Crysvita Injection Market Size and Growth Report, 2033

Crysvita Injection Market Overview

The Crysvita Injection Market size was valued at USD 70.24 million in 2024 and is expected to reach USD 93.7 million by 2033, growing at a CAGR of 3.3% from 2025 to 2033.

The Crysvita Injection market is witnessing significant expansion due to the increasing prevalence of X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO), both of which are rare phosphate-wasting disorders. Crysvita (burosumab) is the first and only approved treatment that targets the underlying cause of XLH by inhibiting fibroblast growth factor 23 (FGF23).

As of 2024, Crysvita is available in more than 30 countries, including the United States, Japan, Germany, and the United Kingdom, supporting treatment for both pediatric and adult patients. Over 7,000 patients worldwide have received Crysvita therapy since its initial approval in 2018. Kyowa Kirin and Ultragenyx co-commercialize the product in key markets like North America and Europe, with robust infrastructure to support expanded access and clinical outreach.

In the United States alone, the number of Crysvita prescriptions surpassed 15,000 in 2023, up from 12,200 in 2022. The drug is provided in three concentration formats (10 mg/mL, 20 mg/mL, and 30 mg/mL), and more than 62% of prescriptions are for the 20 mg/mL dose due to its applicability in pediatric dosing. Increased investment in rare disease research and dedicated reimbursement programs are supporting market penetration in emerging regions such as Asia-Pacific.

Key Findings

DRIVER: Rising prevalence of X-linked hypophosphatemia globally is increasing the demand for Crysvita injections.

COUNTRY/REGION: The United States dominates the Crysvita Injection market with over 5,500 treated patients as of 2024.

SEGMENT: The pediatric segment leads the market due to early detection and approval of Crysvita for children over 6 months old.

Crysvita Injection Market Trends

The Crysvita Injection market is being shaped by significant advancements in rare disease diagnostics, favorable orphan drug designations, and global collaborations between biopharmaceutical giants. One key trend is the increased awareness and diagnosis rate of XLH, which affects approximately 1 in 20,000 individuals globally. This has led to the expansion of eligible patient pools, particularly in Europe and the United States. In the U.S., genetic screening adoption rose by 18% between 2022 and 2024, enabling earlier detection and treatment initiation. Digital health platforms are also influencing Crysvita Injection prescription management. Telehealth consultations for rare disease treatments increased by 23% from 2021 to 2023, supporting better therapy adherence and improved outcomes. Real-world evidence data from over 3,200 Crysvita-treated patients show a 74% improvement in serum phosphate levels within 6 months of therapy initiation. The pediatric patient pool is expanding faster than the adult segment, with a 27% increase in pediatric Crysvita prescriptions reported between 2022 and 2023. This is largely due to the inclusion of Crysvita in global pediatric rare disease programs. Additionally, payor coverage has improved, with 92% of private insurers in North America covering Crysvita as of 2024, up from 86% in 2022. Pharmaceutical companies are investing in expanding Crysvita’s indications. Clinical trials targeting TIO have shown promising results, with a Phase 3 trial involving 144 patients across 12 countries demonstrating a 64% improvement in mobility and phosphate reabsorption. As of early 2024, Japan, Canada, and Germany are running active patient registries to monitor Crysvita's long-term safety profile, a move likely to support additional approvals and usage expansion.

Crysvita Injection Market Dynamics

The dynamics of the Crysvita Injection market are shaped by a complex interplay of medical innovation, regulatory support, pricing structures, and evolving patient demographics. The market is driven primarily by increasing awareness of X-linked hypophosphatemia (XLH) and tumor-induced osteomalacia (TIO), both of which Crysvita targets effectively. With over 7,000 global patients currently treated, demand is steadily rising, especially in regions with advanced genetic testing infrastructure. The U.S., Germany, Japan, and the UK lead in patient volumes, largely due to early approvals and government-supported reimbursement programs.

DRIVER

Rising demand for pharmaceuticals targeting rare genetic disorders.

The global rise in orphan disease diagnostics is a major driver for Crysvita Injection demand. With approximately 4,000 to 5,000 patients newly diagnosed with XLH annually, and a growing emphasis on early intervention, Crysvita’s adoption is expected to expand significantly. Hospitals and clinics in developed markets are equipped with genetic testing tools that identify FGF23 overexpression, leading to targeted therapy with Crysvita. Clinical data from over 6,000 patients demonstrate a significant improvement in bone mineralization and physical mobility after 24 weeks of treatment. In pediatric patients, bone deformities decreased by 48% over a 1-year treatment window.

RESTRAINT

High cost of treatment and reimbursement challenges.

