The pharmaceutical fill and finish outsourcing market is projected to reach US$ 4,010.51 million by 2028 from US$ 2,657.04 million in 2021; it is expected to register a CAGR of 6.1% from 2021 to 2028.
The rising demand from pharmaceutical and biopharmaceutical industries to meet the demand for fill/finish gap is expected to drive the market growth. According to the US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER), biologics have accounted for 20% to 29% of approvals of new molecular entities (NMEs) in 2020. In 2019, small molecules accounted for 79% of all NME approvals, representing 38 of the 48 NMEs approved by the FDA and biologics accounted for 10 of the 48 NMEs approved or 21% of all NME approvals. In 2018, small molecules accounted for 71% of NME approvals and biologics 29% of NME approvals. In-house capacities companies sometimes lack the ability to manufacture new products. This factor supports the growth of the market. Specialized capabilities, such as lyophilization, filling prefilled syringes and cartridges, or novel therapeutics, require unique manufacturing techniques that biotech technology companies find beneficial to outsource from contract manufacturing organizations, as they are cost-effective. Companies with in-house aseptic fill-and-finish capacity outsource on average 39% of their fill-and-finish needs.
North America is likely to continue its dominance in the pharmaceutical fill and finish outsourcing market during 2021–2028. The US holds the largest share of the market in North America and is expected to continue this trend during the forecast period. Automation advancements such as robotics have been one of the areas of progress for the US fill/finish operations. This primarily reduces the contamination risk to a great extent, thus aiding the regional growth. The overall integration of the supply chain that reduces human interactions is driving the pharmaceutical fill and finish outsourcing market growth. For instance, ABL adopted automation in their fill/finish operations in 2017. The company completed an expansion of aseptic fill/finish operations at its GMP biomanufacturing facility in Rockville, MD. The company installed a fully automated vial filling system. Such factors are expected to aid the growth of the overall pharmaceutical fill and finish outsourcing market.
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Pharmaceutical Fill and Finish Outsourcing Market: Strategic Insights
Market Size Value in US$ 2,657.04 million in 2021 Market Size Value by US$ 4,010.51 million by 2028 Growth rate CAGR of 6.1% from 2021 to 2028. Forecast Period 2021-2028 Base Year 2021
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Pharmaceutical Fill and Finish Outsourcing Market: Strategic Insights
| Market Size Value in | US$ 2,657.04 million in 2021 |
| Market Size Value by | US$ 4,010.51 million by 2028 |
| Growth rate | CAGR of 6.1% from 2021 to 2028. |
| Forecast Period | 2021-2028 |
| Base Year | 2021 |
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Lucrative Regions for Pharmaceutical Fill and Finish Outsourcing Market
- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
Market Insights
Surge in Demand for Biological Products
The rising pipeline of biologic drugs and the increasing preference for such therapeutic interventions are expected to drive the demand for pharmaceutical fill and finish outsourcing during the forecast period. Approximately 60% of fill/finish services involve the clinical and commercial-scale packaging of anti-COVID-19 vaccines. Expansion of facilities is one of the critical factors that biopharma companies are considering during the pandemic. Biopharmaceutical companies are facing issues such as the aforementioned changes and budgetary constraints. Outsourcing is required to overcome these issues and meet the demands of biological products. The outsourcing of biopharmaceutical products from the contract manufacturing organizations is expected to drive the pharmaceutical fill and finish outsourcing industry over the next seven years. Approximately 90% of the installed fill/finish capacity belongs to market participants with commercial-scale production capabilities. Over 85% of the available fill and finish capacity belongs to large-scale companies.
State of Finished Products-Based Insights
Based on state of finished products, the pharmaceutical fill and finish outsourcing market is segmented into solids, semi-solids, and liquids. The liquid segment captured the largest share in 2021 and is expected to continue a similar trend over the forecast period. Growing demand for prefilled syringes and vials in the plastic syringe industries is expected to drive the demand for pharmaceutical fill and finish outsourcing. Application demand of vials in lyophilization is fuelling the growth of the fill and finish services market. Also, the rising number of new entrants in global biologics manufacturing results in the surge in outsourcing activities. Such a factor is anticipated to assist the global pharmaceutical fill and finish outsourcing market.
