Number of pages: 100 | Report Format: PDF | Published date: February 24, 2023
Historical Years – 2020 | Base Year – 2021 | Forecasted Years – 2022-2030
According to the deep-dive market assessment study by Growth Plus Reports, the global trastuzumab biosimilars market was valued at US$ 2.04 billion in 2021 and is expected to register a revenue CAGR of 27.3% to reach US$ 17.90 billion by 2030.
Trastuzumab Biosimilars Market Fundamentals
Trastuzumab is a monoclonal antibody that binds to HER2 receptors found on the surface of HER2-positive tumor cells, by preventing them from receiving growth impulses and putting them towards the immune defense mechanism for elimination. Trastuzumab is used to treat breast cancer. Trastuzumab biosimilars have equivalent clinical and pharmacological properties when administered intravenously or subcutaneously. Trastuzumab biosimilars are preferred, particularly in co-administration with other chemotherapeutic drugs, such as trastuzumab and tucatinib, when necessary, in patients with HER-positive metastatic breast cancer.
Trastuzumab is the generic name for the drug Herceptin. Herceptin (trastuzumab), manufactured by F. Hoffmann-La Roche Ltd., was approved by the U.S. Food and Drug Administration (FDA) in September 1998 and by the European Medicines Agency (EMA) in August 2000. It is envisioned that the usage of biosimilars in routine clinical practice will increase patient access to anti-HER2 therapy by generating more affordable and additional therapeutic options. Biosimilars can result in significant resource savings for healthcare systems in many nations as HER2-targeting medications can be used for a long time and in conjunction with other systemic therapies.
Trastuzumab Biosimilars Market Dynamics
The global trastuzumab biosimilars market is primarily driven by a rise in the prevalence of breast and gastric cancer. In the U.S., there were 287,850 new instances of invasive breast cancer, and about 43,250 deaths from breast cancer in 2022. Additionally, gastric cancer, the second most common cancer in the world, affects nearly two-thirds of people in developing nations. Furthermore, trastuzumab biosimilars are increasingly used as an alternative treatment for chemotherapy owing to the high cost of chemotherapy.
Age increases the likelihood of breast cancer. Women over 50 years who have gone through menopause are specifically at higher risk of this illness. In this population pool, about 8 out of 10 females have breast cancer. Breast cancer risk is greater in mothers who are older than 30 when they give birth to their first child than in those who have never given birth. On the other hand, several research studies showed that excessive usage of different therapies based on hormones and steroids, such as contraceptive pills, regularly in women increases the risk of developing breast cancer. Therefore, the increased usage of hormone therapy and contraceptive pills fuels the cases of breast cancer, which significantly influence the growth of the global trastuzumab biosimilars market. Additionally, the development and recurrence of tumors are also influenced by an unhealthy lifestyle. Breast cancer risk has been linked to both an unhealthy diet and a lack of exercise over the course of a person’s lifetime. Thus, irregular routine, alcohol consumption, smoking, and late pregnancy may lead to breast cancer and gastric cancer, resulting the increased business opportunities in the trastuzumab biosimilars market.
However, the market for trastuzumab biosimilars is hindered due to the severe side effects of the drug. Trastuzumab can cause diarrhea, nausea, fever, heart issues, infections, coughing, and rashes. Trastuzumab therapy has also been reported to raise the incidence of asymptomatic cardiac dysfunction. Moreover, the high cost of trastuzumab biosimilars is one more major factor hindering the revenue growth of the global trastuzumab biosimilars market. Also, the manufacturing challenges associated with oncology biosimilar products are anticipated to restrain market development. The regulatory and clinical challenges may also hinder the market’s expansion, as biosimilars must go through additional clinical trials before receiving regulatory approval.
Trastuzumab Biosimilars Market Ecosystem
The global trastuzumab biosimilars market is analyzed from four perspectives: product, indication, distribution channel, and region.
Trastuzumab Biosimilars Market by Product
Based on the product, the global trastuzumab biosimilars market is segmented as ogivri, herzuma, ontruzant, trazimera, kanjinti, and others.
The ogivri segment accounted for the largest revenue share of the global trastuzumab biosimilars market in 2021. Ogivri was the first approved trastuzumab biosimilar for treating breast cancer in 2017. Adjuvant breast cancer is treated with the prescribed drug ogivri. Ogivri is used in the treatment of early-stage breast carcinoma that is human epidermal growth factor receptor 2 (HER2+) positive and has spread to the lymph nodes, or that is HER2-positive but has not spread to the lymph nodes.
