Biopharmaceutical CMO and CRO Market (By Source: Non-mammalian, Mammalian; By Service Type: Contract Manufacturing [Process Development, Analytical & QC studies, Finish & Fill Operations, Packaging], Contract Research [Oncology, Cardiology, Neuroscience, Inflammation & Immunology, Others; By Product: Biosimilars, Biologics [Monoclonal Antibodies (MAbs), Recombinant Proteins, Vaccines, Antisense, RNAi, & Molecular Therapy, Others) - Global Industry Analysis, Market Size, Opportunities and Forecast, 2019 - 2026

Category : Healthcare and Pharmaceuticals | Delivery Format : PDF | Status: Published | Pages : 190


According to Acumen Research and Consulting, the global Biopharmaceutical CMO & CRO market is expected to grow at noteworthy CAGR around 7.5 % throughout the forecast period and reach around US$ 39 billion by 2026.

CDMO is an organization that provides comprehensive services from the development of drugs through to the production of pharmaceuticals and is often referred to as a contract development and manufacturing organisation, and serves other companies in the pharmaceutical industry. A contract research organization is an organization that offers support in the form of contractual outsourced services for the pharmaceutical, biotechnological and medical device industries.

The report provides analysis of global Biopharmaceutical CMO & CRO market for the period 2015-2026, wherein 2019 to 2026 is the forecast period and 2018 is considered as the base year.

Market Dynamics

The increasing investments of prominent participants in the biopharmaceutical sector to improve their productivity and efficiency have encouraged biomarks to focus more on outsourcing. Today, the outsourcement of resource-intensive steps and, in few cases, the entire biopharmaceutical chain, has begun and thus increased demand for contract-based services.

Fusions and acquisitions help CMOs to provide their customers with integrated bioprocessing services which make CMOs / CROs in turn an attractive and viable way to quickly launch products. In recent years a considerable number of consolidations have occurred in the biopharmaceutical industry. The main aim of these consolidations was to expand businesses and to maintain competitiveness in the production and services markets of bio-pharmaceutical contracts. While biopharmaceutical CMO and CRO industries themselves are relatively advanced, it has resulted in increased pressure on contract biomanufacturers to start new bioprocessing instruments, new therapies and priority shifts in the bio-pharmaceutical industry for products. Contract development and manufacturing organizations (CDMOs) are therefore implementing various business models to best meet the needs of their customers and stakeholders.

In addition, CMOs are also helping to economically expand production capacity through integration of single use systems into production plants. The products of a single use provide a quick turnaround and limit joint activities, including validation for cleaning and changeover. However, because of the regulatory landscape and complexity of service, the contract negotiations between CMOs and customers are difficult. The customers and CMOs face problems relating to IP rights, guarantees and liabilities, prices, and timelines that make negotiations more complex.

Source Outlook

The dominant production systems for the production of large molecules are estimated to be mammalian cell lines. This is due to their abilities to make complex protein therapies complemented with human-like post-translation changes. This segment benefits greatly from new and robust expression systems, improved process monitoring solutions, cell line engineering instruments, automated screening methods and devices. These developments have led to the production of biologics using mammalian cells being more productive and efficient. The powerful factories are recognized as non-mammalian cell lines like the microbial cell line. Innovative strategies for identifying and exploiting the potential of different microbes are in place. In turn, this is expected to contribute to the profitable growth of the non-mammalian biopharmaceutical sector.

Service Type Stance

There are currently several entities offering a wide range of biopharmaceutical manufacturing services on the market. The services vary from researching and discovering applicants to launching the product on the final market. A significant number of space-based CMOs and opportunistic CMOs provide biopharmaceutical companies with a range of services, from cells to supplies and fillings. In addition, the production aspect of their product development program is heavily invested by customers. The most important part of this segment was due to these factors. On the other hand, CROs strive to exploit the potential avenues of the biopharmaceutical sector. In order to contribute to the growth of contracted research organisations, new market participants and small participants focused on the development of biofarmaceuticals are anticipated to choose their new applicants ' discovery programs in contracting research services.

