Eculizumab (Soliris) Market: Opportunities And Challenges Post-Patent Cliff

Report Overview

Eculizumab, marketed as Soliris by Alexion Pharmaceuticals, is a critical treatment for rare and life-threatening conditions such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Its unique mechanism of action, as a complement inhibitor, has positioned it as a first-line therapy in these therapeutic areas. The drug's market dominance has been driven by its efficacy in managing these complex diseases. However, as key patents near expiration, the Eculizumab market is on the brink of significant transformation. The patent cliff, coupled with the impending rise of biosimilars, presents both challenges and strategic opportunities for stakeholders. The entry of biosimilars is expected to introduce competitive pressure, potentially reshaping treatment paradigms, pricing structures, and market share dynamics, particularly as the demand for more cost-effective treatment options grows.

Key Report Deliverables

• Market Landscape Analysis, Examine the current Eculizumab market, covering size, growth drivers, and the impact of patent expiry. Focus on how biosimilars will affect market dynamics, treatment protocols, and pricing.

• Market Growth Forecast, Project future market trends, highlighting opportunities from new indications and the influence of biosimilars on market share, pricing, and competition.

• Regulatory and Market Barriers, Identify barriers to market expansion, including approval processes, reimbursement challenges, and biosimilar market access. Assess the impact of regulatory frameworks like FDA and EMA.

• Competitive Landscape, Analyze key market players, including Alexion and biosimilar manufacturers. Evaluate strategies and potential shifts in market share post-patent expiry.

• Regulatory Challenges, Focus on the regulatory hurdles facing Eculizumab biosimilars, including clinical trial requirements and market access restrictions under FDA and EMA guidelines.

• Strategic Implications, Explore strategic approaches for Alexion and competitors, such as product differentiation, patient support programs, and geographic expansion to defend market share.

Patent Cliff Analysis:

The data indicates a significant rise in sales at risk for Eculizumab (Soliris), which is expected to accelerate as the patent expiration approaches. This increasing percentage reflects the looming challenges as Soliris' exclusivity wanes, opening the door for biosimilars to enter the market. As a result, Alexion Pharmaceuticals is poised to face growing competition, which is likely to lead to a sharp decline in Soliris’ market share and pricing power.

The gradual rise in sales at risk underscores a potential loss of revenue, particularly in the treatment of rare diseases like paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). As biosimilars gain approval and become available, the introduction of lower-cost alternatives will disrupt the market, affecting both domestic and global sales where Soliris has a strong presence.

Given the high sales at risk, Alexion must take proactive steps to mitigate these potential losses. Strategies such as expanding the approved indications for Soliris, pursuing patent extensions, or developing combination therapies to enhance its market position could help defend against biosimilar encroachment. Additionally, strengthening its pipeline with innovative therapies and exploring expansion into emerging markets will be crucial for sustaining revenue streams as the impact of the patent cliff intensifies.

Current Market Scenarios

The Eculizumab (Soliris) market is currently undergoing a transformative period, as the patent expiration for the drug in key global markets is approaching, opening the door for biosimilars to enter. Soliris, developed by Alexion Pharmaceuticals, has been a leading treatment for rare and life-threatening conditions such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). However, with patent exclusivity nearing its end, biosimilars are poised to introduce competition, particularly in the areas where Soliris has established a strong market presence.

The increasing pressure from healthcare systems to reduce the high cost of therapies is contributing to the rising demand for biosimilars. These products, expected to be more cost-effective than the originator drug, are anticipated to gain traction in key regions, including North America and Europe, where regulatory frameworks are becoming more favorable to biosimilars. The U.S. FDA's streamlined biosimilar approval process and the well-established biosimilar market in Europe are creating an environment conducive to biosimilar adoption. In addition to these mature markets, emerging regions such as Asia-Pacific and Latin America, where access to expensive treatments is a significant barrier, are expected to see growing biosimilar uptake.

Despite these opportunities, biosimilars face several challenges. The development process for biosimilars is complex and requires extensive clinical evidence to demonstrate comparability to the originator drug. Regulatory hurdles, particularly around approval pathways and market access, remain significant obstacles. Furthermore, physician and patient adoption of biosimilars will require careful management of perceptions and trust, which will depend on demonstrating long-term safety and efficacy through clinical trials and post-market surveillance.

As the Eculizumab market evolves, Alexion Pharmaceuticals and other stakeholders in the market will need to adapt their strategies to maintain their market position. This may involve pursuing label expansions, exploring complementary treatment options, or advancing innovation through next-generation biologics. Additionally, with the imminent entry of biosimilars, the pricing and market access strategies will play a crucial role in determining the future dynamics of the market. The ability to compete on price while maintaining the clinical differentiation of Soliris will be key to sustaining market leadership in a rapidly changing competitive environment.

