Global Market Size, Forecast, and Trend Highlights Over 2025-2037
Vasculitis Treatment Market size was valued at USD 4.9 billion in 2024 and is anticipated to reach USD 9.3 billion by the end of 2037, growing at a CAGR of 6.9% during the forecast period 2025-2037. In 2025, the industry size of vasculitis treatment is evaluated at USD 5.4 billion.
The upliftment of the market depends upon the available patient pool, who are severely affected by the condition. For instance, as stated by the NIH government report, the patient pool for vasculitis accounts for approximately 2.8 million cases every year, out of which ANCA-associated vasculitis (AAV) is the most severe condition, which caters to almost 45 to 55 cases per million. However, to combat the occurrence, there is a huge supply of active pharmaceutical ingredients (APIs) such as immunosuppressants and corticosteroids by specialized manufacturers from across nations. For instance, the U.S. is responsible for importing 35.5% of its APIs for making vasculitis drugs easily available in the present market.
Moreover, the producer price index (PPI) for immunosuppressants has increased by 4.5% on a yearly basis owing to limitations in APIs and costs related to regulatory compliance. Meanwhile, the consumer price index (CPI) has upsurged by 6.3% for vasculitis therapy solutions, thereby effectively driving the market internationally. Besides, in 2023, the global trade valuation for vasculitis-specific pharmaceutical products has achieved the 1.9 billion mark, with the EU and the U.S. accounting for almost 955 million in 2024, which eventually resulted in a 65.3% allocation to clinical trials. Also, NIH grants worth USD 221 million and the EU Horizon fund of USD 183 million are positively impacting the market expansion.
Vasculitis Treatment Sector: Growth Drivers and Challenges
Growth Drivers
- Rise in the disease prevalence: This is one of the most evident factors, which is highly responsible for uplifting the vasculitis treatment market internationally. For instance, the estimated number of patients suffering from AAV exceeds 250,500, with Europe and North America accounting for approximately 60.5% of the global cases. In addition, in 2025, Germany reported 45,500 cases of vasculitis among patients in the country, which denotes a 12.8% increase since previous years. Therefore, this rising occurrence constitutes the need for treatment options, especially in emerging countries such as India, wherein almost 30.5% of patients remain undiagnosed.
- Advancements in clinical and biological efficacy: The vasculitis treatment market is effectively dominated by biologics, owing to an increased remission rate of 75.3% in comparison to 50.5% for traditional drugs. Besides, the adoption of rituximab has surged by almost 35.8%, especially in the EU region, after gaining approval from the EMA for the AAV condition. Also, the U.S. FDA approval for the newest IL-17 inhibitor has additionally extended treatment options, with a projected sale of USD 500.5 million by the end of 2027, thereby suitable for market expansion globally.
Key Manufacturing Strategies for the Vasculitis Treatment Market
The presence of leading pharmaceutical organizations are initiating market expansion, tactical partnerships, and biologic advancement in the global vasculitis treatment market with the objective of strengthening their positions. For instance, Roche highly dominates with the manufacturing and production of rituximab and successfully captured approximately USD 325.5 billion in the market. Likewise, Pfizer acquired Biohaven Pharmaceuticals to make enhancement in its autoimmune portfolio, which is expected to generate revenue of USD 150.5 million by the end of 2026, thereby creating a prolific opportunity for the market to undergo upliftment.
Vasculitis Treatment Manufacturers' Revenue Growth Opportunities
|
Company |
Strategy |
Revenue Impact (USD) |
Market Share Shift |
|---|---|---|---|
|
Roche |
Rituximab label expansions (EU/U.S.) |
+420.5 million (2023-2025) |
+5.1% (32.2% total) |
|
GSK |
Benlysta off-label adoption |
280.8 million (2023) |
+3.3% (18.1% total) |
|
Pfizer |
Biohaven acquisition (autoimmune R&D) |
150.7 million (projected 2026) |
+4.5% (12.3% total) |
|
Novartis |
IL-17 inhibitor trials |
200.5 million R&D investments |
Expected +7.1% by 2027 |
|
AbbVie |
India biosimilar partnerships |
90.9 million annual revenue |
+2.4% in emerging markets |
Key Expansion Models for Future Vasculitis Treatment Feasibility
The international vasculitis treatment market is undergoing development with the presence of localized manufacturing as well as public-private partnerships, since both these factors are driving accessibility. For instance, suppliers in India entered into a strategic partnership with Apollo Hospitals to provide biosimilars, which in turn, bolstered the revenue by 12.8% between 2022 and 2024. Besides this, there has been expansion of vasculitis treatment coverage to almost 500,250 patients through Brazil’s SUS program, which also generated USD 75.5 million yearly sales for manufacturers, thus effectively amplifying the market development.
