メラノーマ治療の世界市場（2025年～2032年）

世界のメラノーマ治療の市場規模は、2024年に54億米ドルに達し、2032年には83億5,000万米ドルに達すると予測され、予測期間2024年～2032年のCAGRは5.6%で成長する見込みです。

パイプライン医薬品

皮膚がんにはメラノーマ皮膚がんと非メラノーマ皮膚がんの2種類があります。メラノーマ皮膚がんは、メラノサイトからがんに発展する最も一般的な皮膚がんです。メラノーマは白色色素を持つ集団に多く、黒色色素を持つ集団には少ないです。メラノーマは部位により、皮膚メラノーマ、ぶどう膜メラノーマ（眼）、粘膜メラノーマ（鼻、喉、性器、肛門など）に分類されます。皮膚メラノーマにはさまざまな種類があり、表在拡大型メラノーマが最も多く、次いで結節性メラノーマ、悪性黒子型メラノーマ、末端黒子型メラノーマなどがあります。メラノーマの多くは、太陽からの紫外線が原因です。

メラノーマの最も一般的な症状/徴候は、異常なほくろの形成または既存のほくろの発展です。メラノーマの物理的診断には通常チェックリストが用いられ、ほくろの非対称性（Asymmetrical）、境界（Border）、色（Color）、直径（Diameter）、進化（Evolution）を意味するABCDEと呼ばれます。

メラノーマの治療には、手術、放射線療法、化学療法、分子標的治療、免疫療法などがあります。選択される治療は、メラノーマが診断された病期によって異なります。

市場力学：

促進要因と抑制要因

メラノーマ有病率の上昇

メラノーマの有病率と罹患率の上昇は、予測期間における市場成長の主な促進要因です。この成長にはいくつかの要因がありますが、主な要因としては、紫外線への曝露の増加、皮膚メラノーマに対する意識の高まり、診断率の同時向上が挙げられます。国際がん研究機関の統計によると、2023年には世界中で33万9,041件の新たなメラノーマ症例が報告され、2030年には発生率が19％増の40万1,800件に達すると予想されています。さらに、2022年までの5年間の有病率は、世界で約120万人でした。

このような罹患率と有病率の増加は、先進的な治療法の開発を促進し、全体的な治療率を向上させます。これは、将来の市場成長を大きく促進する可能性があります。

メラノーマがんの過少報告が市場成長を抑制する可能性

すべてのがんの中で、メラノーマはその臨床徴候のために最も過小報告されているがんの一つです。メラノーマはほくろから始まるため、多くの人はそれを普通のものと考えて無視するかもしれません。そのため、新しい治療法の普及率が低くなる可能性があります。これは特に、メラノーマに対する認識が低い人々に見られます。また、症例の過少報告は、製品開発のための資源配分やメーカーによる市場拡大のための戦略的計画にも影響を与える可能性があります。

セグメント分析

世界のメラノーマ治療市場は、タイプ、治療法、地域によって区分されます。

治療法セグメントでは免疫療法が市場を席巻する見込み

免疫療法は、現在大きな支持を集めているがん治療の一種です。これは、がん細胞に対する身体の免疫反応を強化することを含みます。免疫療法薬にはさまざまな種類があり、メラノーマでは免疫チェックポイント阻害薬が承認され、広く使用されています。これらの免疫チェックポイント阻害剤は、免疫細胞をブロックするPD-1、PD-L1、CTLA-4などの免疫チェックポイントタンパク質をブロックします。これらのチェックポイントタンパク質をブロックすることにより、免疫チェックポイント阻害剤は身体の免疫細胞を活性化し、がんと闘うようにします。

メラノーマに対しては、ペムブロリズマブ（キイトルーダ）、ニボルマブ（オプジーボ）、イピリムマブ（ヤーボイ）、アテゾリズマブ（テセントリク）が免疫チェックポイント阻害薬として承認されています。メラノーマ治療として承認されているこのクラス別の薬剤には、局所免疫療法として作用するオンコリティックウイルス療法であるT-VEC（Imlygic）、最近承認された腫瘍由来の自己T細胞免疫療法であるlifileucel（Amtagvi）があります。

