Over the years, various research initiatives in this field have helped medical professionals to understand the mechanism behind fibrosis better. In addition, several technological advancements have been made, which have led to the development of new diagnostic tools. These modern diagnostics can help detect and classify fibrosis with increased efficacy and accuracy. During our research, we identified over 110 products that are either marketed or under development for non-invasive diagnosis of fibrotic diseases.
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Once suspected, diagnosis is usually made by pathologists and imaging radiologists. The more accurate the diagnosis, the more effective treatment strategies can be employed. Precise diagnosis and staging of fibrosis are extremely essential for prognosis and progression of the disease.
Fibrosis is a medical condition involving the formation of fibrous connective tissue in response to tissue injury or damage by the natural repair mechanism of our body.
The excess tissue deposition is a result of pathological processes. These pathogenic pathways are further associated with numerous alterations in inflammatory, endothelial and mesenchymal cells, resulting in increased production of fibronectin, osteopontin, hyaluronan, proteoglycans, laminins and various collagen subtypes.
Damaged cells secrete chemokines (signaling proteins) which further induces the activation of immune cells. After the activation of immune cells, various mediators such as reactive oxygen species and free radicals, the immune cells promote increase in the levels of profibrotic growth factors including TGF-beta, PDGF, and CTCF. These growth factors induce the process of fibroblast proliferation and differentiation and leads to the formation of myofibroblasts eventually leads to increase in ECM deposition.
Early detection of fibrosis plays a critical role in facilitating successful treatment of the disease. This condition can be detected in its early stages by timely screening (randomly carried out on large masses) of the patient for deposition of extracellular matrix. In this context, non-invasive methods can play a pivotal role in early diagnosis of such diseases, given that they are biomarker-specific and have a fast turnaround time.
In the recent years, a number of efforts have been undertaken for the development of non-invasive imaging techniques for fibrosis diagnosis, staging and treatment monitoring. The non-invasive approaches mostly include biological (serum biomarker algorithms) or physical (imaging assessment of tissue stiffness) assessments.
Several novel approaches for detecting or staging fibrosis through various assays that are essentially noninvasive or minimally invasive, have been introduced recently. The various non-invasive techniques include:
- Liquid biopsy: It is a popular technique is used to detect various markers present in either blood or serum.
- Genetic assays: There are several genetic assays that profile multigene expression to detect chromosomal aberrations and mutations.
- Image-based diagnostics: This involves the use of image-based methods, including Raman scattering, spectrophotometry and fluorescence in situ hybridization (FISH).
- 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
- 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.
As per our base case forecast projections of the non-invasive diagnostics market for cystic fibrosis, for the period 2020-2030. Our estimates suggest that, in 2020, the market is likely to be worth USD 1,451 million, and this value is projected to reach USD 1,850 million by 2030, growing at a CAGR of 2%, during the given time period. Similarly, for liver fibrosis our estimates suggest that, in 2020, the market is likely to be worth USD 202 million and this value is projected to reach USD 2,295 million by 2030, growing at a CAGR of 28%, during the given time period. On the other hand, for pulmonary fibrosis, for the period 2020-2030. Our estimates suggest that, in 2020, the market is likely to be worth USD 19 million, and this value is projected to reach USD 100 million by 2030, growing at a CAGR of 18%, during the given time period.
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
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