HER2, also known as Human Epidermal Growth Factor 2, is a protein that plays a significant role in cell growth and cell division. The HER2/neu gene encodes it and belongs to the family of receptors known as Receptor Tyrosine Kinase (RTK). HER2 is found on the surface of many cells. The overexpression of HER 2 has been linked with many types of cancer like gastric cancer, Ovarian cancer, Thoracic neoplasms, Bronchial neoplasms, and Breast cancer. HER2 overexpression confers worse biological behavior and clinical aggressiveness in breast cancer. Breast cancer cells with higher than normal levels of HER2 are called HER2-positive. Trastuzumab was the 1st drug used for the treatment of HER2-positive diseases, and since then, many treatments and therapies have been indicated for HER2-positive cancer. HER2-positive cancers grow and spread faster but react better towards the therapy given, like trastuzumab course, than HER 2 negative. About 20% of breast cancers are HER2-positive. Extensive research is being conducted globally to discover new and novel molecules to be used, like pembrolizumab, which is used for the treatment of many indications like Non-small Cell Lung Cancer. The development and launch of new products will thus increase the revenue of the market in the forecasted years. According to a research article, 1.1 million new cases of gastric cancer were estimated in 2020, with the incidence 2x in males than in females. The annual burden of Gastric cancer is expected to increase to approximately 1.8 million new cases by 2040.
A number of these inhibitors are in the market, while many are in ongoing clinical trials. Various companies have various products in their pipelines, with 342 products in various stages of clinical trials – 13 in Phase 4, 38 in Phase 3, 82 in Phase 2, and 83 in Phase 1 of the clinical trials.
Key developments of HER2
- In August 2022, FDA approved Enhertu (fam-trastuzumab deruxtecan-nxki) as the 1st HER2-directed therapy for patients with previously treated HER2-Mutated Metastatic Non-small Cell Lung Cancer.
- In August 2022, FDA approved Enhertu (fam-trastuzumab deruxtecan-nxki) as the 1st HER2 directed therapy for patients with HER2-Low Metastatic Breast Cancer.
- In January 2021, FDA approved Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of patients with previously treated HER2-positive Advanced Gastric Cancer.
- In January 2018, FDA approved supplemental NDA (sNDA) for Gilotrif (afatinib) for 1st line treatment of patients with EGFR Mutation-Positive Non-small Cell Lung Cancer.
Approved HER2 molecules
- Herceptin (trastuzumab)
- Perjeta (pertuzumab)
- Gilotrif (afatinib)
- Irene (pyrotinib)
- Kadcyla (ado-trastuzumab emtansine)
- Enhertu (fam-trastuzumab deruxtecan-nxki)
- Vizimpro (dacomitinib)
- Aidixi (disitamab vedotin)
- Tukysa (tucatinib)
- Trazimera (trastuzumab-qyyp)
- Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
- Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
- Pozenveo (poziotinib)
- trastuzumab rezetecan (SHR-A1811)
- varlitinib (ASLAN001)
- Cipterbin (inetetamab)
- Herzuma (trastuzumab-pkrb)
- tesevatinib (KD019)
- sapitinib (AZD8931)
- Exkivity (mobocertinib)
- zanidatamab (ZW25)
- Margenza (margetuximab)
- MRG002)
- ETBX-021)
- HER-2/neu peptide vaccine)
- anbenitamab (KN026)
- anvatabart opadotin (ARX788)
- sunvozertinib (DZD9008)
- BMS690514)
- Ontruzant (trastuzumab-dttb)
- AST-301)
- trastuzumab duocarmazine (SYD985)
- DP303c
- EG1206A (pertuzumab biosimilar)
- HER2Bi-armed ATC
- NeuVax (nelipepimut-S)
- CUDC-101
- GB221 (trastuzumab biosimilar)
- BI 1810631
- Hervelous (trastuzumab biosimilar)
- Kanjinti (trastuzumab-anns)
- MM 111
- Rexomun (ertumaxomab)
- zenocutuzumab (MCLA-128)
- A166
- AEE788
- AryoTrust (trastuzumab biosimilar)
- BAT8001
- GQ1001
- HS627 (pertuzumab biosimilar)
- MVA-BN-HER2
- Ogivri (trastuzumab-dkst)
- Zercepac (trastuzumab biosimilar)
- anti-HER2 antibody conjugated with pegylated liposomal doxorubicin (MM-302)
- cinrebafusp alfa (PRS-343)
- dHER2+AS15
- pirotinib (KBP-5209)
- trastuzumab mafodotin (IKS014)
- ALT02 (trastuzumab biosimilar)
- AU-101
- BCD-178 (pertuzumab biosimilar)
- BL-M07D1
- CAM-H2
- EO1001
- Eirgasum (trastuzumab biosimilar)
- Faceptor (trastuzumab biosimilar)
- HLX11 (pertuzumab biosimilar)
- HLX22
- Her-VAXX
- IAH0968
- IMM2902
- ISB 1302
- JK07
- JSKN003
- Lovaxin B (OST-HER2)
- MP412
- MT-5111
- SBT6050
- SCRI-huCAR19v1
- TX05 (trastuzumab biosimilar)
Drugs in the Pipeline of HER2
- Nerlynx (neratinib)
- Tukysa (tucatinib)
- Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
- Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
- Pozenveo (poziotinib)
- trastuzumab rezetecan (SHR-A1811)
- varlitinib (ASLAN001)
- tesevatinib (KD019)
- sapitinib (AZD8931)
- Exkivity (mobocertinib)
- zanidatamab (ZW25)
- Margenza (margetuximab)
- MRG002
- ETBX-021
- HER-2/neu peptide vaccine
- anbenitamab (KN026)
- anvatabart opadotin (ARX788)
- sunvozertinib (DZD9008)
- BMS690514
- AST-301
- trastuzumab duocarmazine (SYD985)
- DP303c
- EG1206A (pertuzumab biosimilar)
- HER2Bi-armed ATC
- NeuVax (nelipepimut-S)
- CUDC-101
- GB221 (trastuzumab biosimilar)
- BI 1810631
- Hervelous (trastuzumab biosimilar)
- Kanjinti (trastuzumab-anns)
- MM 111
- Rexomun (ertumaxomab)
- zenocutuzumab (MCLA-128)
- A166
- AEE788
- AryoTrust (trastuzumab biosimilar) and many more
Clinical Activity and Developments of HER2
As of July 2023, various companies have approximately 342 products for 465 diseases. For these diseases, many trials are being conducted by players globally. For instance,
- Wuhan University is conducting a Phase 4 clinical trial to explore triple-targeted neoadjuvant treatment of HER2-positive Breast Cancer with Pyrotinib in combination with Trastuzumab and Pertuzumab that is expected to complete by September 2027.
