U.S. Biopharmaceuticals Market Size, Share & COVID-19 Impact Analysis, By Type (Immunomodulators {Monoclonal Antibodies, Cytokines and Others}, Enzymes {Hydrolases, Lyases and Others}, Vaccines {Recombinant Vaccines/Conjugate/Subunit, Inactivated, Live Attenuated, and Toxoid}, Hormones {Human Growth Hormones, Insulin and Others}, and Others), By Application (Cardiology, Oncology, Respiratory and Others), By Distribution Channel (Hospital Pharmacies, Drug Stores & Retail Pharmacies, and Online Pharmacies), and Country Forecast, 2023-2030

The U.S. biopharmaceuticals market size was worth USD 185.89 billion in 2022 and is projected to grow at a CAGR of 8.5% during the forecast period. 

Biopharmaceuticals are medicines manufactured from the cells of a living organism. These drugs are created by the genetic engineering of bacteria, fungi, and plants to create human proteins or by the insertion and expression of animal genes. The penetration and adoption of these drugs are increasing across the country owing to the rising demand for advanced treatment regimes for a wide range of chronic and rare diseases. The growing prevalence of chronic illnesses and rising awareness about the available treatment options among the patient population are contributing to the growing consumption of biopharmaceuticals across the country.

• According to the Centers for Disease Control and Prevention (CDC), six in ten adults in the U.S. are living with at least one chronic disease, such as cardiovascular disease, cancer, or diabetes.

Moreover, the active investments made by market players to get regulatory approvals for multiple indications, coupled with the introduction of technologically advanced products, are likely to propel the sales of biopharmaceuticals during the forecast period. Thus, a huge population of patients with unmet needs is encouraging manufacturers to actively invest in research and development activities to expand the treatment options for these diseases.

The outbreak of the COVID-19 pandemic positively impacted the U.S. market growth due to increased regulatory approvals for various drugs and strong sales performance of certain products.

U.S. Biopharmaceuticals Market Trends

Growing Emphasis on Monoclonal Antibody-based Therapeutics

One of the prevailing trends witnessed in the U.S. market is the growing focus of market players on revolutionizing medical treatments by exploiting the immune system against chronic diseases. For instance, the application of monoclonal antibodies (mAbs) as an important immunotherapeutic agent is growing along with its clinical significance in treating ailments, such as allergies, neurodegenerative disorders, autoimmune diseases, infectious diseases, and cancer. To ensure target delivery, monoclonal antibodies are cultured from naturally occurring antibodies with target-specific epitopes. Antibodies can also be prepared to eliminate specific pathogens by modulating the immune function through altering certain pathways. The benefits offered in terms of manufacturing and efficacy in treating a wide range of conditions are influencing market players to make strategic alliances to expand their product ranges.

• For instance, in August 2023, the Biomedical Advanced Research and Development Authority (BARDA) signed an agreement with Regeneron Pharmaceuticals Inc. The agreement was made to support the company in the clinical development of and regulatory licensure process for the next-generation COVID-19 monoclonal antibody therapies indicated as a prevention measure against the SARS-CoV-2 infection.

U.S. Biopharmaceuticals Market Growth Factors

Rising Prevalence of Chronic Diseases to Drive Demand for Biopharmaceuticals

The market in the U.S. is projected to experience notable growth due to the rising prevalence of chronic diseases, such as cancer, diabetes, and heart disease, as well as growth in the country’s ageing population. The market’s growth is expected to be further supported by the increasing acceptance of biopharmaceuticals by the patient population, who are becoming increasingly aware of the effectiveness and availability of biopharmaceuticals. Moreover, the increasing expenditure in the healthcare sector is expected to drive the demand.

• For instance, the Pharmaceutical Research and Manufacturers of America (PhRMA) represents leading biotech companies in the U.S. The research and development expenditure made by its members reached around USD 101 billion in 2022.

According to the Multiple Sclerosis Association of America, there were nearly one million individuals living with multiple sclerosis in the U.S., as per a research article published in 2022.

RESTRAINING FACTORS

Availability of Drugs at High-Cost May Limit Market Growth

One of the main factors limiting the consumption of biopharmaceuticals is the high cost of biopharmaceutical medications, which needs to be significantly reduced to make them commercially viable for patients. Furthermore, a substantial investment is required to create biopharmaceutical products as drug failures and the waste of investments in research and development may prevent the market players from investing, which is likely to impede the growth of this market during the forecast period. Furthermore, the high cost of biomedical research and treatment may prevent the patient population from opting for these treatment regimes due to their low disposable incomes, thus limiting the market's development.

• For example, a full course of a mAb used for treating multiple sclerosis, such as Campath (Alemtuzumab), costs upto USD 60,000 according to a study published in the Antibodies Journal in 2023. Furthermore, it stated that the most therapeutic mAbs are administered intravenously in a hospital setting and to maintain efficacy, repeated administrations of these antibodies are typically required. This can increase a patient’s economic burden as these therapies are quite costly. This factor may cause a major decline in the preference for this treatment, which may hamper the demand for these drugs, therefore limiting the U.S. biopharmaceuticals market growth during the forecast period.