Trastuzumab Biosimilars Market by Indication
Based on the indication, the global trastuzumab biosimilars market is segmented into breast cancer, metastatic gastric cancer, colorectal cancer, and others. The breast cancer segment is sub-segmented into adjuvant breast cancer and metastatic breast cancer.
The breast cancer segment accounted for the largest revenue share of the global trastuzumab biosimilars market in 2021. Breast cancer is the most prevalent cancer in women and represents a significant global public health challenge. Invasive breast cancer is predicted to affect one in eight women in the U.S. over the length of their lifetimes. In addition to nearly 64,000 new instances of non-invasive breast cancer in women from this country, over 266,000 new cases of invasive breast cancer were anticipated to be diagnosed in 2018. Approximately 80% of breast cancer cases found in women are due to aging and lifestyle-related risk factors.
Hormones are often used in birth control methods, which may increase the possibility of breast cancer. The chance of breast cancer is slightly higher in women who use oral contraceptives. Breast cancer is caused by increased usage of birth control among women. Alcohol consumption is associated with a higher risk of developing breast cancer, and the risk increase brought on by this factor increases with the quantity of alcohol consumed. For instance, females who consume two to three drinks of alcohol per day have a 20% higher possibility of developing breast cancer than women who do not drink alcohol. Additionally, the lack of exercise may increase the possibility of breast cancer, particularly in women post-menopause. Hence, unbalanced lifestyles, increase in the geriatric population, and excessive usage of steroids and birth control in women have resulted in an increase in the prevalence of breast cancer, fueling the global trastuzumab biosimilars market revenue growth.
Trastuzumab Biosimilars Market by Distribution Channel
Based on the distribution channel, the global trastuzumab biosimilars market is segmented into hospital pharmacies, online pharmacies, and others.
The hospital pharmacies segment accounted for the largest revenue share for the global trastuzumab biosimilars market in 2021. As there is more capital to spend on state-of-the-art medicine stocks, hospital pharmacies have taken the lead. Due to the availability of numerous multi-specialty facilities, hospital pharmacies have the necessary drugs to provide patients with comprehensive treatment. This segment accounts for a substantial market revenue share due to a number of factors, including the rising number of cancer patients, ongoing clinical advancements in the field of oncology therapy, and the expanding accessibility to healthcare reimbursements in many developed countries. As more people are becoming aware of the numerous advantages of biosimilars treatment, such as the affordability of trastuzumab biosimilars and the decreased risk of complications, the hospital pharmacies segment dominates the global market.
Trastuzumab Biosimilars Market by Region
Based on the region, the global trastuzumab biosimilars market is segmented into North America, Europe, Asia Pacific, and the rest of the world.
North America accounted for the largest revenue share of the global trastuzumab biosimilars market in 2021. Breast cancer is the second most prevalent form of cancer in women, with anticipated 290,560 new cases in the U.S. in 2022. Also, estimated new cases of rectal cancer and colon cancer for 2022 were about 44,850 and 106,180, respectively, bringing the overall number of new cases of colorectal cancer to 151,030. The high prevalence of breast cancer and gastric cancer in North America is the most crucial factor driving the need for trastuzumab biosimilars for treatment. The high incidence of cancer in North America has resulted in increased demand for efficient therapy. A large population base, rise in health awareness, growth in healthcare spending, and decrease in production costs also represent the market’s future potential. North America has established regulatory standards for oncology biosimilars. Moreover, the region is home to the bulk of ongoing clinical trials focused on biosimilars, fueling regional market development.
Trastuzumab Biosimilars Market Competitive Landscape
Leading players operating in the trastuzumab biosimilars market include:
Trastuzumab Biosimilars Market Strategic Developments
Trastuzumab (Herceptin) is a HER2-targeted medication used in the treatment of both early-stage and advanced HER2-positive breast tumors.
Increase in the prevalence of breast and gastric cancer and rise in the need for new treatment strategies are the key trends governing the development of the global trastuzumab biosimilars market.
Amgen Inc., Pfizer Inc., Samsungbioepis Co. Ltd, Merck & Co., Biocon Limited, and Mylan Inc. are among the top market players.
Stringent regulations and the complexity of the product development process are the major restraining factors for the revenue growth of the global trastuzumab biosimilars market to its full potential.
The global trastuzumab biosimilars market is expected to register growth at a revenue CAGR of 27.3% during the forecast period from 2020 to 2030.
*Insights on financial performance are subject to the availability of information in the public domain