Aseptic Pharma Processing Equipment Market Size, Share & Trends Analysis Report By Component (Processing Equipment, Packaging Equipment), By Applications (Ophthalmic Suspensions, Sterile Injectables, Reconstituted Lyophilized Powders for Injection, Aqueous-Based Aerosols for Inhalation, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Market Overview

The global aseptic pharma processing equipment market size was valued at USD 9,239.58 million in 2022. It is estimated to reach USD 18,348.02 million by 2031, growing at a CAGR of 7.92% during the forecast period (2023–2031).

Pharmaceutical processing, which includes operations like blending, granulation, milling, coating, tablet pressing, filling, and others, is the process of making drugs. The production of pharmaceuticals must adhere to strict quality standards and specifications. As a result, all equipment used to manufacture pharmaceuticals must conform to good manufacturing practices (GMPs). Further, sterile products can be widely classified into two main categories according to how they are produced. The first one is sterilized after the drug formulations/components have been filled and sealed in the final container, also called terminally sterilized products.

Sterilization can also be carried out right before a mass product is filled. In the second case, all subsequent processing, filling, and sealing operations are conducted aseptically to prevent recontamination of the sterilized product. This is called the aseptic processing of pharmaceuticals. It is recognized that aseptic processes play an essential role in making sterile formulations that cannot be terminally sterilized. In addition, aseptic pharma processing equipment is used commercially to thermally sterilize the formulations (liquid or powder) for packaging into previously sterilized containers under sterile conditions to produce shelf-stable products that do not need refrigeration.

Highlights

• Processing equipment dominates the component segment
• Sterile injectables dominate the application segment
• North America is the highest shareholder in the global market

Market Dynamics

Global aseptic pharma processing equipment market drivers:

High growth in the generics and biopharmaceuticals markets

The aseptic pharma processing equipment market is estimated to witness a healthy shift in the coming years owing to rising healthcare spending, increasing prevalence of chronic diseases, and the introduction of novel drugs. Moreover, with the introduction of the COVID-19 pandemic, the demand for various generic drugs such as antibiotics, antivirals, steroids, and multivitamins has increased tenfold since 2020. This propels the pharma industries to increase production capacity within the current good manufacturing practices (cGMP) guidelines.

Many blockbuster drugs have also lost their patents in recent years, with more to follow in the coming years. This will enable the entry of low-cost generic counterparts in the market, which are likely to boost the volume of drugs sold. By the end of 2021, when patents for several prescription products expired in mature markets such as the U.S. and the U.K., the overall sales of these drugs were set to abridge by more than hundreds of billion. However, the increase in sales volume is driven by growth in the sales of the generic and biopharmaceutical counterparts of the branded drugs. This growth in production volume is expected to drive the aseptic pharma processing equipment market.

Growing demand for contract manufacturing organizations (cmos) for aseptic manufacturing of pharmaceutical products

The pandemic has created an opportunity for contract manufacturing organizations (CMOs) or contract development manufacturing organizations (CDMOs) for contractual pharmaceutical manufacturing. CMOs help in reducing the workload of the parent pharmaceutical company. In addition, the CMOs improve work efficiency and help in increasing the production of the parent company for which they work and also help the company to reduce its overall expenses. Demand for contract development and manufacturing organizations in the pharma industries for drug manufacturing, commercializing the drug, and other operating activities increases the need for more accurate and advanced machinery and automated systems for manufacturing pharmaceuticals in aseptic conditions. This is predicted to drive the overall market of aseptic pharmaceutical equipment during the forecast period.

Global aseptic pharma processing equipment market restraint:

High capital investment

Setting up the aseptic pharma processing equipment is a one-time process with a shelf life of a minimum of 10 years. However, the equipment and systems cost is high, which restricts many pharmaceutical manufacturers from setting up an in-house aseptic pharma processing plant. Therefore, the high price of aseptic processing equipment restricts many buyers and forces them to go with the conventional terminal sterilization method. This is expected to hinder the market expansion for the aseptic pharma processing equipment market.

