North America In-Vitro Diagnostics Market
North America is at the forefront of personalized medicine and genomics research. There is increasing integration of genomics and molecular diagnostics into routine patient care. Companies are involved in developing advanced genetics, and companion diagnostics have substantial opportunities for in-vitro diagnostics market. North America particularly the United States and Canada, has been a hub for genomics research centers have contributed to understanding the genetic basis of diseases, identifying biomarkers, and developing targeted therapies. Moreover, the US and Canada have launched precision medicine initiatives to integrate genomics into clinical practices. As the in-vitro diagnostics is widely used for diagnostics or treatment of cancer North America has been a leader in cancer genomics, with extensive research and clinical trials focused in understanding the genetic drivers of various type of cancer. North America hosts numerous clinical trials focused on cancer genomics. These trials aim to evaluate the efficacy of targeted therapies, immunotherapies, and other innovative treatments based on the genomics characteristics of patient’s tumors. American Cancer Society estimates that in the US in 2023, a total of 1.9 million new cancer cases (about 5,370 cases each day) and 609,820 deaths from cancer are expected to occur. The number of new cancer cases per year is expected to rise.
In Addition, the precision medicine initiatives in US and Canada aim to control genomic information and individualized data to provide treatment and preventives measures. Additionally, the generic has become increasingly accessible in North America.
North America In-Vitro Diagnostics Market: Segmental Overview
Based on end user, the market is segmented into hospitals, laboratories, homecare, and others. In 2022, the hospitals segment held the largest share of the market due to an increase in hospitalizations, which need rapid diagnostics. Additionally, it is projected that the continued expansion of the healthcare infrastructure would improve the current hospital facilities. As a result, there is a rising demand for IVD testing performed in hospitals. However, the homecare segment is expected to grow at the fastest rate during the forecast period.
North America In-Vitro Diagnostics Market: Impact of COVID-19 Pandemic
The COVID-19 pandemic led to a huge demand for in-vitro diagnostics and rapid tests. Thus, the demand for RT-PCR procedures, assays, kits, and reagents rose at an exponential pace in 2020 and 2021, as these diagnostic technologies offer results in less time. With this, various companies in the medical industry shifted their focus to developing and commercializing molecular diagnostics and testing solutions. Modifications made by the US FDA in approval procedures in February 2020 resulted in the expedition of the launch of diagnostics solutions. Companies in North America received Emergency Use Authorization (EUA) certificates from the US Food and Drug Administration (FDA). Therefore, more than 70 companies commercialized their serological tests for use in North American countries.
North America In-Vitro Diagnostics Market Analysis: Competitive Landscape and Key Developments
Abbott Laboratories, F. Hoffmann-La Roche Ltd, Danaher Corp, Siemens AG, Sysmex Corp, Thermo Fisher Scientific Inc, Becton Dickinson and Co, bioMerieux SA, Bio-Rad Laboratories Inc, and Qiagen NV are among the key companies operating in the North America in-vitro diagnostics market. The market leaders focus on new product launches, expansion and diversification, and acquisition strategies, which allow them to access prevailing business opportunities.
- In October 2022, Thermo Fisher Scientific showcased its latest innovative research and diagnostic technologies at the 2022 annual meeting and expo of the Association for Molecular Pathology (AMP) that took place at the Phoenix Convention Center from Nov 1 to 5. The solutions on display were designed to address a broad range of disease states and include assays and instruments that leverage real-time and digital PCR and next-generation sequencing (NGS) platforms.
- In October 2022, QIAGEN received CE certification for its leading IVD kit and fully automated NeuMoDx platforms under the European Union’s new In-Vitro Diagnostic Medical Devices Regulation (IVDR), replacing the previous IVDD rules.
- In October 2021, Bio-Rad Laboratories, Inc. launched the CFX Opus 96 Dx System and the CFX Opus 384 Dx System, real-time PCR detection systems listed with the U.S. FDA for IVD testing that meet the CE-IVD requirement. Both systems are registered with regulatory bodies for IVD use in Singapore and Canada.
- In March 2021, QIAGEN launched the QIAcube Connect MDx, a flexible platform for automated sample processing available to molecular diagnostic laboratories in the US and Canada, the European Union, and other markets worldwide. QIAcube Connect MDx is an enhanced instrument from the QIAcube product line for IVD applications that test samples taken from the human body.
