医薬品充填および仕上げアウトソーシング市場 - 2031年の成長予測、統計および事実

  • Report Code : TIPRE00017482
  • Category : Pharmaceuticals
  • Status : Published
  • No. of Pages : 158
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医薬品の充填および仕上げのアウトソーシング市場は、2021 年の 26 億 5,704 万米ドルから 2028 年までに 40 億 1,051 万米ドルに達すると予測されています。 2021 年から 2028 年までに 6.1% の CAGR が記録されると予想されています。

充填/仕上げギャップの需要を満たすための製薬およびバイオ医薬品業界からの需要の高まりが予想されます市場の成長を促進します。米国食品医薬品局 (FDA) の医薬品評価研究センター (CDER) によると、2020 年の新しい分子実体 (NME) の承認の 20% ~ 29% を生物製剤が占めています。 2019年には、小分子がすべてのNME承認の79%を占め、FDAによって承認された48のNMEのうち38を占め、生物製剤が承認された48のNMEのうち10、またはすべてのNME承認の21%を占めました。 2018年には、低分子がNME承認の71%を占め、生物製剤がNME承認の29%を占めました。社内に生産能力がある企業には、新製品を製造する能力が不足している場合があります。この要因が市場の成長を支えています。凍結乾燥、プレフィルドシリンジやカートリッジの充填、または新しい治療薬などの特殊な機能には、独自の製造技術が必要です。バイオテクノロジー企業にとっては、費用対効果が高いため、受託製造組織にアウトソーシングすることが有益であると考えられます。社内に無菌充填および仕上げの能力がある企業は、充填および仕上げのニーズの平均 39% を外部委託しています。

北米は、2021 年から 2028 年にかけて、医薬品の充填および仕上げのアウトソーシング市場で優位性を維持する可能性があります。米国は北米市場で最大のシェアを占めており、予測期間中この傾向が続くと予想されます。ロボット工学などの自動化の進歩は、米国の充填/仕上げ作業の進歩分野の 1 つです。これにより主に汚染リスクが大幅に軽減され、地域の成長が促進されます。人間の接触を減らすサプライチェーンの全体的な統合が、医薬品の充填および仕上げのアウトソーシング市場の成長を推進しています。たとえば、ABL は 2017 年に充填/仕上げ作業に自動化を導入しました。同社は、メリーランド州ロックビルにある GMP バイオ製造施設での無菌充填/仕上げ作業の拡張を完了しました。同社は、完全に自動化されたバイアル充填システムを導入しました。このような要因は、医薬品充填および仕上げアウトソーシング市場全体の成長を促進すると予想されます。


戦略的洞察

医薬品充填および仕上げアウトソーシング市場にとって有利な地域       

市場洞察

生物由来製品の需要の急増

生物学的製剤のパイプラインの増加と、そのような治療介入に対する嗜好の高まりにより、予測期間中に医薬品の充填および仕上げのアウトソーシングの需要が高まることが予想されます。充填/仕上げサービスの約 60% には、抗 COVID-19 ワクチンの臨床規模および商業規模の包装が含まれます。施設の拡張は、バイオ医薬品企業がパンデミック中に検討している重要な要素の 1 つです。バイオ医薬品企業は、前述の変化や予算の制約などの問題に直面しています。これらの問題を克服し、生物由来製品の需要を満たすためにはアウトソーシングが必要です。受託製造組織からのバイオ医薬品製品のアウトソーシングは、今後 7 年間、医薬品の充填および仕上げのアウトソーシング業界を推進すると予想されます。設置された充填/仕上げ能力の約 90% は、商業規模の生産能力を持つ市場参加者に属しています。利用可能な充填および仕上げ能力の 85% 以上が大規模企業に属しています。

完成品の状態に基づく洞察

完成品の状態に基づいて、医薬品充填および仕上げアウトソーシング市場は固形物、半製品に分類されます。 -固体と液体。液体セグメントは2021年に最大のシェアを獲得し、予測期間中同様の傾向が続くと予想されます。プラスチック注射器業界におけるプレフィルド注射器およびバイアルの需要の高まりにより、医薬品の充填および仕上げのアウトソーシングの需要が高まることが予想されます。凍結乾燥におけるバイアルの用途需要が、充填および仕上げサービス市場の成長を促進しています。また、世界的な生物製剤製造への新規参入者の増加により、アウトソーシング活動が急増しています。このような要因は、世界の医薬品充填および仕上げアウトソーシング市場を支援すると予想されます。

