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Colorectal Cancer (CRC) Pipeline Analysis Report

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    Report

  • 150 Pages
  • August 2024
  • Region: Global
  • Expert Market Research
  • ID: 5997638
The drug pipeline is significantly driven by the increasing prevalence of colorectal cancer, with an estimated 152,810 new cases expected in the United States in 2024, making it a major health concern. This includes approximately 81,540 cases in men and 71,270 in women, highlighting the significant health burden of this disease.

Key Takeaways

  • Major companies involved in the colorectal cancer drug pipeline market include Takeda Pharmaceuticals International AG, Eli Lilly and Company, Immatics Biotechnologies GmbH, Daiichi Sankyo Co., Ltd., Millennium Pharmaceuticals, Inc., Pfizer & Co., Inc., and Bristol-Myers Squibb Company.
  • The current drug pipeline for colorectal cancer includes promising candidates such as cetuximab, bevacizumab, panitumumab, and regorafenib, among others. These drugs are at various stages of development and offer new hopes for targeted treatment options.
  • Regulatory agencies are providing support through expedited pathways for drug approvals and designations, encouraging rapid development and market availability of new therapies.

Report Coverage

The colorectal cancer drug pipeline analysis provides an overview of recent advancements and ongoing clinical trials. The report highlights progress in targeted therapies and immunotherapies, aiming for improved survival rates and quality of life. It covers innovative approaches such as checkpoint inhibitors that enhance immune response and antibody-drug conjugates that deliver cytotoxic agents directly to cancer cells. The competitive landscape examines collaborations and strategic partnerships that accelerate R&D. It also discusses regulatory milestones achieved by investigational drugs, highlighting their impact on future treatment paradigms, and promising more effective and personalized treatment options for colorectal cancer patients.

Colorectal Cancer Drug Pipeline Outlook

Colorectal cancer is a significant health concern globally, characterized by the abnormal growth of cells in the colon or rectum. It is often diagnosed at an advanced stage, making treatment challenging. Colorectal cancer can be categorized into early-stage, locally advanced, and metastatic stages, each requiring different treatment strategies. Treatment often involves a combination of surgery, chemotherapy, targeted therapy, and immunotherapy.

Advances in targeted therapies, such as monoclonal antibodies and receptor inhibitors, are enhancing colorectal cancer treatment. Immunotherapy and personalized medicine offer promising long-term outcomes, particularly for advanced cases. The market is witnessing increased investment in R&D and regulatory approvals for innovative drugs, underscoring a dynamic landscape focused on improving survival rates and patient care.
In 2023, significant advancements in colorectal cancer treatment were highlighted by the FDA recently approved fruquintinib (Fruzaqla), for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have previously received treatments including fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy, as well as an anti-VEGF therapy and, if appropriate, an anti-EGFR therapy. Fruquintinib demonstrated a significant improvement in overall survival and progression-free survival in the FRESCO-2 trial, a global phase III study. This approval provides a novel chemotherapy-free treatment option, addressing the critical need for effective therapies for patients with metastatic colorectal cancer.

These approvals and ongoing developments underscore the dynamic and evolving nature of colorectal cancer therapeutics, offering new treatment options and hope for improved patient outcomes.

Colorectal Cancer- Pipeline Drug Profiles

Recent developments in colorectal cancer treatment have introduced several promising drugs currently in clinical trials:
  • Tisotumab Vedotin: This antibody-drug conjugate targets tissue factors expressed in some colorectal cancers. It delivers a cytotoxic agent directly to cancer cells, minimizing damage to healthy tissue and showing the potential to reduce tumor size in clinical trials.
  • Tucatinib with Trastuzumab and TAS-102: This combination therapy targets HER2-positive metastatic colorectal cancer. Tucatinib enhances the efficacy of trastuzumab and TAS-102 by blocking HER2 signaling pathways, offering a novel approach for patients resistant to standard treatments.
  • A2B530: Developed by A2 Biotherapeutics Inc., this is an engineered T-cell receptor therapy designed to target cancer-specific antigens in colorectal cancer, aiming to enhance the immune system's ability to eliminate cancer cells effectively.

Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of colorectal cancer drugs based on various segmentations such as:

Analysis by Route of Administration

  • Oral
Oral drugs like regorafenib are used in colorectal cancer for their convenience and ease of administration. This route improves patient compliance by allowing for at-home treatment regimens, which can target angiogenesis and tumor cell proliferation effectively. Oral therapies are especially beneficial for maintaining consistent drug levels in the body, contributing to better management of the disease.
  • Parenteral
Intravenous therapies such as cetuximab and bevacizumab provide direct delivery of monoclonal antibodies, enhancing their efficacy in targeting specific cancer pathways. These drugs are particularly effective in treating advanced and metastatic colorectal cancer by blocking growth signals and inhibiting angiogenesis, thereby slowing tumor progression, and improving patient outcomes.
  • Others
Intraperitoneal chemotherapy and localized delivery methods are explored in colorectal cancer to increase drug concentration at tumor sites. These approaches aim to improve treatment efficacy while minimizing systemic exposure, thereby reducing side effects. This localized therapy can deliver higher doses directly to the cancer cells, enhancing therapeutic outcomes for patients.

Analysis by Phase

According to EMR analysis, Phase II clinical trials dominate the colorectal cancer drug pipeline. The number of colorectal cancer drugs currently in Phase 2 clinical trials varies as new trials are continually initiated and completed. However, as of the latest data, there are over 2,400 ongoing Phase 2 trials for colorectal cancer drugs worldwide. These trials involve a wide range of therapeutic approaches, including targeted therapies, immunotherapies, and combination treatments.

  • Preclinical Phase: Laboratory and animal studies to assess safety and efficacy.
  • Phase I: Small-scale human trials focusing on safety and dosage.
  • Phase II: Larger trials to evaluate efficacy and side effects.
  • Phase III: Large-scale trials to confirm effectiveness, monitor side effects, and compare with standard treatments.
  • Phase IV: Post-marketing studies to gather more information on risks, benefits, and optimal use.

Analysis by Drug Class

  • Small Molecule
Small molecule drugs like regorafenib and irinotecan target multiple pathways involved in cancer cell growth and angiogenesis. By inhibiting these pathways, these drugs provide effective treatment options for advanced colorectal cancer, helping to slow disease progression and improve patient outcomes through targeted therapy.
  • Polymer
Polymeric formulations, such as liposomal irinotecan, enhance drug delivery by encapsulating the drug in a liposome, which reduces systemic toxicity. This allows for higher therapeutic doses with fewer side effects, improving the drug's effectiveness and patient tolerance in colorectal cancer treatment.
  • Monoclonal Antibody
Monoclonal antibodies like cetuximab and panitumumab specifically target receptors on cancer cells, such as EGFR. By blocking growth signals, these drugs inhibit tumor proliferation and enhance immune-mediated tumor cell destruction, offering a powerful strategy for treating colorectal cancer.
  • Peptides
Peptide-based therapies are being developed to disrupt cancer cell signaling and apoptosis. These therapies offer novel mechanisms to inhibit tumor growth and survival, providing a new approach to colorectal cancer treatment by directly interfering with the pathways that support cancer progression.
  • Gene Therapy
Gene therapy involves modifying genetic material to correct mutations or enhance immune responses. Although still largely experimental in colorectal cancer, this innovative approach holds promise for personalized treatments by addressing the genetic underpinnings of the disease and potentially providing long-term solutions.

Colorectal Cancer Drug Clinical Trials Assessment- Competitive Dynamics

Here are a few notable participants involved in colorectal cancer research and development:

These advancements represent significant steps forward in colorectal cancer treatment, potentially offering patients more effective and less burdensome options.

Takeda Pharmaceuticals International AG

Takeda Pharmaceuticals International AG, headquartered in Tokyo, Japan, is a leader in precision medicine and targeted therapy for colorectal cancer. The company focuses on developing novel therapies such as alectinib, which targets specific genetic mutations to improve treatment efficacy. Takeda's approach emphasizes genomic profiling to deliver personalized cancer treatments that enhance patient outcomes through innovative research and development.

Eli Lilly and Company

Eli Lilly and Company, based in Indianapolis, Indiana, is at the forefront of developing innovative therapies for colorectal cancer. The company's portfolio includes ramucirumab, an angiogenesis inhibitor that blocks blood vessel growth to tumors, slowing cancer progression. Eli Lilly's research focuses on advancing treatments that target the underlying mechanisms of tumor growth, aiming to improve survival rates and patient quality of life.

Immatics Biotechnologies GmbH

Immatics Biotechnologies GmbH, headquartered in Tübingen, Germany, specializes in developing adoptive cell therapies for colorectal cancer. The company engineers T-cells to target tumor-specific antigens, enhancing the immune system's ability to destroy cancer cells. Immatics focuses on personalized immunotherapies that offer precision targeting and improved efficacy in cancer treatment.

