Global Pharmaceutical Sterile Fill-Finish Market Research Report 2024(Status and Outlook)

Global Pharmaceutical Sterile Fill-Finish Market Research Report 2024(Status and Outlook)

Report Overview

In pharmaceutical manufacturing, fill-finish operations are critical, since fill-finish is the last step before a product is packaged and ultimately delivered to the patient. By the time a drug reaches this stage, the drug product is highly valuable, as it has already been through labor- and cost-intensive production stages, including upstream processing, cell culture or fermentation and downstream purification. Failures in the integrity of the fill-finish stage can introduce microbial contamination and generate issues with formulation and doing.

The adoption of single-use or single-use equipment is the overarching trend in filling services. The use of aseptic kits in final filling services including single-use techniques can significantly reduce the risk of cross-contamination and reduce cleaning requirements. The use of facilities geared toward multi-product usage is one of the current trends across the industry. Additionally, manufacturers are actively developing fully automated, state-of-the-art filling-finishing packages to reduce the risks associated with operator involvement.

The global Pharmaceutical Sterile Fill-Finish market size is projected to reach US$ 6822.33 Million by 2029 from US$ 4936.96 million in 2022 at a CAGR of 5.97% during 2023-2029. Rising demand to reduce overall investment in drug development, filling Technological advancements in packing operation processes and increasing demand for outsourcing of fill-finish services will be the core drivers driving the growth of the pharmaceutical sterile fill-finish market.

The accuracy and success rate of drug filling plays an important role in reducing the overall cost of drug development. Some active pharmaceutical ingredients have strong efficacy and high cost, and the handling and filling of pharmaceutical powders such as active pharmaceutical ingredients in clinical development must be cautious. At the same time, the filling of biological products is an important link in the production process. Its production process is very complicated and unstable, so it is not suitable for terminal sterilization, and it needs to be sterilized during filter filling.

While traditional stainless steel systems require additional cleaning and sterilization (CP/SP) in traditional aseptic filling processes, single-use systems eliminate the critical sterilization step and further shorten the time by simplifying end-of-batch breakdown Changeover times and purge operations. Many pharmaceutical, biopharmaceutical and contract manufacturing organizations are adopting single-use fill-finish systems, especially for biologics. Technological advancements in aseptic fill operations involve the use of isolators and restricted access barrier systems (RABS), which create robust aseptic manufacturing environments that effectively separate operators from the fill completion process. Disposable systems also offer economic advantages, such as significantly less installation and clean-up time, which reduces labor costs. Single-use systems also help reduce capital costs and chemicals used while minimizing utilities and water. The increasing pace of technological advancements in the filling-finishing manufacturing process is actively driving the market growth.

Due to complex production and limited resources, it is common for the entire pharmaceutical industry to partner with CDMOs. The CDMO assists in the development and manufacture of aseptically filled finished products. Companies often consider outsourcing the filling and finishing of biopharmaceuticals to a CMO for production capacity or specialized manufacturing capabilities. The growing popularity of contract manufacturing organizations (CMOs) among various biotechnology companies is also considered to be a significant factor driving the market growth.

In addition, the growing demand for pharmaceutical sterile fill-finish in emerging markets will also become an important reason for the expansion of the entire pharmaceutical sterile fill-finish market. Emerging markets such as India and China will provide lucrative opportunities for the players in this market. At the same time, the COVID-19 pandemic has spurred the development of COVID-19 vaccines, antibody therapies, antiviral drugs, and various other related pharmaceutical products. The pandemic has severely affected countries such as Brazil, India, the United States, and major European countries, increasing the demand for biopharmaceutical products, thereby boosting pharmaceutical production. Vaccines and biologics require special manufacturing and filling equipment and procedures to ensure product quality and safety, which requires advanced analytical capabilities and adaptable aseptic filling techniques. This has also become the driving force for market development.

Segment by Type, the Pharmaceutical Sterile Fill-Finish can be split into Glass Vials, Disposable Syringes, etc. Glass Vials type occupies the highest market share, reaching 39.66% in 2021. Most biological products and vaccines are packed in glass vials to ensure extreme safety and avoid leakage. The Prefilled Syringes market is expected to register the fastest CAGR of 7.32% during the forecast period. Prefilled syringes are a well-established drug delivery technology for novel complex biologics and traditional small molecule drugs. They offer several advantages over other container types, such as reduced medication errors, fast and safe dosing and preparation, longer storage times, and lower risk of spillage, all of which contribute to development costs and reduced batch sizes . Hence, the segment is poised to witness considerable growth throughout the forecast period owing to the aforementioned factors.

