Esoteric testing allows the analysis of rare substances or molecules that are not performed in a routine clinical lab. Many large commercial lab companies outsource complex tests to reference and esoteric testing labs. However, as technology continues to expand laboratory testing, tests that are considered esoteric today may become routine in just a few years. This is often the result of work performed by dedicated research and development scientists.
These tests are ordered when a physician requires additional detailed information, outside routine lab testing, to complete a diagnosis, establish a prognosis or choose and monitor a therapeutic regimen. Esoteric testing generally requires sophisticated instruments and materials as well as specialized personnel to perform and analyze results. The tests are typically outsourced to independent, specialized clinical reference laboratories because it is not cost effective for hospitals and physician office laboratories to perform the tests in-house. The American Chemical Society publishes the Directory of Rare Analyses (DORA) which catalogues rarely ordered clinical tests and provides details on the labs performing them.
The market is driven is the rising cases of infectious and rare diseases and other diseases. According to the European Commission, approximately 27 to 36 million people suffer from rare disease in European region. Also, according to the Centre for Disease Control and Prevention, 2017, the number of cases of salmonella were around 54,285. Hence this growing burden of rare diseases is expected to increase the demand for esoteric testing market growth during the forecast period.
Growing patient awareness about the benefits of personalized medicine is one of the key factors resulting in the increased use of molecular diagnostics and genomics & proteomics technologies. Esoteric tests, which involve the analysis of 'rare' molecules or substances, are an essential part of individualized treatment regimens for many chronic diseases and conditions. These tests enable healthcare providers to make an informed clinical decision and reduce the likelihood of unnecessary adverse events. Some of the most widely used personalized treatment regimens include chemotherapy selection for breast cancer using gene expression profiles, therapeutic drug monitoring tests to select drugs for resistant HIV strains; and drugs selection based on the genetics and molecular profile of patients with autoimmune diseases.
Developing economies such as India, China, South Korea, Brazil, Turkey, Russia, and South Africa are expected to offer potential growth opportunities for the major players operating in the esoteric testing services market. This can be attributed to the high disease prevalence, large patient population, improving healthcare infrastructure, and growing medical tourism in these countries.
The incidence of chronic diseases, such as cancer, has increased significantly in these countries. According to 2012 WHO estimates, annually, more than 60% of the total number of new cancer cases occur in Africa, Asia, and Central and South America. Moreover, the increasing competition in mature markets will further compel esoteric testing service providers to focus on emerging markets. This factor will drive the growth of the market in the forecast period.
The esoteric testing industry is impacted by the frequently changing laws and regulations by regional governments. Regulations govern various clinical laboratory operations with the incorporation of various technical, operational, personnel, and quality requirements to ensure that the services provided by laboratories are accurate, reliable, and timely. There are repeated changes in these regulations, which creates complexities in the process of delivering esoteric testing services.
For instance, the Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing performed on humans in the US through the Clinical Laboratory Improvement Amendments (CLIA), passed by Congress in 1988. In total, CLIA covers approximately 254,000 laboratory entities. This factor will hamper the growth of the market in the forecast period.
The global esoteric testing market is segmented based on test type by endocrinology testing, infectious diseases testing, oncology testing, neurology testing, toxicology testing, others. The oncology testing segment held the largest market share. The rising importance of early diagnosis and treatment for cancer will impact positively on the market growth in this segment. According to the World Health Organization, cancer is one of the second leading cause of death worldwide. In 2018, around 1.8 million new cases were reported with cancer globally. The most common type of cancers are lung, breast and prostate cancer.
Furthermore, the increasing investments of R&D activities is expected to drive the demand of testing. According to the European Federation of Pharmaceutical Industries and Associations, 2017, the overall sales of pharmaceutical industry worldwide was recorded to be approximately 852,647 million USD. Hence, the aforementioned factors are expected to boost the market growth in this segment.
The endocrinology testing segment is expected to have positive market growth in the forecast period. Endocrine disorders such as Cushing's syndrome and hypothyroidism may cause weight gain and exacerbate metabolic dysfunction in obesity. Other forms of endocrine dysfunction, particularly gonadal dysfunction (predominantly testosterone deficiency in men and polycystic ovarian syndrome in women), and abnormalities of the hypothalamic-pituitary-adrenal axis, the growth hormone-IGF-1 system and vitamin D deficiency are common in obesity. As a result, endocrinologists may be referred people with obesity for endocrine testing.
