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세계의 의약품 Fill Finish 아웃소싱 시장 보고서(2025년)
Pharmaceutical Fill and Finish Outsourcing Global Market Report 2025
상품코드 : 1824437
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

의약품 Fill Finish 아웃소싱 시장 규모는 향후 수년간 강력한 성장이 예상됩니다. 2029년에는 연평균 복합 성장률(CAGR) 8.6%로 성장할 전망이며, 52억 5,000만 달러로 성장이 예측됩니다. 예측 기간의 성장은 전문적인 서비스에 대한 수요, 세계 시장 확대, 핵심 역량에 대한 주력, 신약의 급속한 시장 진입, 제조 능력의 유연성, 변동에 대응하기 위한 유연한 제조 능력의 필요성 예측 등에 기인할 것으로 보입니다. 예측기간 주요 동향으로는 생물제제 아웃소싱 증가, 지속가능성에 대한 대처, 아웃소싱 거점의 지리적 확대, 효율화를 위한 기술통합, 개발제조위탁기관(CDMO) 증가 등이 있습니다.

향후 5년간의 성장률 8.6%라고 하는 예측은 전회 예측으로부터 0.1%라고 하는 미감소를 반영하고 있습니다. 이 감소는 주로 미국과 타국가 간 관세의 영향 때문입니다. 무역 마찰은 이탈리아 및 중국에서 개발된 무균 바이알 충전기 및 동결건조 장비의 가격을 늘려 생산 병목 현상과 환자에게 생물학적 제형의 비용 상승을 초래함으로써 미국 의약품 제조에 지장을 초래할 수 있습니다. 또한 상호관세와 무역 긴장 증가 및 제한 증가로 인한 세계 경제와 무역에 대한 악영향으로 그 영향이 더욱 광범위해질 것으로 보입니다.

생물학적 제제에 대한 수요 증가는 향후 의약품 충전 및 마무리 아웃소싱 시장의 성장을 이끌 것으로 예측됩니다. 생물학적 제형은 종종 생물학적 제제 또는 바이오시밀러라고 불리며, 생물 유래 또는 생물 유래 성분을 포함하는 의약품의 카테고리입니다. 의약품 제조업체는 제조의 Fill Finish 단계를 아웃소싱하는 것으로, 제조 수탁 기관(CMO)의 전문 지식과 인프라를 활용할 수 있습니다. 이에 따라 제약회사는 생물학적 제제의 개발, 연구, 규모 확대에 집중할 수 있는 한편, 효율적이고 비용 효과적인 Fill Finish 작업을 CMO에 의지할 수 있습니다. 예를 들어, 2023년 9월 미국에 본사를 둔 제네릭 의약품 및 의약화학 제조업체의 업계 단체인 AAM(Association for Accessible Medicines)은 2022년에는 바이오시밀러 의약품에 의한 연간 절약액이 4,080억 달러를 넘어 2021년에 비해 350억 달러 증가했다고 보고했습니다. 이 동향은 지난 몇 년 동안 저축액의 연간 성장률이 일관되게 7-10%임을 보여줍니다. 따라서 생물학적 제제에 대한 수요 증가가 의약품 Fill Finish 아웃소싱 시장을 밀어올릴 것으로 예측됩니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향 및 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역전쟁 및 관세, 그리고 코로나 및 회복이 시장에 미치는 영향을 포함한 거시경제 시나리오

제5장 세계의 성장 분석 및 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별 및 국가별 분석

제8장 아시아태평양 시장

제9장 중국 시장

제10장 인도 시장

제11장 일본 시장

제12장 호주 시장

제13장 인도네시아 시장

제14장 한국 시장

제15장 서유럽 시장

제16장 영국 시장

제17장 독일 시장

제18장 프랑스 시장

제19장 이탈리아 시장

제20장 스페인 시장

제21장 동유럽 시장

제22장 러시아 시장

제23장 북미 시장

제24장 미국 시장

제25장 캐나다 시장

제26장 남미 시장

제27장 브라질 시장

제28장 중동 시장

제29장 아프리카 시장

제30장 경쟁 구도 및 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹 및 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문 및 전략