免疫療法薬は、ステージ1からステージ4のメラノーマがんにおいて、手術の補助療法として主に処方されます。これらの薬剤は、メラノーマの重症度に応じて単剤または併用で処方されます。さらに、これらの薬剤の中には売上高の高いトップセラー医薬品もあります。例えば、メルクのキイトルーダは、2023年に250億米ドル近い売上高を記録し、現在最も売れている医薬品です。この医薬品は様々ながんの適応症で承認されていますが、最初に承認されたのは切除不能または転移性のメラノーマでした。さらに、オプジーボとヤーボイの併用は進行期メラノーマの治療に広く処方されています。これら2つの薬剤は、世界的にトップセラーの薬剤でもあります。最近2022年には、ブリストル・マイヤーズスクイブのオプデュアラグが、切除不能または転移性のメラノーマへの使用が承認されました。この医薬品は、発売2年目の2023年に6億2,700万米ドルを売り上げています。これらの要因はすべて、メラノーマ治療市場における免疫療法の優位性を反映しています。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • メラノーマの罹患率の上昇
    • 製品承認と市場アクセスの増加
  • 抑制要因
    • メラノーマがんの報告不足
  • 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• 疫学
• 価格分析
• パイプライン分析
• 特許分析
• 規制分析

第6章 タイプ別

• 表在拡大型メラノーマ
• 結節性メラノーマ
• 悪性黒子型メラノーマ
• 末端黒子型メラノーマ
• その他

第7章 治療法別

• 手術
• 免疫療法
  • ペムブロリズマブ
  • ニボルマブ
  • イピリムマブ
  • リフィレセル
  • その他
• 標的療法
  • BRAF阻害剤
  • MEK阻害剤
  • KIT阻害剤
• 化学療法
• 放射線治療

第8章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • スペイン
  • イタリア
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋
• 中東・アフリカ

第9章 競合情勢

• 競合シナリオ
• 市況・シェア分析
• M&A分析

第10章 企業プロファイル

• Merck & Co., Inc.
  • 会社概要
  • 製品ポートフォリオ
    • 製品説明
    • 製品の主要業績評価指標（KPI）
    • 実績および予測の製品販売
    • 製品販売量
  • 財務概要
    • 企業収益
    • 地域別収益シェア
    • 収益予測
  • 主な発展
    • 合併と買収
    • 主な製品開発活動
    • 規制当局の承認等
  • SWOT分析
• Bristol-Myers Squibb Company.
• Amgen, Inc.
• IOVANCE Biotherapeutics, Inc.
• Novartis AG
• F. Hoffmann-La Roche Ltd
• Pfizer Inc.
• Immunocore Holdings plc.
• Eisai Co., Ltd.
• Delcath Systems, Inc.
• Regeneron Pharmaceuticals Inc.
  • パイプライン製品の説明
  • 製品の主要業績評価指標（KPI）
  • 主な活動
  • 市場参入のタイムライン
  • 製品普及率
  • 売上推定と予測
• Moderna, Inc.
• Immatics N.V.
• BioNTech SE.
• Philogen S.p.A.

第11章 付録

The global melanoma therapeutics market reached US$ 5.40 billion in 2024 and is expected to reach US$ 8.35 billion by 2032, growing at a CAGR of 5.6% during the forecast period 2024-2032.

Pipeline Drugs

There are two types of skin cancers, namely melanoma skin cancer and non-melanoma skin cancer. Melanoma skin cancer is the most prevalent form, with cancer developing from melanocytes. Melanoma is most common in populations with white-pigmented skin and is less common in populations with dark-pigmented skin. Based on the location, melanomas can be classified as skin melanoma, uveal melanoma (eye), and mucosal melanoma (nose, throat, genitals, anus, etc.). There are different types of skin melanomas, with superficial spreading melanoma being the most common one, followed by nodular melanoma, lentigo maligna melanoma, acral melanoma, and others. Most melanomas are caused due to ultraviolet radiation from the sun.