Market Dynamics

“Eculizumab’s critical role in rare disease treatment sustains market demand”

Eculizumab (Soliris) maintains strong demand due to its critical role in treating rare diseases such as paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), where it is one of the few approved therapies. The high unmet need in these areas ensures its continued use, especially as alternative treatments remain limited.

The drug's established efficacy in preventing complement-mediated damage in PNH and aHUS supports its integration into treatment regimens, making it indispensable for clinicians managing these complex conditions. Eculizumab’s ability to prolong survival and improve quality of life for these patients solidifies its position in standard care protocols.

Furthermore, expanding clinical evidence and potential for label extensions into new indications present future growth avenues, reinforcing its market relevance. The drug's clinical track record and support programs also help ensure ongoing access, particularly in emerging markets with rising rare disease awareness.

“Patent expiry and biosimilars threaten pricing power and market share”

The impending patent expiration of Eculizumab (Soliris) is expected to have a significant impact on its revenue streams. As the patent protection expires, biosimilars are set to enter the market, providing cost-effective alternatives that challenge Soliris' pricing and market share. While biosimilars have not yet gained approval in all markets, their entry into regions such as Europe and the U.S. will be pivotal in driving competition, particularly as healthcare providers and payers increasingly prioritize cost containment in the rare disease space.

Biosimilars, once approved, will directly pressure the premium pricing of Soliris, leading to potential price erosion, especially in markets with rigorous reimbursement policies. In emerging markets where access to expensive therapies is limited, the availability of biosimilars could accelerate their adoption, further compressing Soliris' market share and profit margins.

Additionally, the high cost of Soliris, which has historically been a barrier to broader patient access, could become an even greater challenge as more affordable alternatives become available. From a strategic perspective, this biosimilar competition will force Alexion Pharmaceuticals to focus on differentiating Soliris through clinical innovation, expanding its patient access programs, and exploring next-generation complement inhibitors or other therapeutic avenues to maintain its market position and revenue generation.

“Biosimilars and emerging markets offer new growth avenues”

The entry of biosimilars to the Eculizumab (Soliris) market creates both challenges and opportunities. While biosimilars will likely exert pricing pressure on Soliris, they also offer an opportunity to expand access to life-saving treatments, especially in cost-sensitive regions. As healthcare systems increasingly focus on cost containment, biosimilars present a viable solution for treating rare diseases like paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), where Soliris currently holds a dominant position. This shift opens doors for both biosimilar manufacturers and Alexion Pharmaceuticals to tap into new revenue streams while ensuring broader access to therapies without compromising clinical outcomes.

In emerging markets, where healthcare access is improving and rare disease diagnoses are rising, there are significant growth opportunities for both Soliris and its biosimilars. The growing awareness of conditions such as PNH and aHUS in regions like Asia-Pacific, Latin America, and the Middle East creates an urgent demand for effective and affordable treatments. As these markets expand, biosimilars could provide the necessary affordability, while Soliris continues to benefit from its established clinical position in these high unmet need areas.

Moreover, Eculizumab's potential for expansion into new indications offers an additional growth avenue. Ongoing research into its efficacy in treating other complement-mediated diseases, as well as its use in combination therapies, presents opportunities for Alexion to further broaden Soliris' market reach. For example, exploring its potential in other rare diseases or expanding its use in the transplant and autoimmune spaces could offer significant revenue opportunities beyond its current indications.

As precision medicine continues to evolve, Eculizumab could also find new applications in targeted treatment regimens, particularly as the understanding of complement system-related diseases deepens. In addition to biosimilars, Alexion's ability to innovate and extend the therapeutic lifecycle of Soliris will be key to securing its place in the evolving pharmaceutical landscape.

“Biosimilar adoption and cost-efficiency drive market dynamics”

• Patent Expiry and Biosimilar Impact

  The upcoming patent expiration of Eculizumab (Soliris) will introduce biosimilars, creating pricing pressures and threatening market share. While Soliris remains critical for treating rare diseases like PNH and aHUS, biosimilars will drive cost competition, especially in price-sensitive regions. Alexion Pharmaceuticals will need to focus on differentiating the product through innovation or patient access strategies to mitigate the impact.

• Biosimilar Adoption in Developed and Emerging Markets

  Biosimilar uptake is accelerating globally, reshaping the Eculizumab market. In developed markets like the U.S. and Europe, streamlined approval processes are paving the way for biosimilars to enter faster. In emerging markets, expanding healthcare access and the need for cost-effective treatments are increasing biosimilar adoption. This fragmentation of the market will increase competition, requiring Alexion to adapt its strategy.

• Cost-Effectiveness in Rare Disease Treatment

  The growing preference for cost-effective therapies, driven by the high price of Soliris and the rise of biosimilars, is reshaping treatment landscapes. As healthcare systems focus on affordability, biosimilars are expected to gain more traction, pressuring Soliris to compete on price and value in order to maintain its market share.