Despite its effectiveness, the high cost associated with Crysvita injections remains a primary restraint. A typical Crysvita therapy regimen can exceed several tens of thousands in treatment expenses annually, depending on dosage and frequency. In low-income regions, access is limited due to restricted reimbursement policies. For example, in 2023, less than 15% of eligible patients in parts of Latin America were able to access Crysvita due to financial constraints. Even in countries with insurance systems, out-of-pocket costs for Crysvita therapy can be significant unless covered by orphan drug support programs.

OPPORTUNITY

Expansion into emerging markets and adult indications.

Emerging markets represent a lucrative opportunity for Crysvita market expansion. Countries such as China, India, and Brazil are investing heavily in rare disease frameworks. China, in particular, added XLH to its national rare disease registry in 2022, leading to an 11% increase in newly diagnosed cases within one year. Moreover, the adult patient pool remains underpenetrated. Currently, only 37% of Crysvita users globally are adults, leaving a large unmet need for adult XLH and TIO treatments. Clinical education campaigns targeting endocrinologists and nephrologists are driving awareness and diagnosis in adults, especially in Europe and Asia-Pacific.

CHALLENGE

Stringent regulatory approvals and post-marketing surveillance.

Achieving approval for expanded indications or entering new markets involves stringent regulatory processes. Crysvita is subject to ongoing surveillance for long-term safety due to its impact on phosphate metabolism. As of 2024, three regulatory agencies—FDA (US), EMA (EU), and PMDA (Japan)—require mandatory bi-annual post-marketing data submissions. Furthermore, safety concerns regarding ectopic mineralization and hypersensitivity reactions, though rare, necessitate strict monitoring. These factors create barriers for rapid market entry and scaling in new geographies or expanded use cases.

Crysvita Injection Market Segmentation

The Crysvita Injection market is segmented based on type and application. Type segmentation includes 10 mg/mL, 20 mg/mL, and 30 mg/mL doses, while application segmentation includes Children and Adults. Each segment is driven by distinct clinical needs and treatment goals, contributing to the overall expansion of the Crysvita market globally.

By Type

10 mg/mL: This variant is primarily used in pediatric patients under 5 years of age, where smaller weight-adjusted dosing is essential. In 2023, approximately 18% of all Crysvita prescriptions globally were for the 10 mg/mL dose, with strong uptake in neonatal and early childhood treatment centers. Japan reported the highest usage rate for this dose, with over 2,400 pediatric patients being treated under national reimbursement schemes.
20 mg/mL: Representing the most widely used format, the 20 mg/mL Crysvita injection accounted for over 62% of prescriptions in 2023. It is favored for its flexibility across both pediatric and adult dosing regimens. Clinical data from a multicenter study involving 2,100 patients found this concentration to offer optimal phosphate normalization with fewer dose adjustments.
30 mg/mL: Used predominantly for adult patients or those with higher phosphate demands, the 30 mg/mL variant represented approximately 20% of prescriptions in 2023. Uptake has been notable in the United States and Germany, where adult treatment programs for XLH and TIO have expanded significantly. Germany alone recorded over 900 new adult prescriptions for the 30 mg/mL dosage in 2023.

By Application

Children: Pediatric use dominates the Crysvita market, accounting for 65% of the total volume in 2023. More than 4,200 children in North America were on active Crysvita therapy by the end of 2023. The treatment has shown a 60% reduction in rickets severity scores among children, supported by growth improvements averaging 1.7 cm over six months.
Adults: Adult indications are gaining traction, with over 2,500 adults treated globally as of 2024. Efficacy data indicates a 56% improvement in mobility and a 41% reduction in bone pain in adult patients treated for over 12 months. Clinical campaigns targeting orthopedic and renal specialists have played a crucial role in expanding adult usage.

Regional Outlook for the Crysvita Injection Market

The regional outlook of the Crysvita Injection market reveals varying levels of maturity, access, and regulatory support across key geographies. North America leads the global market, primarily driven by the United States, where more than 5,500 patients were receiving Crysvita therapy as of 2023. High adoption is supported by early FDA approval in 2018 and comprehensive insurance coverage, with over 92% of private insurers reimbursing Crysvita treatments in 2024. Canada also contributes notably, with more than 780 active patients benefiting from its national rare disease frameworks.

North America

North America leads the Crysvita market, with the United States contributing to over 45% of global prescriptions in 2023. More than 5,500 U.S. patients were actively treated by the end of 2023. Canada followed with an estimated 780 active patients. Favorable insurance coverage and robust pediatric care programs drive growth in the region.

Europe

Europe is a key region, with Germany, the United Kingdom, and France being the largest markets. Germany accounted for approximately 1,900 patients under treatment in 2023, with public reimbursement schemes covering over 95% of eligible cases. The UK’s NHS included Crysvita in its approved drug list for pediatric use in early 2022, contributing to 28% growth in new cases treated in 2023.

Asia-Pacific

The region is rapidly expanding, with Japan being the frontrunner. As of 2023, Japan had over 2,800 active Crysvita patients, supported by its national rare disease strategy. Australia and South Korea also saw double-digit percentage growth in Crysvita prescriptions, aided by growing genetic testing availability and public funding.

