Scleroderma, Localized

INSIDE INFORMATIONS BioSenic publishes new evidence of beneficial effects of arsenic trioxide treatment supporting clinical trial for systemic sclerosis Arsenic trioxide (ATO) therapeutic potential to treat systemic sclerosis (SSc) is now confirmed in a new preclinical model - Fra2- characterized by severe pulmonary lesions Mont-Saint-Guibert, Belgium, September 19, 2023, 7.00 am CEST – BIOSENIC (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, today announces the publication of data providing additional key indications of its lead API (Active Pharmaceutical Ingredient) arsenic trioxide (ATO) to treat systemic sclerosis (SSc) in a peer-reviewed international journal. The data are published in an article entitled ‘Arsenic trioxide demonstrates efficacy in a mouse model of preclinical systemic sclerosis’ in the international journal “Arthritis Research & Therapy”. This work studies the effects of ATO on a preclinical auto-immune disease model, that develops severe abnormal vascular remodeling of pulmonary arterioles and nonspecific interstitial pneumonia-like lung disease, closely resembling human systemic sclerosis (SSc)-associated pulmonary hypertension. Marked beneficial effects of ATO on skin and lung fibrosis, vascular damage and scleroderma-like lesions have been previously described by Kavian et al. (J Immunol 2012 May; Arthritis Rheum 2012 Oct) in vitro and in SSc preclinical models, at the Cochin Institute’s facilities in Paris, France. The new data, in a third valuable preclinical model, show a significant reduction in inflammatory infiltration and a strong improvement in vascular remodeling, mediated by an immune status improvement, particularly involving T-cells. These findings represent a substantial advancement in understanding of the complex interplay between inflammation-driven fibrosis and the pathophysiology of SSc. These results give ground to the proposed clinical relevance of ATO treatment in SSc, and more generally in autoimmune pathologies, where lung is often impacted by fibrosis and vascular remodeling. In oncology, ATO is now recognized as a first-line treatment for acute promyelocytic leukaemia, with demonstrated safety and long-term remission. BioSenic had recently further demonstrated the safety and efficacy of ATO treatment in successful clinical programs targeting chronic Graft-versus-Host Disease, in a phase 2 and Systemic Lupus Erythematosus (SLE), in a phase 2a trial. BioSenic believes that the clinical data it has helped to generate over the past decade, together with its ongoing efforts to understand the cellular pathways that are controlled by ATO administration at the right dose and time, now allow for further expansion of clinical trials targets. This applies to new indications in autoimmunity and inflammatory diseases. This is a reason why BioSenic specifically selected SSc for a systematic clinical approach to testing ATO as a novel first-in-class therapy. François Rieger, PhD, Chairman and CEO, BioSenic said: "BioSenic is now focusing on the final preparations for its phase 3 trial with ATO targeting chronic Graft-versus-Host Disease, one of the most common complications affecting survival of allogeneic hematopoietic stem cell transplantation patients. It is also essential that BioSenic continues to pave the way for clinical progression of its ATO programs to treat systemic lupus erythematosus and systemic sclerosis. These new pre-clinical data add to the raft of in vitro and in vivo experimental data generated by BioSenic, by the scientific community and across the industry, supporting the potential of arsenic salt medication in correcting the pathophysiological parameters of the immune system gone awry in a number of autoimmune diseases. These results demonstrate the potential of ATO on the cellular characteristics of damaged organs, with chronic and aggravating functional abnormalities. This will provide invaluable knowledge for BioSenic’s ATO application and formulation for the ongoing clinical development, and further contribute towards the future success of ATO’s late-stage clinical development. Compounded observations, both widely published and collected in various international studies, fully justify the initiation of trials on SSc patients, in need of new and decisive medications, other than existing palliative ones. The hope for success is high and BioSenic is working hard in translating the present fundamental results into real therapeutic advances with the necessary help of available international funding.” About BioSenic BioSenic is a leading biotech company specializing in the development of clinical assets issued from: (i) the arsenic trioxide (ATO) platform (with