Worldwide Biopharmaceutical Contract Manufacturing Industry to 2030 - Featuring 3P Biopharmaceuticals, 53 Biologics and Adagene Among Others

DUBLIN, Aug. 10, 2021 /PRNewswire/ -- The "Biopharmaceutical Contract Manufacturing Market by Type of Product, Scale of Operations, Expression System, Company Size, Biologics and Key Geographical Regions - Industry Trends and Global Forecast to 2030" report has been added to ResearchAndMarkets.com's offering.

This report features an extensive study on the contract service providers within the biopharmaceutical industry. The study features in-depth analyses, highlighting the capabilities of a diverse set of biopharmaceutical CMOs and contract development and manufacturing organizations (CDMOs).

Over the years, the rising popularity of biologics has led to a paradigm shift in healthcare. In the last decade alone, the annual number of approvals of biopharmaceuticals, by the US FDA, have steadily risen. In fact, in 2019, a total of 28 biopharmaceutical products (including monoclonal antibodies, recombinant proteins and gene therapies) were approved in the US. Further, over 8,000 biological pharmaceutical products are currently under clinical investigation, across the world. Given the evident benefits (including high efficacy, target specificity and favorable safety profiles) of biologics over small molecule drugs, the biopharma market is poised to witness continued and consistent growth over the next several years. However, biologics production is a complex and capital-intensive process fraught with a wide range of challenges. Some of key concerns of contemporary innovators include the rate of attrition of pipeline drugs/therapies, prolonged development timelines, complex molecular structure (which demand niche and specialized expertise), current facility limitations and capacity constraints, and safety and efficacy-related issues.

Given the technical and operational challenges outlined above, an increasing number of drug developers have demonstrated the preference to outsource various parts of their biologics manufacturing operations. The landscape of contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) market, specifically those that claim to have biologics-related capabilities, features a mix of large, mid-sized and small companies. As a result of several mergers and acquisitions, the market is now fairly consolidated with a number of established players operating as one-stop-shops. Moreover, since the biopharmaceutical sector is amongst the most highly regulated industries in the world, biopharma CMOs, specifically those offering regulatory assistance, are perceived as attractive strategic partners (especially to the smaller developer companies). With outsourcing being increasingly accepted as a viable and beneficial business model within the biopharmaceutical industry, we anticipate the biologics manufacturing services market to grow at a steady pace in the coming years.

Amongst other elements, the report includes:

• A detailed review of the overall landscape of the biopharmaceutical contract manufacturing market, featuring an elaborate list of active CMOs, along with information on a number of relevant parameters, such as year of establishment, company size, location of headquarters, types of biologics manufactured (peptides/proteins, antibodies, vaccines, cell therapies, gene therapies, antibody drug conjugates, vectors, biosimilars, nucleic acids and others), scale of operation (preclinical, clinical and commercial), types of expression systems used (mammalian, microbial and others), type of bioreactor used (single-use bioreactors and stainless steel bioreactors), mode of operation of bioreactors (batch, fed-batch and perfusion), bioprocessing capacity and type of packaging.
• A detailed landscape of the biopharmaceutical manufacturing facilities established across the key geographical regions (North America, Europe, Asia-Pacific and Rest of the World), and including an analysis based on the location of these facilities, highlighting key manufacturing hubs for biologics.
• Elaborate profiles of key players that claim to have a diverse range of capabilities related to the development, manufacturing and packaging of biologics. Each profile provides an overview of the company, its financial performance (if available), information related to its service portfolio, manufacturing facilities, and details on partnerships, recent developments (expansions), as well as an informed future outlook.
• 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.
• A case study on the growing global biosimilars market, highlighting the associated opportunities for biopharmaceutical CMOs and CDMOs.
• 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.
• 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.
• A qualitative analysis, highlighting the various factors that need to be taken into consideration by biopharmaceutical therapeutics/drug developers while deciding whether to manufacture their respective products in-house or engage the services of a CMO.
• A review of the various biopharmaceutical based manufacturing initiatives undertaken by big pharma players (shortlisted on the basis of the revenues generated by the top 10 pharmaceutical companies in 2019), highlighting trends across various parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation, types of biologics manufactured and type of product.
• An analysis of the recent collaborations (signed since 2015) focused on the contract manufacturing of biologics, based on various parameters, such as the year the agreement was signed, type of agreement, focus area, types of biologics manufactured, therapeutic area and geographical regions.
• A detailed analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired during 2015-2020, along with the geographical distribution of this activity. The analysis also depicts the relationship between important deal multiples (based on revenues), number of employees and experience of the acquired company.
• A detailed analysis of the recent expansions undertaken (since 2015) by various service providers for augmenting their respective biopharma contract manufacturing service portfolios, based on a number of parameters, including year of expansion, purpose of expansion (capacity expansion and new facility), types of biologics manufactured, geographical location of facility, and most active players (in terms of number of instances).
• An analysis of the recent developments within the biopharmaceutical contract manufacturing industry, highlighting information on the funding and technology advancements related to biomanufacturing.
• A detailed capacity analysis, taking into consideration the individual development and manufacturing capacities of various stakeholders (small, mid-sized, large and very large CMOs/CDMOs) engaged in the market, using data from both secondary and primary research. The study examines the distribution of global biopharmaceutical manufacturing capacity by scale of operation (preclinical/clinical, commercial), company size (small, mid-sized, large and very large), and geography (North America (the US and Canada), Europe (Italy, Germany, France, Spain, the UK and rest of Europe), Asia-Pacific (China, India, Japan, South Korea and Australia), Latin America, Middle East and North Africa).
• An informed estimate of the annual demand for biologics, taking into account the top 25 biologics, based on various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products.
• 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 pharmaceutical industry.
• A survey analysis featuring inputs solicited from various experts who are directly/indirectly involved in providing contract manufacturing services to biopharmaceutical developers.

