ARPA-H, $176M 투자로 주문형 장기 인쇄 지원

장기 부족과 주문형 바이오프린팅의 필요성

Organ donations are a key medical tool keeping millions of people alive, with almost 50,000 transplants performed yearly in just the USA. Still, the supply of organs is insufficient to satisfy demand, with 13 people dying every day in the USA while waiting for an organ transplant, and over 103,000 people on the national waiting list.

이 부족은 더 많은 장기 기증을 통해 부분적으로 완화될 수 있으며, 이는 여전히 중요한 정책 과제입니다. 그러나 호환 가능한 기증자를 찾는 일은 전체 기증자 부족만큼이나 큰 도전입니다.

Ideally, the ability to “produce” any organ on demand would offer a superior solution. But it would still not remove the problem of compatibility, or the need to take anti-rejection drugs, which weaken the immune system. Transplanted organs also tend to have a shorter lifespan than the original.

“환자가 이식받은 경우에도 장기는 보통 15-23년만 지속되며, 거부 반응을 방지하기 위해 평생 동안 비용이 많이 들고 심각한 건강 문제를 일으킬 수 있는 약물을 복용해야 합니다.”

The current situation also leads to stark inequality in outcomes. Because of factors like geographic distance and the need for specific blood type matches, rural populations and minority groups face significantly higher hurdles. The data on these disparities is concrete:

• Waiting List Representation: While Black Americans make up approximately 28% of the transplant waiting list, they received only about 23% of transplants in 2024.
• Transplant Disparity: Conversely, White Americans comprised roughly 39% of the waiting list but received nearly 49% of all transplants.
• Donor Availability: Biological matching often requires donors of similar ethnic backgrounds, yet donation rates vary widely. White individuals accounted for roughly 67% of all donors in 2024, compared to approximately 13% for Black and 15% for Hispanic individuals.

On-demand organs that could be implanted in any patient regardless of demographics would be a massive equalizer in this system.

This is the exact goal of a series of awards granted by the Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS). ARPA-H was created in 2022 with a $1 billion congressional appropriation and signed into law by President Joe Biden.

“전 세계 이식 역사상 보편적으로 매치된 장기를 개발한 적이 없습니다. 정확히 매치된 기능성 인간 장기를 프린팅하는 것은 이식 의학의 가능성을 근본적으로 바꾸고 수많은 생명을 구할 것입니다.”

– Alicia Jackson, Ph.D., ARPA-H Director

Its Personalized Regenerative Immunocompetent Nanotechnology Tissue (PRINT) program is looking to encourage the development of organ printing technology that does not require immunosuppressive drugs.

“목표는 환자 자신의 세포 또는 바이오뱅크의 세포를 사용해 몇 시간 안에 면역 매치된 대체 장기, 예를 들어 신장, 심장, 간 등을 빠르게 생산하는 것입니다.”

3D 바이오프린팅이란 무엇이며 장기가 어려운 이유

3D printing, or additive manufacturing, is now a relatively familiar technology. It started with plastic filaments and is now becoming feasible with many materials, including metals. The next frontier is printing organic tissues.

세포를 개별적으로, 복잡한 3D 레이아웃과 다중 레이어로 추가함으로써 3D 바이오프린팅은 장기가 필요로 하는 정확한 형태와 질감을 복제할 수 있습니다. 최초의 성공적인 개념 증명 중 하나는 2016년 Wake Forest University에서 기능적이고 생존 가능한 3D 프린팅 귀를 만든 것이었습니다. (ARPA-H 자금 지원을 받은 수혜 대학 중 하나인 Wake Forest University 페이지에서 바이오프린팅에 대해 더 읽을 수 있습니다.)

The bioprinting market, for now mostly limited to niche use cases and academic research, is already a $2.91B market (in 2025) and is expected to grow by 12.54% CAGR until 2034.

The idea is to either produce organs from a patient’s own cells, removing all risk of immune reaction, or to use cells from a biobank modified to achieve the same result. The technology has recently made good progress, including using ultrasound for guided bioprinting, bioprinting pancreas islets for diabetes treatment, and creating 3D printed skin for lab experiments and skin grafts.

ARPA-H의 PRINT 프로그램 설명

Overview

The goal of the program is to achieve what has been so far an elusive target: 3D print a human-sized organ, with all the cells, blood vessels, and tissue materials that allow it to function as a heart, filter blood and produce urine as a kidney, and uphold metabolism as a liver.

A success of the program, for now focused on these 3 key organs, could later be expanded to the pancreas and lungs. The PRINT program total is up to $176.8 million over 5 years. Details and timing of the exact payment will depend on each of the selected research teams meeting aggressive and accelerated milestones.

The program was launched in 2024, requiring proposals from researchers focused on three technical areas:

• Generate all necessary organ cell types from the best cell source(s).
• Large-scale manufacturing of organ cell types.
• Organ biofabrication and IND-enabling in vivo testing.

In 2026년 1월, it announced the selected research teams for the program.

Who Received ARPA-H PRINT Funding

Carnegie Mellon University

The Pittsburgh-based university aims to create a cost-effective immune-silent bioprinted liver that is ready for first-in-human trials in five years, under the project named LIVE, or Liver Immunocompetent Volumetric Engineering.

