In the United States, Cancer is a leading cause of death that can be detected early because of molecular diagnostic tests. This is why the molecular diagnostics is the primary growth driver for this market. United States molecular diagnostics market is anticipated to cross US$ 9 billion by the end of year 2024.
Utilization of molecular diagnostics which help to reduce healthcare costs for patients by avoiding unnecessary drugs, medical care, and chemotherapy. It is also useful to detect cancer biomarkers to improve the survival rate of patients. The capability of molecular diagnostics to authenticate cancer biomarkers and improve patient care will lead to the growth of this market during the projected period.
Presently, in the field of medical diagnostics, molecular diagnostics for cancer test offers one of the key areas for innovation and expansion. Molecular oncology tests have emerged as a substantial market segment. The United States leads the regional market for blood screening and blood products. Molecular diagnostics is also a significant tool for Food Pathogen Detection Testing and HLA Testing as well as other diseases.
Characterization & Application of the United State Molecular Diagnostics Market
The United States molecular diagnostics market based on application; the market is broadly characterized into Oncology Test, Infectious diseases, Genetic tests. The Oncology molecular diagnostics market is determined by technological advancements, growing prevalence of cancer, and rising focus on personalized medicine.
In the current scenario diagnostics market, molecular diagnostics for infectious disease test offers one of the dazzling areas for innovation and growth. The most prevailing and profitable sector is expected to continue to rise in Infectious diseases. The innovations in molecular technologies continue to improve and grow and also reduce the time span it takes to diagnose infectious disease. Showcasing the rising technologies from both research laboratories and clinical, the Molecular Diagnostics for Infectious Disease conference is now in its ninth year in Washington, DC.
A new diagnostic approach that may considerably change the practice of medicine is the expansions in genomics and proteomics. Recognize genetic and chromosomal variations that are related to disease or risk states are Genetic test. Molecular diagnostics are multifaceted laboratory techniques that analyze and identify biomarkers, genetic sequences, metabolites and other molecules. Helping patients and their doctors identify individuals with a susceptibility to a particular disease, identify whether the patients have a disease at earlier stages of illness, evaluate the efficiency of an exacting drug therapy for an individual and describes the accurate nature of a disease.
Oncology Test has been classified into four main categories: Breast Cancer Test, Colorectal Cancer Test, Prostate Cancer Test and Other Cancer Test. Infectious Disease Test has been classified into four main categories, namely, Virology, HAI, HPV and Critical Care Test and Genetic Test has been segmented into Blood Screening, HLA and Food Pathogen Test. Genetic test drives all way ahead from Infectious and Oncology Test owing to Food Pathogen Test Volume. Breast cancer is dominating the market share of Oncology Test and Virology leads all other segments of share in the Infectious test market.
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United State Molecular diagnostics Market: Reimbursement policy
United States reimbursement policy is a considerable determinant for commercial success in the molecular diagnostics market. Physicians more often than not adopt a diagnostic regardless of its clinical validity due to lack of sufficient reimbursement. Proper reimbursement emphasizes on to the payers choice to cover the diagnostics and the reimbursement that they provide. A diagnostics for reimbursement by Centers for Medicare and Medicaid Services (CMS) for Medical health, Medicaid, and Veteran patients is the most important reimbursement function. The main insurer in the United State is (CMS) Centers for Medicare and Medicaid Services, and many payers follow its reimbursement decisions. In recent times, the legislation was proposed (Medicare Advanced Laboratory Diagnostics Act of 2007) to develop the reimbursement process for molecular diagnostics in the United States.
Challenges in the United States Molecular Diagnostics Market
• Reimbursement Capabilities
Without sufficient reimbursement, physicians generally will not adopt a diagnostic regardless of its clinical validity. Sufficient reimbursement depends on whether or not payors choose to cover the diagnostic and the level of reimbursement that they offer.
• Regulatory Issues
The regulatory environment is a vital modulating factor for the pharmaceutical and diagnostics industry. One of the other key constraints on the successful and widespread adoption of the novel diagnostic tools involves government regulation of molecular diagnostic assays.
• Quality Checkpoints, Awareness & Acceptance
Methodologies are changed rapidly, making it difficult for the companies to develop standard materials to maintain the quality of the tests. Given the expense of the tests and materials, various laboratories have been less willing to pay more for the controls. Quality is developed only after new tests are implemented and are standardized.
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