3D Printed Drugs – Guide (Updated 10-12-2026)

Category: Blog,Healthcare 3D Printing Guide

Oct 11, 2026

3D-printed drugs are medicines made layer by layer, allowing you to tailor each tablet’s dose, shape, and release profile to a single patient, sometimes combining several drugs into one tablet. This guide to pharmaceutical 3D printing covers how 3D-printed medicines are made, their uses and benefits for patients, the technical, regulatory, and financial challenges, the key companies, and how the FDA, the UK, and the EU now regulate point-of-care printing.

Updated October 2026. New developments are marked “Update (October 2026)” in each section, and summarized in the last section, “What has changed since August 2025?”

With advances in 3D printing technology, materials, and formulations, the number of research publications [Figure 1] and startups in the space has increased. The intrinsic advantages of additive manufacturing include mass customization and complexity for free, empowering pharmaceutical professionals in creating innovative solutions. Spritam by Aprecia, a seizure medication with a quick-release profile approved in 2015, remains the only FDA-approved 3D-printed medication, but more newcomers are successfully challenging the regulatory barriers. For example, Chinese startup Triastek received Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its first 3D-printed drug product, T19, a rheumatoid arthritis medication. Triastek’s gastric-retention anticoagulant T20G received FDA IND clearance in February 2025. An upcoming European/UK regulatory update on point-of-care 3D printing may enable widespread adoption of 3D printing in extemporaneously compounded medications, per Anna Worsley from FabRx at a recent 3DHEALS conference on the same subject.

Update (October 2026): The UK update is now in force (July 23, 2025), and FDA has proposed its own distributed manufacturing pathway. See the regulatory section below. Our August 14, 2025 webinar, 3D Printed Pharmaceuticals, brought together Alvaro Goyanes (FABRX), Seng Han Lim (Craft Health), Niklas Sandler (CurifyLabs) and Thomas Forbes (NIST). Read the event recap or watch the full session on demand.

In this guide, we will address the major questions related to 3D-printed drugs. This guide does not include discussion related to other 3D-printed drug delivery medical devices. The following main questions will be addressed:

What additive manufacturing processes are used to 3D print pharmaceuticals?
What are the major additive manufacturing applications of 3D-printed drugs?
How can 3D-printed drugs benefit patients?
Some of the major technical challenges facing the industry
What are the key regulatory questions and challenges facing the industry?
What are the main financial challenges facing the industry?
Who are the major players in the space?
What are some of the latest industrial trends?
What has changed since August 2025? (new)

Figure 1. Number of publications focusing on “3D printed drugs” by year

Which additive manufacturing process has been used to 3D print pharmaceuticals?

About seven major manufacturing processes are used to 3D-print pharmaceuticals. Startups working in the area are indicated next to the process types below:

Vat Photopolymerization
1. SLA
2. DLP – FabRx
Material Jetting
Binder Jetting – Aprecia (ZipDose, used for Spritam)
Powder bed fusion
1. SLS – FabRx, Sinterit
Material Extrusion:
1. FDM (Fused Deposition Modeling) – FabRx, CraftHealth, Nourish3d
2. DPE (Direct Powder Extrusion) – FabRx
3. MED (Melt Extrusion Deposition) – Triastek
4. SSE (Semisolid Extrusion) – FabRx, Craft Health (CraftMake), CurifyLabs, MB Therapeutics
Direct Energy Deposition
Sheet Lamination
3D Screen Printing – Laxxon Medical

A new 3D printing method, 3D Screen Printing, was recently introduced to the market by Laxxon Medical, branded as SPID (Screen Printing Innovative Drug). For those interested, you can find the publication here.

Update (October 2026): Semi-solid extrusion has become the main printing process in pharmacies and hospitals because it runs at low temperatures and suits chewables and small batches. GMP-certified printers built on this platform, such as FabRx’s M3DIMAKER and Craft Health’s CraftMake, are now being placed in hospitals and pharmacies. FABRX co-founder Alvaro Goyanes compares the M3DIMAKER to a single-serve coffee machine for the compounding pharmacy in Lattice Podcast Episode 112.

What are the major applications of 3D-printed drugs?