제36장 부록

AJY
영문 목차

영문목차

Pharmaceutical fill and finish outsourcing involves the practice of contracting with specialized pharmaceutical manufacturing companies to provide services related to pharmaceutical filling and sealing operations into end-use containers with the required sterility and accuracy. This outsourcing is employed by pharmaceutical and biopharmaceutical companies to leverage specialized expertise, avoid the high costs associated with acquiring automated equipment, meet stringent regulatory agency standards, enhance efficiency, and gain flexibility in terms of production capacity.

The primary types of pharmaceutical fill and finish outsourcing products are liquids, solids, and semi-solids. Liquids refer to pharmaceutical formulations that are pourable and consist of a combination of active drug or chemical components and inert components. These formulations may be processed from organic substances isolated from animal origin, organic substances isolated from microorganisms, and inorganic substances. Pharmaceutical and biopharmaceutical companies commonly utilize these outsourcing services for their production needs.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sharp rise in U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the healthcare sector, especially in the supply of essential medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are grappling with higher costs for imported surgical tools, imaging systems, and consumables like syringes and catheters, many of which have limited domestic substitutes. These escalating expenses are putting pressure on healthcare budgets, prompting some providers to delay equipment upgrades or pass increased costs on to patients. Furthermore, tariffs on raw materials and components are disrupting the manufacturing of vital drugs and devices, leading to supply chain delays. In response, the industry is adopting diversified sourcing strategies, expanding local production where feasible, and pushing for tariff exemptions on critical medical products.

The pharmaceutical fill and finish outsourcing market research report is one of a series of new reports from The Business Research Company that provides pharmaceutical fill and finish outsourcing market statistics, including pharmaceutical fill and finish outsourcing industry global market size, regional shares, competitors with a pharmaceutical fill and finish outsourcing market share, detailed pharmaceutical fill and finish outsourcing market segments, market trends and opportunities, and any further data you may need to thrive in the pharmaceutical fill and finish outsourcing industry. This pharmaceutical fill-and-finish outsourcing market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The pharmaceutical fill and finish outsourcing market size has grown strongly in recent years. It will grow from $3.53 billion in 2024 to $3.77 billion in 2025 at a compound annual growth rate (CAGR) of 6.9%. The growth in the historic period can be attributed to the emergence of contract development and manufacturing organizations (CDMOs, demand for specialized services, shift to outsourced models, market expansion strategies, and stringent regulatory requirements.

The pharmaceutical fill and finish outsourcing market size is expected to see strong growth in the next few years. It will grow to $5.25 billion in 2029 at a compound annual growth rate (CAGR) of 8.6%. The growth in the forecast period can be attributed to demand for specialized services, global market expansion, focus on core competencies, rapid market entry for new drugs, flexibility in manufacturing capacity, anticipated need for flexible manufacturing capacity to accommodate fluctuation. Major trends in the forecast period include increased biologics outsourcing, sustainability initiatives, geographic expansion of outsourcing hubs, technological integration for efficiency, rise in contract development and manufacturing organizations (CDMOs).

The forecast of 8.6% growth over the next five years reflects a slight reduction of 0.1% from the previous projection. This reduction is primarily due to the impact of tariffs between the US and other countries. Trade tensions could hinder U.S. drug manufacturing by inflating prices of sterile vial-filling machines and lyophilization equipment developed in Italy and China, resulting in production bottlenecks and higher biologic drug costs for patients. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.

