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Pharmaceutical Aseptic Fill & Finish CMO Market

The global pharmaceutical aseptic fill & finish CMO market size was valued at USD 2,100 million in 2021 and is projected to reach around USD 4,200 million in 2030 exhibiting a CAGR of 11.5% in the forecasted period. The growing demand for generic medicines and biologics is expected to upsurge the market growth. Moreover, rising need for innovative processes and production techniques, which have proven considerably effective in meeting regulatory requirements, necessity to decrease complete investment for emerging drugs, growing technological developments in fill-finish manufacturing processes and rising demand for fill-finish outsourcing are the major factors driving the growth of the market of the pharmaceutical aseptic fill & finish CMO. However, the factors such as process failures and cost of production are anticipated to confine the market growth rate.

The customary process of fill-finish involved the practice of stainless-steel equipment connected through reusable valves, tubing, and piping. Though, with the increasing importance of specialized equipment, product safety, expertise, and care, much of this work has been subcontracted to contract manufacturers. Additionally, biosimilars are gradually influencing the need for more fill-finish CMOs. General, CMOs discloses an annual 10% -15% growth in development owing to biological drugs, mainly those presently in development for the US market in the upcoming years.

The eruption of COVID-19 positively impacted the market as pharma companies abruptly were faced with the challenge of manufacturing the many millions of vaccine doses that would possibly be needed. Many corporations such as Pfizer and AstraZeneca transported non-COVID-19 biologics out of their registered manufacturing networks to make area for the new vaccines. Owing to compressed timelines and developing scaling challenges for the COVID-19 vaccines and medicines, CMOs hired contract manufacturing service agreements at an extraordinary rate with the onset of the pandemic.

Moreover, the use of multi-product-use-oriented amenities is among the present trends observed across the industry. For example, in November 2020, Baxter’s BioPharma Solutions business, a CMO that focusses in parenteral pharmaceuticals, broadcasted the expansion of its disinfected fill-finish manufacturing facilities across Bloomington.

Type Insights

Based on type, the pharmaceutical aseptic fill & finish CMO market is segmented into vial filling services, ampoule filling services, and prefilled syringes filling services. In 2021, the vial filling services segment dominated the market with the maximum market share. The rising demand for syringes, global use of vials in lyophilisation, and the increasing use of disposable packaging for biologics has accounted for the major revenue in the market. The growing prevalence of diabetes, and increasing new product launches are anticipated to boost the market growth in the forecasted period.

Application Insights

Based on the application, the pharmaceutical aseptic fill & finish CMO market is categorized as vaccines, biologics and biosimilars, generics, and patented small molecules. In 2021, the vaccines segment ruled the market with the largest market share. The pandemic has opened up many opportunities for pharmaceutical companies to boost their coronavirus vaccine R&D. Moreover, the growing demand for sterile components and high-quality products in the fill-finish process is expected to boost the segment growth in the forecasted period.

Region Insights

In Asia Pacific, the market is projected to witness the fastest CAGR over the forecasted period. The region is also accounted for the largest market share of 35% in 2021 owing to factors such as growing investment by the corporations in clinical research, improving healthcare infrastructure, more number of CMOs increasing and rising number of fill-finish facilities being created in the region. For instance, In August 2021, Lonza is totalling capacity at its biologics developing facility in Guangzhou, China, by mounting a new fill-finish line. Furthermore, wages and material cost is inexpensive in China and India that pushes the market. The quick expansion of the biopharmaceutical industry could be a major factor boosting the demand for pharmaceutical aseptic fill & finish CMO in the region.

Moreover, as per the Indian Drug Manufacturers Association, as of July 2021, there has been a sudden increase in the cost of raw materials for the vital drugs, called active pharmaceutical ingredients (API) in the pharma segment by up to 140% in multiple cases then the pre-pandemic level, which is perplexing for the industry. The complete growth, be around 50% due to high-priced imports and stock disturbances from China, has elevated concerns about the accessibility of drugs and could lead to shortages, mainly of those essential in COVID therapy.

Key Companies Insights

The market for pharmaceutical aseptic fill & finish CMO market is moderately competitive. With the rising applications of Pharmaceutical aseptic fill & finish CMO market, new players are considering to enter the market. The companies are also involved in activities like joint ventures, acquisitions, partnerships, mergers, and collaborations. These activities aid in growing the effect of the players in the pharmaceutical aseptic fill & finish CMO market, ultimately boosting the market growth. Some of the key companies working in the global pharmaceutical aseptic fill & finish CMO market include:

• Baxter BioPharma Solutions
• Boehringer Ingelheim
• Vetter Pharma
• Fresenius Kabi
• Pfizer CentreOne
• Aenova
• WuXi Biologics
• Jubilant HollisterStier
• Bushu Pharmaceuticals
• LSNE Contract Manufacturing
• Ajinomoto Bio-Pharma Services
• CMIC CMO
• GRAM (Grand River Aseptic Manufacturing)
• TAIYO Pharma Tech Co.,Ltd.
• HALIX
• Cognate BioServices
• Afton Scientific
• Novasep
• Emergent BioSolutions
• Seikagaku
• Jiangshu YAOHAI Bio-pharmaceutical
• Akron Biotech
• Symbiosis Pharmaceutical Services
• Other players

Some of the Recent Developments:

• In November 2021, Baxter International Inc. announced an around USD 100 million expansion of its sterile fill/finish manufacturing capability located in Halle/Westfalen, Germany. This facility is worked by BioPharma Solutions (BPS).
• In August 2021, Pfizer Inc. and Trillium Therapeutics Inc. entered into a definitive agreement under which Pfizer will acquire Trillium that develops advanced therapies for the treatment of cancer.
• In April 2021, Bushu Pharmaceuticals signed a business agreement with Suzuken to provide support facilities for new pharmaceutical product introductions for specialty pharmaceutical manufacturers considering to enter the Japanese market.

Segments

By Type

• Ampoule Filling Services
• Vial Filling Services
• Prefilled Syringes Filling Services

By Application

• Vaccines
• Biologics and Biosimilars
• Generics
• Patented Small Molecules

By Geography

• North America
  • S.
  • Canada
  • Mexico
• Europe
  • K.
  • Germany
  • France
  • Italy
  • Spain
  • Russia
• Asia-Pacific
  • Japan
  • China
  • India
  • Australia
  • South Korea
  • ASEAN
• Latin America
  • Brazil
  • Argentina
  • Colombia
• MEA
  • South Africa
  • Saudi Arabia
  • UAE
  • Egypt