Global Pharmaceutical Aseptic Fill - Finish CMO Market Overview 2022

The Global Pharmaceutical Aseptic Fill & Finish CMO Market Size Is Projected to Reach US$ 6.82 Billion by 2029 from US$ 4.934 Billion in 2022 at a CAGR of 5.97% during 2023-2029.- Bossonresearch.com

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 labour- 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 dosing.

According to Bosson Research, the global Pharmaceutical Aseptic Fill & Finish CMO 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.
Driving Factors

Rising need to reduce overall investment in drug development End-use Insights

For formulation (formulation) scientists, their job is to scale up the raw material supply chain from experimental samples to industrial production to produce marketed products. Formulation (formulation) scientists want to spend more time innovating and less time spent troubleshooting supply chain issues or experiencing surprises from incremental or new regulatory burdens.

Judging from the amount of investment, the financial pressure of the pharmaceutical industry is ever-present. R&D investments in the pharmaceutical industry can be substantial, with costs accounting for 35% of total product-to-market expenditure.

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. Therefore, there is a need for a filling device that minimizes drug loss while complying with regulations. Under this need to reduce the overall cost of drug development, the demand for pharmaceutical aseptic filling continues to rise.

Increased Biologics Demand and Diversity

As the demand for biologics increases and their diversity increases, so does the need for manufacturing capacity and aseptic filling/finishing operations. Compared with traditional chemical drugs, which are synthesized by drug manufacturers through precise formulations, biological agents are manufactured in living organisms. And it tends to produce larger and more complex molecules, which have the advantages of higher target specificity and lower toxicity. The biologics market is driven by the aging population due to the increasing number of people with diseases, especially those with chronic diseases who require long-term healthcare and medication, resulting in an increasing demand for healthcare in society.

Aseptic filling/finishing refers to the process of filling finished drug products into sterile packaging containers including vials, syringes, ampoules and cartridges. Of all the steps involved in biologics production, fill/finish is one of the most critical and a heavily outsourced operation. In fact, even a minute of error during the filling/finishing process can lead to microbial contamination, which can lead to loss of drug products, production delays, and most importantly, risks to the health of patients.

Most biopharmaceutical products are inherently fragile like proteins, and there are some stability problems during drug processing and filling. In addition, biopharmaceuticals are easily contaminated, which brings huge economic losses to manufacturers. Filling and finishing processes provide advanced aseptic solutions to prevent contamination of biopharmaceutical products.

Technological advances in filling-finishing manufacturing processes

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. Many equipment manufacturers in the filling process manufacturing market focus on the development of barrier isolation systems, which are integrated filling process machines capable of performing all stages of the filling process. Stand-alone equipment for filling-finishing operations is time consuming and expensive compared to barrier isolation systems, thus making the entire process complex and prone to contamination. An example of an isolator system is the SA25 Aseptic Filling Workcell from Vanrx Pharma systems.

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. For example, PreVAS (Syntegon Technology GmbH) is the first fully pre-validated, pre-assembled and pre-sterilized single-use filling system for vials, syringes, cartridges and ampoules. This is primarily because single-use systems eliminate the need for costly and time-consuming sterilization processes. 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.

Growing Demand in Emerging Markets

Most of the global biomanufacturing is located in North America, Western Europe, Ireland and the United Kingdom. The emergence of a global biosimilar licensing pathway helps manufacturers expand capacity by leveraging technologies designed to minimize costs and spread capital investment across multiple products. Rising living standards across the world and the desire of many governments to localize vaccine and biologics manufacturing to serve their respective populations are driving the demand for local biologics production. This is a factor that will significantly drive the need to expand biomanufacturing capabilities from the West to emerging markets. These economies include countries in Asia, Eastern Europe, South America and Africa. Specifically, India, China, Russia, Brazil and Malaysia. Emerging markets such as India and China will provide lucrative opportunities for the players in this market. This is mainly attributed to low labor and raw material costs, increasing research activities, favorable government support, and technological integration and advancement.

Increased demand for outsourcing of filling-finishing services

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.

Fill-to-finish services remain the most common outsourced biopharmaceutical manufacturing activity. Biologics dose filling and final compounding processes require specialized care because they are often one of the most expensive processes and because they require the highest safety standards and protocols. The traditional filling process involves the use of stainless steel equipment connected by reusable pipes, valves and tubing. However, with the growing importance of product safety, expertise, specialized equipment and care, much of the work has been outsourced to contract manufacturers. Additionally, biosimilars are increasingly impacting the need for more filling CMOs.

Many small biotech and biopharmaceutical companies tend to outsource their fill-fill operations to CMOs, as both the CMO and the company bear the overall development costs, reducing the possibility of risk and ultimately boosting the market growth.

In addition, CMOs possess excellent technical skills, contribute to the innovation of various drug discovery and maintain financial stability. For example, Berkshire's CMO for aseptic manufacturing developed a new aseptic fill-finish procedure for customers with limited pharmaceutical products. It was observed that 1.1 L of drug product could be produced in a single run, resulting in less product loss.

End-use Insights

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 Aseptic Fill & Finish CMO market.

The Pharmaceutical Aseptic Fill & Finish CMO Market is consolidated competitive and consists of several major players. In terms of market share, few of the major players are currently dominating the market. Some prominent players are vigorously making acquisitions with the other companies to consolidate their market positions across the globe. Some of the market players are Bausch + Lomb, Alcon, Optos, PLC, Carl Zeiss, Topcon Corporation ,etc.

Many pharmaceutical, biopharmaceutical and contract manufacturing organizations are adopting single-use fill-finish systems, especially for biologics.

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 Aseptic Fill & Finish CMO in emerging markets will also become an important reason for the expansion of the entire Pharmaceutical Aseptic Fill & Finish CMO 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.

Global Pharmaceutical Aseptic Fill & Finish CMO Market: Competitive Landscape

Currently, the concentration in the Pharmaceutical Aseptic Fill & Finish CMO 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. Key players in the market include Baxter Pharmaceutical Solutions LLC,,Fresenius Kabi,, Pfizer CentreOne,, AbbVie, Vetter Pharma,,etc.

Key players in the Pharmaceutical Aseptic Fill & Finish CMO 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 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

Jiangsu Yaohai Bio-Pharmaceutical

Seikagaku

Techdow

Akron Biotech



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