key target indications including Graft-versus-Host Disease (GvHD), systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) and (ii), the development of innovative products to meet unmet needs in orthopedics.Following a reverse merger in October 2022, BioSenic combined a strategic positionings and strengths to use, separately and combined, an entirely new arsenal of various anti-inflammatory and anti-autoimmune formulations using the immunomodulatory properties of ATO/oral ATO (OATO) with its innovative cell therapy platform and strong IP for tissue repair protection.BioSenic is based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium. Further information is available at http://www.biosenic.com. About BioSenic technology platforms BioSenic’s technology is based on two main platforms: The ATO platform, which has been successfully developed, has immunomodulatory properties with fundamental effects on the activated cells of the immune system. The first effect is the increase of the cell oxidative stress in activated B, T and other cells of the innate/adaptative immune system to the point they will enter a cell death program (apoptosis) and be eliminated. The second effect is potent immunomodulatory properties on several cytokines involved in inflammatory or autoimmune cell pathways, with return to homeostasis. One direct application is its use in onco-immunology to treat GvHD (Graft-versus-Host Disease) in its chronic, established stage. cGvHD is one of the most common and clinically significant complications affecting long-term survival of allogeneic hematopoietic stem cell transplantation (allo-HSCT). cGvHD is primarily mediated by the transplanted immune cells that can lead to severe multiorgan damage. BioSenic has been successful in a Phase 2 trial with its intravenous formulation, which has orphan drug designation status by FDA and EMA. The Company is heading towards an international Phase 3 confirmatory study, with its new, IP-protected, OATO formulation. Another selected target is moderate-to-severe forms of systemic lupus erythematosus (SLE), using the same oral formulation. ATO has shown good safety and significant clinical efficacy on several affected organs (skin, mucosae and the gastrointestinal tract) in an early Phase 2a study. Systemic sclerosis is also part of the clinical pipeline of BioSenic. This serious chronic disease badly affects skin, lungs or vascularization, and has no actual current effective treatment. Preclinical studies on pertinent animal models are positive, giving good grounds to launch a Phase 2 clinical protocol. The allogeneic cell and gene therapy platform developed by BioSenic, with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs), which can be stored at the point of use in hospitals. ALLOB represents a unique and proprietary approach to organ repair and specifically to bone regeneration, by turning undifferentiated stromal cells from healthy donors into bone-forming cells on the site of injury. ALLOB has recently been evaluated in a randomized, double-blind, placebo-controlled Phase 2b study in patients with high-risk tibial fractures, using its optimized production process, after a successful first safety and efficacy study (Phase 1/2a) on fractured long bones, with late-delayed union. However, in June 2023, BioSenic decided to suspend its interventional trial on fracture healing using ALLOB, following negative results obtained for the primary endpoint in this exploratory Phase 2b clinical trial, interpreted as a failure of a too early cell injection, just after fracture. BioSenic is now focusing on determining the best time to optimise the efficacy of ALLOB (choice between early or late treatment). Note: Biosenic has reevaluated a previous important and years-long clinical development program. In March 2023, after the clinical identification of distinct OA subtypes, BioSenic delivered a new post-hoc analysis of its Phase 3 JTA-004 trial on knee OA, demonstrating positive action on the most severely affected patient subpopulation. This new post-hoc analysis drastically changes the therapeutic profile of the combined components and allows for better patient targeting in future clinical developments. This leads to a next generation of JTA, off-the-shelf enhanced viscosupplement to treat knee osteoarthritis (OA), made of a unique combination of mammalian plasma proteins, derivatives of hyaluronic acid (a natural component of synovial fluid in the knee) and a third active component. JTA or some derivatives are intended to provide effective lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic (OA) pain and inflammation. The company, will nevertheless focus its present R&D and clinical activities on a