Merkel Cell Carcinoma Therapeutics Market

Market Overview

The global Merkel cell carcinoma therapeutics market size valued at USD 3.01 billion in 2022. It is estimated to reach USD 4.17 billion by 2031, growing at a CAGR of 3.78% during the forecast period (2023–2031). There has been a growing incidence of Merkel cell carcinoma, especially in the developed regions of the world. This growth can be primarily attributed to the aging population worldwide; thus, the surge in the aging population further drives the global Merkel cell carcinoma therapeutics market. Moreover, there is a surge in the research and development by key players to develop novel Merkel cell carcinoma therapeutics, thereby boosting the market expansion.

Merkel cell carcinoma (MCC) is an aggressive and rare type of skin cancer. It typically develops in the Merkel cells, found in the top layer of the skin (epidermis). Merkel cells are responsible for the sense of touch and are closely associated with nerve endings. MCC usually appears as a painless, firm, shiny lump or nodule on the skin, often on sun-exposed areas such as the head, neck, and limbs.

Merkel cell carcinoma is a highly aggressive cancer that can quickly spread to other parts of the body, including distant organs and lymph nodes. The treatment choice for Merkel cell carcinoma depends on the patient's overall health, the cancer stage, and other specific factors. There are several treatment modalities available. Treatment options may include radiation therapy, surgery to remove the tumor, and sometimes chemotherapy or immunotherapy.

Market Dynamics

Global Merkel Cell Carcinoma Therapeutics Market Drivers

Rising Prevalence of Merkel Cell Carcinoma

The rising incidence of MCC worldwide, particularly in developed regions like North America and Europe, is a prominent aspect driving the growth of the MCC therapies market. The American Cancer Society reported that approximately 2,000 instances of MCC are identified annually in the United States, with the occurrence rate steadily increasing in recent decades. Likewise, a research paper published in PubMed revealed that from 2000 to 2013, there was a significant 95% rise in the number of reported instances of MCC, in contrast to a 57% increase for melanoma and a 15% increase for all other types of 'solid' malignancies. The incidence rate of Merkel cell carcinoma (MCC) in the United States was 0.7 per 100,000 person-years in 2013, resulting in 2,488 cases.

Moreover, the incidence of MCC exhibited an exponential growth pattern with advancing age, ranging from 0.1 to 1.0 to 9.8 (per 100,000 person-years) in the age categories of 40–44, 60–64, and 85+ years, respectively. As a result of the increasing age of the "baby-boom" generation, it is projected that the incidence of US MCC will rise to 2,835 cases in 2020 and 3,284 cases in 2025. Hence, the increasing incidence of MCC, in conjunction with the aging demographic, is propelling the growth of the global market.

Growing Research and Development

Another factor contributing to the growth of the MCC therapeutics market is the progress made in developing innovative therapeutics for MCC. For instance, in October 2022, Tempus, a precision medicine company, announced its collaboration with Kartos Therapeutics to create a companion diagnostic (CDx) for the ongoing Phase II clinical trial of navtemadlin (KRT-232). This CDx aims to identify patients with TP53 wild-type (TP53WT) Merkel cell carcinoma (MCC) who are suitable for treatment with the drug candidate.

In May 2023, Phio Pharmaceuticals obtained approval from the US Food and Drug Administration (FDA) to begin a clinical trial of PH-762, an investigational new drug (IND) for treating skin carcinomas. PH-762, an INTASYL chemical, decreases the expression of cell death Protein 1 (PD-1), which hampers the ability of T lymphocytes to eliminate cancer cells. The company plans to initiate the Phase Ib clinical trial of intratumoral PH-762 in patients with cutaneous squamous cell carcinoma, melanoma, and Merkel cell carcinoma later this year.

Global Merkel Cell Carcinoma Therapeutics Market Restraint

Lack of Diagnosis or Misdiagnosis

A significant limitation of the MCC therapeutics market is the absence of accurate or incorrect MCC diagnoses, resulting in delayed or inadequate treatment and unfavorable prognosis. Due to its same visual characteristics and symptoms, MCC is frequently misidentified as other cutaneous diseases, including basal cell carcinoma, melanoma, squamous cell carcinoma, or cysts.

Diagnosing MCC can be challenging because of its rarity and the need for specific testing, such as immunohistochemistry, electron microscopy, or polymerase chain reaction (PCR), to definitively detect the existence of MCPyV or MCV. Consequently, a significant number of people suffering from MCC are accurately diagnosed once the disease has reached an advanced stage. This diminishes the likelihood of survival and amplifies the expenses and complexity of treatment.

Global Merkel Cell Carcinoma Therapeutics Market Opportunities

Development of Personalized Medicine and Biomarkers 

The advancement of personalized medicine and biomarkers for MCC enhances the ability to diagnose, predict the outcome, and treat MCC, hence offering opportunities for global market expansion. Personalized medicine is a medical practice or approach that customizes treatment depending on the characteristics of each patient, including their genetic composition, molecular profile, and reaction to medication.

Biomarkers are biological markers that may be quantified within the body, including genes, proteins, or metabolites. They offer insights into a disease's existence, intensity, or advancement, as well as the efficacy or harmfulness of a treatment. By combining personalized medicine with biomarkers, MCC can find the patients most benefit from immunotherapy and then carefully track their progress and side effects. PD-L1 expression on tumor cells or the tumor microenvironment can be a biomarker for predicting the response to avelumab or other PD-L1 inhibitors. Likewise, the amount of MCPyV or MCV present in the blood or tissue can function as a biomarker for tracking the progression and reappearance of the disease.

