무균 Fill Finish 제조 시장 : 분자 유형별, 제공 포장 용기 유형별, 의약품 유형별, 사업 규모별, 기업 규모별, 대상 치료 영역별, 지역별 - 업계 동향과 세계 예측(-2035년)
Aseptic Fill Finish Manufacturing Market by Type of Molecule, Type of Packaging Container Offered, Type of Drug Product, Scale of Operation, Company Size, Target Therapeutic Area and Geographical Regions : Industry Trends and Global Forecasts, Till 2035
상품코드 : 1648557
리서치사 : Roots Analysis
발행일 : 2025년 01월
페이지 정보 : 영문 263 Pages
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한글목차

세계의 무균 Fill Finish 제조 시장 규모는 2035년까지의 예측 기간 중 9%의 CAGR로 확대하며, 현재 54억 달러에서 2035년까지 150억 달러로 성장할 것으로 예측됩니다.

FILL/FINISH는 제품 다운스트림 공정의 최종 공정으로, 정제된 의약품의 벌크 제제를 필요한 부형제 및 안정제와 혼합하여 임상 사용 또는 상업적 유통에 적합한 제형으로 제형화하여 분주하는 작업입니다. 이러한 작업은 일반적으로 무균 조건에서 이루어지며 대부분 자동화되어 있습니다. 무균 충진 마감 제조는 최종 제제의 무균성과 안전성을 유지하기 위해 특수 자동화 장비, 클린룸 설치, 숙련된 인력, 지속적인 모니터링이 필요하다는 점은 특기할 만합니다. 의약품의 부적절한 충전에 따른 문제를 고려하고 최종 제품의 품질을 보장하기 위해 혁신가들은 무균 충전 및 마무리 작업을 위탁업체에 아웃소싱하는 것을 선호하고 있습니다. 현재, 위탁 충전 및 마감 서비스는 제약 분야에서 가장 많이 아웃소싱되는 서비스 중 하나입니다. 아웃소싱 증가 추세에 힘입어 무균 충전/마무리 서비스 시장의 기회는 향후 안정적인 속도로 증가할 것으로 예상됩니다.

Aseptic Fill Finish Manufacturing Market-IMG1
Aseptic Fill Finish Manufacturing Market-IMG2

세계의 무균 Fill Finish 제조 시장에 대해 조사했으며, 시장의 개요와 제공 포장 용기 유형별, 의약품 유형별, 사업 규모별, 기업 규모별, 대상 치료 영역별, 지역별 동향 및 시장에 참여하는 기업의 개요 등을 제공하고 있습니다.

목차

제1장 서문

제2장 개요

제3장 서론

제4장 무균 FILL/FINISH 서비스 프로바이더의 상황

제5장 생물제제 FILL/FINISH 서비스 프로바이더의 상황

제6장 소분자 FILL/FINISH 서비스 프로바이더의 상황

제7장 기업 개요 : 북미의 무균 FILL/FINISH 서비스 프로바이더

제8장 기업 개요 : 유럽의 무균 FILL/FINISH 서비스 프로바이더

제9장 기업 개요 : 아시아태평양의 무균 FILL/FINISH 서비스 프로바이더

제10장 파트너십과 협업

제11장 시장 규모의 평가와 기회 분석

제12장 사례 연구 : 의약품 포장용 로봇 공학

제13장 사례 연구 : 무균 FILL/FINISH용 READY-TO-USE 포장 부품

제14장 결론

제15장 이그제큐티브 인사이트

제16장 부록 1 : 표 형식 데이터

제17장 부록 2 : 기업·단체 리스트

KSA
영문 목차

영문목차

ASEPTIC FILL FINISH MANUFACTURING MARKET: OVERVIEW

As per Roots Analysis, the global aseptic fill finish manufacturing market is estimated to grow from USD 5.4 billion in the current year to USD 15 billion by 2035, at a CAGR of 9% during the forecast period, till 2035.

The market sizing and opportunity analysis has been segmented across the following parameters:

Type of Molecules

Type of Packaging Containers Offered

Type of Drug Products

Target Therapeutic Area

Scale of Operation

Company Size

Key Geographical Regions

ASEPTIC FILL FINISH MANUFACTURING MARKET: GROWTH AND TRENDS

Fill / finish is the final step in the downstream processing of a product, wherein the purified bulk formulation of the drug product is mixed with the necessary excipients and stabilizers and formulated and aliquoted into the appropriate dosage forms for clinical use or commercial distribution. These operations are usually carried out under aseptic conditions and are mostly automated. It is worth mentioning that aseptic fill finish manufacturing requires specialized automated equipment, clean room setup, skilled personnel, and continuous supervision to maintain the sterility and safety of the final drug product. Given the challenges associated with improper filling of drugs and to ensure the quality of end-products, innovators have developed a preference for outsourcing their aseptic fill / finish operations to contract service providers. Presently, contract fill-and-finish services are among the most outsourced services in the pharmaceutical domain. Driven by the growing trend of outsourcing, the opportunity within the aseptic fill / finish services market is anticipated to increase at a steady pace in the foreseen future.