2022-2024 Vasculitis Treatment Market Feasibility Models
|
Region |
Model |
Revenue Impact |
Key Outcome |
|---|---|---|---|
|
India |
Hospital-pharma partnerships |
+12.2% revenue growth |
Biosimilar adoption surge |
|
EU |
Centralized bulk procurement |
-18.3% drug costs |
Higher biologic penetration |
|
Brazil |
Government subsidized program (SUS) |
USD 75.5 million annual sales |
500,250 patients covered |
|
U.S. |
Medicare Part B expansion |
+9.4% supplier revenue |
Improved market access |
Challenges
- Delays in regulatory acceptance: The presence of administrative hurdles deliberately challenges the vasculitis treatment market, due to factors such as stringent trial requirements and prolonged approval. However, to overcome this, the U.S. FDA in 2023 issued the latest post-pandemic guidelines, which are essential for long-term safety follow-up for autoimmune treatment and enable large patient cohorts. These modifications resulted in an upsurge of developmental expenditure by an estimated 20.5% and, at the same time, strengthened the acceptance timeline by 13 to 19 months, especially for novel biologics.
- High out-of-pocket expenses: The aspect of affordability remains a barrier for the vasculitis treatment market accessibility across different nations, which includes restrictions in insurance coverage and expensive treatment packages. The yearly out-of-pocket cost in the U.S. exceeds USD 3,200 for biologic therapy options, which eventually forces almost 41% of total patients to get rid of treatment services in the country. Besides, Medicare Part B ensures 80.8% of infusion expenses, but 20.5% of coinsurance leaves elderly patients with excessive bills, thus negatively impacting the market growth.
Vasculitis Treatment Market: Key Insights
| Report Attribute | Details |
|---|---|
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
6.9% |
|
Base Year Market Size (2024) |
USD 4.9 billion |
|
Forecast Year Market Size (2037) |
USD 9.3 billion |
|
Regional Scope |
|
Vasculitis Treatment Segmentation
Drug Class (Biologics, Corticosteroids, Immunosuppressants)
Based on drug class, the biologics segment is projected to account for the highest share of 42.8% in the vasculitis treatment market by the end of 2037. This domination is fueled by their ability to bring out superior clinical results and ensure targeted efficacy. Drugs such as tocilizumab (IL-6 inhibitor) and rituximab (anti-CD20), both account for an estimated 75.5% of the segment’s overall revenue, which is highly driven by EMA and FDA acceptance. Besides this, NIH-based studies denote a reduced biologics relapse rate by 50.5% in comparison to the 80.8% remission rate of cyclophosphamide, thus driving the segment’s development.
Disease Type (ANCA-associated Vasculitis (AAV), Large Vessel Vasculitis, Medium Vessel Vasculitis, Small Vessel Vasculitis)
Based on disease type, the ANCA-associated Vasculitis (AAV) segment is expected to hold a considerable share of 38.9% in the vasculitis treatment market during the forecast period. There is a huge rise in the occurrence of this particular vasculitis, accounting for a 6.5% growth rate, along with its increasing unmet requirements. Besides, the presence of the EU orphan drug designations has gained accelerated accessibility to therapy options, including avacopan. It is a complementary C5a inhibitor, which is estimated to generate USD 1.7 billion every year by the end of 2030. Also, the implementation of telemedicine services is yet another driver for the segment’s growth, which has improved diagnostic rates by 25.7% in the U.S. rural area.
Our in-depth analysis of the global vasculitis treatment market includes the following segments:
|
Drug Class |
|
|
Disease Type |
|
|
Route of Administration |
|
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Customize this ReportVasculitis Treatment Industry- Regional Synopsis
North America Market Analysis
The North America vasculitis treatment market is anticipated to hold the largest share of 48.9% by the end of the forecast timeline. This growth is driven by the existence of NIH, wherein next-generation IL-17 inhibitors are continuously being prioritized to generate a revenue of USD 7.5 million in 2024. Besides, the region comprises expensive out-of-pocket spending, which is more than USD 3,050 every year, which is limiting access for almost 30.5% of patients in the country. Furthermore, the availability of subcutaneous biologic formulations and telehealth services implementation are also driving the market expansion in the country.
