チェックポイント阻害剤不応性がんの世界市場-2023年～2030年

概要

世界のチェックポイント阻害剤難治性がん市場は、そのダイナミクスに影響を与える様々な要因によって、長年にわたって大きな成長と変貌を遂げてきました。難治性がんは、治療がすぐに奏効しない場合や、最初は奏効するが後に耐性が生じる場合があります。

免疫系の"ブレーキ"が解除された後の自然免疫系の潜在的な抗腫瘍活性に対する腫瘍学者の関心は、食品医薬品局（FDA）による抗CTLA-4療法の認可や、抗PD-1療法の有望な初期臨床所見の報告によって再燃しています。がん免疫療法の発展は、CTLA-4やPD-1といった免疫チェックポイントの同定によって確実に後押しされています。

特に新興経済諸国における政府投資と研究は、PDL-1阻害剤のような新規チェックポイント阻害剤の先端技術の利用を引き続き促進し、世界のチェックポイント阻害剤難治性がん市場を押し上げると思われます。

市場力学：市場促進要因と市場抑制要因

さまざまな適応症での共同研究および承認取得の増加

新興経済諸国は、高額の投資、所得水準、インフラ整備に牽引され、ヘルスケア分野の改善において急速な成長を遂げています。難治性がん治療薬としてのチェックポイント阻害剤の需要が高まっている国もあります。さまざまな国との共同研究、買収、技術進歩に伴うライセンス契約は、市場の成長を促進する重要な要因です。

2023年5月8日、商業段階にあるバイオテクノロジー企業Mirati Therapeutics, Inc.と、地域ベースの臨床研究を実施する世界有数の腫瘍研究機関であるSarah Cannon Research Institute（SCRI）が戦略的パートナーシップを締結し、臨床試験の募集方法における多様性の拡大が目標に掲げられています。

さらに、2023年3月29日、リジェネロン・ファーマシューティカルズ・インクは、進行非小細胞肺がん（NSCLC）でPD-L1発現が1％未満の高齢者の初回治療として、プラチナ製剤ベースの化学療法と併用するリブタイヨ（セミピリマブ）の欧州委員会（EC）承認を取得しました。これは、転移性または限局性の悪性腫瘍で、最終化学放射線療法を受ける資格がなく、EGFR、ALK、ROS1の異常を示さない患者を対象としています。

さらに、2023年2月10日、ジェンペルリ（dostarlimab-gxly）は、米国食品医薬品局（FDA）により、米国FDAが承認した検査で同定された、ミスマッチ修復欠損（dMMR）再発または進行した子宮内膜がんを有し、いかなる状況においてもプラチナ製剤を含む前治療中または治療後に進行し、根治的手術または放射線療法の適応がない成人患者の治療薬として承認されました。

さらに、がんに対する新薬や解決策の利用が増加しています。非小細胞肺がん患者の増加と化学療法の増加、革新的な製品開発のための研究は、チェックポイント阻害剤難治性がん市場の成長を促進する主な要因です。

チェックポイント阻害剤に伴う生命を脅かす合併症

ICIは成人では有望な結果を示しているにもかかわらず、小児における安全性についてはあまり情報がないです。70％以上の患者が軽度から重度のCTLA-4阻害による用量依存性の副作用を経験していることが証明されています。さらに、18の臨床研究のメタアナリシスでは、CTLA-4阻害剤の大量投与を受けた患者は、治療関連死亡のリスクが高いことが判明しました。

PD-1阻害剤を投与された患者の16-37％、PD-L1阻害剤を投与された患者の12-24％が、疲労が最も頻度の高い副作用であったが、PD-1/PD-L1阻害剤に関連する毒性はCTLA-4阻害剤に関連する毒性よりも軽微でした。重要な臓器に対する予期せぬオフターゲット効果は、臓器がまだ未発達の若者の生命を危険にさらす可能性があるため、これは特に憂慮すべきことです。

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
    • さまざまな適応症における共同研究および規制当局の承認の拡大
    • 技術的進歩と開発の高まり
  • 抑制要因
    • チェックポイント阻害剤に伴う生命を脅かす合併症
  • 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
• サプライチェーン分析
• 価格分析
• 規制分析
• SWOT分析
• 特許分析
• ロシア・ウクライナ戦争の影響分析
• DMI意見

