Global Lumasiran Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

Lumasiran Market Analysis

The global lumasiran market is positioned for significant growth, driven by the increasing incidence of primary hyperoxaluria type 1 (PH1) and the rising demand for effective therapeutic solutions. Lumasiran, a small interfering RNA (siRNA) therapeutic agent, has shown efficacy in reducing urinary oxalate levels, thereby addressing a critical unmet need in the treatment of PH1. The FDA’s approval of lumasiran marks a significant milestone in managing this rare metabolic disorder, offering a novel approach to therapy. The market's expansion is further fueled by a growing awareness of rare diseases and an emphasis on improving patient outcomes. As healthcare providers and patients recognize the importance of early intervention and effective treatment options, lumasiran is increasingly seen as a pivotal therapy. Additionally, advancements in research and development, supported by government initiatives and funding, are enhancing the landscape for rare disease treatments. The increasing focus of pharmaceutical companies on innovative therapies and a rising understanding of primary hyperoxaluria are likely to contribute to the market's robust growth, making lumasiran a cornerstone in the management of this rare condition.

Lumasiran Market Size

The global lumasiran market size was valued at USD 181.95 million in 2024 and is projected to reach USD 572.27 million by 2032, with a CAGR of 15.40% during the forecast period of 2025 to 2032. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Lumasiran Market Trends

“Increasing Focus on Personalized Medicine”

A notable trend in the lumasiran market is the increasing focus on personalized medicine, particularly in the treatment of rare diseases such as primary hyperoxaluria type 1 (PH1). As awareness of genetic disorders grows, healthcare providers are recognizing the need for tailored therapeutic approaches that address individual patient profiles. Lumasiran, a small interfering RNA (siRNA) therapy, exemplifies this shift by targeting the underlying genetic cause of PH1, effectively lowering urinary oxalate levels. For instance, clinical trials have demonstrated that lumasiran can significantly reduce urinary oxalate concentrations in patients, showcasing its potential for personalized treatment regimens. This trend is further supported by advancements in genomic testing, allowing for early diagnosis and treatment customization based on genetic markers. As healthcare systems increasingly adopt personalized medicine, the demand for innovative therapies such as lumasiran is expected to rise, paving the way for improved patient outcomes and a growing market presence.

Report Scope and Lumasiran Market Segmentation  

Lumasiran Market Definition

Lumasiran is a targeted RNA interference therapy developed for the treatment of primary hyperoxaluria type 1 (PH1), a rare genetic disorder that leads to excessive production of oxalate, resulting in kidney damage and other serious complications. By inhibiting the production of the enzyme glycolate oxidase, lumasiran effectively reduces oxalate levels in the liver, thereby helping to prevent the progression of kidney disease and other symptoms associated with PH1. Administered via subcutaneous injection, it represents a significant advancement in the management of this condition, offering a novel therapeutic approach to patients.

Lumasiran Market Dynamics

Drivers

• Increasing Incidence of Rare Diseases

The increasing incidence of rare diseases, including primary hyperoxaluria type 1 (PH1), is significantly driving the demand for targeted therapies such as Lumasiran. According to the National Organization for Rare Disorders (NORD), approximately 1 in 10 Americans is affected by a rare disease, with an estimated 30 million people in the U.S. living with a condition classified as rare. Specifically for PH1, studies estimate that it affects about one in fifty thousand individuals, making it a rare but impactful condition. As awareness and diagnostic capabilities improve, more patients are being identified, which increases the need for effective treatments. The growing prevalence of such conditions emphasizes the necessity for specialized therapies, positioning Lumasiran as a critical option in the management of PH1 and contributing to its market growth. This trend is supported by a broader move towards personalized medicine, which highlights the importance of targeted therapies in addressing unique patient needs.

• Increasing Patient Advocacy Groups

Patient advocacy groups play a crucial role in raising awareness about primary hyperoxaluria type 1 (PH1) and promoting the availability of treatments such as Lumasiran, significantly influencing treatment uptake. Organizations such as the American Association for Kidney Patients (AAKP) and the National Kidney Foundation (NKF) actively educate patients and healthcare providers about rare kidney diseases, including PH1. A survey conducted by the National Organization for Rare Disorders (NORD) found that 8% of patients felt more informed about their conditions due to advocacy efforts, which often include educational campaigns, support networks, and partnerships with pharmaceutical companies. This increased awareness helps in the timely diagnosis of PH1 and encourages patients and their families to seek out targeted therapies such as Lumasiran, thereby enhancing its market penetration. The collaboration between advocacy groups and healthcare providers further solidifies the importance of awareness in driving demand for effective treatments.

Opportunities

• Increasing Technological Advancements in Treatment Solutions

As the field of genetic therapies expands, lumasiran stands to benefit significantly from advancements in related technologies, such as CRISPR gene editing and next-generation sequencing (NGS). For instance, CRISPR technology has shown promise in directly correcting genetic mutations associated with various disorders, potentially leading to more effective and permanent solutions for conditions such as primary hyperoxaluria type 1 (PH1). These advancements could enhance lumasiran's role as part of a comprehensive treatment strategy, enabling personalized therapies tailored to an individual's genetic makeup. Furthermore, the integration of NGS can facilitate the identification of PH1 patients who may respond best to lumasiran, improving patient outcomes through targeted therapy. This synergy positions lumasiran as a vital option within an evolving treatment landscape and broadens its market appeal as a cutting-edge solution for managing rare genetic disorders. By capitalizing on these innovations, companies can strengthen lumasiran's market presence and create new opportunities for patient access and engagement.

