Isolator based Aseptic Filling Systems Market, 2020-2030

Isolator based Aseptic Filling Systems Market, 2020-2030

  • October 2020 •
  • 170 pages •
  • Report ID: 5995357 •
  • Format: PDF
INTRODUCTION
Fill / finish is considered a critical aspect of pharmaceutical manufacturing. It is, therefore, imperative for drug manufacturers to ensure that formulations enclosed in primary containers are safe for consumption / administration. Despite being well established, there are several concerns associated with the contemporary drug filling process, such as the risk of contamination, filling errors (inaccurate dose dispensation), and labelling-related issues. In fact, experts in the industry believe that around 80% of product recalls may be attributed to packaging-related concerns. Contamination is one of the key concerns related to fill / finish operations. To ensure the safety of consumers, a lot of effort is put into maintaining an aseptic environment during the fill / finish step. In this regard, manual intervention in filling lines is not only a threat to product safety (being more susceptible to contamination from contact with laborers), but also inefficient. Over the years, the growing complexity of modern pharmaceuticals (especially biologic drugs and complex small molecule APIs), has created a corresponding need for the automation of routine, repetitive tasks, such as fill / finish. As a result, the drug filling process is gradually becoming more demanding, in terms of specialized equipment and infrastructure, and handling expertise.

Over the past couple of decades, pharma equipment manufacturers have developed more efficient, reliable and cost-effective machinery, involving the required isolators and restricted access barrier systems (RABS), to their proprietary filling lines. Many of such systems are designed to eliminate the need for human intervention, thereby, addressing the risk of operator-associated contamination. In addition, the use of filling lines where parts of the equipment are individually isolated, has been associated with notable cost saving opportunities. In such cases, developers need not invest in large, high-end cleanrooms for housing such filling lines. Currently, over 130 isolator-based filling and closing systems are available in the market, and equipment developers are still engaged in further improvement efforts. Given that more than 5,000 biopharmaceutical product candidates are currently under development, the opportunity for aseptic fill / finish equipment developers is anticipated to continue to grow at a substantial pace over the next decade.

SCOPE OF THE REPORT
The ‘Isolator based Aseptic Filling Systems Market, 2020-2030’ report features an extensive study of the current landscape of isolator based aseptic filling systems and the future opportunities associated with such systems. It features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. In addition to other elements, the report features:
A detailed assessment of the overall landscape of the isolator based aseptic filling systems, highlighting the contribution of industry players and providing information on various types of systems (filling, and turnkey solutions), scale of operation (clinical and commercial), system throughput, compatible primary containers (ampoules, bottles, capsules, cartridges, syringes, vials and others), type of formulation and range of fill volume.
An insightful competitiveness analysis of isolator based aseptic filling systems, taking into consideration the scale of operation, system throughput, compatible primary containers, type of formulation and other important product related specifications.
Elaborate profiles of companies offering isolator based aseptic filling systems. Each profile features a brief overview of the company, its financial information (if available), proprietary product(s), recent developments and an informed future outlook.
A discussion on general regulatory guidelines for aseptic processing, and specific recommendations related to isolator and blow / fill / seal technologies used in the aseptic fill / finish process.
An analysis of various developments / recent trends related to aseptic processing market, offering insights on [A] partnerships and collaborations established within the industry, and [B] conferences held in this space.

One of the key objectives of the report was to understand the primary growth drivers and estimate the future opportunity within the market. Based on several parameters, such as annual fill / finish pharma capacity, number of automatic filling lines installed and growth trends across various geographies, we have provided an informed estimate of the likely evolution of the market, in the mid to long term, for the period 2020-2030. The chapter features the likely distribution of the opportunity across [A] scale of operation (clinical and commercial), [B] type of compatible primary container (ampoules, bottles, capsules, cartridges, syringes, vials and others), [C] system throughput (low throughput, medium throughput and high throughput), [D] end-user (pharmaceutical companies, contract service providers and others) and [E] geographical regions (North America, Europe, Asia-Pacific and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, portraying the conservative, base and optimistic tracks of the market’s evolution.

The opinions and insights presented in this study were influenced by discussions conducted with stakeholders in this domain.

All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this report are in USD, unless otherwise specified.

RESEARCH METHODOLOGY
The research, analysis and insights presented in this report are backed by a deep understanding of insights gathered from both secondary and primary sources. For all our projects, we conduct interviews with experts in the area (academia, industry and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
Annual reports
Investor presentations
SEC filings
Industry databases
News releases from company websites
Government policy documents
Industry analysts’ views

While the focus has been on forecasting the market till 2030, the report also provides our independent view on various non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

KEY QUESTIONS ANSWERED
Who are the leading isolator based aseptic filling system developers?
What are the recent developments in the aseptic processing domain?
What are the latest regulatory guidelines for aseptic fill / finish manufacturers?
What factors are likely to influence the evolution of this upcoming market?
How is the current and future opportunity likely to be distributed across key market segments?

CHAPTER OUTLINES
Chapter 2 is an executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of the aseptic filling systems market in the mid to long term.

Chapter 3 provides an overview of drug fill / finish process, and various aseptic fill / finish techniques. It also highlights the need for aseptic fill / finish in drug manufacturing, and various traditional and advanced aseptic fill / finish techniques currently being used in the pharma industry. Further, the chapter highlights a comparison between isolator and RABS systems, as well as various advantages associated with the advanced aseptic fill / finish methods and its future perspectives.

Chapter 4 provides an overview of the overall landscape of the isolator based aseptic filling systems, highlighting the contribution of industry players and providing information on various types of systems (filling, and turnkey solutions), scale of operation (clinical and commercial), system throughput, compatible primary containers (ampoules, bottles, capsules, cartridges, syringes, vials and others), type of formulation and range of fill volume.

Chapter 5 provides a detailed insightful competitiveness analysis of isolator based aseptic filling systems, taking into consideration the scale of operation, system throughput, compatible primary containers, type of formulation and other important product related specifications.

Chapter 6 includes detailed profiles of the companies offering isolator based aseptic filling systems. Each profile features a brief overview of the company, its financial information (if available), proprietary product(s), recent developments and an informed future outlook.

Chapter 7 providers general regulatory guidelines for aseptic processing, and specific recommendations related to isolator and blow / fill / seal technologies used in the aseptic fill / finish process.

Chapter 8 provides an analysis of various developments / recent trends related to aseptic processing market, offering insights on [A] partnerships and collaborations established within the industry, and [B] conferences held in this space.

Chapter 9 presents a detailed market forecast, highlighting the distribution of the opportunity across [A] scale of operation (clinical and commercial), [B] type of compatible primary container (ampoules, bottles, capsules, cartridges, syringes, vials and others), [C] system throughput (low throughput, medium throughput and high throughput), [D] end-user (pharmaceutical companies, contract service providers and others) and [E] geographical regions (North America, Europe, Asia-Pacific and rest of the world).

Chapter 10 summarizes the entire report. It presents a list of key takeaways and offers our independent opinion on the current market scenario. Further, it summarizes the various evolutionary trends that are likely to influence the future of this market.

Chapter 11 is a collection of executive insight(s) of the discussion(s) that were held with key stakeholder(s) in this market.

Chapter 12 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 13 is an appendix, which contains the list of companies and organizations mentioned in the report.