According to The Insight Partners’ research, the global molecular diagnostics market accounted for US$ 16,258.97 million in 2021 and is expected to reach US$ 36,176.65 million by 2028, registering an annual growth rate of 12.1% from 2021 to 2028. Increasing demand for point-of-care & developments by market players and rising prevalence of associated diseases are the key elements stimulating the market expansion.
Point-of-care (POC) is one of the emerging healthcare services being aggressively adopted by medical professionals and patients. It is extensively used for treatment, diagnosis, and patient monitoring. Several medical device manufacturers are actively operational in product innovation and development. In July 2021, Siemens Healthineers started manufacturing molecular diagnostic kits, including the COVID-19 testing at Vadodara, India facility. In September 2021, Agilent Technologies signed a worldwide distribution agreement with Visiopharm to market the pathology software and pathology staining solutions.
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Leading players dominating the global molecular diagnostics market are Abbott; Agilent Technologies, Inc; Thermo Fisher Scientific Inc; F. Hoffmann-La Roche Ltd; Qiagen; BioMerieux SA; Illumina, Inc; Danaher; Siemens Healthineers AG; Novartis AG; and TBG Diagnostics Limited, among others.
- In March 2020, Abbott received emergency use authorization (EUA) from FDA for its fastest available molecular point-of-care test to detect novel coronavirus (COVID-19).
- In October 2021, Agilent Technologies received FDA companion diagnostic approval for its Ki-67 IHC MIB-1 pharmDx, which is used to detect high-risk early breast cancer.
- In September 2021, Thermo Fisher Scientific Inc launched SpeciMAX, a stabilized saliva collection kit.
In terms of end users, the market segmentation comprises diagnostic laboratories, hospitals & clinics, research & academic institutes, and others. The diagnostic laboratories segment captured 39.77% market share in 2021, amassing US$ 6,465.87 million. Further, it is slated to accumulate US$ 14,746.61 million by 2028, propelling at 12.5% CAGR during the forecast period.
Our regional analysis states that North America dominated the market in 2021 with 44.21% share of the domain, accounting for US$ 7,188.09 million. It is likely to hit US$ 16,261.41 million by 2028, featuring a CAGR of 12.4% over the forecast period. The market in Asia Pacific was assessed at US$ 3,072.95 million in 2021 and is supposed to be worth US$ 7,488.57 million by 2028.
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Molecular diagnostics finds applications in oncology, infectious diseases, genetic testing, cardiac disorders, immune system disorders, etc. The increasing prevalence of relevant indications is certain to demand more diagnostic processes. For instance, cancer is one of the leading causes of fatalities worldwide. However, if detected at the onset only can help initiate the suitable treatment and curb the chances of death in most cases. The POC diagnosis plays a vital role in the early detection and monitoring of carcinogenic instances. Apart from cancer, the cardiovascular diseases (CVDs) also require the same diagnosis. India has reported a figure of 185 per 100,000 people at an early stage of CVD. Besides, as per the data published by the UK government in November 2021, the rate of COVID-19 stands at 423 per 100,000 people in the country. Such rising occurrences of target diseases bolster the global molecular diagnostics market.
On the contrary, the limitations associated with molecular testing restrict the growth of global molecular diagnostics market.
On the basis of disease area, the market is fragmented into infectious disease, oncology, genetic testing, cardiac diseases, immune system disorders, and others. The infectious diseases segment held 42.27% market share in 2021. It was valued at US$ 6,873.36 million in 2021 and is estimated to generate US$ 15,497.97 million by 2028 to grow at 12.3% CAGR during 2021–2028.
As per the technology, the industry is divided into polymerase chain reaction (PCR), in situ hybridization, isothermal nucleic acid amplification technology (INAAT), DNA & next-generation sequencing (NGS), DNA microarrays, and others. The PCR segment led the business in 2021 with 47.62% market share holding a revenue total of US$ 7,741.79 million. It is anticipated to garner US$ 17,708.50 million by 2028, expanding at 12.5% CAGR during the forecast period.
According to products and services, the molecular diagnostics market sphere is fragmented into assays & kits, instruments, and services & software. The assays and kits segment occupied 64.51% market share in 2021 with a valuation of US$ 10,488.44 million. It is forecasted to accrue US$ 24,029.13 million by 2028, surging at 12.6% CAGR along the forecast period.
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