Sterile Injectable Drugs Market Overview
The sterile injectable drugs market is expected to register a growth rate of about 10.5% over the forecast period, 2018 to 2023. The increasing number of biologics, antibody-drug conjugates, and monoclonal antibodies in development, as well as clinical trials, has led primarily to the growth of the sterile injectable drugs. The development and manufacture of the sterile injectable are slow, often the industry encounters a shortage of these products due to their complexity and capital-intensive nature.
North America retains its dominance in this market due to:
- Recent changes in the US Food and Drug Administration (FDA) regulations on manufacturing sites
- The large presence of multi-national medical devices companies
- Disease management
- Awareness in the society
All of which are expected to have positive effects over the forecast period.
Advent of Pre-filled Syringes are Expected to Drive the Sterile Injectable Drugs Market
In the past one era of healthcare, biologics, are increasingly becoming the driving force of the pharmaceutical industry. Prefilled syringes have gained increased acceptance as delivery systems for injectable drugs for the treatment of chronic diseases. Prefilled syringes are mainly sterilized via autoclaving or by ionizing radiation. The factors such as its convenience, accuracy, affordability and safety with sterility have made injections easier for both doctors and patients for the correct dosage of the drug.
There is increasing utilization of this delivery device for injectable drugs in the market which over the forecast period would grow even more as a large number of biologics manufacturers are dependent on prefilled syringes. Other drivers include R&D focus on the development of biotech-engineered anti-cancer drugs and rising outsourcing activities across the value chain, which are expected to boost the supply of injectable drug products over the forecast period.
High Expenses Associated with Inventory Management Acts as a Major Barrier for Sterile Injectable Drugs Market
The supply chain of pharmaceutical industry deals with a continuous supply and usage in a wide variety of materials with large quantities that it is expected to provide for. The management of product variety and trade dependent on costs within a short time frame is a big problem that often faced. In the US, each year there is a high shortage of vital medicines used in the hospitals and other healthcare facilities which jeopardize patient health, comfort and safety adding to high healthcare costs.
The cost of establishing a sterile injectable plant is much higher primarily to several stringent regulations with aseptic requirements and complex manufacturing process. For example, in 2018 the FDA posted a warning letter for the Claris plant in India (specialist in sterile injectable drugs), due to recalls related to substandard products. This hinders the collaboration of major companies and the expansion of portfolios in emerging markets. Thus, inventory management acts as a major barrier for this market.
Another limitation include stringent regulatory requirement for high-end machinery needed for the manufacture of sterile injectable products.
North America Expected to Retain Major Share in the Sterile Injectable Drugs Market
In North America, the recent change in healthcare reforms, high adoption of drugs for oncology-related diseases in hospitals, better infrastructure and high healthcare expenditure from government boost the growth of this market, over 2018-2023. In recent years, several hospital chains across the US, Canada, and Mexico have faced drug shortages for several chronic diseases such as cancer and pain management for which major companies such as Baxter and Pfizer looks for more collaboration opportunities with sterile injectable specialist companies. In 2018, Pfizer planned to expand manufacturing unit in Michigan specifically for making sterile injectable drugs with self-contained production rooms under FDA regulations. Thus, over the forecast period, the majority share of this market is expected to retained by the North America region.
Key Developments in the Sterile Injectable Drugs Market
- Jul 2018: Berkshire Sterile Manufacturing received USD 2 million loan from MassDevelopment for expansion of their manufacturing unit in the US.
- Apr 2018: Endo International PLC reached an agreement to acquire Somerset Therapeutics, LLC with USD 190 million acquisition deal.
Reasons to Purchase the Sterile Injectable Drugs Market Report
- Current and future of Sterile Injectable Drugs market outlook in the developed and emerging markets
- Analysis of various perspectives of the market with the help of Porter’s five forces analysis
- The segment that is expected to dominate the market
- Regions that are expected to witness the fastest growth during the forecast period
- Identify the latest developments, market shares, and strategies employed by the major market players
- 3-month analyst support, along with the market estimate sheet (in Excel)
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1.1 Market Definition
2. Research Methodology
3. Executive Summary
4. Key Inferences
5. Market Overview
5.1 Current Market Scenario
5.2 Porter's Five Forces Analysis
5.2.1 Bargaining Power of Suppliers
5.2.2 Bargaining Power of Consumers
5.2.3 Threat of New Entrants
5.2.4 Threat of Substitute Product and Services
5.2.5 Competitive Rivalry within the Industry
6. Market Dynamics
6.1 Market Drivers
6.1.1 Rising R&D Focus on Development of Biotechnology-Engineered Anti-Cancer Drugs
6.1.2 Rapid Growth in the Usage of in Pre-filled Syringes for Biologic Products
6.1.3 Increased out-sourcing Activities across Value Chain Expected to Boost Supply of Injectable Products
6.2 Market Restraints
6.2.1 High Expenses Associated with Inventory Management
6.2.2 Stringent Regulatory Requirement for High-End Machinery
6.3 Market Opportunities
6.4 Key Challenges
7. Market Segmentation
7.1 By Molecule Type
7.1.1 Small Molecule
7.1.2 Large Molecule
7.2 By Drug Class
7.2.1 Blood factors
7.2.3 Peptide Hormone
7.2.5 Monoclonal Antibodies (mAbs)
7.3 By Application
7.3.3 Cardiovascular Diseases
7.3.4 Autoimmune Diseases
7.3.5 Infectious Diseases
7.4 By Geography
7.4.1 North America
188.8.131.52 Rest of Europe
184.108.40.206 South Korea
220.127.116.11 Rest of Asia-Pacific
7.4.4 Middle East & Africa
18.104.22.168 South Africa
22.214.171.124 Rest of MEA
7.4.5 South America
126.96.36.199 Rest of South America
8. Competitive Landscape
8.1 Mergers & Acquisition Analysis
8.2 Agreements, Collaborations, and Partnerships
8.3 New Products Launches
9. Key Players
9.3 Gilead Sciences, Inc.
9.4 GlaxoSmithKline plc
9.5 Johnson & Johnson
9.6 Merck & Co., Inc
9.7 Novartis AG
9.8 Novo Nordisk A/S
9.9 Pfizer Inc
*List Not Exhaustive
10. Market Future