selective, accelerated development of its autoimmune (ATO/OATO) platform. For further information, please contact: BioSenic SAFrançois Rieger, PhD, Chief Executive OfficerTel: +33 (0)671 73 31 59investorrelations@biosenic.com International Media Enquiries:IB CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20 8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency For French Investor Enquiries:Seitosei ActifinGhislaine GasparettoTel: +33 (0)1 56 88 11 22ggasparetto@actifin.fr Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release. BioSenic publishes new evidence of beneficial effects of arsenic trioxide treatment supporting clinical trial for systemic sclerosis Arsenic trioxide (ATO) therapeutic potential to treat systemic sclerosis (SSc) is now confirmed in a new preclinical model - Fra2- characterized by severe pulmonary lesions Mont-Saint-Guibert, Belgium, September 19, 2023, 7.00 am CEST – BIOSENIC (Euronext Brussels and Paris: BIOS), the clinical-stage company specializing in serious autoimmune and inflammatory diseases and cell therapy, today announces the publication of data providing additional key indications of its lead API (Active Pharmaceutical Ingredient) arsenic trioxide (ATO) to treat systemic sclerosis (SSc) in a peer-reviewed international journal. The data are published in an article entitled ‘Arsenic trioxide demonstrates efficacy in a mouse model of preclinical systemic sclerosis’ in the international journal “Arthritis Research & Therapy”. This work studies the effects of ATO on a preclinical auto-immune disease model, that develops severe abnormal vascular remodeling of pulmonary arterioles and nonspecific interstitial pneumonia-like lung disease, closely resembling human systemic sclerosis (SSc)-associated pulmonary hypertension. Marked beneficial effects of ATO on skin and lung fibrosis, vascular damage and scleroderma-like lesions have been previously described by Kavian et al. (J Immunol 2012 May; Arthritis Rheum 2012 Oct) in vitro and in SSc preclinical models, at the Cochin Institute’s facilities in Paris, France. The new data, in a third valuable preclinical model, show a significant reduction in inflammatory infiltration and a strong improvement in vascular remodeling, mediated by an immune status improvement, particularly involving T-cells. These findings represent a substantial advancement in understanding of the complex interplay between inflammation-driven fibrosis and the pathophysiology of SSc. These results give ground to the proposed clinical relevance of ATO treatment in SSc, and more generally in autoimmune pathologies, where lung is often impacted by fibrosis and vascular remodeling. In oncology, ATO is now recognized as a first-line treatment for acute promyelocytic leukaemia, with demonstrated safety and long-term remission. BioSenic had recently further demonstrated the safety and efficacy of ATO treatment in successful clinical programs targeting chronic Graft-versus-Host Disease, in a phase 2 and Systemic Lupus Erythematosus (SLE), in a phase 2a trial. BioSenic believes that the clinical data it has helped to generate over the past decade, together with its ongoing efforts to understand the cellular pathways that are controlled by ATO administration at the right dose and time, now allow for further expansion of clinical trials targets. This applies to new indications in autoimmunity and inflammatory diseases. This is a reason why BioSenic specifically selected SSc for a systematic clinical approach to testing ATO as a novel first-in-class therapy. François Rieger, PhD, Chairman and CEO, BioSenic said: "BioSenic is now focusing on the final preparations for its phase 3 trial with ATO targeting chronic Graft-versus-Host Disease, one of the most common complications affecting survival of allogeneic hematopoietic stem cell transplantation patients. It is also essential that BioSenic continues to pave the way for clinical progression of its ATO programs to treat systemic lupus erythematosus and systemic sclerosis. These new pre-clinical data add to the raft of in vitro and in vivo experimental data generated by BioSenic, by the scientific community and across the industry, supporting the potential of arsenic salt medication in correcting the pathophysiological parameters of the immune system gone awry in a number of autoimmune diseases. These results demonstrate the potential of ATO on the cellular characteristics of damaged organs, with chronic and aggravating functional abnormalities. This will provide invaluable knowledge for BioSenic’s ATO application and formulation for the ongoing clinical development, and further contribute towards the future success of ATO’s late-stage clinical development. Compounded