The greatly increased design freedom in 3D-printed tablets allows more customization across many aspects of existing pharmaceuticals. Here we list some of the major applications and potential markets as follows:

Well-controlled complex release profile by design. This largely depends on the complexity of geometry, according to Professor XiaoLing Li (Triastek) during the 3DHEALS conference.
Polypills
Pattern (e.g. Braille, data matrix)
Color
Taste
Different formulations (e.g., chewable tablets)
Dosage

Update (October 2026): Dosage is where most clinical activity now sits: exact doses for one patient, printed in the hospital or pharmacy, mostly for children and rare diseases. Polypills are next: at our 3D Printed Pharmaceuticals event, FABRX described combining several extrusion methods in one printer to make them.

How can 3D printed drugs (potentially) benefit patients?

Personalization of tablets with unique release profiles that fit a patient’s unique biometrics (i.e. weight, size, metabolism, renal function, etc.) For example, the team at Craft Health published a paper on an in vitro study of targeted release at different locations in the colon.
Improved compliance – For example, better flavor, color, and texture for pediatric patients. For example, this published meta-review summarized a variety of pediatric medications that can be 3D printed via various processes to improve patient palatability/compliance.
Decentralized drug delivery process – For example, researchers at FabRx published a paper demonstrating a smartphone based 3D printing process that can allow patients to create variable tablets fitting their treatments at home.
Significant reduction in formulation development time, i.e. “rapid prototyping”
Reducing batch manufacturing cost, perfect for personalized medicine.
Revival of some abandoned drugs due to small target market
“Endless (design) possibilities”
Extension of expiring patents or generics for pharmaceutical companies.

Update (October 2026): what the clinical evidence shows so far. The 2026 review by Gioumouxouzis and colleagues counted 10 clinical studies and one community-pharmacy study. The best-known comes from Santiago de Compostela, Spain. Four children with maple syrup urine disease took printed chewable isoleucine for six months. Their blood levels sat closer to target and varied less than with hand-filled capsules (Goyanes et al., 2019). A follow-up at the same hospital used a GMP-compliant printer for six children with three metabolic disorders. Other studies include a non-randomized comparison in 91 premature infants receiving levothyroxine, and bioequivalence studies in healthy volunteers. In a Madrid community pharmacy, FabRx reported cost reductions of up to 35% for printed minoxidil capsules compared with manual compounding (nine patients). In October 2026, a doctoral thesis from Åbo Akademi University and its spin-off CurifyLabs examined dose accuracy for pharmacist-dispensed printed gels. At our August 2025 event, FABRX said it has taken part in more than 30 hospital clinical trials (recap). In Episode 112, Goyanes also describes a printed hydroxyurea project for children with sickle cell disease, in collaboration with a team in Montreal.

Some of the major technical challenges facing the industry:

As with any emerging technology in healthcare, there are several challenges before the industry can be widely adopted and scaled. These are identified as some of the major challenges:

Lack of 3D-printable, safe materials for 3D-printed drugs. Importantly, many 3D printing processes involve heating, which limits the number of APIs to non-thermally sensitive ones.
There is limited knowledge on matching 3D printing processes with APIs (Active Pharmaceutical Ingredients). However, we have made a lot of progress then. The creative design also helps. For example, it is hard to 3D print insoluble APIs, but some startups are tackling this challenge by creating compartments that can contain the insoluble components.
Lack of long-term clinical validation.
Inability to scale to the same level as conventional mass manufacturing methods. While none of the current 3D printing drug manufacturing processes can achieve the same production volume as traditional powder compression techniques, MED (Triastek) and SPID (Laxxon) seem most promising for high-volume production.
Lack of well-defined quality control process

Update (October 2026): Two further challenges stand out as printing moves into pharmacies. First, quality control for a batch that is one patient’s supply needs non-destructive testing, such as near-infrared or Raman spectroscopy, and those methods still need validation. Second, results depend on trained operators, written procedures, and validated cleaning between products. Early hospital studies used food-grade or non-GMP printers, so their results are proof of concept only. Vendors are building checks into the machine: FABRX’s printers carry a balance, a pressure sensor, a camera, and AI-based monitoring (Episode 112), and CraftHealth uses pre-mixed inks that need no heating or UV curing. NIST is applying FDA’s Quality by Design framework to measure dose variability at point-of-care sites (event recap).

