You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 26, 2024

RUXIENCE Drug Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Fonds voor Wetenschappelijk Reumaonderzoek (FWRO)Phase 4
Universitaire Ziekenhuizen KU LeuvenPhase 4
Fate TherapeuticsPhase 1

See all RUXIENCE clinical trials

Pharmacology for RUXIENCE
Mechanism of ActionCD20-directed Antibody Interactions
Established Pharmacologic ClassCD20-directed Cytolytic Antibody
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 RUXIENCE Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

RUXIENCE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: RUXIENCE

Introduction to RUXIENCE

RUXIENCE, a biosimilar of the biologic drug rituximab, is used to treat various conditions including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and certain types of rheumatoid arthritis. Understanding the market dynamics and financial trajectory of RUXIENCE is crucial for stakeholders in the pharmaceutical industry.

Global Rituximab Biosimilars Market Overview

The global rituximab biosimilars market, which includes RUXIENCE, has been experiencing significant growth. In 2021, the market size was approximately $1.77 billion, and it grew to $2.05 billion in 2022 at a compound annual growth rate (CAGR) of 16.1%[1][4].

Market Growth Projections

The market is expected to continue its upward trend, reaching $3.42 billion by 2026 at a CAGR of 13.6%[1]. By 2028, the market is projected to grow to $4.89 billion, driven by factors such as an aging population, increased healthcare access, and the rising prevalence of chronic diseases[4].

Key Drivers of Market Growth

Several factors are driving the growth of the rituximab biosimilars market:

Government Initiatives

Government initiatives to promote the use of biosimilars have been instrumental in driving market growth. These initiatives often include regulatory support and incentives for the development and use of biosimilars[4].

Increased Healthcare Expenditure

Rising healthcare expenditure globally has led to increased demand for cost-effective treatments, making biosimilars like RUXIENCE more attractive[4].

Biopharmaceutical R&D Expenditure

Significant investments in research and development (R&D) by biopharmaceutical companies have enhanced the quality and efficacy of biosimilars, further boosting market growth[4].

Low Cost of Biosimilars

Biosimilars are generally cheaper than their branded counterparts, which makes them more accessible to a wider patient population. This cost-effectiveness is a major driver of market growth[4].

Emerging Markets

The growth in emerging markets, where there is a high demand for affordable healthcare solutions, is also contributing to the expansion of the rituximab biosimilars market[4].

Impact of Biosimilar Entry on Prices

The entry of biosimilars into the market has a significant impact on drug prices. Studies have shown that biologics facing biosimilar competition can experience price decreases, offering substantial savings to payers, patients, and society. For instance, prices of biologics can drop by 6.6% to 66.0% within one to five years after the entry of biosimilars, depending on the drug, indication, and geographic setting[3].

Financial Performance of Key Players

The financial performance of companies involved in the biosimilars market can provide insights into the overall market dynamics.

AbbVie

While AbbVie's financial reports do not specifically focus on rituximab biosimilars, the company's overall performance can indicate broader industry trends. AbbVie reported a decrease in net revenues in 2023, partly due to the impact of biosimilar competition on its flagship drug Humira[2].

Pfizer

Pfizer's financial reports highlight the operational growth in non-COVID-related revenues, which can include biosimilars. Despite a decline in overall revenues due to the waning demand for COVID-19 vaccines and treatments, Pfizer's non-COVID revenues grew operationally by 8% in 2023[5].

Strategic Trends in the Market

Several strategic trends are shaping the future of the rituximab biosimilars market:

Leveraging Revised FDA Regulations

Companies are leveraging revised FDA regulations to streamline the development and approval process for biosimilar drugs. This includes taking advantage of new pathways and guidelines that facilitate faster and more efficient development[4].

Strategic Partnerships and Collaborations

Establishing strategic partnerships and collaboration agreements with large players is a key trend. These partnerships help in expanding research and development activities and accessing broader markets[4].

Extensive R&D Investments

Investing extensively in R&D activities is crucial for the development of effective and innovative biosimilars. This includes focusing on new drug developments and improving existing biosimilars[4].

Market Challenges

Despite the growth, the rituximab biosimilars market faces several challenges:

Regulatory Hurdles

Navigating complex regulatory environments remains a challenge. Biosimilar manufacturers must comply with stringent regulatory requirements, which can be time-consuming and costly[4].

Supply Chain Disruptions

Global events such as the Russia-Ukraine war have led to supply chain disruptions, affecting the availability and pricing of biosimilars. These disruptions can impact market growth and stability[1].

Competition

The biosimilars market is becoming increasingly competitive. Multiple biosimilars entering the market can lead to price wars and reduced market share for individual products[3].

Patient and Payer Impact

The entry of biosimilars like RUXIENCE has a significant impact on patients and payers:

Cost Savings

Biosimilars offer substantial cost savings, making treatments more affordable for patients. This can lead to better healthcare outcomes and increased patient access to necessary treatments[3].

Formulary Placement

The placement of biosimilars in formularies is crucial for their adoption. Manufacturer-payer dynamics play a significant role in determining the extent to which biosimilars are included in formularies and thus accessible to patients[3].

Conclusion

The market dynamics and financial trajectory of RUXIENCE and other rituximab biosimilars are characterized by rapid growth driven by government initiatives, increased healthcare expenditure, and the low cost of biosimilars. Despite challenges such as regulatory hurdles and supply chain disruptions, the market is expected to continue growing, offering significant cost savings to patients and payers.

Key Takeaways

  • The global rituximab biosimilars market is projected to grow significantly, reaching $4.89 billion by 2028.
  • Key drivers include government initiatives, increased healthcare expenditure, and the low cost of biosimilars.
  • Biosimilar entry leads to significant price decreases, offering substantial savings.
  • Strategic trends include leveraging revised FDA regulations, forming strategic partnerships, and investing in R&D.
  • Challenges include regulatory hurdles, supply chain disruptions, and increasing competition.

FAQs

Q: What is the current market size of the global rituximab biosimilars market?

The current market size of the global rituximab biosimilars market was approximately $2.66 billion in 2023[4].

Q: How is the market expected to grow in the coming years?

The market is expected to grow to $3.02 billion in 2024 and reach $4.89 billion by 2028 at a CAGR of 12.8%[4].

Q: What are the key drivers of market growth for rituximab biosimilars?

Key drivers include government initiatives, increased healthcare expenditure, low cost of biosimilars, and growth in emerging markets[4].

Q: How do biosimilars impact drug prices?

Biosimilars can lead to significant price decreases, offering substantial savings to payers, patients, and society. Prices can drop by 6.6% to 66.0% within one to five years after biosimilar entry[3].

Q: What are the major challenges faced by the rituximab biosimilars market?

Challenges include regulatory hurdles, supply chain disruptions, and increasing competition in the market[1][4].

Sources

  1. Rituximab Biosimilars Global Market Report 2023. Biosimilar Development.
  2. AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results. AbbVie Investors.
  3. Estimating the impact of biosimilar entry on prices and expenditures. Taylor & Francis Online.
  4. Global Rituximab Biosimilars Market Report 2024. The Business Research Company.
  5. Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance. Pfizer.

More… ↓

⤷  Subscribe

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.