3D Bioprinting White Spaces Analysis

3D Bioprinting Overview

Tissue injury and dysfunctioning commonly occurs in humans; however, not in all cases, the tissue regeneration capability of a human body is able to cope up with the damage caused. The conventional approach used to deal with this type of trauma involves transplantation of damaged tissues or organs; this is further associated with several limitations, including non-availability of compatible organ donor, risk of graft rejection (due to the body’s immunological reaction) and post-surgical infection / complication. Another tissue engineering approach involves the amalgamation of cells, biomolecules and growth factors with scaffolds, in order to develop a three-dimensional (3D) functional tissue that mimics the human tissue. However, this technique is less effective, time consuming and can lead to non-homogenous distribution of cells in the matrix, making it logistically and financially non-feasible for clinical applications. To improve on this aspect, additive manufacturing, specifically 3D bioprinting, is being explored in the tissue engineering domain. The 3D bioprinting technique employs bioinks (consisting of living cells and biomaterials) to fabricate complex anatomical structures (tissues, cartilages and organs), in a layer-by-layer pattern, with the help of computer-aided printers. Further, 3D bioprinting offers a range of benefits over the conventional tissue engineering techniques, including high accuracy, enhanced resolution, fast processing time and low cost. Owing to the layer-wise construction, bioprinted tissues consist of pores, which promote easy perfusion of gas and nutrients, as well as enable intercellular and intracellular communication. It is worth mentioning that Organovo was the first company to enter the 3D bioprinting space by printing functional blood vessels in 2010.

Despite the various advantages associated with 3D bioprinting, the technology is associated with certain challenges. One of the key challenges is the stringent requirement to maintain the quality across each step (designing the model, selection of the bioink, printing validation and post-printing) executed before the transplantation. Further, the lack of a robust design software might hamper the manufacturing of a mechanically stable 3D construct. In this regard, various industry stakeholders and academicians have undertaken initiatives in order to further develop / improve this technology for use across a variety of applications, including cartilage repair, fabrication of bone, organ and skin (for transplantation), drug testing, toxicology screening, and cancer research, by using diseased tissue models. As a result, the intellectual capital related to different 3D bioprinting techniques, such as extrusion bioprinting, inkjet printing, laser assisted bioprinting and stereolithography, has also grown. In light of such developments, it is important to keep track of both pockets of innovation and key areas of improvement for stakeholders to remain competitive in this upcoming field of the healthcare domain. This report captures some of the key R&D-related trends and provides competitive intelligence on the intellectual property in the field of 3D bioprinting.

Scope of the Report

The “3D Bioprinting: Intellectual Property Landscape” report features an extensive study of some of the key historical and contemporary intellectual property (IP) documents (featuring granted patents, patent applications and other documents), describing the various types of 3D bioprinting. The insights generated in this report have been presented across two deliverables, namely a MS Excel workbook and a MS PowerPoint deck, summarizing the ongoing trend in this domain.

Key inclusions are briefly described below:

• Overall Intellectual Property Landscape
  An analytical perspective of the various patents and affiliated IP documents that have been published related to 3D bioprinting, since 2000. An in-depth analysis of published IP documents, representing unique patent families across various global jurisdictions, featuring insightful inferences related to both historical and recent R&D trends within this niche, yet rapidly evolving applications in the biotechnology and pharmaceutical industry.
• Popular / Relevant Prior Art Search Expressions
  An examination of IP literature, shortlisting key words and phrases used to describe 3D bioprinting. The analysis also includes details on the historical use of the aforementioned terms across different IP filings, key affiliated terms (which can be used to identify other relevant IP search terms and establish relationships between prior art search expressions), and other related trends.
• Patent Valuation Analysis
  A competitive benchmarking and valuation analysis of the key members of unique patent families captured in the report, taking into consideration important parameters, such as type of IP document, year of application, time to expiry, number of citations and jurisdiction (factoring in value associated with the gross domestic product (GDP) of a particular region).
• Patentability and Freedom to Operate
  A systematic approach to identify relevant areas of innovation by analyzing published IP documents (representative of unique patent families), by defining the uniqueness of patented / patent pending innovations, in order to assess the scope of patentability in this domain, and pinpoint jurisdictions wherein new and / or modified claims may be filed without infringing on existing IP. 
• Analysis of Patent Applications
  A detailed summary of the various patent applications (representative of unique patent families) that were filed across different jurisdictions and their relative value in the IP ecosystem. The analysis classified the intellectual capital in terms of type of innovation and the innovation (such as a product class, enabling technologies or method of use), thereby, offering the means to identify active arenas of research and assess innovation-specific IP filing trends.
• Analysis of Granted Patents
  An analysis of the granted patents (representative of unique patent families) across different global jurisdictions and their relative value in the IP ecosystem. The analysis also features a meaningful classification system, segregating granted IP into relevant categories (namely type of innovation and innovation) to help develop a detailed perspective on the diversity of intellectual capital (having marketing exclusivity) related to 3D bioprinting, and the assessing likelihood for innovators to enter into promising research areas. 
• Pockets of Innovation and White Spaces
  An insightful analysis of the various CPC codes used in published IP literature (representative of unique patent families) and their affiliated families, offering the means to identify historical and existing pockets of innovation (based on the functional area / industry described by the elaborate and systematic IP classification approach, mentioned earlier); the analysis also features a discussion on prevalent white spaces (based on type of innovation and innovation in this field of research.
• Claim Analysis
  One of the objectives of the report was to analyze and summarize key inferences from the independent claims mentioned in granted, active patents (representative of unique patent families) in the dataset. Using a systematic segregation approach, we have analyzed trends associated with the preamble, type of patent (product patent or method patent), type of claim (open ended claim or closed ended claim) and key elements of a claim (individual aspects of an innovation that are covered in a singular claim).