The publisher's " Atopic dermatitis (AD) - Market Insights, Epidemiology, and Market Forecast-2032" report delivers an in-depth understanding of the AD, historical and forecasted epidemiology as well as the AD market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.
The AD market report provides current treatment practices, emerging drugs, AD market share of the individual therapies, current and forecasted AD market Size from 2019 to 2032 segmented by seven major markets. The Report also covers current AD treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.
AD presents different symptoms depending on the age of the person. Itching is the hallmark of AD. Sore or painful skin and poor sleep caused by itching are also common. People with AD may develop rashes anywhere on the body that can ooze, weep fluid and bleed when scratched, making skin vulnerable to infection. Skin can become dry and discolored, and repeated scratching may cause thickening and hardening of the skin (lichenification).
The exact cause of AD is unknown. AD is caused by a complex interaction of immune dysregulation, epidermal gene mutations, and environmental factors that disrupt the epidermis causing intensely pruritic skin lesions. However, it is not contagious. There is currently no reliable biomarker that can distinguish the disease from other entities. However, the most commonly used biomarker is elevated total and/or allergen-specific serum IgE.
Currently, the treatment regimen of AD involves the use of topical treatment options such as emollients, topical corticosteroids (TCS) topical calcineurin inhibitors (TCIs) and systemic treatment such as immunosuppressant, corticosteroids, and others (phototherapy). Additionally, certain systemic therapies like Dupixent, Rinvoq, Olumiant, Cibinqo, Opzelura and others are also approved for AD in the 7MM.
AD market is expected to witness a significant growth rate owing to launch of potential mid and late stage therapies in the coming years, assisted by an increase in the prevalent population of AD.
The AD epidemiology division provides insights about historical and current AD patient pool and forecasted trends for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
The disease epidemiology covered in the report provides historical as well as forecasted AD epidemiology [segmented as total prevalent cases of AD, total diagnosed prevalent cases of AD, severity-specific distribution of AD in adults, severity-specific distribution of AD in pediatric population, gender-specific prevalence of AD in adults, diagnosed prevalent cases of pruritus in AD in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.
Estimates show that the highest cases of AD in the 7MM were in the United States, followed by Japan, Germany, the United Kingdom, Italy, France, and Spain in the year 2021.
Drug chapter segment of the AD report encloses the detailed analysis of AD marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the AD clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Note: Detailed Current therapies assessment will be provided in the full report of AD
Drug chapter segment of the AD report encloses the detailed analysis of AD marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the AD clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Note: Detailed emerging therapies assessment will be provided in the final report.
The treatment of AD aims to reduce the duration, severity, and frequency of disease exacerbations (flares). It is implemented in a step-wise manner according to disease severity (mild, moderate, or severe).
The total market size of AD in the United States is expected to increase with a CAGR of 10.9% in the study period (2019 - 2032).
The total market size of AD in the Japan is expected to increase with a CAGR of 8.2% in the study period (2019 - 2032).
Analyst Commentary
Lebrikizumab is a novel, investigational, monoclonal antibody acquired by Eli Lilly when the company entered into a definitive agreement to acquire Dermira. The drug is designed to bind IL-13 with very high affinity to specifically prevent the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. It has received Fast Track designation in the US from the FDA for moderate-to-severe AD in patients aged ≥12 years and ≥40 kg. The drug is expected to enter the US in 2022. Almirall has licensed the rights to develop and commercialize lebrikizumab to treat dermatology indications, including AD, in Europe. Further, it has been reported that the development schedule of the drug remains on schedule with submission to the EMA expected in 2022 and subsequent approval and release estimated to be obtained in 2023. Moreover, in March 2021, the company initiated a new Phase III trial in Japan, with the primary completion date of July 2022. Considering these developments, we anticipate the drug to enter the Japanese market in 2023.
Note: Detailed emerging therapies assessment will be provided in the final report.
The AD market report provides current treatment practices, emerging drugs, AD market share of the individual therapies, current and forecasted AD market Size from 2019 to 2032 segmented by seven major markets. The Report also covers current AD treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.