observations, both widely published and collected in various international studies, fully justify the initiation of trials on SSc patients, in need of new and decisive medications, other than existing palliative ones. The hope for success is high and BioSenic is working hard in translating the present fundamental results into real therapeutic advances with the necessary help of available international funding.” About BioSenic BioSenic is a leading biotech company specializing in the development of clinical assets issued from: (i) the arsenic trioxide (ATO) platform (with key target indications including Graft-versus-Host Disease (GvHD), systemic lupus erythematosus (SLE) and systemic sclerosis (SSc) and (ii), the development of innovative products to meet unmet needs in orthopedics.Following a reverse merger in October 2022, BioSenic combined a strategic positionings and strengths to use, separately and combined, an entirely new arsenal of various anti-inflammatory and anti-autoimmune formulations using the immunomodulatory properties of ATO/oral ATO (OATO) with its innovative cell therapy platform and strong IP for tissue repair protection.BioSenic is based in the Louvain-la-Neuve Science Park in Mont-Saint-Guibert, Belgium. Further information is available at http://www.biosenic.com. About BioSenic technology platforms BioSenic’s technology is based on two main platforms:1) The ATO platform, which has been successfully developed, has immunomodulatory properties with fundamental effects on the activated cells of the immune system. The first effect is the increase of the cell oxidative stress in activated B, T and other cells of the innate/adaptative immune system to the point they will enter a cell death program (apoptosis) and be eliminated. The second effect is potent immunomodulatory properties on several cytokines involved in inflammatory or autoimmune cell pathways, with return to homeostasis. One direct application is its use in onco-immunology to treat GvHD (Graft-versus-Host Disease) in its chronic, established stage. cGvHD is one of the most common and clinically significant complications affecting long-term survival of allogeneic hematopoietic stem cell transplantation (allo-HSCT). cGvHD is primarily mediated by the transplanted immune cells that can lead to severe multiorgan damage. BioSenic has been successful in a Phase 2 trial with its intravenous formulation, which has orphan drug designation status by FDA and EMA. The Company is heading towards an international Phase 3 confirmatory study, with its new, IP-protected, OATO formulation. Another selected target is moderate-to-severe forms of systemic lupus erythematosus (SLE), using the same oral formulation. ATO has shown good safety and significant clinical efficacy on several affected organs (skin, mucosae and the gastrointestinal tract) in an early Phase 2a study. Systemic sclerosis is also part of the clinical pipeline of BioSenic. This serious chronic disease badly affects skin, lungs or vascularization, and has no actual current effective treatment. Preclinical studies on pertinent animal models are positive, giving good grounds to launch a Phase 2 clinical protocol. 2) The allogeneic cell and gene therapy platform developed by BioSenic, with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs), which can be stored at the point of use in hospitals. ALLOB represents a unique and proprietary approach to organ repair and specifically to bone regeneration, by turning undifferentiated stromal cells from healthy donors into bone-forming cells on the site of injury. ALLOB has recently been evaluated in a randomized, double-blind, placebo-controlled Phase 2b study in patients with high-risk tibial fractures, using its optimized production process, after a successful first safety and efficacy study (Phase 1/2a) on fractured long bones, with late-delayed union. However, in June 2023, BioSenic decided to suspend its interventional trial on fracture healing using ALLOB, following negative results obtained for the primary endpoint in this exploratory Phase 2b clinical trial, interpreted as a failure of a too early cell injection, just after fracture. BioSenic is now focusing on determining the best time to optimise the efficacy of ALLOB (choice between early or late treatment).Note: Biosenic has reevaluated a previous important and years-long clinical development program. In March 2023, after the clinical identification of distinct OA subtypes, BioSenic delivered a new post-hoc analysis of its Phase 3 JTA-004 trial on knee OA, demonstrating positive action on the most severely affected patient subpopulation. This new post-hoc analysis drastically changes the therapeutic profile of