세계의 체크포인트 억제제 불응성 암 시장(2023-2030년)

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