Injectable drug delivery is the mode of introduction of a drug directly into the bloodstream of a patient. Drugs are directly injected into the bloodstream of patients, owing to which they need to be sterile. Sterile injectable drugs are usually available in liquid form.
Sterile injectable drugs are usually permit to transport directly into blood stream sometimes. The manufacturing of sterile injectable drugs is a complex process and recurs high initial investment and operating cost.
Major factor that is increasing the demand for sterile injectable is increasing number of cancer cases. According to the World Cancer Research Fund International (WCRFI), around 14.1 million cancer cases were accounted worldwide in 2012. As per the WCRFI, till 2035, the number is expected to reach 24 million.
Small molecule monoclonal antibodies are used for cancer treatment therapy. Cancer therapies are the import engine of the growth of the sterile oncology injectable market.
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Focus of the Manufacturers on Technologies, Materials and Robust Manufacturing Process
The supply of drugs is short in the U.S., with some shortage continuing for multiple years. The majority of these drugs are generic sterile injectable products. Companies are focusing on increase in supply of sterile oncology injectable.
Manufactures are now focusing on superior technology and procurement of higher grade raw materials. Contract manufacturing organization can help to address drug shortage problem in North America and Europe. They adopt new technologies and rapidly transfer in sterile injectable manufacturing processes.
Dynamics of the Sterile Oncology Injectable Market
The global sterile oncology injectable market is projected witness significant growth over the forecast period due to rising prevalence of cancer globally. Increase in investment by drug manufactures in the development of sterile oncology injectable, short time frame for approval of new drug in cancer treatment are some of the key factor boosting demand for sterile oncology injectable market globally.
Rapid FDA approvals of sterile oncology injectable along with shortened approval times for drug development in cancer care is helping manufacturers to accelerate drug supplies.
These factors are eventually boosting the growth of the global sterile oncology injectable market. However, stringent rules and regulations in manufacture of sterile oncology injectable and high quality and care required in manufacturing, challenges in storage, packaging and distribution of oncological sterile injectable are likely to hamper the growth of sterile oncology injectable market. Also, sterile drugs require complex equipment for manufacturing.
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Market Expansion Due to Agreements and Partnerships
Sterile oncology injectable manufacturers are focusing on partnership and geographical expansion in different countries to establish facilities in various regions. Pfizer has expanded its oncology portfolio with acquisition of Hospira.
Hospira has a broad sterile injectable product line, which includes acute care and oncology injectable. Baxter also acquired India-based injectable firm Claris Injectable Limited and expanded its portfolio in anti-infective, analgesics and critical care and oncology injectable.
Regional Market Outlook
North America will continue to dominate the global market due to the availability of advanced technologies and more number of clinical trial, surge in demand for innovative medical technology in the U.S. According to the National Institute of Cancer in 2016, around 1,685,210 new cancer cases are likely to be diagnosed in the U.S.
Europe is expected to hold second large market share in global sterile oncology injectable market due to growing prevalence of chronic diseases. Competition from low-cost pharmaceutical manufacturing countries such as India and China has led to discontinuation of many products.
Asia Pacific is expected to exhibit attractive market share owing to increase in health awareness and demand for advanced medical technology in oncology treatment and increasing investments on low-cost pharmaceutical manufacturing.
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Competition Outlook
Examples of some of the key players identified in the global sterile oncology injectable market are Eli Lilly & Company, Biocon Ltd, Baxter International Inc., Hikma Pharmaceuticals PLC, Mylan N.V., Sandoz International GmbH, Teva Pharmaceuticals Industries Ltd, and Pfizer Inc., among others. Sterile oncology injectable are used for cancer treatment and therapies.
Recent M&A activities have fueled the growth prospect for sterile oncology injectable. Recent deal of US$ 17 Billion between Pfizer & Hospira provides platform for growth for Pfizer’s Global Established Pharmaceutical (GEP) business.
Hospira’s generic sterile injectable products, including acute care and oncology injectable have provided boost to Pfizer’s sterile injectable offerings in oncology market. However, preference of large molecules offers a global opportunity to its manufacturers, as these are the common molecules recently used globally for oncology application.
Sterile CMOs
- Catalent Pharma Solutions
- Baxter
- Akorn
- Althea
- Vetter
- Piramal Pharma Solutions (ColdStream Laboratories)
- IDT Biologica.
Medium Scale Manufacturers/Providers
- Biocon Ltd
- Baxter International Inc.
- Hikma Pharmaceuticals PLC
- Sandoz International GmbH
Large Scale Manufacturers/Providers
- Mylan N.V
- Teva Pharmaceuticals Industries Ltd
- Pfizer Inc.
Eli Lilly & Company
Market Segmentation
By Molecule Type
- Small Molecule
- Large Molecule
By Product type
- Chemotherapy
- Monoclonal Antibodies
- Cytokines
- Peptides Hormones
By Indication
- Ovarian Cancer
- Breast Cancer
- Lung Cancer
- Pancreatic Cancer
- Other
By Distribution Channel
- Hospitals
- Retail Pharmacies
- Online Pharmacies
By Region
- North America
- Latin America
- Western Europe
- Eastern Europe
- Asia Pacific Excluding China & Japan
- China
- Japan
- Middle East & Africa
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