HER2+ Market to Accelerate Substantially by 2034, Predicts DelveInsight | Key Companies – Zymeworks, Jazz Pharmaceuticals, Ambrx, AnBogen Therapeutics, Enliven Therapeutics, Roche

With the improvement of the disease understanding and more research activities, pharmaceutical companies have their potential drug candidates that are being evaluated in clinical trials for the treatment of HER2+. Approval of some of these drug candidates is anticipated to take place during the forecast period, ultimately changing the HER2+ market scenario in the concerned regions.

New York, USA, April 17, 2024 (GLOBE NEWSWIRE) — HER2+ Market to Accelerate Substantially by 2034, Predicts DelveInsight | Key Companies – Zymeworks, Jazz Pharmaceuticals, Ambrx, AnBogen Therapeutics, Enliven Therapeutics, Roche

With the improvement of the disease understanding and more research activities, pharmaceutical companies have their potential drug candidates that are being evaluated in clinical trials for the treatment of HER2+. Approval of some of these drug candidates is anticipated to take place during the forecast period, ultimately changing the HER2+ market scenario in the concerned regions.

DelveInsight’s HER2+ Market Insights report includes a comprehensive understanding of current treatment practices, emerging HER2+, market share of individual therapies, and current and forecasted HER2+ market size from 2020 to 2034, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan].

Key Takeaways from the HER2+ Market Report

  • As per DelveInsight’s analysis, the HER2+ market is anticipated to grow at a significant CAGR by 2034.
  • HER2+ breast cancer accounts for about 15% of all cancers in the United States. In 2023, an estimated 44,000 people were diagnosed with HER2+ breast cancer. 
  • Leading TROP-2 inhibitor companies such as Zymeworks, Jazz Pharmaceuticals, Ambrx, AnBogen Therapeutics, Enliven Therapeutics, Roche, and others are developing novel HER2+ that can be available in the HER2+ market in the coming years.
  • Some of the key HER2+ include Zanidatamab, ARX788, ABT-101, ELVN-002, and Giredestrant, among others. 
  • In December 2023, the FDA granted Breakthrough Therapy designation for BNT323/DB-1303 for the treatment of advanced endometrial cancer in patients who progressed on or after treatment with immune checkpoint inhibitors.

Discover which therapies are expected to grab the HER2+ market share @ HER2+ Market Report

HER2+ Market Dynamics

The market dynamics of HER2+ breast cancer have seen significant shifts over the years, shaped by advancements in treatment options and diagnostic technologies. This subtype of breast cancer accounts for about 20% of all breast cancer cases and has been a focal point for research and pharmaceutical development. With the emergence of targeted therapies such as Herceptin (trastuzumab) and Perjeta (pertuzumab), there has been a remarkable improvement in the prognosis and survival rates for patients with HER2+ breast cancer.

Pharmaceutical companies have been in a race to develop newer, more effective HER2-targeted therapies, leading to a competitive landscape within the HER2+ market. This competition has been a boon for patients, as it has not only expanded treatment options but also driven down costs through the availability of biosimilars. As a result, patients now have access to a range of therapies, from monoclonal antibodies to small molecule inhibitors, offering more personalized treatment approaches.

Another notable aspect of the HER2+ market dynamics is the emphasis on early detection through improved diagnostic tools. Technologies such as HER2 testing have become standard in breast cancer diagnosis, allowing healthcare providers to tailor treatments to the specific characteristics of the tumor. This shift towards precision medicine has not only improved patient outcomes but also influenced the overall landscape of cancer care, paving the way for a more targeted and effective approach to HER2+ breast cancer management.

HER2+ Treatment Market 

Currently, there exist various forms of anti-HER2-targeted treatment, including monoclonal antibodies, tyrosine kinase inhibitors, and antibody-drug conjugates. The combination of different anti-HER2 monoclonal antibodies with chemotherapy shows increased effectiveness against HER2-overexpressing cells, displaying a synergistic anti-tumor impact as opposed to using a single form of treatment alone.

ENHERTU, developed through collaboration between Daiichi Sankyo and AstraZeneca, is a targeted antibody combined with a topoisomerase inhibitor. It’s used to treat adult patients with unresectable or metastatic NSCLC, as well as approved for gastric and breast cancer. HERCEPTIN, developed by Roche, is an antibody designed to target receptors found on tumor surfaces, preventing cancer spread by blocking these receptors from receiving growth signals. This drug is approved for breast and gastric cancer among other indications. KEYTRUDA, a product of Merck, is a humanized antibody utilized in cancer immunotherapy. It binds to the PD-1 protein, aiding immune cells in killing cancer cells more effectively. Its approvals span a range of cancers, including gastric, colorectal, and NSCLC.

NERLYNX, developed by Puma Biotechnology, is an intracellular kinase inhibitor that binds irreversibly to EGFR, HER2, and HER4. Introduced in July 2017, NERLYNX is used for extended adjuvant treatment in adult patients with early-stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy. TUKYSA, developed by Seagen, is an oral medication functioning as a tyrosine kinase inhibitor targeting the HER2 protein. In laboratory studies, TUKYSA demonstrated the inhibition of HER2 and HER3 phosphorylation, consequently suppressing downstream MAPK and AKT signaling pathways, cell proliferation, and exhibiting anti-tumor effects in HER2-expressing tumor cells.

Learn more about the FDA-approved HER2+ @ HER2+ Drugs

Key Emerging HER2+s and Companies

Some of the drugs in the pipeline include Zanidatamab (Zymeworks/Jazz Pharmaceuticals), ARX788 (Ambrx), ABT-101 (AnBogen Therapeutics), ELVN-002 (Enliven Therapeutics), and Giredestrant (Roche) among others.