Geography Covered
- The United States
- EU5 (Germany, France, Italy, Spain, and the United Kingdom)
- Japan
AD Disease Understanding and Treatment Algorithm
Atopic dermatitis (AD) also called eczema, is a chronic condition and the most common type of skin inflammation that usually starts in early childhood, but can occur at any age and can be recurrent or persistent throughout life. Half of the patients with moderate-to-severe eczema also have asthma, hay fever (allergic rhinitis), and food allergies. It is the most common chronic skin disease in children.AD presents different symptoms depending on the age of the person. Itching is the hallmark of AD. Sore or painful skin and poor sleep caused by itching are also common. People with AD may develop rashes anywhere on the body that can ooze, weep fluid and bleed when scratched, making skin vulnerable to infection. Skin can become dry and discolored, and repeated scratching may cause thickening and hardening of the skin (lichenification).
The exact cause of AD is unknown. AD is caused by a complex interaction of immune dysregulation, epidermal gene mutations, and environmental factors that disrupt the epidermis causing intensely pruritic skin lesions. However, it is not contagious. There is currently no reliable biomarker that can distinguish the disease from other entities. However, the most commonly used biomarker is elevated total and/or allergen-specific serum IgE.
Currently, the treatment regimen of AD involves the use of topical treatment options such as emollients, topical corticosteroids (TCS) topical calcineurin inhibitors (TCIs) and systemic treatment such as immunosuppressant, corticosteroids, and others (phototherapy). Additionally, certain systemic therapies like Dupixent, Rinvoq, Olumiant, Cibinqo, Opzelura and others are also approved for AD in the 7MM.
AD market is expected to witness a significant growth rate owing to launch of potential mid and late stage therapies in the coming years, assisted by an increase in the prevalent population of AD.
AD Epidemiology
The AD epidemiology division provides insights about historical and current AD patient pool and forecasted trends for every seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.
Key Findings
The disease epidemiology covered in the report provides historical as well as forecasted AD epidemiology [segmented as total prevalent cases of AD, total diagnosed prevalent cases of AD, severity-specific distribution of AD in adults, severity-specific distribution of AD in pediatric population, gender-specific prevalence of AD in adults, diagnosed prevalent cases of pruritus in AD in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.
Country Wise AD Epidemiology
Estimates show that the highest cases of AD in the 7MM were in the United States, followed by Japan, Germany, the United Kingdom, Italy, France, and Spain in the year 2021.
- as per the publisher's estimates, total prevalent population of AD in the seven major markets was 65,445,311 cases in 2021. The cases in the 7MM are expected to increase during the study period, i.e., 2019 - 2032.
- as per the publisher's estimates the total diagnosed prevalent population of AD cases were highest in the United States. The diagnosed prevalent cases were estimated to be 24,193,284 in 2021in the US.
- As per the analysis, in the US, mild AD accounted for the highest cases in 2021, followed by moderate to severe AD with 9,713,457 and 6,458,373, respectively, in adults.
- In the EU5 countries, the prevalent population of AD was maximum in Germany with 6,002,742 cases, followed by the UK with 5,393,687 cases in 2021. While, the least number of cases were in Spain, with 3,304,045 cases in 2021.
- Among the gender-specific prevalent contribution, females are affected more by AD than males. In 2021, there were 6,090,942 cases of AD in males and 10,095,456 cases in females in the US.
- The diagnosed prevalence of chronic pruritus in AD cases in the US was 13,758,438 in 2021.
- as per the publisher's estimates, Japan accounted for 6,938,196 diagnosed prevalent cases of AD in 2021.
