ESOTERIC TESTING MARKET SIZE AND SHARE ANALYSIS - GROWTH TRENDS AND FORECASTS (2023 - 2030)

The esoteric testing market size is expected to reach US$ 54.9 billion by 2030, from US$ 25.9 million in 2023, at a CAGR of 11.3% during the forecast period. Esoteric tests are specialized diagnostic tests used to guide treatment decisions and monitor the progression for diseases like cancer, neurological disorders, and infectious diseases. These tests analyze DNA, RNA, proteins, metabolites, and antibodies to provide information about an individual's molecular and genetic profile. The increasing prevalence of chronic diseases, advances in genomics, and the shift towards personalized medicine are key factors driving the growth of the esoteric testing market.

The esoteric testing market is segmented by type, technology, service provider, and region. By type, the market is segmented into endocrinology, oncology, molecular diagnostics, neurology, immunology, genetic testing, and others. Molecular diagnostics is expected to account for the largest share during the forecast period owing to the rising adoption of genomic and proteomic testing services.

Esoteric Testing Market Regional Insights

• North America is expected to be the largest market for esoteric testing during the forecast period, accounting for over 40.7% of the market share in 2023. The growth of the market in North America is attributed to the high incidence of target diseases, favorable reimbursements, and the presence of leading service providers in the region.
• Europe is expected to be the second-largest market for esoteric testing, accounting for over 28.3% of the market share in 2023. The growth of the market in Europe is attributed to the availability of research funding and investments in the biotechnology sector in the region.
• Asia Pacific is expected to be the fastest-growing market for esoteric testing, growing with a CAGR of over 14.2% during the forecast period. The growth of the market in Asia Pacific is attributed to improving healthcare infrastructure, rising disposable incomes, and increasing awareness about advanced diagnostic tests in the region.

Analyst’s Views

The healthcare industry's fastest-growing section is the esoteric testing market. Most of the investors are interested in bringing new technology and innovation to this market. These investors recognize the immense potential for growth and profitability in the esoteric testing market. They are keen on funding companies that can offer groundbreaking solutions and disrupt traditional testing methods. With their support, the industry is poised to witness significant advancements and improvements in diagnostic capabilities. These advancements can lead to more accurate and efficient diagnoses, ultimately improving patient outcomes. Additionally, the integration of new technology and innovation in esoteric testing can also help reduce healthcare costs by streamlining processes and eliminating the need for unnecessary tests.

Figure 1. Global Esoteric Testing Market Share (%), by Region, 2023

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Esoteric Testing Market Drivers

• Rising prevalence of chronic and infectious diseases: The rising prevalence of chronic diseases such as cancer, cardiovascular diseases, and neurological disorders is a major factor driving growth in the esoteric testing market. The global burden of chronic diseases is rapidly increasing. According to the World Health Organization, chronic diseases account for 71% of deaths worldwide. The early diagnosis of chronic diseases requires specialized esoteric tests such as genomic testing, molecular diagnostics, and oncology biomarker testing. These tests help in understanding disease prognosis, making treatment decisions and monitoring progression. The demand for esoteric tests is therefore rising for the diagnosis and management of chronic diseases.
• Technological advancements in esoteric testing: Recent advances in genomics, proteomics, metabolomics, and molecular diagnostics have expanded the scope of esoteric testing. Technologies like next-generation sequencing allow high-speed sequencing of genes enabling genomic testing. Mass spectrometry and flow cytometry enable the identification of proteins and biomarkers from samples. Automation has increased the efficiency of esoteric labs. Labs are adopting advanced software solutions for managing sample tracking, analysis, and result reporting. Big data analytics enables insights from large volumes of patient data. The integration of advanced technologies is enhancing the capabilities of esoteric labs and driving market growth. For instance, on June 20, 2023, Diatech Pharmacogenetics, an Italy-based leader in the development, production, and commercialization of pharmacogenetics tests for cancer, established a collaboration agreement with Janssen Pharmaceuticals NV, a pharmaceutical company, with the aim of improving access to precision medicine for patients with bladder cancer.
• Increased demand for personalized medicine: The shift towards personalized medicine is creating substantial demand for esoteric testing. These specialized tests analyze a patient's unique genetic makeup, biomarkers and protein profiles to determine targeted therapies personalized to the individual. Pharmacogenomics testing, for instance, identifies how a person's genetics affect his response to drugs enabling personalized therapies. The demand for companion diagnostics is also rising, which involves using esoteric tests to determine targeted therapies. The adoption of personalized medicine thus necessitates advanced esoteric testing services.
• Favorable reimbursement policies: Government and private insurance providers are increasingly including esoteric testing procedures under their coverage policies. Medicare and Medicaid have expanded reimbursement for a number of esoteric tests aiding market growth. Private insurers are also partnering with esoteric labs to provide affordable access to patients. Favorable reimbursement scenarios reduce the out-of-pocket expenditure for patients and improve accessibility to esoteric testing. This is expected to increase test volumes and revenues for esoteric labs.