Zanidatamab, a HER2-targeted bispecific antibody developed through Zymeworks’ exclusive Azymetric platform, binds to two distinct sites on the HER2 protein found on various cancer cells. It is currently undergoing clinical trials as a precision treatment for patients with solid tumors that exhibit HER2 expression. These trials include investigations in biliary tract cancers, breast cancer, and colorectal cancer. The FDA has acknowledged zanidatamab with a Breakthrough Therapy designation for its development in previously treated HER2 gene-amplified biliary tract cancers (BTC), as well as two Fast Track designations—one for its use as a standalone therapy in refractory BTC, and another for its combination with standard chemotherapy in first-line treatment of gastroesophageal adenocarcinoma (GEA).

ARX788, an antibody-drug conjugate targeting HER2, is currently under investigation in numerous clinical trials for breast cancer, gastric/gastroesophageal junction (GEJ) cancer, and other types of solid tumors. It has exhibited promising effectiveness against tumors in various preclinical cancer models, including both high- and low-HER2-expressing breast cancers, ovarian cancer, and gastric cancer. Findings presented at SABCC revealed that ARX788 remains active following treatment with KADCYLA, suggesting potential efficacy post-ENHERTU as well. The FDA has granted Fast Track Designation to ARX788 for HER2+ metastatic breast cancer and Orphan Drug Designation for its use in gastric cancer.

ABT-101, a powerful small molecule kinase inhibitor, targets various cancer-causing kinases such as the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2, also known as ERBB2). Compared to other treatments in clinical development, ABT-101 shows promising therapeutic potential and a notably safer profile. It addresses the urgent medical need for drugs combating HER2-activating mutations (e20i) in HER2-related cancers. AnBogen Therapeutics announced in September 2022 that the US FDA has approved an amendment to the investigational new drug (IND) protocol for its Phase Ib/II trial of ABT-101. Currently, the drug is undergoing evaluation in a Phase IIa clinical trial for HER2 mutant NSCLC. As per the company’s pipeline, they are aiming to submit a New Drug Application (NDA) by 2027 for the treatment of HER2 mutant NSCLC.

The anticipated launch of these emerging therapies are poised to transform the HER2+ market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the HER2+ market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.

To know more about HER2+ clinical trials, visit @ HER2+ Treatment Drugs 

HER2+ Overview

HER2+ refers to a specific type of breast cancer characterized by the overexpression of a protein called human epidermal growth factor receptor 2. This protein plays a crucial role in cell growth and division, but when it is overproduced, it can lead to uncontrolled growth of cancer cells. HER2+ breast cancer accounts for about 20% of all breast cancers and tends to be more aggressive than other types. However, advancements in medical research have led to targeted therapies that specifically attack the HER2 protein, offering new hope for patients with this subtype of breast cancer. These targeted treatments, such as Herceptin and Perjeta, have significantly improved survival rates and outcomes for HER2+ breast cancer patients, highlighting the importance of personalized medicine in cancer treatment.

For individuals diagnosed with HER2+ breast cancer, treatment often involves a combination of surgery, chemotherapy, radiation therapy, and targeted therapy. The presence of the HER2 protein can be identified through testing, helping doctors tailor treatment plans to target this specific characteristic of the cancer cells. With ongoing research into new therapies and a better understanding of the molecular mechanisms behind HER2+ breast cancer, the outlook for patients continues to improve. Additionally, awareness campaigns and screening efforts play a vital role in early detection, offering the best chances for successful treatment and recovery.

HER2+ Epidemiology Segmentation

The HER2+ report takes into the account of historical, current, and forecasted HER2+ patient pool. In 2023, there were approximately 3,600 males and 2,200 females affected with HER2-positive gastric cancer in the United States.

The HER2+ market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into:

  • Total Incident Cases of Selected Indications 
  • Total Eligible Patient Pool for HER2+ in Selected Indications
  • Total Treated Cases in Selected Indications for HER2+ 

Download the report to understand what epidemiologists are saying about how HER2+ patient trends in 7MM @ HER2+ Epidemiological Insights

HER2+ Report Metrics Details
Study Period 2020–2034
HER2+ Report Coverage 7MM [The United States, the EU-4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]
Key HER2+ Companies Zymeworks, Jazz Pharmaceuticals, Ambrx, AnBogen Therapeutics, Enliven Therapeutics, Roche, and others
Key HER2+ Zanidatamab, ARX788, ABT-101, ELVN-002, and Giredestrant, among others

Scope of the HER2+ Market Report

  • HER2+ Therapeutic Assessment: HER2+ current marketed and emerging therapies
  • HER2+ Market Dynamics: Attribute Analysis of Emerging HER2+ Drugs
  • Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
  • Unmet Needs, KOL’s views, Analyst’s views, HER2+ Market Access and Reimbursement

Discover more about HER2+ drugs in development @ HER2+ Clinical Trials

Table of Contents

1. HER2+ Market Key Insights
2. HER2+ Market Report Introduction
3. HER2+ Market Overview at a Glance
4. HER2+ Market Executive Summary
5. Disease Background and Overview
6. HER2+ Treatment and Management
7. HER2+ Epidemiology and Patient Population
8. Patient Journey
9. HER2+ Marketed Drugs
10. HER2+ Emerging Drugs
11. Seven Major HER2+ Market Analysis
12. HER2+ Market Outlook
13. Potential of Current and Emerging Therapies
14. KOL Views
15. Unmet Needs
16. SWOT Analysis
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer
20. About DelveInsight

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About DelveInsight

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