Soliris (Eculizumab) Market Trends and Forecast
The future of the global soliris (eculizumab) market looks promising with opportunities in the PNH and aHUS markets. The global soliris (eculizumab) market is expected to grow with a CAGR of 5.5% from 2025 to 2031. The major drivers for this market are the rising diagnosis rate of complement-mediated disorder, the growing adoption of targeted biologics, and the increase in healthcare spending.
• Lucintel forecasts that, within the type category, plasma exchange is expected to witness higher growth over the forecast period.
• Within the application category, PNH is expected to witness higher growth.
• In terms of region, North America is expected to witness the highest growth over the forecast period.
Emerging Trends in the Soliris (Eculizumab) Market
The soliris (eculizumab) market is undergoing changes due to the presence of biosimilar products, increased marketing opportunities, as well as new initiatives aimed at improving cross-border accessibility. These trends are essential to consider by all parties interested in the evolving situation.
• Introduction of Biosimilars: The introduction of biosimilars, such as Amgen’s Bkemv, highlights increased competition in the Soliris market. Amgen Soliris Copy is a well-known biologic therapy. Soliris biosimilars are an opportunity to lower the cost of treatment and increase patient availability, but creates difficulties for originator companies who need to defend their market share as well as demonstrate why their biologic is originally valued.
• Expansion into New Indication: Regulatory approvals for additional indications such as NMOSD in China and myasthenia gravis in Japan show an increasing Soliris Labeled Indications Coverage trend in therapeutic areas. This is advantageous not only for patients with these rare diseases but also widens the market for Soliris. It shows that there is continuous clinical research for new therapies as well as for already existing ones.
• Global Market Penetration: These strategies focus on how best to market Soliris in new territories, especially in countries which had little or no prior access to the drug, demonstrating the further advancement of none-diagnosed medical requirements on a global scale. Gaining access to various health systems means overcoming a national regulatory framework, pricing policy, and developed epithelial structures so that patients everywhere can receive this therapy.-
• Focus on Rare Disease Management: More healthcare systems are beginning to adopt rare disease management due to its increasing importance. Treatments Soliris serves as a case study in how targeted therapies work. This might help with future investments for rare diseases and the research and development of specific treatments.
• Economic and Accessibility Challenge: Soliris’ price creates economic challenges, especially for low-middle income countries. Some ways to address these problems are establishing patient assistance programs, negotiating pricing strategies, and changing how funding is structured. Innovation is at risk if looking to increase affordability.
As for having a Soliris (eculizumab) market, there is a great shift with the appearance of biosimilars, entering new therapeutic areas, and trying to enhance global accessibility all culminating at once. Soliris now faces some opportunities and challenges with his patients, healthcare providers, and pharmaceutical companies
Recent Development in the Soliris (Eculizumab) Market
The market for soliris (eculizumab) has experienced notable shifts and updates recently because of scientific progress, wider therapeutic uses, changes in regulation, and new competition within the marketplace. Soliris is a monoclonal antibody treatment used for rare blood disorders such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Its high cost is offset by its great effectiveness, especially with the rising prevalence of rare diseases. Soliris also continues to affect market dynamics because of interest from biosimilars, strategic mergers, and policy-driven pricing and accessibility pressures. All of these factors simultaneously redefine Soliris’ future in the biopharmaceutical industry and create challenges and opportunities at the same time.
• New Indications Added to the Label: New regulatory approvals for Soliris include new ‘generalized myasthenia ‘gravies (gMG) and ‘neuromyelitis optica spectrum disorder (NMOSD) allowing for greater therapeutic reach. This also helps capture a greater share of the patient population beyond hematological conditions, broadening market reach and increasing revenues. It also proves the drug’s effectiveness in complement-mediated disorders. A subsequent rush of investment into clinical trials and clinical innovation has followed. Soliris is establishing strong position in the management of rare diseases and shifting the paradigm toward more precise medicine therapies.
• Surge in Development of Biosimilar: The global interest in developing biosimilars is now on surge due to the expiry of patents on Soliris. Targeting North America and Europe, players like Amgen and Samsung Bioepis are already working on getting regulatory approval. These companies are planning to market these biosimilars at a lower cost. Increased development of biosimilar drugs is giving competition which is good for lowering the price of Soliris as well as it’s market share. The lower cost novel drugs will help ease the access in emerging markets. The market dynamics for healthcare is encouraged due to the shift towards biosimilars which aids affordability.
