Molecular Diagnostics Global Market estimated to be worth $18.7 billion by 2026

Molecular diagnostics comprises a range of techniques used for detection of genomic variants and causal agents of diseases; they facilitate detection, diagnosis, sub-classification, prognosis, and monitoring response to therapy. Molecular diagnostics is the outcome of the fruitful interplay among laboratory medicine, genomics knowledge, and technology in the field of molecular genetics, especially with significant discoveries in the field of molecular genomic technologies. In the coming years, molecular diagnostics will continue to be of critical importance to public health worldwide because these methods can detect sensitive markers and are less intrusive than a traditional biopsy. The molecular diagnostics technology has a very broad range of applications like the detection of infections, screening of different types of cancers, organ transplantation, cancer care, genetic disorders screening and NIPT testing etc., where, technologies like NGS, PCR, INAAT, in-situ hybridization, micro-array etc are being used.   

According to IQ4I Research, the molecular diagnostics global market is expected to reach $18,668.9 million by 2026 growing at a high single digit CAGR from 2019 to 2026 due to the growing demand of molecular-based tests which are rapid and precise with early detection. The factors driving the growth of the molecular diagnostics market are increasing prevalence of different types of cancers, infectious diseases, genetic disorders and other diseases, increasing awareness of personalized medicine, companion diagnostics and also growth in the point of care testing, sequencing-based tests and other molecular techniques. Molecular diagnostics plays a pivotal role in the evaluation of the disease and for the effective response for specific therapy. However, the complex regulations for the approval of molecular diagnostic tests, availability of alternative technologies, high cost of the tests, and also shortage of technical experts are some of the restrains for the growth of the molecular diagnostics market.

Molecular diagnostics global market is segmented based on products, technology, applications and end-users. The product category is segmented into consumables, instruments and software services. As estimated by IQ4I Research, the consumables segment accounted for the largest revenue in 2019 and expected grow at a double digit CAGR from 2019 to 2026. Among the technologies, PCR accounted for the largest revenue in 2019 followed by In-situ hybridization and NGS.

Among application, the largest revenue was generated by infectious diseases segment followed by oncology in 2019. With respect to end user, in 2019, Clinical/centralized laboratories accounted for the largest revenue and the market is expected to grow at a double digit CAGR from 2019 to 2026, this can be mainly attributed to technological advancements, as clinics and centralized laboratories provide novel technologies with more advanced instruments and diagnostic tests when compared to hospitals and also tests in clinics and centralized laboratories are cost effective than in hospitals.

Among various geographic market segments, North America molecular diagnostics commanded the largest revenue in 2019 which is growing at a strong single digit CAGR from 2019 to 2026 due to the rise in early  cancer screening, increased demand for personalized medicine, increased innovation in technologies related to medical diagnostics, advancements and emergence of new diseases; likewise, Asia-Pacific is expected to grow at a early teen CAGR from 2019 to 2026,due to the increased awareness of the high specificity, sensitivity and ease with which the tests can be carried out which has led to a wide range of applications and a great number of both quantitative and qualitative assays and tests are available which could detect causes and clinical conditions of the diseases are driving the market.

Molecular diagnostics market is experiencing rapid growth because of approvals, agreements and acquisitions, For instance, In May 2019, F. Hoffmann-La Roche Ltd, received US Food and Drug Administration (FDA) 510(k) for the Cobas TV/MG test for use on the Cobas 6800/8800 Systems for the detection of Trichomonas vaginalis (TV) and/or Mycoplasma genitalium (MG) DNA in both symptomatic and asymptomatic patients. Similarly, in August 2018, Exact Sciences Corp. and Pfizer Inc. collaborated to co-promote Cologuard, the first and only FDA-approved non-invasive stool DNA screening test for colorectal cancer. Considering the attractiveness of the molecular diagnostics market, several venture capitalists are aggressively investing in developing instruments, assays and tests. According to IQ4I analysis, among the funding received by 20 molecular diagnostic companies during the period 2018-2019, the disclosed deal amount was worth ~$XX million.  For example in October 2019, Sense Biodetection received ($15.9 million) funding from Cambridge Innovation Capital and Earlybird, seed round investor Mercia Asset Management, and Innovate UK to develop a portfolio of instrument-free, point-of-care molecular diagnostic  tests. The tests will use a "simple and ultra-rapid alternative" to PCR.

Due to the increased need for the precise and reliable technology, there is a rapid growth in technological advancements. For instance, the latest innovation is a nanopore reader which was used to read Ebola virus genome within 44 seconds, such progression in computational biology and associated areas with the use of software algorithms have led to treat patients far more quickly and efficiently by clinicians thereby reducing the time of diagnosis.

Along with the technological advancements, the other factors which is influencing the growth of the market includes product launches, for instance, in October 2019, Roche announced the commercial availability of two tests, for use on the automated cobas 6800/8800 Systems in countries accepting the CE mark. The cobas EBV (Epstein-Barr virus) and cobas BKV (BK virus) tests provide reliable, standardized, high-quality results for clinical decision-making to help manage the risk of infection and improve the management of severely immuno-compromised transplant patients.

According to data analyzed by IQ4I, there were about XX clinical trials on ctDNA, cfDNA, CTC and companion diagnostics of which XX% were in phase 3, XX% in phase2/phase3, XX% were in phase 2, XX% in phase1/phase2, XX% in phase 1 and 7.5% in early-screening etc. Most of the phase 3 clinical trials are focused on colorectal cancer, breast and lung cancer which could result in new early and companion diagnostic tests for these life threatening cancers.

Major players in the molecular diagnostics global market are F. Hoffmann-La Roche AG (Switzerland), Danaher Corporation (U.S.), bioMérieux (France), Hologic, Inc. (U.S.), Becton, Dickinson and Company (U.S.), Abbott Laboratories (U.S.), Qiagen (Germany), Exact Sciences Corp. (U.S.), Myriad Genetics, Inc. (U.S.) and Grifols, S.A. (Spain).

Some of the other prominent players in the molecular diagnostics market are Thermo-fisher scientific. (U.S.), Siemens AG (Germany), Luminex (U.S.), Agilent (U.S.), Illumina (U.S.), Diasorin (Italy), Genomic Health (acquired by exact sciences) (U.S.), Myriad Genetics (U.S.), Natera (U.S.) and other companies.