第6章 COVID-19分析

第7章 免疫チェックポイント阻害薬タイプ別

• PD-1阻害剤
• PDL-1阻害剤
• CTLA-4阻害剤

第8章 疾患タイプ別

• 転移性黒色腫
  • 遺伝子組換えヒトNGF点眼薬
  • 血清由来点眼薬
• 非小細胞肺がん
• 頭頸部がん
• ホジキンリンパ腫
• その他

第9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
  • イタリア
  • スペイン
  • 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
  • オーストラリア
  • その他アジア太平洋地域
• 中東・アフリカ

第10章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第11章 企業プロファイル

• Bristol Myers Squibb
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• Merck & Co., Inc.
• Genentech USA, Inc.
• AstraZeneca
• Regeneron Pharmaceuticals, Inc.
• GSK plc
• Novartis AG
• Pfizer, Inc.
• Janssen Global Services, LLC
• Incyte

第12章 付録

Overview

The global checkpoint inhibitor refractory cancer market has witnessed significant growth and transformations over the years, with various factors influencing its dynamics. Refractory cancer, might not respond to treatments right away or it may react to therapy at first but later develop resistance to it.

Oncologists' interest in the innate immune system's potential antitumor activity following the immune system's 'brakes' have been freed has been rekindled by the Food and Drug Administration's authorization of anti-CTLA-4 therapy and reports of encouraging early clinical findings for anti-PD-1 therapy. The development of cancer immunotherapy has certainly been boosted by the identification of immune checkpoints like CTLA-4 and PD-1.

Government investments and research, particularly in developing economies, will continue to drive utilization of advanced technology for novel checkpoint inhibitors such as PDL-1 inhibitors and boost the global checkpoint inhibitor refractory cancer market.

Market Dynamics: Drivers & Restraints

Growing collaborations and regulatory approvals for various indications

Developed economies have been witnessing rapid growth in betterment of their healthcare sectors, driven by high investments, income levels, and infrastructure development. Several countries have experienced substantial demand for checkpoint inhibitor for refractory cancer treatment owing to the rising research. Various collaborations, acquisitions and license agreement with technological advancements among different countries will be a crucial factor driving the growth of the market.

On May 8, 2023, increasing diversity in clinical study recruitment practices is the goal of a strategic partnership established by Mirati Therapeutics, Inc., a biotechnology company at commercial stage, and Sarah Cannon Research Institute (SCRI), among the world's top oncology research institutions conducting community-based clinical studies.

Furthermore, on March 29, 2023, for the initial therapy of older adults suffering from advanced non-small cell lung cancer (NSCLC) and less than 1% PD-L1 expression, Regeneron Pharmaceuticals, Inc. got European Commission (EC) authorization for Libtayo (cemiplimab) in conjunction with platinum-based chemotherapy. This comprises individuals with metastatic or localized malignancies who do not qualify for final chemoradiation and who do not exhibit EGFR, ALK, or ROS1 abnormalities.

Additionally, on February 10, 2023, Jemperli (dostarlimab-gxly) has been approved by the US Food and Drug Administration (FDA) as a therapy of adult patients having mismatch repair-deficient (dMMR) recurring or progressed endometrial cancer, as identified by a US FDA-approved test, who have progressed during or after a prior platinum-containing treatment in any circumstance and are not applicants for curative surgery or radiation.

Furthermore, the rising utilization of novel medicines and solutions for cancer. Rising non-small cell lung cancer cases and increasing chemotherapy procedures along with research for innovative product development will be a major factor driving the growth of the checkpoint inhibitor refractory cancer market.

Life-threatening complications associated with the checkpoint inhibitors

There is not much information about ICIs' safety in children, despite the fact that they have showed promising results in adults. It was proven that over 70% of patients experienced dose-dependent adverse effects from mild to severe CTLA-4 blocking. Additionally, a meta-analysis of 18 clinical studies found that individuals receiving larger doses of CTLA-4 inhibitors had a higher risk of treatment-related mortality.

Fatigue was the most frequent side effect, affecting 16-37% of patients who got PD-1 inhibitors and 12-24% of patients who received PD-L1 inhibitors, although the toxicities associated with PD-1/PD-L1 blockades appeared less severe than those associated with CTLA-4 inhibitors. It is especially alarming as unforeseen off-target effects on vital organs can endanger the lives of youngsters whose organs are still developing.

Segment Analysis

The global checkpoint inhibitor refractory cancer market is segmented based on immune checkpoint inhibitors type, disease type and region.

