Biologics Contract Manufacturing Market Industry Trends and Global Forecasts to 2035 - ResearchAndMarkets.com

The "Biologics Contract Manufacturing Market Industry Trends and Global Forecasts to 2035, by Type of Service Offered, Type of Biologic Manufactured, Type of Expression System Used, Scale of Operation, Company Size and Key Geographical Regions" report has been added to ResearchAndMarkets.com's offering.

The global biologics contract manufacturing market is estimated to grow from USD 22.2 billion in the current year to USD 58 billion by 2035, at a CAGR of 9.12% during the forecast period to 2035.

Given the benefits offered by biological products, such as specificity, efficacy and safety, it has captured the attention of both industry stakeholders and patients. In fact, in 2023, the USFDA approved 17 biological products (including monoclonal antibodies and recombinant proteins). In addition, currently, several biologics are being investigated across different geographies for a myriad of disease indications, including immunological, oncological and rare disorders.

Despite the success of biopharmaceutical products, the production of biologics is a complex and cost intensive process coupled with multiple challenges, such as long development timelines, a high rate of attrition of pipeline drugs / therapies, 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 end-to-end solutions, including bioprocess development and optimization. As outsourcing gains wider acceptance as a practical and advantageous business model in this sector, the global market for biologics contract manufacturing is anticipated to experience significant growth 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 the industry. Some key findings from the report include:

• Currently, more than 305 contract manufacturing organizations (CMOs) are engaged in the production of biologics; over 90% of such players provide FDF manufacturing services.
• Around 70% of the stakeholders operate at all scales of operation to cater to the diverse needs of customers; notably, mammalian cell-based expression systems have emerged as a popular choice among CMOs.
• The competition among service providers that claim to be focused on the niche and upcoming drug classes is fierce; it is primarily influenced by the success of several blockbuster therapies in the recent past.
• In the past decade, a shift in trend has been observed in the biopharmaceutical contract manufacturing industry as more players have set up their manufacturing facilities in developing regions across Asia-Pacific.
• Over the last five years, more than 695 deals have been inked by biologics CMOs; most of the collaborations were inked for the manufacturing of vaccines, antibodies and cell therapies.
• In order to maintain a competitive edge and establish themselves as one-stop-shops, players are expanding their existing capabilities and service portfolios; the domain has witnessed over 135 mergers and acquisitions.
• Considering the enormous opportunities associated with biologics contract manufacturing, investors have actively extended funds, amounting to USD 7.5 billion, across more than 90 funding instances in the past eight years.
• Driven by the growing demand, CMOs have made elaborate investments to expand their existing capacities and capabilities, primarily for niche biologics; this trend is most pronounced in the US and China.
• More than 215 initiatives were undertaken by big pharma players; more than 80% of such initiatives were focused on partnerships and expansions.
• Though the existing installed capacity is sufficient to meet the current annual demand for biologics, we anticipate that CMOs are likely to invest in installing incremental capacity to meet the long-term demand.
• The global installed biopharmaceutical contract manufacturing capacity is spread across various geographies; notably, large players account for 80% of the total capacity.
• With the growing pipeline of biologics and the increased preference for outsourcing, the biopharmaceutical contract manufacturing services market is anticipated to witness steady growth in the foreseen future.
• As more developers outsource various aspects of their respective manufacturing operations, we expect the biologics CMOs market to grow at an annualized rate of over 9% in the coming decade.

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. Whilst commercial scale manufacturing is projected to be the primary driver of the overall market, 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.

Key Players in the Biologics Contract Manufacturing Market

• AGC Biologics
• Boehringer Ingelheim
• Catalent
• Cell Therapies
• Charles River Laboratories
• FUJIFILM Diosynth Biotechnologies
• KBI Biopharma
• Kemwell Biopharma
• Lonza
• Miltenyi Biotec
• Minaris Regenerative Medicine
• Samsung Biologics
• Sandoz
• Vetter Pharma
• Wuxi Biologics

REASONS TO BUY THIS REPORT

• The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
• Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
• The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

ADDITIONAL BENEFITS

• Complimentary PPT Insights Packs
• Complimentary Excel Data Packs for all Analytical Modules in the Report
• 10% Free Content Customization
• Detailed Report Walkthrough Session with Research Team

Key Topics Covered:

1. PREFACE

2. RESEARCH METHODOLOGY

3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS

4. EXECUTIVE SUMMARY

5. INTRODUCTION

6. MARKET LANDSCAPE

6.1. Chapter Overview

6.2. Biopharmaceutical Contract Manufacturers: Overall Market Landscape

7. REGIONAL CAPABILITY ANALYSIS

8. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN NORTH AMERICA

8.1. Chapter Overview

8.2. Biopharmaceutical Contract Manufacturing in the US: Regulatory Scenario

8.3. Leading Biopharmaceutical CMOs in North America

• AGC Biologics
• Catalent
• FUJIFILM Diosynth Biotechnologies
• KBI Biopharma
• Charles River Laboratories

8.4. Other Leading Biopharmaceutical CMOs in North America

• Cytiva
• Patheon
• Piramal Pharma Solutions

9. BIOPHARMACEUTICAL CONTRACT MANUFACTURING IN EUROPE

9.1. Chapter Overview

9.2. Biopharmaceutical Contract Manufacturing in Europe: Regulatory Scenario

9.3. Leading Biopharmaceutical CMOs in Europe

• Boehringer Ingelheim (BioXcellence)
• Lonza
• Sandoz
• Vetter Pharma
• Miltenyi Biotec

9.4. Other Leading Biopharmaceutical CMOs in Europe

• Novasep
• Olon
• Rentschler Biopharma

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

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