Global Biopharmaceutical Contract Manufacturing Markets, 2022-2035: Focus on Niche Therapeutic Areas, Integration/Adoption of Innovative Technologies, Increase in Financial Inflow and Budgets

DUBLIN, Nov. 3, 2022 /PRNewswire/ -- The "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" report has been added to  ResearchAndMarkets.com's offering.

The "Biopharmaceutical Contract Manufacturing Market" 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.

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, biologics manufacturing 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 (such as biologics manufacturing). In fact, currently over 275 companies claim to be biopharma CDMO / biopharma CMO, 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 (biopharma CDMO / biopharma CMO) to grow at a commendable pace in the coming years.

Scope of the Report

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.

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.

Our year-wise projections of the current and future opportunity have further been segmented 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)
• Key geographical regions (North America, Europe, Asia-Pacific, Latin America and MENA).

Key Questions Answered

• Who are the key players engaged in offering contract manufacturing services for biopharmaceuticals?
• What are the different partnerships and expansion initiatives undertaken by biopharmaceutical contract manufacturers in the recent past?
• Which regions represent the current key contract manufacturing hubs for biopharmaceuticals?
• What is the current, installed capacity for contract manufacturing of biopharmaceuticals?
• What is the current, global demand for biologics? How is the demand for such candidates likely to evolve in the foreseen future?
• What percentage of the biopharmaceuticals manufacturing operations are presently outsourced?
• What factors should be taken into consideration while deciding whether the manufacturing operations for biopharmaceuticals should be kept in-house or outsourced?
• How is the current and future opportunity likely to be distributed across key market segments?

Future of the Biopharmaceutical CMOs Market

• Outsourcing Activities to Witness Significant Growth in the Coming Years
• Shift from One-time Contracts to Strategic Partnerships
• Integration / Adoption of Innovative Technologies
• Focus on Niche Therapeutic Areas
• Growing Biosimilars Market to Contribute to the Growth of the Contract Services Segment
• Capability and Expertise Expansions by CMOs to become One-Stop-Shops
• Offshoring Outsourcing Activities to Maximize Profits and Expand Existing Capacities
• Increase in Financial Inflow and Outsourcing Budgets
• Challenges Faced by both Sponsors and Service Providers
• Concluding Remarks

Leading Biopharmaceutical CMOs

Leading Biopharmaceutical CMOs in North America 

• AGC Biologics
• Catalent (Catalent Pharma Solutions)
• Cytiva (GE Healthcare)
• FUJIFILM Diosynth Biotechnologies
• KBI Biopharma
• Patheon (acquired by Thermo Fisher Scientific)
• Piramal Pharma Solutions

Leading Biopharmaceutical CMOs in Europe 

• Boehringer Ingelheim (BioXcellence)
• Lonza
• Novasep
• Olon
• Rentschler Biopharma
• Sandoz

Leading Biopharmaceutical CMOs in China 

• WuXi Biologics

Leading Biopharmaceutical CMOs in India

• Kemwell Biopharma

Leading Biopharmaceutical CMOs in Japan

• Minaris Regenerative Medicine
• Takara Bio

Biopharmaceutical Contract Manufacturing in South Korea

• Celltrion
• Samsung BioLogics

Leading Biopharmaceutical CMOs in Australia

• Cell Therapies
• Luina Bio

Key Topics Covered:

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

For more information about this report visit https://www.researchandmarkets.com/r/8ibnim

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