Global Adalimumab Market - 2022-2029

Global Adalimumab Market - 2022-2029

Market Overview

Adalimumab market was valued at USD 3829.40 million in 2021. It is forecasted to reach USD YY million by 2029, growing at a CAGR of 5.2% during the forecast period (2022-2029).

Adalimumab is approved under the brand name Humira for the treatment of Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), Crohn's Disease (CD), and Plaque Psoriasis (Ps). Adalimumab is a recombinant human IgG 1 monoclonal antibody that targets tumour necrosis factor (TNF). It acts by binding to the tumour necrosis factor (TNF) and inhibiting its interaction with the p55 and p75 cell surface TNF receptors. It lyses surface tumour necrosis factor expressing cells. It is effective in modulating the biological responses induced or regulated by TNF involving the changes in the levels of adhesion molecules responsible for leukocyte migration.

Adalimumab is developed by using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. It is produced by recombinant DNA technology in a mammalian cell expression system. It is supplied as either a single-use, prefilled pen or as a single-use, 1 mL filled glass syringe.

Market Dynamics

Rising Prevalence of Autoimmune Disorders is Driving the Growth of the Market

The market is driven by the increasing demand for adalimumab with the increasing prevalence of autoimmune diseases. According to the National Stem Cell Foundation (NSCF), approximately 4% of the world’s population is suffering from one autoimmune disease. Rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, psoriatic arthritis, plaque psoriasis, and others are the most common autoimmune diseases. According to the National Psoriasis Foundation, approximately 2% to 3% of the global population i.e., 125 million people are suffering from Psoriasis worldwide. Approximately, 30% of patients with psoriasis develop psoriatic arthritis, chronic inflammatory arthritis that leads to joint deformations and disability. Ankylosing spondylitis affects around 0.1% and 1.4% of people worldwide. It is most frequent in men in comparison to women. According to the Arthitis Foundation, around 80% of people develops the symptoms of ankylosing spondylitis in the age group at or before age of 30 years. Around, 5% of patients would develop ankylosing spondylitis in the age group of 45 or older.

Favorable Reimbursement Coverage for Adalimumab is Boosting the Market Growth

The better availability of the reimbursement coverage for adalimumab shall stimulate market growth. Around, 99% of national commercial, Medicare Part D, and Medicaid patients cover the adalimumab. Chinese regulators had also included adalimumab in the country’s National Reimbursement Drug List (NRDL). Chinese regulators provide with an average of 61% in price cuts of adalimumab with pharma companies.

Adverse Effects Associated with the use of Adalimumab is Hampering the Market Growth

The market is hindered by the adverse effects associated with the use of the adalimumab. Several adverse effects such as nausea, abdominal pain, hyperlipidemia, hematuria, hypercholesterolemia, back pain, rash, headache, hypertension, and others are observed among the patients. Redness, swelling or pain is observed at the site of injection of the adalimumab. It also increases the risk of developing a fungal, bacterial, and viral infection that can spread through the body. Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis and tuberculosis have been observed among the patients treated with adalimumab.

COVID-19 Impact Analysis

The global adalimumab market has received immense impetus from the COVID-19 pandemic, as several institutes, organizations, and companies are focussing on evaluating the potential of adalimumab for the treatment of the COVID-19. There is increasing research and development activities for adalimumab for the COVID-19. It has been observed that the Covid-19 patients who had administered the anti-TNF therapies for the treatment of inflammatory bowel disease and inflammatory arthritis were less likely to be hospitalised. The anti-TNF therapies are effective in neutralizing the TNF, a major component of the cytokine response part of the damaging excess inflammatory phase of COVID-19. Therefore, institutes and organizations are focussing on conducting clinical trials for examining the efficacy and safety of adalimumab among patients with COVID-19. For instance, in October 2020, Researchers at the University of Oxford in the United Kingdom had planned to initiate a new clinical trial to evaluate the effectiveness of the adalimumab for the treatment of the COVID-19 patients in community care settings, primarily in care homes. The clinical trial i.e., AVID-CC would be led by the Oxford Clinical Trials Research Unit (OCTRU) and would enroll up to 750 patients from community care homes.

Epidemiology

According to the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019, the estimation that the prevalence of Rheumatoid Arthritis (RA) was resulted in 3.26 million in 2019. Women are two to three times as likely to be affected in comparison to men. It has been observed that around one in 12 women and one in 20 men would develop an inflammatory autoimmune rheumatic disease during their life. According to Giegerich E et.al. 2018, the diagnosed prevalence of Crohn’s Disease was 6 cases per 100,000 in lower-income Asia-Pacific, 46 cases per 100,000 in high-income Asia-Pacific, 133 cases per 100,000 in Europe, and 210 cases per 100,000 in North America in 2017. The diagnosed prevalence of Crohn’s Disease is highest among people of age-group 40-54 years. The prevalence of ankylosing spondylitis was observed to be 23.8 per 10,000 in Europe, 16.7 per 10,000 in Asia, 31.9 10,000 in North America, 10.2 10,000 in Latin America and 7.4 per 10,000 in Africa.