Esoteric Testing Market Opportunities

• Emerging markets: Emerging economies offer significant growth opportunities to esoteric testing providers. The market in developing countries is currently underpenetrated but has high expansion potential. Factors like rising income levels, increasing health awareness and growth of medical infrastructure are expected to increase demand for specialized lab testing. Local governments are undertaking initiatives to improve access and establish advanced esoteric labs. Strategic expansion in high potential markets can enable companies to tap into a wider patient pool and achieve growth.
• Point-of-care esoteric testing: Point-of-care (POC) esoteric testing presents an exciting opportunity for market players. POC testing involves use of advanced rapid diagnostic tests near patient settings like physician clinics, hospital ERs and critical care units. POC tests enable quick turnaround times by eliminating transport of samples to central labs. Companies are developing innovative POC immunoassay, molecular assay and sequencing platforms. POC testing can help improve patient outcomes through rapid diagnosis. The integration of microfluidics, nanotechnology and mobility makes POC testing more efficient.
• Direct-to-consumer testing: The availability of direct-to-consumer (DTC) esoteric testing services also opens up growth avenues. DTC testing allows patients to access specialized tests directly without prescriptions. Consumers can order test online and get the results confidentially. DTC tests include nutritional, genetic, microbiome, sexual health testing etc. Companies are utilizing online channels and social media to increase awareness and drive DTC sales. DTC testing makes esoteric testing more accessible to general population.
• Strategic acquisitions: The esoteric testing market is witnessing increasing consolidation through acquisitions. Large biopharma corporations are acquiring esoteric testing providers to integrate diagnostics with drug development. Smaller niche companies are being acquired to gain competitive edge in genetic testing and oncology diagnostics. Acquisitions provide companies access to innovative technologies, expand test menus and enter new regional markets. Acquisitions thus represent an attractive growth strategy for market players to strengthen their capabilities and widen market presence.

Esoteric Testing Market Trends

• Integration of automation and AI: Esoteric labs are increasingly adopting automation and artificial intelligence to enhance efficiency, accuracy and output. Robotic sample handling systems automate tasks like aliquoting and transport thereby lowering manual errors. Machine learning algorithms are utilized to scrutinize data and identify patterns leading to faster and consistent results. Natural language processing facilitates seamless data capture from physician notes into lab systems. Companies are partnering with technology providers to implement automation and AI. Integration of these technologies is enabling labs to scale up operations and achieve higher throughput.
• Liquid biopsy gaining prominence: Liquid biopsy is an emerging technology trend in the esoteric testing market. Liquid biopsy involves analysis of biomarker signatures in body fluids like blood to detect cancers. It is minimally invasive compared to tissue biopsies. Liquid biopsy provides real time information about tumor mutations aiding treatment decisions. Companies are developing ultra-sensitive assays to improve liquid biopsy testing. Liquid biopsy has potential for screening and monitoring of cancers. Esoteric labs are increasingly adopting this technology owing to its benefits.
• Biomarker discovery and validation: Extensive research is being conducted globally to discover and validate new biomarkers for diseases. Discovery of unique protein and genetic biomarkers can help develop novel esoteric tests with higher predictive value. Labs are utilizing advanced proteomics, genomics and bioinformatics techniques to identify biomarkers through analysis of disease samples. Partnerships are taking place between esoteric labs and pharmaceutical companies to co-develop companion diagnostics based on biomarker data. Biomarker discovery is expected to expand the menu of molecular testing panels aiding diagnostics.
• Shifting focus towards preventive testing: There is an increasing focus on preventive esoteric testing for early detection of diseases. Preventive screening helps in identifying individuals at high risk and probability of developing diseases. For instance, genomic testing is done to determine cancer susceptibility. Esoteric labs are offering preventive tests for chronic diseases, cancers, neurological disorders and inherited conditions. Population level preventive screening programs also utilize advanced lab tests. Early identification can improve clinical outcomes and lower treatment costs. This is anticipated to propel the demand for preventive esoteric testing.

Esoteric Testing Market Restraints

• High costs and inadequate reimbursements: Esoteric tests are priced substantially higher compared to conventional lab tests which can hinder adoption. Complex esoteric tests often cost thousands of dollars depending on the technology and condition. Despite insurance coverage expansion, many payers have unfavorable reimbursement policies with lower payouts for esoteric testing procedures. Patients are left to bear a significant portion of testing costs leading to affordability issues. The lack of supportive reimbursement frameworks thus remains a key market challenge.
• Stringent regulatory guidelines: Companies offering esoteric testing services need to comply with stringent regulatory standards regarding quality control, accuracy, validation, etc. Regulatory agencies like Food and Drug Administration and Centers for Medicare & Medicaid Services have framed rigorous guidelines for the approval and monitoring of esoteric tests. The approval process for LDTs in the U.S. is anticipated to tighten further. Complex regulatory requirements lead to increased costs and longer times for test commercialization and impact profitability margins for labs. This can restrain the growth of the esoteric testing market.
• Shortage of trained professionals: There is a shortage of suitably qualified and trained staff for performing specialized esoteric tests. Technicians require extensive training in advanced molecular biology, genetics, bioinformatics, and clinical knowledge to accurately run and interpret the results of newer esoteric tests. Labs need to continuously educate their workforce regarding rapidly evolving testing technologies. The personnel constraint can lead to slower adoption of innovative platforms thereby restraining market expansion. Building specialized teams is essential for labs to scale up operations.

