Market Overview
- The Global Liposomal Doxorubicin Market is expected to grow at a high CAGR during the forecasting period (2020-2027).
- Liposomal Doxorubicin is a chemotherapy drug that contains doxorubicin (Adriamycin) wrapped up in a fatty covering called a liposome. Doxorubicin blocks an enzyme called topoisomerase 2 that cancer cells need to divide and grow. Liposomal doxorubicin is doxorubicin contained in tiny spheres called pegylated liposomes. These spheres keep the doxorubicin in the bloodstream longer, so that more of the drug reaches the cancer cells. It is used for the treatment of several types of cancer, including breast cancer, ovarian cancer, Kaposi's sarcoma, multiple myeloma, among others.
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Market Dynamics
- The global liposomal doxorubicin market is driven by the rising number of cancer cases. For instance, according to the World Health Organization (WHO), cancer accounts for 13% of deaths globally every year. Moreover, a 70% increase in cancer incidences is anticipated over the next couple of decades and the global geriatric population is anticipated to nearly double from 12% to 22%, from 2015 to 2022. The incidence of all cancer types worldwide is anticipated to increase at a CAGR of 2.5% during 2015-2030. The mortality rate of cancers is likely to increase at a higher rate compared to the incidence rate during 2015-2030, at a CAGR of 2.6%.
- The market growth is also estimated to boost over the forecast period, due to rising product development by manufacturers and new players entering the market. For instance, in March 2019, Cytori Therapeutics, Inc. has filed a formal new drug application pre-submission request to the European Medicine Agency (EMA) for Doxorubicin Hydrochloride Cytori. This submission is the precursor to filing an Article 58 Application for a Marketing Authorization Application (MAA) via EMA’s centralized approval procedure. In June 2017, the EMA Committee for Medicinal Products for Human Use (CHMP) confirmed that Doxorubicin Hydrochloride Cytori was eligible for the submission of an MAA via the centralized procedure.
- However, there are some side-effects associated with Liposomal Doxorubicin which are expected to hamper the growth of the market over the forecast period. Some of the side-effects include increased risk of getting an infection, breathlessness and looking pale, bruising, bleeding gums and nosebleeds, tiredness and weakness (fatigue) during and after treatment, soreness, redness and peeling of your hands and feet, loss of appetite and weight loss, diarrhea or constipation, among others.
Market Segmentation Analysis
- Based on product type, the market is segmented into Doxil/Caelyx, Lipodox, Myocet, and Others. Doxil/Caelyx segment accounted for the highest market share in 2018, owing to the rising incidence of ovarian and breast cancers. The increasing demand for Doxil or Caelyx (J&J) as a second-line treatment for ovarian carcinoma is also expected to boost the growth of the market over the forecast period. Caelyx/Doxil is a novel pegylated liposomal formulation of the first-generation anthracycline, doxorubicin. The pharmacokinetics of this polyethylene-glycol-coated liposome is characterized by a reduced volume of distribution, a long intravascular circulating half-life, and slow plasma clearance compared with free doxorubicin.
- By application, the liposomal doxorubicin market is segmented into Kaposi sarcoma, leukemia, breast cancer, multiple myeloma, ovarian cancer, endometrial cancer, liver cancer, bone sarcoma, kidney cancer, and others. Among these, breast cancer accounted for the highest market share in 2018, owing to rising demand for the treatment in increasing breast cancer cases globally. According to Breastcancer.org, about 1 in 8 U.S. women (about 12%) develop invasive breast cancer throughout her lifetime. In 2019, an estimated 268,600 new cases of invasive breast cancer are expected to be diagnosed in women in the U.S., along with 62,930 new cases of non-invasive (in situ) breast cancer. About 2,670 new cases of invasive breast cancer are expected to be diagnosed in men in 2019. A man’s lifetime risk of breast cancer is about 1 in 883. However, with increasing treatments for cancer, the breast cancer incidence rates in the U.S. began decreasing in the year 2000, after increasing for the previous two decades. They dropped by 7% from 2002 to 2003 alone. According to the American Cancer Institute, Doxorubicin is used during the advanced breast cancer treatment as a chemo drug. It is observed that currently, 3 million women diagnosed with breast cancer are there in the United States. Hence, with the increasing burden of breast cancer leads to a rise in demand for the treatment.
Market Geographical Analysis
North America is dominating the global liposomal doxorubicin market accounting for the largest market share in 2018, owing to the increasing number of cancer cases and consequently growing demand for doxorubicin in mono and combination chemotherapies. According to the National Cancer Institute, in 2016, an estimated 229,875 women were living with ovarian cancer in the United States. The number of new cases of ovarian cancer was 11.4 per 100,000 women per year. The number of deaths was 7.0 per 100,000 women per year. As of January 2019, there are more than 3.1 million women with a history of breast cancer in the U.S. Also, the growing number of partnerships, mergers, and acquisitions for clinical trials with technologically advanced doxorubicin formulations is also driving the growth of the market in this region. The Doxil brand and generic had US sales of USD 196 million for the 12 months ending in March 2017
Market Competitive Trends
- The liposomal doxorubicin market is highly competitive with the presence of a large number of major players. Some of the major players in the global Liposomal Doxorubicin market include Johnson & Johnson, SRS Pharmaceuticals Pvt. Ltd., Sun Pharmaceutical Industries Ltd., Cadila Pharmaceuticals, Merck & Co., Cipla, Inc., Pfizer Inc., among others.
- The key players are adopting various growth strategies such as product launches, mergers & acquisitions, partnerships, and collaborations which are contributing to the growth of the liposomal doxorubicin market globally. For instance,
- In January 2019, Celsion Corporation, an oncology drug development company, announced results from Phase I TARDOX trial of ThermoDox® conducted at the University of Oxford, United Kingdom. The TARDOX trial evaluated the safety and efficacy of ThermoDox®, Celsion’s proprietary heat-activated liposomal encapsulation of doxorubicin, along with focused ultrasound for the treatment of liver cancer.
- In May 2017, Drugmaker Dr. Reddy's on Wednesday has received approval from the US FDA to launch anti-cancer drug doxorubicin hydrochloride liposome injection. Dr. Reddy's partnered with Natco Pharma to develop the drug, considered to be an extremely complex product.
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