It will receive $28.5M from ARPA-H for this project.

The engineered livers will be initially produced to address acute liver failure, with the long-term goal of addressing all liver failure.

“우리가 만드는 간은 약 2~4주 동안 지속될 것입니다. 이는 환자 자신의 간이 재생될 시간을 주며, 이후에는 간 이식이 필요 없어 다른 환자들을 위한 간을 확보할 수 있게 됩니다.”

– Adam Feinberg, Professor of Biomedical Engineering at Carnegie Mellon

Wake Forest University

The university located in Winston-Salem, N.C., will seek to produce clinical-grade vascularized renal tissue to augment renal function in patients suffering from kidney disease.

This project will work in parallel with both preclinical trials and the development of a plan for commercialization. This way, the technique should not only perform well medically, but also be viable from an economic point of view, providing “a cost-efficient solution to the nation’s growing donor organ shortage.”

Wyss Institute

The Harvard research institute, located in Boston, will develop universal, clinical-scale liver tissue from adult stem cells.

The Lewis lab has created another method, called SWIFT (sacrificial writing into functional tissue), in which hundreds of thousands of stem-cell-derived aggregates are concentrated into a dense, living matrix of organ-building blocks (OBBs) that contains about 200 million cells per milliliter.

With a focus on adequate vascularization (blood vessel development), the research team hopes their technology can benefit all sorts of patients with liver dysfunction.

University of California, San Diego

The university will print livers using stem cells produced by local firm Allele Biotechnology. It will receive around $25M from ARPA-H for this task.

The liver will be tailored to an individual’s unique anatomy and physiology, without the need for donor tissue or immunosuppressants. This should ideally ensure long-term functionality and integration of the 3D-printed organs.

“우리가 다른 사람들의 압출 프린팅과 다른 점은 전체 페이지를 동시에 프린팅한다는 것이며, 이는 그들이 하는 것보다 실제로 10,000배 빠릅니다.”

– Shaochen Chen, Professor in the university’s Jacobs School of Engineering

Human trials are expected in five years if everything goes according to plan.

University of Texas Southwestern Medical Center

The Dallas-based university will receive nearly $25M for the development of a transplantation-ready liver capable of providing full function in patients with liver failure. The program is called Vascularized Immunocompetent Tissue as an Alternative Liver (VITAL).

“UTSW는 최근 1,000번째 간 이식을 기념한 강력한 장기 이식 프로그램을 보유하고 있습니다. 이 프로젝트는 생물 의학 혁신을 통해 환자 치료를 진전시키는 대담한 단계이며, 엔지니어, 임상의, 과학자를 결합해 발견을 현실 솔루션으로 전환하고, 기능성 장기 프린팅이 현실이 되는 미래를 형성합니다.”

– Dr. Samuel Achilefu, Ph.D., Inaugural Chair of Biomedical Engineering

This means not only a functional organ metabolically, but also reconnecting blood vessels to restore blood flow and establishing a bile duct system for fluid transport.

왜 ARPA-H가 장기 프린팅 일정 가속화를 이끌 수 있는가

3D-printing organs has been a trendy idea that is only slowly making its way into practical clinical applications. This is because recreating something as complex as organs—made of hundreds of billions of cells with many complex sub-types—requires mastering details that are often poorly understood.

처음부터 장기를 설계하는 것은 엔진이 어떻게 작동하는지 정확히 알지 못한 채 알려진 부품으로 제트 엔진을 조립하는 것과 같습니다. 다행히 살아있는 세포, 특히 줄기세포는 스스로 조직을 형성하도록 설계되어 연구자들을 돕습니다.

The sudden influx of money by ARPA-H into this topic should help accelerate the timeline to start seeing printable organs that are potentially superior to the usual donated organs.

3D 바이오프린팅 및 재생 의학에 대한 투자

United Therapeutics

United Therapeutics는 3D Systems (DDD ) Corporation과의 파트너십을 2017년에 체결하는 등 바이오프린팅 분야의 선구자로 오랜 역사를 가지고 있습니다 .

The company is focused on rare diseases (interstitial lung disease – ILD, Pulmonary Arterial Hypertension – PAH, and neuroblastoma) and end-stage lung diseases.

This also means that while 3D bioprinting is important for the future of the company, it is also a traditional biotech company at the same time. This gives the company more than $1.6B in TTM (Trailing Twelve Months) operating cash flow and a solid cash reserve to keep financing innovation without risking excessive dilution of existing shareholders.

The company’s revenues have steadily risen in the 2020s, in large part thanks to its growing sales from Tyvaso, the most prescribed U.S. prostacyclin (for the treatment of Pulmonary Arterial Hypertension – PAH), which still grew 10% year-to-year in 2025.

In bioprinting, the company is still at the R&D stage, with its most advanced product for lung transplant, with alternative kidney and liver also in development.

Outside of organs, the company’s R&D schedule is mostly focused on expanding Tyvaso’s applications to increase its sales.

So, as 3D printing is getting a lot more attention and research budget, companies like United Therapeutics, with a head start in the field and already starting clinical trials, might have a clear advantage in commercializing an early form of the technology, likely followed by several decades of improvement (and the associated renewed or new patents).

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