AD Drug Chapters
Drug chapter segment of the AD report encloses the detailed analysis of AD marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the AD clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Marketed Drugs
Dupixent (Sanofi/Regeneron Pharmaceuticals)
Dupixent is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins and is not an immunosuppressant. Data from Dupixent clinical trials have shown that IL-4 and IL-13 are key drivers of the type 2 inflammation that plays a major role in AD, asthma, and chronic rhinosinusitis with nasal polyposis (CRSwNP). In May 2020, the US FDA approved Dupixent (dupilumab) for children aged 6 - 11 years with moderate-to-severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Dupixent is currently approved in more than 60 countries, and more than 190,000 patients have been treated globally.Eucrisa (Pfizer)
Eucrisa (crisaborole) is a non-steroidal phosphodiesterase-4 (PDE4) inhibitor indicated for the topical treatment of mild-to-moderate AD in patients 2 years of age and older. It is currently available as a 2% ointment. In March 2020, the US FDA approved Pfizer’s supplemental new drug application (sNDA) for Eucrisa (crisaborole) ointment, 2%, extending the lower age limit from 24 months down to 3 months in children with mild-to-moderate AD. The drug is a small, boron-based molecule with low molecular weight, which allows easier penetration into the skin. The EMA also approved Staquis (crisaborole) to treat adults and children from 2 years of age with mild to moderate AD, in March 2020.Corectim Ointment (Japan Tobacco and Torii Pharmaceutical)
Corectim (delgocitinib) Ointment 0.5% is a non-steroidal topical product and the world’s first topical JAK inhibitor that improves AD by inhibiting the action of all members of the JAK family [JAK1, JAK2, JAK3, and tyrosine kinase 2], which play a key role in immune activation signaling in cells, by suppressing the overactivation of immune responses. In October 2016, Japan Tobacco and Torii Pharmaceutical signed an exclusive agreement for co-development and commercialization of JT’s original compound, JTE-052 (delgocitinib), for topical use in dermatological indications in Japan.Olumiant (baricitinib) (Eli Lilly and Company)
Baricitinib (LY3009104) - discovered by Incyte and developed under license by Lilly and marketed as Olumiant - is an oral selective Janus kinase (JAK) 1/JAK2 inhibitor. It inhibits several cytokines in AD pathogenesis, including thymic stromal lymphopoietin, IL-4, IL-5, IL-13, IL-22, and IL-31. The drug works by blocking the action of enzymes known as JAK1/JAK2 inhibitor that mediate the pathways involved in the inflammatory process in AD. In addition, the drug is already approved in EU for the treatment of moderate and severe AD. It is the first medicine for moderate and severe AD that patients can be taken orally. It is also approved in over 40 countries for the treatment of adults with moderate to severe AD who are candidates for systemic therapy. Eli Lilly and partner Incyte have filed a regulatory review for JAK inhibitor Olumiant to treat AD in the US.Rinvoq (AbbVie)
Upadacitinib (ABT-494) - discovered and developed by AbbVie scientists and marketed as Rinvoq - is a selective and reversible JAK inhibitor that was approved by FDA and EMA in August 2019 and December 2019, respectively, for adult patients with moderately to severely active rheumatoid arthritis. JAKs are intracellular enzymes that transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Upadacitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs. The European Commission in August 2021 approved Rinvoq to treat adults (15 mg and 30 mg) and adolescents (15 mg) with AD. In January 2022, the US FDA approved Rinvoq for the treatment of moderate to severe AD in adults and children 12 years of age and older whose disease did not respond to previous treatment and is not well controlled with other pills or injections, including biologic medicines, or when use of other pills or injections is not recommended.Cibinqo (Pfizer)
Abrocitinib (PF-04965842) is an oral, small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 modulates multiple cytokines involved in the pathophysiology of AD, including interleukin (IL)-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP). Abrocitinib reversibly inhibits JAK1 by blocking the adenosine triphosphate (ATP) binding site. In January 2022, the US FDA approved Cibinqo for the treatment of adults living with refractory, moderate-to-severe AD whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable. In addition to receiving regulatory approval in the US, CIBINQO has received marketing authorization in the European Union, Great Britain, Japan, Korea, the United Arab Emirates, Norway, Iceland, and Singapore.Adbry/ Adtralza (LEO Pharma)
Tralokinumab (Adbry/ Adtralza) is a fully human monoclonal antibody that specifically neutralizes the IL-13 cytokine, a key driver of the underlying inflammation in AD, and inhibits its interaction with the IL-13 receptor α1 and α2 subunits (IL-13Rα1 and IL13Rα2). Adtralza has been approved by the European Commission for adults with moderate-to-severe AD in Europe and by the Medicines and Healthcare products Regulatory Agency in Great Britain, in June 2021. Additional regulatory filings are underway with other health authorities worldwide. In December 2021 the US FDA approved Adbry (tralokinumab-ldrm) for the treatment of moderate-to-severe AD in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.Opzelura (Incyte Corporation)
