According to DelveInsight's analysis, the growth of the
systemic sclerosis market is expected to be mainly driven by
increasing prevalence, patient awareness, and the launch of
potential therapies with novel mechanisms that are being
investigated to improve the management of systemic sclerosis during
the forecast period (2024–2034).
LAS
VEGAS, June 27, 2024 /PRNewswire/ --
DelveInsight's Systemic Sclerosis Market
Insights report includes a comprehensive understanding of
current treatment practices, systemic sclerosis emerging drugs,
market share of individual therapies, and current and forecasted
market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan].
Key Takeaways from the Systemic Sclerosis Market
Report
- According to DelveInsight's analysis, the market size for
systemic sclerosis is expected to grow significantly by
2034.
- Systemic sclerosis usually appears in women aged 30–40, and it
occurs in slightly older men. In approximately 85% of cases,
systemic sclerosis develops in individuals aged 20–60 years.
- Leading systemic sclerosis companies such as Kyowa
Hakko Kirin, AstraZeneca, Cabaletta Bio, Mitsubishi Tanabe Pharma,
Genentech, Inc., Amgen, GlaxoSmithKline, Boehringer Ingelheim,
and others are developing novel systemic sclerosis drugs that can
be available in the systemic sclerosis market in the coming
years.
- The promising systemic sclerosis therapies in the pipeline
include Brodalumab, Anifrolumab, CABA-201, Inebilizumab,
RO7303509, HZN-825, Belimumab, Avenciguat (BI 685509), and
others.
- In March 2024,
CABA-201 received an Orphan Drug Designation (ODD) for the
treatment of systemic sclerosis. In addition, it has also been
granted Fast Track Designation (FTD) by the US FDA in January 2024 for the same.
Discover which therapies are expected to grab the major systemic
sclerosis market share @ Systemic Sclerosis Market
Report
Systemic Sclerosis Overview
Systemic sclerosis, also known as scleroderma, is a chronic
autoimmune disease characterized by the hardening and tightening of
the skin and connective tissues. The condition arises due to the
overproduction and accumulation of collagen in the skin and
internal organs, leading to fibrosis. The exact cause of systemic
sclerosis is not well understood, but it is believed to involve a
combination of genetic predisposition and environmental factors,
which trigger an abnormal immune response.
Symptoms of systemic sclerosis vary widely depending on the
organs affected and the severity of the disease. Common symptoms
include skin thickening and hardening, particularly on the fingers,
hands, and face, Raynaud's phenomenon, and joint pain. As the
disease progresses, it can affect internal organs, leading to
complications such as esophageal dysfunction, pulmonary fibrosis,
renal crisis, and heart issues.
Diagnosing systemic sclerosis involves a combination of clinical
evaluation, laboratory tests, and imaging studies. A physical
examination often reveals characteristic skin changes and blood
tests may show specific autoantibodies, such as anti-centromere or
anti-topoisomerase I (Scl-70) antibodies. Imaging techniques like
high-resolution computed tomography (HRCT) of the lungs and
echocardiography can assess the extent of internal organ
involvement. A skin biopsy may also be performed to confirm the
diagnosis by showing typical histopathological changes associated
with the disease.
Systemic Sclerosis Epidemiology Segmentation
The systemic sclerosis epidemiology section provides insights
into the historical and current systemic sclerosis patient pool and
forecasted trends for the 7MM. It helps recognize the causes of
current and forecasted patient trends by exploring numerous studies
and views of key opinion leaders.
The systemic sclerosis market report proffers
epidemiological analysis for the study period 2020–2034 in the 7MM
segmented into:
- Total Diagnosed Prevalent Cases of Systemic Sclerosis
- Gender-specific cases of Systemic Sclerosis
- Age-specific cases of Systemic Sclerosis
- Type-specific cases of Systemic Sclerosis
- Severity-specific cases of Systemic Sclerosis
- Complications Associated with Systemic Sclerosis
Systemic Sclerosis Treatment Market
While no treatment has been shown to alter the overall
progression of the disease, the therapy aims to address specific
organ involvement early on to prevent irreversible damage,
enhancing both quality of life and survival. Disease-modifying
drugs can be recommended based on the clinical presentation and
potential visceral damage. Special attention should be given to
symptomatic drug treatments. Hematopoietic stem cell
transplantation may be an option for patients with rapidly
progressing systemic sclerosis who are at risk of organ failure,
but it should only be performed at high-volume centers.
