: Project Insulin is a nonprofit in need of support across every stage of development — from strain engineering to regulatory strategy.

“We solicited proposals from several firms and made it clear we are a nonprofit that requires significant assistance with all aspects of development, manufacturing, and regulatory compliance, and cost. In return we received not only proposals with accurate numbers, which helped us learn what our budget should be, but also assistance with marketing and more. The amount of patience and energy people have given is tremendous,” Moyal emphasizes.

“When speaking with one CRO that we felt ready to move forward with, they told us that we would save more money in the long run and ensure that we are optimizing our drug development pathway if we hired a Chief Scientific Officer (CSO) before getting started. That piece of advice led us to taking a step back and hiring our CSO, and we are now getting back to interviewing CROs,” says Moyal. “I was shocked when they made that suggestion, since it wasn’t a decision that would make them money in the short term. But they believe in us and in our work, and they want us to succeed. That stands out as such a cool moment of solidarity and buy-in for what we're trying to do.”

Building Toward Strategic Partnerships

According to Eric Moyal, Project Insulin sees significant potential for partnerships that could help extend access and drive affordability, but the organization isn’t jumping in prematurely. “We’re laying the groundwork now,” Moyal says, “so that when we do move forward, we can do it in a way that’s sustainable and impactful.”

Some of these opportunities lie within government programs, such as the Department of Veterans Affairs, Medicare, and Medicaid. Because each agency or program has its own operational priorities and reimbursement mechanisms, Project Insulin is taking a tailored approach, building models to understand the potential impact of each collaboration. Moyal believes state-level Medicaid programs could be an effective starting point, offering scalable avenues for affordable insulin access.

In parallel, the team is exploring partnerships with mission-aligned private and municipal organizations. Entities such as Cost Plus Drugs, Outreach RX, and local health systems. Project Insulin is also evaluating white-label distribution opportunities and mail-order fulfillment models that would allow them to maintain control over pricing and access while expanding reach through existing infrastructure.

Rewiring the Supply Chain for Equity

The founding of Project Insulin coincided with a shift in both public awareness and infrastructure. As more brick-and-mortar pharmacies close and mail-order prescriptions become commonplace, the barriers to direct-to-patient distribution have lowered. “We’re fortunate to be launching at a time when patients and the system are more open to new ways of delivering medications,” says Eric Moyal.

Project Insulin is evaluating two models to enable mail-order fulfillment: developing its own internal platform or outsourcing to mission-aligned partners. Either path would take advantage of existing capabilities to minimize cost and accelerate launch.

But not all patients can be reached through mail alone. To address this, Project Insulin is building a hybrid distribution model that combines direct-to-patient shipments with partnerships across the healthcare safety net. Plans include working with federally qualified health centers (FQHCs), mobile clinics, and community health distribution sites to ensure that even patients in underserved areas have access to affordable insulin.

By bypassing pharmacy benefit managers, wholesalers, and insurance middlemen, the model keeps patients, rather than intermediaries, at the center of the supply chain.

Expanding Access Globally

While Project Insulin’s immediate focus is on lowering insulin costs in the United States, the organization’s vision extends far beyond domestic borders. “The scale of lives we can help can grow from a few million to 400–500 million people worldwide,” says Moyal.

In many regions, particularly in low- and middle-income countries (LMICs), the problem isn’t just affordability; it’s outright scarcity. Countless patients go without insulin not because it’s too expensive, but because it simply isn’t available. To achieve that long-term vision will require establishing manufacturing capabilities in different regions/countries. Moyal sees that as a real challenge but also an exciting opportunity — and another area where partnerships could play a big role.

Moyal envisions a future where localized manufacturing hubs in underserved global regions can produce biosimilar insulin sustainably and affordably. These facilities would reduce reliance on fragile global supply chains and enable more equitable access. He also dreams of developing heat-stable insulin formulations suitable for distribution in areas without reliable refrigeration, such as parts of sub-Saharan Africa.

Funding, as always, will be the hinge point for global expansion. But the need — and the opportunity — are immense.

Fueling a Movement

Although fundraising started slowly, Project Insulin has gained significant traction in 2024 and 2025. The organization has attracted growing public awareness and key technical experts, validating its strategy for developing a biosimilar insulin glargine product.

In July 2025, Project Insulin appointed Dr. Allison Ortigosa as its first Chief Scientific Officer. With over 18 years in bioprocess development, including 16 years at Merck & Co., where she helped bring multiple biologics and vaccines from laboratory scale to commercial manufacturing, Dr. Ortigosa brings deep technical expertise to a pivotal stage in the nonprofit’s journey. Notably, she served as the drug substance technical lead for insulin glargine, the very molecule Project Insulin is now developing as a biosimilar. Her appointment signals the organization’s readiness to transition from planning to hands-on drug development and regulatory execution.

In fall 2025, Project Insulin plans to begin drug development work with a yet-to-be-announced CRO partner. Conversations are also underway with contract manufacturers, fill/finish service providers, and potential distribution partners.

“Each step forward adds credibility and validates our process,” says Moyal. The organization has already raised $330,000 and is aiming to raise an additional $750,000–1,000,000 in the next six months. These funds will support team expansion, preparation for a first meeting with the U.S. Food and Drug Administration (FDA), process development, analytical comparability studies against the reference product (Lantus^®, Sanofi), in vivo testing, stability studies, and other preclinical work. The long-term regulatory goal is to secure FDA designation as an interchangeable biosimilar, enabling pharmacy-level substitution and wider adoption.

While advancing toward phase I clinical trials and eventual FDA filing within five years, Project Insulin is also navigating real-world manufacturing constraints. Fill-finish capacity and cold chain logistics are major bottlenecks, particularly as many CDMOs prioritize production of high-demand GLP-1 drugs, as well as investments in equipment for innovative techniques like gene expression.

Fundraising remains critical. The bulk of Project Insulin’s support so far has come from more than 250 individuals and small donors through recurring crowdfunding campaigns, supplemented by family foundations contributing between $10,000 and $50,000. “All donations make a huge difference,” Moyal emphasizes. “With the right support, we can fundamentally change how patients in the United States access affordable medications.”