Opzelura (Ruxolitinib) is a potent, selective inhibitor of JAK1 and JAK2 that, when applied topically, provides the opportunity to directly target diverse pathogenic pathways that underlie AD. It is a prescription topical cream for the short-term, non-continuous treatment of mild to moderate eczema (atopic dermatitis) not controlled on topical therapies in people 12 and older without weakened immune systems.Note: Detailed Current therapies assessment will be provided in the full report of AD
AD Emerging Drugs
Drug chapter segment of the AD report encloses the detailed analysis of AD marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the AD clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Lebrikizumab (Eli Lilly and Company)
Lebrikizumab (Ly3650150, Drm06), a novel, investigational, monoclonal antibody, is designed to bind IL-13 with very high affinity to specifically prevent the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. IL-13 is believed to be a central pathogenic mediator that drives multiple aspects of the pathophysiology underlying the range of signs and symptoms of AD by promoting type II inflammation and mediating its effects on tissue, resulting in skin barrier dysfunction, itch, skin thickening, and infection. The FDA has granted Fast Track designation to lebrikizumab for moderate-to-severe AD in patients aged 12 years and older and 40 kg or greater. Eli Lilly has exclusive rights for the development and commercialization of lebrikizumab in the US and the rest of the world outside Europe.Etrasimod (Arena Pharmaceuticals)
Etrasimod (APD334) is a next-generation, once-daily, oral, highly selective sphingosine 1-phosphate (S1P) receptor modulator discovered by Arena and designed for optimized pharmacology and engagement of S1P receptor 1, 4, and 5 providing systemic and local effects on specific immune cell types. The drug has the potential to treat multiple immune-mediated inflammatory diseases, including ulcerative colitis, Crohn’s disease, AD, and alopecia areata. In November 2020, based on the compelling profile in the ADVICE trial, the company mentioned that the drug would be proceeding further into a Phase III registration program.Roflumilast (Arcutis Biotherapeutics)
Topical Roflumilast cream (ARQ-151) is a small molecule inhibitor of phosphodiesterase type 4 (PDE4), an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases the production of anti-inflammatory mediators. It has been implicated in a wide range of inflammatory diseases, including psoriasis, eczema, and chronic obstructive pulmonary disease (COPD).FB825 (Oneness Biotech)
FB825 is a humanized monoclonal antibody that binds to the CεmX domain of membrane form IgE, leading to the death of IgE+ B lymphocytes by inducing apoptosis and antibody-dependent cellular cytotoxicity (ADCC). The drug has both therapeutic as well as preventive effects in allergic diseases. In April 2020, LEO Pharma signed a worldwide exclusive licensing agreement with Oneness Biotech (Taiwan) covering the development and commercialization of the novel AD drug candidate, FB825. Moreover, the company plans to proceed with primary efficacy analysis in Q4 2021. Furthermore, the data readout is anticipated in March 2022 and completion of the clinical study report is expected in Q2 2022.DS107 (DS Biopharma)
DS107 (DGLA, Daleuton) is a novel, immunomodulating, bioactive lipid that targets the immune activation and skin barrier dysfunction of AD by inhibiting the expression of CD40. Inhibition of CD40 in AD patients down regulates T-cell activation and downstream Th2, Th1, Th17, and Th22 cytokine production (DS Biopharma, 2018). The drug has completed Phase II clinical studies for moderate-to-severe AD in adults in both topical cream and oral formulations and is phase III ready.B244 (AOBiome Therapeutics)
AOBiome’s B244 is a patented, proprietary, topical formulation incorporating a single strain of beneficial ammonia-oxidizing bacteria (AOB), Nitrosomonas eutropha D23. B244 is designed to repopulate the skin microbiome with AOBs normally found on the body but frequently stripped away by most soaps. Once deployed on the skin, B244 converts ammonia to nitrite, known to have antibacterial properties, and to nitric oxide, a signaling molecule known to regulate inflammation and vasodilation. The drug is currently undergoing a phase II trial pruritus (itch) caused by AD (eczema) in adults ages 18 - 65 years in various locations.Note: Detailed emerging therapies assessment will be provided in the final report.
AD Market Outlook
The treatment of AD aims to reduce the duration, severity, and frequency of disease exacerbations (flares). It is implemented in a step-wise manner according to disease severity (mild, moderate, or severe).
- Off-label treatment, especially systemic immunosuppressants and systemic (oral and injectable) corticosteroids (SCSs) are frequently prescribed for patients unresponsive to topical therapy. Systemic corticosteroids (SCS) are indicated for short-term treatment of acute severe AD. Although SCS rapidly improves symptoms, they are not recommended for long-term use because of the adverse events.
- Optimal AD management includes topical corticosteroids (TCs) as the first-line treatment for AD flare-ups. The potencies of these topical corticosteroids range from the group I, which is most potent (e.g., clobetasol [Temovate]), through group VII, which is least potent (e.g., hydrocortisone 1%). However, TCS has various side-effects and is not recommended for long-term use. The principal complication of prolonged application of topical corticosteroids, especially those of higher-potency, is skin atrophy. Other local complications include telangiectasia, striae, hypopigmentation, and corticosteroid acne.
