3D printing first got widespread public attention in 2013, when it was specifically mentioned by President Obama in his State of the Union Address. 3D printing is a manufacturing process where an object is created with the help of a layer-by-layer material approach. Each layer can be considered a thin horizontal cross-section of the final product. It uses Computer Aided Design (CAD) i.e. a digital blueprint to create rapid prototypes, spare parts and final products. 3D printing uses materials like thermoplastics, plastic composites, metals, alloys, ceramics etc. 3D printing as an end-use manufacturing technology is still not fully developed but it has the potential to transform the conception, manufacturing and logistics processes.
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The 3D Bioprinting for Life Science R&D Market can revolutionise the life sciences industry. For pharmaceutical companies, 3D bioprinting technology advances can solve the key issue of innovation in R&D drug discovery. According to medical experts, pharmaceutical companies in the future will not sell drugs but chemical inks, applications and blueprints. Organisations would have to completely rethink their development and manufacturing models, as well as the way they handle customer relationships.
The drug testing market is likely to be the main driver of the 3D Bioprinting for Life Science R&D Market. Since 2011, a group of U.S government agencies have been investing in something known as ‘Human on a chip’ or ‘Body on a chip’. The objective is to create a miniature human organ system that mimics the bodily response to harmful agents, enabling the development of potential therapies. The pharmaceutical industry could use such equipment to test drugs more efficiently due to human stem cells and at a much lower cost. It would also be less risky.
The second 3D Bioprinting for Life Science R&D Market driver could be patients wanting to print personalised medicine at home which matches their genetic profile or medical history. This may well be one of the most profound business transformations in the pharmaceutical industry. While it is still in the early stages, the cost advantages and the quality outcome could be massive indeed.
There can be several constraints for the 3D Bioprinting for Life Science R&D Market. They are described below –
- Quality and regulatory issues – 3D bioprinting have enabled patients, physicians as well as hospitals to print their own devices. This poses a challenge for regulatory bodies in terms of adhering to quality standards like ISO 13485. Ensuring device traceability throughout its lifestyle is also very important, right from the digital blueprint stage to the patient-specific organ stage. The Unique Device Identification philosophy might also need to be extended to 3D bio-printed devices. This technology must be used with great caution to make sure there are no regulatory violations. New and unapproved printed devices which need to be implanted on an emergency basis may also require emergency approval from the authorities.
- Material and production constraints- Hypothetically speaking, most digital 3D blueprints can be printed. However, like any other manufacturing process, it has certain problems. 3D printing is only possible with a limited number of materials, the build size of the final product is fairly small and it is difficult to get the kind of precision found in more traditional manufacturing processes. In addition, 3D bioprinting is much slower with each organ taking several hours or even days to print.
- Ethical concerns- The 3D Bioprinting for Life Science R&D Market must deal with a host of ethical concerns which can be raised. Since these organs will be made for human or animal use, a number of uncomfortable questions can be asked. For e.g. – “What happens when organs with non-human cells are created? Who controls their production? Who ensures their quality?”
The largest 3D Bioprinting for Life Science R&D Market is the U.S, followed by Europe and the Asia Pacific.
A few companies involved in the 3D Bioprinting for Life Science R&D Market are EnvisionTEC, Regenovo, Organovo, 3D Systems, 3D Biotek, Advanced Biomatrix, Bespoke Innovations, Digilab and Nano3D Biosciences.
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