Global aseptic pharma processing equipment market opportunities:

Increasing investment in r&d

The high rise in the sales of pharmaceuticals has been witnessed in the last few years attributed to the rising incidence of chronic disorders, growing geriatric population, high prevalence of infectious diseases, and increasing focus toward targeted therapy. The rising global demand for pharmaceuticals has fueled the growth of pharmaceutical products worldwide. Productivity improvement has been noticed in the pharmaceutical production industry, with increased research and clinical trials being conducted by pharmaceutical manufacturers. In addition, the outbreak of the COVID-19 pandemic has increased the focus of pharmaceutical companies to develop effective medicines and vaccines against the SARS-CoV virus infection. In this scenario, establishing effective workflows and processes to lessen the time and costs involved in drug and vaccine development has gained significance. This, in turn, creates growth opportunities for the aseptic pharma processing equipment market.

Regional Analysis

North America Dominates the Global Market

Based on region, the global aseptic pharma processing equipment market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Rest-of-the-World (ROW). 

North America is the most significant global aseptic pharma processing equipment market shareholder and is anticipated to exhibit a CAGR of 6.64% during the forecast period. North America is a region of substantial importance for aseptic pharma processing. It is home to widespread technological innovation, and major pharmaceutical companies are quickly adapting the automation trend to process drug formulations and maintain aseptic conditions efficiently. Many companies operate in this region as government regulations and programs support market growth. North America is home to several aseptic pharma processing equipment manufacturers and service providers. In addition, the pharmaceutical giants are also located in the region. Therefore, the industry's increasing demand for advanced pharmaceutical equipment and automation to reduce time and labor costs is the primary factor driving the market growth.

Europe is projected to exhibit a CAGR of 7.75% over the forecast period. The growth of the European region can be mainly attributed to the growing demand for generics, other therapeutics, and other drugs, which indirectly increases the burden on manufacturing plants. With the introduction of COVID-19, many European companies have increased their production capacity and technological advancement to meet the requirements of novel therapeutics. For instance, in 2021, the European Commission (EC) bought an additional 150 million doses of Moderna's COVID-19 vaccine for delivery in 2022. Moderna announced the new contract on June 22, 2021, press release. With this additional order, the total number of doses confirmed and purchased by the EC has reached 460 million. This increases the demand and the growth of the aseptic pharma processing equipment market. In addition, the high market share of this region is also attributed to many manufacturing companies, which aim to bring about consistent technological development for their products, such as systems, equipment, and consumables used for aseptic pharma processing.

The Asia-Pacific (APAC) aseptic pharma processing equipment market is anticipated to proliferate in the forthcoming years. The region comprises many countries with high scientific achievement potential, particularly in pharmaceuticals. The Asia-Pacific region's low- and middle-income countries are witnessing a constant increase in the incidence of various genetic disorders. The high prevalence rate of chronic diseases, aging populations, changes in lifestyle, and genetic factors are a few of the common risk factors associated with economic development and the epidemiologic transition of the Asia-Pacific region. In addition, Asia-Pacific represents one of the most attractive markets worldwide for the aseptic pharma processing equipment market. It has the two most populous countries on its borders: China and India. The demographics and accelerated economic growth in the region are the most supportive factors influencing the development of the Asia-Pacific aseptic pharma processing equipment market.

The Latin America aseptic pharma processing equipment market is still in its intermediary phase. The country is the manufacturing hub for many of the suppliers in the U.S. and Canada, attributed to the low cost of services available in the region. Multinational pharmaceutical companies are drawn to the region by the overall double-digit rate of market growth. However, before executives move their business into any one country, they carefully weigh the opportunities against the economic, regulatory, and political risks. This has led to steady growth in the region's aseptic pharma processing equipment market revenue.

The Rest-of-the-World (RoW) consists of several other promising nations, such as Saudi Arabia, the U.A.E., Egypt, Argentina, and Africa. In this region, the expenditure toward aseptic production of pharmaceuticals is escalating due to the growing healthcare infrastructure. Dominated by regions such as Saudi Arabia and South Africa, the overall aseptic pharma processing equipment revenue is expected to increase as most of the regional pharmaceutical companies aim to follow the cGMP guidelines for manufacturing aseptic products and seem to welcome automation in the manufacturing process.

Segmental Analysis

The global aseptic pharma processing equipment market is segmented by component and application.

Based on components, the global aseptic pharma processing equipment market is divided into packaging equipment and processing equipment. 

