Biopharmaceutical CMO & CRO Market Report

Biopharmaceutical CMO & CRO Market Analysis By Source (Mammalian, Non-mammalian), By Service Type (Contract Manufacturing, Contract Research), By Product, And Segment Forecasts, 2014 - 2025

Published: July 2017  |  210 Pages  |  Format: PDF  |  Report ID: GVR-1-68038-500-7

Industry Insights

The global biopharmaceutical CMO & CRO (contract manufacturing & research) market size was estimated at 18,088.9 million in 2016. With significant growth in biologics pipeline, biopharmaceutical industry is facing drought of manufacturing facilities. Contract services have emerged as a panacea to overcome the issues of manufacturing capacity.

These services are growing and becoming more strategic, targeted, and better planned. Many new facilities and expansions are recently established, underway, and planned. These factors are expected to play pivotal role in enhancing the share of CMOs/CROs in the overall biopharmaceutical market.

Germany biopharmaceutical market, by contract manufacturing service, 2014 - 2025 (USD Million)

Germany biopharmaceutical market

Several biopharmaceutical firms are engaged in strategic outsourcing relationships with CMO partners. The goal of this partnership is to focus on core competencies as well as to have access to skilled expertise and robust analytical tools.

Outsourcing solutions are recognized as “strategic competitive weapon” within the biopharmaceutical sphere owing to the advantages offered by CMOs/CROs. Ability of these services to shorten development timelines and to overcome budget constraints, the demand for CMO services continues to grow.

Growing demand for outsourcing has led CMOs/CROs to make significant capital investments for capacity expansions. CMOs & CROs are observed to be more responsive than before to accommodate the needs of biopharmaceutical arena.

Previously, number of existing outsourcing services for large molecules was relatively less owing to the lack of matured bioproduction technologies. However, in current scenario, the biopharmaceutical outsourcing market is observed to be at the threshold of transformation by providing technologies and solutions for entire biopharmaceutical process chain.

Initiatives are undertaken to address the contract negotiations related issues between CMOs/CROs and clients. Both parties are engaged in standardizing the contract terms to avoid the frequent need for negotiations on new contracts.

However, several well-stablished players and big pharma clients are observed to keep the bioproduction process in-house. This is mainly due to the fact that large molecules production is technologically complex.

Moreover, these companies are expanding their in-house biologic development capabilities. These factors are expected to impede the market growth up to certain extent throughout the forecast period.

Source Insights

Growing mammalian system titers and yields have resulted in the large share of mammalian cell line-based manufacturing systems. Prominent entities are engaged in expansion of their mammalian-based production system by establishing new mammalian -based facilities. In addition, usage of transgenic mammalian cell lines for biopharmaceutical development have generated ample of opportunities for the progress of this segment.

Microbial cell line-based platforms are expected to be source of lucrative revenue generation in this space. This can be attributed to the ongoing technological advancements in the bioprocessing such as introduction of next-generation single-use microbial bioreactors.

Service Type Insights

Contract manufacturing dominated the market share in 2016 owing to the availability of wide range of services ranging from cell cultivation to fill/finish activities. CMOs and opportunistic CMOs in the market place are engaged in capitalizing the generated avenues by establishing new plants and expanding existing facilities. Contract manufacturing solutions range from cell line development to packaging solutions.

Cumulative R&D expenditure in the biopharmaceutical sector is expected to generate lucrative opportunities for the growth of contract research services in the coming years. With respect to therapeutic area, contract research services for oncology captured the largest share owing to the presence of substantial number of cancer biopharmaceuticals in pipeline.

Product Insight

CMOs & CROs are anticipated to create a new benchmark for the effective and reproducible production of biopharmaceuticals including biologics and biosimilars. Growing acceptance of biologics and high production cost of these products have led to the large share of biologics outsourcing. Monoclonal Antibodies (MAbs) held the largest share owing to the presence large number of approved MAbs for clinical practice.

In addition, traditional drug developers are making strategic alliances with CMOs to build their MAbs portfolio. For instance, in January 2015, Sanofi and Boehringer Ingelheim signed an alliance that projected toward the extension of Sanofi’s manufacturing capacity network for therapeutic MAbs.

Ability of relatively lower-priced biosimilars to reduce patients out-of-pocket spending is driving the segment growth. Moreover, owing to the cost saving advantage of biosimilar many entities are geared toward the development of products for this segment.

Global biopharmaceutical CMO & CRO market size by region, 2016 (%)

Global biopharmaceutical CMO & CRO market

Regional Insights

U.S is estimated to have the largest number of biomanufacturing facilities, which in turn, has resulted in the largest share of North America region. Moreover, presence of effective regulatory bodies to monitor the overall biopharmaceutical development process to ensure the product safety and efficacy is driving the regional market of North America.

Presence of low-cost manufacturing centers in the Asian countries such as India and China have driven significant attention from global biopharma companies to outsource their biomanufacturing process in these countries. These countries accelerate biopharmaceuticals production at lower manufacturing and operating cost.

In addition, conducting clinical trials in Asian countries such as India is relatively less expensive compared to western countries. As a consequence of these factors, this region is expected to emerge as the fastest growing regional market throughout the forecast period.

Competitive Insights

Some of the key participants in the space include Lonza; Boehringer Ingelheim GmbH; Rentschler Biotechnologie GmbH; Inno Biologics Sdn Bhd; JRS Pharma (Celonic GmbH); BIOMEVA GmbH; ProBioGen; FUJIFILM Diosynth Biotechnologies U.S.A., Inc.; TOYOBO CO., LTD; Samsung BioLogics; Patheon; CMC Biologics; Binex Co., Ltd.; AbbVie Inc.; and WuXi Biologics. Capacity expansions and investments are one of the major strategic initiative undertaken by these prominent leaders to enhance their share in the market.

Report Scope

Attribute

Details

Base year for estimation

2016

Actual estimates/Historical data

2014 - 2016

Forecast period

2017 - 2025

Market representation

Revenue in USD Million and CAGR from 2017 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

15% free customization scope (equivalent to 5 analyst working days)

If you need specific market information, which is not currently within the scope of the report, we will provide it to you as a part of customization


Segments covered in the report

This report forecasts revenue growth at global, regional & country levels and provides an analysis on the 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 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

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