Abstract, Snapshot, Market Analysis & Market Definition: Global Biopharmaceuticals Contract Manufacturing Market
The global Biopharmaceuticals Contract Manufacturing market size is projected to reach US$ 23.28 billion by 2026, from US$ 15.08 billion in 2020, at a CAGR of 7.5% during 2021-2026. 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.
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.
Market Segmentation, Outlook & Viewpoint: Global Biopharmaceuticals Contract Manufacturing Market
Source Market Segmentation & Outlook (Revenue, USD Million, 2014 - 2025)
Service Market Segmentation & Outlook (Revenue, USD Million, 2014 - 2025)
Process Development
Fill & Finish Operations
Analytical & QC Studies
Packaging
Product Market Segmentation & Outlook (Revenue, USD Million, 2014 - 2025)
Biologics
- Monoclonal Antibodies (MAbs)
- Recombinant Proteins
- Vaccines
- Antisense, RNAi, & Molecular Therapy
- Others
Biosimilars
Key Players, Recent Developments & Regional Insights: Global Biopharmaceuticals Contract Manufacturing Market
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.
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.
Key Insights Covered: Global Biopharmaceuticals Contract Manufacturing Market
1. North America, Europe, Asia Pacific, Middle East & Africa, Latin America market size (sales, revenue and growth rate) of Biopharmaceuticals Contract Manufacturing industry.
2. Global major manufacturers" operating situation (sales, revenue, growth rate and gross margin) of Biopharmaceuticals Contract Manufacturing industry.
3. Global major countries (United States, Canada, Germany, France, UK, Italy, Russia, Spain, China, Japan, Korea, India, Australia, New Zealand, Southeast Asia, Middle East, Africa, Mexico, Brazil, C. America, Chile, Peru, Colombia) market size (sales, revenue and growth rate) of Biopharmaceuticals Contract Manufacturing industry.
4. SWOT analysis, New Project Investment Feasibility Analysis, Upstream raw materials and manufacturing equipment & Industry chain analysis of Biopharmaceuticals Contract Manufacturing industry.
5. Global market size (sales, revenue) forecast by regions and countries from 2019 to 2024 of Biopharmaceuticals Contract Manufacturing industry.
Research Methodology: Global Biopharmaceuticals Contract Manufacturing Market
- Data collection and base year analysis is done using data collection modules with large sample sizes. The market data is analyzed and forecasted using market statistical and coherent models. Also market share analysis and key trend analysis are the major success factors in the market report. To know more please Request a Sample Report.
- Demand Side Primary Contributors: OEMs, Industrial Professionals, Researches, Suppliers and Distributors, Group Purchasing Organizations, Associations, Insurers, Universities, Technological Writers, Scientists, Promoters, Investors among others.
- Supply Side Primary Contributors: Product Managers, Marketing Managers, C-Level Executives, Distributors, Market Intelligence, Regulatory Affairs Managers among other