HERG Screening Market

Market Overview

The global HERG screening industry size was valued at USD 1,942.10 million in 2022. It is projected to reach USD 6,365.64 million by 2031, growing at a CAGR of 14.10% during the forecast period (2023-2031).

The protein Kvl1.1, the alpha subunit of a potassium ion channel, is produced by the human ether-a-go-go-related gene, or HERG. It is employed in helping to support heart action. The cardiac action potential's repolarizing current through its channels is moderated, assisting the heartbeat. The HERG assessments are now one of the regulatory authority’s top demands before submitting an investigational new medication. Manual/automatic patch clamp assays, HERG radioligand binding assays, fluorescence polarization assays, and microelectrode arrays are a few of the HERG screening tests. The HERG current is measured in various concentrations during the automatic patch-clamp experiment. It is performed before and after its exposure to the test chemicals. Then, using a method called dosage formulation analysis, the IC50 values are calculated.

Highlights

• The Gene KCNH segment is the major contributor to the market by type.
• The voltage-gated ion segment is the major contributor to the market by ion channel.
• The antiarrhythmic segment is the major contributor to the market by application.
• North America is the major revenue contributor by region.

Market Dynamics

Global HERG Screening Market Drivers:

Rising Prevalence of Heart Diseases

Heart disease is the primary cause of death for both men and women worldwide. According to the American College of Cardiology, an American will experience a myocardial infarction every 40 seconds. It went on to say that in 2017, emergency medical services assessed 356,461 Americans to have experienced out-of-hospital cardiac arrest; emergency medical services treatment was started in 52% of those cases. Only 18.7% of the patients had an initial heart rhythm shockable by an automated external defibrillator, ventricular fibrillation, or ventricular tachycardia. 10.4% of adults survived hospital discharge, and 8.4% had good functional status.

Sedentary lifestyles and common risk factors like hypertension (which ranges from 28% in the United Arab Emirates to 41% in Libya and Morocco), diabetes (which ranges from 4% in the Islamic Republic of Iran to 19% in Sudan), and hypercholesterolemia (which ranges from 14% in Lebanon to 52% in the Islamic Republic of Iran) are to blame for the prevalence of cardiovascular diseases. In conclusion, this rise in the incidence of heart disorders will cause the drug discovery market to develop, supporting the expansion of the HERG screening market.

Global HERG Screening Market Restraint:

HERG Screening Products are Expensive

Due to the negative market growth, the price of the vial used in HERG screening is high. The cost of the products used in the screening process has increased due to the usage of modern technology. The Eurofins DiscoverX Corporation sells precision recombinant HERG potassium ion channel membrane preparation for USD 879 per vial. These elements are anticipated to limit market expansion.

Global HERG Screening Market Opportunities:

Untapped Markets

Companies engaged in product manufacture or entering distributor relationships with smaller businesses operating in new markets. In addition, markets are untapped in China, India, Brazil, Russia, and South Africa. Additionally, heart disease is becoming more common in these countries. In India, there were 23.8 million people who had ischemic heart disease, according to a research paper published in 2016. In 2016, India reported 1,6.5 million stroke cases. As a result, businesses have much potential to grow due to the increased prevalence in these untapped markets.

Regional Analysis

North America Dominates the Global Market

The global HERG screening industry is bifurcated into four regions: North America, Europe, Asia-Pacific, and LAMEA. 

North America is the major revenue contributor and is expected to exhibit a CAGR of 12.30% during the forecast period. North America and Latin America have been separated into market segments, with the U.S. and Canada making up the remainder of North America. According to the American College of Cardiology, a myocardial infarction will occur in a United States citizen every 40 seconds. According to the report, 356,460 Americans experienced out-of-hospital cardiac arrest in 2017, and emergency medical services were called in for 52% of those cases. Only 18.75% of the initial cardiac rhythms reported were ventricular fibrillation, ventricular tachycardia, or shockable by an automated external defibrillator. 10.4% of adults survived to be discharged from the hospital, and 8.4% were in good functional status.

Europe is expected to exhibit a CAGR of 14.50% during the forecast period. The market for HERG screening is mainly comprised of Europe's western and eastern regions, both of which are considered significant contributors. The need for HERG Screening has been further segmented into Germany, France, the United Kingdom, Italy, and Spain, as well as the other nations that comprise Western Europe. In addition to the other countries formed in Western Europe, these are also included. 

Segmental Analysis

The global HERG screening market is segmented by type, ION channel, and application.

Based on type, the global HERG screening market is bifurcated into Gene KCNH2 and Mutant KCNH2.