the combined components and allows for better patient targeting in future clinical developments. This leads to a next generation of JTA, off-the-shelf enhanced viscosupplement to treat knee osteoarthritis (OA), made of a unique combination of mammalian plasma proteins, derivatives of hyaluronic acid (a natural component of synovial fluid in the knee) and a third active component. JTA or some derivatives are intended to provide effective lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic (OA) pain and inflammation. The company, will nevertheless focus its present R&D and clinical activities on a selective, accelerated development of its autoimmune (ATO/OATO) platform. For further information, please contact: BioSenic SAFrançois Rieger, PhD, Chief Executive OfficerTel: +33 (0)671 73 31 59investorrelations@biosenic.com International Media Enquiries:IB CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20 8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency For French Investor Enquiries:Seitosei ActifinGhislaine GasparettoTel: +33 (0)1 56 88 11 22ggasparetto@actifin.fr Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

May 31, 2023 -- Researchers at the National Institutes of Health and their colleagues have identified genomic variants that cause a rare and severe inflammatory skin disorder, known as disabling pansclerotic morphea, and have found a potential treatment. Scientists discovered that people with the disorder have an overactive version of a protein called STAT4, which regulates inflammation and wound healing. The work also identified a drug that targets an important feedback loop controlled by the STAT4 protein and significantly improves symptoms in these patients. The results were published in the New England Journal of Medicine . The study was led by researchers at the National Human Genome Research Institute (NHGRI), part of NIH, in collaboration with researchers from the University of California, San Diego (UCSD) and the University of Pittsburgh. Researchers from the National Institute of Arthritis and Musculoskeletal and Skin Diseases and the National Institute of Allergy and Infectious Diseases, both part of NIH, also participated in the study. Only a handful of patients have been diagnosed with disabling pansclerotic morphea, a disorder first described in the medical literature around 100 years ago. The disorder causes severe skin lesions and poor wound healing, leading to deep scarring of all layers of the skin and muscles. The muscles eventually harden and break down while the joints stiffen, leading to reduced mobility. Because the disorder is so rare, its genetic cause had not been identified until now. “Researchers previously thought that this disorder was caused by the immune system attacking the skin,” said Sarah Blackstone, a predoctoral fellow within NHGRI's Inflammatory Disease Section, a medical student at the University of South Dakota and co-first author of the study. “However, we found that this is an oversimplification, and that both skin and the immune system play an active role in disabling pansclerotic morphea.” The researchers used genome sequencing to study four individuals with disabling pansclerotic morphea and found that all four have genomic variants in the STAT4 gene. The STAT4 gene encodes a type of protein that helps turn genes on and off, known as a transcription factor. The STAT4 protein not only plays a role in fighting infections but also controls important aspects of wound-healing in the skin. The scientists found that the STAT4 genomic variants result in an overactive STAT4 protein in these four patients, creating a positive feedback loop of inflammation and impaired wound-healing that worsens over time. To stop this harmful feedback loop, they targeted another protein in the inflammatory pathway that interacts with the STAT4 molecule and is called Janus kinase, also known as JAK. When the researchers treated the patients with a JAK-inhibiting drug called ruxolitinib, the patients’ rashes and ulcers dramatically improved. “So far, there has not been a standard treatment for this disorder because it’s so rare and not well-understood. However, our study gives an important new treatment option for these patients,” said Blackstone. Existing treatments for disabling pansclerotic morphea are designed to halt the progression of the disorder, but previous therapies have been mostly ineffective, often with severe side effects. People with the disorder typically don’t live more than 10 years after their diagnosis. The study suggests that ruxolitinib could be an effective treatment for patients with this disorder. Ruxolitinib is part of a broader class of drugs called JAK inhibitors, which are