Product Snapshot

Contracting services are flattering a gradually common cost-saving approach to produce large molecules, including biological and biosimilar products, effectively and replicably. Because biological treatments in patients are becoming increasingly popular, many conventional pharmaceutical producers are looking for opportunities for entry into the biological market. The high biological character of this segment has resulted in its dominance, its complex production steps and its increased success rate in comparison to other drug molecules. The CMOs have been able to meet increasing demand of biological production service efficiently by applying single-use bioreactors, disposable plastic containers, continuous purification processing, and in-time Quality Analyzes. In addition, several companies invest in biosimilar development, with the aim of exceeding the safety, effectiveness, disposal or cost of earlier innovative medicines. This has boosted innovator manufacturers ' level of competition, which in turn is likely to benefit CMOs.

Regional Stance

CMOs are produced in the USA with a significant number of approved products. There is a lack of resources and budget for establishing facilities with well-equipped resources by several small and medium-sized biopharmaceutical companies (SMEs). In turn, the interdependency between CMOs and SMEs in the United States has increased, which has led to dominance of the U.S. market.

CAGR is expected to be the fastest in the projection period on Asia Pacific biopharmaceutical market CMO & CRO. In Asia, costs-related advantages, like lower labor costs and operating costs, are a key reason for the increase in outsourcing. Because of the large volume of molecular production in that country, India is expected to show significant progress.

Lack of global biosimilar approval regulatory symmetry has driven the Indian market significantly. By 2016 50 biosimilars had been approved in India, out of which only 24 in Europe and five in the United States were approved.

Market Segmentation

Global Biopharmaceutical CMO & CRO Market, By Source

  • Non-mammalian
  • Mammalian

Global Biopharmaceutical CMO & CRO Market, By Service Type

  • Contract Manufacturing
    • Process Development
      • Upstream
      • Downstream
    • Analytical & QC studies
    • Finish & Fill Operations
    • Packaging
  • Contract Research
    • Oncology
    • Cardiology
    • Neuroscience
    • Inflammation & Immunology
    • Others

Global Biopharmaceutical CMO & CRO Market, By Product

  • Biosimilars
  • Biologics
    • Monoclonal Antibodies (MAbs)
    • Recombinant Proteins
    • Vaccines
    • Antisense, RNAi, & Molecular Therapy
    • Others

Global Biopharmaceutical CMO & CRO Market, By Geography

  • North America.
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa (MEA)

The market research study on “Biopharmaceutical CMO and CRO Market - Global Industry Analysis, Market Size, Opportunities and Forecast, 2019 - 2026” offers detailed insights on global Biopharmaceutical CMO & CRO market segments with market dynamics and their impact. The report also covers basic technology development policies.

The report provides an analysis of the latest industry trends from 2015 to 2026 in all sub-segment segments and forecasts revenue and volume growth on the global, the regional and country levels.

Key Players & Strategies

Due to the presence of a large number of developed, medium to small CMOs and CROs, this market is fragmented in nature. Many market participants are held in private or form part of the portfolios of private equity firms. Some key CMOs are Boehringer Ingelheim GmbH, Lonza, Rentschler Biotechnologie GmbH, JRS Pharma (Celonic GmbH), TOYOBO Biologics, LTD, FUJIFILM Diosynth Biotechnologies U.S.A., Patheon, CMC Biologics, and WuXi Biologics.

In order for CMOs to improve the project performance and product quality their automation and innovative technologies are integrated in their plants. The interest of large molecular producers in the CMOs has thus driven them to congregate the mounting demand for biologics. Charles River Laboratories International (LC) Inc.; PRA Health Sciences; LabCorp; ICON plc.; and Parexel International Corporation are committed to offering contract research services for large molecular production. Contract research services for large molecular production.

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