During our research, we identified over 110 products that are either marketed or under development for non-invasive diagnosis of fibrotic diseases.
It is worth highlighting that more than 90% products have already been developed and are available for use; examples of recently approved devices include (in reverse chronological order of approval) ENVISIA Genomic Classifier (2019), FibroTouch (2018), LiverMultiScan (2015) and FibroScan (2013).
In addition, majority (84) of the products have been / are being developed as assay-kits. Examples of products developed as assay-kits include (in alphabetical order) ActiTest (Biopredictive), DELFIA Neonatal IRT kit (PerkinElmer), EU2v1 (Yourgene Health) and Proprium Fibro-CHI Diagnostic Kit (Hangzhou Proprium Biotech).It is worth mentioning that majority (104) of the products are designed in such a way that a medical expert is required to perform the diagnosis. On the other hand, there are certain self-tests (7%) that can be used independently by the patients. Examples of such products include (in alphabetical order) Air Next (NuvoAir), Cystic fibrosis solution (patientMpower), FibroScan (Echosens) and Lung monitor (Vitalograph).
Noninvasive Biomarkers – Advances in the field of biotechnology have enabled the development of several minimally invasive / non-invasive approaches for diagnosis of fibrotic diseases which include imaging diagnostics and biomarker-based assays.
During our research, we came across 63 industry players that are presently engaged in the development of non-invasive diagnostics for fibrotic diseases. Presently, the market is characterized by the presence of very large (more than 10,000 employees), large (500-10,000 employees), mid-sized players (51-200 employees), and small-sized firms (up to 50 employees).
Even though efforts for development of non-invasive diagnostics for fibrotic have been undertaken by players based all across the globe, majority of the developers (~60%) are headquartered in North America. Within North America US has emerged as a prominent region where 34 product developers are located. This is followed by players based in Europe (30%); within this region, majority (7) of the developers are headquartered in France. Further, eight players are located in Asia Pacific. Examples of small-sized players based in Asia Pacific include (in alphabetical order) 4DMedical, AmCad Biomed, Genomic Diagnostics, Hangzhou Proprium Biotech and Sysmex.
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As the number of players involved in the development of non-invasive diagnostics for fibrotic diseases continue to increase, recent years have witnessed several partnerships and collaborations being established between various stakeholders involved in this domain, the number of partnerships has increased gradually between 2016 and 2019, at a CAGR of 75%. The maximum number of partnerships (11) were inked in 2019; majority (3) of these deals were acquisitions followed by licensing deals (2). It is worth highlighting that till May 2020, four partnerships have been inked between various stakeholders. The overall trend shows a promising growth in the number of partnerships.
Non-Invasive Fibrosis Disease Market – Among the biomarker-based tests, liquid biopsy (based on the analysis of biofluids such as blood, urine and / or plasma), a relatively new concept, has emerged as a versatile and promising non-invasive cancer diagnostic method for the detection of not only cancer but also fibrosis
Nearly 20% agreements were signed by various players for distribution of non-invasive diagnostics for fibrosis, during the given time period. Some recently signed distribution agreements include (in reverse chronological order) collaborations between NuvoAir and Roche (January 2020), and BillionToOne and Eluthia (October 2019). This is followed by agreements for merger and acquisition (16%) and product development and commercialization (13%).
The companies based in North America and Europe were also involved in intercontinental partnering activity. On the contrary, companies in Asia-Pacific were involved only in a limited number of partnership agreements.
The future market is likely to be driven by the agreements inked between the companies based in North America and Europe. However, the increase in distribution and supply channels in Asia-Pacific countries is likely to foster more partnering activity in this region, as well.
Most of the agreements signed during the given time period were international agreements. The companies headquartered in the US have signed seven agreements with partners based in the same country and eight agreements with partners based out of the US. Further, UK based developers have signed five international and two local deals. With Europe, developers based in Germany, Sweden and Switzerland have signed only international agreements. On the contrary, developers based in Japan have inked agreements with partners based in the same country.
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