The treatment of systemic sclerosis is tailored to address
specific manifestations such as skin, lung, gastric, heart, and
kidney issues. Most therapies aim to treat the affected organs to
prevent irreversible damage and to enhance both quality of life and
survival. The primary manifestations of SSc are cutaneous and
pulmonary and recommended treatments include Intravenous
Cyclophosphamide, Methotrexate, Mycophenolate Mofetil, or
Azathioprine. Cyclophosphamide is particularly prescribed for
improving skin conditions in patients with SSc-associated
interstitial lung disease.
For scleroderma pulmonary fibrosis, antifibrotic therapies like
D-penicillamine, Esbriet (pirfenidone), and Ofev (nintedanib) are
utilized. Raynaud's phenomenon (RP) and digital ulcers are commonly
treated with calcium-channel blockers, phosphodiesterase 5
inhibitors, and angiotensin-converting enzyme inhibitors.
In cases of severe diffuse cutaneous SSc (dcSSc), autologous
hematopoietic stem cell transplantation has been shown to improve
patient survival, cutaneous symptoms, pulmonary involvement, and
overall quality of life.
To know more about systemic sclerosis treatment guidelines,
visit @ Systemic Sclerosis Management
Systemic Sclerosis Pipeline Therapies and Key
Companies
Some of the drugs in the pipeline include Brodalumab (Kyowa
Hakko Kirin), Anifrolumab (AstraZeneca), CABA-201 (Cabaletta Bio),
and Inebilizumab (Mitsubishi Tanabe Pharma), among others.
Brodalumabis is an innovative monoclonal antibody that
functions as an Interleukin 17 receptor antagonist, targeting the
inflammatory cytokine pathway. It blocks Interleukin 17
interactions with cytokines IL-17A, IL-17F, IL-17C, IL-17A/F
heterodimer, and IL-25. Kyowa Kirin submitted a supplemental New
Drug Application (sNDA) to Japan's
Ministry of Health, Labour and Welfare (MHLW) in December 2021, based on Phase III study results
in Japanese patients with systemic sclerosis, characterized by
moderate to severe skin sclerosis. In June
2022, the company presented the positive outcomes from this
Phase III study at the EULAR (European Alliance of Associations for
Rheumatology) 2022 Congress.
CABA-201, a fully human CD19-CAR T cell investigational
therapy that includes a 4-1BB component, is engineered to deplete
CD19-positive B cells deeply and temporarily after a single
infusion. This approach aims to "reset" the immune system,
potentially leading to long-term remission without ongoing therapy
for patients with autoimmune diseases. In October 2023, the US FDA approved the IND
application for CABA-201 for a Phase I/II study targeting systemic
sclerosis. By March 2024, the drug
was granted an Orphan Drug Designation (ODD) for systemic sclerosis
treatment. Additionally, it received Fast Track Designation (FTD)
from the US FDA in January 2024 for
the same condition. The company has started a Phase I/II open-label
study (RESET-SSc) of CABA-201 in systemic sclerosis patients,
dividing participants into two parallel cohorts: six patients with
severe skin involvement and six patients with pulmonary, cardiac,
or renal involvement, regardless of skin condition.
The other therapies in the pipeline include
- RO7303509: Genentech, Inc.
- HZN-825: Amgen
- Belimumab: GlaxoSmithKline
- Avenciguat (BI 685509): Boehringer Ingelheim
The anticipated launch of these emerging therapies for systemic
sclerosis are poised to transform the market landscape in the
coming years. As these cutting-edge therapies continue to mature
and gain regulatory approval, they are expected to reshape the
systemic sclerosis market landscape, offering new standards of
care and unlocking opportunities for medical innovation and
economic growth.
Discover more about systemic sclerosis drugs in development
@ Systemic Sclerosis Clinical Trials
Systemic Sclerosis Market Dynamics
The dynamics of the systemic sclerosis market are expected to
change in the coming years. Based on the role of B cells and the
published clinical data with CD19-CAR T therapy in systemic
sclerosis, it is believed that CABA-201 may transform the treatment
for systemic sclerosis. Kyowa Kirin submitted an sNDA for
brodalumab in treating systemic sclerosis, and the launch of
this drug will boost the systemic sclerosis market. Additionally,
the development of a potential biomarker that allows for
tracking and predicting the severity and potential progress of the
disease, as well as the effectiveness of any therapeutic
intervention, is crucial. Since pulmonary involvement is a
leading cause of morbidity and mortality in systemic sclerosis,
there is a need for more effective treatments that can
stabilize or improve lung function and delay disease
progression.
