Biopharmaceutical CMO And CRO Market Size, Share & Trends Analysis Report By Source (Mammalian, Non-mammalian), By Service (Contract Manufacturing, Contract Research), By Product, And Segment Forecasts, 2022 - 2030

Report Overview

The global biopharmaceutical CMO and CRO market size was valued at USD 29.4 billion in 2021 and is anticipated to grow at a compound annual growth rate (CAGR) of 6.6% over the forecast period. There was unprecedented growth in 2020 due to the COVID-19 pandemic. The rising investments in the biopharmaceutical industry by the prominent participants to enhance their productivity and efficiency have driven the bio manufacturers to increase their focus on outsourcing activities. Currently, biopharma companies have begun outsourcing the resource and capital-intensive steps and, in a few cases, the entire chain of biomanufacturing, thereby boosting the demand for contract-based services.

The coronavirus pandemic has resulted in disruptions in the supply chain of the overall pharmaceutical industry. However, the biopharmaceutical CMO & CRO has responded well to the outbreak as such organizations are the beneficiaries of supply chain disruptions. The CMOs and CROs based in the western hemisphere would especially benefit during the pandemic. For instance, the Australian government partnered with Sandoz and plans to provide an investment of around 50 million euros to spur the production of integrated antibiotics in Europe. Mergers and acquisitions help CMOs offer integrated bioprocessing services to their clients, which, in turn, makes CMOs/CROs an attractive and feasible option for the rapid product launch.

In recent years, the biopharmaceutical industry has witnessed a significant number of consolidations. These consolidations were mainly aimed at business expansion and to stay competitive in the biopharmaceutical contract manufacturing and services market. Although the biopharmaceutical CMO & CRO industry itself is relatively developed, the inception of new bioprocessing tools, novel therapeutics, and the priority shifts in the bio/pharmaceutical industry pertaining to products has increased the pressure on the contract biomanufacturers. As a result, CDMOs are adopting different business models for addressing the needs of their clients and stakeholders in the best possible way.  

Furthermore, the integration of single-use systems in production facilities helps the CMOs to economically expand the manufacturing capacity. The single-use products offer fast turnaround and limit allied activities, such as cleaning and changeover validation. However, the contract negotiations between CMOs and customers are observed to be difficult owing to the regulatory landscape and complexity of service. Clients and CMOs are facing issues pertaining to the IP rights, warranty & liabilities, prices & timelines, which increases the complexity of negotiations.

Source Insights

The mammalian segment held the highest market share of more than 55% in 2021 owing to the lack of internal expertise in the industry. This is attributed to their capabilities to add human-like post-translational modifications to complex protein therapeutics. Furthermore, the segment is greatly benefited from the introduction of novel and enhanced expression systems, improved process monitoring solutions, cell line engineering tools, automated screening methods, and disposable devices.

These developments have led to more productive and efficient manufacturing of biologics using mammalian cells. Non-mammalian cell lines, such as microbial cell lines, are recognized as potent factories. Innovative strategies are being implemented to identify and explore the potential of various microbes. This, in turn, is anticipated to contribute to the non-mammalian biopharmaceutical manufacturing segment.

Service Insights

The contract research segment is expected to exhibit the fastest CAGR of 7.5% over the forecast period owing to the increasing outsourcing of research activities by biopharmaceutical companies. A substantial number of CMOs and opportunistic CMOs present in the space are engaged in providing biopharma entities with plenty of services including end-to-end coverage from cell cultivation to fill/finish services. Furthermore, clients are investing heavily to outsource the manufacturing aspect of their product development program.

These factors have resulted in the largest share of this segment. On the other hand, CROs are striving to capitalize on the potential avenues in the industry. New market entrants and small-scale players, which are focused on the development of biopharmaceuticals are anticipated to opt for the contract research services for their discovery programs of new candidates, thereby boosting the segment growth.

Product Insights

The biologics segment dominated the market with the largest revenue share of over 81% in 2021. This growth is attributed to the high specificity of biologics, complex manufacturing steps, and a higher success rate as compared to other drug molecules. The use of single-use bioreactors, continuous purification processing, disposable plastic containers, and real-time quality analysis has enabled the CMOs to meet the increasing service demand for biologics production effectively.