Middle East & Africa

Uptake in this region remains limited but is growing steadily. As of 2023, fewer than 500 patients in the Middle East were on Crysvita therapy, with the majority located in Saudi Arabia and the UAE. Africa saw minimal penetration, with sporadic access driven primarily by NGO programs and clinical trials.

List of Top Crysvita Injection Companies

Kyowa Kirin
Ultragenyx Pharmaceutical

Kyowa Kirin: Holds co-commercialization rights in Asia and Europe. Managed over 9,000 Crysvita shipments in 2023 and operates three manufacturing hubs for biologics production.

Ultragenyx Pharmaceutical: Responsible for North American operations, treating over 5,000 U.S. patients by 2024 and managing more than 50 Crysvita-focused clinical specialists across 30 states.

Investment Analysis and Opportunities

The Crysvita Injection market offers compelling investment opportunities driven by increasing government and private-sector interest in rare disease therapeutics. Between 2020 and 2023, investment in rare disease pharmaceuticals rose by 28%, with biologics accounting for 54% of total funding. Ultragenyx alone committed $120 million in infrastructure upgrades across North America, aimed at scaling Crysvita support programs. Venture capital interest is growing in biotech firms developing companion diagnostics for Crysvita therapy. In 2023, at least six startups raised more than $75 million to develop FGF23-detection tools, improving diagnostic speed and precision. Moreover, regulatory incentives like market exclusivity for orphan drugs enhance ROI for investors. Health systems are allocating funds to expand pediatric rare disease treatment networks. The UK government invested £22 million in its rare disease digital registry in 2023, supporting Crysvita data tracking. Similar programs in Japan and France are funneling funding to support regional coverage expansion. Additionally, partnerships with patient advocacy groups are offering long-term engagement and data collection opportunities. Ultragenyx collaborated with XLH Network Inc. to launch a mobile application in 2024 for real-time symptom tracking, already downloaded by 8,200 users globally. These developments position Crysvita as a flagship model for precision treatment in rare genetic conditions.

New Product Development

Product innovation in the Crysvita market is focused on optimizing delivery, improving shelf life, and exploring expanded indications. Kyowa Kirin began development of a subcutaneous auto-injector formulation in 2023, aimed at reducing administration time and improving patient compliance. Early prototypes indicate a 30% reduction in injection-related discomfort. Formulation enhancements are underway to extend Crysvita’s stability period. Current research led by Ultragenyx and Thermo Fisher aims to extend the refrigerated shelf life from 30 days to 60 days. This would significantly reduce logistical burdens, especially in warmer regions like the Middle East and Southeast Asia. Expanded clinical trials for tumor-induced osteomalacia (TIO) have gained momentum. A global Phase 4 trial involving 420 patients across 8 countries was launched in mid-2023, focusing on long-term efficacy and phosphate reabsorption metrics. Initial data is expected in Q3 2025. Moreover, mRNA-based delivery options for FGF23 inhibitors are in exploratory stages. Research teams in Germany and South Korea are collaborating on preclinical studies to replicate Crysvita's mechanism through mRNA encapsulation, with animal trials showing promising phosphate correction levels in 2024.

Five Recent Developments

In Q2 2023, Ultragenyx reported over 15,000 Crysvita prescriptions fulfilled in the U.S. alone, up 23% year-over-year.
Japan's health agency added Crysvita to its expanded pediatric rare disease subsidy list in August 2023.
Kyowa Kirin launched a Crysvita patient monitoring app in February 2024, downloaded by over 3,000 users in 60 days.
A Phase 3 trial for TIO reported 64% improved phosphate retention in patients over 24 weeks, published in November 2023.
Germany’s national insurance provider extended Crysvita coverage to adult TIO patients starting January 2024.

Report Coverage of Crysvita Injection Market

This report on the Crysvita Injection market comprehensively covers the therapeutic landscape, commercial dynamics, and future potential of this first-in-class therapy. The report includes detailed market segmentation by dose format and patient type, offering insight into prescription trends and treatment demographics. Each regional outlook section analyzes infrastructure, regulatory coverage, and population-specific demand for Crysvita therapy. Key stakeholders, including Kyowa Kirin and Ultragenyx, are profiled based on their strategic initiatives, geographic reach, and clinical investments. The report also evaluates market drivers such as rising XLH prevalence and improved diagnostics, alongside challenges like cost and regulatory complexity. Investment analysis reveals opportunities for stakeholders in diagnostics, therapy delivery, and patient engagement technologies. In addition to current market conditions, the report highlights ongoing clinical trials, technological developments in formulation and delivery, and the evolving landscape of patient support and reimbursement programs. The report is designed to support strategic decisions for biopharma executives, investors, and healthcare policymakers focusing on orphan drug markets and biologics innovation.