Biopharmaceuticals Contract Manufacturing Market Size, Share & Trends Report

Biopharmaceuticals Contract Manufacturing Market Size, Share & Trends Analysis Report By Source (Mammalian, Non-mammalian), By Product (Biologics, Biosimilars), By Service (Process Development), And Segment Forecasts, 2021 - 2028

  • Published Date: Jan, 2021
  • Base Year for Estimate: 2020
  • Report ID: GVR-2-68038-698-1
  • Format: Electronic (PDF)
  • Historical Data: 2016 - 2019
  • Number of Pages: 139

Report Overview

The global biopharmaceuticals contract manufacturing market size was valued at USD 15.8 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 5.7% during the forecast period. The success of the biopharmaceutical market can be majorly attributed to the contract manufacturers. Reduction in the overall investment required to bring a new drug product to market, providing access to expensive technologies, quick entry of products in the markets, and greater flexibility are some advantages offered by Contract Manufacturing Organizations (CMOs), which have prompted the companies to outsource their biopharmaceutical manufacturing. Furthermore, with a perpetual expansion of the biopharmaceutical industry, companies are facing production issues, such as lack of expertise and sophisticated equipment, while practicing in-house manufacturing.

India biopharmaceuticals contract manufacturing market size, by service, 2016-2028 (USD Million)

The maturity of biotechnology and the availability of external funding has resulted in the growth in the number of early-stage bio/pharma companies. These companies are recognized as core customers of CMOs as these organizations lack the capabilities for the development of robust manufacturing operations. Key players are going for capacity expansion to fulfill the growing demand. For instance, in 2020, Thermo Fisher Scientific announced an investment of USD 180.0 million for the construction of a new commercial manufacturing site in Plainville, Mass for viral vector development and manufacturing services. In 2019, Boehringer Ingelheim invested USD 84 million for the expansion in Mexico to increase production.

The customers and CMOs are engaged in standardizing agreement terms for making contract negotiations easy. This is to address the issues pertaining to the regulatory landscape and the complexity of service delivery. IP rights, warranty & liabilities, prices & timelines are major issues cited by CMOs and clients, which are making negotiations innately difficult. Breakthrough technological advancements and innovations in bioprocessing have played a pivotal role in the progress of contract service providers by overcoming the manufacturing issues, such as high production cost and the need for changeover with every batch. Single-use bioprocessing systems are one of the most significant innovations as it helps in reducing the overall production and scale-up costs.

Furthermore, the 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, acquisitions, and joint ventures are among the common strategies observed across the industry, as they help CMOs offer integrated bioprocessing services, which, in turn, makes them a more reliable option for a rapid product launch for commercial use. However, large-scale firms consider outsourcing perilous due to the loss of strategic control and limited management oversight. As a result, major pharma companies opt to maintain in-house manufacturing operations. This is expected to challenge the growth of CMOs to a certain extent.

Service Insights

Process development services led the global market in 2020 and accounted for a share of over 33%. This is due to high capital expenditure in downstream processing. Moreover, downstream operations demand vigorous attention for final product recovery and purification steps to maintain product quality and prevent wastage.

CMOs have provided biopharma players with a wide array of services ranging from cell cultivation to final packaging of the product. The manufacturing services offered by CMOs are process development, fill & finish operations, analytical & QC studies, and packaging.

With the growing quality concerns and regulatory changes for biopharmaceutical development, the analytical & QC studies segment is expected to record the fastest CAGR 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.

Product Insights

Although, contract manufacturers have played a vital role in the success of both biologics and biosimilars; the biologics product segment led the market in 2020 with a share of over 80%. The segment will maintain the dominant position throughout the forecast period due to the huge commercial success of biologics, which is depicted through the presence of a large number of FDA-approved biologics in the market.

Among all the biologics, Monoclonal Antibodies (MAb) have captured the largest share in 2020. A high capital requirement for the construction of a MAb plant has accelerated the uptake of contract services for Mab production, thereby contributing to the segment’s growth.

However, the biosimilars segment is estimated to register the fastest CAGR over the forecast period. This is because biosimilars production is one of the key strategies for business expansion as investments in biosimilars manufacturing helps in the fast market reach of the biopharmaceuticals. Moreover, biosimilars have supported the biopharmaceutical CMO industry with respect to cost-saving advantages.

