Global Sterile Injectable Market is expected to grow at a CAGR of XX% to reach market value of USD XXXX million by 2025.
An injectable compounded medication is a sterile drug to be administered into the body using a needle and syringe or an I.V. administration set and needle device.
New FDA inspection protocols would improve the quality of Sterile Injectable Drugs considerably. The US Food and Drug Administration (FDA) is modernizing inspection programs with a new way of assessing, recording and reporting data from surveillance and pre-approval inspections for sterile drugs. The New Inspection Protocol Project (NIPP) uses standardized electronic inspection protocols to collect data in a more structured manner for more consistent facility oversight and faster and more efficient analyses. The protocols also include additional questions related to quality culture in facilities.
For instance, in February 2017, FDA warned Pfizer’s Hospira sterile injectable site in Kansas, after finding visible particulates in their products.
Global Sterile Injectable Market 2016-2025, in USD Million
The rising prevalence of chronic diseases is driving the global sterile injectable market.
According to National Health Council, in 2016, chronic diseases affect approximately 133 million Americans, representing more than 40% of the total population of the country. By 2020, that number is projected to grow to an estimated 157 million, with 81 million having multiple conditions.
The rising investment in technically advanced sterile injectable pharmaceutical production facilities will drive the global sterile injectable market. For instance, in July 2018, Pfizer had increased its commitment to U.S. manufacturing with a USD 465 million investment to build one of the most technically advanced sterile injectable pharmaceutical production facilities in Portage, Michigan. This U.S. investment will strengthen Pfizer’s capability to produce and supply critical, life-saving injectable medicines for patients across the globe.
The shortage of sterile injectable drugs is expected to hamper the growth of global sterile injectable market. The FDA has been paying increased attention to quality control, an especially critical issue for injectable drugs. Drug shortages do occur when an FDA enforcement action for non-compliance with current good manufacturing practices (cGMPs) causes the primary or sole manufacturer of a drug to halt or delay production.
For instance, In May 2018, Pfizer, which is the world’s largest maker of sterile injectable drugs, had 370 products that are depleted or in limited supply, 102 of which the company has indicated will not be available until 2019. Due to which Sterile injectable product portfolio of Pfizer has declined by 9% in developed markets, one reason Pfizer modestly narrowed its revenue expectations for 2018.
The global sterile injectable market is segmented based on application which include oncology cardiovascular diseases, infectious diseases, diabetes, and others. The use of injectable drugs in oncology is expected to grow at high rates in North America due to the increased cases of oncology. According to National Cancer Institute the cancer cases has increased at the rate of 13.1% from 2012 to 2016.
The expansion of production sites for oncology products will drive the global sterile injectable market.
For instance, in July 2017, Alembic Pharma introduced oncology site for injectable and lyophilized generics. The site has manufacturing capacity for 60 million tablets and capsules, and approximately 20 million vials of liquid injectable and lyophilized concentrates. These cancer medicines will be marketed in the Middle East and North Africa as well as Australia, South Africa and the LIS.
North America holds the major market share for sterile injectable in 2017, and it is expected to maintain the growth over the forecast period. It is due to the increasing in production sites for generic sterile injectable.
For instance, in August 2017, Fresenius Kabi have invested USD 250 million to turn a U.S. site to showcase its sterile injectable capabilities.
Market share of Global Sterile Injectable Market by Region, 2017
North America 39.71%
Asia Pacific 11.03%
South America 4.24%
Rest of the World 9.70%
The increasing in expansion of production sites, acquisition and product launches is driving the global sterile injectable market.
For instance, in April 2018, Endo International plc. acquired Somerset Therapeutics, LLC, a New Jersey based specialty pharmaceutical company that develops and markets sterile injectable and ophthalmic drugs for the U.S. market.
In August 2018, Nevakar Inc., entered into an exclusive licensing agreement with Endo International plc's subsidiary, Endo Ventures Limited, for the development of five differentiated, sterile injectable products in the U.S. and Canada.
In May 2018, Mithra entered into a contract agreement with Midas Pharma for the development of a sterile injectable product at the Mithra CDMO.
In August 2017 Athenex, Inc. launched three previously disclosed sterile injectable molecules through its subsidiary Athenex Pharma Solutions (APS). They are Epinephrine, Norepinephrine, and Phenylephrine.
Why purchase the report?
• Visualize the composition of the Sterile Injectable Market across each indication, in terms of molecule type, by drug type, by application, and by distribution channel highlighting the key commercial assets and players.
• Identify commercial opportunities in Sterile Injectable Market by analyzing trends and co-development deals.
• Excel data sheet with thousands of data points of the Sterile Injectable Market – level 4/5 segmentation
• PDF report with the most relevant analysis cogently put together after exhaustive qualitative interviews and in-depth market study
• Product mapping in excel for the Sterile Injectable products of all major market players
• Raw Material Suppliers/ Buyers
• Product Suppliers/ Buyers
• Industry Investors/Investment Bankers
• Education & Research Institutes
• Research Professionals
• Emerging Companies
1. GLOBAL STERILE INJECTABLE MARKET-SCOPE AND METHODOLOGY
1.1. Research Methodology
1.2. Scope of the market
2. GLOBAL STERILE INJECTABLE MARKET –TRENDS AND DEVELOPMENTS
2.1. Key Market Trends and Developments in Sterile Injectable Market
3. INDUSTRY ANALYSIS
3.4. Pricing Analysis
3.6. Supply Chain Analysis
3.7. Reimbursement policies
3.8. Technological Advancements
3.9. PEST analysis
3.10. Porter’s Five Forces Analysis
4. GLOBAL STERILE INJECTABLE MARKET SEGMENTATION
4.1. BY MOLECULE TYPE
4.1.1. Small Molecule
4.1.2. Large Molecule
4.2. BY DRUG TYPE
4.2.1. Monoclonal Antibodies
4.2.5. Blood factors
4.3. BY APPLICATION
4.3.2. Cardiovascular Diseases
4.3.3. Infectious Diseases
4.4. BY DISTRIBUTION CHANNEL
4.4.1. Hospital Pharmacies
4.4.2. Online Pharmacies
4.4.3. Retail Pharmacies
4.4.4. Drug Stores
5. GLOBAL STERILE INJECTABLE MARKET – BY GEOGRAPHY
5.1. Geographic Overview
5.2. North America
5.2.1. The U.S.
5.3.2. The U.K.
5.3.6. Rest of Europe
5.4. South America
5.4.3. Rest of South America
5.5. Asia Pacific
5.5.5. Rest of Asia Pacific
5.6. Rest of World
6. COMPETITIVE LANDSCAPE
6.1. Competitive Scenario
6.2. Heat Map Analysis
6.3. Product Benchmarking
7. COMPANY PROFILES
7.1. Amgen Inc.
7.2. Baxter International Inc.
7.3. Gilead Sciences Inc.
7.4. GlaxoSmithKline plc
7.5. Johnson & Johnson Merck & Co. Inc.
7.6. Novartis AG
7.7. Novo Nordisk A/S
7.8. Pfizer Inc.
7.10. Merck & Co., Inc.
8. Key companies to watch
9. Emerging Companies
10.2. List of Tables
10.3. Expert Panel Validation
10.5. Contact Us