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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, 2022-2029

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

 

KEY MARKET INSIGHTS

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The global immunology market size was valued at USD 97.93 billion in 2021. The market is projected to grow from USD 104.12 billion in 2022 to USD 184.21 billion by 2029, exhibiting a CAGR of 8.5% during the forecast period. The global COVID-19 pandemic has been unprecedented and staggering, with immunology drugs experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels. Based on our analysis, the global market exhibited a slower growth of 6.0% in 2020 as compared to 2019.


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


Rising awareness about immunological diseases such as rheumatoid arthritis, psoriatic arthritis in both developing and developed nations and the rising occurrence of immunological disorders due to environmental factors are critical reasons for increasing the demand for immunological drugs in the market.



  • For instance, according to the 2020 National Diabetes Statistics report published by the Centers for Disease Control and Prevention (CDC), there was a 30% increase in the prevalence of type 1 diabetes during 2017-2020 in the U.S. There were 1.25 million people in 2017, which increased to 1.6 million in 2020.


Moreover, existing players operating in the global market focus on constant improvements and advancement their products for improved patient treatment and outcomes for the patients, which is anticipated to propel the market growth during the study period.



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


COVID-19 IMPACT


Robust Efforts by Key Players Led COVID-19 Pandemic to Have a Minimal Impact on the Market Growth


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



  • For instance, in the financial year 2020, AbbVie Inc. reported an increase of 13.2% in the sales generated from the drugs compared to 2019. Moreover, in 2021, the company generated USD 25,284.0 million from its immunology segment, witnessing an increase of 14.1% compared to 2020.


However, a few players, such as Merck & Co., Inc., witnessed a decline in revenues generated from these drugs due to the COVID-19 pandemic. This factor has resulted in slower market growth during 2019-2020. Moreover, the slower market growth is partially also attributed to the loss of patents of blockbuster drugs during the past few years, postponement of regulatory approvals for new drugs, and increased uptake of biosimilars during the pandemic, and delayed or canceled patient visits to hospitals and clinics.



  • For instance, according to a 2020 study published by NCBI, there were 43.6% missed appointments more than once, and the no-show rate was 17.2% in a total of 376 rheumatoid arthritis patients during the COVID-19 pandemic.


However, the increasing uptake of immunology drugs in 2021, along with a rising number of drug approvals and launches, is anticipated to fuel the immunology market growth during the forecast period.


LATEST TRENDS


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Growing Penetration of Biosimilars to Boost the Market


The increasing demand for biosimilars owing to their similar efficiency and lower costs is significantly increasing 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 fight infections for patients undergoing chemotherapy, 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 the market players to introduce biosimilars to the reference drugs in the market.



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


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



  • For instance, according to a 2021 report published by McKinsey, by 2030, biologic products worth around USD 170 billion will lose patent protection, and the potential launch of around 6 biosimilars by key players is expected to increase the uptake of biosimilars among the population.


DRIVING FACTORS


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


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



  • For instance, according to the National Stem Cell Foundation’s research article, approximately 4% of the world’s population is infected by at least one of 80 and more autoimmune disorders.


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



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

  • For instance, in September 2020, Lupin launched a generic rheumatoid arthritis drug, Leflunomide, in the U.S., which is projected to drive 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 the market growth during the forecast period.


RESTRAINING FACTORS


High Cost of Treatment and Adverse Effects Associated with Product to Restrict Market Growth


Despite the increasing prevalence of immunological disorders in key regions, factors, such as high cost and adverse effects associated with these drugs, restrict the market growth during the forecast period. The high price of biologics is partly due to the costly manufacturing facilities and the large investment in research and development necessary to take biologics through clinical trials and FDA approval processes.



  • For instance, according to a 2020 study article published by Springer Nature, the rate of drug failure in the development stage is higher, and only 10-20% of the drugs tested are successful and reach the market, due to which the development of new drugs costs around USD 3.00 billion.


Additionally, these drugs are related with various damaging effects such as infections, allergic reactions, muscle aches, fever, fast/irregular/pounding heartbeat, and others. Hence, the factors mentioned above and the limited compensation policies in developing economies to obstruct the market growth during the study period.


SEGMENTATION


By Drug Class Analysis


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


Based on drug class, the global market is divided into monoclonal antibody (mAb), fusion proteins, immunosuppressants, and others.


The monoclonal antibody (mAb) segment held the dominating share in 2021. The domination is attributed to the recognized monoclonal antibodies’ clinical efficiency such as rituximab, adalimumab, and the treatment of autoimmune diseases and chronic and rare conditions. Additionally, a higher number of authorizations for mAb’s for the treatment of various conditions favors segmental growth.