commonly used to treat arthritis, eczema, ulcerative colitis and other chronic inflammatory diseases. “The findings of this study open doors for JAK inhibitors to be a potential treatment for other inflammatory skin disorders or disorders related to tissue scarring, whether it is scarring of the lungs, liver or bone marrow,” said Dan Kastner, M.D., Ph.D., an NIH distinguished investigator, head of NHGRI’s Inflammatory Disease Section and a senior author of the paper. “We hope to continue studying other molecules in this pathway and how they are altered in patients with disabling pansclerotic morphea and related conditions to find clues to understanding a broader array of more common diseases,” said Lori Broderick, M.D., Ph.D., a senior author of the paper and an associate professor at UCSD. The National Human Genome Research Institute (NHGRI) is one of the 27 institutes and centers at the NIH, an agency of the Department of Health and Human Services. The NHGRI Division of Intramural Research develops and implements technology to understand, diagnose and treat genomic and genetic diseases. Additional information about NHGRI can be found at: https://www.genome.gov. About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov . NIH…Turning Discovery Into Health ® References Baghdassarian et al (2023). Variant STAT4 and Response to Ruxolitinib in an Autoinflammatory Syndrome. New England Journal of Medicine. DOI: 10.1056/NEJMoa2202318 Source: NIH Posted: May 2023

NEW YORK, June 23, 2022 /PRNewswire/ -- As per Zion Market Research study, The global scleroderma diagnostics and therapeutics market was approximately USD 2232.5 million in 2021 and is anticipated to reach nearly USD 4127.6 million by 2028, with a compound annual growth rate (CAGR) of about 9.2 percent over the forecast period. Key Industry Insights & Finding of the Scleroderma Diagnostics and Therapeutics Market Reports: As per the analysis shared by our research analyst, the Scleroderma Diagnostics and Therapeutics Market is expected to grow annually at a CAGR of around 9.2 % (2022-2028). Through the primary research, it was established that the Scleroderma Diagnostics and Therapeutics Market was valued approximately USD 2232.5 Million in 2021 and is projected to reach to roughly USD 4127.6 Million by 2028. Major factors such as favorable reimbursement policies, heavy investment in R&D and drug development, and well-established healthcare infrastructure are boosting the growth of the market in this region. The growing prevalence of the disease and technological advancement in the field of medical devices are also propelling the growth of the market in this region. Europe is anticipated to hold the second-most position in the market owing to an increase in initiatives and proactive awareness regarding the diagnostics for scleroderma. Zion Market Research published the latest report titled as "Scleroderma Diagnostics And Therapeutics Market By Diagnostic Test Type (Blood Tests, Imaging Techniques, Skin Biopsy, Pulmonary Function Tests, And Electrocardiogram & Echocardiogram), By Indication (Systemic Scleroderma And Localized Scleroderma), By Drug Class (Prostacyclin Analogues, Endothelin Receptor Antagonists, Phosphodiesterase 5 Inhibitors – PHA, Immunosuppressors, Analgesics, Calcium Channel Blockers, And Others), And By Region – Global And Regional Industry Overview, Market Intelligence, Comprehensive Analysis, Historical Data, And Forecasts 2022 – 2028." into their research database. Scleroderma Diagnostics and Therapeutics Market : Overview Scleroderma is an autoimmune disease wherein healthy tissue is substituted with thick, dense, fibrous tissue. It is a chronic, albeit rare, condition. The immune system normally aids in the body's defense against sickness and infection. The immune system in scleroderma patients causes other cells to create excessive collagen. This excess collagen builds up in the organs and skin, causing hardness and thickness similar to the process of scarring. While scleroderma has no cure, therapy can help to alleviate symptoms, reduce progression, and enhance the quality of life. Scleroderma can impact several other body parts, such as the gastrointestinal system, joints, muscles, blood vessels, kidneys, and lungs, in addition to the skin. Scleroderma can be life-threatening in its most severe forms. Get a Free Sample Report with All Related Graphs & Charts (with COVID 19 Impact Analysis): Our Free Sample Report Includes: 2022 Updated Report Introduction, Overview, and In-depth industry analysis COVID-19 Pandemic Outbreak Impact Analysis Included 180 + Pages Research Report (Inclusion of Updated Research) Provide Chapter-wise guidance on Request 2022 Updated Regional