The Gene KCNH2 segment is the major contributor to the market and is estimated to exhibit a CAGR of 15.20% during the forecast period. As it is responsible for transporting positively charged potassium atoms out of the cells, this channel is particularly crucial for the creation of electrical impulses as well as their transmission. This is because it is responsible for moving potassium atoms. The KCNH2 gene is in charge of directing the synthesis of potassium channels and is responsible for providing the required instructions for doing so. The KCNH2 mutation was the primary factor contributing to the eventual development of cardiac arrhythmia. Similarly, prolonged QT syndrome can be caused by a deficiency in the KCNH2 gene or a mutation. Estimates suggest that the prevalence of prolonged QT syndrome ranges from around one in every five thousand to one in every ten thousand people worldwide.

Based on ion channels, the global HERG screening market is bifurcated into voltage-gated ion channels, ligand-gated ion channels, and others.

The voltage-gated ion segment is the major contributor to the market and is estimated to exhibit a CAGR of 15.15% during the forecast period. Na+, Ca+, and K+ are the voltage-gated ion channel family members whose variations in cell membrane potential mediate open and closed states. Neurons, heart muscle, and skeletal muscle cells, among others, depend on these channels to maintain the ionic gradients necessary for regular cell activity. These channels precisely control the transit of ions across cell membranes. The 2016 paper in PubMed states that these channels are crucial targets for the therapy of conditions like epilepsy and neuropathic pain. Voltage-gated ion channels are increasingly being used to treat these disorders, which is majorly boosting the market growth for this sector.

The ligand-gated ion channel opens when a particular ligand binds to the receptor's extracellular domain. Additionally, it causes conformational alterations that open channel gates and let ion inflow across the plasma membrane. Nicotinic acetylcholine receptors, GABBA receptors, P2X receptors, and ionotropic glutamate receptors are all components of the ligand gate channel. The discovery of novel, safe ion-channel targeted pharmaceuticals, and the usage of ligand-gated ion channels for enhancing throughput are driving the market expansion of this category.

Mechanosensitive ion channels and transient receptor potential channels are different varieties of ion channels. The demand for drug screening for HERG in the early stages of drug discovery and development, the rising trend of outsourcing these ion channels, and the rising number of pharmaceutical and biotechnology companies outsourcing ion channel services are the key factors contributing to the development of this segment.

Based on application, the global HERG screening market is bifurcated into antiarrhythmic, antipsychotic, antibiotic, and others.

The antiarrhythmic segment is the major contributor to the market and is estimated to exhibit a CAGR of 15.60% during the forecast period. Premature beats and symptomatic tachycardias are treated with antiarrhythmic drugs. These can be taken orally for long-term treatment or intravenously in an emergency. These medications either prevent pacemaker tissue from firing abnormally or slow the transmission of impulses in tissues that conduct too quickly or engage in reentry. The usage of these assays for the treatment of arrhythmia, research studies examining the safety and efficacy of HERG screening, and an increase in cardiovascular illnesses worldwide are all driving the market's expansion. Torsion de Pointes (TdP) and even mortality can ensue from the QT interval lengthening caused by the blockage of the HERG ion channel. The study also concluded that cardiotoxicity was brought on by HERG inhibition, which is a significant risk during the medication development process.

Antipsychotic medications are approved for treating specific mental health issues whose symptoms include psychotic experiences. The HERG screening market is expanding due to a rise in the number of patients with anxiety and other bipolar disorders, cell lines like the HERG 1A-HEK293 recombinant cell line being used for electrophysiological measurements, and case studies being conducted by researchers on antipsychotic drugs using HERG channels. For instance, a 2019 article on the impact of cariprazine on HERG 1A and HERG 1A/3.1 potassium channels was published in the European Journal of Pharmacology. The study found that cariprazine selectively interacted with the open states of the HERG 1A channels to decrease HERG 1A and HERG 1A/3.1 currents rather than altering the protein trafficking of the HERG 1A and HERG 1A/3.1 channels.

Antibiotics like sparfloxacin are employed for HERG screening, and their growing utility in drug discovery drives market expansion. The market is also growing dramatically due to a rise in the use of these antibiotics as a positive control in testing the ability of new medications to lengthen the QT interval. Since these antibiotics are known to block the HERG potassium K+ channel, there currently needs to be more mechanical knowledge that is restricting the market's expansion.

Antimalarial and antihistamines are further applications for the HERG screening industry. The market is expanding due to rising research on the efficacy and safety of medications for HERG screening utilizing patch clamp assay, pharmaceutical and biotechnology businesses using HERG screening assays for drug development, and the existence of standardized protocols for these assays. For instance, the preclinical assessment of QT prolongation risk before first administration in humans is required by the International Conference on Harmonization (ICH), S7A (Food and Drug Administration, 2001), and S7B (Food and Drug Administration, 2005a) guidelines.

Recent Developments

• March 2020- An alliance was formed between Charles River Laboratories and Deciphex, a pioneer in preclinical digital pathology software-as-a-service. The firms co-developed deep learning-enabled technologies to assist expedited pathology analytics. Charles River will serve as the only contract research company providing the Patholytix preclinical solution to clients.