Lindmik research | new trends in the global dermatological drug market
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——Acne vaccine, cell and gene therapy are advancing by leaps and bounds

1. The demand for complex skin diseases has exploded
Skin is the largest organ system in the human body, which can protect the internal organs of the human body from bacterial infection and other injuries. Most of us have experienced skin diseases at some stage of our lives. Recently, however, due to environmental pollution, mental stress, lifestyle and other factors, the prevalence of skin diseases such as acne, atopic dermatitis (AD), psoriasis and rosacea has increased dramatically. As a result, dermatology, or the branch of medicine dealing with skin and various skin diseases, has achieved remarkable growth.

It is estimated that the global dermatology market is expected to climb at a compound annual growth rate (CAGR) of 11.5%, from $19.9 billion in 2020 to $59.3 billion in 2030. In the past few years, dermatology has witnessed technological progress, new drug approval and several heavy investment mergers and acquisitions. Major companies in this field include goldmine, almirall, Amgen, Sanofi, Alberto, eljian, Lilly, GlaxoSmithKline, Janssen and Novartis.

According to the China Health Statistics Yearbook, the number of dermatological outpatient and emergency patients in China in 2012 was 82.4197 million, and the number of dermatological outpatient and emergency patients in China in 2019 was 120.3001 million, an increase of 45.96% over 2012. In 2012, the number of discharged patients with skin and subcutaneous tissue diseases in China was 257700, and the per capita medical cost was 4721.90 yuan; In 2019, the number of discharged patients with skin and subcutaneous tissue diseases in China was 843700, and the per capita medical cost was 6514.03 yuan. The compound growth rate of discharged patients from 2012 to 2019 was 21.86%, and the compound growth rate of per capita medical cost was 5.51%.

The incidence rate of dermatosis in China is increasing year by year, and the market scale of dermatological drugs is also increasing. By the end of 2021, the scale of China's dermatological medicine market has reached 19.56 billion yuan, and the compound annual growth rate from 2019 to 2020 has reached 5.4%.

2. Acne vaccine, personalized medicine, CRISPR new breakthrough, completely changing dermatology
Several technological breakthroughs have made it possible to detect skin diseases at an early stage. Last month, Ampel biosolutions, headquartered in Virginia, announced a breakthrough in precision and personalized medicine, which could completely change the way doctors treat lupus, psoriasis, atopic dermatitis and scleroderma. It is a kind of gene expression data obtained from patients' skin biopsy through machine learning method to characterize the development of disease. It is possible to treat skin diseases before the disease damage begins by accurately diagnosing and characterizing molecular abnormalities, overturning the traditional way doctors treat chronic skin diseases.

The blockbuster products being developed include acne vaccine, which is a common bacterial skin disease affecting teenagers and young people. In December last year, Sanofi acquired origin biotechnology and obtained the developing variety ori-001, which is the first candidate vaccine against acne. The vaccine fights a bacterium parasitic in human skin and prevents it from producing toxins that cause inflammation. The phase 1 / 2 trial of the vaccine is scheduled to start in 2023.

Similarly, last year, GlaxoSmithKline signed a potential $224million deal with eligo Bioscience, whose eligo biotechnology technology uses CRISPR technology platform (a technology that can edit genes) to inhibit inflammation induced gene expression. Abeona therapeutics, Aegle therapeutics, castlecreek Biosciences and other companies are also using cell and gene therapy to treat epidermolysis bullosa, a rare genetic skin disease that can lead to very fragile skin.

In recent years, the number of approved dermatological products has increased, driving market growth. In June 2022, elililly and Incyte announced that FDA approved olumiant as the first systemic treatment for alopecia areata, an autoimmune disease that causes acute hair loss. Olumiant was first approved for rheumatoid arthritis in 2018.

In April 2022, FDA approved the epsolay topical cream of sol gel technologies and Galderma for the treatment of adult rosacea rhinitis. Rosacea is a skin condition that causes facial redness, usually a small, red, pus filled lump. In July 2021, FDA approved twyneo cream, which is the first fixed dose of retinoic acid and benzoyl peroxide compound semi-solid preparation for the treatment of acne erythematosa or inflammatory lesions of acne erythematosa.

3. FDA Approves several new drugs for eczema
Atopic dermatitis (AD), also known as eczema, is characterized by dry, inflamed, and itchy skin patches. It can appear at any age, but it is particularly common in childhood.
Janus kinases (JAKs) are intracellular enzymes that usually play a role in pro-inflammatory cell responses. JAK inhibitors are a new class of drugs for the treatment of atopic dermatitis.

On January 14 this year, FDA approved Pfizer's cibinqo tablet (abrocitinib), a JAK inhibitor for adults with moderate to severe AD. Pfizer has set the target sales of cibinqo at $3billion. On the same day, FDA also approved rinvoq tablets (upadacitinib, upatinib), another JAK inhibitor, for the treatment of moderate to severe AD in adults and children aged 12 years and over. Albright predicts that rinvoq's risk adjusted sales will exceed $7.5 billion in 2025. Both drugs were approved for marketing in Europe last year.

