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세계의 모듈형 Fill Finish 마이크로 팩토리 시장 보고서(2025년)
Modular Fill-Finish Micro-Factory Global Market Report 2025
상품코드 : 1877827
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

모듈형 Fill Finish 마이크로 팩토리 시장 규모는 최근 급속히 확대되고 있습니다. 2024년 15억 6,000만 달러로 평가되었고, 2025년에는 17억 4,000만 달러에 달하고, CAGR 11.6%로 성장할 전망입니다. 이 성장은 무균 주사제 수요 증가, 제약 업계에서의 모듈러 제조의 보급 확대, Fill Finish 공정의 아웃소싱 증가, 바이오의약품 및 백신 생산의 확대, 소로트 생산에 대한 주목 증가 등이 요인으로 생각됩니다.

모듈형 Fill Finish 마이크로 팩토리 시장 규모는 향후 수년간 급속한 성장이 예상됩니다. 2029년에는 26억 7,000만 달러에 달하고, CAGR은 11.2%를 나타낼 전망입니다. 예측기간 동안 성장요인으로는 분산형 제조 투자 증가, 맞춤형 의료 수요 증가, 첨단 무균기술 보급 확대, 생물학적 파이프라인 확대, 지역 의약품 제조를 지원하는 정부 시책 증가 등이 있습니다. 예측 기간 동안의 주요 동향은 자동화 기술의 발전, 단일 사용 시스템 혁신, 모듈형 클린룸 솔루션의 발전, 마이크로팩토리 설계의 연구 개발, 제조 분야에서 인공지능의 통합을 포함합니다.

맞춤형 의료에 대한 수요 증가는 향후 몇 년간의 모듈형 Fill Finish 마이크로 팩토리 시장의 성장을 이끌 것으로 예측됩니다. 맞춤형 의료는 개인의 유전적 특성, 환경 요인, 생활 습관에 따라 질병의 예방, 진단, 치료를 맞춤화하는 의료 접근법입니다. 개인화된 의료 수요 증가는 유전체학와 생명공학의 진보에 의해 추진되고 있으며, 이들은 개인의 유전자 프로파일에 맞춘 치료를 가능하게 하여 효능과 안전성의 향상을 실현합니다. 모듈형 Fill Finish 마이크로 팩토리는 개별 환자의 요구 사항을 충족하도록 설계된 유연하고 소형이며 신속한 제조 솔루션을 제공하여 개인화된 의료 생산을 가속화합니다. 예를 들어 미국에 본사를 둔 비영리 단체 '맞춤형 의료연합'에 따르면 2024년 2월 시점에서 FDA(미국식품의약품국)는 2023년 희소질환 환자를 위한 새로운 맞춤형 치료법 16건을 승인했습니다. 이는 2022년 6건 승인에서 상당한 증가가 됩니다. 따라서 맞춤형 의료에 대한 수요 증가가 모듈형 Fill Finish 마이크로 팩토리 시장의 성장을 가속하고 있습니다.

모듈형 Fill Finish 마이크로 팩토리 시장의 주요 기업은 무균 제조에서 생산 효율, 정확성 및 확장성을 향상시키기 위해 유연하고 교체 가능한 무균 충전 플랫폼과 같은 혁신적인 솔루션 개발에 주력하고 있습니다. 유연하고 교체 가능한 무균 충전 플랫폼은 무균 환경 내에서 여러 용기 유형과 배치 크기를 수용할 수 있는 고급 시스템으로 다양한 제품 및 생산 요구 사항에 따라 신속한 구성 변경을 가능하게 합니다. 예를 들어, 2025년 2월에는 스웨덴에 본사를 둔 수탁개발제조기관(CDMO)인 리시팜 AB사가 공정개발, 파일럿 스케일, 임상공급제조를 지원하도록 설계된 새로운 모듈식 무균충전 시스템을 도입했습니다. 이 시스템은 등급 A아이솔레이터 내에서 작동하며 적절한 제조 기준(GMP)을 완벽하게 준수하므로 GMP 호환 무균 충전 공정을 보장합니다. 배치 당 500 - 50,000 단위의 소규모 배치 생산에 최적화되어 있으며 주사기 및 바이알 등 다양한 제품 유형을 지원할 수있는 교체 가능한 모듈로 탁월한 유연성을 제공합니다. 비용 효율적인 설계로 고가치 제품의 손실을 500ml 미만으로 최소화하고 희귀질환, 세포 및 유전자 치료 및 기타 고급 치료법의 임상 개발 프로젝트에 특히 유용합니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