Overview of Alternative Therapeutics

The emergence of biosimilars for Eculizumab (Soliris) following the patent expiry is expected to reshape the landscape of treatment for rare diseases like paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Biosimilars will offer more affordable alternatives to Soliris, potentially increasing treatment access in regions with cost-sensitive healthcare systems. These alternatives will mirror the efficacy and safety profiles of the originator drug, thereby providing cost-effective solutions for patients without compromising clinical outcomes. As the biosimilar market grows, it will likely create market fragmentation, offering healthcare providers and patients more treatment options while intensifying price competition for Soliris.

In addition to biosimilars, advancements in biologic therapies and complement inhibitors are diversifying the treatment landscape for diseases treated by Soliris. New agents targeting complement-mediated diseases may offer alternatives with similar or improved therapeutic efficacy. Furthermore, innovations in combination therapies and targeted biologics are gaining traction, particularly for conditions like aHUS. As precision medicine continues to progress, these alternative treatments are positioning themselves as competitive options for patients, offering potential improvements in efficacy, safety, and cost-effectiveness.

For Alexion Pharmaceuticals, responding to these shifts through pipeline expansion, next-generation therapies, and strategic pricing will be critical to maintaining its market position as biosimilars and alternative biologic treatments gain ground in the rare disease space.

Competitive Landscape

The competitive landscape for Eculizumab (Soliris) is becoming increasingly dynamic as biosimilars and alternative therapies begin to enter the market. With the approaching expiration of Eculizumab’s patent, biosimilars are poised to introduce cost-effective alternatives, which will exert significant pricing pressure on the originator drug. Biosimilars are expected to mirror Soliris' efficacy and safety profiles, offering similar clinical outcomes at a reduced cost. Once approved, these biosimilars will present a direct challenge to Alexion Pharmaceuticals, especially in cost-sensitive healthcare systems. As biosimilar competition increases, particularly in regions like Europe and North America, Soliris' market share is likely to be affected, especially in key indications like paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

In addition to biosimilars, alternative biologic therapies targeting complement-mediated diseases are gaining momentum. New complement inhibitors, developed by competitors, are becoming viable treatment options for rare diseases traditionally treated by Soliris. These therapies could offer similar or enhanced therapeutic efficacy, which poses further competitive pressure on Soliris as they enter the market. Additionally, the growing landscape of combination therapies in rare diseases could provide opportunities for alternatives to Soliris, further fragmenting the market.

The rise of next-generation biologics and targeted therapies adds another layer of competition. New treatment regimens in the rare disease space are increasingly exploring innovative approaches, such as gene therapies and monoclonal antibodies, which may position themselves as alternatives to Soliris in the future. As precision medicine and biologics evolve, Alexion will need to respond by expanding its pipeline, focusing on new indications, or differentiating Soliris through patient access and support programs.

These emerging treatments, along with biosimilar competition, present significant challenges for Soliris, compelling Alexion to strengthen its competitive strategy. Diversification into new therapeutic areas and continued investment in innovation will be crucial for maintaining Soliris’ market position as alternative treatments continue to reshape the competitive landscape.

North America Eculizumab (Soliris) Market

The Eculizumab (Soliris) market in North America is driven by the established treatment protocols for paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). The market is expected to face increased competition with the upcoming expiration of Soliris' patent, allowing for the entry of biosimilars. In the U.S., healthcare systems are under increasing pressure to control costs, and the availability of biosimilars will likely offer more affordable alternatives to Soliris. Although Soliris will continue to be part of treatment regimens in specialized centers, its market share is anticipated to decrease as biosimilars gain market approval. In Canada, while healthcare systems provide significant coverage for rare diseases, cost considerations may drive a shift toward biosimilars as they become available.

Europe Eculizumab (Soliris) Market

The European market for Eculizumab is influenced by the rising diagnosis and treatment of PNH and aHUS. However, the approval of biosimilars will introduce pricing pressures on Soliris, particularly in countries like the U.K., Germany, and France, where public healthcare systems are focused on controlling healthcare costs. As regulatory bodies like the EMA facilitate the approval of biosimilars, these products are expected to enter the market in increasing numbers, which will likely reduce Soliris' market share in both public and private healthcare settings. Despite this, Soliris will continue to play a role in clinical treatment regimens, particularly for patients who require specialized care or are resistant to alternative treatments.

Asia Pacific Eculizumab (Soliris) Market

The Asia Pacific region presents both opportunities and challenges for the Eculizumab market. In countries such as China and India, the incidence of PNH and aHUS is increasing, contributing to the growing demand for biologics. However, the high cost of Soliris limits its accessibility in these markets. The approval of biosimilars in the region is expected to address this gap by providing cost-effective alternatives. Regulatory environments in Japan and South Korea are favorable for biosimilars, which will increase competition for Soliris as these alternatives become more accessible. The shift towards biosimilars, alongside growing demand for biologics in emerging markets, will likely reduce Soliris' market share, particularly in countries with constrained healthcare budgets.