In January 2021, Sanofi acquired kymab at a price of up to $1.5 billion. Through this transaction, Sanofi will obtain kylab's candidate drug in the phase 2 trial - ky1005 (amlitelimab), a monoclonal antibody used to treat a variety of inflammatory diseases, including ad and cancer. This month, Sanofi and dupixent (dupilumab) became the first and only biological drug in the United States to treat children with moderate to severe eczema.

Leo Pharma was approved by the United States in December 2021 as an injectable drug adbry (tralokinumab ldrm). It is the first and only biological product that can specifically bind and inhibit IL-13 cytokines, which are the key drivers of atopic dermatitis. As early as 2016, Leo Pharma signed an exclusive global license agreement with AstraZeneca for tralokinumab. Similar drug adtralza (tralokinumab) was authorized by the European Commission in June 2021.

Elililly also announced the positive top line results of the phase 3 test of lebrikizumab, an IL-13 monoclonal antibody. Lilly plans to submit lebrikizumab's biological agent license application (BLA) for the treatment of atopic dermatitis to FDA in the second half of 2022.

Amgen and kylin announced a US $1.2 billion intended transaction to jointly develop and commercialize khk4083 (rocatinlimab), which is currently in the phase 3 pilot phase. Khk4083 is a human monoclonal antibody based on the patented technology of kylin, which is used to treat moderate and severe AD. AstraZeneca also uses the same Concorde Kirin Technology in fasenra (benarizumab), which has been approved for the treatment of asthma and is currently in phase 2 clinical trials of AD.

4. There are also heavy varieties of psoriasis approved
Psoriasis (commonly known as psoriasis) is an immune-mediated inflammatory disease, and some progress has been made recently. The most common is plaque psoriasis, which is characterized by dry, itchy and raised skin patches covered with scales. In December, 2021, FDA approved atezla of Amgen for the treatment of plaque psoriasis. The drug generated $451million in sales revenue in the first quarter of 2022.

Enbrel, the second drug of Amgen to treat the same disease, almost doubled its sales in the last quarter to $862million. South Korea SamSung bioepis is a biosimilar drug with reference to Enbrel, named benepali (etanercep), which is a pre filled syringe injection. In January this year, Samsung biopharmaceutical agreed to spend US $2.3 billion to acquire the shares of Biogen in Samsung bioepis, a joint venture between Biogen and Samsung established in 2021 to develop and manufacture biosimilars.

In May, dermavant Sciences obtained FDA approval for the listing of vtama (tapinarof, benvid Maud cream, listed in China in May 2019), which is an external cream for the treatment of adult plaque psoriasis. Vtama is the first steroid free topical therapy of its kind.

People with psoriasis often have joint inflammation, resulting in arthritis symptoms, which is called psoriatic arthritis. BMS' deucravacitinib is currently under regulatory review in several regions, including the United States, Europe and Japan. If approved, it will become the first selective allosteric Tyk2 inhibitor for the treatment of moderate to severe plaque psoriasis and will compete with otezla of Amgen. Tyk2 is the abbreviation of tyrosine kinase 2 and a member of JAK family. The therapeutic value of targeting this pathway in autoimmune diseases has been supported by human genetics. FDA will make an approval decision on deucravacitinib in September. BMS estimates that deucravacitinib will reach $4billion in sales at its peak.

In October 2021, moonlake immunotherapeutics and helix acquisition reached a business merger agreement, focusing on promoting the three specific nano antibody sonelokemab, which is in the phase 2 trial stage and is used to treat psoriasis and other skin and joint diseases.

In 2021, protagonist therapeutics revised its cooperation agreement with Janssen Pharmaceutical to increase the transaction amount to $987.5 million. As early as 2017, the two companies announced a transaction to develop pn-235, the first oral IL-23 receptor antagonist currently in the second stage of plaque psoriasis. In March this year, protagonist therapeutics received a milestone payment of $25million. If approved, the drug will become the first targeted oral therapy for plaque psoriasis.

5. Le Ming's point of view
The growth of skin diseases, technological progress and publicity activities are stimulating the growth of skin disease product market. The covid-19 pandemic has increased the use of remote dermatology. Doctors are increasingly using mobile applications, telemedicine, machine learning algorithms, nano medicine, artificial intelligence and other technologies to treat skin diseases.

JAK inhibitors, such as Pfizer's cibinqo, Alberto's rinvoq and Lilly's olumiant, are becoming a new class of drugs. However, data have linked these therapies to an increased risk of cardiovascular events and cancer. Therefore, the market hot spot has shifted to the selective inhibition of Tyk2, such as deucravacitinib of BMS.

In terms of global sales, the North American dermatological drug market contributed the largest market share in 2021, more than 35%. Europe is the second largest market, with a revenue share of more than 30% in 2021. However, by 2030, the Asia Pacific market is likely to expand at the highest compound annual growth rate of 12.2%. Given these predictions, we may see more transactions, drug approvals and technological advances in the coming years.

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