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

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별/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 구도와 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹과 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문, 전략

제36장 부록

SHW
영문 목차

영문목차

A modular fill finish micro factory is a compact, prefabricated facility designed for the sterile filling, packaging, and finishing of biopharmaceutical or vaccine products. It incorporates modular units to provide flexibility, rapid deployment, and scalable production while ensuring compliance with good manufacturing practices.

The main product types of modular fill finish micro factories include automated modular fill finish systems, semi-automated modular fill finish systems, and manual modular fill finish systems. Automated modular fill finish systems are fully integrated, flexible, and scalable manufacturing units that automatically carry out sterile filling, capping, and labeling of pharmaceutical products within modular production setups. They are suitable for both clinical and commercial-scale operations and are used across pharmaceuticals, biotechnology, contract manufacturing organizations, and other sectors. These systems cater to various end users, including pharmaceutical companies, biotechnology companies, research institutes, and others.

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 sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

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

The modular fill-finish micro-factory market size has grown rapidly in recent years. It will grow from $1.56 billion in 2024 to $1.74 billion in 2025 at a compound annual growth rate (CAGR) of 11.6%. The growth during the historic period can be attributed to the rising demand for sterile injectable drugs, the increasing adoption of modular manufacturing in the pharmaceutical industry, the growing outsourcing of fill finish operations, the expansion of biologics and vaccine production, and the heightened focus on small batch manufacturing.

The modular fill-finish micro-factory market size is expected to see rapid growth in the next few years. It will grow to $2.67 billion in 2029 at a compound annual growth rate (CAGR) of 11.2%. The growth during the forecast period can be attributed to the rising investment in decentralized manufacturing, the increasing demand for personalized medicines, the growing adoption of advanced aseptic technologies, the expansion of the biologics pipeline, and the increasing government initiatives supporting local drug manufacturing. Major trends during the forecast period include technological advancements in automation, innovations in single-use systems, progress in modular cleanroom solutions, research and development in microfactory design, and the integration of artificial intelligence in manufacturing.

The increasing demand for personalized medicines is expected to drive the growth of the modular fill finish micro factory market in the coming years. Personalized medicine is a medical approach that customizes the prevention, diagnosis, and treatment of diseases based on an individual's genetic, environmental, and lifestyle characteristics. The growing demand for personalized medicines is driven by advancements in genomics and biotechnology, which enable treatments tailored to an individual's genetic profile for improved efficacy and safety. Modular fill finish micro factories accelerate the production of personalized medicines by offering flexible, small batch, and rapid manufacturing solutions designed to meet individual patient requirements. For example, in February 2024, according to the Personalized Medicine Coalition, a United States-based non-profit organization, the FDA approved 16 new personalized therapies for patients with rare diseases in 2023, a significant increase compared to six approvals in 2022. Therefore, the rising demand for personalized medicines is fueling the growth of the modular fill finish micro factory market.

Leading companies in the modular fill finish micro factory market are focusing on creating innovative solutions such as flexible and interchangeable aseptic filling platforms to improve production efficiency, precision, and scalability in sterile manufacturing. Flexible and interchangeable aseptic filling platforms are advanced systems capable of handling multiple container types and batch sizes within a sterile environment, allowing quick configuration changes to meet varied product and production requirements. For instance, in February 2025, Recipharm AB, a Sweden-based contract development and manufacturing organization, introduced a new modular sterile filling system designed to support process development, pilot-scale, and clinical supply manufacturing. The system operates within a Grade A isolator and fully complies with Good Manufacturing Practice standards, ensuring a GMP-compliant aseptic filling process. Optimized for small batch production ranging from 500 to 50,000 units per batch, it provides exceptional flexibility with interchangeable modules compatible with different product types such as syringes and vials. Its cost-efficient design minimizes high-value product loss to less than 500 milliliters, making it particularly beneficial for clinical development projects in rare diseases, cell and gene therapies, and other advanced modalities.