According to application scenarios, pharmaceutical aseptic filling can be divided into vaccines, biological products and biosimilars, generic drugs and other sectors. In 2021, the vaccine segment has the highest market share, already reaching 38.85%, and will maintain this position during the forecast period. In addition, the market size of Biologics and Biosimilar and Generics will maintain a compound growth rate of more than 6.5%.

On basis of geography, the Pharmaceutical Sterile Fill-Finish market is segmented into North America, Europe, Asia-Pacific, South America, Middle East and Africa, etc. Asia-Pacific is the most important market for pharmaceutical sterile fill-finish, and in In 2021, it has already occupied more than 40% of the market share. During the forecast period, the Asia-Pacific market will continue to expand at the highest CAGR of 8.11%. This is mainly attributed to low labor and raw material costs, increasing research activities, favorable government support, and technological integration and advancement. Meanwhile, increasing number of CMOs expanding in the region and numerous bottling facilities under construction are also driving the market expansion. For example, Thermo Fisher will increase its aseptic filling capabilities with a new facility in Singapore. The facility will then initially provide a high-speed sterilization line approved for live viruses, which must first be filled with large-scale expertise in Singapore, before providing the additional capability of standard filling/finishing.

Currently, the concentration in the pharmaceutical sterile fill-finish market is low. According to our calculations, the two concentration indicators CR5 and HHI used to measure the market are 50.74% and 6.71% respectively, showing a relatively low level of concentration in 2022. In 2023, we expect the market concentration to decrease. More than 130 companies are actively providing aseptic fill/seal services for small molecules. Recently, many of the service providers mentioned above have also formed strategic alliances and/or acquired other players to further enhance their respective service offerings. This trend is also likely to continue for the foreseeable future. Key players in the market include Baxter Pharmaceutical Solutions LLC, Fresenius Kabi, Pfizer CentreOne, AbbVie, Vetter Pharma, Jubilant HollisterStier LLC, Ajinomoto Bio-Pharma Services, GRAM (Grand River Aseptic Manufacturing), Boehringer Ingelheim, WuXi Services, PCI, Pharma Aenova, TAIYO Pharma Tech Co.,Ltd., CMIC HOLDINGS Co., Ltd., Emergent BioSolutions, Bushu Pharmaceuticals, Novasep, HALIX, Symbiosis Pharmaceutical Services, Afton Scientific, Jiangshu YAOHAI Bio-pharmaceutical, Seikagaku, Techdow, Akron Biotech.

This report provides a deep insight into the global Pharmaceutical Sterile Fill-Finish market covering all its essential aspects. This ranges from a macro overview of the market to micro details of the market size, competitive landscape, development trend, niche market, key market drivers and challenges, SWOT analysis, value chain analysis, etc.

The analysis helps the reader to shape the competition within the industries and strategies for the competitive environment to enhance the potential profit. Furthermore, it provides a simple framework for evaluating and accessing the position of the business organization. The report structure also focuses on the competitive landscape of the Global Pharmaceutical Sterile Fill-Finish Market, this report introduces in detail the market share, market performance, product situation, operation situation, etc. of the main players, which helps the readers in the industry to identify the main competitors and deeply understand the competition pattern of the market.

In a word, this report is a must-read for industry players, investors, researchers, consultants, business strategists, and all those who have any kind of stake or are planning to foray into the Pharmaceutical Sterile Fill-Finish market in any manner.

Global Pharmaceutical Sterile Fill-Finish Market: Market Segmentation Analysis

The research report includes specific segments by region (country), manufacturers, Type, and Application. Market segmentation creates subsets of a market based on product type, end-user or application, Geographic, and other factors. By understanding the market segments, the decision-maker can leverage this targeting in the product, sales, and marketing strategies. Market segments can power your product development cycles by informing how you create product offerings for different segments.

Key Company

Baxter Pharmaceutical Solutions LLC

Fresenius Kabi

Pfizer CentreOne

AbbVie

Vetter Pharma

Jubilant HollisterStier LLC

Ajinomoto Bio-Pharma Services

GRAM (Grand River Aseptic Manufacturing)

Boehringer Ingelheim

WuXi Biologics

PCI Pharma Services

Aenova

TAIYO Pharma Tech Co.,Ltd.

