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Last Updated: February 9, 2025

CRYSVITA Drug Profile


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Summary for Tradename: CRYSVITA
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for CRYSVITA
Recent Clinical Trials for CRYSVITA

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Kyowa Kirin Co., Ltd.Phase 4
Kyowa Kirin Pharmaceutical Development LtdPhase 1/Phase 2
Yale UniversityPhase 4

See all CRYSVITA clinical trials

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for CRYSVITA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for CRYSVITA Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for CRYSVITA Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory of CRYSVITA

Introduction to CRYSVITA

CRYSVITA, a biologic drug developed by Ultragenyx Pharmaceutical Inc. and Kyowa Kirin, is used to treat X-linked hypophosphatemia (XLH) and other phosphate-wasting disorders. The drug has been a significant player in the pharmaceutical market, exhibiting robust growth and strong market dynamics.

Market Growth and Projections

The CRYSVITA market has experienced rapid and considerable growth in recent years. Projections indicate that this substantial expansion will continue from 2023 to 2031, with the market expected to develop revenue at a remarkable CAGR during the forecast period from 2024 to 2032[1].

Revenue Growth

In the second quarter of 2024, CRYSVITA revenue reached $114 million, representing a 37% growth compared to the same period in 2023. This includes significant growth in Latin America and Turkey, with product sales increasing by 140% in these regions[2].

For the third quarter of 2024, CRYSVITA revenue was $98 million, showing a 31% growth compared to the same period in 2023, with Latin America and Turkey contributing $36 million, an 85% increase[5].

Geographical Performance

  • North America and EMEA: Sales in these regions have seen substantial increases, with North America experiencing 43% growth and EMEA seeing a 19% increase due to continued growth in global strategic products and the impact of foreign exchange rates[3].
  • Latin America and Turkey: These regions have shown remarkable growth, with product sales increasing by 140% and 85% in the second and third quarters of 2024, respectively[2][5].
  • Asia Pacific: While there was a decline in sales of certain products in China, other countries and products in the APAC region helped recover this decline, resulting in a 6% overall gain[3].

Drivers of Market Growth

Several factors are driving the growth of the CRYSVITA market:

Increasing Demand

The increasing number of patients being treated with CRYSVITA, especially in regions where the drug has recently been approved or launched, is a significant driver. For instance, the approval for the TIO indication in Europe in 2022 has boosted sales[3].

Market Penetration

Further market penetration in existing and new territories is expected to continue driving growth. Kyowa Kirin's plan to start its own sales in North America and the ongoing collaboration with Ultragenyx are key strategies in this regard[3].

Regulatory Approvals

New regulatory approvals and indications are expanding the market reach of CRYSVITA. The drug's approval for additional indications and its launch in new countries are crucial factors in its growth trajectory[3].

Financial Performance

Revenue Figures

  • Second Quarter 2024: CRYSVITA revenue was $114 million, with total revenues for Ultragenyx reaching $147 million[2].
  • Third Quarter 2024: CRYSVITA revenue was $98 million, contributing to total revenues of $139 million for Ultragenyx[5].

Operating Expenses and Profitability

While revenue has been increasing, operating expenses have also risen. For the nine months ended September 30, 2024, Ultragenyx reported total operating expenses of $537 million, including cost of sales, research and development, and selling, general, and administrative expenses[5].

However, the company is targeting improved profitability, with Kyowa Kirin aiming for a core operating profit increase and a return on equity (ROE) close to 10% in their medium-term business plan[3].

Challenges and Restraints

Despite the strong growth, the CRYSVITA market faces several challenges:

Competition

The biologic drug market is highly competitive, with other treatments and potential substitutes posing a threat. The competition outlook and market concentration ratio are critical factors to consider[4].

Regulatory and Pricing Pressures

Changes in regulatory environments and pricing pressures, such as the impact of the National Health Insurance (NHI) price revision in Japan, can affect sales and profitability[3].

Macro-Economic Factors

Macro-economic factors, including foreign exchange rates and economic downturns, can influence the market's performance. A thorough PESTEL analysis and Porter's Five Forces analysis are essential to understand these impacts[4].

Regional Dynamics

The CRYSVITA market is analyzed across various regions, each with its unique dynamics:

North America

This region has seen significant growth, driven by the drug's performance and the upcoming transition to Kyowa Kirin's own sales operations in North America[3].

Europe

Europe has been a strong market, with the approval for the TIO indication in 2022 contributing to increased sales[3].

Asia Pacific

The APAC region, while experiencing some declines in certain product sales, has overall shown a 6% gain due to other products and countries compensating for the losses[3].

Latin America and Turkey

These regions have demonstrated remarkable growth, with product sales increasing substantially in recent quarters[2][5].

Future Outlook

The future outlook for CRYSVITA is promising, with several factors contributing to its continued growth:

Market Penetration and Expansion

Further market penetration and expansion into new territories are expected to drive growth. Kyowa Kirin's plan to increase sales by JPY19.8 billion (or 17%) globally is a testament to this strategy[3].

Regulatory Approvals and Indications

New regulatory approvals and additional indications will continue to expand the drug's market reach.

Technological and Licensing Revenues

Increases in technology licensing revenues, including royalties from other products, are also expected to contribute to overall revenue growth[3].

Key Takeaways

  • Robust Revenue Growth: CRYSVITA has shown significant revenue growth, with a 37% increase in the second quarter of 2024 and a 31% increase in the third quarter.
  • Geographical Expansion: Strong performance in North America, EMEA, Latin America, and Turkey, with ongoing market penetration in these regions.
  • Regulatory Approvals: New indications and approvals, such as the TIO indication in Europe, have boosted sales.
  • Challenges: Competition, regulatory pressures, and macro-economic factors pose challenges to the market.
  • Future Outlook: Continued growth is expected through further market penetration, new regulatory approvals, and increased licensing revenues.

FAQs

1. What is CRYSVITA used for?

CRYSVITA is used to treat X-linked hypophosphatemia (XLH) and other phosphate-wasting disorders.

2. Who are the key players involved in the CRYSVITA market?

The key players are Ultragenyx Pharmaceutical Inc. and Kyowa Kirin.

3. What has been the revenue growth of CRYSVITA in recent quarters?

In the second quarter of 2024, CRYSVITA revenue grew by 37% to $114 million, and in the third quarter, it grew by 31% to $98 million.

4. Which regions have shown the most significant growth for CRYSVITA?

North America, EMEA, Latin America, and Turkey have shown significant growth.

5. What are the main challenges facing the CRYSVITA market?

The main challenges include competition, regulatory and pricing pressures, and macro-economic factors.

Cited Sources

  1. Market Research Intellect: Global Crysvita Injection Market Size, Trends and Projections.
  2. GlobeNewswire: Ultragenyx Reports Second Quarter 2024 Financial Results and Corporate Update.
  3. Kyowa Kirin: Results Presentation Fiscal 2022.
  4. HTF Market Intelligence: Crysvita Market Analysis by Relevant Business Segment & Application.
  5. Ultragenyx: Ultragenyx Reports Third Quarter 2024 Financial Results and Corporate Update.

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