• Strategic Partnerships and Licensing Agreement: In a bid to strengthen its rare disease portfolio, AstraZeneca acquired Alexion Pharmaceuticals, which produces Soliris. The $39 billion deal integrated Soliris into AstraZeneca’s global strategy, improving their distribution and research and development Soliris also helps in the Continuous next generation of complement inhibitors development, such as Ultomiris. With such partnerships and licensing deals, better innovations are obtained in a timely manner, making the drugs easy to access in other regions. They improve the patient care process and competitiveness of the parent company in the market at the same time. The mergers show the importance of Soliris in the rare disease drugs market.
• Regulatory and Reimbursement Challenge: Soliris has come under scrutiny regarding its pricing and reimbursement policies, especially with some European countries. The steep treatment costs have resulted in some healthcare authorities either limiting or delaying approval for reimbursement. To gain access to these markets, manufacturers have tended to enter into price or risk-sharing agreements. These changes are guiding the future orphan drug reimbursement paradigm while increasing the burden on manufacturers to prove clinical and economic value. This paradigm makes it more difficult to enter the market and requires more rigorous health economics research to justify the adoption of Soliris into different healthcare systems.
• Expansion and Access Programs Globally: Some new geographical markets such as parts of Asia, Latin America, and the Middle East have been added to the list of regions where Soliris is available through expanded access programs. These efforts target the patient population suffering from rare diseases who have limited access to treatments. The expansion also corresponds to the increasing healthcare spending in emerging economies along with heightened awareness for rare diseases. Access programs enhance collaboration with the government and non-governmental organizations, which improves the long-term sustainability of treatment. Consequently, Soliris can gradually expand its global footprint supporting revenue while enhancing equitable access to treatment around the world.
Recent trends regarding the Soliris market demonstrate how innovation and competition are intricately bound together with regulation and global expansion. New approvals widen its scope, whereas biosimilars and partnerships shift commercial approaches. Market access barriers still exist in the form of regulatory and reimbursement policies, although sponsored initiatives from other countries help offset these barriers. Collectively, these factors indicate a highly vibrant and shifting marketplace where strategic adaptability and velocity enable enduring advancement. In Soliris’s competitive post-patent phase, focus will probably turn towards innovation, cost, and worldwide reach in appealing impact to rare disease treatment.
Strategic Growth Opportunities in the Soliris (Eculizumab) Market
Despite the challenges posed by complement-mediated disorders, soliris (eculizumab) remains promising and continues to provide robust growth opportunities in multiple therapeutic areas. The expanding research into rare diseases coupled with improved diagnostic measures provides ample potential for enhancing the existing scope of Soliris. Some of the most promising fields include oncology, neurology, nephrology, and new emerging autoimmune disorders. Furthermore, the orphan drug designation and accelerated regulatory pathways add significant commercial value to new indications. Focused strategic growth opportunity analysis by application allows stakeholders to optimize investment portfolios, improve patient outcomes, and foster innovation in precision medicine for complex, underserved medical conditions.
• Paroxysmal Nocturnal Hemoglobinuria: The primary application of Soliris remains a PNH, which is documented in many studies as its initial and most assessed indication. In PNH treatment, the ability of Soliris to significantly reduce hemolysis and transfusion dependence is unparalleled. Increases in patient numbers due to earlier identification associated with improved diagnostics and awareness is supportive of market growth. Continued real-world data validating long-term efficacy and safety augments verticals in market growth. PNH patients usually require treatment for life, which also supports revenue. Steady demand is projected as PNH patients will be continuously maintained as treated subjects. Soliris’ established position in this market will continue to support its standing and patient loyalty. While there is growing competition from biosimilars, this segment will remain a cornerstone of differentiation for Soliris.
• Atypical Hemolytic Uremic Syndrome: The expansion of the use of Soliris for treating aHUS significantly expands the potential market in the field of nephrology. AHUS is an ultra-rare disorder, yet life-threatening condition which dysregulates the complement system. There are very few approved treatments, which makes Soliris stand out among the rest. A significantly critical therapeutic option, it has the ability to prevent kidney failure and decrease dependency on dialysis. Growth in infrastructure for the treatment of nephrology disorders is further enhanced by increasing global disease awareness and demand. In addition to this, adult and pediatric treatment approvals broaden the addressable market. Soliris’ enduring position gives a strong foundation for long-term growth across all forms of aHUS and greater market expansion.