The processing equipment segment is responsible for the most significant market share and is anticipated to exhibit a CAGR of 6.15% over the forecast period. The equipment is used to manufacture any drug (solid or liquid) in a sterile environment. Drug production involves aseptic pharmaceutical processing, divided into several unit operations, including blending, granulating, milling, coating, tablet pressing, and filling. The aseptic pharmaceutical manufacturing process has exact specifications and quality-control guidelines. Therefore, it is essential that businesses that make pharmaceuticals follow good manufacturing practices. In addition, the equipment used for the aseptic processing of pharmaceuticals is pharmaceutical feeders, filling equipment, metal detection, mixing equipment, pneumatic conveying equipment, drying equipment, pharmaceutical extruders, pharmaceutical mills, pharmaceutical granulation equipment, pharmaceutical tablet compression, and pharmaceutical equipment. Some critical companies offering devices to the global aseptic pharma processing equipment market include Bosch GmbH, Automated Systems of Tacoma (AST), Steriline, and Weiler Engineering, Inc.

The global aseptic pharma packaging equipment market can be classified into three basic categories: inspection machines, labeling machines, and aseptic packaging machines. Inspection machines visualize the equipment's condition in the aseptic processing. Labeling machines are pivotal in pharmaceutical industries by putting labels around the containers. Aseptic packaging machines include flexible aseptic filling and closing machines for sterile injectable applications and life sciences products. With automated machines and their ability to fill and close vials, syringes, and cartridges, the end user can rely upon a single machine that addresses current product needs and uncertain future pipeline demands. In addition, the impressive growth in demand for aseptic sterilized packaging material and advancement in the systems involved in maintaining the sterile condition while filling or packaging is the primary factor driving the market's growth. Some of the key companies offering packaging equipment to the global aseptic pharma processing equipment market include DuPont, JBT, Syntegon Technology (Germany), IMA S.p.A. (Italy), Körber AG (Germany), Uhlmann Group (Germany), and OPTIMA Packaging Group.

Based on application, the global aseptic pharma processing equipment market is segmented into ophthalmic suspensions, sterile injectables, reconstituted lyophilized powders for injection, aqueous-based aerosols for inhalation, and others. 

The sterile injectables segment owns the highest market share and is estimated to exhibit a CAGR of 7.74% during the forecast period. Sterile injectables are liquids filled in vials or syringes used for the injections. Sterile fill/finish is used to process and pack sterile injectables. While liquid solutions, suspensions, and emulsions are typical candidates for sterile fill/finish operations, powder fills and lyophilization (i.e., freeze-drying to preserve and obtain more excellent stability) are also performed under aseptic conditions. Each drug product component needs to be sterilized before aseptic fill/finish. This includes active pharmaceutical ingredients (APIs), water for injection (WFI), and any other excipients part of a formulation. Equipment and container systems are also sterilized.

Ophthalmic suspension treats eye swelling caused by infections, injury, surgery, or other conditions. The most common ophthalmic suspension is fluorometholone (FML). Sterility is essential for ophthalmic formulations because they come into direct contact not only with the surface of the cornea but also with precorneal tissue. Sterile, topical, ophthalmic suspensions are typically manufactured aseptic addition of sterile micronized raw material into a sterile vehicle or aseptic addition of a sterile raw material to a sterile medium followed by ball milling aseptic addition of the sterile concentrate into a sterile vehicle. In the cases where coloring agents are used in the ophthalmic formulations, it is denied by the FDA for approval.

In addition, any formulations that cause excessive itchiness, redness, and eye irritation are also denied approval. The most effective way to avoid stringent regulatory norms is to partner with a contract manufacturing organization (CMO) which are aware of the exact process of how to operate in the area of ophthalmic suspension manufacturing and can help in designing the entire testing and manufacturing pipeline following all the guidelines required for regulatory approval.

Recent Developments

• March 2023- Steriline, an Italian producer of fill/finish lines for aseptic processing injectable drugs, delivered a line to Berkshire Sterile Manufacturing (BSM), a U.S. contract development and manufacturing organization (CDMO) performing filling and packaging of injectable drugs for the pharmaceutical and biotechnology industries.
• August 2022- Grand River Aseptic Manufacturing (GRAM) concluded Phase II of its facility expansion, including installing two new sterile Bausch+Strobel filling lines. GRAM's filling capacity now exceeds 50 million units per year, with space to serve a wider variety of pharma and biotech clients, thanks to the addition of three fill lines.