The vasculitis treatment market in the U.S. is significantly growing, owing to the adoption of biologic-based drugs that account for USD 220.5 million in 2024, especially for vasculitis-based research and development activities. Besides, the presence of Medicare expenditure in the country has surged by 15.8%, that is USD 800.5 million on a yearly basis. This expenditure further covers a yearly spending of USD 901.5 billion, especially allocated to low-income patients. Moreover, the existence of administrative organizations such as the U.S. FDA constitutes benefits, including a reduction of approval time by 30.7% in the case of accepting orphan drugs.
There is a huge opportunity for the vasculitis treatment market upliftment in Canada, owing to an estimated 8.8% allocation of the overall domestic healthcare and medical budget that effectively prioritizes biologics treatment for patients with the condition. In addition, the availability of public drug plans takes into consideration approximately 70.5% of spending for rituximab, but at the same time, almost 31% of patients experience a delay in treatment facilities owing to barriers in accessibility. Therefore, all these factors effectively cater to the increasing demand of the market in the country.
Europe Regional Market Size & Growth
The Europe vasculitis treatment market is estimated to hold a share of 29.2% during the forecast period. This regional development is facilitated by an increase in the prevalence of chronic disorders and the availability of universal healthcare coverage policies. Countries such as the UK and Germany both dominate approximately 45.7% of the overall regional revenue, which is further attributed to the implementation of orphan drug designations and biosimilar implementation. Besides, there is a provision of €2.8 billion by the EU Health Data Space for rare disease research and development activities, which also include AAV therapy solutions, thus bolstering the market growth in the region.
The vasculitis treatment market in Germany is experiencing continuous upliftment and is highly driven by the rising incidence rate of the condition, the presence of strict cost controls, and increased biosimilar implementation. The country comprises the AMNOG pricing law, which tends to diminish biologic pricing by 20.5%, leading to accelerated biosimilar penetration, which further is projected to record 40.2% of the total market by the end of 2030. Besides, there has been a provision of €501 million of funding for undertaking research activities to identify solutions for overcoming autoimmune diseases, thereby suitable for market expansion.
The vasculitis treatment market upliftment in the UK is supported by rapid approval of drugs and other medical products by NICE, telemedicine adoption, and funding by the NHS. For instance, there has been an allocation of £124 million by the NHS for healthcare professionals to adopt telemedicine as the ultimate treatment solution to aid rare disorders by ensuring reduced delays by approximately 26%. Besides, the country’s Rare Diseases Framework, as of 2023, has readily prioritized early intervention of biologics by creating an 11% reduction in hospital accommodations, thus a prolific opportunity for market development.
Competitive Landscape & Strategic Initiatives
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
There is a huge presence of key organizations in the vasculitis treatment market globally, with an aim to expand their market presence through different strategies. Factors such as biologic dominance, advanced therapies, biosimilar disruption, strategic partnerships and collaborations, and focus on emerging markets are effectively initiated by organizations. For instance, Pfizer and Celltrion compete with each other with biosimilars as their product portfolio, and successfully captured a combined share of 18% in the market. Likewise, Abbvie and Novartis AG made an investment in next-generation IL-17/JAK inhibitors and targeted a growth rate of 10.8% in the market.
Here is a list of key players operating in the global market:
|
Company Name (Country) |
Market Share |
Industry Focus & Key Products |
|---|---|---|
|
Roche (Switzerland) |
22.2% |
Biologics (Rituximab), orphan drug development |
|
GSK (UK) |
18.3% |
Repurposed biologics (Benlysta for off-label vasculitis) |
|
Pfizer (U.S.) |
12.4% |
Biosimilars (Rituximab biosimilar), immunosuppressants |
|
Novartis (Switzerland) |
10.8% |
IL-17 inhibitors, JAK inhibitors |
|
AbbVie (U.S.) |
8.2% |
Biologics (adalimumab), partnerships in emerging markets |
|
Celltrion (South Korea) |
xx% |
Biosimilars (rituximab, infliximab) |
|
Biocon (India) |
xx% |
Affordable biosimilars for Asia-Pacific markets |
|
CSL Limited (Australia) |
xx% |
Plasma therapies, autoimmune research |
|
Hovid Berhad (Malaysia) |
xx% |
Generic immunosuppressants, regional distribution |
Below are the areas covered for each company under the top 15 global manufacturers:
Recent Developments
- In January 2024, Roche declared the U.S. FDA approval of the extended utilization of rituximab (Rituxan), especially suitable for pediatric granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
- In November 2021, ChemoCentryx broadcasted the acceptance of avacopan by the U.S. FDA, which is the first oral complement C5a inhibitor suitable for aiding patients with severe AAV conditions.
Author Credits: Radhika Pawar
- Report ID: 7687
- Published Date: May 20, 2025
- Report Format: PDF, PPT
