Biopharmaceuticals Contract Manufacturing Market Report

Biopharmaceuticals Contract Manufacturing Market Analysis Report By Source, By Service (Process Development, Analytical & QC Studies), By Product (Biologics, Biosimilars), And Segment Forecasts, 2018 - 2025

  • Published Date: Sep, 2018
  • Base Year for Estimate: 2017
  • Report ID: GVR-2-68038-698-1
  • Format: Electronic (PDF)
  • Historical Data: 2014 - 2016
  • Number of Pages: 139

Report Overview

The global biopharmaceuticals contract manufacturing market size was valued at USD 12.14 billion in 2017 and is projected to exhibit a CAGR of 7.5% during the forecast period. The success of the biopharmaceutical market can be majorly attributed to contract manufacturers. Reduction in overall investment required to bring a new drug product to market, providing access to expensive technologies, quick entry of products in markets, and greater flexibility are some advantages offered by contract manufacturing organizations (CMOs). This has prompted several large companies to outsource their biopharmaceutical manufacturing operations.

India biopharmaceuticals contract manufacturing market size

With perpetual expansion of the biopharma industry, manufacturers are facing several issues such as lack of expertise and sophisticated equipment while practicing in-house manufacturing. The maturity of biotechnology and the availability of external funding has resulted in a spurt of early stage bio/pharma companies. These companies are recognized as core customers of CMOs as they lack capabilities for the development of robust manufacturing operations.

Along with significant expansions of established CMOs, such as Boehringer Ingelheim and Lonza, several additional competitors are making an entry in this high-volume CMO market. For instance, Samsung entered the biopharmaceutical CMO market as Samsung Biologics in 2013 and is expanding its bioreactor capacities for growth in the sector. This company owns three plants with a capacity of around 362,000 liters and is in the process of assessing the fourth plant, mostly outside South Korea.

Customers and CMOs are engaged in standardizing contract terms for making contract negotiations easy. This is to address issues pertaining to the regulatory landscape and the complexity of service. IP rights, warranty, and liabilities, prices, and timelines are major issues cited by CMOs and clients that are making negotiations inherently difficult.

Breakthrough technological advancements and innovations in bioprocessing have played a pivotal role in the progress of contract service providers by overcoming issues such as high production cost and need of changeover with every batch. Single-use bioprocessing systems are one of the most significant innovations as they help in reducing overall production and scale-up costs. Furthermore, fast turnaround offered by single-use products while limiting allied activities, such as changeover and cleaning validation, has supported the growth of CMOs to a major extent.

Mergers and acquisitions are one of the common strategies adopted in this market, as it helps CMOs offer integrated bioprocessing services to clients. This, in turn, makes them a more reliable option for a rapid product launch for commercial use.

However, large firms consider outsourcing perilous due to the loss of strategic control and limited management oversight. As a result, large pharma companies opt to maintain their manufacturing operations in-house. This, in turn, is expected to restrain the growth of CMOs to a certain extent in the foreseeable future.

Source Insights

Intensive investigation carried out on the usage of various sources and species for biopharmaceutical development is expected to drive the market. The main objective of these investigations is to enhance the productivity and efficiency of various sources for biopharmaceutical manufacturing.

Based on source, the market is bifurcated into mammalian and non-mammalian-based contract manufacturing. The mammalian-based segment dominated the market in 2017 owing to higher cost as well as the adoption rate of a mammalian system for biologics production. Companies engaged in providing contract services using mammalian cell culture include AbbVie Contract Manufacturing, AMRI, Avid Bioservices, Boehringer Ingelheim Biopharmaceuticals Gmbh, and Catalent Pharma Solutions.

In addition to this, a major percentage of biopharmaceutical products in the pipeline are mammalian expressed. Consequently, companies like Lonza and Charles River are making significant investments in the expansion of their mammalian cell culture manufacturing facilities for biologics and biosimilars. For instance, in October 2017, Lonza acquired a clinical-stage mammalian manufacturing site in the U.S. from Shire plc. The plant is equipped with single-use bioreactors of 1,000L and 2,000L capacities, coupled with downstream purification capabilities.

Non-mammalian cell line -E. Coli is recognized as a widely adopted non-mammalian cell culture for biopharmaceutical production owing to its rapid access and cost-effective cultivation. Development of transgenic non-mammalian expression systems holds great promise for the significant growth of this segment throughout the forecast period. Abbott Bioresearch, Avecia Biotechnology, BioReliance, Biovitrum AB, Dow Pharmaceutical, and Celltrion are some companies working as CMOs using microbial cultures.

