Medical & Imaging Labs

Industry Profile Report

Dive Deep into the industry with a 25+ page industry report (pdf format) including the following chapters

Industry Overview Industry Structure, How Firms Opertate, Industry Trends, Credit Underwriting & Risks, and Industry Forecast.

Call Preparation Quarterly Insight, Call Prep Questions, Industry Terms, and Weblinks.

Financial Insights Working Capital, Capital Financing, Business Valuation, and Financial Benchmarks.

Industry Profile Excerpts

Industry Overview

The 7,500 medical and imaging labs in the US perform analytical and diagnostic services for patients and health care providers. Medical labs provide a variety of testing services, including routine clinical, anatomic pathology, genetic, and esoteric tests. Other types of testing include drug use, risk assessment for life insurance, and dental. Imaging labs provide diagnostic procedures, including x-rays; MRI, CT and PET scans; ultrasound; mammography; nuclear medicine; and fluoroscopy.

Competition from Health Care Providers and Academia

Medical and imaging labs compete with hospitals, clinics, physicians, and universities for services.

Complying With Government Regulation

Medical and imaging labs must be licensed and must adhere to federal and state government regulations which establish technical, operational, personnel and quality requirements.

Industry size & Structure

The average medical and imaging lab employs 37 workers and generates $7-8 million in annual revenue.

    • A typical medical lab operates out of single location, employs 63 workers, and generates about $11 million annually.
    • A typical imaging lab operates out of a single location, employs about 17 workers, and generates about $4.5 million annually.
    • The medical lab industry consists of about 3,300 companies, employs 206,800 workers, and generates about $36 billion annually.
    • The imaging lab industry consists of about 4,200 companies, employs about 72,200 workers, and generates about $19 billion annually.
    • Large medical labs include Laboratory Corporation of America, Quest Diagnostics, and Sonic Healthcare. Large imaging labs include RadNet, Imaging Healthcare Specialists, and Intrinsic Imaging.
                                  Industry Forecast
                                  Medical & Imaging Labs Industry Growth
                                  Source: Vertical IQ and Inforum

                                  Coronavirus Update

                                  Apr 25, 2022 - CMS Waivers Cancelled
                                  • The Centers for Medicare and Medicaid Services (CMS) issued guidance in early April that terminates numerous blanket waivers applicable to skilled nursing facilities (SNFs), inpatient hospices, intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs), and end-stage renal disease (ESRD) facilities. CMS expressed concern “about how residents’ health and safety has been impacted by the regulations that have been waived, and the length of time for which they have been waived.” A CMS waiver of ITM requirements for facility and medical equipment to reduce disruption of patient care and potential exposure/transmission of among those cancelled.
                                  • A federal program that allocated tens of millions of dollars to defray the cost of COVID-19 testing and treatment for the uninsured ended in late March. Health care experts are concerned that uninsured individuals may not seek testing and treatment when exposed or sick because they are worried about the cost, miss the window for prevention therapies, or end up requiring more costly care in the emergency room. The program began in May 2020. It reimbursed hospital, clinics, doctors, laboratories, and other service providers for COVID-19 care of the nation’s uninsured population, which totals about 28 million people.
                                  • The US Supreme Court allowed a vaccine mandate to stand for medical facilities that take Medicare or Medicaid payments. "We agree with the Government that the [Health and Human Services] Secretary's rule falls within the authorities that Congress has conferred upon him," said the majority, writing that the rule "fits neatly within the language of the statute. After all, ensuring that providers take steps to avoid transmitting a dangerous virus to their patients is consistent with the fundamental principle of the medical profession: first, do no harm."
                                  • The US Department of Health and Human Services (HHS) has rolled back a Trump-era policy that had limited Food and Drug Administration (FDA) oversight of lab-developed tests (LDTs), which include a wide range of in vitro diagnostics. Although limited in scope, LDTs have grown in use over the past two decades. The Trump administration revoked what authority the FDA had established over LDTs, including requirements that certain COVID-19 tests go through the agency’s emergency review process. The FDA has also updated its policies for COVID-19 tests including coronavirus LDTs as well as rapid diagnostics for use in home and healthcare settings. The agency said it plans to focus its review efforts on emergency authorization requests for mass-produced at-home and point-of-care tests, including for use with or without a prescription, in addition to certain lab-based, high-throughput diagnostics that can screen samples for multiple diseases at once.
                                  • Federal health officials, testing laboratories, and test makers are weighing how to implement the lessons they have learned from the coronavirus pandemic to prepare for the next one. Two key topics are what types of government incentives could help keep companies prepared to quickly develop tests in the face of a new emergency, and whether to stockpile key testing supplies. Experts are also exploring how test makers can create products that can be used at home to simultaneously screen for flu, COVID, and other common respiratory viruses. The government is working with the diagnostics industry to ensure the gains in domestic manufacturing are not lost over time.
                                  • The US has made progress in its pandemic readiness during the coronavirus outbreak but is not ready for another pandemic, according to Dr. Anne Schuchat of the Centers for Disease Control and Prevention. Schuchat cited " our public-private smorgasbord of clinical laboratories and testing, our regulatory environment for how new lab tests can be rolled out, the public health capacity [being] very weak in terms of ability to get the contact tracing done" as key issues that need to be addressed. "Our health care system was overwhelmed in many places," she added "The supply chain is very interdependent internationally. This was a really complex, systemwide assault."
                                  • Efforts to fix US health system weaknesses that undermined the response to COVID-19 are being impacted by disagreements about how to prepare for future pandemics, according to Bloomberg Law. Some lawmakers are pushing for billions of dollars to upgrade hospitals and data systems, while others want to boost public health funding to revitalize local and state health departments. An early proposal with the potential to affect medical laboratories comes in the Biden administration's infrastructure plan, which would provide $30 billion over four years to increase the public stockpile of medical countermeasures and discover faster ways to develop vaccines, tests, and therapies.
                                  • Medical imaging and imaging analytics tools are gaining wide use to improve detection of COVID-19 infections. A particular focus has been placed on the use of CT scans to identify COVID-19 and accelerate treatment of the disease. The COVID-19 CT Scan Collaborative has been launched as a result to accelerate the use of CT scans for COVID-19 diagnosis and treatment. Partners in the collaborative say that, because new radiology protocols typically take years to develop, this real-time collaboration will help radiologists around the world view anonymized CT scans to improve their results. Research teams that develop the most effective clinical protocol for the use of CT scans in fighting COVID-19 will receive awards from a $1.8 million fund.
                                  • The Food and Drug Administration (FDA) has temporarily relaxed requirements for digital pathology devices to encourage clinicians to review scanned images of slides remotely during the coronavirus pandemic. Greater availability of the digital technology could help reduce pathologists' risk of exposure to the coronavirus and prevent disruptions to critical pathology services, FDA officials said in a COVID-19 guidance document. Pathologists were required to work within clinical laboratories, hospitals and other healthcare settings holding a CLIA license prior to the coronavirus pandemic.
                                  • The Radiological Society of North America has launched its own COVID imaging repository.
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