• Generalized Myasthenia Gravis: The use of Soliris with patients gMG is a strategic extension into neurology. Soliris works best with patients that have anti-AChR antibodies; this was previously a gap in treatment for this population. This uses a broader patient population than its original orphan indication, increasing commercial desirability. Growing awareness among neurologists and inclusion into treatment algorithms is facilitating faster uptake. This therapeutic approach not only broadens the range of conditions that can be treated, but also serves as a foundation for complement inhibition in other neurologic conditions, enhancing the market value of Soliris.
• Neuromyelitis Optica Spectrum Disorder: With NMOSD being an exceptionally uncommon inflammatory condition that impacts the central nervous system, Soliris is demonstrating remarkable effectiveness. Trials have demonstrated its potential to reduce relapse rates and conserve neurological functionality. Diagnostics are continuously improving, making early detection of NMOSD more common, which expands the pool of potential patients. Soliris’ indication for NMOSD reinforces its position in neuroimmunology. This positioning helps to strategically distinguish from other market participants and highlights the importance of complement inhibition for purposes other than hematology. The effectiveness of Soliris for NMOSD strengthens the case for further expanding the neurological indications for the product.
• Autoimmune and Complement-Mediated Condition: Emerging studies are considering the application of Soliris for systemic lupus erythematosus and catastrophic antiphospholipid syndrome. While these potential applications remain investigational, they may create large untapped markets. Inflammation and autoimmune disease processes also involve the complement system, which enhances the prospect of Soliris in this area. The opportunity can be realized with sustained investment in clinical trial frameworks and academic collaborations. If validated, Soliris could change treatment paradigms of several immunological diseases, defining a new chapter in its expanding journey.
Proactive strategic expansion soliris is pursuing adds on new and existing therapeutic areas. PNH and aHUS comprise core indications that will continue to drive revenue, while new uses gMG and NMOSD expand the market use base. Broader autoimmune disorders research may provide high-impact opportunities later. These changes encompass the growing focus on precision medicine and biologics for chronic and rare diseases. By attending to unfulfilled clinical needs and preserving high efficacy benchmarks, Soliris will have diverse therapeutic options to leverage. These sharpen future Soliris market strategies while enhancing prominence and competitive edge.
Soliris (Eculizumab) Market Driver and Challenges
The soliris (eculizumab) market is influenced by technological evolution, economic forces, and regulations, which are sometimes in conflict. Demand for Soliris, a high-cost life-saving biologic, is always under immense scrutiny, especially considering its price. Increased biotechnology and diagnostic capabilities expand the market, complemented by regulatory orphan drug incentives, which tend to ease the approval process. These advances, however, face challenges from pricing, biosimilars, and reimbursement policies. All stakeholders need to bear in mind these dynamics in order to navigate market risks and seize new opportunities as they arise. Highlighting the key drivers and challenges positions stakeholders to understand the sustainability and adaptableness of Soliris amidst the healthcare competition.
The factors responsible for driving the soliris (eculizumab) market include:
1. Orphan Drug Policies and their Regulatory Advantage: Soliris enjoys the benefits of receiving orphan drug designations for several indications, which offers advantages such as market exclusivity as well as granting certain tax benefits, and faster approval processes. These incentives shorten the time for new drugs to enter the market and reduce development risks, making it financially viable to target rare conditions. Support from regulators in the United States and Europe bolsters the Soliris’ ability to broaden its therapeutic range. This factor also improves investment confidence and bolsters strategic plans for developing treatments for rare diseases.
2. Widening Scope of Rare Complement-Mediated Disorder: Better clinical diagnosis is driving the increasing incidence of PNH, aHUS, and NMOSD, which broadens the patient population for Soliris. Although these conditions are rare, they are severe and usually need both prompt and long-term treatment. The market is well supplied, as Soliris offers The increasing identification of these rare diseases reinforces the consistent demand and creates a base for durable therapy adoption. With improving healthcare services for rare diseases, Soliris should anticipate a wider market globally.
3. New Developments on Complement Inhibition Research: SolirisÄX%$%X action mechanism is being validated in light of recent advancements within the complement pathway research. New disorders are being associated with this biological pathway as the complement systemÄX%$%Xs dysfunction role in diseases is better understood. These changes justify additional clinical testing and broaden SolirisÄX%$%X potential use claim. In addition, first-generation Soliris therapeutics are being developed into next-phase drugs such as Ultomiris, furthering its foundational role in the field.
