U.S. Immunology Market Size, Share & COVID-19 Impact Analysis, By Drug Class (Monoclonal Antibody (mAb), Fusion Proteins, Immunosuppressants, and Others), By Disease Indication (Rheumatoid Arthritis, Psoriatic Arthritis, Plaque Psoriasis, Ankylosing Spondylitis, Inflammatory Bowel Disease, Prophylaxis of Organ Rejection, and Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and Country Forecast, 2023-2030

The U.S. immunology market size was worth USD 51.84 billion in 2022 and is projected to grow at a CAGR of 10.3% during the forecast period.

In the U.S., there is a significant rise in the cases of Autoimmune Disease (AD) cases among the population. The growing prevalence rate of these diseases is eventually increasing the demand for immunology drugs. Also, the rising initiatives by key players to launch new drugs and biosimilars to promote market growth.

• For instance, as per the National Institutes for Health (NIH) article in 2020, autoimmune diseases are rare, however they collectively affect 5.0% to 8.0% of the U.S. population.

Similarly, increased awareness and developed healthcare infrastructure are contributing to the expansion of the U.S. immunology market.

The COVID-19 pandemic had a slight negative impact on the market’s growth due to multiple disturbances in the supply chain and limited visits to healthcare professionals.

U.S. Immunology Market Trends

Introduction of Biosimilars by Major Players

One of the most prominent trends witnessed in the U.S. market for immunology is the introduction of biosimilars. Biosimilar products are efficient and cost-effective. Also, the majority of immunological drugs have patent expiry issues in the U.S. Therefore, the intense need for such products has increased the focus on various market players to gain U.S. FDA approval for multiple indications.

• For example, in March 2023, Sandoz received the U.S. Food and Drug Administration (FDA) approval for a citrate-free High-Concentration Formulation (HCF) of biosimilar Hyrimoz (adalimumab-adaz) injection.

U.S. Immunology Market Growth Factors

Surge in Cases of Autoimmune Disorders to Augment Market Growth

Autoimmune disorders are the most common type of disease in the U.S. The prevalence of these diseases has increased significantly over the last few decades due to several factors, including obesity, lifestyle, infection, and genetics. There are 80-100 known autoimmune and autoimmune-related conditions, including Hashimoto’s thyroiditis, Type 1 diabetes, Sjögren’s, and celiac disease. This dramatic increase in prevalence is significantly increasing the demand for products in the immunology market.

• For instance, according to the Centers for Disease Control’s (CDC) National Diabetes Statistics Report 2022, it is estimated that there are a total of 37.3 million cases of diabetes in the U.S.

Due to the high prevalence of autoimmune diseases, there is a high demand for various immunological drugs. In addition, this has prompted many pharmaceutical companies to participate in clinical trials to develop safe and efficient drugs for the treatment of these diseases. Also, some of the companies have reported a number of successful clinical trials. Thus, the immunology market in the U.S. is expected to experience a strong CAGR during the forecast period.

According to an article published by the Global Autoimmune Institute, in 2022, approximately 14.0 million people were affected by autoimmune diseases in the U.S.

RESTRAINING FACTORS

Side Effects and High Cost Associated with Immunology Drugs Restrict Market Expansion

Despite the robust application of these drugs, certain limiting factors are anticipated to hamper the immunology market growth during the forecast period. Several side effects associated with immunological products significantly limit the market's growth prospects. The possible adverse effects of these drugs include breathing problems, blood in the urine or dark urine, pain, swelling, or weakness in muscles or joints, swollen lymph nodes, diarrhea, constipation, and enlarged spleen or liver.

Similarly, immunological drugs and biologics require high-cost manufacturing facilities and large R&D investments for clinical trials and the regulatory approval processes of the U.S. FDA. Also, immunotherapy is very costly in most chronic disease treatments. Such high costs associated with immunological drugs and several side effects are limiting the U.S. immunology market growth.