Key market players are working on various challenges to make esoteric testing more affordable, and easily accessible.

Recent Developments

New product launches

• On June 21, 2023, Cardio Diagnostics Holdings, Inc, a pioneer in AI-driven precision cardiovascular medicine tests, announced the U.S. launch of PrecisionCHD. This groundbreaking test marks a significant milestone in the fight against coronary heart disease (CHD), the most common type of heart disease and the primary cause of heart attacks. It is the second product to be released from Cardio Diagnostics’ cutting-edge suite of AI-driven molecular cardiovascular disease technologies.
• On June 20, 2023, Veravas, a leading innovator in clinical diagnostics, announced the launch of its groundbreaking VeraBIND (Biomarker Isolation and N-richment for Detection) technology. With millions of assays conducted daily in clinical laboratories worldwide, the search for specific biomarkers to identify early-stage diseases is becoming increasingly crucial. However, the inherent challenges posed by diverse patient sample types, including urine, saliva, and blood, can lead to false positive or negative results. VeraBINDing the sample during collection or preparation transforms complex samples into a matrix-free sample which enhances the performance of on-market tests and can allow healthcare professionals to realize a significant breakthrough in biomarker detection.
• On February 28, 2023, Cardio Diagnostics Holdings announced the launch of PrecisionCHD, an integrated epigenetic-genetic blood test for the early detection of coronary heart disease. PrecisionCHD is the second clinical test that uses its artificial intelligence (AI)-enabled Integrated Epigenetic-Genetic Engine. The test uses epigenetic (DNA methylation) and genetic (single nucleotide polymorphism) biomarkers with a machine-learning model developed by analyzing billions of genomic and epigenomic data points.

Acquisition and partnerships

• On July 12, 2023, BPGbio, Inc., a leading AI-powered biopharma that focuses on oncology, neurology and rare diseases, announced that the company has signed a collaborative agreement with Grupo Terralpe, Inc., a renowned private investment group based in Mexico City and Boston, Mass, U.S. Together, the companies will commercialize the pstateDx test, BPGbio’s prostate cancer diagnostic test, in Mexico, U.S. BPGbio’s pstateDx test is the first diagnostic product discovered by the company’s AI-powered Interrogative Biology platform to be commercially launched. The pstateDx test is a non-PSA based, unique molecular diagnostic blood test that measures filamin A, a key biological driver of prostate cancer.
• On July 11, 2023, Alveo Technologies, Inc., a leader in molecular sensing and diagnostics with its proprietary be.well technology platform, launched a web-based partner portal and suite of enablement software tools to further drive innovative partnerships onto the platform to co-develop and commercialize rapid, point of need diagnostic solutions across multiple life sciences industry sectors. Furthermore, its newest partnership with the Fraunhofer Institute for Cell Therapy and Immunology IZI extends the platform into the large animal veterinary sector. The institute belongs to the Fraunhofer-Gesellschaft, the world’s leading applied research organization.
• In February 2021, S.R.L. Diagnostics, a diagnostics chain with the largest accredited lab network, has linked an agreement with the U.S.-based Mayo Clinic Laboratories. The collaboration aims to facilitate initiatives between the two organizations to help physicians maintain lifelong knowledge and skills for safe clinical practice.

Figure 2. Global Esoteric Testing Market Share (%), by Service Provider, 2023

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Top Companies in Esoteric Testing Market

• LabCorp
• Quest Diagnostics
• OPKO Health
• Miraca Holdings
• Myriad Genetics
• Sonic Healthcare
• Cardio Diagnostics Holdings, Inc
• Veravas
• BPGbio, Inc.
• Fulgent Genetics
• Alveo Technologies, Inc.
• R.L. Diagnostics

Definition: Esoteric testing refers to specialized diagnostic tests that analyze biomarkers, DNA, RNA, proteins and other substances to provide information about rare conditions, personalized therapy selection, and disease monitoring. These tests require advanced instrumentation and are performed at dedicated reference labs by trained personnel. Esoteric tests guide treatment decisions for complex cases and conditions where conventional lab tests are inadequate. They include genomic testing, proteomic analysis, flow cytometry, and molecular diagnostic assays for cancers, neurological disorders, inherited diseases, and infectious diseases. Esoteric testing enables early diagnosis, targeted therapy selection and precise disease management.

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