North America Cutaneous T-Cell Lymphoma (CTCL) Therapeutics Market Size, Share & COVID-19 Impact Analysis, By Drug Class (Histone Deacetylase (HDAC) Inhibitors, Monoclonal Antibody, Antineoplastic Agent, and Others), By Disease Type (Mycosis Fungoides (MF), Sezary Syndrome (SS), and Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies & Drug Stores, and Online Pharmacies), and Regional Forecasts, 2021-2028

The North America cutaneous T-cell lymphoma (CTCL) therapeutics market size was USD 225.9 million in 2020. The market is projected to grow from USD 240.9 million in 2021 and is expected to reach USD 587.4 million in 2028 at a CAGR of 13.6% in the 2021-2028 period. The impact of COVID-19 has been unprecedented and staggering, with cutaneous t-cell lymphoma therapeutics witnessing a slow growth in demand across North America amid the pandemic. Based on our analysis, the North American market witnessed a growth of 8.2% in 2020 as compared to the average year-on-year growth during 2017-2019. The sudden rise in CAGR is attributable to the market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.

Cutaneous T cell Lymphoma  is a rare disease with mycosis fungoides (MF) as a common type and sezary syndrome (SS) being the leukemic form. The condition advances with skin, node, metastasis, blood, and later stages show poor prognosis. The treatment is focused on symptomatic management according to the clinical staging and subtype of the disease. Skin-directed topical treatment is the mainstay of therapy in the early stages. However, there is an absence of long-term curative therapies for advanced disease.

This market is expected to witness significant growth due to increasing prevalence of the condition. It is known that the condition affects males twice as often as females and it affects older people more often than younger people. Hence, growing geriatric population coupled with increasing awareness pertaining to the rare cancer type are primary reasons that have led to the increased diagnosis of the condition, thereby boosting demand for cutaneous t-cell lymphoma therapeutics. For instance, according to an article by the Cleveland Clinic, about 3,000 new cell lymphoma patients are diagnosed in the U.S. each year, and about 16,000 to 20,000 people in the U.S. have mycosis fungoides.

Delay in CTCL Diagnoses Lead to a Slower Growth in the North America Market

The outbreak of the COVID-19 pandemic had a slow growth impact on the cutaneous-t cell lymphoma therapeutics market in North America. A few of the key market players reported a slight decline in revenue during the eruption of COVID-19. The reallocation of healthcare resources, a decline in the number of diagnostic procedures, such as skin biopsies, and disruption in the treatment rate affected major players' sales volumes and revenues. The pandemic had a negative impact on cancer detection services and outcomes for patients. The COVID-19 lockdown severely affected daily activities in outpatient clinics, emergency services, elective surgery and rehabilitation. Across the pandemic timeframe, the diagnosis rate of new cases declined significantly during the initial peak period of the COVID-19 pandemic.

As per an article published by the PLOS, a precipitous drop of 15% has been observed in the total number of skin biopsies, an 18% drop in biopsies for keratinocyte carcinoma (KC), and a 27% decline in melanoma patient diagnosis rate across the U.S. during the initial 8 months period of the COVID-19 pandemic. The Dermatology Centre at Salford Royal Trust has reported a dramatic drop in urgent skin cancer referrals since the COVID-19 crisis began.

However, post the peak period of the pandemic, the rate of skin biopsies has significantly grown, especially after June, specifically due to the huge backlog of cases. Hence, the abovementioned factor has helped mitigate the negative impact of the pandemic up to a certain extent, thus witnessing only a moderate decline across the year 2020. 

LATEST TRENDS

Increasing Clinical Trials Pertaining to the Development of Novel Therapeutics to Lead to Future Growth Prospects

An increasing number of clinical trials pertaining to the development of novel therapeutics is one of the major trends witnessed across the North America market. Currently, there are no curative therapeutics for this condition, and consecutive treatments tend to be given until loss of response. Hence, growing research on the development of novel cutaneous T-cell lymphoma therapeutics to treat the condition will strongly support market expansion. For instance, in September 2021, Soligenix, Inc.’s candidate HyBryte demonstrated positive results in Phase 3, pivotal FLASH (Fluorescent Light Activated Synthetic Hypericin) study in patients suffering from early stage of this disease. The aforementioned factors are anticipated to offer a lucrative growth opportunity for the North America market growth to flourish in the forthcoming years.