A recent systematic review and associated guidance from the European Society of Endocrinology provide a useful evidence summary and clear guidelines on endocrine testing and treatment in people with obesity. With the exception of screening for hypothyroidism, most endocrine testing is not recommended in the absence of clinical features of endocrine syndromes in obesity, and likewise hormone treatment is rarely needed. These guidelines should help reduce unnecessary endocrine testing in those referred for assessment of obesity and encourage clinicians to support patients with their attempts at weight loss, which if successful has a good chance of correcting any endocrine dysfunction. This factor will drive the growth of market in the forecast period. Further, the market is also classified based on technology as flow cytometry, Chemiluminescence immunoassay, mass spectrometry, radio immunoassay and others. The flow cytometry segment is held the largest market share. Flow cytometry (FCM) is an instrumental tool for rapid detection and characterization of microbial cells based on their light scatter and fluorescence properties. Flow cytometry allows analysis of complex populations according to user-defined cell characteristics, with typical analysis rates concentrates.
Flow cytometers utilize lasers as light sources to produce both scattered and fluorescent light signals that are read by detectors such as photodiodes or photomultiplier tubes. These signals are converted into electronic signals that are analyzed by a computer and written to a standardized format data file. Cell populations can be analyzed and/or purified based on their fluorescent or light scattering characteristics.
The extremely high information density of the data derived from flow cytometry assays is an absolute requirement to begin to elucidate the extremely complex immune system. Flow cytometry technology continues to evolve at a fast pace, as it has for a quarter of a century. This evolution includes a continuous infusion of applications into the clinical environment indeed, the power of flow cytometry for clinical diagnosis and prognosis is already evident from the fact that virtually every modern hospital has at least one of these instruments. This factor will drive the growth of market in the forecast period.
By region, the esoteric testing market is segmented into North America, South America, Europe, Asia-Pacific, Middle-East, and Africa. Among all of the regions, North America dominated the global esoteric testing market and is expected to grow at the highest CAGR during the forecast period due to increasing number of R&D activities and investments on it.
As per the data of National Organization of Rare Diseases, around 30 million people were suffering from some type of diseases (2019). Also, almost one out of ten individuals in America have rare diseases and more than half of these are children. According to the Pharmaceutical Research & Manufacturers of America, in 2018, the R&D expenditure by biopharmaceutical companies was around 79.6 billion USD in the United States. Thus, with growing burden of rare diseases and increasing investment into research and development activities the demand for esoteric testing is expected to propel the market growth in this region.
For instance, in 2017, Myriad Genetics, Inc. launched the EndoPredict test in the US for patients with ER+ HER2- early-stage breast cancer. This test launch will strengthen the company’s oncology product portfolio and represents advancement in the treatment of patients with breast cancer.
Also, in 2017, Bristol-Myers Squibb Company and Foundation Medicine collaborated to leverage Foundation Medicine's comprehensive genomic profiling and molecular information solutions to identify predictive biomarkers such as Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI) in patients.
The Asia-Pacific region is expected to have third-largest share due to presence of a large patient pool, availability of skilled technicians at a comparatively lower price, and a defined regulatory framework favoring expedited product approvals. Furthermore, the booming medical tourism industry in countries such as India, China, and Malaysia are expected to boost demand for the market. These factors stimulate market growth over the forecasted period in the region.
The esoteric testing market is highly competitive with the presence of several international and local markets. Product diversification, revenue generation, and opportunities intensify the market competition Bayer Healthcare, Biogen, Biotest AG, CSL Behring, Ferring B.V., Genentech, Kedrion, Novo Nordisk, Octapharma, Pfizer, Sanofi SA, are the leading market players with significant market share. The major players are using product development, novel product launches, market expansion, and product diversification strategies for holding their position in the market.
The companies are entering into collaborations, mergers, strategic partnerships, and acquisitions to expand their presence and meet the rising demand for the esoteric testing market across the globe. For instance,