A new study by FMI titled ‘Biopharmaceutical Contract Manufacturing Market: Global Industry Analysis 2012–2016 and Opportunity Assessment 2017–2027’, has listed out the key points being considered by Biopharmaceutical contract manufacturing companies to emerge and stay sustainably profitable in the long run. The North American Biopharmaceutical contract manufacturing market is expected to expand at a CAGR of close to 10%, and is expected to remain as a main sink market for revenues, as most of the biopharmaceutical contract manufacturing facilities are located in this region. Europe is expected to remain as the main source market for biopharmaceutical contract manufacturing services. However, with the increasing demand and availability of large sterile spaces required for biopharmaceutical contract manufacturing in countries such as China, the biopharmaceutical contract manufacturing market is witnessing a move to Asia, to countries such as China and South Korea.
The report finds that Biopharmaceutical contract manufacturing capacity is tight across the industry, regardless of the location. Globally, biopharma companies have spent over US$ 50 Bn in just the past five years on new plants and equipment. Much of that has been in tax havens like Ireland and Singapore, and in emerging markets. About a quarter of the projects have been in the U.S. There just aren’t enough facilities, and those that are available are too old for modern drugs. It takes nearly four years to design, build, and qualify a new plant. Large-scale plants can cost between US$ 1 Bn and US$ 2 Bn. Patheon’s recent acquisition of Roche’s small facility in biopharmaceutical contract manufacturing sector was attractive because it was inexpensive, but is far from the norm. Much of the ongoing capacity expansion in the biopharmaceutical contract manufacturing industry is customer-funded.
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Biosimilar and biologics manufacturing are presenting strong growth opportunities for biopharmaceutical contract manufacturing organizations. The global biopharmaceutical contract manufacturing market is in a state of large consolidation, as participants in the biopharmaceutical contract manufacturing market look to inorganic growth strategies to offer integrated solutions to customers. For instance, leading players in biopharmaceutical contract manufacturing market – Patheon, Catalent, and AMRI have acquired IRIX Pharmaceuticals, Pharmatek, and Euticals, respectively. These biopharmaceutical contract manufacturing companies have been aggressive in expanding their products/services/capabilities through strategic alliances. Similarly, Aenova maintained its market position in the biopharmaceutical contract manufacturing market after the acquisition of Haupt Pharma AG, and by selling its Temmler business in 2015. Both, biopharmaceutical contract manufacturing companies – Fareva and Famar have successfully adopted an integration strategy of acquiring manufacturing facilities in Europe from large pharmaceutical companies.
Reinventing the European advanced therapies sector may fuel outsourcing activities to biopharmaceutical contract manufacturing players in the region. The next generation therapy market is driven by biological treatment options. These biologics demand more research and clinical trials, and hence, to reduce the cost, most research activities are outsourced to biopharmaceutical contract manufacturing players. The region is richly endowed with venture capitalists, which makes the availability of funding easier for biopharmaceutical contract manufacturing organizations. Potential margins for biopharmaceutical contract manufacturing companies are better in Europe as compared to the U.S. Factors noted by customers while approaching a biopharmaceutical contract manufacturing company are various. As per a NICE survey, a biopharmaceutical contract manufacturing company is selected based on location, quality of service, cGMP compliance, specific expertise in therapeutic area of focus, reputation and area of expertise, and infrastructure.
The top activity outsourced to biopharmaceutical contract manufacturing companies is analytical testing, followed by toxicity testing and fill/finish operations. Dominant outsourcing activities across the biopharmaceutical sector are restricted to services where a high degree of specialization may be required. While outsourcing to biopharmaceutical contract manufacturing companies can address a host of limitations, it comes with its own set of problems – protecting intellectual property rights, effectively handling cross-contamination issues, and complying with quality standards.
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Rising focus on cost-effective biopharmaceutical contract manufacturing and the popularity of biosimilar added with the existence of patent cliff of blockbuster biologic drugs in the near future is expected to boost the growth of the biopharmaceutical contract manufacturing market. Big biopharmaceutical companies focusing on reduction in operating costs through the outsourcing of R&D and commercialization of biologic drugs to biopharmaceutical contract manufacturing companies could also increase the growth of the biopharmaceutical contract manufacturing market during the forecast period. However, complex manufacturing guidelines & regulatory processes, limited capacity for large-volume biopharmaceuticals, and high investments requirement to establish a biopharmaceutical contract manufacturing facility will continue to pose challenges to widespread adoption of outsourcing services in biopharmaceutical contract manufacturing market.
Some of the key biopharmaceutical contract manufacturing companies analyzed in this report titled Biopharmaceutical contract manufacturing market include Lonza Group Ag, Baxter Healthcare Corporation, Samsung Biologics Co., Ltd., Fujifilm Diosynth Biotechnologies, Boehringer Ingelheim GmbH, Patheon N.V., Rentschler Biotechnologie GmbH, Biomeva GmbH, ProBioGen AG, Cytovance Biologics Inc, Kbi Biopharma Inc, WuXi Biologics (Cayman) Inc., Abzena Plc, Vetter Pharma International GmbH, Sandoz International GmbH, Catalent Inc, and AbbVie Contract Manufacturing.