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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 Regional Forecast, 2023-2030

Region : Global | Format: PDF | Report ID: FBI100657



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The immunology market size was valued at USD 102.41 billion in 2022 and is projected to grow from USD 97.58 billion in 2023 to USD 194.28 billion by 2030, exhibiting a CAGR of 10.3% during 2023-2030. North America dominated the global market with a share of 55.09% in 2022.

Immunology agents or drugs modify the immune response by suppressing or enhancing the immune system. They are deployed to combat infections and prevent or treat certain immunological or autoimmune disorders, such as rheumatoid arthritis, psoriatic arthritis, type 1 diabetes, and others.

The growing awareness of immunological diseases in both developed and developing nations and the increasing prevalence of immunological disorders due to environmental factors are critical reasons for the rising demand for immunological drugs in the market.

  • For instance, according to research published by the Annals of the Rheumatic Diseases in May 2023, the worldwide prevalence of rheumatoid arthritis was approximately 1%, although this figure may vary across various demographic groups.

Moreover, existing players operating in the global market are focusing on upgrading their product portfolio and continuous innovation to improve patient treatment outcomes. This focus is anticipated to propel global market growth over the forecast period.

  • For instance, in November 2021, AbbVie Inc. announced positive results from a phase III clinical trial on risankizumab (SKYRIZI) in psoriatic arthritis.


Key Players’ Robust Efforts Led to Minimal Impact on the Market during COVID-19 Pandemic

The COVID-19 outbreak had a minimal impact on immunology drug sales. Several market players did not report any drop in the sales of products related to this market since pharmaceutical companies significantly improved their supply chain management, R&D capabilities, and increased investment in manufacturing management and quality control.

  • For instance, in 2020, AbbVie Inc. reported a 13.2% increase in sales generated from immunology drugs compared to 2019. Moreover, in 2021, the company witnessed an increase of 14.1% compared to 2020. In 2022, this segment experienced 14.4% growth compared to 2021.

However, a few players, such as Merck & Co., Inc., witnessed a decline in revenues generated from these drugs due to the COVID-19 pandemic. Moreover, the market's sluggish growth can be partially attributed to the loss of patents for blockbuster drugs, postponement of regulatory approvals for new drugs, increased uptake of biosimilars, and delayed or canceled patient visits to hospitals.

In 2022, the market grew at a slower pace compared to 2021. Furthermore, the market is projected to witness a decline in 2023 due to the loss of patent protections for several drugs. However, the increasing uptake of immunology drugs along with rising drug approvals and launches is anticipated to fuel global market growth.


Growing Penetration of Biosimilars to Boost Market Development

The increasing demand for biosimilars, owing to their similar efficiency and lower costs, is significantly driving the uptake of biosimilars in both developed and developing regions. The higher costs of biologics restrict the availability and affordability of drugs to the patient population, especially in developing regions.

  • For instance, Neulasta, a drug manufactured by Amgen to combat infections for chemotherapy patients, costs more than USD 10,000 per ml, whereas its biosimilar, Ziexentzo, costs around USD 6,500 per ml.

Additionally, the number of brands losing exclusivity is rising, which is anticipated to create opportunities for market players to introduce biosimilars to compete with reference drugs in the market.

  • For instance, in February 2021, Viatris Inc. launched Hulio, a biosimilar to adalimumab, in Canada for the same indications as Humira, such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and other disorders.

Moreover, the expected patent expiration of top-selling biological drugs also presents opportunities for key market players to invest in the research and development of biosimilars, thus boosting the market growth.

These are the prominent trends in the global market expected to contribute significantly to market expansion.

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Rising Prevalence of Autoimmune Disorders and Increasing Novel Therapies to Propel Market Growth 

Various environmental factors, including exposure to toxic chemicals, stress, dietary components, gut dysbiosis, and infections, contribute to a large patient pool suffering from autoimmune diseases. Currently, autoimmune diseases represent the third most common cause of chronic illness in the U.S., and around 50 million people suffer from at least one form of autoimmune disease in the country.

  • For instance, according to research published in the journal Current Opinion in Immunology in February 2023, the worldwide incidence and prevalence of autoimmune diseases were 19.1% and 12.5%, respectively.

The increasing demand for these drugs among the patient population is driving market players to develop and launch new drugs in the global market. As a result, the pipeline portfolio of key players in the immunological drugs segment is growing significantly.

  • For instance, in April 2022, there were around 30 pipeline projects at Sanofi in the immunology segment, while Johnson & Johnson Services, Inc. had around 20 pipeline candidates targeting various autoimmune indications such as rheumatoid arthritis, psoriatic arthritis, inflammatory bowel disease, and others.

  • Considering another instance, the introduction of the generic rheumatoid arthritis drug, Leflunomide, in the U.S. by Lupin in September 2020 is expected to be a key driver of immunology market growth during the forecast period.

