Fill Finish Manufacturing Market by Product (Consumables (Prefilled Syringes (Glass, Plastic), Vial (Glass), Cartridge), Instrument (System (Stand alone, Integrated), Machine Type (Automated, Manual))), End User (CMO, Biopharma) - Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2022-2030

According to Nova one advisor, the global Fill Finish Manufacturing market size is expected to hit around USD 19.2 billion by 2030 from valued at USD 9.2 billion in 2022 and growing at a CAGR of 11.7% from 2022 to 2030.

 Fill finish manufacturing is defined as an introduction of a drug product into a container or delivery system (and subsequent packaging) under aseptic conditions which is essential to ensure the safety and efficacy of the product. Some of the challenges to fill finish manufacturing processes include maintaining sterility of components, production and equipment areas. The fill finish process involves introduction of a drug product in any form such as powder, solution, suspension in containers such as syringes, vials, cartridges, etc. For a typical biopharmaceutical, the fill finish step involves the thawing of the frozen product solution, pH buffering agent preparations and finally filling the solution into vials or syringes. In the case of sensitive products like proteins, the vials are often freeze-dried (lyophilized) in order to increase the shelf-life period. Most of the biopharmaceutical products are fragile in nature like proteins and have several stability problems during pharmaceutical processing and filling, in addition, biological drugs are prone to the contamination that could lead to huge economic losses for the manufacturers. The fill and finish process provides advanced aseptic solutions to prevent contamination of biopharmaceutical products.

Report Scope of the Fill Finish Manufacturing Market

Market Dynamics of Fill Finish Manufacturing Market

Driver: Rising technological advancements in fill-finish manufacturing processes

Technological advancements in aseptic fill-finish operations involve the usage of isolators and restricted-access barrier systems (RABS), which create robust sterile manufacturing environments that effectively separate human operators from the fill-finish process. Many equipment manufacturers in the fill finish manufacturing market are focusing on the development of barrier isolation systems, which are integrated fill-finish machines capable of carrying out all stages of fill-finish processes. In contrast to barrier isolation systems, standalone equipment used in fill-finish operations is both time-consuming and expensive, thus making the entire process complex and prone to contamination. The SA25 Aseptic Filling Workcell by Vanrx Pharma systems is an example of an isolated system. Owing to the benefits of isolators or RABS, many biopharmaceutical companies are adopting these machines in drug production facilities.

In traditional aseptic fill-finish processes, conventional stainless-steel systems require additional cleaning and sterilization (CIP/SIP), whereas a single-use system eliminates the critical steps of sterilization and further reduces the changeover time by simplifying end-of-batch breakdown and decontamination operations. Many pharmaceutical, biopharmaceutical, and contract manufacturing organizations are adopting single-use fill-finish systems, particularly for biologics. For instance, PreVAS (Syntegon Technology GmbH) is the first completely pre-validated, pre-assembled, and pre-sterilized single-use filling system available for vial, syringe, cartridge, and ampoule filling. This is mainly because single-use systems eliminate the need for sterilizing processes that are expensive and time-consuming. There are also economic advantages associated with single-use systems, such as the set-up and clean-down time being significantly reduced, thereby reducing labor costs. Single-use systems also help with a reduction in capital costs and chemicals used, along with minimizing utilities and water. The increasing pace of technological advancements in fill-finish manufacturing processes is positively driving the market growth.

Restraint: High costs associated with isolators/RABS

RABS and Isolators have advanced features and functionalities. The equipment provides an enclosed environment which reduces the risk of contamination. RABS and Isolators are priced high as compared to standalone systems. The average price of RABS and isolators is around USD 4.0 million to USD 8.0 million, which is high from standalone systems. In small companies this severely restricts their accessibility. The adoption of isolators and RABS is very low as compared to standalone systems in underdeveloped or developing countries. Standalone systems are still used in small pharmaceutical and biopharmaceutical companies, R&D laboratories, and academic institutes.

Opportunity: Emerging markets

Most of the global biomanufacturing is in North America, Western Europe, Ireland, and the UK. The emergence of global biosimilars licensure pathways has helped manufacturers expand capabilities by leveraging technologies aimed at minimizing costs and amortizing capital investments over multiple products. Rising standards of living across the globe and the desire of many governments to have local vaccines and sufficient biologics manufacturing to serve respective populations are driving the demand for the local production of biologics. This is a factor that will significantly drive the demand to expand biomanufacturing capabilities from the West to emerging markets. These economies include countries across 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 players functioning in this market. This can be mainly attributed to low labor and raw material costs, rising research activity, favorable government support, and technological integration & advancements.