The most common symptoms/sign of melanoma is formation of an abnormal mole or the development of existing moles. A checklist is usually followed to physically diagnose melanoma, and it is called ABCDE, which refers to asymmetrical, border, color, diameter, and evolution of moles.

The treatment for melanoma includes surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy. The treatment of choice depends on the stage at which the melanoma is diagnosed.

Common treatment algorithm by stage of melanoma:

Market Dynamics: Drivers & Restraints

The rising prevalence of melanoma

The rising prevalence and incidence of melanoma are the major drivers for market growth in the forecast period. There are several factors contributing to this growth and the major ones are increased exposure to UV radiation, increasing awareness of skin melanoma, and concurrent improvement in diagnosis rate. As per the International Agency for Research on Cancer statistics, in 2023, 339,041 new melanoma cases were reported across the world, and in 2030, the incidence is expected to reach 401,800 cases, which is an increase of 19%. Moreover the 5-year prevalent cases till 2022 were apprximately 1.2 million worldwide.

This increase in incidence and prevalence promotes the development of advanced treatments and also improved the overall treatment rate. This can significantly drive the market growth in future.

Underreporting of melanoma cancer may restrain the market growth.

Of all the cancers, melanoma is one of the most underreported cancers due to its clinical signs. Melanoma starts as a mole, and many people may ignore, considering it as a regular one. This may lead to lower adoption rate of newer treatments. This is especially seen among population with less awareness of melanoma. Underreporting of cases may also impact the resource allocations for product development and strategic plans for market expansion by manufacturers.

Segment Analysis

The global melanoma therapeutics market is segmented based on type, therapy and region.

Immunotherapy in the therapy segment is expected to dominate the market

Immunotherapy is a type of cancer treatment that is gaining huge traction currently. It involves strengthening the body's immune responses against cancerous cells. There are different types of immunotherapy drugs, and in melnoma, immune check-point inhibitors are approved and are widely used. These immune check-point inhibitors, block the immune check-point proteins such as PD-1, PD-L1, and CTLA-4 which block the immune cells. By blocking these check-point proteins, immune check-point inhibitors activate the body's immune cells to fight against cancers.

For melanoma cancer, the approved immune check-point inhibitors are pembrolizumab (Keytruda), nivolumab (Opdivo), Ipilimumab (Yervoy), Atezolizumab (Tecentriq). The other drugs in this class approved for melanoma treatment are T-VEC (Imlygic) which is an oncolytic virus therapy acting as a local immunotherapy, and the recently approved a tumor-derived autologous T cell immunotherapy called lifileucel (Amtagvi).

Immunotherapy drugs are majorly prescribed as adjuvant treatment option with surgery in stage 1 to stage 4 melanoma cancers. These drugs can be prescribed as monotherapy or in combination based on the severity of melanoma. Moreover, some of these drugs are top selling pharmaceuticals with highest sales. For instance, Keytruda by Merck & Co., Inc. is the top selling drug at present with recorded sales of nearly US$ 25 billion in 2023. Although the drug was approved for various cancer indications, it was first approved for unresectable or metastatic melanoma. Moreover, the combination of Opdivo and Yervoy is widely prescribed in the treatment of advanced stage melanoma. These two drugs are also top selling drugs world wide. Recently in 2022, Opdualag by Bristol-Myers Squibb Company was approved for use in unresectable or metastatic melanoma. The drug has generated US$627 million in 2023 which is the second year of its launch. All these factors reflect the dominance of immunotherapy in melanoma treatment market.

Geographical Analysis

North America is expected to hold a significant share of the melanoma therapeutics market.

