North America Molecular Diagnostics Market Size

North American Molecular Diagnostics Market Analysis

The North America Molecular Diagnostics Market size is estimated at USD 10.80 billion in 2024, and is expected to reach USD 14.89 billion by 2029, growing at a CAGR of 6.63% during the forecast period (2024-2029).

COVID-19 had a profound impact on the studied market. Molecular diagnostics has been widely used in the past few years to detect COVID-19. Various market players were launching innovative point-of-care molecular diagnostics to meet the rising demand for rapid diagnostics of infectious diseases. For instance, in July 2022, BioGX, a global provider of easy molecular diagnostic solutions, launched a point-of-care (POC) CE-marked, three-gene multiplex COVID-19 test on its pixl platform. Also, in April 2021, Thermo Fisher Scientific Inc. was granted emergency use authorization (EUA) from the FDA for its amplitude solution with the TaqPath COVID-19 high-throughput combo kit, a tool for rapidly scaling high-sensitivity PCR testing. The growth of the molecular diagnostics market is slightly subsidized currently due to the decrease in the number of COVID -19 cases. However, the studied market is expected to report stable growth over the forecast period owing to the high demand for molecular diagnostics in multiple applications and technological advancements in molecular diagnostic products in the region.

The market is mainly driven by increasing demand for point-of-care diagnostics, recent advancements in pharmacogenomics, and large outbreaks of bacterial and viral epidemics.

The molecular diagnostics test must be precise, rapid, and also be able to measure the infectious burden. The increase in infectious diseases and cancer cases in the United States has led to trends shifting from traditional diagnostic methods to molecular diagnostics. For instance, according to data published by the American Academy of Pediatrics, in March 2022, more than 1 million people in the United States have long-term hepatitis B infections, and people who are infected with hepatitis B as a baby have a 90% chance of developing severe, chronic conditions like liver cancer in their lifetime. The identification of these diseases at an early stage has become easy using molecular tests, coupled with pharmacogenomics, which is expected to fuel market growth.

In situ hybridization is a growing technology in the molecular diagnostics branch that is used to locate and detect specific mRNA sequences in preserved tissue sections or cell preparations. The launches by several market players are expected to boost the availability of products for molecular diagnostics. For instance, in April 2021, BIO-TECHNE launched NOVEL DNASCOPE In Situ Hybridization assays for chromogenic detection of DNA copy numbers and structural variations. The RNAscope technology is an advanced in situ hybridization (ISH) assay that enables visualization of single-molecule gene expression with single-cell resolution directly in intact cells and tissues. The advancements in technology and product launches are expected to propel the usage of in situ hybridization for various applications such as genetic disease screening and cancer detection.

The strategic initiatives taken by the market players are also propelling the growth of the market. For instance, in February 2021, Bio-Rad Laboratories Inc. received EUA approval from the FDA for multi-target Reliance SARS-CoV-2, FluA, FluB, RT-PCR, and Reliance SARS-CoV-2 RT-PCR assay kits. The multi-target assay kit simultaneously detects and differentiates SARS-CoV-2, influenza A, and influenza B in a single multiplex reaction. Such launches are also expected to contribute to the growth of the market during the forecast period.

Therefore, owing to the aforementioned factors such as the high burden of infectious diseases, and the rising demand for molecular diagnostics leading to increasing product launches, the studied market is anticipated to witness growth over the analysis period. However, the stringent regulatory framework is likely to impede the market growth.