Furthermore, several companies are investing in biosimilar development to outperform the safety, efficacy, disposition, or cost of earlier in-class innovator drugs. This has increased the level of competition amongst innovator manufacturers, which in turn, is likely to benefit the CMOs.

Regional Insight

North America held the largest revenue share of 33.97% in 2021. This can be attributed to the local presence of several service providers in the region. Also, a significant number of approved products in the U.S. are being manufactured by CMOs. The presence of several small- and mid-size biopharmaceutical entities (SMEs) lack the resources and budget to establish facilities with well-equipped resources. This, in turn, has increased an inter-dependency between CMOs and SMEs in the U.S., resulting in the dominance of the U.S. market. Asia Pacific is expected to grow at a significant CAGR during the forecast period.

The key reason for the rise in outsourcing in Asian countries includes cost-associated benefits, such as lower labor costs and operating costs across the region. India is anticipated to exhibit significant progress owing to the high volume of large molecule production in this country. The lack of global regulatory symmetry for biosimilar approval has significantly driven the Indian market. In 2016, there were 50 approved biosimilars in India, out of which only 24 were approved in Europe and 5 in the U.S.

Key Companies & Market Share Insights

The market is fragmented in nature due to the presence of a substantial number of developed as well as medium- to small-sized CMOs and CROs. Several market participants are privately held or are a part of private equity firms’ portfolios.The CMOs are integrating automation and innovative technologies at their plants to improve their capabilities in terms of project throughput and product quality. This has driven the interest of large molecule manufacturers in the CMOs to meet the growing demand for biologics.

Charles River Laboratories International, Inc.; PRA Health Sciences; ICON plc.; Pharmaceutical Product Development, LLC; LabCorp; and Parexel International Corporation are engaged in offering contract research services for large molecule production. Market players focus on various business strategies including mergers, acquisitions, product launches, etc. For instance, in December 2021, Discovery Life Sciences completed and announced the acquisition of In Vitro ADMET Laboratories (IVAL). With this move, the company aims to expand its skilled workforce allowing them to competently cater to the rising outsourcing of research activities.

In December 2021, Cerba HealthCare made a public announcement with regards to their acquisition of the Viroclinics-DDL group. With this, it has entered into the CRO space with special attention towards precision medicine for auto-immune diseases. In November 2021, Lonza published a press release stating their acquisition of the Exosomics Service Unit. This aims at increasing their capacity to develop and manufacture exosomes in the future. Some of the key players in the global biopharmaceutical CMO & CRO market are:

• Boehringer Ingelheim GmbH

• Lonza Group AG

• Inno Biologics Sdn Bhd

• Rentschler Biopharma SE

• JRS Pharma

• Biomeva GmbH

• ProBioGen AG

• Fujifilm Diosynth Biotechnologies U.S.A., Inc.

• Toyobo Co., Ltd.

• Samsung Biologics

• Patheon

• CMC Biologics

• WuXi Biologics

• AbbVie Inc.

• Binex Co., Ltd.

• Charles River Laboratories International, Inc.

• PRA Health Sciences

• Parexel International Corporation

Biopharmaceutical CMO & CRO Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For the purpose of this study, Grand View Research has segmented the global biopharmaceutical CMO & CRO market report on the basis of source, service, product, and region:

• Source Outlook (Revenue, USD Million, 2017 - 2030)

  • Mammalian

  • Non-mammalian

• Service Type Outlook (Revenue, USD Million, 2017 - 2030)

  • Contract Manufacturing

    • Process Development

      • Downstream

      • Upstream

    • Fill & Finish Operations

    • Analytical & QC Studies

    • Packaging

  • Contract Research

    • Oncology

    • Inflammation & Immunology

    • Cardiology

    • Neuroscience

    • Others

• Product Outlook (Revenue, USD Million, 2017 - 2030)

  • Biologics

    • Monoclonal antibodies (MAbs)

    • Recombinant Proteins

    • Vaccines

    • Antisense, RNAi, & Molecular Therapy

    • Others

  • Biosimilars

• Regional Outlook (Revenue, USD Million, 2017 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • China

    • India

    • Japan

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Colombia

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE