North America Basal Cell and Squamous Cell Carcinoma Therapeutics Market Size, Share & COVID-19 Impact Analysis, By Drug Class (Monoclonal Antibodies, Antineoplastic, Hedgehog Pathway Inhibitors, and Others), By Route of Administration (Oral, Topical, and Parenteral); By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies), and Forecast, 2021-2028

The North America basal cell and squamous cell carcinoma therapeutics market size was USD 578.2 million in 2020 and is projected to grow from USD 825.6 million in 2021 to USD 2,353.4 million in 2028 at a CAGR of 16.1% in the 2021-2028 period. The impact of COVID-19 was unprecedented and staggering, with basal cell and squamous cell carcinoma therapeutics witnessing a negative impact on demand across the region amid the pandemic. Based on our analysis, the North America basal cell and squamous cell carcinoma therapeutics industry exhibited a lower growth of 26.5% in 2020 as compared to the average year-on-year growth during 2017-2019. The rise in CAGR is attributable to this market’s demand and growth, returning to pre-pandemic levels once the pandemic is over.

Out of the total skin cancer prevalence globally, non-melanoma cancers account for roughly 2% of the total population, while melanoma skin cancer accounts for around 98% of the total population. Basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) are two major types of non-melanoma skin cancers. The majority of the cases of skin cancers are basal cell carcinomas. If BCC and SCC remain untreated, there is a higher risk of spread to other parts of the body with the help of lymph nodes. The first line of treatment for non-melanoma skin cancer is surgery. Out of all patients, the majority of the patients opt for surgery and excision procedures for treatment, while approximately 5-10% of patients select medication as the first line of treatment. Patients suffering from advanced and metastatic forms of BCC and SCC are not considered good candidates for surgery.

• According to the Centers for Disease Control and Prevention (CDC), around 3.5 to 4.0 million people in the U.S. were suffering from non-melanoma skin cancers in 2020. Basal cell carcinoma accounted for around 80% of total incidences in the region. Also, around 10% of these patients are not considered good candidates for surgery due to the advanced stage of cancer and age of the patient, among other factors. This factor presents a large patient pool requiring additional treatment.

The rising prevalence of advanced BCC and SCC cases leads to an increasing number of patients requiring medications. Furthermore, an increasing number of approvals by regulatory authorities for new drugs in the U.S. is driving the market's growth. 

• For instance, in February 2021, the U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC).

Moreover, the companies including Bristol-Myers Squibb, Genentech, Inc., Sirnaomics, and AiViva BioPharma, Inc. are conducting clinical trials for the development of innovative therapeutics for the treatment of BCC and SCC is likely to increase the number of new product launches in the near future which is also anticipated to drive the market growth in near future. For instance, out of all the clinical trial candidates, 16.6% are in Phase-III/IV and show promising results to be approved for use in basal cell carcinoma treatment.

Decrease in Diagnosis Rate amid COVID-19 Pandemic to Restrict Market Growth

The COVID-19 pandemic had a negative impact on the North America basal cell and squamous cell carcinoma therapeutics market. The surge in the number of COVID-19 cases severely impacted the number of diagnoses and subsequently hampered the ongoing treatments in North America. The strong focus of healthcare systems towards managing the COVID-19 pandemic, the significant decline in the number of diagnostic procedures, and the decrease in procedures such as skin lesion biopsies resulted in a decline in detection of new cases, especially during the initial phase COVID-19 Pandemic.

Additionally, the COVID-19 pandemic was accountable for disrupting medical practices, severely hampered daily outpatient visits, elective procedures, and rehabilitation programs. The skin cancer therapies were categorized as a low priority during the COVID-19 pandemic, which significantly hampered the growth of the North America basal cell and squamous cell carcinoma therapeutics industry during the first half of 2020.

• For instance, according to a report published by the American Academy of Dermatology (AAD), the number of skin cancer diagnoses in the U.S. declined 46% from March to May 2020 compared to 2019.

Major market players such as F. Hoffmann-La Roche Ltd. and Eli Lilly and Company reported a reduction in revenues during 2020. For instance, Eli Lilly and Company recorded a 1.3% decline in revenues generated by Erbitux in 2020 compared to the revenue generated in 2019.

LATEST TRENDS

Rising Regulatory Approvals and Growing Adoption of Monoclonal Antibodies to Support Market Growth

The key players operating in the market are investing heavily in developing innovative products for the treatment of basal cell and squamous cell carcinoma. The major pharmaceutical companies operating in the market are conducting research studies to gain extended product approval for their existing oncology solutions. This factor is anticipated to increase product launches for North America basal cell and squamous cell carcinoma therapeutics in the near future.

For Instance, In July 2021, Merck received the U.S. Food and Drug Administration (FDA) approval of Keytruda as an expanded label for treating patients with cutaneous squamous cell carcinoma (cSCC), which cannot be cured through radiation therapy or surgery. Development of innovative therapies and new product approvals are anticipated to provide favorable conditions for the market's growth in North America.

DRIVING FACTORS

Increasing Prevalence of Non-Melanoma Skin Cancer to Drive Demand for Therapeutic Solutions

The growing prevalence of non-melanoma cancer and a significant rise in the number of inoperable patients in the region are accountable for the increasing demand for novel basal cell and squamous cell carcinoma therapeutics during the forecast period. It is observed that the risk of skin cancer among the aged population is significantly more as compared to the general population.

• For instance, according to the data published by the International Agency for Research on Cancer, the incidence of basal cell carcinoma in the U.S. was 131 cases per 100,000 population. The incidence of squamous cell carcinoma was 32.86 cases per 100,000 population in 2020.

The increasing number of patients in the advanced stage who are poor candidates for surgery due to the compromised immune system is anticipated to increase the demand for effective medications to treat non-melanoma skin cancers. Thus, boosting the North America basal cell and squamous cell carcinoma therapeutics market growth during the forecast period.

RESTRAINING FACTORS

High Cost of Drug Therapies and Availability of Alternative Treatment Options to Limit Market Growth

Although there have been significant developments in the treatment of the disease, along with the introduction of innovative therapies, certain factors are limiting their adoption. One of the major factors responsible for hampering market growth is the high costs associated with basal cell and squamous cell carcinoma therapeutics.

• For instance, according to the research studies published in the journal of the American Medical Association and National Center for Biotechnology Information, the average annual cost of biologics for the treatment of basal cell carcinoma and squamous cell carcinoma is around USD 90,000-150,000 in the U.S. Similarly, the annual cost of monoclonal antibody medication is around USD 70,000 in the U.S.

Additionally, the increasing preference of patients and healthcare providers towards alternative options, including surgical excision, MOHS surgery, curettage and electrodesiccation, radiation therapy, and photodynamic therapy, is one of the prominent factors restraining the market growth. The comparatively low cost and high efficiency of these procedures is the primary reason for the higher adoption of alternative treatment options. Thus, it is responsible for limiting the market growth during the forecast period.

SEGMENTATION

By Drug Class Analysis

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Introduction of New Drugs by Market Players to Drive Growth of Hedgehog Pathway Inhibitors

Based on the drug class, the market is segmented into monoclonal antibodies, antineoplastic, hedgehog pathway inhibitors, and others.

The hedgehog pathway inhibitors segment accounted for the largest share in 2020 owing to the increasing regulatory approvals for hedgehog pathway inhibitors as the first line of treatment in major markets. Moreover, the introduction of new hedgehog pathway inhibitors and recent product approvals in this category is also driving the market segment growth during the forecast period.

• For instance, the National Comprehensive Cancer Network (NCCN) and the American Academy of Dermatology recommend medication therapy if the patient is not eligible for the first line of treatments such as surgical and radiation treatment hedgehog pathway inhibitors. Similarly, the American Cancer Society and Canadian Dermatology Association recommend Vismodegib (Hedgehog Pathway Inhibitor) recommended therapy for patients with locally advanced or metastatic basal cell carcinoma (BCC).

The monoclonal antibodies segment is likely to showcase significant growth during the forecast period attributed to the increased adoption of monoclonal antibodies in the treatment of BCC & SCC and recent product launches in this segment.

According to investor presentations and annual reports, Libtayo (cemiplimab-rwlc) is anticipated to achieve peak sales of USD 1.20 billion globally to treat cutaneous squamous cell carcinoma (cSCC).

Similarly, RP1, intra-tumoral injection, is estimated to reach peak sales of roughly USD 1.70 billion globally by the end of 2024. Thus, the increasing number of product launches in this segment is anticipated to drive growth during the forecast period.

By Route of Administration Analysis

Increasing Product Launches was Responsible for Dominance of Oral Segment in 2020

The market is segmented into oral, parenteral, and topical drugs based on the route of administration. The oral medicines segment held the largest share in the market in 2020 and is estimated to show significant growth in the near future. The growing preference of patients towards oral drugs and increasing adoption of hedgehog pathway inhibitors are anticipated to support segment growth.

• According to the data available on clinicaltrails.gov, more than 40% of the total basal cell carcinoma (BCC) clinical trials belong to the oral route of administration. This factor is anticipated to support the domination of the oral route of administration in the near future.

The parenteral segment accounted for a comparatively lower share in the market. However, the increasing patient population in the U.S., growing preference towards monoclonal antibodies, and higher efficiency of parenteral therapies compared to the other route of administrations are anticipated to drive the segment growth during the forecast period.