Key Topics Covered:

1. PREFACE

2. EXECUTIVE SUMMARY

3. INTRODUCTION

4. COMPETITIVE LANDSCAPE
4.1. Chapter Overview
4.2. Biopharmaceutical Contract Manufacturers: Overall Market Landscape
4.2.1. Analysis by Year of Establishment
4.2.2. Analysis by Company Size
4.2.3. Analysis by Location of Headquarters
4.2.4. Analysis by Type of Product
4.2.5. Analysis by Types of Biologics Manufactured
4.2.6. Analysis by Scale of Operation
4.2.7. Analysis by Types of Expression Systems Used
4.2.8. Analysis by Type of Bioreactors
4.2.9. Analysis by Mode of Operation of Bioreactors

5. MANUFACTURING FACILITIES OF BIOPHARMACEUTICAL CONTRACT MANUFACTURING ORGANIZATIONS (CMOs)
5.1. Chapter Overview
5.2. Key Assumptions and Methodology
5.3. Overall Landscape of Biopharmaceutical Contract Manufacturing Facilities
5.3.1. Analysis by Type of Product
5.3.2. Analysis by Scale of Operation
5.3.3. Analysis by Type of Expression System Used
5.4. Biopharmaceutical Contract Manufacturing Facilities in North America
5.5. Biopharmaceutical Contract Manufacturing Facilities in Europe
5.6. Biopharmaceutical Contract Manufacturing Facilities in Asia-Pacific

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
10.1. Chapter Overview
10.2. Biosimilars: An Introduction
10.3. Biosimilars: Development Stages
10.4. Regulatory Requirements for Licensing of Biosimilars
10.5. Need for Outsourcing Biosimilar Development and Manufacturing
10.6. Impact of Biosimilars on the Global Contract Manufacturing Market
10.6.1. Pipeline Analysis of Biosimilars, 2013 versus 2020
10.7. Biosimilars Contract Manufacturing Service Providers
10.8. Challenges Associated with Outsourcing of Biosimilar Manufacturing Operations

11. CASE STUDY: COMPARISON OF SMALL AND LARGE MOLECULES DRUGS / THERAPIES
11.1. Chapter Overview
11.2. Small Molecule and Large Molecule Drugs / Therapies
11.2.1. Comparison of General Characteristics
11.2.2. Comparison of Key Specifications
11.2.3. Comparison of Manufacturing Process
11.2.4. Comparison of Key Manufacturing Challenges