The increasing demand for biologic drugs is anticipated to drive the growth of the pharmaceutical fill and finish outsourcing market in the future. Biologic drugs, often referred to as biologics or biosimilars, are a category of pharmaceutical products derived from living organisms or containing components sourced from living organisms. By outsourcing the fill and finish phase of production, drug manufacturers can leverage the expertise and infrastructure of contract manufacturing organizations (CMOs). This enables pharmaceutical companies to concentrate on the development, research, and scaling of their biologic drugs while relying on CMOs for efficient and cost-effective fill and finish operations. For example, in September 2023, the Association for Accessible Medicines (AAM), a US-based trade association for manufacturers of generic prescription drugs and pharmaceutical chemicals, reported that in 2022, annual savings from biosimilar drugs exceeded $408 billion, reflecting a $35 billion increase compared to 2021. This trend indicates a consistent annual growth rate of 7-10 percent in savings in recent years. Therefore, the rising demand for biologic drugs is expected to boost the pharmaceutical fill and finish outsourcing market.

The rise in investments in biopharmaceutical research and development (R&D) is significantly fueling the growth of the pharmaceutical fill and finish outsourcing market. R&D investments refer to the financial resources allocated to activities aimed at discovering, developing, and eventually bringing new biopharmaceutical products to market. With a strong emphasis on innovation and drug development, pharmaceutical companies may increase their allocation of resources to research and development. Outsourcing fill and finish services allows these companies to redirect resources and investments toward core R&D activities. For instance, in January 2023, Roche Holding AG, a biopharmaceutical manufacturer based in Switzerland, announced a 3.7% increase in its R&D expenditure for 2022 compared to 2021. Consequently, the heightened investments in research and development by biopharmaceutical companies are driving the pharmaceutical fill and finish outsourcing market.

Product innovations represent a significant trend gaining traction in the pharmaceutical fill and finish outsourcing market. Companies within this sector are actively developing new and innovative products to maintain their competitive edge. For example, in January 2024, Stevanato Group, an Italy-based provider of drug containment and delivery solutions for the pharmaceutical and life sciences industries, introduced the EZ-fill Kit and a laboratory fill and finish service. The EZ-fill Kit is designed to streamline the filling process for small batches of injectable drugs, making it particularly beneficial during clinical trials and early commercial phases. This innovation helps pharmaceutical companies enhance small batch production, reduce costs, and accelerate time-to-market. Furthermore, the new non-GMP laboratory fill and finish service facilitates early evaluation of how the fill-and-finish process affects product performance. These innovations aim to improve efficiency and uphold high standards in drug development and production.

Leading companies in the pharmaceutical fill and finish outsourcing market are prioritizing the development of sustainable packaging materials and methods to reduce their carbon footprint and promote environmental conservation. Sustainable packaging involves creating and utilizing packaging that minimizes its environmental impact throughout its entire lifecycle. For instance, in November 2023, Amcor, an Australia-based pharmaceutical packaging company, launched next-generation HealthCare Recycle-Ready Medical Laminates. Amcor is producing all-film packaging that meets device application performance requirements while decreasing the overall carbon footprint of the final package and ensuring recyclability in the polyethylene stream. This solution features a polyethylene (PE) laminate that is a monomaterial suitable for various packaging formats, enabling it to replace non-recyclable lidding for 3D thermoformed packages with recyclable lidding for products such as drapes, protective materials, catheters, injection systems, and tubing systems.

In January 2023, AstraZeneca Pharmaceuticals LP, a US-based biopharmaceutical company, completed the acquisition of CinCor Pharma Inc. for $1.8 billion. This strategic move allows AstraZeneca to strengthen its cardiorenal portfolio by incorporating CinCor's promising compound, baxdrostat (CIN-107). Baxdrostat, an aldosterone synthase inhibitor (ASI), is designed to lower blood pressure in patients with treatment-resistant hypertension, including those with chronic kidney disease. CinCor Pharma Inc. is a US-based clinical-stage biopharmaceutical company specializing in kidney disease medications and treatments.