Daiichi Sankyo Co., Ltd.
Daiichi Sankyo Co., Ltd., based in Tokyo, Japan, is a leader in targeted therapies for colorectal cancer. The company is developing trastuzumab deruxtecan, an antibody-drug conjugate for HER2-positive colorectal cancer. This therapy combines targeted delivery of cytotoxic agents with antibody specificity, aiming to improve treatment outcomes and reduce side effects.

Other key players in the market include Millennium Pharmaceuticals, Inc., Pfizer & Co., Inc., Bristol-Myers Squibb Company.

Reasons To Purchase This Report

The colorectal cancer drug pipeline analysis report offers invaluable insights into the latest advancements and future trends in colorectal cancer treatment. It provides detailed evaluations of emerging therapies, pipeline assessment, and competitive landscape analysis, enabling informed investment decisions and strategic planning.

Key Questions Answered in the Colorectal Cancer Drug Pipeline Analysis Report

  • What is the current state of the colorectal cancer drug pipeline?
  • How many companies are currently involved in colorectal cancer drug development?
  • What is the number of drugs in Phase III and Phase IV trials for colorectal cancer?
  • Which organisations are at the forefront of colorectal cancer drug research?
  • What are the effectiveness and safety profiles of the drugs in the colorectal cancer pipeline?
  • What opportunities and challenges exist in the colorectal cancer clinical trial landscape?
  • Which companies are leading the major clinical trials for colorectal cancer drugs?
  • Which regions are involved in clinical trials for colorectal cancer?
  • What are the recent clinical trial results for colorectal cancer drugs?
  • What are the emerging trends in colorectal cancer clinical trials?