DRIVING FACTORS

Promising Therapeutics Pipeline in Cutaneous T-cell Lymphoma Market to Augment Market Growth

Rising number of novel CTCL therapeutics being launched and growing efforts from several manufacturers to develop potential drugs for the treatment of CTCL are among the major factors anticipated to support the North America cutaneous T-cell lymphoma therapeutics market growth during the forecast period. An increasing number of clinical trials conducted by major players to develop novel treatment drugs has offered lucrative opportunities for the cutaneous t-cell lymphoma therapeutics industry to flourish in North America. Around 20-25 key companies are developing this therapeutics in the region. Among them, Soligenix Inc. has the drug candidate in the most advanced stage (Phase III).

In May 2017, miRagen Therapeutics announced that its product candidate, MRG-106 had established orphan drug designation from the European Commission to treat cutaneous t-cell lymphoma. Such regulatory breakthroughs in other developing regions is expected to pave the way for new product launches in North America.

In April 2021, Bioniz Therapeutics announced that the European Commission (EC) approved orphan designation to BNZ-1 for the treatment of CTCL. Hence, such factors are anticipated to drive the industry’s growth rate.

Improved Diagnosis Techniques to Increase Adoption of Drugs Leading to Market Growth

Cutaneous t-cell lymphomas continue to represent a significant diagnostic challenge. Lack of definitive molecular markers and variation in clinical presentation make a diagnosis of the condition especially challenging. However, across the past decade, several advancements in diagnosis techniques pertaining to rare diseases have augmented the diagnosis process level, thus propelling the rate of reported cases.

Progressive techniques, such as next-generation sequencing (NGS), have enabled a much deeper understanding of the genomic scenario of CTCL by uncovering epigenetic dysregulations and aberrant genetic pathways. Moreover, single-cell profiling is promptly advancing the understanding of a patient’s specific tumor landscape. Such studies have paved the way for future research that will establish effective therapeutic targets with more durable clinical responses in the treatment of the disease.

Furthermore, owing to advancements in diagnosis techniques, several other rare forms of the condition have been identified and provided a scope for the development of more advanced targeted therapeutics.

RESTRAINING FACTORS

High Cost of Therapeutics to Hinder Market Growth in Forecast Period

High cost associated with CTCL therapeutics is anticipated to restrict market growth to a certain extent, especially in middle-income countries. For instance, as per the British Journal of Dermatology, this condition was estimated to cost USD 73,389.0 in the average patient's lifetime. Furthermore, as per the Journal of Dermatological Treatment, the annual treatment cost per person with drugs such as vorinostat is around USD 65,000.0 while bexarotene costs around USD 239,424. Other drugs, such as Denileukin Diftitox, Romidepsin, and Vorinostat, were less effective and cost more than methotrexate.

SEGMENTATION

By Drug Class Analysis

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Presence of Novel Drugs in the Monoclonal Antibody Segment to Lead to Segment’s Strong Market Share

The monoclonal antibody segment accounted for a dominant share of the North America market for cutaneous t-cell lymphoma therapeutics in 2020. Specifically, the introduction of innovative monoclonal antibodies against presumptive pathogenic molecules has resulted in targeted approaches toward the clinical management of this group of disorders.

Poteligeo is a monoclonal antibody developed by Kyowa Kirin to treat CTCL. The drug initially generated a revenue of USD 18.0 million in 2017. However, in 2018, the U.S. FDA approval led to the launch of Poteligeo across the U.S. The drug witnessed a significant surge in its total revenue from 2018 and 2019 due to high adoption across the U.S. for the treatment of this disease. Furthermore, the segment is expected to witness lucrative growth across the forecast period owing to the increasing number of drug candidates in the category to be launched by the end of the analysis period.  

Histone deacetylase (HDAC) inhibitors have been a promising new treatment approach for cutaneous T-cell lymphoma. Vorinostat, a pan-HDAC-I, and Istodax, a bicyclic pan-HDAC-I, have been U.S. FDA approved for treating relapsed or refractory CTCL. Furthermore, various drugs are in the pipeline across the category, which are estimated to be launched by the end of the forecast period. For instance, Panobinostat is an HDAC inhibitor forecasted to be launched by 2026 by Novartis. The aforementioned factors are supporting HDAC inhibitors based cutaneous t-cell lymphoma therapeutics segmental growth.

By Disease Type Analysis

Strong Adoption of Therapeutics for Sezary Syndrome (SS) to Lead to Segment’s Dominance

The sezary syndrome (SS) segment held the highest market share in 2020 and is anticipated to reflect a significant CAGR across the analysis timeframe. High shares of the segment is majorly due to the fact that sezary syndrome (SS), which is an advanced stage of the condition is primarily responsive to treatment with systemic drug therapies such as Bexarotene, Denileukin Diftitox, Methotrexate, Pralatrexate, Romidepsin, and Vorinostat. Hence, the comparatively high adoption of cutaneous T-cell lymphoma therapeutics in the treatment of sezary syndrome (SS) is one of the major factors supporting the segment's growth.