Major companies operating in the pharmaceutical fill and finish outsourcing market include Groninger and Co. GmbH, Merck and Co.Inc., Abbott Laboratories, Wockhardt Limited., Boehringer Ingelheim International GmbH, Becton Dickinson and Company, AbbVie Inc., Teva Pharmaceuticals Industries Ltd., Recipharm AB., Lonza Group AG, Catalent Inc., Dr. Reddys Laboratories Ltd., West Pharmaceutical Services Inc., Sun Pharmaceutical Industries Ltd., Patheon N.V., Piramal Enterprises Ltd., Gerresheimer AG, CordenPharma International, Fujifilm Diosynth Biotechnologies, Optima Packaging Group GmbH, Jubilant HollisterStier LLC., Ajinomoto Bio-Pharma Services, Cytovance Biologics Inc., Grand River Aseptic Manufacturing, Baxter Pharmaceutical Solutions LLC., Halo Pharma Inc., MabPlex Inc., August Bioservices

North America was the largest region in the pharmaceutical fill and finish outsourcing market in 2024. The regions covered in the pharmaceutical fill and finish outsourcing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the pharmaceutical fill and finish outsourcing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The pharmaceutical fill and finish outsourcing market includes revenues earned by entities by providing outsourcing of aseptic or sterile filling and finishing services. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Pharmaceutical Fill and Finish Outsourcing Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on pharmaceutical fill and finish outsourcing market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for pharmaceutical fill and finish outsourcing ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The pharmaceutical fill and finish outsourcing market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. Pharmaceutical Fill and Finish Outsourcing Market Characteristics

3. Pharmaceutical Fill and Finish Outsourcing Market Trends And Strategies

4. Pharmaceutical Fill and Finish Outsourcing Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Pharmaceutical Fill and Finish Outsourcing Growth Analysis And Strategic Analysis Framework

6. Pharmaceutical Fill and Finish Outsourcing Market Segmentation

7. Pharmaceutical Fill and Finish Outsourcing Market Regional And Country Analysis

8. Asia-Pacific Pharmaceutical Fill and Finish Outsourcing Market

9. China Pharmaceutical Fill and Finish Outsourcing Market

10. India Pharmaceutical Fill and Finish Outsourcing Market

11. Japan Pharmaceutical Fill and Finish Outsourcing Market

12. Australia Pharmaceutical Fill and Finish Outsourcing Market

13. Indonesia Pharmaceutical Fill and Finish Outsourcing Market

14. South Korea Pharmaceutical Fill and Finish Outsourcing Market

15. Western Europe Pharmaceutical Fill and Finish Outsourcing Market

16. UK Pharmaceutical Fill and Finish Outsourcing Market

17. Germany Pharmaceutical Fill and Finish Outsourcing Market

18. France Pharmaceutical Fill and Finish Outsourcing Market

19. Italy Pharmaceutical Fill and Finish Outsourcing Market

20. Spain Pharmaceutical Fill and Finish Outsourcing Market

21. Eastern Europe Pharmaceutical Fill and Finish Outsourcing Market

22. Russia Pharmaceutical Fill and Finish Outsourcing Market

23. North America Pharmaceutical Fill and Finish Outsourcing Market

24. USA Pharmaceutical Fill and Finish Outsourcing Market

25. Canada Pharmaceutical Fill and Finish Outsourcing Market

26. South America Pharmaceutical Fill and Finish Outsourcing Market

27. Brazil Pharmaceutical Fill and Finish Outsourcing Market

28. Middle East Pharmaceutical Fill and Finish Outsourcing Market

29. Africa Pharmaceutical Fill and Finish Outsourcing Market

30. Pharmaceutical Fill and Finish Outsourcing Market Competitive Landscape And Company Profiles

31. Pharmaceutical Fill and Finish Outsourcing Market Other Major And Innovative Companies

32. Global Pharmaceutical Fill and Finish Outsourcing Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Pharmaceutical Fill and Finish Outsourcing Market

34. Recent Developments In The Pharmaceutical Fill and Finish Outsourcing Market

35. Pharmaceutical Fill and Finish Outsourcing Market High Potential Countries, Segments and Strategies

36. Appendix

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