North America currently holds a significant market share in the melanoma therapeutics market due to various factors including, higher demand for novel therapies, major revenue generated by market players, and increasing prevalence of melanoma. Any emerging drug is expected to first get launched in the U.S. market due to higher demand, and all the melanoma therapeutics in the current market were first launched in the U.S., providing first access to the patients in the country. Due to higher per-capita income and spending on healthcare, the melanoma treatments are sold at higher prices in the North America market as compared to other nations. Due to this, manufacturers generate a majority of their revenue from the region.

For instance, Opdualag manufactured by Bristol-Myers Squibb Company has generated US$ 627 million in 2023, out of which 98.5% is from U.S. market. Moreover, Kimmtrak manufactured by Immunocore Holdings plc., which was approved for uveal melanoma has generated 238 million in 2023, of which more than 70% is from U.S. This signifies the dominance of U.S. in the global melanoma therapeutics market.

Competitive Landscape

The major global players in the melanoma therapeutics market are Merck & Co., Inc., Bristol-Myers Squibb Company., Amgen, Inc., IOVANCE Biotherapeutics, Inc., Novartis AG, F. Hoffmann-La Roche Ltd, Pfizer Inc., Immunocore Holdings plc., Eisai Co., Ltd., and Delcath Systems, Inc. among others.

Emerging Players

The emerging players in the melanoma therapeutics market include Regeneron Pharmaceuticals Inc., Moderna, Inc., Immatics N.V., BioNTech SE., Philogen S.p.A., and Shanghai Kechow Pharma, Inc. among others.

Key Developments

• In February 2024, the U.S. Food and Drug Administration (FDA) provided accelerated approval for AMTAGVI (lifileucel) for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody. AMTAGVI developed by Iovance Biotherapeutics, Inc. is a novel polyclonal tumor infiltrating lymphocyte (TIL) cell therapy.
• In August 2023, the European Commission (EC) approved Opdivo (nivolumab) manufactured by Bristol Myers Squibb, as a monotherapy for the treatment of adults and adolescents 12 years of age and older with stage IIB or IIC melanoma who have undergone complete resection.
• In March 2024, China National Medical Products Administration (NMPA) approved MEK Inhibitor Kolupin (Tunlametinib) for treating advanced NRAS-mutant melanoma. KeChow Pharma developed Kolupin and is the first MEK inhibitor independently developed in China.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, and product pipelines, and forecasts upcoming pharmaceutical advancements.
• Type Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient Type delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global melanoma therapeutics market report would provide approximately 54 tables, 46 figures, and 195 pages.

Target Audience 2023

• Manufacturers: Pharmaceutical, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Technology & Innovation: R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Type
• 3.2. Snippet by Therapy
• 3.3. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Rising Prevalence of Melanoma
    • 4.1.1.2. Rising Product Approvals and Market Access
  • 4.1.2. Restraints
    • 4.1.2.1. Underreporting of Melanoma Cancer
  • 4.1.3. Opportunities
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Epidemiology
• 5.3. Pricing Analysis
• 5.4. Pipeline Analysis
• 5.5. Patent Analysis
• 5.6. Regulatory Analysis

6. By Type

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 6.1.2. Market Attractiveness Index, By Type
• 6.2. Superficial Spreading Melanoma*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Nodular Melanoma
• 6.4. Lentigo Maligna Melanoma
• 6.5. Acral Lentiginous Melanoma
• 6.6. Others

7. By Therapy

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapy
  • 7.1.2. Market Attractiveness Index, By Therapy
• 7.2. Surgery*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Immunotherapy
  • 7.3.1. Pembrolizumab
  • 7.3.2. Nivolumab
  • 7.3.3. Ipilimumab
  • 7.3.4. Lifileucel
  • 7.3.5. Others
• 7.4. Targeted Therapy
  • 7.4.1. BRAF Inhibitors
  • 7.4.2. MEK Inhibitors
  • 7.4.3. KIT Inhibitors
• 7.5. Chemotherapy
• 7.6. Radiation Therapy