What are the key regulatory questions and challenges facing the industry?

While FDA-approved 3D-printed drugs are currently scarce, as noted at the beginning of this article, the uptick in research activity [Figure 1] suggests more commercialization in the space. In fact, the FDA CDER (Center for Drug Evaluation and Research) already has dedicated resources in the space, indicating a cleaner future drug approval process.

The top questions FDA wanted to address also parallel the top regulatory challenges. Drug and equipment developers should pay close attention to the following technical questions:

What critical parameters affect the printability of various materials for drug products?
What are the critical process parameters for each 3D printing technology?
How can we assess the performance of 3D-printed drug products?
Can we use traditional in vitro testing methods for 3D-printed drug products?
How can we determine when and how a specific 3D geometric design may not perform as expected?
What are the critical characteristics of intermediate products for 3D printing, such as 3D-printing inkjet inks, filaments, substrates, and cartridges?
What critical factors in 3D-printed design affect drug release rates and mechanisms?

Additional regulatory challenges from the FDA perspective also include the following:

To what extent can the 3D-printing process be controlled to ensure the quality of 3D-printed drug products? For example, consider the multiple components associated with 3D printing processes, namely 3D printers, printing materials, and intermediate products and processes.
What are the best ways to address existing questions while recognizing that the technology is changing rapidly?

Update (October 2026): new rules for printing at the point of care.

United States. On July 13, 2026, FDA proposed a registration pathway for distributed manufacturing. A central hub’s quality unit would control a network of identical manufacturing units registered as one establishment. Comments closed September 11, 2026. The proposal does not cover pharmacy compounding. Printed doses made by a pharmacy for an individual prescription remain compounded drugs, which are not FDA-approved, and the pharmacy carries the quality burden.
United Kingdom. The Human Medicines (Amendment) (Modular Manufacture and Point of Care) Regulations came into force on July 23, 2025. A licensed control site holds a Decentralised Manufacturing Master File and oversees the point-of-care sites under it. Centralised manufacture remains the default, and each designation needs a justified clinical benefit (MHRA).
France. In October 2026, ANSM authorized MB Therapeutics as a pharmaceutical establishment to make printing cartridges for hospital pharmacies.
European Union. 3D printing is on the European Medicines Agency’s list of enabling technologies followed by its Quality Innovation Group, but there is no EU-wide point-of-care framework yet.

The open questions are now practical. Who releases each batch? Who reports adverse events? Who runs a recall across many sites? At our 3D Printed Pharmaceuticals event, CurifyLabs argued that printing dosage forms already listed in pharmacopeias may ease regulators’ concerns, and that a shared formulation library lets pharmacies reuse validated templates.

Some of the main financial challenges facing the industry:

Extemporaneously compounding may not be a profitable enough business model for technology startups to survive.
Larger pharmaceutical players are still hesitant to adapt. Partly, this is because the 3D-printed drug industry is still early with many technical and regulatory challenges mentioned above. However, this attitude is clearly changing lately due to a combination of expiring patents and new U.S. Medicare pricing legislation shortening the pricing power of new small molecule drugs.

Update (October 2026): Startups are answering the first point with a razor-and-blade model: place printers in pharmacies, then sell validated formulations, cartridges, and software. PharmaTher’s CraftMake network and CurifyLabs’ Pharma Printer, with its formulation library, follow this pattern. Published cost estimates for hospital-printed hydrocortisone run from about €1.58 to €3.11 per formulation, depending on batch size and quality assurance (Gioumouxouzis et al., 2026). Our speakers also discussed the economics of compounding pharmacies as demand for GLP-1 medications grows (on-demand session), and FABRX is expanding into the US through Pete Pharma (Episode 112).

Who are the major players in space?

