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Biologics Contract Manufacturing Market: Industry Trends and Global Forecasts, Till 2035 - Distribution by Type of Service(s) Offered, Biologic Manufactured, Expression System Used, Scale of Operation, Company Size, and Key Geographical Regions
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Biologics Contract Manufacturing Market: Overview

As per Roots Analysis, the global biologics contract manufacturing market is estimated to grow from USD 23.8 billion in the current year to USD 55.0 billion by 2035, at a CAGR of 8.8% during the forecast period, till 2035.

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

Type of Service Offered

Type of Biologic Manufactured

Type of Expression System Used

Scale of Operation

Company Size

Geographical Regions

Biologics Contract Manufacturing Market: Growth and Trends

The biologics contract manufacturing sector has seen significant growth in recent years due to the several benefits offered by biological products, such as specificity, efficacy and safety. It is worth mentioning that the biopharmaceutical industry has witnessed a shift from small-molecule drugs to complex biologics like monoclonal antibodies, vaccines, cell and gene therapies, and biosimilars. In fact, the USFDA approved over 50 biological products (including monoclonal antibodies and recombinant proteins) in 2024. This growing pipeline of new therapies, coupled with the increasing number of biologics approvals, drives the demand for external manufacturing capacity.

Despite the success of biopharmaceutical products, producing biologics is technically challenging and requires significant capital investment in specialized facilities, equipment, and expertise, such as long development timelines, regulatory and compliance-related issues, and inconsistencies related to the quality attributes of the final product. As a result, an increasing number of biopharmaceutical drug developers are relying on contract manufacturers for comprehensive solutions, encompassing bioprocess development and optimization. With outsourcing becoming increasingly recognized as a practical and advantageous business model in this sector, substantial market growth for biologics contract manufacturing is expected throughout the forecast period.

Biologics Contract Manufacturing Market: Key Insights

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

Biologics Contract Manufacturing Market - IMG1
Biologics Contract Manufacturing Market - IMG2
Biologics Contract Manufacturing Market - IMG3

Biologics Contract Manufacturing Market: Key Segments

Contract Manufacturing Market for API is Likely to Dominate the Biologics Contract Manufacturing Market During the Forecast Period

Based on the type of service(s) offered, the market is segmented into API and FDF. It is worth highlighting that majority of the current biologics contract manufacturing market is captured by APIs. This can be attributed to the fact that manufacturing of biopharmaceuticals API demand significant capital investments, which include facility costs (development and maintenance), material costs, labor costs and a number of other ancillary expenses. Therefore, stakeholders rely on the expertise of CMOs for API production.

Cell Therapies is the Fastest Growing Segment of the Biologics Contract Manufacturing Market During the Forecast Period

Based on the type of biologic manufactured, the market is segmented into antibodies, cell therapies, vaccines and other biologics. It is worth highlighting the antibodies capture the maximum share within the biopharmaceutical contract manufacturing market. This can be attributed to the fact that more than 100 antibodies have been approved across the globe and an increasing number of clinical trials related to antibodies are also underway.

Mammalian Expression System is Expected to Capture the Highest Share of the Biologics Contract Manufacturing Market During the Forecast Period

Based on the type of expression system used, the market is segmented into mammalian, microbial and others. It is worth highlighting that currently, the market is likely to be driven by revenues generated through biopharmaceutical projects employing mammalian expression systems. This can be attributed to the higher usage of such systems owing to their high protein yielding ability, enhanced folding and post-translational modifications, and improved batch-to-batch uniformity.

By Scale of Operation, Commercial Scale is Likely to Dominate the Biologics Contract Manufacturing Market During the Forecast Period

Based on the scale of operation, the market is segmented into preclinical / clinical and commercial scale. The commercial scale manufacturing segment is projected to be the primary driver of the overall market. Further, it is worth highlighting that the biologics manufacturing market at preclinical / clinical scale is likely to grow at a relatively higher CAGR.

Large and Very Large Companies Hold Maximum Share within the Biologics Manufacturing Market

Based on company size, the market is segmented into small companies, mid-sized, and large and very large companies. While large and very large companies account for a relatively higher market share, it is worth highlighting that the biologics contract manufacturing market for small companies is likely to witness substantial market growth in the coming years.

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, Middle East and North Africa, and Latin 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 Biologics Contract Manufacturing Market

Primary Research Overview

Biologics Contract Manufacturing Market: Research Coverage

Key Questions Answered in this Report

Reasons to Buy this Report

Additional Benefits

TABLE OF CONTENTS

1. PREFACE

1.1. Biopharmaceutical Contract Manufacturing Market Overview

2. RESEARCH METHODOLOGY

3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS

4. EXECUTIVE SUMMARY

5. INTRODUCTION

6. MARKET LANDSCAPE

7. REGIONAL CAPABILITY ANALYSIS

8. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN NORTH AMERICA

9. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN EUROPE

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

11. NICHE BIOPHARMACEUTICAL SECTORS

12. CASE STUDY: OUTSOURCING OF BIOSIMILARS

13. CASE STUDY: COMPARISON OF SMALL AND LARGE MOLECULE DRUGS / THERAPIES

14. CASE STUDY: IN-HOUSE MANUFACTURING

15. MAKE VERSUS BUY DECISION MAKING FRAMEWORK

16. BIG PHARMA INITIATIVES

17. PARTNERSHIPS AND COLLABORATIONS

18. MERGERS AND ACQUISITIONS

19. RECENT EXPANSIONS

20. RECENT DEVELOPMENTS

21. CAPACITY ANALYSIS

22. DEMAND ANALYSIS

23. TOTAL COST OF OWNERSHIP FOR BIOPHARMACEUTICAL CONTRACT MANUFACTURING ORGANIZATIONS

24. GLOBAL BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET

25. BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY TYPE OF SERVICE OFFERED

26. BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY TYPE OF BIOLOGIC MANUFACTURED

27. BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY TYPE OF EXPRESSION SYSTEM USED

28. BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY SCALE OF OPERATION

29. BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY COMPANY SIZE

30. BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY GEOGRAPHY

31. BIOPHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY LEADING PLAYERS

32. CASE STUDY: VIRTUAL PHARMACEUTICAL COMPANIES

33. SWOT ANALYSIS

34. FUTURE OF THE BIOPHARMACEUTICAL CMO MARKET

35. CONCLUSION

36. EXECUTIVE INSIGHTS

37. APPENDIX I: TABULATED DATA

38. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

39. APPENDIX III: DETAILS OF PARTNERSHIPS AND COLLABORATIONS

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