Pharmaceutical Fill and Finish Outsourcing Market, by State of Finished Products – 2021 and 2028
- Sample PDF showcases the content structure and the nature of the information with qualitative and quantitative analysis.
Based on content, the pharmaceutical fill and finish outsourcing market is segmented into organic substances isolated from microorganisms, organic substances isolated from animals, and inorganic substances. The organic substances isolated from microorganisms segment hold a considerable market share and is projected to continue a similar trend during the forecast period. Advances in pharmaceutical fill and finish outsourcing have enabled successful implementation of the reduction in contamination risks in the supply chain. Such an end-to-end integration has successfully aided the demand for organic substances isolated from microorganisms, thus aiding the demand for pharmaceutical fill and finish outsourcing.
Companies operating in the pharmaceutical fill and finish outsourcing market adopt the product innovation strategy to meet the evolving customer demands across the world, which also permits them to maintain their brand name in the global market.
Pharmaceutical Fill and Finish Outsourcing Market
The global pharmaceutical fill and finish outsourcing market is segmented based on the state of finished products, and content. Based on state of finished products, the market is categorized into liquids, solids, and semi-solids. By content, the market is segmented into organic substances isolated from microorganisms, organic substances isolated from animals, and inorganic substances. Based on regions, the global pharmaceutical fill and finish outsourcing market is segmented into North America, Europe, Asia Pacific, South and Central America and Middle East and Africa. The North America market is segmented into United States, Canada and Mexico. Europe market is segmented into France, Germany, Italy, Spain, United Kingdom and Rest of Europe. Asia Pacific is segmented into China, Japan, South Korea, India, Australia and Rest of Asia Pacific. Middle East and Africa is segmented into South Africa, Saudi Arabia, UAE and Rest of Middle East and Africa. South and Central America is bifurcated into Brazil, Argentina and Rest of South and Central America.
Companies operating in the market are Abbott, TEVA PHARMACEUTICAL INDUSTRIES LTD, Dr. Reddy's Laboratories, Sun Pharmaceutical Industries Ltd, Piramal Enterprises Ltd., MabPlex International Ltd, WOCKHARDT, Cytovance Biologics, Thermo Fisher Scientific Inc. (Patheon N.V), Boehringer Ingelheim International GmbH amongst others.
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
State of Finished Products, and Content
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States
Frequently Asked Questions
Biopharmaceutical companies and pharmaceutical companies outsource a portion of the products from the contract outsourcing companies to meet the unmet demand of the companies. This process is termed as the pharmaceutical fill and finish outsourcing.
Rising investment in biopharmaceutical sectors and growing demand for biologics is expected to drive the market
Based on content, organic substances isolated from microorganisms took the forefront lead in the worldwide market by accounting largest share in 2020 and is expected to continue a similar trend over the forecast period.
The liquid segment accounted for the largest share in 2021 and is expected to continue during the forecast period.
Companies operating in the market are Abbott, TEVA PHARMACEUTICAL INDUSTRIES LTD, Dr. Reddy's Laboratories, Sun Pharmaceutical Industries Ltd, Piramal Enterprises Ltd., MabPlex International Ltd, WOCKHARDT, Cytovance Biologics, Thermo Fisher Scientific Inc. (Patheon N.V), Boehringer Ingelheim International GmbH amongst others.
Global pharmaceutical fill and finish outsourcing market is segmented by region into North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America. North America is likely to continue its dominance in the pharmaceutical fill and finish outsourcing market during 2021–2028. The US holds the largest share of the market in North America and is expected to continue this trend during the forecast period. Automation advancements such as robotics have been one of the areas of progress for the US fill/finish operations. This primarily reduces the contamination risk to a great extent, thus aiding the regional growth. The overall integration of the supply chain that reduces human interactions is driving the pharmaceutical fill and finish outsourcing market growth.
The List of Companies - Pharmaceutical Fill and Finish Outsourcing Market
- Abbott
- Teva Pharmaceutical Industries Ltd
- Dr. Reddy's Laboratories
- Sun Pharmaceutical Industries Ltd
- Piramal Enterprises Ltd
- MabPlex International Ltd
- Wockhardt
- Cytovance Biologics
- Thermo Fisher Scientific Inc. (Patheon N.V.)
- Boehringer Ingelheim International GmbH
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
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- Develops the analysis team’s expertise and market understanding
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- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
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Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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