By Distribution Channel Analysis

Growing Shift of Patients Towards Online Platforms Attributed to Higher Growth of the Segment

On the basis of the distribution channel, the North America basal cell and squamous cell carcinoma therapeutics market is segmented into hospital pharmacies, retail pharmacies, and online pharmacies.

The hospital pharmacies segment held the largest share in the market in 2020.  Increasing hospital admissions for treatment of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) coupled with the growing adoption of biologics to treat non-melanoma cancer is responsible for the growth of the hospital pharmacies segment. The parenteral drugs are strictly administered by trained medical staff and primarily purchased from hospital pharmacies, which are responsible for driving the segment's growth during the forecast period.

•  According to the report published by the Canadian Institute for Health Information, more than 3 million hospital admissions occurred with a hospitalization rate of 7,699 per 100,000 between 2019-2020. The demand for BCC and SCC medications is significantly higher in hospital-attached pharmacies owing to the hospital administration of parenteral drugs.

The online pharmacies segment is anticipated to be one of the fastest-growing segments due to favorable regulatory policies for online selling of prescription drugs, changing customer preference towards online pharmacies due to the attractive offers and ease of use coupled with the growing number of online pharmacies in the region.

REGIONAL INSIGHTS

The U.S. accounted for USD 547.3 million in 2020 owing to the increasing patient pool suffering from basal cell and squamous cell carcinoma, the presence of major players in the market, the introduction of novel therapies in the country by market players and favorable reimbursement policies.  Also, the growing incidence of advanced BCC and SCC is leading to a rising patient pool eligible for oral and parenteral treatment options. This is anticipated to lead to a higher demand for novel drugs in the treatment of basal cell and squamous cell carcinoma in the U.S. during the forecast period. Moreover, the increasing number of advanced phase clinical trials with growing research and development activities in the country are anticipated to support the market growth during the forecast period.

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  • For instance, in September 2018, Regeneron Pharmaceuticals Inc. received the U.S. FDA approval for Libtayo for the treatment of patients with Squamous Cell Carcinoma (SCC).  
  
  
  • Additionally, in October 2020, AiViva BioPharma, Inc., announced initiation of dosing the patients diagnosed with superficial or nodular basal cell carcinoma (BCC) with AIV001 in Phase 2 trials.
  
  
  
  

Canada is anticipated to hold a significant market share in the market during the forecast period. This is attributable to the rising prevalence of BCC and SCC in the country, the growing healthcare industry, rising R&D for and the increasing government initiatives for awareness towards treatment of non-melanoma skin cancers.

KEY INDUSTRY PLAYERS

Strong Distribution Network Portfolio and Stout Brand Presence Help Dominate Market

This market is consolidated with prominent key companies accounting for majority share of the market in 2020. The diverse portfolio of major players, along with the strong and widespread distribution network across the region, are some of the key factors attributed to the dominance of the players in the market.

F. Hoffmann-La Roche Ltd., Regeneron Pharmaceuticals Inc., Merck & Co., Inc., Sanofi, and Sun Pharmaceutical Industries Ltd., are among the major players operating in the market in 2020. Additionally, these companies have a strong domestic presence in the U.S. Market players are further reinforcing their market presence through strategic partnerships, acquisitions and mergers, and launch of novel solutions.

• For instance, in January 2020, Merck & Co., Inc. collaborated with Astex Pharmaceuticals (U.K.) and Taiho Pharmaceutical Co, Ltd. for the development of small-molecule inhibitors KRAS oncogene and other drug targets. KRAS oncogene is presently being evaluated cancer treatment.

In the current competitive landscape of the market, other players such as Bausch Health Companies Inc. and Eli Lilly and Company are continuously focusing on the development of innovative therapeutics in order to establish their foothold in the market.

LIST OF KEY COMPANIES PROFILED:

• F. Hoffmann-La Roche Ltd. (Switzerland)


• Eli Lilly and Company (U.S.)


• Merck & Co., Inc. (U.S.)


• Sanofi (France)


• Regeneron Pharmaceuticals Inc. (U.S.)


• Bausch Health Companies Inc.  (Canada)


• Sun Pharmaceutical Industries Ltd. (India)

KEY INDUSTRY DEVELOPMENTS:

• June 2021 - Regeneron Pharmaceuticals Inc. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had approved Libtayo for the treatment of advanced basal cell carcinoma (laBCC).


• July 2019 - the European Commission (EC) has granted authorization for marketing Libtayo for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who cannot be treated with curative surgery or curative radiation.

REPORT COVERAGE

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The North America basal cell and squamous cell carcinoma therapeutics market report provides a detailed analysis of the market and focuses on key aspects such as leading companies, product types, and leading applications of the product. Besides this, the report offers insights into the market trends and highlights key industry developments. In addition to the aforementioned factors, the report encompasses several factors that have contributed to the growth and advancement of the market over the recent years.

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