• Growing Investment in Research and Development (R&D)

Investment in research and development (R&D) for lumasiran is a crucial strategy that companies are employing to expand its indications beyond primary hyperoxaluria type 1 (PH1) and potentially increase its market share. For instance, research into the efficacy of lumasiran in treating other forms of hyperoxaluria or related metabolic disorders could open new avenues for its application, attracting a broader patient population. Additionally, studies exploring combination therapies that pair lumasiran with other medications or therapies aimed at managing kidney disease could enhance treatment effectiveness and appeal to healthcare providers seeking comprehensive solutions for their patients. This proactive approach bolsters lumasiran's market presence and positions it as a versatile therapeutic option within the expanding landscape of genetic therapies. By focusing on R&D to investigate these new indications, companies can capitalize on unmet medical needs, further driving adoption and ultimately improving patient outcomes, making this a significant market opportunity.

Restraints/Challenges

• Market Access and Pricing

Market access and pricing represent significant challenges for Lumasiran due to its innovative nature, which typically leads to high treatment costs. For instance, Lumasiran has an annual cost could exceed 100 thousand dollars, making it essential for healthcare systems and insurance providers to evaluate its reimbursement rates and demonstrate cost-effectiveness compared to existing treatment options. In many countries, particularly those with stringent healthcare budgets or different reimbursement models, securing access can be challenging. For instance, in some European countries, therapies for rare diseases must demonstrate substantial clinical benefit and economic value to be included in national health plans. The difficulty in negotiating these reimbursement rates can lead to disparities in patient access, particularly in regions where healthcare resources are limited. This situation highlights the broader challenge of ensuring equitable access to cutting-edge therapies while balancing cost constraints in healthcare systems worldwide.

• Complex Regulatory Frameworks

The availability of long-term efficacy and safety data for Lumasiran poses a considerable market challenge, as initial clinical trials, while promising, may not fully capture the therapy's performance over extended periods. Healthcare providers and patients require robust evidence to support the sustained benefits and potential risks associated with the treatment. For instance, the long-term implications of RNA interference therapies, such as Lumasiran, remain uncertain, particularly concerning their impact on kidney function and overall patient health over time. This uncertainty can lead to hesitancy among healthcare providers in prescribing the therapy and may deter patients from opting for it, especially if they are concerned about possible adverse effects that may not have been evident in shorter trials. Additionally, regulatory bodies may require extensive long-term data before approving broader indications, further complicating the therapy's market access and adoption, ultimately hampering the overall market growth.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Lumasiran Market Scope

The market is segmented on the basis of drug class, application, dosage form, route of administration, demographic, end users, and distribution channel. The growth amongst these segments will help you analyse meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Drug Class

• Miscellaneous Metabolic Agents
• Others

Application

• Primary Hyperoxaluria
• Others

Dosage Form

• Injection
• Solution

Route of Administration

• Subcutaneous

Demographic

• Adult
• Pediatric

End-Users

• Clinics
• Hospitals
• Diagnostic Centers
• Others

Distribution Channel

• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy

Lumasiran Market Regional Analysis

The market is analysed and market size insights and trends are provided by country, drug class, application, dosage form, route of administration, demographic, end users, and distribution channel as referenced above.

The countries covered in the market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E., South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America leads the lumasiran market, primarily due to the presence of prominent key players in the pharmaceutical industry and a high prevalence of primary hyperoxaluria. The region boasts a well-established healthcare infrastructure that facilitates the rapid adoption of innovative treatments. Additionally, increased government support for research and development initiatives contributes to advancements in therapeutic options, further enhancing the market landscape. This combination of factors positions North America as a significant player in the lumasiran market, driving growth and access to effective treatments for patients.

Asia-Pacific is projected to experience substantial growth during the forecast period, driven by an increasing emphasis from pharmaceutical companies on developing therapies for rare diseases. Rising social awareness regarding conditions such as primary hyperoxaluria is encouraging more patients to seek effective treatment options. Moreover, enhanced government support for research and development initiatives is facilitating the introduction of innovative therapies. Coupled with escalating healthcare expenditure in the region, these factors are expected to significantly boost the lumasiran market, improving access to vital treatments for patients suffering from rare metabolic disorders.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.  

Lumasiran Market Share

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

Lumasiran Market Leaders Operating in the Market Are:

• Alnylam Pharmaceuticals, Inc (U.S.)

Latest Developments in Lumasiran Market

• In November 2020, Alnylam has announced that the U.S. Food and Drug Administration (FDA) has approved OXLUMO (lumasiran), making it the first and only treatment authorized for Primary Hyperoxaluria Type 1 to reduce urinary oxalate levels in both pediatric and adult patients

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