4. The Emerging Countries’ Expansion: Countries in Asia, Latin America, and the Middle East are significantly improving their infrastructure for treating rare diseases. Soliris is being introduced into neglected areas via early access programs and public-private partnerships. These attempts improve the global reach, expand the patient base, and increase revenue streams from diverse regions. Evolving healthcare systems in these areas translate to progressive wider acceptance and growing adoption of Soliris.
5. Strategic Industry Partnerships and Mergers and Acquisitions Activity: Strategic mergers and acquisitions, like AstraZeneca picking up Alexion, have bolstered investment and commercial strength for Soliris. Work with research groups and regional healthcare systems is also pushing forward R&D. These partnerships add value to the drug’s competitive position, enhance the reliability of the supply chain, and assist in lifecycle management planning. This trend of consolidation in the industry strengthens Soliris’ position in the context of treatment possibilities for rare diseases.
Challenges in the soliris (eculizumab) market are:
1. The High Costs of Treatment and Pricing Pressure: Alongside this, Soliris is the most expensive drug on the market, so elicits some pushback from payer markets and regulators. Limitations on access impact the public more within developing markets. Greater scrutiny on cost-effectiveness analysis and budget impact assessments presents greater barriers to reimbursement. A set of these circumstances can restrict market expansion despite clinical demand.
2. Multiple New Biosimilar Competitors Entering: With SolirisÄX%$%Xs original patents expiring, a number of subsidiary versions are being designed and marketed. These alternatives pose a threat to SolirisÄX%$%X market territory. Companies are being forced to respond through differentiating strategies, altering prices, or switching to newer options such as Ultomiris.
3. Strict Regulatory and Reimbursement Policies: The disparate regulatory frameworks and differing payer systems make market access cumbersome. In Europe and Asia, the evidence-based requirements that accompany the regionÄX%$%Xs cost-benefit analysis are particularly troublesome in terms of providing timely access. These shifting paradigms require companies to spend heavily on clinical and pharmacoeconomic strategies that will yield the necessary data.
Strong scientific validation, demand from the rare disease community, and regulatory incentives fuel the Soliris market. However, it is further burdened by intense biosimilar competition, increasing costs, stringent regulations, and constant market pressure. These risks are offset by strategic partnerships and diversification into new geographies and applications. Achieving long-term growth depends on how effectively innovativeness is balanced with cost-containment. Stakeholders must be flexible with the frameworks for pricing, access, and the science. The overall market direction is still cautiously optimistic, supported by innovation and global growth despite an unforgiving competitive landscape and stringent biopharmaceutical industry regulations.
List of Soliris (Eculizumab) Companies
Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. With these strategies soliris (eculizumab) companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the soliris (eculizumab) companies profiled in this report include-
• Alexion
• Akari Therapeutics
• Amgen
• Apellis Pharmaceuticals
Soliris (Eculizumab) Market by Segment
The study includes a forecast for the global soliris (eculizumab) market by type, application, and region.
Soliris (Eculizumab) Market by Type [Value from 2019 to 2031]:
• Plasma Exchange
• Plasma Infusion
Soliris (Eculizumab) Market by Application [Value from 2019 to 2031]:
• PNH
• aHUS
• Others
Soliris (Eculizumab) Market by Region [Value from 2019 to 2031]:
• North America
• Europe
• Asia Pacific
• The Rest of the World
Country Wise Outlook for the Soliris (Eculizumab) Market
Soliris is a monoclonal antibody that inhibits the action of the complement protein C5. It is used to treat several rare diseases, including Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS), and Neuromyelitis Optica Spectrum Disorder (NMOSD). Recently, the Soliris market in the United States, China, Germany, India, and Japan has seen new regulatory milestones and increases in competition and therapeutic indications, which are changing the landscape for this important drug.
• United States: The U.S. Food and Drug Administration (FDA) granted approval to Amgen for Bkemv, the first biosimilar to Soliris. This expands the market for patients with rare blood disorders such as PNH and aHUS, increasing treatment access and decreasing costs. Bkemv has been designated as an interchangeable biosimilar, Meaning it provides no clinically important differences from Soliris. The approval also comes with a boxed warning on the risk of serious infections with Neisseria meningitidis. There is significant risk and major need for patient oversight considering the warning.
