NAICS Code 541715-06 - Pharmaceutical Research Laboratories

Marketing Level - NAICS 8-Digit

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NAICS Code 541715-06 Description (8-Digit)

Pharmaceutical Research Laboratories are companies that conduct research and development activities related to the creation of new drugs and medicines. These laboratories are responsible for discovering and developing new drugs, testing their safety and efficacy, and obtaining regulatory approval for their use. The work of pharmaceutical research laboratories is critical to the healthcare industry, as it leads to the development of new treatments for a range of diseases and conditions.

Tools

Tools commonly used in the Pharmaceutical Research Laboratories industry for day-to-day tasks and operations.

  • High-performance liquid chromatography (HPLC)
  • Mass spectrometry (MS)
  • Nuclear magnetic resonance (NMR) spectroscopy
  • Gas chromatography (GC)
  • Infrared (IR) spectroscopy
  • Ultraviolet-visible (UV-Vis) spectroscopy
  • X-ray crystallography
  • Differential scanning calorimetry (DSC)
  • Dynamic light scattering (DLS)
  • Surface plasmon resonance (SPR)
  • Isothermal titration calorimetry (ITC)
  • Circular dichroism (CD) spectroscopy
  • Fluorescence spectroscopy
  • Electrophoresis
  • Polymerase chain reaction (PCR)
  • Microarray technology
  • Next-generation sequencing (NGS)
  • Cell culture systems
  • Animal models

Industry Examples of Pharmaceutical Research Laboratories

Common products and services typical of NAICS Code 541715-06, illustrating the main business activities and contributions to the market.

  • Drug discovery
  • Preclinical research
  • Clinical trials
  • Pharmacology
  • Toxicology
  • Formulation development
  • Analytical testing
  • Quality control
  • Regulatory affairs
  • Medical writing

Certifications, Compliance and Licenses for NAICS Code 541715-06 - Pharmaceutical Research Laboratories

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

  • Good Laboratory Practice (GLP): GLP is a quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived, and reported. The US FDA provides GLP certification.
  • Current Good Manufacturing Practice (Cgmp): cGMP is a set of regulations enforced by the FDA to ensure that pharmaceutical products are safe, pure, and effective. The FDA provides cGMP certification.
  • Clinical Laboratory Improvement Amendments (CLIA): CLIA regulates laboratory testing and requires clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
  • International Organization for Standardization (ISO) 9001:2015: ISO 9001:2015 is a quality management system standard that helps organizations ensure they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service.
  • International Conference on Harmonisation (ICH) Guidelines: ICH guidelines are a set of international standards for the development, registration, and post-approval of pharmaceutical products. The guidelines are developed by the ICH, which is a joint initiative between regulatory authorities and the pharmaceutical industry.

History

A concise historical narrative of NAICS Code 541715-06 covering global milestones and recent developments within the United States.

  • The Pharmaceutical Research Laboratories industry has a long and rich history dating back to the 19th century. In 1856, William R. Warner founded Warner & Company, which later became Warner-Lambert, one of the largest pharmaceutical companies in the world. In 1898, Felix Hoffmann, a chemist at Bayer, synthesized aspirin, which became one of the most widely used drugs in the world. In the 20th century, the industry saw significant advancements, including the discovery of penicillin in 1928 by Alexander Fleming, the development of the first oral contraceptive in 1960, and the introduction of the first statin drug in 1987. In recent years, the industry has focused on developing new treatments for diseases such as cancer, Alzheimer's, and HIV/AIDS. In the United States, the Pharmaceutical Research Laboratories industry has a more recent history. In the 1950s and 1960s, the industry experienced significant growth due to the introduction of new drugs such as antibiotics and corticosteroids. In the 1980s and 1990s, the industry saw a shift towards biotechnology and the development of new drugs such as monoclonal antibodies and gene therapies. In the 21st century, the industry has continued to innovate, with the development of new treatments for diseases such as hepatitis C and cancer. The industry has also faced challenges such as increasing competition from generic drugs and rising healthcare costs. Overall, the Pharmaceutical Research Laboratories industry has a rich history of innovation and advancement, and it continues to play a critical role in improving human health.

Future Outlook for Pharmaceutical Research Laboratories

The anticipated future trajectory of the NAICS 541715-06 industry in the USA, offering insights into potential trends, innovations, and challenges expected to shape its landscape.

  • Growth Prediction: Growing

    The pharmaceutical research laboratories industry in the USA is expected to grow in the coming years due to the increasing demand for new and innovative drugs. The industry is expected to benefit from the aging population, which will require more medical attention and new treatments. Additionally, the industry is expected to benefit from the increasing prevalence of chronic diseases such as cancer, diabetes, and heart disease. The industry is also expected to benefit from the increasing investment in research and development by pharmaceutical companies. However, the industry is also expected to face challenges such as increasing competition, regulatory hurdles, and rising costs. Overall, the industry is expected to grow steadily in the coming years.

Industry Innovations for NAICS Code 541715-06

Recent groundbreaking advancements and milestones in the Pharmaceutical Research Laboratories industry, reflecting notable innovations that have reshaped its landscape.

  • Development Of New Cancer Treatments: Pharmaceutical research laboratories have made significant progress in the development of new cancer treatments, including immunotherapies and targeted therapies. These treatments have shown promising results in clinical trials and are expected to improve the survival rates of cancer patients.
  • Gene Therapy: Pharmaceutical research laboratories have made significant progress in the development of gene therapies, which have the potential to cure genetic diseases such as cystic fibrosis and sickle cell anemia. These therapies involve the insertion of a healthy gene into the patient's cells to replace a defective gene.
  • Development Of New Vaccines: Pharmaceutical research laboratories have made significant progress in the development of new vaccines, including vaccines for COVID-19. These vaccines have been developed in record time and have shown high efficacy rates in clinical trials.
  • Artificial Intelligence In Drug Discovery: Pharmaceutical research laboratories are increasingly using artificial intelligence to accelerate the drug discovery process. AI algorithms can analyze large amounts of data and identify potential drug candidates more quickly and accurately than humans.
  • Development Of New Treatments for Rare Diseases: Pharmaceutical research laboratories are increasingly focusing on the development of treatments for rare diseases, which affect a small percentage of the population. These treatments are often expensive to develop and may require special regulatory approval, but they can be life-changing for patients with rare diseases.

NAICS Code 541715-06 - Pharmaceutical Research Laboratories

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