- Topical calcineurin inhibitors, such as pimecrolimus (Elidel) and tacrolimus (Protopic), are immunomodulators and are considered second-line therapy. They are generally reserved for short-term or intermittent long-term therapy in persons with moderate-to-severe AD, especially when there is concern that the ongoing use of topical corticosteroids is causing adverse effects, such as atrophy.
- Besides the above-mentioned off-label therapies, the treatment regimen of AD also involves certain approved and marketed therapies. Pfizer’s Eucrisa/Staquis (crisaborole, 2%) is a non-steroidal, phosphodiesterase-4 (PDE4) inhibitor that is approved for the topical treatment of mild-to-moderate AD in patients 2 years of age and older. It was approved in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan in December 2016, with a label expansion in March 2020, extending the lower age limit from 24 months down to 3 months in children, which makes it the only medication for such young population.
- Additionally, Dupixent (dupilumab), which is considered a blockbuster drug, is a fully-human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins and is not an immunosuppressant. It is being jointly developed by Regeneron and Sanofi and is FDA approved for the treatment of asthma and chronic rhinosinusitis with nasal polyposis (CRSwNP), along with AD.
- Another therapy, Corectim (delgocitinib) Ointment 0.5%, is a nonsteroidal topical product and the world’s first topical JAK inhibitor that improves AD by inhibiting the action of all members of the JAK family. It is currently only approved in Japan for AD; however, Leo Pharma has licensed the drugs from Japan Tobacco (JT) to develop and commercialize the drug in the US and EU markets.
- In September 2020, Olumiant (baricitinib), an oral selective JAK 1/JAK2 inhibitor, received approval in the European Union to treat adult patients with moderate-to-severe AD who are candidates for systemic therapy. It is the first oral JAK inhibitor to treat moderate-to-severe AD in adult patients who are candidates for systemic therapy in the EU and offers a different mode of action to the currently available treatment options. It is not yet approved by the FDA due to a black box warning associated with KAK inhibitors. However, it is approved to treat rheumatoid arthritis (RA) in the US and over 60 countries. Additionally, Eli Lilly and partner Incyte have filed a regulatory review for Olumiant to treat AD in the US.
- The European Commission in August 2021 approved Rinvoq to treat adults and adolescents with AD. Discovered and developed by AbbVie, the drug is a selective and reversible JAK inhibitor. In January 2022, the US FDA approved Rinvoq for the treatment of moderate to severe AD in adults and children 12 years of age and older whose disease did not respond to previous treatment.
- Another recently approved drug, Opzelura (ruxolitinib) cream, is a potent, selective inhibitor of JAK1 and JAK2 that, when applied topically, provides the opportunity to directly target diverse pathogenic pathways that underlie AD. In September 2021, Incyte announced that the US FDA had approved Opzelura (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild-to-moderate AD in non-immunocompromised patients aged ≥12 whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States
- Cibinqo (abrocitinib) is an oral, small molecule, Janus kinase (JAK) 1 inhibitor developed by Pfizer for AD in the pediatric and adult population. The US FDA granted Priority Review designation to the company’s NDA for Abrocitinib (100mg and 200mg); however, the decision is pending owing to the safety concerns associated with JAK inhibitors. In September 2021, UK’s MHRA granted marketing authorization for abrocitinib for adults and adolescents with moderate-to-severe AD. In September 2021, Japanese MHLW also approved the drug to treat moderate-to-severe AD in adults and adolescents aged ≥12 with inadequate response to existing therapies.
- Adbry/ Adtralza (tralokinumab) specifically neutralizes the IL-13 cytokine, a key driver of the underlying inflammation in AD. According to the trial results in the adult population, tralokinumab 300 mg combined with TCS as needed was effective and well-tolerated in patients with moderate‐to‐severe AD. The US FDA approved Adbry (tralokinumab-ldrm) for the treatment of moderate-to-severe AD in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable, in December 2021 and in June 2021, Adtralza was approved by the European Commission for adults with moderate-to-severe AD in Europe and by the Medicines and Healthcare products Regulatory Agency in Great Britain. Additional regulatory filings are underway with other health authorities worldwide. The company has completed multiple Phase III trials and is still conducting another Phase III trial to treat moderate-to-severe AD in adults.