Regional Analysis

Based on region, the global Merkel cell carcinoma therapeutics market is bifurcated into North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global Merkel cell carcinoma therapeutics market shareholder and is expected to expand substantially during the forecast period. The market in North America is projected to dominate due to the high incidence of MCC, the accessibility to advanced treatments, the presence of major industry participants, and the favorable reimbursement policies in the region. For instance, the prevalence of MCC in the United States nearly doubled from 2000 to 2013 and is projected to surpass 3000 cases year by 2025. This rise could be attributed to a growing elderly population and advancements in diagnostic identification. Moreover, about 80% of Americans diagnosed with MCC are aged 70 or above. This is expected to stimulate the expansion of the regional market.

Furthermore, several research organizations have increased their interest in the research and development of MCC therapeutics. For instance, in February 2023, six researchers at the Fred Hutchinson Cancer Center were awarded grants of about USD 3.5 million from the Kuni Foundation. This brings the foundation's total contribution to Fred Hutch to over USD 12 million since 2020. The proposed projects aim to assess the utility of circulating tumor DNA (ctDNA) as a biomarker for Merkel cell carcinoma (MCC), create a therapeutic antibody to eliminate metastatic breast cancer, engineer an oncolytic measles virus for the treatment of B-cell non-Hodgkin lymphoma (B-NHL), examine the safety and feasibility of novel combination therapy for retroperitoneal liposarcoma, and employ multiomics and artificial intelligence to develop personalized therapy for meningioma. As a result, this is expected to accelerate the expansion of the North American market during the forecast period.

Europe is expected to experience the second-highest growth rate, primarily because of the growing awareness, increased research and development efforts, and the enhanced healthcare infrastructure in the region. There is a significant increase in the occurrence of MCC in this region, contributing to the further expansion of the market. As per the European Network of Cancer Registries, the occurrence of MCC in Europe rose by 95% between 1995 and 2007. Moreover, there has been a significant increase in the approval of novel medications for managing MCC.

For instance, in November 2023, Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) had recommended the approval of KEYTRUDA, Merck's anti-PD-1 therapy, in combination with gemcitabine and cisplatin. The information provided is intended especially for adult patients whose biliary tract cancer is locally advanced, incurable, or has spread to other areas. KEYTRUDA is approved for treating adult and pediatric patients with Merkel cell carcinoma (MCC) that has come back or spread to other tissues or parts of the body. These factors are expected to expedite the regional market's growth.

The Asia-Pacific region is expected to experience the highest pace of development due to its vast population, increasing demand for improved healthcare, and the emergence of new markets in the region. The incidence of MCC is progressively rising. In Australia, the incidence rate of MCC is 2.5 per 100,000 individuals, while in New Zealand, it is 0.96 per 100,000 individuals. Similarly, there has been an increase in the geriatric population in the region. According to the U.N., the Asia-Pacific population is experiencing a more rapid increase in the proportion of older people compared to any other region globally. The current Asia-Pacific population of those aged 60 years or over is 630 million, accounting for 60 percent of the total older people worldwide. By 2050, the global population is expected to reach 1.3 billion.

Moreover, the presence of an increasingly elderly population contributes to a higher likelihood of acquiring MCC, thereby enhancing the growth of the Asia-Pacific market for Merkel cell carcinoma therapeutics. However, the market in this region may need help due to the low diagnosis rate, limited awareness, and high treatment expenses.

Segmental Analysis

The global Merkel cell carcinoma therapeutics market is segmented by treatment type and distribution channel.

Based on treatment type, the global Merkel cell carcinoma therapeutics market is divided into chemotherapy, immunotherapy, combination therapy, and others.

Immunotherapy is the administration of medications that activate or augment the immune system to combat cancer cells, either through intravenous or subcutaneous injection. Immunotherapy is a contemporary and highly efficient therapeutic alternative for MCC, particularly for patients with severe or recurring illnesses. In 2017, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio), the initial immunotherapy medication for MCC. Avelumab is a monoclonal antibody targeting the PD-L1 protein in cancer cells, hindering their ability to evade the immune system.

Avelumab has demonstrated encouraging outcomes in enhancing individuals' survival and quality of life with advanced Merkel cell carcinoma (MCC). In 2018, the Food and Medication Administration provided rapid approval for pembrolizumab (KEYTRUDA®, Merck & Co. Inc.), an immunotherapy medication, to be used in adult and pediatric patients with recurrent locally progressed or metastatic Merkel cell cancer (MCC). These approvals are expected to stimulate the expansion of the segment.

Based on distribution channels, the global Merkel cell carcinoma therapeutics market is segmented into retail pharmacies, hospital pharmacies, and online pharmacies.

The hospital pharmacy is the designated location where medications are distributed or given to patients who are either admitted or receiving treatment within the hospital. This can occur through prescribed medications or those available for purchase without a prescription. Hospital pharmacists are vital in overseeing the hospital's medicine supply chain. This encompasses the acquisition, retention, and dissemination of pharmaceuticals. Their role includes mitigating drug shortages, managing inventory, and ensuring appropriate medication storage conditions.

The hospital pharmacy is the primary and most influential means of distributing MCC therapeutics. This is because the majority of MCC drugs, including chemotherapy, immunotherapy, and combination therapy, are administered through intravenous injection. Due to the nature of these treatments, they necessitate careful monitoring and supervision by medical personnel.

Recent Developments

• March 2023- The FDA approved Incyte's Zynyz (retifanlimab-dlwr) for treating metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in adult patients.
• October 2023-Immunomic Therapeutics, Inc. (ITI) disclosed the outcomes of its phase 1 clinical trial assessing the safety and tolerability of ITI-3000, a plasmid DNA (pDNA) vaccine designed to treat patients afflicted with Merkel cell carcinoma (MCC). The study demonstrated that ITI-3000 was safe and well tolerated, as no dose-limiting toxicities, treatment-related adverse events, or severe adverse reactions were reported.