Immunology Market Size, Share & Industry 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, 2024-2032

The global immunology market size was valued at USD 97.58 billion in 2023. The market is projected to grow from USD  103.18 billion in 2024 to USD  257.39 billion by 2032, exhibiting a CAGR of 12.1% during the forecast period. North America dominated the global market with a share of 55.39% in 2023. Moreover, the U.S. immunology market size is projected to grow significantly, reaching an estimated value of USD 131.25 billion by 2032, driven by the surge in cases of autoimmune disorders.

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, there is an increasing focus on research and development initiatives for upgrading the product portfolio of key companies to improve patient treatment outcomes. This focus is anticipated to propel the global market growth over the forecast period.

• For instance, in October 2023, Rise Therapeutics’ investigational new drug (IND) application was accepted by the U.S. Food and Drug Administration (FDA) for the Phase I clinical trial of R-2487 to treat rheumatoid arthritis.

The COVID-19 outbreak had a slight negative impact due to the drop in the drug sales of several companies. Although few players witnessed a decline in their revenues in 2020, it is attributed to the loss of patents for blockbuster immunology drugs and delayed or cancelled patient visits to hospitals. However, in 2022, the market returned to the pre-pandemic level with rising drug approvals and launches. The market witnessed steady growth in 2023 with the increasing research and development initiatives for the advancements of biosimilars.

Immunology Market Trends

Growing Adoption of Biosimilars to Augment Market Expansion

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, market players are launching unbranded biosimilars at cheaper rates, which makes it cost-efficient for the patients to get the treatment as they can do so in a more affordable manner.

• For instance, in October 2023, Boehringer Ingelheim launched an unbranded version of Humira AbbVie's biosimilar and sold it at 81.0% cheaper rates than it.

Moreover, the loss of patent exclusivity 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.

• For instance, in January 2023, AbbVie's top-selling biologic drug Humira, used to treat rheumatoid arthritis, lost its patent after 20 years. Such prominent global immunology market trends are expected to contribute significantly to market expansion.

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

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Immunology Market Growth Factors

Rising Number of Cases of Autoimmune Disorders and Increasing Innovative Therapy Options 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 data published by the University of Oxford in May 2023, the new population-based study conducted on 22.0 million individuals found that one in ten individuals is affected by autoimmune disorders.

The increasing demand for these drugs among the patient population is driving market players to develop and launch new drugs in the global immunology market. The increasing regulatory approval of new drugs for the treatment of autoimmune disorders fuels the growth of the market.

• For instance, as of February 2023, Regeneron Pharmaceuticals, Inc. and Sanofi announced the U.S. Food and Drug Administration (FDA) approval for Kevzara to treat polymyalgia rheumatica (PMR), an inflammatory rheumatic disease.

The market growth is expected to be boosted over the forecast period due to increasing awareness of autoimmune disorders in both developed and developing nations, as well as potential pipeline candidates.

RESTRAINING FACTORS

Adverse Effects and High Treatment Costs Associated with Drugs Hinders Market Growth

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 Pfizer, the development of biosimilars takes around 5 to 9 years at a cost of USD 100.0 million, excluding regulatory costs.

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.

Immunology Market Segmentation Analysis

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 2023. The increasing efficiency associated with monoclonal antibodies for the treatment of chronic and rare conditions, including autoimmune diseases, is contributing to market growth. Antibodies include infliximab, 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.

• In January 2023, Gilead Sciences, Inc. collaborated with EVOQ Therapeutics, Inc., with an aim to utilize EVOQ’s NanoDisc technology for developing the treatment of rheumatoid arthritis (RA) and lupus.

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. Furthermore, the heightened efficacy of immunosuppressants has spurred a rapid surge in their utilization in emerging economies, propelling the segment’s accelerated growth rate.

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By Disease Indication Analysis

Rising Prevalence of Rheumatoid Arthritis Boosted Segment Growth

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 2023. 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 Bureau of Statistics in 2023, an estimated 3.7 million individuals in Australia suffered from arthritis, and 13.9% are suffering 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 Dominated the Market Owing to Increased 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 of the global market in 2023. This was attributed to the growing number of patients with immunological or autoimmune disorders seeking hospitalizations and medical treatment, as well as the presence of 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.

REGIONAL INSIGHTS

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

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North America generated a revenue of USD  54.05 billion in 2023.  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.

List of Key Companies in Immunology Market

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.

LIST OF KEY COMPANIES PROFILED

• AbbVie, Inc. (U.S.)


• Janssen Global Services, LLC (U.S.)


• Eli Lilly and Company (U.S.)


• Novartis AG (Switzerland)


• Pfizer Inc. (U.S.)


• Bristol-Myers Squibb Company (U.S.)


• Merck Sharp & Dohme Corp. (U.S.)


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


• Amgen Inc. (U.S.)


• Astellas Pharma Inc. (Japan)


• UCB SA (Belgium)

KEY INDUSTRY DEVELOPMENTS:

• November 2023- UCB announced results for its long-term Phase 2b study for the drug BIMZELX for the treatment of ankylosing spondylitis. The drug showed improvements in curing the signs and symptoms associated with the disease and can provide quality of life for upto five years.


• October 2023- Novartis AG announced the approval of Cosentyx by the U.S. Food and Drug Administration (FDA). It is the only approved treatment for the hidradenitis suppurativa (HS) condition.


• June 2023- Sandoz announced the launch of Hyrimoz injection, a high-concentration formulation used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and other immunological diseases.


• 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.


• April 2021- Novartis AG signed an agreement with F. Hoffmann-La Roche Ltd. with an aim to transfer technology for the Actemra/RoActemra API used for the treatment of rheumatoid arthritis.

REPORT COVERAGE

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.

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Report Scope & Segmentation