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BD (BDX) Boosts Molecular Diagnostics Portfolio With New Tests

Over the past few months, the Molecular Diagnostics market has been prospering well on the back of the COVID-19 havoc, followed by the surge in Monkeypox cases. Apart from these instances, the niche space has been gaining considerably on the back of various diseases caused by other viruses. These instances greatly benefited key MedTech players in the Molecular Diagnostics business like Becton, Dickinson and Company BDX, popularly known as BD.

Last month, BD received the FDA’s approval for the BD Onclarity HPV (human papillomavirus) Assay to be used with the ThinPrep Pap Test. The two most common Pap vials currently used by laboratories in the United States are the BD SurePath Liquid-based Pap Test vial and the Hologic ThinPrep Pap Test PreservCyt Solution vial.

The same month, BD received the FDA’s Emergency Use Authorization (EUA) for a new molecular diagnostic combination test for SARS-CoV-2, Influenza A + B and Respiratory Syncytial Virus — BD Respiratory Viral Panel assay for BD MAX System. The test, for use on the BD MAX Molecular Diagnostic System, is expected to aid in combatting illness in the current and future respiratory virus seasons.

In January, BD received the FDA’s EUA for a molecular polymerase chain reaction (PCR) assay for Mpox virus detection — VIASURE Monkeypox Virus Real Time PCR Reagents for BD MAX System.

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The recent progress made by BD is expected to solidify its foothold in the global Molecular Diagnostics business, thereby boosting its overall Life Sciences segment.

Industry Prospects

Per a report by MarketsandMarkets, the global molecular diagnostics market is anticipated to reach $30.2 billion by 2027 from $23.2 billion in 2022 at a CAGR of 5.4%. Factors like the emergence of new viruses, technological advancements in molecular diagnostics and the growing awareness of early disease diagnosis are likely to drive the market.

Given the market potential, the latest developments are expected to significantly strengthen BD’s business worldwide.

Comparison With Peers

Last month, BD’s peer Thermo Fisher Scientific Inc. TMO announced the launch of its Applied Biosystems TrueMark STI Select Panel, a PCR research use-only test designed to detect Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium in one test, as well as RNase P, included as a human internal control.

The same month, TMO announced better-than-expected fourth-quarter 2022 results. Thermo Fisher saw robust year-over-year revenue growth in the Analytical Instruments, and Laboratory Products and Biopharma Services segments. In the fourth quarter, the company opened a state-of-the-art bioanalytical lab in Richmond, VA, to support its clinical research business and the increasing demand for analytical services to accelerate drug development.

Another peer of BD, Bio-Rad Laboratories, Inc. BIO, announced its fourth-quarter 2022 results last month. On a geographic basis, BIO experienced double-digit currency-neutral year-over-year core revenue growth in the Americas and Asia, while Europe posted a more modest increase, primarily reflecting ongoing supply-chain constraints for diagnostic products.

In November 2022, Bio-Rad announced an expanded portfolio of independent quality controls products, now including InteliQ and Liquichek compact vials, for the Abbott Alinity ci-series integrated clinical chemistry and immunoassay testing instruments.

Another renowned name in the PCR space and BD’s peer, Qiagen N.V. QGEN, announced the certification of QuantiFERON-TB (tuberculosis) Gold Plus (QFT-Plus) under the European Union’s In Vitro Diagnostic Medical Devices Regulation (IVDR) last month. QFT-Plus, endorsed by the WHO, aids in the indirect detection of the bacteria that causes TB. The IVDR certification of QFT-Plus follows the QIAGEN ipsogen JAK2 RGQ PCR Kit, as well as the NeuMoDx Systems and reagents, which gained IVDR CE-marking in late 2022.

The same month, QGEN announced better-than-expected fourth-quarter 2022 results. Ongoing double-digit sales growth in Qiagen’s non-COVID product portfolio, a high level of profitability and strong cash flow were the major upsides. The QIAcuity digital PCR system delivered solid double-digit constant exchange rate (CER) growth for 2022, supported by the launch of the latest assays for biopharma applications. Further, QuantiFERON-TB registered solid double-digit CER growth in 2022, led by the continued conversion of the latent TB market from the traditional skin test.

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