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

Industry Insights

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.

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 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 development of robust manufacturing operations.

India biopharmaceuticals contract manufacturing market

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 regulatory landscape and 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 rapid product launch for commercial use.

However, large firms consider outsourcing perilous due to 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 source and species for biopharmaceutical development is expected to drive the market. The main objective of these investigations is to enhance 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 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 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 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 system holds great promise for 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

Among all biologics, Monoclonal Antibodies (MAb) captured the largest share in 2017. Large capital requirement for 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 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 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 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 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.

Report Scope

Attribute

Details

Base year for estimation

2017

Actual estimates/Historical data

2014 - 2016

Forecast period

2018 - 2025

Market representation

Revenue in USD Million and CAGR from 2018 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 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, and country levels and provides an analysis of 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

      • U.S.

      • Canada

    • Europe

      • Germany

      • France

    • Asia Pacific

      • China

      • India

    • Latin America

      • Brazil

    • Middle East & Africa

      • South Africa

Key questions answered by the report
Request for Customization

Choose License Type

Single User - $4,950
Multi User (2-5) - $5,950
Enterprise Access - $7,950

Buy Chapters or Sections

Avail customized purchase options to meet your exact research needs:

  • Buy sections of this report
  • Buy country level reports
  • Request for historical data
  • Request discounts available for Start-Ups & Universities

Why Choose Us

  • Research support

    24/5 Research support

    Get your queries resolved from an industry expert.

  • Custom research service

    Custom research service

    Design an exclusive study to serve your research needs.

  • Quality assurance

    Quality assurance

    A testimonial for service in the form of BBB "A" Accreditation.

  • BBB Rating dandb
  • Information security

    Information security

    Your personal and confidential information is safe and secure.

  • grand view research PCI DSS complaint grand view research paypal verified