pc 버전으로 이동 중 [시장보고서]세계의 바이오의약품 수탁 생산 시장 : 제공되는 서비스 유형별, 생산되는 생물학적 제제 유형별, 사용되는 발현계 유형별, 사업 규모별, 기업 규모별, 주요 지역별 - 업계 동향과 예측(2022-2035년)
세계의 바이오의약품 수탁 생산 시장 : 제공되는 서비스 유형별, 생산되는 생물학적 제제 유형별, 사용되는 발현계 유형별, 사업 규모별, 기업 규모별, 주요 지역별 - 업계 동향과 예측(2022-2035년)
Biopharmaceutical Contract Manufacturing Market by Type of Service Offered, Type of Biologic Manufactured, Type of Expression System Used, Scale of Operation, Company Size, and Key Geographical Regions : Industry Trends and Global Forecasts, 2022 - 2035
상품코드 : 1130891
리서치사 : Roots Analysis
발행일 : 2022년 09월
페이지 정보 : 영문 799 Pages
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한글목차

바이오의약품 수탁 생산(Biopharmaceutical Contract Manufacturing) 시장에 대해 조사분석했으며, 현재 시장 구도와 향후 10년간의 가능성, 주요 성장요인과 동향, 주요 기업 등에 대한 최신 정보를 제공합니다.

목차

제1장 서문

제2장 개요

제3장 서론

제4장 시장 구도

제5장 지역 생산능력 분석

제6장 북미의 바이오의약품 수탁 생산

제7장 유럽의 바이오의약품 수탁 생산

제8장 아시아태평양 및 기타 지역의 바이오의약품 수탁 생산

제9장 틈새 바이오의약품 부문

제10장 사례 연구 : 바이오시밀러 아웃소싱

제11장 사례 연구 : 저분자·고분자 의약품/치료 비교

제12장 사례 연구 : 사내 생산

제13장 생산 vs. 구입 의사결정 프레임워크

제14장 대형 제약회사의 이니셔티브

제15장 파트너십과 협업

제16장 인수합병(M&A)

제17장 최근 확장

제18장 최근 발전

제19장 생산능력 분석

제20장 수요 분석

제21장 바이오의약품 수탁 생산 조직의 총소유비용

제22장 시장 예측과 기회 분석

제23장 사례 연구 : 가상 제약 기업

제24장 SWOT 분석

제25장 바이오의약품 CMO 시장의 미래

제26장 조사 분석

제27장 결론

제28장 인터뷰 기록

제29장 부록 I : 표 형식 데이터

제30장 부록 II : 기업/조직 리스트

LSH 22.10.13
영문 목차

영문목차

INTRODUCTION

Over the last few decades, the development landscape of small molecule drugs has been significantly impacted by various biotechnology breakthroughs. Further, with the advent of novel technologies, biologics have made a significant impact in the pharmaceutical domain, delivering ground-breaking treatment for a myriad of disease indications, including immunological, oncological and rare disorders. In this context, it is worth highlighting those 14 biopharmaceutical products (including cell therapies, gene therapies, monoclonal antibodies and recombinant proteins) were approved in the US alone, in 2021. Further, promising results from ongoing clinical research initiatives have encouraged various government and private firms to make significant investments in this domain. For instance, in 2021, a sum of over USD 70 billion was invested in the cell and gene therapy domain. However, manufacturing of biologics is fraught with various challenges. Some of the key concerns of contemporary innovators include rate of attrition of pipeline drugs / therapies, prolonged development timelines, current facility limitations, regulatory and compliance-related issues, and inconsistencies related to quality attributes of the final product. Therefore, therapy developers are actively exploring avenues that enable them to overcome the existing challenges. Amongst other alternatives, outsourcing has emerged as a lucrative option for biologic drug developers.

Currently, a significant number of players engaged in the biopharmaceutical domain prefer to outsource various operations to contract service providers. In fact, currently over 275 companies claim to offer contract manufacturing services for biologic therapeutics, in compliance with the regulatory standards. It is also worth highlighting that biopharmaceutical contract manufacturers are actively trying to consolidate their presence in this field by entering into strategic alliances in order to meet the indubitably rising demand for biologics. For this purpose, substantial expansions, and mergers and acquisitions have been reported in this market, as service providers strive to become one-stop-shops, to cater to the diverse needs of their clientele. With outsourcing being increasingly accepted as a viable and beneficial business model within this field, we anticipate the biopharmaceutical contract manufacturing market to grow at a commendable pace in the coming years.