PD-1 Inhibitors checkpoint inhibitors type segment accounted for approximately 57% of market share

An inhibitor receptor called PD-1 is important in the regulation of T-cell mediated responses through programmed death signaling. Through blocking the CD28-costimulatory signaling pathway, PD-1 engagement can decrease the release of cytokines including IL-2, IFN, and TNF in addition to cell proliferation. Activated monocytes, natural killer cells, dendritic cells, T cells, and B cells are only a few immune cell types that have been found to express PD-1 within tumour microenvironment (TME).

Immunotherapies that target the PD-1 pathway have been shown to alter the way that certain malignancies, such as Merkel cell carcinoma, head and neck squamous cell carcinoma (HNSCC), melanoma, and non-small-cell lung cancer (NSCLC), are treated. Three monoclonal antibodies, Nivolumab, Pembrolizumab, and Cemiplimab, have been approved by the US FDA as PD-1 inhibitors.

On August 22, 2023, based on the findings of the CheckMate -76K trial, Bristol Myers Squibb was granted approval by the European Commission (EC) to market Opdivo (nivolumab) as a standalone treatment for the adjuvant treatment of adolescents and adults 12 years of age or older having stage IIB or IIC melanoma who additionally underwent complete resection. In stages IIB, IIC, III, and stage IV resected melanoma, Opdivo is currently the sole PD-1 inhibitor that is approved as an adjuvant treatment.

Geographical Penetration

North America accounted for around 37% of market share in 2022

Due to the rising need for checkpoint inhibitor refractory cancer in healthcare, manufacturers in North America have chances of increasing their operations. Increasing expenditure on healthcare, advancement of technologies and different types of products for several diseases, along with increase in biopharmaceutical or biotechnology business establishment across the region are also contributing to the growth of checkpoint inhibitor refractory cancer market share of this region.

The market in this area is growing as several products as well as indications are receiving approvals from U.S.FDA or EC. The aforementioned elements attest to North America's hegemonic position in the world.

North America continues to be a key player in the global checkpoint inhibitor refractory cancer market, with United States leading the way. Government initiatives promoting infrastructure development and investment, and a focus on rising advancements have fueled the demand for checkpoint inhibitor for refractory cancer in the United States have been proactive in executing several initiatives or surgical procedures, stimulating these medications demand.

COVID-19 Impact Analysis

The outbreak of the COVID-19 pandemic in late 2019 created unprecedented challenges for industries worldwide, including the global checkpoint inhibitor refractory cancer market. As countries grappled with lockdowns, supply chain disruptions and reduced economic activity, the pharmaceutical sector, with a significant consumer of various checkpoint inhibitors, was significantly impacted. The widespread lockdowns and restrictions imposed by the pandemic, which began in early 2020, had an effect on a number of initiatives all around the world.

Major medical and biotechnology industries came to a standstill and shifted their attention towards the management of COVID-19, leading to a slump in demand for checkpoint inhibitor refractory cancer. Now several research studies have been initiated and companies have again started trial for their products efficiency. Overall, the impact of the pandemic on the global checkpoint inhibitor refractory cancer market is expected to be relatively moderate, with the market continuing to grow steadily due to the ongoing need and research for innovative products, like PD-1 inhibitors.

Key Developments

• on September 15, 2023, the anti-PD-1 therapy KEYTRUDA, developed by Merck, was recommended for approval by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for the adjuvant therapy of individuals with non-small cell lung cancer (NSCLC) who have been identified at a high likelihood of recurrence after complete tumor removal and platinum-based chemotherapy.
• On March 9, 2023, Imfinzi (durvalumab) therapy with neoadjuvant chemotherapy prior to surgery and as adjuvant monotherapy following surgery showed a statistically substantial and practical enhancement in survival without any events versus neoadjuvant chemotherapy only followed by surgical treatment for patients having resectable early-stage non-small cell lung cancer (NSCLC), according to encouraging high-level outcomes from the anticipated interim evaluation of the AEGEAN Phase III, placebo-controlled trial.
• On December 9, 2022, for the management of adults as well as children who are two years of age or older having metastatic or unresectable alveolar soft part sarcoma (ASPS), Genentech, a subsidiary of the Roche Group, got FDA approval for Tecentriq (atezolizumab). Younger patients are more likely to develop ASPS, a rare and sneaky soft tissue sarcoma that can be advanced at diagnosis, spread gradually but inexorably throughout the years, and frequently recur after surgery.

Competitive Landscape

The major global players in the market include: Bristol Myers Squibb, Merck & Co., Inc., Genentech USA, Inc., AstraZeneca, Regeneron Pharmaceuticals, Inc., GSK plc, Novartis AG, Pfizer, Inc., Janssen Global Services, LLC and Incyte.