CMIC HOLDINGS Co., Ltd.

Emergent BioSolutions

Bushu Pharmaceuticals

Novasep

HALIX

Symbiosis Pharmaceutical Services

Afton Scientific

Jiangshu YAOHAI Bio-pharmaceutical

Seikagaku

Techdow

Akron Biotech

Market Segmentation (by Type)

Glass Vials

Disposable Syringes

Prefilled Syringes

Filling

Others

Market Segmentation (by Application)

Vaccines

Biologics and Biosimilar

Generics

Other

Geographic Segmentation

North America (USA, Canada, Mexico)

Europe (Germany, UK, France, Russia, Italy, Rest of Europe)

Asia-Pacific (China, Japan, South Korea, India, Southeast Asia, Rest of Asia-Pacific)

South America (Brazil, Argentina, Columbia, Rest of South America)

The Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, South Africa, Rest of MEA)

Key Benefits of This Market Research:

Industry drivers, restraints, and opportunities covered in the study

Neutral perspective on the market performance

Recent industry trends and developments

Competitive landscape & strategies of key players

Potential & niche segments and regions exhibiting promising growth covered

Historical, current, and projected market size, in terms of value

In-depth analysis of the Pharmaceutical Sterile Fill-Finish Market

Overview of the regional outlook of the Pharmaceutical Sterile Fill-Finish Market:

Key Reasons to Buy this Report:

Access to date statistics compiled by our researchers. These provide you with historical and forecast data, which is analyzed to tell you why your market is set to change

This enables you to anticipate market changes to remain ahead of your competitors

You will be able to copy data from the Excel spreadsheet straight into your marketing plans, business presentations, or other strategic documents

The concise analysis, clear graph, and table format will enable you to pinpoint the information you require quickly

Provision of market value (USD Billion) data for each segment and sub-segment

Indicates the region and segment that is expected to witness the fastest growth as well as to dominate the market

Analysis by geography highlighting the consumption of the product/service in the region as well as indicating the factors that are affecting the market within each region

Competitive landscape which incorporates the market ranking of the major players, along with new service/product launches, partnerships, business expansions, and acquisitions in the past five years of companies profiled

Extensive company profiles comprising of company overview, company insights, product benchmarking, and SWOT analysis for the major market players

The current as well as the future market outlook of the industry concerning recent developments which involve growth opportunities and drivers as well as challenges and restraints of both emerging as well as developed regions

Includes in-depth analysis of the market from various perspectives through Porter’s five forces analysis

Provides insight into the market through Value Chain

Market dynamics scenario, along with growth opportunities of the market in the years to come

6-month post-sales analyst support

Chapter Outline

Chapter 1 mainly introduces the statistical scope of the report, market division standards, and market research methods.

Chapter 2 is an executive summary of different market segments (by region, product type, application, etc), including the market size of each market segment, future development potential, and so on. It offers a high-level view of the current state of the Pharmaceutical Sterile Fill-Finish Market and its likely evolution in the short to mid-term, and long term.

Chapter 3 makes a detailed analysis of the market's competitive landscape of the market and provides the market share, capacity, output, price, latest development plan, merger, and acquisition information of the main manufacturers in the market.

Chapter 4 is the analysis of the whole market industrial chain, including the upstream and downstream of the industry, as well as Porter's five forces analysis.

Chapter 5 introduces the latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by manufacturers in the industry, and the analysis of relevant policies in the industry.

Chapter 6 provides the analysis of various market segments according to product types, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments.

Chapter 7 provides the analysis of various market segments according to application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.

Chapter 8 provides a quantitative analysis of the market size and development potential of each region and its main countries and introduces the market development, future development prospects, market space, and capacity of each country in the world.

Chapter 9 introduces the basic situation of the main companies in the market in detail, including product sales revenue, sales volume, price, gross profit margin, market share, product introduction, recent development, etc.

Chapter 10 provides a quantitative analysis of the market size and development potential of each region in the next five years.

Chapter 11 provides a quantitative analysis of the market size and development potential of each market segment (product type and application) in the next five years.

Chapter 12 is the main points and conclusions of the report.