3D bioprinting will begin to realize its true potential within the coming decade
3D bioprinting constitutes a raft of technologies, commercial and not-yet commercial, which have the potential to significantly impact a number of major markets, including in vitro testing for more efficient drug discovery and toxicity testing of personal consumer products, as well as the clinical fields relating to implant/grafting of human tissue.
Though not yet employed within its addressable markets (current bioprinter sales and products are to research and development organisations only), the potential for rapid deployment in some areas already exists, subject to adequate funding being made available.
Drug discovery is a highly expensive process which in most cases will end in failure to gain regulatory clearance (see figure 1). The reason for this high failure rate is related to the lack of sufficiently accurate pre-clinical (prior to human volunteer) testing methodologies which have to date been limited to 2-dimensional human cell assays together with animal testing.
Fig. 1. Drug discovery process
Different species can react to different drugs in very different ways, and further, 2-dimendional cell cultures behave very differently in terms of coalescence and proliferation compared to cells which inhabit a 3-dimensional environment. In short, humans are not 2-dimensional 70kg mice.
For some time therefore, medical researchers have sought means to mimic the 3-dimensional human tissue environment in the laboratory in an effort to make the drug discovery process more reliable, thereby (a) reducing complications associated to human clinical trials of novel drugs, (b) lowering the costs resulting from late-stage failures, (c) ensuring that dead-ends are abandoned quickly in order that attention can be focused on more promising avenues, and (d) shortening the drug discovery process timescale so that potentially life-saving drugs make it to the market as soon as possible.
Development of 3D assays has remained a challenge however, as the degree of precision required to emulate cell-to-cell communication in vivo (in the body) has proved elusive. Computer controlled 3D bioprinting, combined with curable bioinks, has now enabled the fabrication of 3D tissue, which moreover can survive for significantly longer periods of time compared to their 2D counterparts, enabling longer term impact of a novel drug on human tissue cultures to be analysed.
Cosmetic/consumer product testing
In 2013 the European Union (EU) enforced new legislation banning the use of animal testing on all personal consumer products. No such product, or any ingredient thereof, may be tested on animals, and no product/ingredient which has been tested on animals outside of the EU may be retailed within the EU. This has proved a major driver for companies in this sector to seek new means of testing the safety of their new products, not least as the EU represents the largest single market for cosmetics and other such products.
For example, in October 2013, the world's largest cosmetic company, L'Oreal, entered into an agreement with 3D bioprinting company Organovo to explore the use of 3D bioprinting for cosmetic safety testing, specifically skin care products.
The longer term holy grail of 3D bioprinting is the ability to be able to print viable human tissue for grafting or implant into the human body. Research is already underway looking at the 3D bioprinting of non-vascular tissue (thin tissue which does not require a network of nutrient delivering capillaries) such as skin and cartilage. Work in this area is expected to commence clinical trials in the immediate future and will reduce the need for mechanical implants and human donors.
On a 30 year horizon, it is hoped that clinicians will be able to 3D bioprint vascular (thick) tissue such as a human kidney or liver. Transplant waiting lists continue to grow disproportionately in comparison to the availability of donor organs and 3D bioprinting of organs would have a number of advantages over donor organs including:
- Earlier transplant when the patient is healthier yielding better outcomes
- Reduced possibility of organ rejection where the organ is grown from the patient's own cells
- Reduced requirement for eg. dialysis or other life supporting intervention, and
- Reduced need for lifelong medication to supress the immune system.
This report provides a realistic timeline for the development and commercialisation of the 3D bioprinting technologies in what are largely heavily regulated application areas. A challenge matrix is presented, and evaluations of the addressable markets and their value provided. Forecasts are given for the period 2014-2025.
In addition to detailing each of the technologies currently employed, together with their state of commercialisation, future application areas are discussed including:
- Medical - tissue engineering, drug discovery, regenerative medicine, dental implants etc.
- Cosmetic/personal consumer product screening
- Food and animal products
The report is informed by in depth interviews with the organisations working in the area of 3D bioprinting, analysing the challenges they face, both technological and otherwise, as well as the different business models employed.
The potential losers resulting from the large-scale uptake of 3D bioprinting are also outlined, emphasising their need for organisations working in the areas listed above to understand the technology and its likely evolutionary path.
This report draws on the wealth of experience of IDTechEx in the area of 3D printing in general, supported by expert opinion. The particular hurdles faced by each application area are addressed, and a timeline for the progressive commercialisation(s) presented (see figure 2).
Fig. 2. Commercialisation timeline