Molecular Diagnostics in Oncology, Genetic/Inherited Diseases, and NIPT, 2023-2028

In recent decades, the introduction of various new genetic technologies for research use and diagnostics has revolutionized many areas and opened new frontiers in healthcare. For example, next-generation sequencing (NGS) technologies have become widely used in genetic diseases, and have grown rapidly in oncology, due to the comprehensive insights they can provide at a relatively low cost. While older, PCR continues to be innovated and remains a central tool in molecular diagnostics laboratories of all kinds, and in situ hybridization techniques (ISH) such as FISH are still vital for understanding gene expression and genetic alterations in situ. The application areas are distinct in many ways, but the domains of oncology and inherited/genetic diseases have significant overlap and bridges between them as well as largely sharing advancements in relation to the technologies used.

Cancer testing is maturing to precision medicine, where numerous biomarkers are essential for precise diagnosis, therapy selection, therapy monitoring and early detection of cancer recurrence for the given patient. With the unfortunate rising statistics of cancer in the developed world, innovation is a must. Growth rates in cancer testing tend to be higher than in other IVD fields. Diagnostic tests for effective cancer screening are needed more than ever. As this report goes to print several significant developments are taking place. New reagents, bioinformatics, sequencing technologies, and improved histological tests are among the trends in this multifaceted report. Many of these advances are initially turned into tests as services, most often as LDTs but also FDA-approved or CE-IVD tests. The importance of this industry is seen in the flurry of activity between companies where one or both are involved in cancer diagnostics. There has been a large amount taking place in companion diagnostics in particular.

In addition, the fields of rare inherited/ genetic diseases and NIPT have become areas of new breakthroughs in healthcare. As genomic databases have grown exponentially along with knowledge about genetic diseases, there has been a shift to new tools and uses. Newborn screening was an early example of inherited/ genetic disease testing, but many additional applications have emerged. Carrier screening can be used to identify healthy individuals who carry a recessive mutation for an inherited disorder and could therefore pass the disorder on to their offspring if the other parent is also a carrier for that inherited disease. Prenatal testing can be used to identify fetuses with chromosomal abnormalities or genetic mutations that would result in the birth of an affected newborn. Women who experience recurrent miscarriages can be tested to determine if there is a genetic cause; or if their fetuses could not survive due to an inherited disorder. Inherited risk of cancer can be estimated and predicted in order to adjust lifestyle or frequency of testing.

These and other technologies and applications in oncology, rare inherited/ genetic disease, and NIPT molecular diagnostic testing are covered in the report. Segment markets of the technologies are comprehensively covered. The report contains detailed market data on the following IVD segments for their use in molecular testing:

Molecular Diagnostics in Oncology Market by Segment, 2023-2028

• Oncology assays(incl. CDx)
• Colon cancer molecular screen
• ISH/ FISH
• HPV
• CTCs

Molecular Diagnostics Market in Rare Inherited/ Genetic Diseases and NIPT by Segment, 2023-2028

• Prenatal testing - NIPT
• Genetic/inherited disease testing, assays

Regional Market and Forecast

Geographically, North America is the largest market for these areas of testing; but is experiencing slightly lower growth rates than other regions such as APAC and ROW. Ample opportunities exist for participants in the market due to the development of new technologies, changing government regulations and standards, and joint ventures and partnerships. A truly global report, the report provides market sizing and forecast for all regions:

• Asia Pacific Market for Molecular Diagnostics in Oncology, Rare Inherited/ Genetic Diseases and NIPT, 2023-2028
• European Market for Molecular Diagnostics in Oncology, Rare Inherited/ Genetic Diseases and NIPT, 2023-2028
• N. American Market for Molecular Diagnostics in Oncology, Rare Inherited/ Genetic Diseases and NIPT, 2023-2028
• RoW Market for Molecular Diagnostics in Oncology, Rare Inherited/ Genetic Diseases and NIPT, 2023-2028