Pharmaceutical Manufacturers

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 1,900 pharmaceutical manufacturers in the US are engaged in researching, developing, manufacturing and marketing chemically-derived drugs and biologicals for human or veterinary use. A few large, multinational firms dominate the industry; but there are also a large number of smaller start-up or development firms, particularly in the biotech segment.

Competition From Generic Products

Branded prescription drugs face competitive challenges from generic pharmaceutical manufacturers.

Expanded Managed Care Influence

Managed Care Organizations (MCOs), Medicaid, and other government agencies continue to seek price discounts on or increased rebates for pharmaceuticals.

Industry size & Structure

An average pharmaceutical manufacturer generates about $118 million in annual revenue and has about 159 employees.

    • The pharmaceutical manufacturing industry consists of about 1,900 companies with $233 billion in sales and 312,600 employees.
    • A few large, multinational firms dominate the industry, but there is also a large number of smaller, start-up, or development firms, particularly in the biotech segment.
    • Large pharmaceutical manufacturers include Pfizer, Merck, Johnson & Johnson, Eli Lilly, and Bristol-Myers Squibb.
    • The states with the highest number of pharmaceutical manufacturers are California, New Jersey, New York, Florida and Texas.
    • The largest concentration of biotech firms are in California, Texas, Pennsylvania, Massachusetts, and Wisconsin.
                                      Industry Forecast
                                      Pharmaceutical Manufacturers Industry Growth
                                      Source: Vertical IQ and Inforum

                                      Coronavirus Update

                                      May 8, 2022 - Use of J&J Vaccine Limited By FDA
                                      • The US Food and Drug Administration (FDA) revised its emergency authorization to sharply limit the use of Johnson & Johnson's COVID-19 vaccine due to a rare but potentially fatal blood clotting condition called thrombosis with thrombocytopenia syndrome (TTS). Only individuals who are 18 years of age and older who "would otherwise not receive a COVID-19 vaccine" due to availability or their choice should now take Johnson & Johnson's one-shot regiment. Health officials have confirmed 60 cases of TTS following Johnson & Johnson's vaccine, nine of which have been fatal. Women between the ages of 30 and 49 are most vulnerable to the blood clotting disorder, according to the Centers for Disease Control and Prevention.
                                      • The coronavirus responsible for causing COVID-19 remains volatile and unpredictable, which makes it difficult to predict the features of the next variant. Pharmaceutical manufacturers may benefit if vaccine and treatment formulations must be modified as a result. Many experts say that no evidence so far conclusively indicates whether the next variant is likely to be weaker or to have greater vaccine resistance. Low levels of vaccination, declining immunity without boosters, and vaccine inequity in a globalized world could increase transmission and aid viral mutations. Dr. Semih Tareen, a virologist and senior director of gene therapy at Sana Biotechnology, said that the biggest challenge right now is vaccine inequity.
                                      • People who test positive for COVID-19 would be eligible for a free course of antiviral medicine under a “test to treat” program announced by President Biden. The proposal has been hailed as a potential breakthrough by some doctors, who say it will make it far easier for people at heightened risk of severe disease to get the lifesaving drugs quickly — especially for those who don’t have regular doctors. But the American Medical Association is critical of the plan, saying that prescribing decisions should be made “under the guidance and supervision of physicians with expertise to deal with complex medications.”
                                      • A deal has been reached to give poorer nations greater access to pharmaceutical manufacturer Merck's antiviral COVID-19 pill molnupiravir. The pill can be taken at home following a positive test for COVID-19 to avoid major complications and hospitalization. Merck will allow production by other companies during the pandemic and won’t receive royalties from the sale of the low-cost version during the pandemic. A molnupiravir course of 40 pills for five days is expected to cost about $20 in poorer nations, an official involved in the talks with drug makers told Reuters news service. That is far below the $700 per course that the US agreed to pay for an initial delivery of 1.7 million courses. The official cited initial estimates from drug makers, which are subject to change. The agreement allows 27 drug makers from India, China, Africa, Asia, and the Middle East to produce ingredients and the finished drug.
                                      • The two antiviral pills were approved in late December 2021 to combat COVID-19 infections in the early stages, but many experts say that they are unlikely to be widely available soon enough to make an immediate dent in a wave of cases driven by the highly infectious omicron variant. Both Pfizer’s Paxlovid and the less effective molnupiravir made by Merck can be taken at home to ward off serious disease and avoid hospitalization and major complications. The limited supply of pills is first slated to go toward those most likely to suffer grave consequences from an infection, such as people who are elderly and those with underlying conditions like obesity or diabetes.
                                      • About 55% of Americans became more worried about drug affordability during the pandemic, according to research findings cited by insurance industry advocacy group America’s Health Insurance Plans. The group is using these findings and more in its push for federal legislation that would lower prescription drug prices. An immediate goal is legislation aimed at lowering prescription drug prices by limiting deals between name brand and generic manufacturers in which brand drug makers compensate generics for allowing an agreed-upon amount of time to elapse before they enter the market. These types of settlements are called pay-for-delay deals.
                                      • Many drug manufacturing facility inspections have been postponed due to the coronavirus pandemic. Some industry experts say that the inspection backlog is delaying new drug approvals and is leading industry stakeholders to warn of impending shortages of existing medicines. FDA officials denied that the dramatic drop in inspections has slowed drug approvals, according to The New York Times. Several drug manufacturers, including Spectrum Pharmaceuticals, Biocon Biologics, and Bristol Myers Squibb, have issued statements noting deferred FDA action regarding drug approvals because of the agency’s inability to conduct inspections.
                                      • Companies like Pfizer and Moderna have immunity from liability for adverse outcomes related to their COVID-19 vaccines. The Food and Drug Administration can't be held liable for authorizing a vaccine for emergency use, nor can firms that mandate inoculation as a condition of employment. Immunity from liability comes from the Public Readiness and Emergency Preparedness Act. The 2005 law empowers the Department of Health and Human Services secretary to provide legal protection to companies making or distributing critical medical supplies, such as vaccines and treatments, unless there's "willful misconduct" by the company. The protection lasts until 2024.
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