Why Purchase the Report?

• To visualize the global checkpoint inhibitor refractory cancer market segmentation based on immune checkpoint inhibitors type, disease type and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of checkpoint inhibitor refractory cancer market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global checkpoint inhibitor refractory cancer market report would provide approximately 53 tables, 49 figures and 186 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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 Immune Checkpoint Inhibitors Type
• 3.2. Snippet by Disease Type
• 3.3. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Growing collaborations and regulatory approvals for various indications
    • 4.1.1.2. Rising technological advancements and developments
  • 4.1.2. Restraints
    • 4.1.2.1. Life-threatening complications associated with the checkpoint inhibitors
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. SWOT Analysis
• 5.6. Patent Analysis
• 5.7. Russia-Ukraine War Impact Analysis
• 5.8. DMI Opinion

6. COVID-19 Analysis

• 6.1. Analysis of COVID-19
  • 6.1.1. Scenario Before COVID
  • 6.1.2. Scenario During COVID
  • 6.1.3. Scenario Post COVID
• 6.2. Pricing Dynamics Amid COVID-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion

7. By Immune Checkpoint Inhibitors Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Immune Checkpoint Inhibitors Type
  • 7.1.2. Market Attractiveness Index, By Immune Checkpoint Inhibitors Type
• 7.2. PD-1 Inhibitors*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. PDL-1 Inhibitors
• 7.4. CTLA-4 Inhibitor

8. By Disease Type

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 8.1.2. Market Attractiveness Index, By Disease Type
• 8.2. Metastatic Melanoma*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.2.3. Recombinant Human NGF Eye Drops
  • 8.2.4. Serum-Derived Eye Drops
• 8.3. Non-Small Lung Cancer
• 8.4. Head and Neck Cancers
• 8.5. Hodgkin Lymphoma
• 8.6. Others

9. By Region

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 9.1.2. Market Attractiveness Index, By Region
• 9.2. North America
  • 9.2.1. Introduction
  • 9.2.2. Key Region-Specific Dynamics
  • 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Immune Checkpoint Inhibitors Type
  • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.2.5.1. U.S.
    • 9.2.5.2. Canada
    • 9.2.5.3. Mexico
• 9.3. Europe
  • 9.3.1. Introduction
  • 9.3.2. Key Region-Specific Dynamics
  • 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Immune Checkpoint Inhibitors Type
  • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.3.5.1. Germany
    • 9.3.5.2. UK
    • 9.3.5.3. France
    • 9.3.5.4. Italy
    • 9.3.5.5. Spain
    • 9.3.5.6. Rest of Europe
• 9.4. South America
  • 9.4.1. Introduction
  • 9.4.2. Key Region-Specific Dynamics
  • 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Immune Checkpoint Inhibitors Type
  • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.4.5.1. Brazil
    • 9.4.5.2. Argentina
    • 9.4.5.3. Rest of South America
• 9.5. Asia-Pacific
  • 9.5.1. Introduction
  • 9.5.2. Key Region-Specific Dynamics
  • 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Immune Checkpoint Inhibitors Type
  • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type
  • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.5.5.1. China
    • 9.5.5.2. India
    • 9.5.5.3. Japan
    • 9.5.5.4. Australia
    • 9.5.5.5. Rest of Asia-Pacific
• 9.6. Middle East and Africa
  • 9.6.1. Introduction
  • 9.6.2. Key Region-Specific Dynamics
  • 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Immune Checkpoint Inhibitors Type
  • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Disease Type

10. Competitive Landscape

• 10.1. Competitive Scenario
• 10.2. Market Positioning/Share Analysis
• 10.3. Mergers and Acquisitions Analysis

11. Company Profiles

• 11.1. Bristol Myers Squibb*
  • 11.1.1. Company Overview
  • 11.1.2. Product Portfolio and Description
  • 11.1.3. Financial Overview
  • 11.1.4. Key Developments
• 11.2. Merck & Co., Inc.
• 11.3. Genentech USA, Inc.
• 11.4. AstraZeneca
• 11.5. Regeneron Pharmaceuticals, Inc.
• 11.6. GSK plc
• 11.7. Novartis AG
• 11.8. Pfizer, Inc.
• 11.9. Janssen Global Services, LLC
• 11.10. Incyte

LIST NOT EXHAUSTIVE

12. Appendix

• 12.1. About Us and Services
• 12.2. Contact Us