Bioprinting
This article is part 2 of our innovation in 3D printing article series, explore part 1 here.
Three dimensional (3D) bioprinting uses 3D printing to generate tissue-like structures that are used in medical and tissue engineering fields. Bioprinting is used in basic medical/cell biology research, the production of pathology models, organ models for drug screening (see our Organoid article) and regenerative medicine for the future replacement of tissue and organs.
Analogous to conventional 3D printing (discussed in part 1 of our ‘innovation in printing’ article series), bioprinting uses a layer-by-layer method to deposit material into a pre-defined 3D structure that mimics the natural architecture of tissue. However, instead of using traditional materials such as molten polymer, bioprinting uses “bioink” comprising living cells, biomaterials or active molecules to produce 3D biological structures. Bioinks are traditionally loaded in an exogenous matrix (which may, for example, be scaffold based), but as technology has developed, bioinks are increasingly used in a scaffold-free manner. Importantly, autologous (patient derived) cells can be used in the bioink. This allows for a personalised end product: whether this is an in in vitro model (containing the disease-causing mutations allowing for more accurate drug screening) or biological tissue (minimising tissue rejection when implanted into the host).
Global patent filing trend
The global 3D bioprinting market is valued at $1.3 billion in 2024 and is expected to almost double in value by 2029 as the technology develops1. In recent years, the number of patent filings directed towards the use of bioprinting in general, has remained largely at a plateau. However, there are signs that patent filings are now increasing (Figure 1).
Whilst initially the US led the way in terms of patent filings, by 2019 South Korea had overtaken the US as the global leader (Figure 2). This increase is driven by both academic groups (43% of top filers are academic institutions such as Pohang University of Science and Technology, and Sungkyunkwan University) and industry players (such as Rokit Healthcare Inc. and T And R Biofab Co. Ltd.). There has been a steady increase of filings from 2020 onwards from China, indicating that China may be an emerging player in the industry.
Figure 1: Ten-year trend (2013 – 2022) – global patent filings
Figure 2: Ten-year trend (2023 – 2022) – global patent filings by jurisdiction
In years 2017 to 2019, patent applications towards bioprinting methodologies and scaffold production appeared more frequently, whilst in later years, 2021 to 2022, patent applications towards bioink became more common (Figure 3). This indicates that bioprinting techniques have become somewhat established and that global innovation is more focused on materials for organ or tissue-specific customisation. Currently, a limited number of bioinks exist which are both bioprintable and which accurately represent the tissue architecture needed to restore organ function post-printing2. This trend also confirms the move away from exogenous scaffolds which may elicit adverse host responses and interfere with direct cell–cell interaction, as well as assembly and alignment of cell-produced extra cellular matrix. Organovo Inc. (“Organovo”), discussed below, is an example of a company that appears to have made recent developments in scaffold-free bioprinting.
Figure 3: Ten-year trend (2013 – 2022) – global patent filings by sub uses
Key players
Leading the market with the highest number of patent family filings in the last 10 years is Organovo Inc, a US company that develops scaffold-free bioprinted human tissue (Figure 4). Organovo’s main focus is generating human liver tissue which they plan to administer as ‘organ patches’ to help repair damaged liver. This helps to delay or reduce the need for a transplant. In addition, Organovo generate human tissue for use in toxicology and disease modelling platforms and have patent families directed towards bioprinted breast, skin, kidney and vasculature (as well as liver). Organovo has entered various research partnerships, for example with Merck Sharp & Dohme Corp. (“Merck”) and L’Oreal. The agreement with Merck gives access to Organovo’s human liver technology for use in drug development, whilst the agreement with L’Oreal gives access to Organovo’s human skin technology for use in testing beauty and skin care products. For example, EP3215603B1 is directed towards bioprinted skin tissue with Organovo and L’Oreal as co-applicants.
Notably, Organovo uses its own proprietary NovoGen MMX 3D bioprinter to generate the tissue. Considering the highly anticipated market growth and therapeutic promise, it is perhaps unsurprising that there have been several high-profile litigation cases with other key industry players. A long-running dispute with Bico Group ended in 2022 with Bico and Organovo agreeing to a licensing agreement, whereby Bico Group has access to Organovo’s foundational patent portfolio relating to device set-ups and tissue engineering methods.
Figure 4: Ten-year trend (2013 – 2022) – global top ten filers
Future
The end goal for many researchers and companies working in bioprinting is to be able to 3D print whole human organs that mimic their natural counterparts for use in implantation.
Currently, there is a disproportion between organ demand and organ availability worldwide, which is impacted by a low quality of available donor organs and difficulty in finding good donor matches to reduce the likelihood of rejection. In the UK, almost 8000 people are waiting for a transplant, with over 400 people dying in 2023 whilst waiting for a transplant3. Furthermore, longer waiting times disproportionately adversely affect ethnic minority communities4. However, whole organ printing is currently still in the development phase, and it is estimated that it will be another decade before fully-functioning bioprinted organs can be implanted into humans 5.
The biggest technical and scientific challenge is keeping whole tissues alive. Whilst companies like Organovo can currently print “patches” of organs for therapy, larger tissues (i.e. whole organs) would not survive as it is not yet possible to mimic the extensive vascularisation needed for sufficient nutrient exchange to keep tissues alive up to implantation. After organ implantation, printed vasculature will need to be integrated with host vasculature. This presents a further challenge for technology creators to address.
1 3D Bioprinting Market Size, Share & Trends [2029] (marketsandmarkets.com)
2 3D bioprinting of cells, tissues and organs | Scientific Reports (nature.com)
3 activity-report-2023-2024.pdf (nhsbtdbe.blob.core.windows.net)
4 Version 9.4 SAS System Output (nhsbtdbe.blob.core.windows.net)
5 3D-printed organs: The future of transplantation | CNN
Bioprinting historically accounted for about only 5% of total 3D printing patent applications but now appears to be gaining traction as the technology matures. General 3D printing has largely plateaued, indicating that the technology is maturing. Driven largely by government initiatives, both general 3D printing and bioprinting is seeing an increase in activity from Asian markets, indicating that the number of patent filings from Asian countries is likely to continue increasing. Whilst general 3D printing is historically dominated by general purpose printing and the transport industry, 3D printing in healthcare, both in the form of medical device printing and bioprinting is on the rise. This shift suggests that industrial players are increasingly focusing on healthcare to address pressing challenges in the field, driven by advances in bioprinting and the growing demand for innovative medical solutions.
This article is part 2 of our innovation in 3D printing article series, explore part 1 here.
Due to an 18-month lag between priority filing (first patent filing) and publication, data for 2023 and 2024 has not been reported.
Oliver Herd, Trainee Patent Attorney and Alia Tayer, European Patent Attorney
Appleyard Lees IP LLP