SCOPE OF THE REPORT

The "Biopharmaceutical Contract Manufacturing Market by Type of Service(s) Offered (API, FDF), Type of Biologic Manufactured (Antibodies, Cell Therapies, Vaccines and Other Biologics), Type of Expression System Used (Mammalian, Microbial and Others), Scale of Operation (Preclinical / Clinical and Commercial), Company Size (Small, Mid-sized, and Large and Very Large), and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America and MENA): Industry Trends and Global Forecasts, 2022 - 2035" report features an extensive study of the current market landscape and the likely future potential associated with the biopharmaceutical contract manufacturing market, over the next decade.

The study also includes a detailed analysis of key drivers and trends within this evolving market. Amongst other elements, the report features:

One of the key objectives of the report was to estimate the existing market size and estimate the future size of biopharmaceutical contract manufacturing market. We have provided informed estimates on the evolution of the market, over the period 2022-2035. Our year-wise projections of the current and future opportunity have further been segmented on the basis of [A] type of service(s) offered (API, FDF), [B] type of biologic manufactured (antibodies, cell therapies, vaccines and other biologics), [C] type of expression system used (mammalian, microbial and others), [D] scale of operation (preclinical / clinical and commercial), [E] company size (small, mid-sized, and large and very large), and [F] key geographical regions (North America, Europe, Asia-Pacific, Latin America and MENA).

In order to account for future uncertainties associated with some of the key parameters and to add robustness to our forecast model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic tracks of the market's evolution.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

KEY QUESTIONS ANSWERED

CHAPTER OUTLINES

Chapter 2 is an executive summary of key insights captured during our research. It offers a high-level view on the current state of biopharmaceutical contract manufacturing market and its likely evolution in the short to mid-term and long-term.

Chapter 3 provides a general introduction to biopharmaceuticals and biopharmaceutical manufacturing processes. The chapter also includes an overview of the various expression systems used for the development of different types of biotherapeutic products. It features a brief overview of contract manufacturing, along with a detailed discussion on the need for outsourcing within the biopharmaceutical industry. Furthermore, it provides information on the challenges faced by players currently engaged in this domain.

Chapter 4 provides a detailed assessment of the current market landscape of companies engaged in offering contract manufacturing services for biologics, including a detailed analysis based on several relevant parameters, such as year of establishment, company size (based on number of employees), location of headquarters, type of service(s) offered (API and FDF manufacturing), type of biologic manufactured (ADCs, antibodies, biosimilars, cell therapies, gene therapies, nucleic acids / oligonucleotides, plasmid DNA / viral vectors, proteins / peptides, vaccines and others), scale of operation (preclinical, clinical and commercial), type of expression system used (mammalian, microbial and others), type of bioreactor used (single use, stainless steel and others) and mode of operation of bioreactor (batch, fed batch and perfusion / continuous).

Chapter 5 provides a detailed landscape of the biopharmaceutical manufacturing facilities established across the key geographical regions (North America, Europe, Asia-Pacific and Rest of the World), highlighting the manufacturing hubs for biologics.

Chapter 6 provides elaborate profiles of key industry players based in North America that offer contract manufacturing services for biologics. Each profile features a brief overview of the company, details related to its biologic-related service portfolio, manufacturing facilities, recent developments, and an informed future outlook.

Chapter 7 provides elaborate profiles of key industry players based in Europe that offer contract manufacturing services for biologics. Each profile features a brief overview of the company, details related to its biologic-related service portfolio, manufacturing facilities, recent developments, and an informed future outlook.

Chapter 8 provides elaborate profiles of key industry players based in Asia-Pacific that offer contract manufacturing services for biologics. Each profile features a brief overview of the company, details related to its biologic-related service portfolio, manufacturing facilities, recent developments, and an informed future outlook.

Chapter 9 provides a detailed discussion on the key enablers in this domain, including certain niche product classes, such as antibody drug conjugates (ADCs), bispecific antibodies, cell therapies, gene therapies and viral vectors, which are likely to have a significant impact on the growth of the contract services market.

Chapter 10 presents a case study on the growing global biosimilars market, highlighting the associated opportunities for biopharmaceutical CMOs and CDMOs.

Chapter 11 presents a case study comparing the key characteristics of small and large molecule drugs, along with details on the various steps involved in their respective manufacturing processes.

Chapter 12 provides a detailed discussion on the benefits and challenges associated with in-house manufacturing, featuring a brief overview of the various parameters that a drug / therapy developer may need to take into consideration while deciding whether to manufacture its products in-house or outsource the production operations.

Chapter 13 presents a qualitative analysis, highlighting various factors that need to be taken into consideration by biopharmaceutical developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.

Chapter 14 provides a review of the various biopharmaceutical-focused manufacturing initiatives undertaken by top 10 big pharma players (shortlisted on the basis of 2021 revenues), highlighting trends across various parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation and type of biologic manufactured.

