Biopharmaceutical CMO & CRO Market Size Report

Biopharmaceutical CMO & CRO Market Size Analysis Report By Source, By Service Type (Contract Manufacturing, Contract Research), By Product (Biologics, Biosimilars), And Segment Forecasts, 2019 - 2025

  • Published Date: May, 2019
  • Base Year for Estimate: 2018
  • Report ID: GVR-1-68038-500-7
  • Format: Electronic (PDF)
  • Historical Data: 2014 - 2017
  • Number of Pages: 240

Industry Insights

The global biopharmaceutical CMO & CRO market size was estimated at 22.47 billion in 2018 and is projected to expand at a CAGR of 7.7% during the forecast period. Rising investment in biopharmaceutical industry by the prominent participants to enhance their productivity and efficiency has driven the biomanufacturers to increase their focus on outsourcing activities. Currently, biopharma companies have begun outsourcing the resource and capital-intensive steps and in few cases, the entire chain of biomanufacturing, thereby boosting demand for contract based services.

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.

India biopharmaceutical market

Although the biopharmaceutical CMO and CRO industry itself is relatively developed, the inception of new bioprocessing tools, novel therapeutics, and the priority shifts in bio/pharmaceutical industry pertaining to products has resulted in an increase in the pressure on the contract biomanufacturers. As a result, Contract Development and Manufacturing Organizations (CDMOs) are adopting different business models for addressing their clients’ and stakeholders’ needs in the best possible way.

Furthermore, 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 is 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, and liabilities, prices and timelines which increases the complexity of negotiations.

Source Insights

Mammalian cell lines are estimated to be the dominant production systems for the manufacturing of large molecules. This is attributed to their capabilities to add human-like post-translational modifications to complex protein therapeutics. The segment is greatly benefited by the introduction of novel and robust enhanced expression systems, improved process monitoring solutions, cell line engineering tools, automated screening methods, and disposable devices. These developments have led to a more productive and efficient manufacturing of biologics using mammalian cells.

Non-mammalian cell lines such as microbial cell line are recognized as the 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 lucrative growth of non-mammalian biopharmaceutical manufacturing segment.

Service Type Insights

Currently, there are several entities in the marketplace which offer a wide range of services for biopharmaceutical manufacturing. The services range from research and discovery of candidate to final market launch of the product. A substantial number of CMOs and opportunistic CMOs present in the space are engaged in providing biopharma entities with plenty of services ranging 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 biopharmaceutical industry. New market entrants and small participants focused on the development of biopharmaceuticals, are anticipated to opt for the contract research services for their discovery programs of new candidates, thereby aiding revenue to the growth of contract research organizations.

Product Insights

Contract services are becoming an increasingly common cost-saving strategy for effective and reproducible manufacturing of large molecules including biologics and biosimilars. With the growing popularity of biological therapeutics for patient care, several conventional drug manufacturers are seeking for the opportunities to enter the biologics market

Global biopharmaceutical CMO & CRO market

The high specificity of biologics, complex manufacturing steps, and a higher success rate compared to other drug molecules, has resulted in the dominance of this segment. Application of single-use bioreactors, continuous purification processing, disposable plastic containers, and real-time quality analysis have enabled the CMOs to meet the increasing service demand for biologics production effectively.

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

Regional Insights

A significant number of approved products in U.S. are being manufactured by CMOs. 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 U.S., resulting in the dominance of the U.S. market.

Asia Pacific biopharmaceutical CMO & CRO market is expected to register the fastest CAGR during the forecast period. The key reason for the rise in outsourcing in Asian countries include cost-associated benefits, such as, lower labor costs and operating cost, across the region. India is anticipated to exhibit significant progress owing to the high volume of large molecule production in this country.

Lack of global regulatory symmetry for biosimilar approval has significantly driven Indian market. As of 2016, there were 50 approved biosimilars in India, out of which only 24 were approved in Europe and five in the U.S.

Biopharmaceutical CMO & CRO 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. Some key CMOs are Lonza; Rentschler Biotechnologie GmbH; Boehringer Ingelheim GmbH; JRS Pharma (Celonic GmbH); Inno Biologics Sdn Bhd; ProBioGen; BIOMEVA GmbH; FUJIFILM Diosynth Biotechnologies U.S.A., Inc.; Samsung BioLogics; TOYOBO CO., LTD; CMC Biologics; Patheon; AbbVie Inc.; Binex Co., Ltd.;and WuXi Biologics.

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. 

Report Scope

Attribute

Details

Base year for estimation

2018

Actual estimates/Historical data

2014 - 2017

Forecast period

2019 - 2025

Market representation

Revenue in USD Million and CAGR from 2019 to 2025

Regional scope

North America, Europe, Asia Pacific, Latin America, Middle East & Africa

Country scope

U.S., Canada, Germany, France, China, India, Brazil, South Africa

Report coverage

Revenue forecast, company share, competitive landscape, growth factors and trends

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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 2014 to 2025. 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, 2014 - 2025)

    • Mammalian

    • Non-mammalian

  • Service Type Outlook (Revenue, USD Million, 2014 - 2025)

    • 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, 2014 - 2025)

    • Biologics

      • Monoclonal Antibodies (MAbs)

      • Recombinant Proteins

      • Vaccines

      • Antisense, RNAi, & Molecular Therapy

      • Others

    • Biosimilars

  • Regional Outlook (Revenue, USD Million, 2014 - 2025)

    • North America

      • U.S.

      • Canada

    • Europe

      • Germany

      • France

    • Asia Pacific

      • China

      • India

    • Latin America

      • Brazil

    • Middle East & Africa

      • South Africa

Key questions answered by the report
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