Researchers (complete list to come)
1. UCL
2. NUS

Startups – (Updated version of this group can be found in 3DHEALS Company Directory)
1. Aprecia
2. Triastek
3. Crafthealth
4. FabRx
5. Laxxon
6. Nourished
7. Natural Machines
8. CurifyLabs
9. Doser
10. Amply Discovery
11. goatAM
12. MB Therapeutics

Larger pharmaceutical Companies
1. GSK
2. Procter and Gamble
3. Merck
4. Evonik

Update (October 2026): PharmaTher (Canada) became Craft Health’s exclusive North American distributor on October 1, 2026, and is placing CraftMake printers in US compounding pharmacies. MB Therapeutics became the first company licensed in France to make printing cartridges as a pharmaceutical manufacturer. Universidade de Santiago de Compostela, working with FabRx, has run the best-known hospital studies of printed medicines in children. In the UK, University Hospital Southampton acquired a GMP-certified FabRx M3DIMAKER in March 2025 for pharmacist-led research. We have tracked PharmaTher’s move in The Lattice Brief (August 8, 2026), when it began testing GMP peptide printing on Craft Health’s platform for 503A compounding pharmacies, and in The Lattice Brief (August 14, 2026).

What are some of the latest industrial trends?

Holistic innovation process – Almost all the companies at the recent 3DHEALS conference described a holistic approach to scaling up their technologies. These include:
1. Software/Database innovation
  1. Heavy reliability on existing materials, design database
  2. Artificial intelligence and machine learning in future formulation development
  3. Software development:
    1. FabRx in fact has a currently free software researchers can try out: https://m3diseen.com/predictions/
    2. Many companies have dedicated software targeting both formulation development and manufacturing process.
2. Design to scale up manufacturing using other emerging technologies such as robotics and automation to achieve continuous manufacturing processes.
Orphan drug – Given current limitations in mass quantity production, most companies are now focusing on orphan drugs which could be a perfect economical fit.
Nutrition – While personalized nutrition has been a past innovation target in the space, with the advancements in 3D printing technologies and digital health at large, the chance of succeeding in the space economically is potentially higher.
Personalization
More decentralized delivery – For example, patients can create personalized tablets at home with a smartphone as described earlier in this article.
Patent extension of expiring drugs or generics.

Update (October 2026): A seventh trend is printing moving into the pharmacy. GMP printers, licensed cartridges and formulation libraries are turning point-of-care printing into a product. Regulators in the UK, the US and France have all acted in the past 15 months. At the industrial end, Triastek’s second US IND (T20G, February 2025) and Laxxon’s new formulation data keep the scale-up route alive.

A quick summary of the updates made throughout this guide:

The UK point-of-care rules are now in force. The “upcoming European/UK regulatory update” we mentioned took effect on July 23, 2025. The UK Medicines and Healthcare products Regulatory Agency (MHRA) now runs a decentralised manufacture framework in which a licensed control site oversees point-of-care sites. MHRA lists 3D-printed products that can only be made at the point of care as one example.
FDA proposed a distributed manufacturing pathway (July 13, 2026). A network of identical manufacturing units could register as one establishment under one quality system run by a central hub. Comments closed September 11, 2026. The proposal does not address pharmacy compounding.
France licensed the first cartridge maker (October 2026). France’s medicines agency (ANSM) granted MB Therapeutics pharmaceutical establishment status to make semi-solid cartridges that hospital pharmacies load into its printers. GMP compliance at the facility was still in progress at the time.
Printers are heading into US compounding pharmacies. PharmaTher became Craft Health’s exclusive North American distributor on October 1, 2026, and plans a network of CraftMake printers starting with 503A compounding pharmacies. It is targeting up to 50 placements in 12 months and a New Drug Application for a rare pediatric therapy by late 2028 (company targets).
The clinical evidence has been counted. A 2026 review in Drug Delivery and Translational Research (Gioumouxouzis et al.) found 10 clinical studies and one community-pharmacy study of printed medicines. Most were single-centre and short, with small cohorts.
Laxxon reported new data. In August 2025, Laxxon Medical announced a development milestone for a modified-release form of Veru’s enobosarm made with SPID. In December 2025, it reported higher bioavailability for its levodopa/carbidopa form (LXM.5) than Sinemet, in a study published in Pharmaceutics (company-reported).
From 3DHEALS. Our August 2025 3D Printed Pharmaceuticals event (now an on-demand course), Lattice Podcast Episode 112 with FABRX’s Alvaro Goyanes (May 2026), and ongoing coverage in The Lattice Brief.
Spritam is still alone. We found no second FDA-approved 3D-printed drug as of October 2026 (2015 approval).