Sterile APIs: Introduction
- Sterile active pharmaceutical ingredients have drastically improved the standards of medical treatment. These active pharmaceutical ingredients (APIs) are highly effective in small doses, and require sophisticated manufacturing facilities and specialized technical capabilities.
- Numerous APIs are sterilized unless the final dosage form is terminally sterilized or produced by a process including a sterilizing filtration step. APIs anticipated for usage in injectable products need to stringently comply with relevant specifications on pyrogens or bacterial endotoxins
- The manufacture of sterile APIs is stringently controlled in order to minimize the risk of contamination with micro-organisms, endotoxins, and particles. If the final dosage form is not to be sterilized by filtration, the APIs should be practically free of particles.
- Sterile dry powder APIs are achieved generally by freeze drying process (lyophilisation or cryodesiccation), which ensures product stability and improved shelf-life of products destined for clinical or commercial applications
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Key Drivers and Restraints of Global Sterile Dry Powder API market
- Earlier, pharmaceutical companies were skeptical to outsource the manufacture of high potency APIs, and a majority of the manufacturing was confined to captive or in-house. A major factor was the risk of safety and patent infringement. However, pharmaceutical companies started experiencing shortage of sterile APIs, as they started to expand geographically. Furthermore, an increase in cost of drug development and commercialization added to the financial burden. Development of regulatory and legal framework has caused outsourcing to be the optimal option for the manufacture of sterile API.
- Pharmaceutical companies can focus on core business activities such as drug development and commercialization, while also take advantage of technical expertise at CMOs instead of investing in expensive API manufacturing setup.
- Patent expiry and subsequent launch of generic versions is a lucrative opportunity for pharmaceutical companies to expand their product portfolio and tap lucrative market segments in this technology driven market. Various biosimilars have been approved in Europe, while the U.S. FDA has approved only one biosimilar to date. Increase in research & development activities and constant attempts toward mimicking branded biological drugs are likely to pave the way for introduction of cost-effective treatment alternatives and consequently, drive the global sterile dry powder API market.
Oncology Application to Lead Global Market
- The global sterile dry powder API market can be segmented based on API type, application, and region
- In terms of API type, the global sterile dry powder API market can be divided into synthetic and biological APIs
- Based on application, the global sterile dry powder API market can be classified into oncology, anti-diabetic, cardiovascular, CNS, musculoskeletal, and other. The oncology segment is estimated to expand significantly owing to the introduction of innovative therapeutic options.
Asia Pacific to be Lucrative Market
- The global sterile dry powder API market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa
- Pharmaceutical companies are skeptical about outsourcing the manufacture of sterile APIs to countries in Asia due to security reasons. However, the outsourcing trend is expected to rise as regulatory policies and restriction guidelines normalize. This is likely to fuel the sterile dry powder API market in Asia Pacific.
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Key Players Operating in Global Sterile Dry Powder API market
Leading players in the global sterile dry powder API market include:
- Dr. Reddy's Laboratories
- Lonza Group
- Sandoz International GmbH
- Pfizer, Inc.
- Merck KGaA
Global Sterile Dry Powder API market: Research Scope
Global Sterile Dry Powder API market, by Type
Global Sterile Dry Powder API market, by Application
This study by TMR is all-encompassing framework of the dynamics of the market. It mainly comprises critical assessment of consumers' or customers' journeys, current and emerging avenues, and strategic framework to enable CXOs take effective decisions.
Our key underpinning is the 4-Quadrant Framework EIRS that offers detailed visualization of four elements:
- Customer Experience Maps
- Insights and Tools based on data-driven research
- Actionable Results to meet all the business priorities
- Strategic Frameworks to boost the growth journey
The study strives to evaluate the current and future growth prospects, untapped avenues, factors shaping their revenue potential, and demand and consumption patterns in the global market by breaking it into region-wise assessment.
The following regional segments are covered comprehensively:
- North America
- Asia Pacific
- Latin America
- The Middle East and Africa
The EIRS quadrant framework in the report sums up our wide spectrum of data-driven research and advisory for CXOs to help them make better decisions for their businesses and stay as leaders.
Below is a snapshot of these quadrants.
1. Customer Experience Map
The study offers an in-depth assessment of various customers’ journeys pertinent to the market and its segments. It offers various customer impressions about the products and service use. The analysis takes a closer look at their pain points and fears across various customer touchpoints. The consultation and business intelligence solutions will help interested stakeholders, including CXOs, define customer experience maps tailored to their needs. This will help them aim at boosting customer engagement with their brands.
2. Insights and Tools
The various insights in the study are based on elaborate cycles of primary and secondary research the analysts engage with during the course of research. The analysts and expert advisors at TMR adopt industry-wide, quantitative customer insights tools and market projection methodologies to arrive at results, which makes them reliable. The study not just offers estimations and projections, but also an uncluttered evaluation of these figures on the market dynamics. These insights merge data-driven research framework with qualitative consultations for business owners, CXOs, policy makers, and investors. The insights will also help their customers overcome their fears.
3. Actionable Results
The findings presented in this study by TMR are an indispensable guide for meeting all business priorities, including mission-critical ones. The results when implemented have shown tangible benefits to business stakeholders and industry entities to boost their performance. The results are tailored to fit the individual strategic framework. The study also illustrates some of the recent case studies on solving various problems by companies they faced in their consolidation journey.
4. Strategic Frameworks
The study equips businesses and anyone interested in the market to frame broad strategic frameworks. This has become more important than ever, given the current uncertainty due to COVID-19. The study deliberates on consultations to overcome various such past disruptions and foresees new ones to boost the preparedness. The frameworks help businesses plan their strategic alignments for recovery from such disruptive trends. Further, analysts at TMR helps you break down the complex scenario and bring resiliency in uncertain times.
The report sheds light on various aspects and answers pertinent questions on the market. Some of the important ones are:
1. What can be the best investment choices for venturing into new product and service lines?
2. What value propositions should businesses aim at while making new research and development funding?
3. Which regulations will be most helpful for stakeholders to boost their supply chain network?
4. Which regions might see the demand maturing in certain segments in near future?
5. What are the some of the best cost optimization strategies with vendors that some well-entrenched players have gained success with?
6. Which are the key perspectives that the C-suite are leveraging to move businesses to new growth trajectory?
7. Which government regulations might challenge the status of key regional markets?
8. How will the emerging political and economic scenario affect opportunities in key growth areas?
9. What are some of the value-grab opportunities in various segments?
10. What will be the barrier to entry for new players in the market?
Note: Although care has been taken to maintain the highest levels of accuracy in TMR’s reports, recent market/vendor-specific changes may take time to reflect in the analysis.