Johnson and Johnson was the first company to introduce a doxorubicin formulation in the market, Doxil. In 1995, J&J received the U.S.FDA approval for the treatment of Kaposi’s sarcoma, breast cancer, multiple myeloma, and ovarian cancer. In 2007, few changes in drug formulation were made as there was a lot of adverse reactions reported. Doxil was distributed and marketed by Janssen Products, LP and was manufactured by Ben Venue Laboratories.
However, in 2013, Ben Venue Laboratories announced the shutdown of its manufacturing unit by the end 2013. Currently, it is manufactured by TTY Biopharm for the U.S. market. Some of the listed doxorubicin manufacturers are Ortho Biotech Products, LP, APP Pharmaceuticals Manufacturing, LLC, Ben venue laboratories, Inc., Pharmachemie B.V., and Bristol-Myers Squibb Company. In 2012, the U.S, FDA approved the importation of the drug and is manufactured by Sun Pharma Global, a subsidiary of Sun Pharmaceuticals Industries, Ltd. And also after a year, the drug was approved as the first generic version of doxil, distributed and marketed by the Sun Pharmaceuticals, Ltd. In April 2016, it was announced that NICE recommended PEGylated liposomal doxorubicin hydrochloride for the treating recurrent ovarian cancer.
The rapidly changing technology, rising patient awareness levels, and growing disposable income are some of the key attributes that account for the market growth. The introduction of technologically advanced drug delivery systems such as nanoparticle or in the PEGylated liposomal capsule form to avoid adverse effects spotted in the conventional doxorubicin formulation is also anticipated to propel the market growth. Moreover, the growing number of cancer cases and increasing adoption of this formulation in various applications are among few factors that are expected to drive the market in the coming few years. The global doxorubicin market was valued at USD 809.6 million in 2015 and is projected to grow at a CAGR of 6.4% over the forecast period. The various brand name for the drug formulations are Rubex, Adriamycin PFS, and Adriamycin RDF.
In 2015, the utility of doxorubicin in breast cancer accounted for the majority share of approximately 21%. According to the estimates of the Breast Cancer Organization, it is forecasted that over 12% of the U.S. women will have invasive ductal carcinoma during their lifetime. Furthermore, based on the report published by the American Cancer Society in 2015, approximately 231,840 new cases of invasive breast cancer were diagnosed among the U.S., women population. The growing incidence rate of breast cancer and subsequently increasing survival rate are some of the attributes the market growth.
In 2015, the U.S. is the most important sector and captured a majority share of the North American segment. The presence of several doxorubicin market players, such as Aeterna Zentaris, Inc., Celsion, Corporation Elan Corporation, among others, is also one of the factors indicative of the growing demand for doxorubicin in this region. The increasing number of mergers and acquisitions and partnerships for clinical trials with technologically advanced doxorubicin formulations is one of the crucial factors driving the doxorubicin market in this region.
In-depth report on global doxorubicin market by Grand View Research: