First discovered in 1916, heparin remains one of the most essential and widely used anticoagulants in modern medicine. It plays a vital role in preventing and treating blood clots, particularly in surgical settings, dialysis treatments, and for patients reliant on central lines for medication or nutrition. Its fast-acting, reversible nature makes it uniquely suited for acute care, providing life-saving benefits in cases where oral anticoagulants aren’t viable.

Despite its critical importance, the global supply chain behind heparin is fragile. The drug is derived primarily from the intestinal mucosa of pigs, with China serving as the dominant supplier due to its scale of production and processing infrastructure. As a result, concerns are now rising as proposed U.S. tariffs on Chinese pharmaceutical imports threaten to disrupt the flow and affordability of heparin.

To better understand the risks and potential solutions, Drug Discovery News spoke with Johanna DeYoung and Blair Kerr, the global industry lead and industry director for healthcare and life sciences at Slalom. They shared insights into the systemic vulnerabilities of the heparin supply chain, the regulatory and technological strategies that could mitigate future shortages, and the emerging role of synthetic alternatives.

Can you outline the primary complexities involved in heparin production, particularly regarding sourcing key ingredients and maintaining consistent quality?

Heparin was discovered over a century ago and is derived from porcine and bovine sources. Because it comes from live animals, there's inherent variability, and the volume needed is staggering. It's estimated that more than a billion pigs are slaughtered annually to meet global demand. Historically, about 60 percent of the US supply has come from pig intestinal mucosa sourced from China.

Even before the distillation process, there are massive quantities of biological material that require heavy-duty, specialized machinery to process. This machinery is expensive, difficult to move, and not easily repurposed.

Heparin manufacturing is complex and time-intensive. The goal is to extract and purify specific components from a very unsterile starting point. Farm animals aren’t known for cleanliness, and pigs, in particular, can host a range of viruses. Epidemiologists often track whether a virus can live in pigs, because if it can survive and evolve in that environment, it’s more likely to become highly resilient. That context helps explain why heparin production involves so many steps, each with its own quality controls, material volume, and variables. It’s a supply chain that’s hard to replicate and even harder to shift quickly. 

How significant is the potential impact of a heparin shortage on patient care, particularly for the estimated 12 million people who rely on it annually?

A shortage of heparin would pose a serious threat to patient care across the healthcare system. It’s a critical medication used across numerous clinical settings including dialysis, surgery, cardiac procedures, pulmonary embolism treatment, clot prevention, deep vein thrombosis, and even for coating medical devices to prevent clotting.

Heparin is one of the most widely prescribed drugs in hospitals. Some estimates suggest that 50–70 percent of inpatients require it, potentially even more than antibiotics. Its role in medicine is so foundational that it's often described as second only to insulin in terms of essential, routine use. Demand for heparin is high and inelastic, and with few viable alternatives, disruptions in the supply could directly compromise health outcomes on a global scale.

Given the current supply chain volatility, what short-term regulatory or production strategies should be considered to mitigate potential Heparin shortages?

A lot of today’s supply chain disruption stems from uncertainty, particularly around tariffs in the pharma sector. It's unclear which countries, ingredients (APIs vs. finished products), or rates will ultimately be targeted. The US sources around 30 percent of its APIs from China, and with over 270 drugs already on the shortage list, simply providing clear regulatory intent could go a long way in reducing anxiety across the industry.

Historically, pharmaceutical tariffs are rarely applied, given the lifesaving nature of these products. In the case of heparin, exempting critical inputs, like pigs or cows raised specifically for heparin production, would be necessary to maintain stable pricing and supply. 

Another strategy is reintroducing bovine Heparin. It was used in the US until the 1990s, when concerns about mad cow disease shifted the market almost entirely to porcine sources. Since bovine and porcine heparin are processed similarly, integrating bovine sources could diversify the supply base, reduce reliance on Chinese exports, and create new global partnerships. That said, this would require regulatory approval and revised quality standards, and could strain current bovine supply, especially if there are potency differences.

On the production side, supply chain visibility is key. Companies benefit significantly from using enterprise data platforms and supply chain control towers, particularly during COVID. These tools enable real-time insights and faster decisions, which are crucial during times of disruption.

Are there any promising synthetic alternatives to heparin that could serve as viable substitutes in case of a prolonged supply disruption?

There’s real potential in synthetic heparin, but more investment is needed to make it viable at scale. A synthetic version could reduce variability, eliminate dependence on animal sources, and result in a purer, safer, and more consistent drug. Additionally, another goal of synthetic heparin is to improve the responsiveness to protamine in case of adverse effects. However, early research indicates that high production costs remain a major barrier to scalability.

Some of the therapeutic areas that heparin treats already have alternatives, such as anticoagulants, and in the event of a shortage, using those can help preserve heparin supplies for use cases where there are no effective substitutes. 

However, it’s worth noting that even synthetic options aren’t immune to supply chain and tariff-related challenges. For example, about half of all generics used in the U.S. are manufactured overseas, and shifting trade policies could increase costs by up to 10%. Compounded drugs present a more complex picture, as tariffs can be assessed in various ways, including import value, consumer price, or third-party sale price. Even synthetic versions may face pricing volatility depending on how raw materials and APIs are treated under evolving trade policies. Some synthetic products still rely on traditional APIs, meaning they could help stretch existing supply further, but they won’t entirely escape global pricing and policy pressures.

What lessons can be drawn from previous supply chain disruptions in the pharmaceutical sector that could inform current strategies for managing the heparin supply crisis?

The pharmaceutical supply chain has faced disruptions from disease outbreaks, natural disasters, geopolitical events, and overreliance on a small number of upstream suppliers. These external threats aren’t going away; in fact, they’re expected to become more frequent. If we take past lessons seriously, we should be building more resilient and diversified supply chains now.

The vulnerability of the heparin supply chain isn’t new, but awareness and proactive planning are still lacking. The American Heart Association has called on Congress to revive legislation like the Pharmaceutical Supply Chain Risk Assessment Act and Mapping America's Pharmaceutical Supply Act that they first proposed in 2023 to identify weak points and strengthen the system before a crisis hits.

Once a shortage occurs, patient safety must be the top priority. After the 2017 hurricane in Puerto Rico disrupted heparin production, many providers switched to an anticoagulant, Enoxaparin. Researchers found that medication error rates increased for both heparin and its alternative, 153 percent and 114 percent, when prescribers were forced to adopt different behaviors in the wake of a heparin shortage.  With drug shortages lasting an average of 181 days, provider education is critical. Communication through multiple channels like email, daily standups, leadership coordination across therapeutic areas, and EMR alerts can guide safer prescribing. Given heparin’s widespread use, condition-specific guidance will also be key to maintaining accurate dosing.

Additionally, as we monitor the heparin supply chain today and wait for clarity on pharma tariffs or regulatory actions, we can look to and learn from supply chain strategies that medical devices will employ as they navigate recently imposed tariffs.