On the other hand, mycosis fungoides (MF) segment is anticipated to witness the highest CAGR during the forecast period. High share of the segment are primarily due to a large patient pool suffering from MF. For instance, as per Kyowa Kirin, in 2018, SS and MF were the two common subtypes of CTCL. Mycosis fungoides is the most common subtype, accounting for 55-70% of cases. Hence, the presence of a large patient pool in the category is one of the major factors responsible for the significant share of the segment.

By Distribution Channel Analysis

Strong Adoption of OTC & Generic Medications Anticipated to Lead to Retail Pharmacies & Drug Stores Segment’s Dominance

In terms of distribution channel, the retail pharmacies & drug stores segment held major market share in North America. The growth is due to the rise in the number of generic products being introduced by domestic and global players, along with the rising number of drugs being labeled over-the-counter drugs.

The online pharmacies segment is expected to grow at a higher CAGR during the forecast period. The growth is attributed to increasing shift of the patient population in metropolitan and capital cities toward e-commerce platforms for procurement of drugs. This is further augmented by the rapid growth of the online pharmacies segment, with leading e-commerce giants entering the lucrative segment in developed and emerging countries.

REGIONAL INSIGHTS

The market stood at USD 225.9 million in 2020. The U.S. accounted for a major portion of the market in 2020. High shares of the region are due to the rapidly growing diagnosed cases of the disease across the U.S. For instance, as per Cleveland Clinic, there are about 3,000 new cases of CTCL in the U.S. each year, and about 16,000 – 20,000 Americans have mycosis fungoides. Furthermore, an increasing number of pharmaceutical companies are focusing on developing drugs for the U.S. market. Also, the presence of a large patient pool with unmet medical needs across the region will further stimulate market expansion. On the other hand, Canada held a minimal market share compared to the U.S.

KEY INDUSTRY PLAYERS

Strong Product Portfolio of Kyowa Kirin Co., Ltd., Bausch Health (Ortho Dermatologics), and Helsinn Healthcare SA to Propel their Market Dominance

This market is consolidated, with major players, such as Kyowa Kirin Co., Ltd., Bausch Health (Ortho Dermatologics), and Helsinn Healthcare SA, holding the largest market share. Kyowa Kirin Co., Ltd. held the highest market share in 2020 due to increased adoption of its brand Poteligeo. Other prominent players operating in the market are Helsinn Healthcare SA, Bausch Health (Ortho Dermatologics), Celgene Corporation, Merck & Co., Inc, Pfizer Inc., and GlaxoSmithKline plc (Stiefel dermatology).

LIST OF KEY COMPANIES PROFILED:

• Kyowa Kirin Co., Ltd. (Tokyo, Japan)


• Merck & Co., Inc. (Kenilworth, U.S.)


• Mallinckrodt plc (Staines-Upon-Thames, U.K.)


• Bausch Health (Ortho Dermatologics) (Quebec, Canada)


• Helsinn Healthcare SA. (Lugano, Switzerland)


• Pfizer Inc. (New York, U.S.)


• GlaxoSmithKline plc (Stiefel dermatology) (London, U.K.)

KEY INDUSTRY DEVELOPMENTS:

• July 2020- Mallinckrodt and Terumo BCT announced positive recommendations in Australia for public funding of UVADEX (methoxsalen) for ECP administration with the THERAKOS CELLEX Photopheresis System for the treatment of cutaneous T-cell lymphoma in adults using the THERAKOS CELLEX Photopheresis System.


• September 2021- Dr. Reddy's Laboratories signed a contract with Citius Pharma to sell its rights to an anti-cancer agent called E7777, after an milestone approval related to the cutaneous T-cell lymphoma. 

REPORT COVERAGE

An Infographic Representation of North America Cutaneous T-Cell Lymphoma (CTCL) Therapeutics Market

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The market report provides a detailed analysis of the industry. It focuses on key aspects, such as leading companies, competitive landscape, drug class, and distribution channel. Moreover, it offers insights into the market trends, the impact of COVID-19, and the prevalence and incidence of CTCL, among others. In addition to the aforementioned factors, the report also encompasses a pipeline analysis of potential drug candidates to treat this type of lymphoma.

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