Product Insights

Contract manufacturers have played a vital role in the success of both biologics and biosimilars. Biologics production by CMOs accounted for the larger revenue share in the biopharmaceuticals contract manufacturing market in 2017. This is majorly due to the massive commercial success of biologics, which is depicted through the presence of a large number of FDA-approved biologics in the market.

Global biopharmaceuticals contract manufacturing market share

Among all biologics, Monoclonal Antibodies (MAb) captured the largest share in 2017. Large capital requirement for the construction of a MAb plant has accelerated the uptake of contract services for MAb production, thereby contributing to the major share of this segment.

However, biosimilars production is considered as one of the key strategies for business expansion compared to biologics because investment in the former helps in fast market reach of biopharmaceuticals. Moreover, biosimilars have supported the biopharmaceutical CMO industry with respect to cost-saving advantages.

Service Insights

CMOs have provided biopharma players a wide array of services ranging from cell cultivation to final product packaging. Manufacturing services offered by CMOs include process development, fill and finish operations, analytical and QC studies, and packaging.

Process development services dominated the market in 2017 with respect to revenue, with downstream processing leading the segment. This is due to high capital expenditure in downstream processing. Moreover, downstream operations demand vigorous attention for final product recovery and purification steps in order to maintain product quality and prevent wastage.

With growing quality concerns and regulatory changes for biopharmaceutical development, analytical and QC studies are expected to grow lucratively during the forecast period. New regulations are being introduced for the production of biologics by CMOs in compliance with regulatory standards to maintain product purity and safety.

Regional Insights

With a high number of biomanufacturing facilities in the U.S., North America dominated the global market with the largest revenue share in 2017. Furthermore, biopharmaceutical-based R&D activities accounted for a major percentage of the total R&D carried out in various sectors in the U.S.

Asian countries are expected to emerge as attractive outsourcing locations for biomanufacturing of large molecules. Low manufacturing and operating costs offered by countries like China and India is a key factor driving the Asia Pacific market. Faster growth in the Korea market is expected to boost revenue generation in the APAC region. 

Biopharmaceuticals Contract Manufacturing Market Share Insights

Some of the key CMOs for large molecule production are Boehringer Ingelheim GmbH; Lonza; Inno Biologics Sdn Bhd; Rentschler Biotechnologie GmbH; JRS PHARMA; AGC Biologics; ProBioGen; FUJIFILM Diosynth Biotechnologies U.S.A., Inc.; TOYOBO CO., LTD; Samsung BioLogics; Thermo Fisher Scientific, Inc.; Binex Co., Ltd.; WuXi Biologics; and AbbVie, Inc.

These service providers are engaged in the expansion of manufacturing capabilities as well as establishing new services to meet growing demand from biopharmaceutical companies. Along with small players, these entities are also engaged in partnerships with established biopharma companies.

Biopharmaceuticals Contract Manufacturing Market Report Scope

Report Attribute


Market size value in 2020

USD 26,844.4 million

Revenue forecast in 2025

USD 21.7 billion

Growth Rate

CAGR of 7.5% from 2018 to 2025

Base year for estimation


Historical data

2014 - 2016

Forecast period

2018 - 2025

Quantitative units

Revenue in USD million and CAGR from 2018 to 2025

Report coverage

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

Segments covered

Type, product, delivery mode, raw material, region

Regional scope

North America; Europe; Asia Pacific; Latin America; MEA

Country scope

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

Key companies profiled

GmbH; Lonza; Inno Biologics Sdn Bhd; Rentschler Biotechnologie GmbH; JRS PHARMA; AGC Biologics; ProBioGen; FUJIFILM Diosynth Biotechnologies U.S.A., Inc.; TOYOBO CO., LTD; Samsung BioLogics; Thermo Fisher Scientific, Inc.; Binex Co., Ltd.; WuXi Biologics; AbbVie, Inc.

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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 biopharmaceuticals contract manufacturing market report on the basis of source, service, product, and region:

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

    • Mammalian

    • Non-mammalian

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

    • Process Development

      • Downstream

      • Upstream

    • Fill & Finish Operations

    • Analytical & QC Studies

    • Packaging

  • 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

      • The U.S.

      • Canada

    • Europe

      • Germany

      • France

    • Asia Pacific

      • China

      • India

    • Latin America

      • Brazil

    • Middle East & Africa

      • South Africa

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