U.S. Biopharmaceuticals Market Segmentation Analysis

By Type Analysis

By type, the market is segmented into hormones, immunomodulators, vaccines, enzymes, and others.

The immunomodulators segment dominated the U.S. market in 2022. The segment’s dominance is largely driven by the increasing number of monoclonal antibodies being approved for multiple indications across the country. The segment’s growth is also attributed to the strong sales performance of established drugs belonging to the cytokines and interferons categories.

• As of December 2022, the U.S. FDA had approved 153 therapeutic monoclonal antibodies, of which 20 were approved for hematological cancer and 39 for solid tumors.

By Application Analysis

In terms of application, the market is segmented into respiratory, cardiology, neurology, oncology, immunology, and others.

The oncology segment accounted for the largest U.S. biopharmaceuticals market share in 2022. The growing adoption of these drugs for the treatment of various cancers is one of the critical factors contributing to the segment’s growth. In addition to this, a large number of companies are increasing their investments to expand their product offerings for the treatment of various cancers. The increasing prevalence of cancer and high unmet needs of patients are some of the factors likely to augment the segment’s growth.

• According to the National Cancer Institute 2023 data, the most common type of cancer in the U.S. is breast cancer, followed by prostate and lung cancer. As per its annual incidence estimates, 300,590 new cases of breast cancer are expected in the U.S. in 2023.

By Distribution Channel Analysis

In terms of distribution channel, the market is segmented into hospital pharmacies, drug stores & retail pharmacies, and online pharmacies.

The hospital pharmacies segment held a major market share in 2022. Most of the drugs categorized under biopharmaceuticals are to be administered under the guidance of a trained medical professional, which will favor the segment’s growth. In addition to this, the growing healthcare expenditure for optimizing hospital pharmacies to ease the procurement process in these settings, coupled with reimbursements offered at these settings, are some of the key factors likely to propel the segment’s growth.

• According to a study published by the American Journal of Health-System Pharmacy in 2022, in 2021, the drug expenditures in the U.S. were USD 39.6 billion (an 8.4% increase from 2020) and USD 105 billion (a 7.7% increase from 2020) in non-federal hospitals and clinics, respectively.

List of Key U.S. Biopharmaceuticals Market Companies

The U.S. market is highly competitive, with market players, such as Pfizer Inc., AbbVie Inc., and Merck & Co., Inc. holding leading positions in 2022. Pfizer and AbbVie hold an apex position in the market due to the strong sales performance of their approved products, such as Comirnaty and Humira, respectively. The companies are focused on expanding their product indications for various applications. Merck & Co., Inc. has also established its presence in the market with its star monoclonal antibody product named Keytruda, which is largely used in oncology therapy.

Some other key players with a substantial presence in the market include Johnson & Johnson, Bristol-Myers Squibb Company, F. Hoffmann-La Roche Ltd., Novartis AG, and others. These companies are actively investing in R&D to expand the application of biopharmaceuticals in various areas. Some of the emerging players in this market are Moderna, Biogen, Vertex Pharmaceuticals, and others. These companies are expanding their footprint in the neurology and respiratory therapeutic categories.

LIST OF KEY COMPANIES PROFILED:

• Pfizer Inc. (U.S.)


• AbbVie Inc. (U.S.)


• Bristol-Myers Squibb Company (U.S.)


• Johnson & Johnson Services, Inc. (U.S.)


• Bayer AG (Germany)


• Lilly (U.S.)


• Sanofi (France)


• Merck & Co., Inc. (U.S.)


• F. Hoffmann-La Roche Ltd. (Switzerland)


• Novartis AG (Switzerland)


• GSK plc (U.K.)


• Takeda Pharmaceutical Company Limited. (Japan)

KEY INDUSTRY DEVELOPMENTS:

• September 2023 – Amgen Inc. is anticipated to acquire Horizon Therapeutics by the fourth quarter of 2023 with an intention to serve patients around the world suffering from rare diseases.


• August 2023 – Pfizer Inc. received the U.S. FDA accelerated approval for its new product ELREXFIO (elranatamab-bcmm). The product is under clinical trial for the treatment of adult patients suffering from Relapsed or Refractory Multiple Myeloma (RRMM).


• July 2023 – AstraZeneca and Sanofi’s Beyfortus (nirsevimab) received approval from the U.S. FDA for the prevention of Respiratory Syncytial Virus (RSV) and Lower Respiratory Tract Disease (LRTD) in newborns and infants.

REPORT COVERAGE

The report provides a detailed analysis of the market. It focuses on key aspects, such as the prevalence of chronic diseases in the U.S. and pipeline analysis. In addition, it includes an overview of the technological developments, key industry developments, and the impact of the COVID-19 pandemic on the market. Besides this, the report also offers insights into the latest market trends and highlights key industry dynamics. It further encompasses several factors that have contributed to the growth of the market in recent years.

Report Scope & Segmentation