医薬品の充填および仕上げのアウトソーシング市場、完成品の状態別 – 2021 年と 2028 年

内容に基づいて、医薬品充填および仕上げアウトソーシング市場は、微生物から分離された有機物質、有機物質に分類されます。動物および無機物質から分離されています。微生物から分離された有機物質セグメントはかなりの市場シェアを占めており、予測期間中同様の傾向が続くと予測されています。医薬品の充填および仕上げのアウトソーシングの進歩により、サプライチェーンにおける汚染リスクの低減を成功裏に実現できるようになりました。このようなエンドツーエンドの統合は、微生物から分離された有機物質の需要を支援することに成功し、医薬品の充填および仕上げのアウトソーシングの需要を支援します。

医薬品の充填および仕上げのアウトソーシング市場で事業を展開している企業は、世界中で進化する顧客の需要を満たすために製品イノベーション戦略を採用しており、これによりブランド名を維持することもできます。世界市場で。

医薬品の充填および仕上げのアウトソーシング市場

世界の医薬品の充填および仕上げのアウトソーシング市場は、以下に基づいて分類されます。完成品の状態や内容など。最終製品の状態に基づいて、市場は液体、固体、半固体に分類されます。市場は内容によって、微生物から分離された有機物質、動物から分離された有機物質、無機物質に分類されます。地域に基づいて、世界の医薬品充填および仕上げアウトソーシング市場は、北米、ヨーロッパ、アジア太平洋、南米、中央アメリカ、中東、アフリカに分割されています。北米市場は、米国、カナダ、メキシコに分かれています。ヨーロッパ市場は、フランス、ドイツ、イタリア、スペイン、英国、その他のヨーロッパに分割されています。アジア太平洋地域は、中国、日本、韓国、インド、オーストラリア、およびその他のアジア太平洋地域に分類されます。中東とアフリカは、南アフリカ、サウジアラビア、UAE、その他の中東とアフリカに分類されます。中南米はブラジル、アルゼンチン、その他の南中米に分かれます。

市場で活動している企業は、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 NV)、Boehringer Ingelheim International GmbH など。  

Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

This text is related
to segments covered.

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

This text is related
to country scope.

Frequently Asked Questions


What is meant by the pharmaceutical fill and finish outsourcing market?

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.

What are the driving factors for the pharmaceutical fill and finish outsourcing market across the globe?

Rising investment in biopharmaceutical sectors and growing demand for biologics is expected to drive the market

Which segment led the pharmaceutical fill and finish outsourcing 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.

Which application segment held the largest revenue (US$ Mn) in the pharmaceutical fill and finish outsourcing market?

The liquid segment accounted for the largest share in 2021 and is expected to continue during the forecast period.

Who are the key players in the pharmaceutical fill and finish outsourcing market?

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.

What is the regional market scenario of the pharmaceutical fill and finish outsourcing market?

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

  1. Abbott
  2. Teva Pharmaceutical Industries Ltd
  3. Dr. Reddy's Laboratories
  4. Sun Pharmaceutical Industries Ltd
  5. Piramal Enterprises Ltd
  6. MabPlex International Ltd
  7. Wockhardt
  8. Cytovance Biologics
  9. Thermo Fisher Scientific Inc. (Patheon N.V.)
  10. 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.

  1. Data Collection and Secondary Research:

As a market research and consulting firm operating from a decade, we have published and advised several client 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 organization 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 last 3 years are scrutinized and analyzed to understand the current market trends.

  1. 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/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:

  • Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
  • Validates and strengthens in-house secondary research findings
  • Develops the analysis team’s expertise and market understanding

Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:

  • Industry participants: VPs, business development managers, market intelligence managers and national sales managers
  • Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.

Below is the breakup of our primary respondents by company, designation, and region:

Research Methodology

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.

  1. 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.

  • 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.

  • 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.

  • 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.

  • 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.

  1. 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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