Key Findings
- The market size of AD in the 7MM is estimated to be USD 15,026 Million in 2021.
- Currently, the treatment regimen of AD in the US involves the use of Topical treatment options such as emollients, topical corticosteroids (TCS) Topical calcineurin inhibitors (TCIs) and systemic treatment such as immunosuppressant, corticosteroids, Dupixent, Eucrisa (Crisaborole) 2% ointment, Corectim Ointment and others.
- Expected Launch of potential therapies such as B244, Lebrikizumab (LY3650150), Etrasimod (APD334), Abrocitinib/PF-04965842, FB825, Nemolizumab (CD14152), DS107, Bermekimab, KY1005, ARQ-151/ Roflumilast cream, and others may increase the market size in coming years.
- Throughout the study period, the United States accounts for the largest market size of AD, in comparison to EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan. The US market accounted for USD 10,476 Million in 2021.
- Among the EU5 countries, Germany had the highest market size with USD 884 Million in 2021, while Spain had the lowest market size of AD with USD 448 Million in 2021.
- The Japanese AD market was USD 1,273 Million in 2021.
The United States Market Outlook
The total market size of AD in the United States is expected to increase with a CAGR of 10.9% in the study period (2019 - 2032).
EU-5 Countries: Market Outlook
The total market size of AD in EU5 is expected to increase with a CAGR of 9.7% in the study period (2019 - 2032).Japan Market Outlook
The total market size of AD in the Japan is expected to increase with a CAGR of 8.2% in the study period (2019 - 2032).
Analyst Commentary
- With the emerging key players in the market, it is quite confirmed that the treatment for AD will evolve in the upcoming years while giving AD patients a new ray of hope.
- Based on the analysis, it is evident that the current market is dominated by the use of Dupixent as the first-line pharmacological treatment of the condition in both adults and adolescents. Moreover, the company is conducting clinical trials to evaluate the safety and efficacy of the drug for pediatric patients. Dupixent was approved by the US FDA for children aged 6 to 11 years with moderate-to-severe AD. We are quite buoyant with respect to the efficacy of the drug for patients 6 months to 5 years of age. If approved, the drug will capture a major market share for all age groups.
- The emerging pipeline for the treatment of adult patients with AD is quite extensive. Among the upcoming therapies and recently approved therapies such as Rinvoq, DS107, Abrocitinib, and Lebrikizumab hold the potential to capture a major market during the forecasted period owing to better efficacy, ROA, patient pool. The drugs such as Rinvoq have recently been approved in the EU-5, the US and Abrocitinib has been approved in UK and Japan
- A black box warning allied with the use of JAK inhibitors is a well-known barrier for the approval of these drugs in the US. However, owing to the recent approval of ruxolitinib (Opzelura; Incyte), a topical selective JAK1/JAK2 inhibitor, for the treatment of mild to moderate AD in non-immunocompromised patients 12 years and older, we believe that the other JAK inhibitors may be approved during the forecasted period provided they demonstrate better efficacy during their clinical development.
- In Japan, the only available JAK inhibitors are Corectim and Cibinqo, which might compete with each other in the Japanese AD market. Other JAK inhibitors are also in development and are expected to be approved during the forecast period 2022─2032.
- The emerging pipeline for the pediatric population with AD holds potential key players such as Dupixent, Abrocitinib, Difamilast, and roflumilast cream. We believe that the drugs may enter the 7MM market soon. Approval of these drugs may provide ray of hope for patients below the age of 6 years suffering from the condition.
- Additionally, therapies like B244, tradipitant, difelikefalin and others are being developed for the treatment of pruritus in AD, which currently has no approved therapy.
- To summarize, various possible treatments for the management of AD will be researched in the near future, and it is safe to expect that the therapeutic space will go through substantial influence throughout the forecast period, 2022 - 2032.
