The Biopharmaceuticals Contract Manufacturing Market is expected to register a CAGR of 7.5% during the forecast period. A contract manufacturing organization (CMO) is a company that serves other companies in the biopharmaceutical industry on a contract basis to provide comprehensive services from drug development through drug manufacturing. This allows major biopharmaceutical companies to outsource those aspects of the business, which can help with scalability or can allow the major company to focus on drug discovery and drug marketing. Biotechnology industries continue to outsource to contract manufacturing organizations (CMOs) to meet their fill-and-finish needs and reduce risk. Some small biotechnology companies outsource their fill-and-finish manufacturing needs because they do not have the in-house capacity and helps obviate the need for capital expenditures and reduces business risk. Moreover, the outsourcing strategy for these companies is highly complex and varies depending on the product life cycle, product phase, volume, and profitability. Some other influencing factor in an outsourcing decision is a company’s view on fill-and-finish’s importance to their drug product portfolio. The current market structure presents biopharmaceutical companies with a shortage of contract manufacturing organization (CMO) capacity to produce biopharmaceuticals, especially in cell culture technology and new modalities and even as demand for outsourcing increases.

Biopharmaceuticals large molecules differ from pharmaceutical small molecules in their size, behavior, their manufacture and the way large molecules work in the human body. manufacturing such large molecules is significantly more complex than producing traditional pharmaceuticals. In fact, biopharma is a highly technical industry, with complex processes involved that relatively few players have entirely mastered. Biopharmaceutical companies growing steadily for several years, and the presence of large pipeline molecules in clinical trials promise continued growth.

Currently, more than 235 companies offer contract manufacturing services for biopharmaceuticals, to handle multiple types of biologics. Majority of the contract manufacturing organizations (CMO) offer services for proteins/peptides, antibodies and vaccines. In addition, mammalian cell-based manufacturing is more popular than microbial expression systems this trend is expected to persist in the coming years as well.

Increasing outsourcing volume by biopharmaceutical industries, increasing investments in research and development and expansion in the service offering of contract manufacturing organizations (CMOs)are the key driving factors in the biopharmaceuticals contract manufacturing market.

Key Market Trends

Antibodies segment is Expected to Witness Robust Growth

Monoclonal antibody therapy is a type of immunotherapy that uses antibodies to bind to certain cells or proteins and will stimulate the patient’s immune system to attack those cells. These therapeutic agents are used for the treatment of different cancers. Monoclonal antibodies are the most important class of biologics. Monoclonal antibodies approval has accounted for almost 20% of all drugs authorized by the FDA in the year 2018. This number had exceeded compared to approvals in the previous years, thus leading to the approval of 27 antibody-based drugs out of a total of 127 new drugs over the past three years.

Antibodies segment holds a significant market share in the biopharmaceuticals contract manufacturing market and is anticipated to show a similar trend over the forecast period. According to Food and Drug Administration (FDA), it has approved 17 biologics in the year 2018, of which 12 are monoclonal antibodies (mAb), three pegylated enzymes, one protein, and one fusion protein.

Technological advancements in monoclonal antibody therapy and increasing research and development activities are the key driving factors in the antibodies segment.

North America is Expected to Hold a Significant Share in the Market and Expected to do Same in the Forecast Period

North America is expected to hold a major market share in the global biopharmaceuticals contract manufacturing market due to presence of number of biopharmaceutical companies with large production capacities leading to high consumption of biologics in this region. Furthermore, growing emphasis on superior biopharmaceutical products, biosimilars led to the increase in the demand for biologicals, biopharmaceutical based research and development activities accounted for a major percentage of the total research and development carried out in various sectors is also fueling the growth of the overall regional market to a large extent.

Competitive Landscape

The Biopharmaceuticals Contract Manufacturing Market is consolidated and consists of few major players. In terms of market share, few of the major players are currently dominating the market. Some of the companies which are currently dominating the market are Boehringer Ingelheim GmbH, Lonza, Inno Biologics Sdn Bhd, Rentschler Biotechnologie GmbH, JRS Pharma (Celonic), Samsung BioLogics, WuXi Biologics, AGC Biologics, ProBioGen AG and FUJIFILM Diosynth Biotechnologies U.S.A., Inc.

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