바이오의약품 수탁제조 시장 : 세계 전망과 예측(2022-2027년)
Biopharmaceutical Contract Manufacturing Market - Global Outlook & Forecast 2022-2027
상품코드 : 1111861
리서치사 : Arizton Advisory & Intelligence
발행일 : 2022년 08월
페이지 정보 : 영문 382 Pages
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한글목차

세계의 바이오의약품 수탁제조 시장 규모는 예측기간 2022-2027년에 14.37%의 CAGR로 확대될 것으로 예측됩니다.

세계의 바이오의약품 수탁제조(Biopharmaceutical Contract Manufacturing) 시장에 대해 조사했으며, 시장 개요와 함께 제품 종류별, 생물제제별, 발현 시스템별, 사업 규모별, 기업 규모별, 기술별, 지역별 동향 및 시장에 참여하는 기업 개요 등을 제공합니다.

목차

제1장 조사 방법

제2장 조사 목적

제3장 조사 과정

제4장 범위와 적용 범위

제5장 보고서 가정과 주의사항

제6장 시장 개요

제7장 서론

제8장 주요 인사이트

제9장 시장 기회와 동향

제10장 시장 성장 촉진요인

제11장 시장 성장 억제요인

제12장 시장 상황

제13장 제품

제14장 생물제제

제15장 발현 시스템

제16장 사업 규모

제17장 기업 규모

제18장 지역

제19장 북미

제20장 유럽

제21장 아시아태평양

제22장 라틴아메리카

제23장 중동 및 아프리카

제24장 경쟁 상황

제25장 주요 기업 개요

제26장 주목할 만한 주요 기업

제27장 기타 저명한 벤더

제28장 보고서 개요

제29장 정량적 요약

제30장 부록

KSM 22.08.23
영문 목차

영문목차

The biopharmaceutical contract manufacturing market is expected to grow at a CAGR of 14.37% during 2022-2027.

Biopharmaceutical companies rely on contract manufacturing organizations (CMOs) to provide capabilities and skills as needed. The CMO has provided most of the company's production in some cases. The market is mainly growing owing to the uptake of branded biologics and biosimilars, mandatory immunization programs for newborns and children to prevent a wide range of diseases, and ongoing global covid-19 vaccine programs to curb the spread of the pandemic.

Biopharmaceutical manufacturing comprises advanced technology, new scientific advances, and highly complex research and development (R & D) companies. A contract manufacturing organization (CMO), also known as a contract development and manufacturing organization (CDMO), is a company that provides the pharmaceutical industry with contract-based drug development and drug manufacturing services. With time, the CMO provides pharmaceutical and biopharmaceutical manufacturers with one of the essential assets in today's fast-paced world. By outsourcing the manufacturing process, pharmaceutical and biopharmaceutical manufacturers can prioritize internal capabilities and free up the internal resources needed to improve process efficiency.

The CMO gave several reasons for the optimistic outlook. These reasons include increasing small, well-funded virtual biotechnology companies, increasing demand for manufacturing services that support cell and gene therapy, and more robust growth in Asia.

MARKET TRENDS AND DRIVERS

Robust Biopharmaceuticals Pipeline

Cell & Gene therapies are emerging as one of the most dynamic fields in medicine with an increased number of ongoing research and development activities. Many vendors and research organizations are engaged in the R&D of cell & gene therapies. The key vendors increasingly conduct clinical trials to gain regulatory approval in the United States with largely untapped potential.

The pipeline for biosimilars continues to grow with the FDA approval of 30 biosimilars and 21 biosimilars launched in the US by July 2021. The total number of biosimilars in the pipeline database grew by 208% in 2020. The number of marketed biosimilars also increased by 226% in the past seven years. The present number of biosimilars in the preclinical phase in 2020 vs. 2013 has increased similarly by 200%. By 2018, the European Union had approved more than 40 biosimilars, and many went on to be commercialized successfully in Australia, Canada, Japan, and South Korea.

Increase in Manufacturing of cell and gene therapy

In the past several years, Gene therapies have continued their rising trend in the biopharmaceutical industry. Biopharma companies are investing in these therapies, and the FDA has encouraged gene therapy development. As gene therapies cost time and money to develop and manufacture, many biopharmaceutical companies are turning to CMOs. For biopharmaceutical companies with no practical manufacturing experience, adopting an established CMO can reduce these operational risks and reduce the manufacturing time. This can be achieved by leveraging the CMO's expertise and skills in installing facilities and navigating regulatory systems.

