report-image

Pharmaceutical Aseptic Fill & Finish CMO Market Analysis By Type(Ampoule Filling Services, Vial Filling Services, Prefilled Syringes Filling Services), By Application(Vaccines, Biologics and Biosimilars, Generics, Patented Small Molecules) & Forecast

  • PUBLISHED ON
  • 24/03/2023
  • NO OF PAGES
  • 205
  • CATEGORY
  • Healthcare & Life Sciences
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
o U.S.
o Canada
o Mexico
• Europe
o U.K.
o Germany
o France
o Italy
o Spain
o Russia
• Asia-Pacific
o Japan
o China
o India
o Australia
o South Korea
o ASEAN
• Latin America
o Brazil
o Argentina
o Colombia
• MEA
o South Africa
o Saudi Arabia
o UAE
o Egypt

Quality Assurance Process

  1. We Market Research’s Quality Assurance program strives to deliver superior value to our clients.

We Market Research senior executive is assigned to each consulting engagement and works closely with the project team to deliver as per the clients expectations.

Market Research Process




We Market Research monitors 3 important attributes during the QA process- Cost, Schedule & Quality. We believe them as a critical benchmark in achieving a project’s success.

To mitigate risks that can impact project success, we deploy the follow project delivery best practices:
  • Project kickoff meeting with client
  • Conduct frequent client communications
  • Form project steering committee
  • Assign a senior SR executive as QA Executive
  • Conduct internal editorial & quality reviews of project deliverables
  • Certify project staff in SR methodologies & standards
  • Monitor client satisfaction
  • Monitor realized value post-project

Case Study- Automotive Sector

One of the key manufacturers of automotive had plans to invest in electric utility vehicles. The electric cars and associated markets being a of evolving nature, the automotive client approached We Market Research for a detailed insight on the market forecasts. The client specifically asked for competitive analysis, regulatory framework, regional prospects studied under the influence of drivers, challenges, opportunities, and pricing in terms of revenue and sales (million units).

Solution

The overall study was executed in three stages, intending to help the client meet its objective of precisely understanding the entire market before deciding on an investment. At first, secondary research was conducted considering political, economic, social, and technological parameters to get a gist of the various aspects of the market. This stage of the study concluded with the derivation of drivers, opportunities, and challenges. It also laid substantial emphasis on understanding and collecting data not only on a global scale but also on the regional and country levels. Data Extraction through Primary Research

The second stage involved primary research in which several market players and automotive parts suppliers were contacted to study their viewpoint concerning the development of their market and production capacity, clientele, and product line. This stage concluded in a brief understanding of the competitive ecosystem and also glanced through the strategies and pricing of the companies profiled.

Market Estimates and Forecast

In the final stage of the study, market forecasts for the electric utility were derived using multiple market engineering approaches. This data helped the client to get an overview of the market and accelerate the process of investment.

Case Study- ICT Sector

Business process outsourcing, being one of the lucrative markets from both supply- and demand- side, has appealed to various companies. One of the prominent corporations based out of Japan approached us with their requirements regarding the scope of the procurement outsourcing market for around 50 countries. Additionally, the client also sought key players operating in the market and their revenue breakdown in terms of region and application.


Business Solution

An exhaustive market study was conducted based on primary and secondary research that involved factors such as labor costs in various countries, skilled and technical labors, manufacturing scenario, and their respective contributions in the global GDP. A comparative study of the market was conducted from both supply- and demand side, with the supply-side comprising of notable companies, such as GEP, Accenture, and others, that provide these services. On the other hand, large manufacturing companies from them demand-side were considered that opt for these services.


Conclusion

The report aided the client in understanding the market trends, including country-level business scenarios, consumer behavior, and trends in 50 countries. The report also provided financial insights of crucial players and detailed market estimations and forecasts till 2033.


CHOOSE LICENSE TYPE
QLOUD
Pricing

Select a license type that suits your business needs

Single User Access

US $4250

Only Four Thousand Two Hundred Fifty US dollar

  • 1 User access
  • 15% Additional Free Customization
  • Free Unlimited post-sale support
  • 100% Service Guarantee until achievement of ROI
Multi User Cost

US $5250

Only Five Thousand Two Hundred Fifty US dollar

  • 5 Users access
  • 25% Additional Free Customization
  • Access Report summaries for Free
  • Guaranteed service
  • Dedicated Account Manager
  • Discount of 20% on next purchase
  • Get personalized market brief from Lead Author
  • Printing of Report permitted
  • Discount of 20% on next purchase
  • 100% Service Guarantee until achievement of ROI
Enterprise User Cost

US $6250

Only Six Thousand Two Hundred Fifty US dollar

  • Unlimited User Access
  • 30% Additional Free Customization
  • Exclusive Previews to latest or upcoming reports
  • Discount of 30% on next purchase
  • 100% Service Guarantee until achievement of ROI