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Last Updated: January 6, 2025

RHOPHYLAC Drug Profile


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Summary for Tradename: RHOPHYLAC
High Confidence Patents:0
Applicants:1
BLAs:1
Pharmacology for RHOPHYLAC
Mechanism of ActionEndogenous Antigen Neutralization
Physiological EffectPassively Acquired Immunity
Established Pharmacologic ClassHuman Immunoglobulin G
Chemical StructureImmunoglobulins
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 RHOPHYLAC Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

RHOPHYLAC Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Biologic Drugs: A Focus on RHOPHYLAC

Introduction

Biologic drugs have become a significant segment of the pharmaceutical market, driven by their efficacy in treating complex and chronic diseases. One such biologic drug is RHOPHYLAC, used primarily for the prevention of RhD immunization in RhD-negative individuals. Here, we will delve into the market dynamics and financial trajectory of biologic drugs, with a specific focus on RHOPHYLAC.

Growth of the Biologics Market

The biologics market has experienced substantial growth over the past few years. By 2023, the market size had reached USD 349.6 billion, and it is projected to grow to USD 699.5 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 7.8% during 2024-2032[4].

Market Drivers

Several factors are driving this growth:

Increasing Burden of Chronic Diseases

The rising prevalence of chronic diseases is a key driver. Biologics offer targeted therapies that are often more effective than traditional small molecule drugs[4].

Technological Advancements

Continuous technological advancements facilitate the development of more targeted and efficient biologic therapies. This includes improvements in drug delivery systems and the use of next-generation technologies like mRNA[4].

Growing Adoption of Biosimilars

Biosimilars, which are biologic drugs that are highly similar to an already approved biologic, are gaining traction. By the end of 2019, 17% of the biologics market was accessible to biosimilars, with biosimilars achieving a 20% share of the market where they were approved and launched[1].

Regulatory Approvals

The escalating approvals of biologics by regulatory agencies also contribute to market growth. This includes approvals under the 351(k) biosimilar pathway, which has streamlined the process for bringing biosimilars to market[1].

Market Exclusivity Dynamics

Unlike small molecule drugs, which have consistent market exclusivity dynamics and are subject to significant generic competition, biologics have more complex exclusivity dynamics. Biologics now represent 42% of the total medicines market, up from 30% in 2014. However, as patents expire, biologics are increasingly exposed to biosimilar competition[1].

Financial Performance of Biologic Companies

Companies involved in the biologics market, such as CSL Limited, have shown strong financial performance. CSL's revenue increased by 13% to US$10,310 million in 2021, with net profit reaching US$2.375 billion. The company's plasma-derived and recombinant products, including those related to biologic therapies, have been crucial in this success[2].

RHOPHYLAC: A Case Study

RHOPHYLAC, an anti-D immunoglobulin, is a biologic drug used to prevent RhD immunization in RhD-negative individuals. Here’s how it fits into the broader market dynamics:

Market Position

RHOPHYLAC is part of the immunoglobulin segment, which has seen strong demand. For example, CSL's immunoglobulin sales were up 21% at constant currency in 2011, reflecting the essential nature of these products[3].

Financial Impact

The financial impact of RHOPHYLAC is significant within its market segment. Immunoglobulins, including RHOPHYLAC, contribute substantially to the revenue of companies like CSL. The strong demand for these products helps maintain a robust financial trajectory for these companies.

Competition and Biosimilars

While RHOPHYLAC is not currently facing direct biosimilar competition, the broader biologics market is increasingly exposed to biosimilars. This could potentially impact the market dynamics for RHOPHYLAC in the future, especially if biosimilars are approved for similar indications.

Provider Adoption Patterns

The adoption of biologic drugs, including RHOPHYLAC, can vary significantly among different provider types. For instance, office-based providers tend to adopt biosimilars more rapidly than hospital-based providers, highlighting the nuanced nature of the market. Factors such as prescribing practices, price reductions, and clinical preferences play important roles in this adoption[5].

Challenges and Opportunities

Plasma Supply Challenges

Companies like CSL have faced challenges related to plasma supply, particularly during the COVID-19 pandemic. Government lockdowns and stimulus packages led to depressed plasma donations. However, initiatives to attract donors back and improve the donor experience are helping to recover plasma volumes[2].

Technological Innovations

Technological advancements, such as next-generation mRNA technology, offer opportunities for innovation in biologic therapies. These innovations can enhance the efficacy and delivery of drugs like RHOPHYLAC, contributing to market growth[2].

Key Takeaways

  • Market Growth: The biologics market is expected to grow significantly, reaching USD 699.5 billion by 2032.
  • Market Drivers: Chronic diseases, technological advancements, and growing adoption of biosimilars are key drivers.
  • Financial Performance: Companies like CSL have shown strong financial performance driven by biologic products.
  • RHOPHYLAC: Part of the immunoglobulin segment, RHOPHYLAC contributes to the financial success of companies like CSL.
  • Competition and Biosimilars: The market is increasingly exposed to biosimilar competition, which could impact RHOPHYLAC in the future.
  • Provider Adoption: Adoption patterns vary among provider types, influenced by factors like price and clinical preferences.

FAQs

What is the projected growth rate of the biologics market?

The biologics market is expected to grow at a CAGR of 7.8% from 2024 to 2032[4].

How significant is the impact of biosimilars on the biologics market?

By the end of 2019, 17% of the biologics market was accessible to biosimilars, with biosimilars achieving a 20% share of the market where they were approved and launched[1].

What are the main drivers of the biologics market growth?

The main drivers include the rising prevalence of chronic diseases, technological advancements, growing adoption of biosimilars, and strong pipeline of biologic drugs[4].

How has the COVID-19 pandemic affected plasma supply for biologic companies?

The pandemic led to depressed plasma donations due to government lockdowns and stimulus packages, but companies are implementing measures to recover plasma volumes[2].

What role do technological innovations play in the biologics market?

Technological innovations, such as next-generation mRNA technology, enhance the efficacy and delivery of biologic drugs, contributing to market growth[2].

Sources

  1. Biologics Market Dynamics: Setting the Stage for Biosimilars - FTC
  2. CSL Ltd Annual Report 2021 - AnnualReports.com
  3. Interim Result Reported profit $483 million, down 3% - CSL
  4. Biologics Market Size to Reach USD 699.5 Billion by 2032 - BioSpace
  5. Provider Differences in Biosimilar Uptake in the Filgrastim Market - AJMC

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