Challenge: Challenges associated with maintaining sterility in fill- finish manufacturing operation

Aseptic fill-finish operations carry more risk than non-sterile processes. They require careful planning, trained personnel, and specialized facilities & equipments for process execution. Maintaining sterility is very important as any contamination can lead to huge financial losses and have immense effects on patients life. In aseptic fill-finishing processes all the components must be sterilized before use.

On the basis of product, the market is segmented into instruments and consumables. The consumables segment is further segmented into vials, cartridges, prefilled syringes and other consumables. The instruments segment is further divided into systems and machines. Machines are divided into automated and semi-automated machines. Systems, are further sub-segmented into integrated systems and standalone systems.

In 2021, the consumables segment dominated the market and is expected to be the fastest-growing segment during the forecast period. Factors driving the growth of segment include wide applications of vials in lyophilization, and the growing use of disposable packaging for biologics.

By end user, the contract manufacturing organizations segment is expected to witness the highest growth in the fill finish manufacturing market during the forecast period.

During the forecast period the contract manufacturing organizations segment is expected to show the highest growth due to rise in new entrants in the biologics manufacturing market and growing outsourcing of fill-finish manufacturing processes from small-sized biopharmaceutical companies.

Europe accounted for the largest market share during the forecast period.

The fill finish manufacturing market is divided into five major regions—Europe, North America, Asia Pacific, Latin America, and Middle East & Africa. In 2021, Europe accounted for the largest share of the global market, closely followed by North America. Factors responsible for growth in region include, growing incidence of chronic disorders, and the increasing focus of major players on increasing their presence in this region.

During the forecast period the Asia Pacific region is expected to witness the highest CAGR, mainly due to overall advancements in the biopharmaceutical industry, expertise & academic excellence and developments in R&D infrastructure in the Asia Pacific region.

Some of the prominent players in the Fill Finish Manufacturing Market include:

Becton, Dickson, and Company (US), Syntegon Technology GmbH (Germany), IMA Industria Macchine Automatiche S.p.A. (Italy), Stevanato Group (Italy), West Pharmaceutical Services, Inc. (US), OPTIMA packaging group GmbH (Germany), Bausch+Strobel (Germany), Groninger & Co.gmbh (Germany), Gerresheimer AG (Germany), SGD Pharma (France), SCHOTT AG (Germany), NIPRO (Japan), Bausch Advanced Technologies Group (US), Vanrx Pharmasystems Inc. (Canada), Maquinaria Industrial Dara, SL (Spain), Marchesini Group S.p.A. (Italy), Steriline S.r.l. (Italy), AST (US), Reagent Chemical & Research, Inc (US), Aseptic Technologies (Belgium).

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For this study, Nova one advisor, Inc. has segmented the global Fill Finish Manufacturing market

By product:

• Consumables
• Prefilled Syringes
• Glass PFS
• Plastic PFS
• Vials
• Glass Vials
• Plastic Vials
• Cartridges
• Other consumables (Ampoules, Bottles, IV Bags)
• Instruments
• Systems
• Integrated Systems
• Standalone Systems
• Machine Type
• Automated Machines
• Semi-automated & Manual Machines

By End User:

• Pharmaceutical & Biopharmaceutical Companies
• Contract Manufacturing Organizations
• Other End Users such as Research & Development Laboratories and Academic Research Institutions

By Regional Outlook

North America

• U.S.
• Canada

Europe

• Germany
• France
• United Kingdom
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Southeast Asia
• Rest of Asia Pacific

Latin America

• Brazil
• Rest of Latin America

Middle East & Africa (MEA)

• GCC
• North Africa
• South Africa
• Rest of Middle East & Africa

Key Benefits for Stakeholders

• This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the global Fill Finish Manufacturing industry analysis from 2022 to 2030 to identify the prevailing Fill Finish Manufacturing industry opportunity.
• The market research is offered along with information related to key drivers, restraints, and opportunities.
• Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
• In-depth analysis of the global Fill Finish Manufacturing industry segmentation assists to determine the prevailing market opportunities.
• Major countries in each region are mapped according to their revenue contribution to the global market.
• Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
• The report includes the analysis of the regional as well as global Fill Finish Manufacturing industry trends, key players, market segments, application areas, and market growth strategies.