MOLECULAR DIAGNOSTICS MARKET ANALYSIS

Molecular diagnostics tests are used for detecting disturbance between specific sequences in Deoxyribonucleic acid (DNA) or Ribonucleic acid (RNA), which may be associated with disease. The disturbance between a single nucleotide polymorphism (SNP), deletions, rearrangements, insertions, and others factors lead to various diseases. Molecular diagnostic test are indicated for infectious diseases, oncology, virology, and sexually transmitted diseases (STDs). Molecular diagnostics are capable of detecting specific disease which helps in providing precision medicine to patients. Governments of various countries are focused on research and development of precision medicine, which is expected to drive growth of the molecular diagnostics market over the forecast period. For instance, in August 2021, Avera Health, a healthcare company, and Sema4, a patient-centered health intelligence company, announced a new collaboration for launching a precision medicine initiative. This initiative would initially focus on advancing oncology care, to provide benefit to patients from data-driven insights that inform targeted cancer treatments.

Global molecular diagnostics market is estimated to be valued at US$ 14,772.2 million in 2022 and is expected to exhibit a CAGR of 11.6% during the forecast period (2022-2030).

Figure 1. Global Molecular Diagnostics Market Share (%), by Product Type, 2022

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Increasing product launches by market players are expected to drive growth of the global molecular diagnostics market.

Increasing product launches by market players are expected to drive growth of the global molecular diagnostics market. For instance, on May 17, 2022, QIAGEN N.V., a provider of sample and assay technologies for molecular diagnostics, applied testing, and academic and pharmaceutical research, announced the launch of the therascreen EGFR plus RGQ PCR Kit, a new in-vitro diagnostic test for sensitive epidermal growth factor receptor (EGFR) mutation analysis, detecting all currently known activating and resistance EGFR mutations. The real-time quantitative polymerase chain reaction (qPCR) test builds on the established therascreen EGFR RGQ PCR Kit and provides improved limits of detection, quicker turnaround times, automated sample extraction options, and automated results analysis.

Figure 2.Global Molecular Diagnostics Market Share (%), by Region, 2022

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Increasing product approvals by regulatory authorities or government organizations is expected to drive growth of market over the forecast period.

Increasing product approvals by regulatory authorities or government organizations is expected to drive growth of molecular diagnostic market over the forecast period. For instance, On April 3, 2020, BD (Becton, Dickinson and Company), a global medical technology company, and BioGX Inc., a molecular diagnostics company, had announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for a new diagnostic test that enables hospitals to screen for COVID-19 (coronavirus) on site and get results in under three hours.

Global Molecular Diagnostics Market - Impact of Coronavirus (Covid-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization declared it a public health emergency on January 30, 2020.

The COVID-19 can affect the economy in three main ways: by directly affecting the production and demand of molecular diagnostics products, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries such as China, India, Saudi Arabia, the U.A.E., Egypt, and others are facing problems with regard to the transportation of molecular diagnostics products from one place to another.

However, the COVID-19 pandemic had a positive impact on the global molecular diagnostics market, owing to increased research and development of molecular diagnostic products to prevent coronavirus. For instance, on March 14, 2022, the Helvetica Health Care Sàrl, a healthcare company published an article on the impact of the COVID-19 pandemic on molecular diagnostics stating that the continuing SARS-CoV-2/COVID-19 pandemic has highlighted the use of molecular diagnostic technologies in the against infectious disease. Scientists and technicians have been developing diagnostics and laboratory medicines from the beginning of the pandemic

Global Molecular Diagnostics Market: Key Developments

On March 27, 2020, Abbott, a multinational medical devices and healthcare company had announced that the U.S. Food and Drug Administration (FDA) had issued Emergency Use Authorization (EUA) for the fastest available molecular point-of-care test for the detection of novel coronavirus (COVID-19), delivering positive results in five minutes and negative results in 13 minutes. The test will run on the company's ID NOW platform for COVID-19 test, providing rapid results in a wide range of healthcare settings such as physicians' offices, urgent care clinics and hospital emergency departments.

Global Molecular Diagnostics Market: Restraint

Product recalls being ordered by regulatory authorities is expected to hamper growth of global molecular diagnostics market over the forecast period. For instance, On December 22, 2021, The U.S. Food and Drug administration (FDA) issued a notice to recall CovClear COVID-19 Rapid Antigen Test and ImmunoPass COVID-19 Neutralizing Antibody Rapid Test by Empowered Diagnostics, a healthcare company. These tests were distributed with labeling indicating that they are authorized by the FDA, but neither test had been authorized, cleared, or approved for distribution or use in the U.S. by the FDA. The FDA is concerned about the potentially higher risk of false results when using unauthorized tests.

Key Players

Major players operating in the global molecular diagnostics market include Hologic,Inc., Grifols, S.A., Abbott Laboratories, Qiagen N.V., F. Hoffmann-La Roche Ltd., Siemens Healthineers, Becton, Dickinson and Company,  Agilent Technologies, Inc.,  Meridian, Cepheid,  and Beckman Coulter, Inc.