Table of Contents
Overview
New York, NY – April 01, 2025 – Global HERG Screening Market size is expected to be worth around USD 6578.7 Million by 2033 from USD 1,938.0 Million in 2023, growing at a CAGR of 13.04% during the forecast period from 2024 to 2033.
HERG (human ether-a-go-go-related gene) screening is a critical component of the drug development process, aimed at assessing the potential for a drug to affect the heart’s electrical activity. The HERG gene encodes a potassium channel responsible for the repolarization of the heart muscle, and its inhibition can lead to prolonged QT intervals, a condition associated with arrhythmias and potentially fatal heart problems, such as Torsades de Pointes.
Due to the high risk of cardiovascular complications, regulatory agencies, including the FDA and EMA, require HERG screening for all new pharmaceutical compounds, particularly those with cardiovascular implications. This safety assessment is an integral part of preclinical testing, enabling researchers to identify drugs that may pose a threat to cardiac health early in the development process.
HERG screening typically involves in vitro testing, using cell-based assays that measure drug effects on HERG channel activity. Additionally, advanced technologies, such as patch-clamp electrophysiology and computational models, are utilized to improve the accuracy and predictability of these tests. With an increasing focus on patient safety and drug efficacy, HERG screening remains a vital step in the drug approval process, ensuring that new treatments do not pose significant risks to heart health.
Key Takeaways
- In the product type analysis, the hERG screening market is segmented into gene KCNH2 and mutant KCNH2, with gene KCNH2 leading the product type segment.
- Under ion channel analysis, various types of ion channels are identified, including voltage-gated, ligand-gated, mechanosensitive, and transient receptor potential channels.
- The antiarrhythmic segment plays a significant role in driving the growth of the hERG screening market, as a range of heart diseases are treated using antiarrhythmic drugs.
- North America holds the largest market share for hERG screening, surpassing Europe and the APAC regions.
- The primary factor fueling the market growth for hERG screening is the increasing prevalence of heart-related illnesses. However, the high cost of screening products is expected to hinder market growth in the coming years.
Segmentation Analysis
- Product Type Analysis: The hERG screening market is segmented into two product types: Genes KCNH2 and Mutant KCNH2. The KCNH2 genes dominate, holding a market share of 71.2% in 2023. These genes are involved in potassium ion transport across cell membranes, crucial for the heart’s electrical signaling and maintaining regular rhythm. In contrast, mutant KCNH2 genes are associated with short QT Syndrome, causing abnormally fast heart muscle recharging, which can lead to life-threatening arrhythmias and sudden cardiac death.
- ION Channel Analysis: The hERG screening market is segmented based on ion channels, including voltage-gated, ligand-gated, mechanosensitive, and transient receptor potential channels. Voltage-gated ion channels dominate, accounting for 68.03% of the market in 2023, with a projected CAGR of 14.9%. These channels, such as Na+, Ca+, and K+, are essential for ion transport across cell membranes, particularly in heart, muscle, and nerve cells. They are also crucial in treating disorders like epilepsy and neuropathic pain, further driving market growth.
- Application Analysis: The hERG screening market is primarily driven by the antiarrhythmic segment, which held a 51.1% share in 2023. Antiarrhythmic drugs treat heart conditions such as premature beats and tachycardia, which contributes to market growth, particularly with rising cardiovascular illnesses. Additionally, the increase in cases of mental health disorders, particularly anxiety and bipolar disorders, has expanded the use of antipsychotic drugs, also tested through hERG screening. Antibiotics like sparfloxacin, used in drug discovery, and the growing demand for antimalarial and antihistamine treatments further fuel market expansion.
Market Segments
By Type
- Gene KCNH2
- Mutant KCNH2
By ION channel
- Voltage gated ion channel
- Ligand gated ion channel
- Mechanosensitive ion channel
- Transient receptor potential channel
By Application
- Antiarrhythmic
- Antipsychotic
- Antibiotic
- Antimalarial
- Antihistamine
Regional Analysis
North America holds the largest market share for hERG screening, accounting for 48.3% in 2023. This significant growth can be attributed to the rising incidence of myocardial infarction in the United States, as reported by the American College of Cardiology. The high prevalence of heart diseases drives the need for hERG screening, contributing to market expansion.
Europe also supports the growth of the hERG screening market, with the U.K. leading as the fastest-growing market within the region. Meanwhile, the Asia Pacific region is expected to experience substantial market growth during the forecast period (2024-2033) due to the increasing prevalence of chronic heart conditions and the rapid rise of inflammatory disorders.
Emerging Trends
- Integration of High-Throughput Screening (HTS) Technologies: High-throughput screening methods have become pivotal in evaluating large compound libraries for potential hERG channel interactions. For instance, the U.S. federal Tox21 program utilized quantitative high-throughput screening (qHTS) to assess approximately 7,871 unique chemicals, highlighting the efficiency of HTS in identifying hERG inhibitors.
- Advancements in Automated Electrophysiology: Automated electrophysiology platforms, such as the PatchLiner®, have enhanced the efficiency of hERG assays. These systems provide stable, high-quality recordings at physiological temperatures, offering a promising alternative to traditional manual patch-clamp techniques.
- Development of Predictive Computational Models: Researchers are increasingly employing computational approaches, including machine learning, to predict hERG inhibition. By analyzing chemical structures, these models can forecast potential cardiotoxicity, aiding early-stage drug development and reducing the reliance on extensive in vitro testing.
Use Cases
- Drug Discovery and Development: In the drug discovery phase, hERG screening is essential to identify compounds that may pose cardiac risks. For example, the manual/automated patch-clamp technique held a significant market share in 2023, driven by its widespread adoption for clinical studies aimed at improving drug safety.
- Regulatory Compliance and Safety Assessment: Regulatory agencies mandate hERG screening to ensure that new pharmaceuticals do not induce arrhythmias. Adhering to guidelines, such as those from the International Council for Harmonisation (ICH), pharmaceutical companies conduct Good Laboratory Practice (GLP)-compliant hERG assays to evaluate potential cardiotoxicity.
- Environmental and Toxicological Evaluations: Beyond pharmaceuticals, hERG screening extends to assessing environmental chemicals and toxins. The Tox21 program’s screening of thousands of compounds underscores the importance of evaluating environmental exposures that could affect cardiac health.
Conclusion
hERG screening is a crucial component in drug development, ensuring the safety of new pharmaceuticals by assessing their potential impact on the heart’s electrical activity. With the increasing prevalence of cardiovascular diseases and regulatory requirements from agencies like the FDA and EMA, the demand for effective hERG screening is growing. Emerging trends such as high-throughput screening technologies, advancements in electrophysiology, and the development of predictive computational models are enhancing the accuracy and efficiency of these assessments. Despite challenges like high costs, the market for hERG screening is expected to continue expanding, particularly in North America and Europe.
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