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Table of Contents

1 Preface
1.1 Introduction
1.2 Objectives of the Study
1.3 Research Methodology and Assumptions
2 Executive Summary
3 Overview of Colorectal Cancer
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Types of Colorectal Cancer
3.5 Diagnosis
3.6 Treatment
4 Patient Profile
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Colorectal Cancer: Epidemiology Snapshot
5.1 Colorectal Cancer Incidence by Key Markets
5.2 Colorectal Cancer- Patients Seeking Treatment in Key Markets
6 Colorectal Cancer: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Colorectal Cancer: Key Facts Covered
7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
7.2 Top Countries Contributing to Clinical Trials in Europe
7.3 Top Countries Contributing to Clinical Trials in North America
7.4 Top Countries Contributing to Clinical Trials in Other Regions
8 Colorectal Cancer, Drug Pipeline Assessment
8.1 Assessment by Treatment Type
8.2 Assessment by Route of Administration
8.3 Assessment by Drug Class
9 Drug Pipeline Comparative Analysis
9.1 List of Colorectal Cancer Pipeline Drugs
9.1.1 By Company
9.1.2 By Phase
9.1.3 By Indication
9.1.4 By Trial Status
9.1.5 By Funder Type
9.2 Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
10 Colorectal Cancer Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
10.1 Comparative Analysis for Late-Stage Drugs
10.1.1 Study Type
10.1.2 Recruitment Status
10.1.3 Company
10.1.4 Funder Type
10.2 Product Level Analysis*
10.2.1 AMT2003
10.2.1.1 Product Description
10.2.1.2 Trial ID
10.2.1.3 Sponsor Name
10.2.1.4 Study Type
10.2.1.5 Drug Class
10.2.1.6 Eligibility Criteria
10.2.1.7 Study Record Dates
10.2.1.7.1 First Submitted
10.2.1.7.2 First Posted
10.2.1.7.3 Last Update Posted
10.2.1.7.4 Last Verified
10.2.1.8 Indication
10.2.1.9 Study Design
10.2.1.10 Recruitment Status
10.2.1.11 Enrollment (Estimated)
10.2.1.12 Location Countries
10.2.1.13 Recent Results
10.2.2 mFOLFOX6
10.2.3 BBI608
10.2.4 Arfolitixorin
10.2.5 Other Drug
11 Colorectal Cancer Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
11.1 Comparative Analysis for Mid-Stage Drugs
11.1.1 Study Type
11.1.2 Recruitment Status
11.1.3 Company
11.1.4 Funder Type
11.2 Product Level Analysis*
11.2.1 Niraparib
11.2.1.1 Product Description
11.2.1.2 Trial ID
11.2.1.3 Sponsor Name
11.2.1.4 Study Type
11.2.1.5 Drug Class
11.2.1.6 Eligibility Criteria
11.2.1.7 Study Record Dates
11.2.1.7.1 First Submitted
11.2.1.7.2 First Posted
11.2.1.7.3 Last Update Posted
11.2.1.7.4 Last Verified
11.2.1.8 Indication
11.2.1.9 Study Design
11.2.1.10 Recruitment Status
11.2.1.11 Enrollment (Estimated)
11.2.1.12 Location Countries
11.2.1.13 Recent Results
11.2.2 AMT2003
11.2.3 Cetuximab
11.2.4 JX-594
11.2.5 Other Drugs
12 Colorectal Cancer Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
12.1 Comparative Analysis for Early-Stage Drugs
12.1.1 Study Type
12.1.2 Recruitment Status
12.1.3 Company
12.1.4 Funder Type
12.2 Product Level Analysis*
12.2.1 MGD007
12.2.1.1 Product Description
12.2.1.2 Trial ID
12.2.1.3 Sponsor Name
12.2.1.4 Study Type
12.2.1.5 Drug Class
12.2.1.6 Eligibility Criteria
12.2.1.7 Study Record Dates
12.2.1.7.1 First Submitted
12.2.1.7.2 First Posted
12.2.1.7.3 Last Update Posted
12.2.1.7.4 Last Verified
12.2.1.8 Indication
12.2.1.9 Study Design
12.2.1.10 Recruitment Status
12.2.1.11 Enrollment (Estimated)
12.2.1.12 Location Countries
12.2.2 HRO761
12.2.3 Nivolumab
12.2.4 Other Drugs
13 Colorectal Cancer Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
13.1 Comparative Analysis for Preclinical and Discovery Stage Drugs
13.1.1 Study Type
13.1.2 Recruitment Status
13.1.3 Company
13.1.4 Funder Type
13.2 Product Level Analysis*
13.2.1 aPD1-MSLN-CAR T cells
13.2.1.1 Product Description
13.2.1.2 Trial ID
13.2.1.3 Sponsor Name
13.2.1.4 Study Type
13.2.1.5 Drug Class
13.2.1.6 Eligibility Criteria
13.2.1.7 Study Record Dates
13.2.1.7.1 First Submitted
13.2.1.7.2 First Posted
13.2.1.7.3 Last Update Posted
13.2.1.7.4 Last Verified
13.2.1.8 Indication
13.2.1.9 Study Design
13.2.1.10 Recruitment Status
13.2.1.11 Enrollment (Estimated)
13.2.1.12 Location Countries
13.2.2 BTG-002814
13.2.3 IM96 CAR-T cells
13.2.4 Nilotinib
13.2.5 Other Drugs
14 Colorectal Cancer, Key Drug Pipeline Companies
14.1 Takeda Pharmaceuticals International AG
14.1.1 Company Snapshot
14.1.2 Pipeline Product Portfolio
14.1.3 Financial Analysis
14.1.4 Recent News and Developments
14.2 Eli Lilly and Company
14.2.1 Company Snapshot
14.2.2 Pipeline Product Portfolio
14.2.3 Financial Analysis
14.2.4 Recent News and Developments
14.3 Immatics Biotechnologies GmbH
14.3.1 Company Snapshot
14.3.2 Pipeline Product Portfolio
14.3.3 Financial Analysis
14.3.4 Recent News and Developments
14.4 Daiichi Sankyo Co., Ltd.
14.4.1 Company Snapshot
14.4.2 Pipeline Product Portfolio
14.4.3 Financial Analysis
14.4.4 Recent News and Developments
14.5 Millennium Pharmaceuticals, Inc.
14.5.1 Company Snapshot
14.5.2 Pipeline Product Portfolio
14.5.3 Financial Analysis
14.5.4 Recent News and Developments
14.6 Pfizer & Co., Inc.
14.6.1 Company Snapshot
14.6.2 Pipeline Product Portfolio
14.6.3 Financial Analysis
14.6.4 Recent News and Developments
14.7 Bristol-Myers Squibb Company
14.7.1 Company Snapshot
14.7.2 Pipeline Product Portfolio
14.7.3 Financial Analysis
14.7.4 Recent News and Developments
15 Regulatory Framework for Drug Approval, By Region16 Terminated or Suspended Pipeline Products

Companies Mentioned

  • akeda Pharmaceuticals International AG
  • Eli Lilly and Company
  • Immatics Biotechnologies GmbH
  • Daiichi Sankyo Co., Ltd.
  • Millennium Pharmaceuticals, Inc.
  • Pfizer & Co., Inc.
  • Bristol-Myers Squibb Company
  • Geographies Covered North America
  • Europe
  • Asia Pacific

Methodology

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