Biologics Manufacturing Outsourcing by Pharma and Biotech Companies

Larger and more established companies continue to look for partners to outsource established products to free up internal capacity for new and upcoming developments in the pipeline. This trend is not so surprising. Pharma R&D Outsourcing helps enterprises save on resources, infrastructure, and other overhead.

SMEs are still a significant source of innovation, with an active pipeline of products under development. Many SMEs do not have the manufacturing capacity and often do not plan to develop these core competencies, so they want to move their products to the clinical stage and ultimately to commercial manufacturing operations.

Overall, pharmaceutical and biotechnology companies' decision to outsource manufacturing directly impacts the contract manufacturing market for bio pharmacy. In this analysis, CMO customers are categorized into

a) companies that do not do in-house biomanufacturing (virtual companies)

b) companies with in-house biomanufacturing.

For virtual businesses, outsourcing all production is usually part of the overall corporate strategy. Most virtual businesses lack the resources and products to justify ownership of a manufacturing facility. On the other hand, companies with organic production bases or resources to build internal capabilities are adopting different production strategies depending on the specific situation and strategy.

A Surge in Manufacturing Capacity Expansion Post Covid by CDMOs and CMOs

Over the next three years, the total capacity will increase by 60% as the CMO invests to meet future demand. Most of this new capacity supports the production of mammalian cell cultures. Given these expansion plans, capacity utilization rates remain in the low 70% range throughout the forecast period.

In addition to expanding production capacity, CMOs invest in other services to meet future customers' needs. CMO plans to invest heavily in manufacturing, analytical, new research centers, and productivity and quality improvements in cell and gene therapy.

The expansion includes a new GMP cleanroom for mRNA development and production, a new process development laboratory for microbial protein and cell and gene therapy (C& GT) projects and additional storage capacity. Expanded capabilities will enable CDMOs to meet the growing demands of the fast-growing C> market.

The new facility is one of several announced or ongoing biomanufacturing investments by Fujifilm Diosynth. In December 2021, the company announced plans to invest the US $533 million to include a viral gene therapy facility and a mammalian cell culture facility in Billingham, Teesside, UK. The new facility is scheduled to be ready by the end of 2023. This investment is part of the $ 977 million global investment package that the company first outlined in June 2021.

In January 2022, Samsung Biologics will begin constructing new manufacturing facilities for C& GT and vaccines using messenger RNA (mRNA), plasmid DNA (pDNA), viral vectors in one place, and multimodal products such as gene therapy and vaccines. The facility complements the RNA vaccine manufacturing facility currently being added to the existing facility in Matsushima, South Korea, and is scheduled to be ready earlier this year (2022).

Product Launches & Regulatory Approvals

Vendors strategically focus on developing and marketing single-use bioprocessing products to remain competitive and gain a foothold in the market. Product approvals and launches, coupled with R&D activities, help vendors to expand their footprint, drive market growth, and maintain their position in the US gene therapy market. Vendors are also aggressively bringing innovative, advanced therapies to penetrate and harness the tremendous growth potential of the market.

MARKET SEGMENTATION

Segmentation by Product Type

Segmentation by Biologics

Segmentation by Expression System

Segmentation by Scale Of Operations

Segmentation by Company Size

GEOGRAPHICAL ANALYSIS

Segmentation by Geography

COMPETITIVE LANDSCAPE

Key Vendors

Key Companies

Other Prominent Vendors

KEY QUESTIONS ANSWERED

TABLE OF CONTENTS

1 RESEARCH METHODOLOGY

2 RESEARCH OBJECTIVES

3 RESEARCH PROCESS

4 SCOPE & COVERAGE

5 REPORT ASSUMPTIONS & CAVEATS

6 MARKET AT A GLANCE

7 INTRODUCTION

8 PREMIUM INSIGHTS

9 MARKET OPPORTUNITIES & TRENDS

10 MARKET GROWTH ENABLERS

11 MARKET RESTRAINTS

12 MARKET LANDSCAPE

13 PRODUCT

14 BIOLOGICS

15 EXPRESSION SYSTEM

16 SCALE OF OPERATIONS

17 COMPANY SIZE

18 GEOGRAPHY

19 NORTH AMERICA

20 EUROPE

21 ASIA PACIFIC

22 LATIN AMERICA

23 MIDDLE EAST AND AFRICA

24 COMPETITIVE LANDSCAPE

25 KEY COMPANY PROFILES

26 KEY COMPANIES TO WATCH

27 OTHER PROMINENT VENDORS

28 REPORT SUMMARY

29 QUANTITATIVE SUMMARY

30 APPENDIX

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