Chapter 15 presents an analysis of the recent collaborations within the biopharmaceutical contract manufacturing industry, based on several relevant parameters, such as year of partnership, type of partnership, type of biologic manufactured, therapeutic area, most active players (in terms of number of deals inked) and regional distribution of partnership activity that have taken place in this domain, during the period 2015-2022.

Chapter 16 provides a detailed analysis of the various mergers and acquisitions that have taken place within this domain, during the period 2015-2022, based on several relevant parameters, such as year of agreement, type of deal, geographical location of companies, type of acquisition, type of biologic manufactured and key value drivers.

Chapter 17 presents a detailed review of expansion initiatives undertaken by biopharmaceutical contract manufacturers, during the period 2016-2022, along with information on several relevant parameters, such as year of expansion, purpose of expansion, type of biologic manufactured and location of expanded facility.

Chapter 18 presents an analysis of the recent developments within the biopharmaceutical contract manufacturing industry, highlighting information on the funding investments made during the period 2016-2022, along with information on the technology advancements related to biomanufacturing.

Chapter 19 provides an estimate of the overall, installed capacity for the manufacturing of biopharmaceuticals, based on information reported by various industry stakeholders in the public domain, highlighting the distribution of the available capacity, based on size of manufacturer (small, mid-sized, and large and very large), scale of operation (preclinical, clinical and commercial), type of expression system used (mammalian, microbial and others) and geography (North America, Europe, Asia-Pacific and Rest of the World).

Chapter 20 presents an informed estimate of the annual demand for biologics, taking into account the top 20 biologics, based on various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products.

Chapter 21 presents a company size-wise, detailed analysis of the total cost of ownership for biopharmaceuticals contract manufacturing organizations, during the period 2022-2042.

Chapter 22 presents an insightful market forecast analysis, highlighting the future potential of biopharmaceutical contract manufacturing market till 2035. We have segmented the market on the basis of type of service(s) offered (API, FDF), type of biologic manufactured (antibodies, cell therapies, vaccines and other biologics), type of expression system used (mammalian, microbial and others), scale of operation (preclinical / clinical and commercial) , company size (small, mid-sized, and large and very large), and key geographical regions (North America, Europe, Asia-Pacific, Latin America and MENA).

Chapter 23 presents a case study on the virtual business model concept, along with its role in the overall biopharmaceutical industry. It also features a discussion on the advantages and risks / challenges associated with outsourcing operations from virtual service providers.

Chapter 24 provides a discussion on affiliated trends, key drivers and challenges, under an elaborate SWOT framework, which are likely to impact the industry's evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall biopharmaceutical industry.

Chapter 25 features an elaborate discussion on the future opportunities / trends within the biopharmaceutical contract manufacturing market that are likely to influence the growth of this domain over the coming years.

Chapter 26 provides a survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing contract manufacturing services to biopharmaceutical developers.

Chapter 27 is a summary of the entire report. It provides the key takeaways and presents our independent opinion of the biopharmaceutical contract manufacturing market, based on the research and analysis described in the previous chapters.

Chapter 28 is a collection of transcripts of interviews conducted with various stakeholders in the industry.

Chapter 29 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 30 is an appendix, which provides the list of companies and organizations mentioned in the report.

TABLE OF CONTENTS

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION

4. MARKET LANDSCAPE

5. REGIONAL CAPABILITY ANALYSIS

6. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN NORTH AMERICA

7. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN EUROPE

8. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN ASIA-PACIFIC AND THE REST OF THE WORLD

9. NICHE BIOPHARMACEUTICAL SECTORS

10. CASE STUDY: OUTSOURCING OF BIOSIMILARS

11. CASE STUDY: COMPARISON OF SMALL AND LARGE MOLECULES DRUGS / THERAPIES

12. CASE STUDY: IN-HOUSE MANUFACTURING

13. MAKE VERSUS BUY DECISION MAKING FRAMEWORK

14. BIG PHARMA INITIATIVES

15. PARTNERSHIPS AND COLLABORATIONS

16. MERGERS AND ACQUISITIONS

17. RECENT EXPANSIONS

18. RECENT DEVELOPMENTS

19. CAPACITY ANALYSIS

20. DEMAND ANALYSIS

21. TOTAL COST OF OWNERSHIP FOR BIOPHARMACEUTICAL CONTRACT MANUFACTURING ORGANIZATIONS

22. MARKET FORECAST AND OPPORTUNITY ANALYSIS

23. CASE STUDY: VIRTUAL PHARMACEUTICAL COMPANIES

24. SWOT ANALYSIS

25. FUTURE OF THE BIOPHARMACEUTICAL CMO MARKET

26. SURVEY ANALYSIS

27. CONCLUSION

28. INTERVIEW TRANSCRIPTS

29. APPENDIX I: TABULATED DATA

30. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

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