ASEPTIC FILL FINISH MANUFACTURING MARKET: KEY INSIGHTS

The report delves into the current state of the aseptic fill finish manufacturing market and identifies potential growth opportunities within the industry. Some key findings from the report include:

Aseptic Fill Finish Manufacturing Market - IMG1
Aseptic Fill Finish Manufacturing Market - IMG2

ASEPTIC FILL FINISH MANUFACTURING MARKET: KEY SEGMENTS

Currently, Biologics Occupy the Largest Share of the Aseptic Fill Finish Manufacturing Market

Based on the type of molecule, the market is segmented into small molecules and biologics. At present, the biologic segment holds the maximum share of the aseptic fill finish manufacturing market. This trend is unlikely to change in the near future.

Syringes is the Fastest Growing Segment of the Aseptic Fill Finish Manufacturing Market

Based on the type of packaging container, the market is segmented into vials, syringes, ampoules, cartridges. Currently, vials hold the maximum share of the aseptic fill finish manufacturing market. It is worth highlighting that aseptic fill finish manufacturing market for syringes is likely to grow at a relatively higher CAGR.

Antibodies are Likely to Dominate the Aseptic Fill Finish Manufacturing Market During the Forecast Period

Based on the type of drug products, the market is segmented into vaccines, recombinant proteins, antibodies, oligonucleotides, gene therapies, cell therapies, other products. At present, antibodies hold the maximum share of the aseptic fill finish manufacturing market. This trend is likely to remain the same in the forthcoming years.

Oncological Disorders Account for the Largest Share of the Aseptic Fill Finish Manufacturing Market

Based on the therapeutic area, the market is segmented into autoimmune disorders, cardiovascular disorders, infectious disorders, oncological disorders, other disorders. While oncological disorders account for a relatively higher market share, it is worth highlighting that the autoimmune disorders segment is expected to witness substantial market growth in the coming years.

Based on the Scale of Operation, Commercial Scale is Likely to Dominate the Aseptic Fill Finish Manufacturing Market During the Forecast Period

Based on the scale of operation, the market is segmented into preclinical / clinical and commercial scale. Whilst commercial scale manufacturing will be the primary driver of the overall market, it is worth highlighting that the aseptic fill finish manufacturing market at preclinical / clinical scale is likely to grow at a relatively higher CAGR.

Large Companies Segment is the Fastest Growing Segment of the Aseptic Fill Finish Manufacturing Market During the Forecast Period

Based on the company size, the market is segmented into large, mid-sized and small companies. At present, large companies hold the maximum share of the aseptic fill finish manufacturing market. It is worth highlighting that the aseptic fill finish manufacturing market for small companies is likely to grow at a relatively higher CAGR.

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific and Rest of the World. Majority share is expected to be captured by players based in North America. It is worth highlighting that, over the years, the market in Asia-Pacific is expected to grow at a higher CAGR.

Example Players in the Aseptic Fill Finish Manufacturing Market

Primary Research Overview

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:

ASEPTIC FILL FINISH MANUFACTURING MARKET: RESEARCH COVERAGE

KEY QUESTIONS ANSWERED IN THIS REPORT

REASONS TO BUY THIS REPORT

ADDITIONAL BENEFITS

TABLE OF CONTENTS

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION

4. ASEPTIC FILL / FINISH SERVICE PROVIDERS LANDSCAPE

5. BIOLOGICS FILL / FINISH SERVICE PROVIDERS LANDSCAPE

6. SMALL MOLECULE FILL / FINISH SERVICE PROVIDERS LANDSCAPE

7. COMPANY PROFILES: ASEPTIC FILL / FINISH SERVICE PROVIDERS IN NORTH AMERICA

8. COMPANY PROFILES: ASEPTIC FILL / FINISH SERVICE PROVIDERS IN EUROPE

9. COMPANY PROFILES: ASEPTIC FILL / FINISH SERVICE PROVIDERS IN ASIA-PACIFIC

10. PARTNERSHIPS AND COLLABORATIONS

11. MARKET SIZING AND OPPORTUNITY ANALYSIS

12. CASE STUDY: ROBOTICS IN PHARMACEUTICAL PACKAGING

13. CASE STUDY: READY-TO-USE PACKAGING COMPONENTS FOR ASEPTIC FILL / FINISH

14. CONCLUDING REMARKS

15. EXECUTIVE INSIGHTS

16. APPENDIX 1: TABULATED DATA

17. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

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