Analysis with Graphical Representation of Size, Share & Trends Includes Updated List of tables & figures Updated Report Includes Top Market Players with their Business Strategy, Sales Volume, and Revenue Analysis Zion Market Research methodology Industry Dynamics: Scleroderma Diagnostics and Therapeutics Market : Growth Drivers Growing prevalence of scleroderma is fostering the growth of the market. In developed as well as developing countries, the prevalence of scleroderma is growing at a rapid rate. This condition affects between 75,000 to 100,000 persons in the United States, the majority of whom are females between the ages of 30 to 50. Twins and family members of people with scleroderma or even other autoimmune connective tissue illnesses like lupus are at an increased risk of developing the condition. Scleroderma can affect children, although the condition affects them differently than it does adults. Such a huge burden of disease has led to increase in awareness and need for diagnosis of the disease. This is ultimately driving the market growth. In addition to this, favorable reimbursement policies, well-developed health infrastructure, and growing necessity for developed diagnostic techniques are some of the key factors that are boosting the growth of the market for scleroderma diagnostics and therapeutics. Scleroderma Diagnostics and Therapeutics Market : Restraints High cost associated with scleroderma diagnostic and treatment is likely to hamper the market growth. The multiorgan nature of systemic sclerosis necessitates long-term monitoring and a variety of approaches to patient management. As a result, it's no surprise that systemic sclerosis is one of the most expensive rheumatic illnesses, with patients using more healthcare dollars per year than their age and sex-matched colleagues with inflammatory myopathies, psoriatic arthritis, and/or RA. Additionally, some of the direct costs for patients with systemic sclerosis include acute-care hospitalization, assistive devices, medications, diagnostic tests as well as visits to healthcare professionals. Thus, the financial cost of systemic sclerosis is substantial, and disease & health conditions have a significant influence on the economic burden thereby impeding the growth of the global scleroderma diagnostics and therapeutics market. In addition to this, factors such as low penetration of the market in underdeveloped countries, adverse effects associated with the drugs, and low spending power in rural areas are also hampering the market growth. Directly Purchase a Copy of the Report @ Global Scleroderma Diagnostics and Therapeutics Market : Opportunities Growing focus on development of innovative methods is estimated to drive the market during the forecast period. Systemic sclerosis is a multifaceted autoimmune disease with a wide range of symptoms and degrees of internal organ damage. All consequences have a substantial influence on the patient's quality of life as well as morbidity and death rates. As a result, there is a growing interest in novel ways of assessing, diagnosing, and monitoring organ involvement. In addition to this, there is an increase in investment in R&D activities by major players for the development of new and effective treatments. Major players are also focusing on the completion of clinical trials for the drugs and looking forward to the approval of the drug for the treatment of scleroderma. All such factors coupled with technological advancements including the implementation of artificial intelligence and internet of things in the field of medical devices are anticipated to generate numerous opportunities for the growth of the global scleroderma diagnostics and therapeutics market during the forecast period. Global Scleroderma Diagnostics and Therapeutics Market : Challenges Strict regulations for the approval of drugs and diagnostic devices for scleroderma may act as a challenge to the market growth. By far there are very less approved drugs for the treatment of scleroderma. Scleroderma is a rare disease and its diagnosis is also challenging. The vague clinical presentation of scleroderma might make diagnosis difficult, resulting in a delayed diagnosis. This also interferes in the development of drugs that can be effectively used to treat the disease. The lack of sufficient data on the efficacy and safety of the drugs leads to the failure of clinical trials. The regulatory bodies across different countries have imposed strict regulations for the approval of drugs and diagnostic devices in order to have appropriate diagnosis and treatment of the disease. This may act as a major challenge to the growth of the market. Global Scleroderma Diagnostics and Therapeutics