Additionally, rising awareness of autoimmune disorders in both developed and developing nations, coupled with potential pipeline candidates, is anticipated to boost market growth during the forecast period.


Market Growth Hindered by Elevated Treatment Costs and Product-Related Adverse Effects 

Despite the increasing prevalence of immunological disorders in key regions, factors such as high costs and adverse effects associated with these drugs may restrict market growth during the forecast period. The steep pricing of biologics can be attributed to the substantial investments in research and development, as well as the costly manufacturing facilities necessary for shepherding biologics through clinical trials and FDA approval processes.

  • For instance, according to a 2020 study article published by the National Institutes of Health (NIH), the rate of drug failure during the development stage is higher. About 10-20% of the drugs tested are successful and reach the market, leading to the considerable expense of approximately USD 1-2 billion for the development of new drugs.

Moreover, these medications come with a range of side effects, such as infections, allergic reactions, muscle aches, fever, fast/irregular/pounding heartbeat, and others. Hence, these factors, coupled with restricted reimbursement policies in developing areas, act as impediments to market growth during the forecast period.


By Drug Class Analysis

Monoclonal Antibody Segment to Lead Backed by its Increasing Approvals and Launches

Based on drug class, the global market for immunology is segmented into monoclonal antibody (mAb), fusion proteins, immunosuppressants, and others. The monoclonal antibody (mAb) segment held the dominant share in 2022. This dominance can be credited to monoclonal antibodies' established clinical efficiency in the treatment of chronic and rare conditions, including autoimmune diseases. These antibodies include rituximab and adalimumab. In addition, a higher number of approvals for mAbs for the treatment of various conditions further supports the growth of this segment.

  • For instance, in August 2021, AstraZeneca received approval from the U.S. FDA for the treatment of adult patients with moderate to severe Systemic Lupus Erythematosus (SLE).

The immunosuppressants segment is expected to grow at the highest CAGR during the forecast period. The rapid growth of this segment is attributed to the strong focus on R&D by leading market players to establish an increasing number of regulatory approvals for these drugs. Moreover, the higher treatment effectiveness of immunosuppressants has led to a rapid increase in their usage in developing nations, driving the segment's faster growth rate.

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By Disease Indication Analysis

Rheumatoid Arthritis Segment to Dominate Backed by its Rising Prevalence

Based on disease indication, the market is segmented into psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, inflammatory bowel disease, prophylaxis of organ rejection, rheumatoid arthritis, and others. The rheumatoid arthritis segment held a dominating share in the market in 2022. The growing number of patients availing treatment and the surging prevalence of rheumatoid arthritis will lead to a rise in demand for drugs in the treatment of rheumatoid arthritis.

  • For instance, according to the data published by the Australian Institute of Health and Welfare in 2023, an estimated 456,000 individuals in Australia suffered from rheumatoid arthritis.

On the other hand, limited drug approvals for conditions such as ankylosing spondylitis, inflammatory bowel disease, and others, coupled with the comparatively high cost of currently marketed drugs, limit the adoption of these drugs among the patient population, especially in emerging countries.

By Distribution Channel Analysis

Hospital Pharmacies Segment to Hold the Highest Market Share Owing to Rising Hospitalizations

Based on distribution channel, the market for immunology is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. The hospital pharmacies segment held a substantial share in the global market in 2022. This was due to the increasing number of hospitalizations and physician visits by patients suffering from immunological or autoimmune disorders and the presence of a well-established healthcare infrastructure.

However, the online pharmacies segment is expected to register the highest CAGR during the forecast period. Evolving regulatory policies for online sales of prescription drugs in developed countries, combined with the entry of leading e-pharmacy players in Germany, the U.K., and other countries, are driving a shift in patient preference toward online pharmacies.


Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and the Middle East and Africa.

North America Immunology Market Size, 2022 (USD Billion)

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North America generated revenue of USD 56.42 billion in 2022. The region held a dominant immunology market share and is poised to expand at a significant CAGR during the forecast period. Higher prevalence of chronic diseases, comparatively higher rates of treatment and diagnosis among the U.S. patient population, and the presence of well-established healthcare infrastructure are factors responsible for the region's dominance in the global market.

Europe is estimated to exhibit a significant CAGR during the forecast period due to the growing occurrence of autoimmune conditions and increasing drug approvals in the region.

  • For instance, according to a 2021 article published by the University of London on autoimmune diseases, 7.0% of the U.K., which is around 4.0 million people, suffer from at least one autoimmune condition.

Asia Pacific is poised to grow at the highest CAGR over the forecast period due to the large pool of patients suffering from autoimmune disorders and the increasing demand for preventive care. Moreover, key players are making efforts to secure approvals and launch drugs targeting autoimmune conditions. Such factors are anticipated to augment market growth in the region during the forecast period.