Latin America Eculizumab (Soliris) Market

The market for Eculizumab in Latin America is influenced by the rising incidence of rare diseases like PNH and aHUS, particularly in countries such as Brazil and Mexico. Despite the increasing awareness and diagnosis of these conditions, the high cost of Soliris presents a significant barrier to broader market penetration. The entry of biosimilars is expected to provide more affordable treatment options, particularly in countries with public healthcare systems where cost containment is a priority. As biosimilars gain approval and market adoption, Soliris will face increased competition, particularly in markets where healthcare budgets are limited. The overall market is likely to shift toward more cost-effective treatment options, reducing Soliris' market share.

Middle East and Africa Eculizumab (Soliris) Market

In the Middle East and Africa (MEA), the market for Eculizumab is still developing, with increasing demand for biologics driven by rising awareness and diagnosis of rare diseases. However, limited healthcare infrastructure and high drug costs present challenges to widespread access to Soliris. The introduction of biosimilars in the MEA region is expected to create more affordable treatment options, which could increase access to care in countries with limited resources. As regulatory agencies in regions such as Saudi Arabia and South Africa begin to approve biosimilars, competition for Soliris will intensify. Access to biologics is likely to improve in the region due to ongoing investments in healthcare infrastructure, but affordability will remain a key factor influencing treatment adoption.

Analyst Perspective

The impending patent expiration of Eculizumab (Soliris) introduces significant competitive pressure, particularly with the anticipated entry of biosimilars. This will impact pricing and market share, especially in cost-sensitive regions such as North America, Europe, and Asia-Pacific. While Soliris continues to be a key treatment for PNH and aHUS, the availability of biosimilars will lead to increased competition. Alexion will need to focus on product differentiation, expanding indications, and strategic pricing to maintain its market position amidst biosimilar adoption.

Case Study (Recent Engagement): Keytruda Patent-Cliff & Price- Erosion Impact Model

PROJECT OBJECTIVE

To evaluate the potential revenue, price, and patient access implications of Keytruda’s 2028 patent cliff, incorporating biosimilar entry dynamics, country-specific adoption curves, and Merck’s lifecycle defense strategies (remarkably the subcutaneous formulation). The goal was to provide the client with a transparent, scenario-based model to anticipate outcomes and inform strategy

GVR SOLUTION

• Built a bottom-up commodity-flow and analogue-based model, anchored on Merck’s $29.5B Keytruda sales in 2024.

• Integrated jurisdictional LOE timelines (EU mid-2028, U.S. 2028–2029 pending litigation outcomes).

• Modeled biosimilar adoption S-curves calibrated to oncology antibody analogues (EU faster via tenders, U.S. slower via contracting).

• Applied price-erosion benchmarks (EU −15–30% Yr-1, deepening to −45–60% by Yr-3; U.S. −10–25% net decline over same horizon).

• Layered lifecycle defenses (SC uptake assumptions of 25–40% of innovator units, combo refresh, contracting) to quantify buffers.

• Delivered outputs as a dynamic Excel scenario tool and a management-ready PPT deck with revenue bridges, sensitivity tornadoes, and SC migration visuals.

IMPACT FOR CLIENT

• Enabled the client to quantify downside vs. defense-optimized revenue trajectories:

  • Base case: 30–40% global revenue decline by Year-3 post-LOE.

  • Downside: 45–55% decline in tender-heavy markets.

  • Defense-optimized: Contained erosion to ~−20–25% with strong SC adoption.

• Gave the client a clear view of which markets drive early erosion (EU) and where strategic contracting or SC migration can preserve share (U.S.).

• Equipped decision-makers with a playbook of watch-points (tender concentration, litigation outcomes, SC IP coverage, combo pipeline) to guide commercial strategy.

• Provided a

  transparent methodology that could be presented to boards/investors with evidence-backed assumptions

WHY THIS MATTERS

• Keytruda is the world’s best-selling cancer drug, representing nearly one-third of Merck’s revenue.

• Patent expiry will reshape both Merck’s earnings profile and global oncology access dynamics.

• Payers and governments stand to benefit from biosimilar entry through lower costs, but manufacturers need to manage cliff risk while capturing upside from lifecycle innovations.

• Understanding how quickly revenues erode and how patient access expands post-biosimilar is critical for:

  • Biopharma companies (strategic planning, pipeline prioritization).

  • Investors (valuing Merck’s cash flows beyond 2028).

  • Payers and policymakers (budgeting for oncology drug spend).

A robust patent cliff model helps clients navigate the dual challenge of price erosion and patient expansion, ensuring strategies are grounded in real-world benchmarks.