Source Insights

The mammalian source segment led the market in 2020 and accounted for the highest share of over 59%. An intensive investigation that is being carried out on the usage of various source and species for biopharmaceutical development is expected to drive the market growth. The main objective of these investigations is to enhance the productivity and efficiency of biopharmaceutical manufacturing. A major percentage of biopharmaceutical products that are in pipeline are mammalian expressed, hence the segment will retain the leading position over the forecast period as well.

Key companies are making significant investments in the expansion of their mammalian cell culture manufacturing facilities for biologics and biosimilar development. For instance, in October 2017 Lonza acquired a clinical-stage mammalian manufacturing site in the United States from Shire plc. The plant is equipped with single-use bioreactors of 1,000L and 2,000L capacities, coupled with downstream purification capabilities. Some of the prominent companies engaged in providing contract service using mammalian cell culture include AbbVie Contract Manufacturing, AMRI, Avid Bioservices, Boehringer Ingelheim Biopharmaceuticals GmbH, and Catalent Pharma Solutions.

Global biopharmaceuticals contract manufacturing market share, by source, 2020 (%)

The non-mammalian source segment is estimated to register the fastest CAGR from 2021 to 2028. Non-mammalian cell line -E. Coli is recognized as the widely adopted non-mammalian cell culture for biopharmaceutical production owing to its easy access and cost-effective cultivation. The development of a transgenic non-mammalian expression system holds great promise for the significant growth of this segment during the forecast period. Abbott Bioresearch, Avecia Biotechnology, BioReliance, Biovitrum AB, Dow Pharmaceutical, and Celltrion are few companies working as CMOs using microbial cultures.

Regional Insights

With a high number of biomanufacturing facilities in the U.S., North America dominated the global market and held the largest revenue share of over 33% in 2020. Furthermore, revenue from biopharmaceutical-based R&D activities held a major percentage out of the total R&D carried out in various sectors in the U.S. However, Asia Pacific is expected to emerge as the fastest-growing regional market from 2021 to 2028. Low manufacturing and operating costs in countries like China and India are some of the key factors driving the regional market. Faster growth in the Korean market is also expected to boost revenue generation from the APAC region.

Key Companies & Market Share Insights

Key service providers are engaged in the expansion of their manufacturing capabilities as well as establishing new services to meet the growing demand of biopharmaceutical companies. All the major biopharmaceutical firms have a wide-ranging product pipeline and are investing in developing new products. For instance, more than 60,000 clinical trials were registered globally in 2018. It is challenging for biopharmaceutical players to carry out a regulatory-compliant manufacturing process solely depending on in-house capacities. This, in turn, is driving the demand for biopharmaceutical contract manufacturing of potential drug candidates. Some of the key companies in the global biopharmaceuticals contract manufacturing market 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

  • AbbVie, Inc.

Biopharmaceuticals Contract Manufacturing Report Scope

Report Attribute

Details

Market size value in 2021

USD 17.0 billion

Revenue forecast in 2028

USD 25.1 billion

Growth rate

CAGR of 5.7% from 2021 to 2028

Base year for estimation

2020

Historical data

2016 - 2019

Forecast period

2021 - 2028

Quantitative units

Revenue in USD million/billion and CAGR from 2021 to 2028

Report coverage

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

Segments covered

Source, service, product, region

Regional scope

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

Country scope

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

Key companies profiled

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; AbbVie, Inc.

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Segments Covered in the Report

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2028. 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, 2016 - 2028)

    • Mammalian

    • Non-mammalian

  • Service Outlook (Revenue, USD Million, 2016 - 2028)

    • Process Development

      • Downstream

      • Upstream

    • Fill & Finish Operations

    • Analytical & QC Studies

    • Packaging

  • Product Outlook (Revenue, USD Million, 2016 - 2028)

    • Biologics

      • Monoclonal Antibodies (MABs)

      • Recombinant Proteins

      • Vaccines

      • Antisense, RNAi, & Molecular Therapy

      • Others

    • Biosimilars

  • Regional Outlook (Revenue, USD Million, 2016 - 2028)

    • North America

      • U.S.

      • Canada

    • Europe

      • Germany

      • France

    • Asia Pacific

      • China

      • India

    • Latin America

      • Brazil

    • Middle East & Africa

      • South Africa

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