- Zhejiang University is conducting a Phase 4 clinical trial toevaluate injectable Albumin-bound Paclitaxel versus Docetaxel for the adjuvant treatment of Breast Cancer that is expected to complete by December 2027.
- Institut fuer Frauengesundheit is conducting a Phase 4 clinical trial to study neoadjuvant treatment of Ontruzant (SB3) in patients with HER2-positive Early Breast Cancer that is expected to complete by July 2023.
|
Molecule name |
Number of studies |
|
Herceptin (trastuzumab) |
1043 |
|
Perjeta (pertuzumab) |
284 |
|
Gilotrif (afatinib) |
215 |
|
Irene (pyrotinib) |
157 |
|
Kadcyla (ado-trastuzumab emtansine) |
140 |
Target Indication Analysis of HER2
Drugs like Herceptin and Perjeta have been approved by the FDA and other regulatory bodies for the treatment of various indications. Herceptin has been approved for various indications as a part of the treatment regimen with doxorubicin, cyclophosphamide, and either docetaxel or paclitaxel. In combination with paclitaxel, it is indicated for Metastatic HER2 positive Breast Cancer, and in combination with cisplatin and capecitabine for HER2 positive Gastric cancer or Gastroesophageal junction Adenocarcinoma. Perjeta is indicated in combination with trastuzumab and docetaxel for Metastatic HER2 positive Breast Cancer, neoadjuvant treatment of HER2-positive locally advanced, inflammatory, or early-stage breast cancer, and as adjuvant treatment in patients with HER2-positive early-stage breast cancer at high risk of recurrence.
HER2 Regional Analysis
HER2 Market
Roche’s global net sales of Herceptin in the fiscal year 2022 were $2,227.68 million, 19% lower than global net sales in the fiscal year 2021, being $2,801.76 million. The net sales of Herceptin were $495.04 in the USA, $438.88 in Europe, and $53.04 million in Japan in the financial year 2022. Perjeta had an overall net sale of $4,250.48 million in the fiscal year 2022, from which $1,594.32 million sales were from the USA itself, while $4,113.2 million net sales in the fiscal year 2021 with a 5% increase in the sales in 2022. The net sales of Herceptin were $905.84 in Europe and $243.36. million in Japan in the financial year 2022. There is a growing market globally for PD-1 Inhibitors, and it is a good global opportunity for the market players.
Latin America
Europe
Asia Pacific
Middle East
North America
Frequently Asked Questions
Herceptin (trastuzumab), Perjeta (pertuzumab), Gilotrif (afatinib), and Irene (pyrotinib) are some of the FDA-approved HER2.
These are used for the treatment of HER2-positive - Breast cancer, Gastric cancer, Ovarian cancer, Thoracic neoplasms, and others.
Roche, Boehringer Ingelheim, Jiangsu Hengrui Pharma, and Knight Therapeutics are some of the major market players for HER2.
Rising incidence of diseases, improvement in technologies, development of new treatment lines in the market, and rising incidence of various types of cancers like Breast cancer, Ovarian cancer, and others are the key opportunities for HER2 in the market.
Key Features of the Reports
- The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
- The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
- The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
- The report tracks recent innovations, key developments, and start-up details that are actively working in the market
- The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
- Roche
- Boehringer Ingelheim
- Jiangsu Hengrui Pharma
- Puma
- Knight Therap
- Pierre Fabre
- Daiichi Sankyo
- AstraZeneca
- Pfizer
- Rongchang Pharma
- Seagen
- Pfizer
- Halozyme
- Spectrum Pharma
- Luye Group
- ASLAN Pharma
- 3SBio
- Nippon Kayaku
- Mundipharma
- Celltrion
- Teva
- Sanofi
- Takeda
- Jazz
- MacroGenics
- ZAI Lab
- Alphamab
- Ambrx
- Dizal Pharma
- Samsung
- AffaMed Therap
- Organon
- Byondis
- Medac