Furthermore, potential therapies are being investigated for the
treatment of systemic sclerosis, and it is safe to predict that the
treatment space will significantly impact the systemic
sclerosis market during the forecast period. Moreover, the
anticipated introduction of emerging therapies with improved
efficacy and a further improvement in the diagnosis rate are
expected to drive the growth of the systemic sclerosis market
in the 7MM.
However several factors may impede the growth of the systemic
sclerosis market. Only 35–50% of systemic sclerosis patients
are eligible for current treatment, and while ERT has shown
benefits mostly in kidney disease and reduction in left ventricular
hypertrophy, it has not demonstrated dramatic improvement in
outcomes for all organ systems. Additionally, reimbursement
challenges, including limited coverage by healthcare payers or
restrictive reimbursement policies, may limit patient access
to expensive SSc therapies.
Moreover, systemic sclerosis treatment poses a
significant economic burden and disrupts patients' overall
well-being and QOL. Furthermore, the systemic sclerosis market
growth may be offset by failures and discontinuation of emerging
therapies, unaffordable pricing, market access,
and a shortage of healthcare specialists. In addition, the
undiagnosed, unreported cases and the unawareness about the
disease may also impact the systemic sclerosis market
growth.
Systemic Sclerosis
Market Report Metrics
|
Details
|
Study Period
|
2020–2034
|
Coverage
|
7MM [the United States,
the EU4 (Germany, France, Italy, and Spain) and the United Kingdom,
and Japan].
|
Key Systemic Sclerosis
Companies
|
Kyowa Hakko Kirin,
AstraZeneca, Cabaletta Bio, Mitsubishi Tanabe Pharma, Genentech,
Inc., Amgen, GlaxoSmithKline, Boehringer Ingelheim,
and others
|
Key Pipeline Systemic Sclerosis Therapies
|
Brodalumab,
Anifrolumab, CABA-201, Inebilizumab, RO7303509, HZN-825, Belimumab,
Avenciguat (BI 685509), and
others
|
Scope of the Systemic
Sclerosis Market Report
- Therapeutic Assessment: Systemic Sclerosis current
marketed and emerging therapies
- Systemic Sclerosis Market Dynamics: Key
Market Forecast Assumptions of Emerging Systemic
Sclerosis Drugs and Market Outlook
- Competitive Intelligence Analysis: SWOT analysis
and Market entry strategies
- Unmet Needs, KOL's views, Analyst's views, Systemic
Sclerosis Market Access and Reimbursement
Download the report to understand which factors are driving
systemic sclerosis market trends @ Systemic Sclerosis
Market Trends
Table of Contents
1.
|
Systemic
Sclerosis Key Insights
|
2.
|
Systemic
Sclerosis Report
Introduction
|
3.
|
Systemic Sclerosis
Overview at a Glance
|
4.
|
Systemic
Sclerosis Executive
Summary
|
5
|
Systemic
Sclerosis Key Events
|
6
|
Epidemiology and Market
Forecast Methodology
|
6.
|
Disease Background and
Overview
|
7.
|
Systemic
Sclerosis Treatment and
Management
|
8.
|
Systemic Sclerosis
Guidelines
|
9.
|
Systemic
Sclerosis Epidemiology and Patient
Population
|
10.
|
Patient
Journey
|
11.
|
Key Endpoints in
Systemic Sclerosis
|
12.
|
Systemic Sclerosis
Marketed Drugs
|
13.
|
Systemic
Sclerosis Emerging
Drugs
|
14.
|
7MM Systemic Sclerosis Market Analysis
|
15.
|
Market Access and
Reimbursement
|
16.
|
KOL Views
|
17.
|
Unmet Needs
|
18.
|
SWOT
Analysis
|
19.
|
Appendix
|
20.
|
DelveInsight
Capabilities
|
21.
|
Disclaimer
|
22.
|
About
DelveInsight
|
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