Market Segment Analysis

The Rheumatoid Arthritis segment is expected to hold the largest share in the Adalimumab market

By disease type, the market is classified as rheumatoid arthritis, psoriatic arthritis, Crohn's disease, ulcerative colitis, and others. The rheumatoid arthritis segment is anticipated to hold the largest share in the adalimumab treatment market. Rheumatoid arthritis is the most common autoimmune arthritis that affects the joints, connective tissues, muscle, tendons, and fibrous tissues. It is characterized by joint pain, stiffness, swelling and decreased movement of the joints. It causes pain and swelling in the wrist and small joints of the hand and feet. Rheumatoid Arthritis can hamper the patient’s mobility and lead to permanent joint damage. The prevalence of rheumatoid arthritis is increasing worldwide. According to the World Health Organization (WHO), the prevalence of rheumatoid arthritis ranges between 0.3% and 1% across the globe. It is most frequent among women in comparison to men.

By Distribution Channel, Hospital Pharmacies Segment is Expected to Witness a High Growth Over the Forecast Period

The market is classified based on the distribution channel as the hospital pharmacies, retail pharmacies, online pharmacies and others. The hospital pharmacies are segmented to have the highest market growth due to the high availability of the adalimumab in the hospital pharmacies. There is a growing usage of the adalimumab for the treatment of autoimmune and skin disorders in hospitals. Adalimumab is effective in reducing the pain, and swelling associated with several disorders.

Geographical Analysis

North America region holds the largest market share global Adalimumab market

North America region is dominating the global adalimumab market accounted for the largest market share in 2021 owing to the high prevalence of Rheumatoid Arthritis (RA), Psoriatic Arthritis, Crohn's Disease, Plaque Psoriasis, and Ulcerative Colitis. According to the National Psoriasis Foundation, around one million people are being affected by Psoriatic Arthritis in the United States. According to the National Institute of Arthritis and Musculoskeletal and Skin Diseases, Plaque Psoriasis is the most frequent form of psoriasis that affects around 6.7 million adults in the United States. As per the National Institute of Health, the prevalence of Crohn's Disease was 201 per 100,000 in the United States.

The United States accounts for the highest market share due to the availability of favorable reimbursement coverage for adalimumab. There is a presence of several market players developing adalimumab. There is increasing research and development activities for examining the potential of adalimumab for the treatment of other indications apart from Rheumatoid Arthritis (RA), Psoriatic Arthritis, Crohn's Disease, and Ulcerative Colitis. The availability of advanced healthcare facilities and infrastructure shall stimulate the market over the forecasted period.

Asia-Pacific region is expected to grow at the fastest CAGR during the forecast period

Asia-Pacific region is estimated to be the fastest-growing region in the global adalimumab market owing to the increasing prevalence of autoimmune diseases with the increasing adoption of unhealthy lifestyles, stress in daily life & immune system malfunction. The growing elder population shall have a positive impact on the market. According to the United Nations Report, there were around 87 million of the population of age-group 65 years or over in India. There is increasing investment for the improvement of the healthcare facilities & infrastructure. There is increasing awareness that autoimmune diseases shall have a positive impact on the market.

There is an increase in the approval of the biosimilars of adalimumab due to the presence of favorable regulatory policies for biosimilars. For instance, in September 2020, Innovent Biologics, Inc. had received the approval for Sulinno (adalimumab injection), a recombinant human anti-TNF-α monoclonal antibody drug from the National Medical Products Administration (NMPA) of China for the treatment of Rheumatoid Arthritis (RA), ankylosing spondylitis and psoriasis in China. The increasing domestic income and purchasing power of people shall boost the demand for adalimumab over the forecasted period.

Competitive Landscape:

The adalimumab market studied is a fragmented market with the presence of a large number of market players. AbbVie Inc, Amgen Inc, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Ltd, F. Hoffmann-La Roche Ltd, Glenmark Pharmaceuticals, Novartis AG, and Pfizer Inc are the major market players with the significant market share. Companies are adopting several growth strategies such as product launches, acquisitions, mergers, collaborations, and licensing for increasing their market presence. For instance,

Mergers & Collaborations:

In September 2020, Sensyne Health plc had entered into the collaboration with the University of Oxford for conducting the clinical trial for evaluating the adalimumab for the treatment of COVID-19. Under the terms of the agreement, Sensyne would provide software for remote data collection and analytics for the AVID-CC Phase II clinical trial of the anti-TNF drug adalimumab to prevent respiratory failure due to COVID-19

Product Launch & Approvals:

On 24th February 2021, AbbVie. had received approval for HUMIRA (adalimumab) from the United States Food and Drug Administration (FDA). The HUMIRA is the subcutaneous biologic treatment for pediatric patients 5 years of age and older with moderately to severely active ulcerative colitis.

On 5th May 2021, Amgen Canada launched Its adalimumab biosimilar (Amgevita), referencing Humira. The biosimilar product is available for all indications of the reference product. This Amgevita includes rheumatoid arthritis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis, Crohn's disease, ankylosing spondylitis, and ulcerative colitis. It is now available in Canada.

On 18th November 2019, Pfizer Inc. announced that it received approval from the United States Food and Drug Administration (FDA) for ABRILADA (adalimumab-afzb) as a biosimilar to Humira (adalimumab). The ABRILADA is used to treat certain patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, juvenile idiopathic arthritis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.

Acquisition:

In May 2020, AbbVie had acquired the Allergan plc

Partnership:

In March 2020, Alvotech HF had entered into an exclusive license partnership with DKSH for the commercialization of AVT02, a biosimilar to AbbVie’s HUMIRA (adalimumab), in selected Asia-Pacific (APAC) markets.