Generic Oncology Sterile Injectable Market Insights
Generic oncology sterile injectables are biologics that have the same active ingredients as that of the branded version, with only the inactive contents of the drugs being different. Manufacturers of generic sterile injectables have to adhere to regulations by the Food and Drug Administration (FDA) for the process of development of these injectables, which are equivalent to that for branded counterparts. These generic oncology sterile injectables are used for the treatment of various types of cancer including breast, prostate, colorectal, melanoma, lung, and bronchus. These injectables are available at low prices, and therefore, are widely preferred over branded. Furthermore, R&D for generic drugs requires less capital, which increases competition to enter into generic oncology sterile injectable market as soon as the patent for branded injectables expires. However, the emergence of biosimilars has increased in past few years. After Europe, the number of biosimilars approved is increasing in the U.S. market. This is expected to contribute largely towards the generic oncology sterile injectable market growth during the forecast period.
The key players in generic oncology sterile injectable market includes, Eli Lilly & Company, Biocon Ltd., Baxter International Inc., Hikma Pharmaceuticals PLC, Mylan N.V., Sandoz International GmbH, Teva Pharmaceutical Industries Ltd., and Pfizer Inc.
Rising number of cancer cases is expected to fuel demand for treatment drugs and injectables. According to the World Cancer Research Fund International (WCRFI), around 14.1 million cancer cases were reported worldwide, in 2012. As per WCRFI, it is projected that by 2035, around 24 million cancer cases are expected to increase. This is expected to drive growth of the generic oncology sterile injectable market.
The global generic oncology sterile injectable market was valued at US$ 8.9 Billion in 2016 and is expected to exhibit a CAGR of 11.4% over the forecast period (2017–2025).
Figure 1. Global Generic Oncology Sterile Injectable Market Value (US$ Mn), By Region – 2016
Expansion of manufacturing facilities and mergers between key players to develop strong pipeline product is expected to propel the generic oncology sterile injectable market growth
Manufacturers in the market are focusing on collaboration and expansion of manufacturing facilities to tap into emerging markets. For instance, In July 2017, India-based Alembic Pharmaceuticals established an oncology manufacturing facility for injectables and lyophilized products in Gujarat. The manufacturing site has a capacity for 60 million tablets and capsules, approximately 20 million vials capacity for liquid injectables and lyophilized product. This new manufacturing facility will develop oncology injectables and lyophilized products for sales in international markets of the U.S., Middle East, North Africa, South Africa, and Australia. Furthermore, in December 2016 the global leader, Baxter International acquired India-based Claris Injectables for expanding its generic injectables product portfolio such as in oncology. This acquisition is expected to strengthen Baxter’s sales in hospitals in order to gain a leading position in generic injectables market. Also, in August 2017, Hikma Pharmaceuticals increased its additional manufacturing capacity by 70 million units exclusively for oncology injectables, which brings up its total to 550 million units. Therefore, this expansion will help Hikma to maintain its position in the market.
In October 2014, Sagent Pharmaceuticals, Inc., a leader in injectables, acquired Omega Laboratories Limited. This acquisition is expected to aid in creating a robust product portfolio in generic injectables and expand Sagent’s global presence. Omega has a strong pipeline consisting of 26 generic injectables, planned to be launched between 2014 and 2019 and this is expected to aid Sagent.
In October 2017, Eli Lilly & Company received intellectual property rights for the vitamin regimen for Alimta (pemetrexed for injection) by the Patent Trial and Appeal Board of the U.S. Patent and Trademark Office (PTO). These rights are expected to aid Eli Lilly & Company for development of next generation medicines.
Generic oncology sterile injectables are used in treatment of various types of cancers such as ovarian, breast, and lung. These drugs are relatively cheaper than branded counterparts. This is owing presence of same active ingredients, although its inactive contents are different. Cost is a major concern for cancer patients, especially in emerging economies such as India, Brazil, and China. Therefore, governments of such countries are taking efforts to reduce cost of medications and increase its accessibility. For instance, the National Pharmaceutical Pricing Authority (NPPA) of India reduced the prices of a few cancer drugs by 86% in March 2017. Generic oncology sterile injectables have a huge potential in such countries, where patient population is high; however, spending power is relatively low. Furthermore, patent expiry is expected to fuel growth of the generic oncology sterile injectables during the forecast period. Also, the emergence of biosimilars has also impacted growth of generics drugs. For instance, according to the Journal of Generics and Biosimilars Initiative, 2017, biosimilars had a major share in Europe since 2013 and in the U.S. since 2015 and the share of biosimilars is expected to increase significantly in the biologicals market. This is expected to eventually boost growth of the generic oncology sterile injectable market.
Generic oncology sterile injectables market is gaining significant traction due to rising prevalence of cancer cases. For instance, according to the National Cancer Institute, in 2016, around 1,685,210 new cases of cancers were reported in the U.S. Manufacturers are focusing on launching new products to offer low cost treatment to patients. For instance, in November, 2017, Mylan N.V. launched Clofarabine Injection (20 mg/20 mL (1 mg/mL) Single-Dose Vials) following U.S. Food and Drug administration approval in the U.S. market. Clofarabine is a generic version of Genzyme's Clolar, which is used for treatment of refractory acute lymphoblastic leukemia for patients aged 1 year to 21 years.
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