8. By Region

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 8.1.2. Market Attractiveness Index, By Region
• 8.2. North America
  • 8.2.1. Introduction
  • 8.2.2. Key Region-Specific Dynamics
  • 8.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 8.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapy
  • 8.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 8.2.5.1. U.S.
    • 8.2.5.2. Canada
    • 8.2.5.3. Mexico
• 8.3. Europe
  • 8.3.1. Introduction
  • 8.3.2. Key Region-Specific Dynamics
  • 8.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 8.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapy
  • 8.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 8.3.5.1. Germany
    • 8.3.5.2. U.K.
    • 8.3.5.3. France
    • 8.3.5.4. Spain
    • 8.3.5.5. Italy
    • 8.3.5.6. Rest of Europe
• 8.4. South America
  • 8.4.1. Introduction
  • 8.4.2. Key Region-Specific Dynamics
  • 8.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 8.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapy
  • 8.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 8.4.5.1. Brazil
    • 8.4.5.2. Argentina
    • 8.4.5.3. Rest of South America
• 8.5. Asia-Pacific
  • 8.5.1. Introduction
  • 8.5.2. Key Region-Specific Dynamics
  • 8.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 8.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapy
  • 8.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 8.5.5.1. China
    • 8.5.5.2. India
    • 8.5.5.3. Japan
    • 8.5.5.4. South Korea
    • 8.5.5.5. Rest of Asia-Pacific
• 8.6. Middle East and Africa
  • 8.6.1. Introduction
  • 8.6.2. Key Region-Specific Dynamics
  • 8.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Type
  • 8.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Therapy

9. Competitive Landscape

• 9.1. Competitive Scenario
• 9.2. Market Positioning/Share Analysis
• 9.3. Mergers and Acquisitions Analysis

10. Company Profiles

Key Market Players

• 10.1. Merck & Co., Inc.*
  • 10.1.1. Company Overview
  • 10.1.2. Product Portfolio
    • 10.1.2.1. Product Description
    • 10.1.2.2. Product Key Performance Indicators (KPIs)
    • 10.1.2.3. Historic and Forecasted Product Sales
    • 10.1.2.4. Product Sales Volume
  • 10.1.3. Financial Overview
    • 10.1.3.1. Company Revenue's
    • 10.1.3.2. Geographical Revenue Shares
    • 10.1.3.3. Revenue Forecasts
  • 10.1.4. Key Developments
    • 10.1.4.1. Mergers & Acquisitions
    • 10.1.4.2. Key Product Development Activities
    • 10.1.4.3. Regulatory Approvals etc.
  • 10.1.5. SWOT Analysis
• 10.2. Bristol-Myers Squibb Company.
• 10.3. Amgen, Inc.
• 10.4. IOVANCE Biotherapeutics, Inc.
• 10.5. Novartis AG
• 10.6. F. Hoffmann-La Roche Ltd
• 10.7. Pfizer Inc.
• 10.8. Immunocore Holdings plc.
• 10.9. Eisai Co., Ltd.
• 10.10. Delcath Systems, Inc.
• Similar data will be provided for each market player.

Emerging Market Players

• 10.11. Regeneron Pharmaceuticals Inc.*
  • 10.11.1. Pipeline Products Description
  • 10.11.2. Product Key Performance Indicators (KPIs)
  • 10.11.3. Key Activities
  • 10.11.4. Market Entry Timelines
  • 10.11.5. Product Penetration Rate
  • 10.11.6. Sales Estimation and Projections
• 10.12. Moderna, Inc.
• 10.13. Immatics N.V.
• 10.14. BioNTech SE.
• 10.15. Philogen S.p.A.
• Similar data will be provided for each market player.

LIST NOT EXHAUSTIVE

11. Appendix

• 11.1. About Us and Services
• 11.2. Contact Us