  • For instance, in January 2022, UCB S.A. received marketing authorization from the Japanese Ministry of Health, Labor, and Welfare for BIMZELX to treat plaque psoriasis.

Latin America and the Middle East and Africa are expected to witness slower growth during the forecast period owing to their developing healthcare infrastructure and lack of favorable reimbursement policies. However, growing awareness of treatment options among people and higher demand for the same are expected to surge the demand for these drugs in these regions during the forecast period.


Strong Portfolio and Growth Strategies by Key Players to Improve Business Outcomes

The current market scenario is consolidated with players such as AbbVie Inc., Janssen Global Services, LLC, Amgen, Pfizer, and Novartis AG. These players maintain a strong focus on the research and development of these drugs and strategic acquisition of other domestic players to strengthen their market position.

  • For instance, in February 2022, Pfizer acquired Arena Pharmaceuticals. This clinical-stage company developed innovative potential therapies for treating several immune-inflammatory conditions. This move allowed the company to broaden its therapeutic immunological drug portfolio.

Moreover, other players, such as Astellas Pharma Inc., Merck Sharp & Dohme Corp., and Bristol-Myers Squibb Company, are continuously engaged in developing novel drugs. They also invest in strengthening their global distribution channels to establish their footprints in emerging regions. These are some of the key factors attributable to the rising global market share of these companies.



  • March 2023 - Eli Lilly and Company received approval from the Indian regulatory agency Directorate General of Commercial Intelligence and Statistics (DGCI). This approval allowed them to launch their drug, Copellor, for the treatment of moderate-to-severe plaque psoriasis and also for psoriatic arthritis.

  • June 2022 - Eli Lilly and Company received approval from the U.S. FDA for OLUMIANT as a first-in-disease systemic treatment for adults with severe alopecia areata (AA), an autoimmune disorder.

  • April 2022 – AbbVie Inc. obtained FDA approval for RINVOQ, expanding its treatment options to address active ankylosing spondylitis in adults.

  • March 2022 – AbbVie Inc. received U.S. FDA approval for Rinvoq to treat moderate to severely active ulcerative colitis in adults.

  • March 2022 – Pfizer Inc. enhanced its product offering by acquiring Arena Pharmaceuticals, a company dedicated to developing cutting-edge therapies for various immuno-inflammatory diseases.


An Infographic Representation of Immunology Market

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The market research report provides a detailed market analysis. It focuses on key aspects such as leading companies, drug class, disease indications, and distribution channels. Furthermore, it offers insights into the market dynamics and market trends and highlights key industry developments. In addition to the factors mentioned above, the report encompasses several factors that have contributed to the market's growth in recent years.

Report Scope & Segmentation



Study Period


Base Year


Estimated Year


Forecast Period


Historical Period


Growth Rate

CAGR of 10.3% from 2023-2030


Value (USD Billion)


By Drug Class

  • Monoclonal Antibody

  • Immunosuppressants

  • Fusion Proteins

  • Others

By Disease Indication

  • Rheumatoid Arthritis

  • Psoriatic Arthritis

  • Plaque Psoriasis

  • Ankylosing Spondylitis

  • Inflammatory Bowel Disease

  • Prophylaxis of Organ Rejection

  • Others

By Distribution Channel

  • Hospital Pharmacies

  • Retail Pharmacies

  • Online Pharmacies

By Region

  • North America (By Drug Class, Disease Indication, Distribution Channel, and Country)

    • U.S.

    • Canada

  • Europe (By Drug Class, Disease Indication, Distribution Channel, and Country/Sub-Region)

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

    • Rest of Europe

  • Asia Pacific (By Drug Class, Disease Indication, Distribution Channel, and Country/Sub-Region)

    • China

    • Japan

    • India

    • Australia

    • Southeast Asia

    • Rest of Asia Pacific

  • Latin America (By Drug Class, Disease Indication, Distribution Channel, and Country/Sub-Region)

    • Brazil

    • Mexico

    • Rest of Latin America

  • Middle East & Africa (By Drug Class, Disease Indication, Distribution Channel, and Country/Sub-Region)

    • GCC

    • South Africa

    • Rest of the Middle East & Africa

Frequently Asked Questions

According to Fortune Business Insights, the global market stood at USD 102.41 billion in 2022 and is projected to reach USD 194.28 billion by 2030.

In 2022, the North America market was USD 56.42 billion.

The market will exhibit steady growth at a CAGR of 10.3% during the forecast period (2023-2030).

By drug class, the monoclonal antibody (mAb) segment leads the market.

The increasing prevalence of immunological disorders and the growing demand for biosimilars are the key drivers of the market.

AbbVie Inc., Janssen Global Services, LLC, F. Hoffmann-La Roche Ltd, and Novartis AG are the top players.

North America dominated the global market in 2022.

Growing immunological disorders’ prevalence, robust R&D initiatives, and multiple product approvals are augmenting the product adoption across the globe.

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