12. CASE STUDY: IN-HOUSE MANUFACTURING
12.1. Chapter Overview
12.2. In-House Manufacturing
12.2.1. Benefits Associated with In-House Manufacturing
12.2.2. Risks Associated with In-House Manufacturing
12.3. Outsourcing in the Biopharmaceutical Industry
12.3.1. Types of Outsourcing Partners
12.4. Manufacturing Approaches Used for Approved Biologics (2016-2020)
12.4.1. Approved Biologics: Analysis by Company Size and Type of Manufacturing Model Adopted
12.4.2. Approved Biologics: Analysis by Company Size and Types of Biologics
12.5. Choosing the Right Strategy: In-House Manufacturing versus Outsourcing

13. MAKE VERSUS BUY DECISION MAKING FRAMEWORK
13.1. Chapter Overview
13.2. Assumptions and Key Parameters
13.3. Biopharmaceutical Contract Manufacturers: Make versus Buy Decision Making
13.3.1. Scenario 1
13.3.2. Scenario 2
13.3.3. Scenario 3
13.3.4. Scenario 4
13.4. Conclusion

14. BIG PHARMA INITIATIVES
14.1. Chapter Overview
14.2. List of Biopharmaceutical Manufacturing Initiatives of Big Pharma Players
14.2.1. Analysis by Number of Initiatives
14.2.2. Analysis by Year of Initiative
14.2.3. Analysis by Purpose of Initiative
14.2.4. Analysis by Type of Initiative
14.2.4.1. Analysis by Type of Partnership
14.2.4.2. Analysis by Type of Expansion
14.2.5. Analysis by Scale of Operation
14.2.6. Analysis by Types of Biologics Manufactured
14.2.7. Analysis by Year of Initiative and Company
14.2.8. Analysis by Purpose of Initiative and Company
14.2.9. Analysis by Year and Type of Initiative
14.2.10. Analysis by Type of Region of Expansion and Company
14.2.11 Analysis by Types of Biologics Manufactured and Company
14.3. Competitive Benchmarking of Big Pharma Players
14.3.1. Harvey Ball Analysis: Big Pharma Investment Summary

15. PARTNERSHIPS AND COLLABORATIONS

16. MERGERS AND ACQUISITIONS

17. RECENT EXPANSIONS

18. RECENT DEVELOPMENTS

19. CAPACITY ANALYSIS

20. DEMAND ANALYSIS

21. MARKET SIZING AND OPPORTUNITY SIZING

22. SWOT ANALYSIS

23. FUTURE OF THE BIOPHARMACEUTICAL CMO MARKET

24. SURVEY ANALYSIS

25. INTERVIEW TRANSCRIPTS

26. APPENDIX 1: TABULATED DATA

27. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Companies Mentioned

• 3P Biopharmaceuticals
• 3SBio
• 53 Biologics
• A.R. BROWN
• Aalto Scientific
• Labyrinth BioPharma (Formely known as AB BioTechnologies)
• AbbVie Contract Manufacturing
• AbCellera Biologics
• Abeona Therapeutics
• ABL
• ABL Bio
• Abzena
• Acasti Pharma
• Accellta
• ACES Pharma
• Achilles Therapeutics
• Acticor Biotech
• Adagene
• Adaptimmune
• AdaptVac
• ADC Bio
• Adimmune
• Advanced Biotherapeutics Consulting
• Advanced Cell Technology
• Advanced Scientifics (Acquired by Thermo Fisher Scientific)
• Advanced Therapy Treatment Centre (ATTC)
• Advaxis
• Advent Bioservices
• Aeras
• Affibody
• Affinita Biotech
• Affinity Life Sciences
• Affymetrix
• Afton Scientific
• AGC Biologics
• Agilis Biotherapeutics
• Agilux Laboratories
• Airway Therapeutics
• Ajinomoto Althea
• Ajinomoto Bio-Pharma Services
• Ajinomoto OmniChem
• Akorn
• Akouos
• Akron Biotech
• Akshaya Bio
• Alcami
• Aldevron
• Alexion
• Allele Biotechnology & Pharmaceuticals
• Allevi
• Alliance Protein Laboratories APL (Acquired by KBI Biopharma)
• Alligator Bioscience
• Almac Group
• Altor BioScience
• Amaran Biotechnology
• Amatsigroup (Acquired by Eurofins)
• AmbioPharm
• American Peptide Company (Acquired by Bachem)
• Amgen
• And Many More Companies!

For more information about this report visit https://www.researchandmarkets.com/r/wjh06o

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