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


The immunosuppressants segment is expected to grow at a higher CAGR during the forecast period. The rapid growth of this segment is attributed to the strong focus on R&D of leading market players to establish the increasing number of regulatory approvals for these drugs. Moreover, increasing the adoption of immunosuppressants in developing nations due to their higher treatment efficacy contributes to its faster growth rate.


By Disease Indication Analysis


Rheumatoid Arthritis Segment to Dominate Backed by its Rising Prevalence


Based on disease indication, the market is divided into psoriatic arthritis, prophylaxis of organ rejection, rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, inflammatory bowel disease, and others.


The rheumatoid arthritis segment led the market in 2021. The growing prevalence of rheumatoid arthritis and increasing number of patients undergoing treatment will lead to a rise in demand for drugs in the treatment of rheumatoid arthritis.



  • For instance, according to Healthline, there are approximately 1.5 million people with rheumatoid arthritis (RA) in the U.S., and out of 100,000 people every year, 71 are diagnosed with the condition.


On the other hand, limited drug approvals for ankylosing spondylitis, inflammatory bowel disease, and other conditions and the comparatively high cost of treatment with 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 Highest Market Share Owing to Rising Hospitalizations


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


The hospital pharmacies segment held the lion’s share in the global market in 2021 due to the increasing number of hospitalization and physician visits by patients suffering from immunological or autoimmune disorders and well-established healthcare infrastructure.


On the other hand, the online pharmacies segment is expected to register a higher 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 countries, such as Germany, the U.K., and others, lead to a shift of patient preference toward online pharmacies.


REGIONAL INSIGHTS


North America Immunology Market Size, 2021 (USD Billion)

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North America generated a revenue of USD 54.04 billion in 2021. The region held a dominating immunology market share and is expected to grow at a significant CAGR during the forecast period. The higher cases of chronic disorders, the existence of advanced healthcare infrastructure, and developed diagnosis and rates of treatment among the patients in the U.S. are the factors accountable for the region's dominance in the global market.


Europe is expected to register an important 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% of the U.K., which is around 4 million people, suffer from at least one autoimmune condition.


The market in the Asia Pacific is anticipated to grow at a higher CAGR due to the large pool of patients suffering from autoimmune disorders and the increasing demand for preventive care. Moreover, increasing efforts of key players for the approvals and launches of drugs for autoimmune conditions are anticipated to augment the 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 & Africa are expected to witness comparatively slower growth owing to their developing healthcare infrastructure and lack of favorable reimbursement policies. However, growing awareness among people and higher demand for treatment options are expected to surge the demand for these drugs in these regions during the forecast period. 


KEY INDUSTRY PLAYERS


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. Major players constantly 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 to broaden its therapeutic immunology 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 and strengthening their global distribution channels to establish their footprints in emerging regions. These are some of the key factors attributable to these companies' rising market share.


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:



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

  • April 2022 – AbbVie Inc. received the U.S. FDA approval for RINVOQ to treat adults with active ankylosing spondylitis.

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

  • March 2022 – Pfizer Inc. acquired Arena Pharmaceuticals, a company that develops innovative potential therapies for the treatment of several immuno-inflammatory diseases to strengthen its product portfolio.

  • February 2022 – UCB S.A. received the marketing authorization from Health Canada BIMZELX (bimekizumab injection) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.


REPORT COVERAGE


An Infographic Representation of Immunology Market

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The global immunology market report provides a detailed market analysis. It focuses on key aspects such as leading companies, drug class, disease indications, and distribution channels. Besides this, 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






















































  ATTRIBUTE



  DETAILS



Study Period



2018-2029



Base Year



2021



Estimated Year



2022



Forecast Period



2022-2029



Historical Period



2018-2020



Unit



Value (USD billion)



Segmentation



By Drug Class, Disease Indication, Distribution Channel, and Region



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, By Disease Indication, By Distribution Channel, By Country)

    • U.S.

    • Canada



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

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

    • Scandinavia

    • Rest of Europe



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

    • China

    • Japan

    • India

    • Australia

    • Southeast Asia

    • Rest of Asia Pacific



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

    • Brazil

    • Mexico

    • Rest of Latin America



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

    • GCC

    • South Africa

    • Rest of Middle East & Africa





 


Frequently Asked Questions

Fortune Business Insights says that the global market stood at USD 97.93 billion in 2021 and is projected to reach USD 184.21 billion by 2029.

In 2021, the market size in North America was USD 54.04 billion.

The market will exhibit steady growth at a CAGR of 8.5% during the forecast period (2021-2028).

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.

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