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Last Updated: December 22, 2024

CHLOROQUINE HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for chloroquine hydrochloride and what is the scope of freedom to operate?

Chloroquine hydrochloride is the generic ingredient in one branded drug marketed by Sanofi Aventis Us and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for CHLOROQUINE HYDROCHLORIDE
Recent Clinical Trials for CHLOROQUINE HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Liverpool School of Tropical MedicinePhase 4
University of ArizonaPhase 1
Translational Genomics Research InstitutePhase 1

See all CHLOROQUINE HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for CHLOROQUINE HYDROCHLORIDE

US Patents and Regulatory Information for CHLOROQUINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us ARALEN HYDROCHLORIDE chloroquine hydrochloride INJECTABLE;INJECTION 006002-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

CHLOROQUINE HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Chloroquine Hydrochloride

Introduction

Chloroquine hydrochloride, and its derivative hydroxychloroquine, are antimalarial drugs that have seen a significant surge in demand and usage beyond their traditional applications. Here, we delve into the market dynamics and financial trajectory of these drugs, highlighting key drivers, challenges, and future projections.

Market Size and Growth Projections

The market for chloroquine phosphate, which includes chloroquine hydrochloride, was valued at USD 850 million in 2023 and is expected to reach USD 1045.39 million by 2031, growing at a CAGR of 3% from 2024 to 2031[1].

For hydroxychloroquine, the global market size stood at USD 894.0 million in 2019 and is projected to reach USD 2,799.0 million by 2032, exhibiting a CAGR of 4.7% during the forecast period[4].

Key Market Drivers

Increasing Demand for Malaria Treatment

The ongoing need for efficient therapies for malaria in endemic areas continues to drive the demand for chloroquine hydrochloride. The antimalarial drugs market, which includes chloroquine, is expected to grow significantly due to the increasing cases of malaria in developing and underdeveloped countries[3].

Expanding Use in Autoimmune Diseases

Hydroxychloroquine, a derivative of chloroquine, is widely used as a first-line treatment for diseases such as rheumatoid arthritis and lupus. This expanded use contributes to the growing market size[4].

COVID-19 Impact

The COVID-19 pandemic has significantly boosted the demand for hydroxychloroquine, despite limited evidence on its effectiveness. Countries like the U.S. and those in Europe have approved its use for COVID-19 treatment, leading to increased production and sales[2][4].

Geographical Market Segmentation

Asia Pacific

Asia Pacific dominates the hydroxychloroquine market, with a market share of 38.8% in 2019. India, in particular, is a major manufacturer and exporter, accounting for an estimated 70% of the world’s demand for hydroxychloroquine[4].

North America and Europe

These regions have also seen significant growth due to the COVID-19 pandemic. The U.S. and European countries have imported large quantities of hydroxychloroquine to combat the virus[4].

Middle East and Africa

These regions hold a significant market share due to the high incidence of malaria. Public health campaigns and efforts to prevent infectious diseases further bolster the market in these areas[1][4].

Product Segmentation

The market for chloroquine phosphate is segmented based on product types such as pharmaceutical grade, analytical grade, reagent grade, industrial grade, and technical grade. Each segment has its own set of applications and demand drivers[1].

Challenges and Risks

Toxicity and Side Effects

Higher doses of chloroquine diphosphate can lead to toxic effects, including QTc interval prolongation, which can result in fatal arrhythmias. Long-term use can also cause retinal toxicity and myopathy[5].

Regulatory and Clinical Evidence

The use of hydroxychloroquine for COVID-19 treatment has been controversial due to limited clinical evidence. Regulatory bodies and health experts have raised concerns about its efficacy and safety in this context[2].

Financial Trajectory

Investment and Research

Increased investment in pharmaceutical research and development is driving the market growth. Companies are ramping up production capacities to meet the surge in demand, particularly for hydroxychloroquine[1][4].

Donations and Stockpiling

Pharmaceutical companies like Novartis and Bayer have donated significant quantities of chloroquine phosphate and hydroxychloroquine to national stockpiles, further indicating the financial commitment to these drugs[2].

Market Trends and Technological Advancements

Technological Advancements

Advancements in diagnostic tools and treatments have increased the effectiveness of antimalarial drugs, including chloroquine hydrochloride. This has led to higher adoption rates and market growth[3].

Public Health Campaigns

Global efforts to prevent infectious diseases and public health campaigns have enhanced the availability and usage of chloroquine phosphate, contributing to market expansion[1].

Key Players and Market Strategies

Major players in the hydroxychloroquine market, such as Zydus Cadila, have increased their production capacities to meet the growing demand. Strategic collaborations and mergers and acquisitions are also shaping the market landscape[4].

Conclusion

The market for chloroquine hydrochloride and its derivatives is driven by a combination of factors including the ongoing need for malaria treatment, expanding use in autoimmune diseases, and the impact of the COVID-19 pandemic. Despite challenges related to toxicity and regulatory scrutiny, the market is expected to grow significantly over the next decade.

Key Takeaways

  • The chloroquine phosphate market is projected to reach USD 1045.39 million by 2031, growing at a CAGR of 3% from 2024 to 2031.
  • Hydroxychloroquine market size is expected to reach USD 2,799.0 million by 2032, with a CAGR of 4.7%.
  • Asia Pacific dominates the hydroxychloroquine market, driven by India's significant manufacturing and export capabilities.
  • The COVID-19 pandemic has significantly boosted demand for hydroxychloroquine.
  • Toxicity and side effects, particularly QTc interval prolongation, are major concerns with chloroquine and hydroxychloroquine use.

Frequently Asked Questions

1. What is the current market size of the chloroquine phosphate market?

The chloroquine phosphate market was valued at USD 850 million in 2023[1].

2. How is the COVID-19 pandemic impacting the hydroxychloroquine market?

The COVID-19 pandemic has significantly increased the demand for hydroxychloroquine, despite limited clinical evidence on its effectiveness for COVID-19 treatment[2][4].

3. Which region dominates the hydroxychloroquine market?

Asia Pacific, particularly India, dominates the hydroxychloroquine market due to its large manufacturing and export capabilities[4].

4. What are the major side effects associated with chloroquine and hydroxychloroquine?

Major side effects include QTc interval prolongation, retinal toxicity, and myopathy, especially with higher doses and long-term use[5].

5. What is the projected CAGR for the hydroxychloroquine market from 2019 to 2032?

The hydroxychloroquine market is projected to grow at a CAGR of 4.7% from 2019 to 2032[4].

Cited Sources:

  1. MarketResearchIntellect, "Global Chloroquine Phosphate Market Size and Forecast".
  2. OpenSecrets, "‘Dark money’ groups pushed Trump to back unproven COVID-19 treatment".
  3. CustomMarketInsights, "Global Antimalarial Drugs Market Size, Trends, Share 2030".
  4. Fortune Business Insights, "Hydroxychloroquine Market Report".
  5. JAMA Network, "Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection".

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