HER2+ Breast Cancer Disease Market Analysis Research Report 2021 – Pipeline Drugs will Face Strong Competition in a Saturated Market – ResearchAndMarkets.com

Dublin – (work wire) – Added “Disease Analysis: HER2 + Breast Cancer” report ResearchAndMarkets.com Show.

Human epidermal growth factor 2 positive (HER2+) breast cancer is characterized by amplification of the HER2/neu oncogene. The publisher estimates that in 2018, there were 2.1 million incidental and 8.6 million five-year metastatic cases of breast cancer worldwide. By 2027, the incidence of incident breast cancer and the incidence of five-year breast cancer is expected to increase to 2.3 million and 9.3 million, respectively.

  • The HER2+ breast cancer market will grow between 2021 and 2025, with sales rising in the United States, Japan and five major European markets (France, Germany, Italy, Spain and the United Kingdom); However, the market will see a slight decline after 2025 as major brands Perjeta and Kadcyla face erosion of biosimilars across all regions. Furthermore, the HER2+ breast cancer market is becoming increasingly crowded, creating fierce competition between approved therapies and pipelines.

  • The high prices of the composite systems will translate into high returns, despite the introduction of biosimilars. The increased use of combination regimens, in conjunction with the continued uptake of new branded therapies and the increased prevalence of disease, will partially offset the decline in revenue caused by biosimilars during the forecast period.

  • Herceptin is the current standard of care therapy, and is used in every line of treatment, primarily as part of a combination regimen. However, it has steadily lost its market share after the introduction of trastuzumab biosimilars in 2019.

  • Despite initially facing reimbursement challenges, Perjeta in combination with Herceptin became the standard of care for both new adjuvant and first-line therapy for HER2+ breast cancer after demonstrating an overall survival benefit in the Phase III Cleopatra and APHINITY studies. Additionally, Roche recently launched Phesgo, a subcutaneous formulation of the formula.

  • Since its approval in 2013, Kadcyla has become the standard of care for both HER2+ breast cancer patients with residual invasive disease after toxin and Herceptin-based therapy, and for patients with metastatic disease who have progressed on a regimen containing trastuzumab.

  • Nerlynx, which is approved for the extended adjuvant preparation, has seen limited commercial success due to a lack of general survival benefit, high rates of diarrhea, and a high price. Although Puma Biotechnology positions Nerlynx as a third-line treatment, the drug may struggle to gain market share in the increasingly crowded third-line market.

  • The unfavorable clinical outcomes of Tykerb and the success of Kadcyla in subsequent lines of treatment have limited the commercial potential of the tyrosine kinase inhibitor. The introduction of Enhertu and other anticipated third-line treatments will limit Tykerb’s future commercial potential.

  • Enhertu was approved as a third-line treatment for advanced or metastatic locally advanced patients after demonstrating strong efficacy results in the pivotal DESTINY-Breast01 Phase II study. Enhertu is currently being tested against the investigator’s choice of treatment in a confirmatory phase III study, DESTINY-Breast02. Daiichi Sankyo and AstraZeneca are also testing Enhertu in phase III DESTINY-Breast03, DESTINY-Breast05 and DESTINY-Breast09, which could support label expansions for Enhertu in multiple treatment settings.

  • Recently approved in the United States and Europe, Tukysa has become the treatment of choice for third-line patients with brain metastases after showing positive efficacy results in a pivotal HER2CLIMB Phase II study. Although Tukysa’s overall commercial potential is currently somewhat limited due to the small volume of heavily pretreated patients with brain metastases, Seagen has recently begun a phase III CompassHER2 RD test for Tukysa in combination with Kadcyla to develop high-risk adjuvants. Trying to expand potential sick population in Tukysa.

  • Margenza was recently approved in the US for a third-line setup, but it has a limited commercial outlook because it will face significant competition from both approved and latecomers in an increasingly crowded market. Although Margenza demonstrated a progression-free survival benefit and a trend toward an overall survival benefit in the SOPHIA Phase III study, Tukysa and Enhertu showed better efficacy results.

  • Major recent events include the launch of Margenza in the US in its third-line setup, as well as European approvals for Tukysa, Phesgo and Enhertu.

  • Key triggers coming in 2021 include results from the Level 1 TULIP Phase 3 enrollment study of trastuzumab duocarmazine (vic-), and key results from the DESTINY-Breast03 Phase 3 trial from Enhertu.

  • The overall likelihood of approval of a stage 1 breast cancer origin is 7.8%, and the average likelihood of a stage 3 advancing the drug is 57.1%. Breast cancer drugs take, on average, 9.7 years from stage 1 to approval, compared to 9.6 years for general oncology.

Main topics covered:


disease background

  • Definition of

  • risk factors

  • symptoms

  • diagnose

  • HER2 status determination

  • patient segmentation

treatment or treatment

  • referral patterns

  • Stage I-III HER2+ inoperable breast cancer

  • HER2+ inoperable stage III breast cancer

  • New/adjuvant treatment regimens

  • Treatment guidelines for stage IV or HER2+ recurrent breast cancer


Marketed Medicines

Tube drugs

Major organizational events

  • NICE Funding for Enhertu & Kesimpta win firsts for England

  • Seagen debuted in the EU with the launch of Tukysa and considers the UK the ‘main’ future market

  • A setback for Athenex, Hanmi as CRL demands a new experience

  • Enhertu Nabs first with independent UK approval

  • Phesgo by Roche can reduce healthcare costs in the EU

  • MacroGenics receives approval for Margenza in HER2-positive breast cancer

  • Early EU approval wins over Daiichi/AZ & Lilly خط line

  • Phesgo & Roclanda are among the new winners of the EMA

  • Scottish HTA approves neratinib treatment for early-stage breast cancer

  • Updated: Several biosimilars to Avastin have been launched in the EU

  • The most recent EU Enhertu filings include AstraZeneca / Daiichi Sankyo

  • Genentech wins FDA approval for Phesgo

  • EU-backed agreement for trastuzumab and apixaban

  • Latifa from England says yes to Kadcyla in early breast cancer

probability of success

Licensing and asset acquisitions

  • Twice as cute: Seattle Genetics, partner of Merck & Co. on two cancer drugs

Clinical Experimental Landscape

  • Sponsors by situation

  • Sponsors by stage

  • Recent events

medication evaluation form

market dynamics

future trends

  • The launch of targeted new therapeutics and label expansions will partially counteract the market decline driven by biosimilars later in the forecast period.

  • Pipeline drugs will face tough competition in a saturated market

  • Implementation of mixed systems will result in high returns

  • Trastuzumab biosimilars will have little impact on the overall market

consensus forecast

Recent events and opinion analyst

  • Oral paclitaxel for breast cancer (March 1, 2021)

  • Oral Paclitaxel for Breast Cancer (December 9, 2020)

  • Poziotinib for Breast Cancer (December 9, 2020)

  • Tukysa for Breast Cancer (May 29, 2020)

  • Kadcyla for Breast Cancer (May 13, 2020)

Upcoming major events

Key Opinion Indicators for Leaders

unmet needs



For more information on this report, visit https://www.researchandmarkets.com/r/emsx99

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