Market : Segmentation The global scleroderma diagnostic and therapeutics market is categorized based on diagnostic test type, indication, drug class, and region. The diagnostic test type segment comprises blood tests, imaging techniques, skin biopsy, pulmonary function tests, and electrocardiogram & echocardiogram. Based on the indication, the global market is bifurcated into systemic scleroderma and localized scleroderma. The drug class segment is classified into prostacyclin analogues, endothelin receptor antagonists, phosphodiesterase 5 inhibitors – PHA, immunosuppressors, analgesics, calcium channel blockers, and others. Get More Insight before [email protected] : List of Key Players of Scleroderma Diagnostics and Therapeutics Market : Bayer AG; Boehringer Ingelheim International GmbH arGentis Pharmaceuticals LLC Celgene Corp. Bristol-Myers Squibb Company F. Hoffman La-Roche Ltd. Corbus Pharmaceuticals Holdings Seattle Genetics Inc. Kadmon Holdings Inc. Emerald Health Pharmaceuticals Prometic Life Sciences Inc. Key questions answered in this report: What are the growth rate forecast and market size for Scleroderma Diagnostics and Therapeutics Market ? What are the key driving factors propelling the Scleroderma Diagnostics and Therapeutics Market forward? What are the most important companies in the Scleroderma Diagnostics and Therapeutics Market Industry? What segments does the Scleroderma Diagnostics and Therapeutics Market cover? How can I receive a free copy of the Scleroderma Diagnostics and Therapeutics Market sample report and company profiles? Report Scope: Free Brochure: Recent Developments In March 2021, Roche received approval for Actemra®/RoActemra® (tocilizumab) subcutaneous injection from the US Food and Drug Administration (FDA) for decreasing the rate of drop in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD), a chronic condition with few treatment options. The FDA has approved Actemra/RoActemra as the first biologic medication for the treatment of the condition. In April 2020, Boehringer Ingelheim received approval from the European Commission for nintedanib for the treatment of people with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Regional Dominance: North America is estimated to rule the market for scleroderma diagnostics and therapeutics. Among the regions, North America is expected to dominate the global scleroderma diagnostics and therapeutics market. Major factors such as favorable reimbursement policies, heavy investment in R&D and drug development, and well-established healthcare infrastructure are boosting the growth of the market in this region. Additionally, the growing prevalence of the disease and technological advancement in the field of medical devices are also propelling the growth of the market in this region. Europe is anticipated to hold the second-most position in the market owing to an increase in initiatives and proactive awareness regarding the diagnostics for scleroderma. On the other hand, the market in Asia Pacific is likely to grow at the highest CAGR during the forecast period. This is majorly due to the wide and easy availability of generic & biosimilar immunosuppressants for the treatment of scleroderma. Global Scleroderma Diagnostics and Therapeutics Market is segmented as follows: Scleroderma Diagnostics and Therapeutics Market : By Diagnostic Test Type Outlook (2022-2028) Blood Tests Imaging Techniques Skin Biopsy Pulmonary Function Tests Electrocardiogram & Echocardiogram Scleroderma Diagnostics and Therapeutics Market : By Indication Outlook (2022-2028) Systemic Scleroderma Localized Scleroderma Scleroderma Diagnostics and Therapeutics Market : By Drug Class Outlook (2022-2028) Prostacyclin Analogues Endothelin Receptor Antagonists Phosphodiesterase 5 Inhibitors – PHA Immunosuppressors Analgesics Calcium Channel Blockers Others Scleroderma Diagnostics and Therapeutics Market : By Region Outlook (2022-2028) North America The U.S. Canada Europe France The UK Spain Germany Italy Rest of Europe Asia Pacific China Japan India South Korea Southeast Asia Rest of Asia Pacific Latin America Brazil Mexico Rest of Latin America Middle East & Africa GCC South Africa Rest of Middle East & Africa Press Release For Scleroderma Diagnostics and Therapeutics Market : Browse Other Related Research Reports from Zion Market Research Orthopedic Soft Tissue Repair Market - Global Industry Analysis : The global Orthopedic Soft Tissue Repair Market accrued earnings worth approximately 5.7 (USD Billion) in 2020 and is predicted to gain revenue of about 11.2 (USD Billion) by 2028, is set to record a CAGR of nearly 6.4% over the period from 2021 to 2028. 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