AD Drugs Uptake
This section focusses on the rate of uptake of the potential drugs recently launched in the AD market or expected to get launched in the market during the study period 2019-2032. The analysis covers AD market uptake by drugs; patient uptake by therapies; and sales of each drug. For example-Lebrikizumab is a novel, investigational, monoclonal antibody acquired by Eli Lilly when the company entered into a definitive agreement to acquire Dermira. The drug is designed to bind IL-13 with very high affinity to specifically prevent the formation of the IL-13Rα1/IL-4Rα heterodimer complex and subsequent signaling, thereby inhibiting the biological effects of IL-13 in a targeted and efficient fashion. It has received Fast Track designation in the US from the FDA for moderate-to-severe AD in patients aged ≥12 years and ≥40 kg. The drug is expected to enter the US in 2022. Almirall has licensed the rights to develop and commercialize lebrikizumab to treat dermatology indications, including AD, in Europe. Further, it has been reported that the development schedule of the drug remains on schedule with submission to the EMA expected in 2022 and subsequent approval and release estimated to be obtained in 2023. Moreover, in March 2021, the company initiated a new Phase III trial in Japan, with the primary completion date of July 2022. Considering these developments, we anticipate the drug to enter the Japanese market in 2023.
Note: Detailed emerging therapies assessment will be provided in the final report.
AD Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase II and Phase III stage. It also analyses AD key players involved in developing targeted therapeutics.Pipeline Development Activities
The report covers the detailed information of collaborations, acquisition and merger, licensing, patent details and other information for AD emerging therapies.Reimbursement Scenario in AD
- Dupixent MyWay is a patient support program designed to help patients access the drug as quickly as possible by providing helpful tools, Supplemental injection training, and one-on-one nursing support and resources. The Dupixent, MyWay Copay Card, helps eligible patients cover the OOP cost of the drug.
- Similarly, Eucrisa4you is a savings and support program designed by Pfizer for crisaborale ointment 2% to help patients with co-pay cards reduce the OOP costs on the patients and family.
- Moreover, Corectim Ointment 0.5%, which is approved and marketed in Japan for the treatment of patients with mild to severe AD, has been included in the National Health Insurance (NHI) price list in 2018 that provides copay option, mandatory treatment coverage and low cost medications based on an individual’s insurance scheme.
- Cloderm Cream patient access card indicated for the relief of the inflammatory and itching symptoms of corticosteroid-responsive skin diseases offers healthcare professionals and their patients new and improved prescription products at low cost or co-pay assistance to eligible candidates.
- Abbvie offers patient assistance programs that provide free AbbVie medicines (including Rinvoq: emerging therapy for AD in the US) to qualifying patients. myAbbVie Assist program supports patients who are being treated by a licensed US healthcare provider on an outpatient basis and prescribed an AbbVie medicine that is included in their assistance program, have limited or no health insurance coverage, demonstrate qualifying financial need and live in the United States.
KOL - Views
To keep up with current market trends, we take KOLs and SME's opinion working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders are group president, Pfizer Biopharmaceuticals, president and CEO, National Eczema Association, vice president of immunology development at Lilly and others. Their opinion helps to understand and validate current and emerging therapies treatment patterns or AD market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.Competitive Intelligence Analysis
We perform Competitive and Market Intelligence analysis of the AD Market by using various Competitive Intelligence tools that include - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.Scope of the Report
- The report covers the descriptive overview of AD, explaining its causes, signs and symptoms, pathophysiology, diagnosis and currently available therapies
Table of Contents
1. Key Insights2. Report Introduction3. Executive Summary4. Key Events5. SWOT Analysis14. Organizations contributing towards AD15. Patient Journey18. Potential of Current Therapies and Emerging Therapies20. Market Drivers21. Market Barriers22. Unmet Needs23. KOL Views26. Capabilities27. Disclaimer28. About the Publisher
6. Atopic Dermatitis Market Overview at a Glance
7. Disease Background and Overview
8. Treatment
9. Atopic Dermatitis Clinical Guideline: American Academy of Dermatology Association (2014)
10. Atopic eczema in under 12s: Diagnosis and management by NICE (updated 2020)
11. Consensus-based European guidelines for the treatment of atopic eczema (atopic dermatitis) in adults and children (2018)
12. Treatment Algorithm
13. Epidemiology and Patient Population
16. Marketed Drugs
17. Emerging Drugs
19. Atopic Dermatitis: Seven Major Market Analysis
24. Market Access and Reimbursement
25. Appendix
List of Tables
List of Figures
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- Sanofi
- Regeneron Pharmaceuticals
- Pfizer
- Japan Tobacco and Torii Pharmaceutical
- Eli Lilly and Company
- AbbVie
- LEO Pharma
- Incyte Corporation
- Arena Pharmaceuticals
- Oneness Biotech
- Galderma
- DS Biopharma
- Janssen
- Kymab
- Arcutis Biotherapeutics
- Qurient
- Cara Therapeutics
- Vanda Pharmaceuticals