• China: In ChinaÄX%$%Xs National Medical Products Administration authorized Soliris for the treatment of adult patients with anti AQP4 antibody positive NMOSD. The release order in Chinese territory of Soliris to treat NMOSD patients was long expected after the drug underwent PREVENT Phase III clinical studies which showed significant reduction in relapse risk for patients under the treatment.
• Germany: Germany still remains one of the largest markets for Soliris as the drug is endorsed to treat PNH, aHUS, and gMG. Citizens suffering from rare health issues are a well-served demographic due to the state’s devotion to the healthcare industry, and the availability of Soliris is further sponsored by ongoing clinical trials and real world data gathering from within the country. The results collated from these studies ensure patient trust regarding the long term benefits and risks accompanying the treatment, thus supporting the further application of Soliris in clinical practice.
• India: In India Soliris as well as other expensive drugs lack support due to the country’s economy and lack of insurance schemes protecting patients suffering from rare diseases. Despite the drug being approved for PNH and aHUS, its steep price makes it difficult to become widely adopted. Currently Soliris is attempting to improve matters through better pricing negotiations alongside patient assistance programs, and if successful Indian patients will be able to access this life saving treatment more widely.
• Japan: A multitude of indications have been confirmed to Japan as having the capability to be treated with Soliris. In September 2023, myasthenia gravis patients became eligible for treatment with Soliris, which further emphasized the product’s usefulness for rare neuromuscular disorders. Moreover, Soliris is now approved in Japan for aHUS, making this complement inhibitor accessible to patients for better disease management.
Features of the Global Soliris (Eculizumab) Market
Market Size Estimates: Soliris (eculizumab) market size estimation in terms of value ($B).
Trend and Forecast Analysis: Market trends (2019 to 2024) and forecast (2025 to 2031) by various segments and regions.
Segmentation Analysis: Soliris (eculizumab) market size by type, application, and region in terms of value ($B).
Regional Analysis: Soliris (eculizumab) market breakdown by North America, Europe, Asia Pacific, and Rest of the World.
Growth Opportunities: Analysis of growth opportunities in different type, application, and regions for the soliris (eculizumab) market.
Strategic Analysis: This includes M&A, new product development, and competitive landscape of the soliris (eculizumab) market.
Analysis of competitive intensity of the industry based on Porter’s Five Forces model.
FAQ
Q1. What is the growth forecast for soliris (eculizumab) market?
Answer: The global soliris (eculizumab) market is expected to grow with a CAGR of 5.5% from 2025 to 2031.
Q2. What are the major drivers influencing the growth of the soliris (eculizumab) market?
Answer: The major drivers for this market are the rising diagnosis rate of complement-mediated disorder, the growing adoption of targeted biologics, and the increase in healthcare spending.
Q3. What are the major segments for soliris (eculizumab) market?
Answer: The future of the soliris (eculizumab) market looks promising with opportunities in the PNH and aHUS markets.
Q4. Who are the key soliris (eculizumab) market companies?
Answer: Some of the key soliris (eculizumab) companies are as follows:
• Alexion
• Akari Therapeutics
• Amgen
• Apellis Pharmaceuticals
Q5. Which soliris (eculizumab) market segment will be the largest in future?
Answer: Lucintel forecasts that, within the type category, plasma exchange is expected to witness higher growth over the forecast period.
Q6. In soliris (eculizumab) market, which region is expected to be the largest in next 5 years?
Answer: In terms of region, North America is expected to witness the highest growth over the forecast period.
Q7. Do we receive customization in this report?
Answer: Yes, Lucintel provides 10% customization without any additional cost.
This report answers following 11 key questions:
Q.1. What are some of the most promising, high-growth opportunities for the soliris (eculizumab) market by type (plasma exchange and plasma infusion), application (PNH, aHUS, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)?
Q.2. Which segments will grow at a faster pace and why?
Q.3. Which region will grow at a faster pace and why?
Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market?
Q.5. What are the business risks and competitive threats in this market?
Q.6. What are the emerging trends in this market and the reasons behind them?
Q.7. What are some of the changing demands of customers in the market?
Q.8. What are the new developments in the market? Which companies are leading these developments?
Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth?
Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution?
Q.11. What M&A activity has occurred in the last 5 years and what has its impact been on the industry?
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