• For instance, as per the American Cancer Society Cancer Action Network 2020, out-of-pocket costs for cancer treatments in the U.S. were USD 5.6 billion in 2018.

U.S. Immunology Market Segmentation Analysis

By Drug Class Analysis

By drug class, the market is segmented into fusion proteins, immunosuppressants, monoclonal antibody (mAb), and others.

The monoclonal antibody (mAb) segment held the largest of the U.S. immunology market share in 2022. The monoclonal antibody (mAb) is majorly used to treat cancer and infectious viral and bacterial diseases. This drug type provides targeted therapy with fewer side effects and more specificity. Such robust benefits of these drugs are expected to propel their adoption of advanced immunology drugs in the market.

Also, multiple players are focusing on FDA approvals and have numerous drugs in their product pipeline. Such strong product demand is expected to foster segmental growth during the forecast period.

• For instance, one of the major players, UCB S.A., has dapirolizumab pegol (anti-CD40L antibody) drug in its pipeline for immunology. Its topline results will be published in H1 2024.

By Disease Indication Analysis

By disease indication, the market can be categorized into inflammatory bowel disease, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, prophylaxis of organ rejection, and others.

The rheumatoid arthritis segment dominated the market in 2022. As the number of rheumatoid arthritis cases increases significantly, an intensive need for efficient treatment is expected to drive the growth of the segment during the forecast period.

• As per the statistics published by the Cleveland Clinic in 2022, about 1.3 million people in the U.S. have rheumatoid arthritis.

By Distribution Channel Analysis

Based on distribution channel, the market is segmented into retail pharmacies, online pharmacies, and hospital pharmacies.

The hospital pharmacies segment held a major share in 2022. The growth rate of this segment is attributed to the large patient population at hospitals for the diagnosis and treatment of several autoimmune disorders. Also, robust healthcare infrastructure and healthcare expenditure are expected to promote segmental growth.

List of Key Companies in U.S. Immunology Market

The competitive landscape of the U.S. immunology market portrays a consolidated nature. The market is dominated by some of the major players, including Amgen, Novartis AG, AbbVie Inc., Pfizer, and Johnson & Johnson Services, Inc. These players hold a major portion of the U.S. market.  The dominance of these players is attributed to robust R&D initiatives and strategic activities to further bolster their market presence. Similarly, Astellas Pharma Inc., Merck Sharp & Dohme Corp., and Bristol-Myers Squibb Company are continuously focusing on developing their pharmaceutical pipelines and expanding their distribution network to gain suitable immunology market share.

LIST OF KEY COMPANIES PROFILED:

• AbbVie, Inc. (U.S.)


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


• Eli Lilly and Company (U.S.)


• Novartis AG (Switzerland)


• Merck Sharp & Dohme Corp. (U.S.)


• Pfizer Inc. (U.S.)


• Astellas Pharma Inc. (Japan)


• UCB SA (Belgium)


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


• Amgen Inc. (U.S.)


• Bristol-Myers Squibb Company (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• August 2023: Regeneron Pharmaceuticals, Inc. received the U.S. Food and Drug Administration (FDA) approval for Veopoz (pozelimab-bbfg) to treat adult and pediatric patients one year of age and older with CHAPLE disease.


• May 2023: Celltrion USA announced the U.S. FDA approval of Yuflyma (adalimumab-aaty),A high-concentration and citrate-free formulation of Humira (adalimumab) biosimilar.


• May 2021: Bristol Myers Squibb Company announced that they received the U.S. FDA approval for Zeposia (ozanimod) 0.92 mg for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD).

REPORT COVERAGE

The U.S. immunology market research report provides a comprehensive analysis of the market. It provides a detailed analysis of the market forecast of various segments, including the drug class, disease indications, and distribution channels. It also highlights insights on the prevalence of the key disease indications, key industry developments, new product launches, and the impact of the COVID-19 pandemic on the U.S. market. Additionally, it encompasses market dynamics, company profiles, and multiple other factors promoting market growth.

Report Scope & Segmentation