In May 2025, Cellular Origins Limited, a United Kingdom-based biotechnology company, partnered with 3P Innovation to advance the industrialization and scalable manufacturing of cell and gene therapies. This partnership aims to optimize production processes, enhance manufacturing efficiency, and provide flexible, compliant, and large-scale CGT manufacturing solutions. 3P Innovation Limited is a United Kingdom-based company that supplies modular fill finish micro factories.

Major players in the modular fill-finish micro-factory market are Groninger And Co. GmbH, Lonza Group AG, Sartorius AG, Turner Industries Group LLC, ATS Life Sciences Systems Inc., IMA Group S.p.A., Recipharm AB, Syntegon Technology GmbH, Truking Technology Limited, Optima Packaging Group GmbH, Marchesini Group SPA, Tofflon Science and Technology Co. Ltd., Comecer S.p.A., G-CON Manufacturing Inc., Aseptic Technologies S.A., Steriline S.r.l., Colanar AG, Litek Pharma Solutions Co. Ltd., SKAN AG, and Modular Mobile Facility.

North America was the largest region in the modular fill-finish micro-factory market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in modular fill-finish micro-factory report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

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

The modular fill-finish micro-factory market consists of sales of sterile connectors, peristaltic pumps, environmental monitoring systems, automated capping units, and cleanroom air handling modules. Values in this market are 'factory gate' values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

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.

Modular Fill-Finish Micro-Factory 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 modular fill-finish micro-factory 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 modular fill-finish micro-factory ? 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 modular fill-finish micro-factory 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. Modular Fill-Finish Micro-Factory Market Characteristics

3. Modular Fill-Finish Micro-Factory Market Trends And Strategies

4. Modular Fill-Finish Micro-Factory 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 Modular Fill-Finish Micro-Factory Growth Analysis And Strategic Analysis Framework

6. Modular Fill-Finish Micro-Factory Market Segmentation

7. Modular Fill-Finish Micro-Factory Market Regional And Country Analysis

8. Asia-Pacific Modular Fill-Finish Micro-Factory Market

9. China Modular Fill-Finish Micro-Factory Market

10. India Modular Fill-Finish Micro-Factory Market

11. Japan Modular Fill-Finish Micro-Factory Market

12. Australia Modular Fill-Finish Micro-Factory Market

13. Indonesia Modular Fill-Finish Micro-Factory Market

14. South Korea Modular Fill-Finish Micro-Factory Market

15. Western Europe Modular Fill-Finish Micro-Factory Market

16. UK Modular Fill-Finish Micro-Factory Market

17. Germany Modular Fill-Finish Micro-Factory Market

18. France Modular Fill-Finish Micro-Factory Market

19. Italy Modular Fill-Finish Micro-Factory Market

20. Spain Modular Fill-Finish Micro-Factory Market

21. Eastern Europe Modular Fill-Finish Micro-Factory Market

22. Russia Modular Fill-Finish Micro-Factory Market

23. North America Modular Fill-Finish Micro-Factory Market

24. USA Modular Fill-Finish Micro-Factory Market

25. Canada Modular Fill-Finish Micro-Factory Market

26. South America Modular Fill-Finish Micro-Factory Market

27. Brazil Modular Fill-Finish Micro-Factory Market

28. Middle East Modular Fill-Finish Micro-Factory Market

29. Africa Modular Fill-Finish Micro-Factory Market

30. Modular Fill-Finish Micro-Factory Market Competitive Landscape And Company Profiles

31. Modular Fill-Finish Micro-Factory Market Other Major And Innovative Companies

32. Global Modular Fill-Finish Micro-Factory Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Modular Fill-Finish Micro-Factory Market

34. Recent Developments In The Modular Fill-Finish Micro-Factory Market

35. Modular Fill-Finish Micro-Factory Market High Potential Countries, Segments and Strategies

36. Appendix

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