Tools commonly used in the In-Vitro/In-Vivo Diagnostic Sbstnc (Manufacturing) industry for day-to-day tasks and operations.

• Chromatography systems
• Mass spectrometers
• Liquid handling systems
• Microplate readers
• Electrophoresis systems
• PCR machines
• Microscopes
• Imaging equipment
• Centrifuges
• Spectrophotometers
• NMR machines
• Flow cytometers
• Microfluidic devices
• Bioreactors
• Freeze dryers
• Lyophilizers
• Autoclaves
• Incubators
• Microarray scanners
• Microtomes

Common products and services typical of NAICS Code 325413-01, illustrating the main business activities and contributions to the market.

• Diagnostic reagents
• Contrast agents
• Radiopharmaceuticals
• Blood glucose test strips
• Pregnancy test kits
• HIV test kits
• Cancer biomarker tests
• Allergy testing kits
• Blood typing reagents
• Coagulation reagents
• Microbial identification kits
• Urine analysis reagents
• Fecal occult blood test kits
• Cardiac marker tests
• Tumor marker tests
• Infectious disease tests
• Genetic testing kits
• Hormone assays
• Immunohistochemistry reagents

The specific certifications, permits, licenses, and regulatory compliance requirements within the United States for this industry.

• Clinical Laboratory Improvement Amendments (CLIA): A set of federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States. The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA).
• Food and Drug Administration (FDA) Registration: In order to manufacture and distribute medical devices, including in vitro diagnostic (IVD) products, in the United States, companies must register with the FDA.
• Good Manufacturing Practice (GMP) Certification: GMP certification ensures that products are consistently produced and controlled according to quality standards. The certification is issued by the International Organization for Standardization (ISO).
• ISO 13485 Certification: ISO 13485 is an international standard that specifies requirements for a quality management system specific to the medical devices industry. The certification is issued by the International Organization for Standardization (ISO).
• Clinical and Laboratory Standards Institute (CLSI) Guidelines: CLSI provides standards and guidelines for medical laboratories and in vitro diagnostic (IVD) manufacturers. Compliance with CLSI guidelines is often required for regulatory approval of IVD products.

A concise historical narrative of NAICS Code 325413-01 covering global milestones and recent developments within the United States.

• The In-Vitro/In-Vivo Diagnostic Sbstnc (Manufacturing) industry has a long history of advancements and milestones. In 1952, Rosalind Franklin discovered the structure of DNA, which led to the development of diagnostic tests for genetic diseases. In 1960, the first enzyme-linked immunosorbent assay (ELISA) was developed, which allowed for the detection of small amounts of antigens or antibodies in a sample. In 1983, the first HIV test was approved by the FDA, which revolutionized the diagnosis and treatment of the disease. In recent history, the industry has seen advancements in personalized medicine, with the development of companion diagnostics that can identify patients who are most likely to benefit from a particular treatment. Additionally, the industry has seen an increase in the use of point-of-care testing, which allows for rapid diagnosis and treatment of patients in remote or underserved areas. In the United States, the In-Vitro/In-Vivo Diagnostic Sbstnc (Manufacturing) industry has seen significant growth in recent years. In 2019, the industry generated $25.5 billion in revenue, up from $22.7 billion in 2015. This growth can be attributed to several factors, including an aging population, an increase in chronic diseases, and advancements in technology. The industry has also seen an increase in mergers and acquisitions, with larger companies acquiring smaller ones to expand their product offerings and increase their market share. Overall, the In-Vitro/In-Vivo Diagnostic Sbstnc (Manufacturing) industry has a rich history of advancements and continues to play a critical role in the diagnosis and treatment of diseases worldwide.

The anticipated future trajectory of the NAICS 325413-01 industry in the USA, offering insights into potential trends, innovations, and challenges expected to shape its landscape.

• Growth Prediction: Growing

  The in-vitro/in-vivo diagnostic substance manufacturing industry in the USA is expected to experience steady growth in the coming years. The increasing prevalence of chronic diseases, such as cancer and diabetes, is driving demand for diagnostic tests, which in turn is fueling growth in the industry. Additionally, the aging population is expected to contribute to the growth of the industry, as older individuals are more likely to require diagnostic tests. Technological advancements in the field of diagnostics, such as the development of point-of-care testing and the use of artificial intelligence, are also expected to drive growth in the industry. However, the industry may face challenges such as regulatory hurdles and competition from alternative diagnostic methods. Overall, the industry is expected to continue to grow in the coming years, driven by increasing demand for diagnostic tests and technological advancements in the field.

Recent groundbreaking advancements and milestones in the In-Vitro/In-Vivo Diagnostic Sbstnc (Manufacturing) industry, reflecting notable innovations that have reshaped its landscape.

• Development Of Liquid Biopsy Tests: Liquid biopsy tests are a non-invasive way to detect cancer by analyzing a patient's blood. This technology has the potential to revolutionize cancer diagnosis and treatment by allowing for earlier detection and more personalized treatment options.
• Use Of Artificial Intelligence In Diagnostics: Artificial intelligence is being used to analyze medical images and other diagnostic data, allowing for more accurate and efficient diagnoses. This technology has the potential to improve patient outcomes and reduce healthcare costs.
• Development Of Point-Of-Care Testing: Point-of-care testing allows for rapid diagnosis of diseases at the point of care, without the need for laboratory testing. This technology has the potential to improve patient outcomes by allowing for earlier diagnosis and treatment.
• Use Of CRISPR Technology In Diagnostics: CRISPR technology is being used to develop highly specific diagnostic tests for a variety of diseases. This technology has the potential to improve the accuracy and efficiency of diagnostic testing.
• Development Of Wearable Diagnostic Devices: Wearable diagnostic devices are being developed to monitor a variety of health parameters, such as heart rate and blood glucose levels. This technology has the potential to improve patient outcomes by allowing for earlier detection and treatment of health issues.