Biopharmaceuticals are biological preparations which are intended to treat range of diseases. The market for biopharmaceuticals is robust with the availability of several biologics, biosimilars, and biobetters in the market. Biopharmaceutical contract manufacturing services include development of large and small biologics from stage of clinical development to commercial scale. Contract Manufacturing Organizations (CMO) offers wide range of services such as cell line development, process optimization, fermentation biotechnology, analytical characterization, cGMP manufacturing, and validation in each stage of clinical development and commercialization. The success of CMO measured by its production capacity and reproducibility. Biopharmaceutical CMOs must over the complexity of large molecule manufacturing through sophisticated cell line development, cell culture manufacturing and quality control. Apart from developmental services, several biopharmaceutical contract manufacturing organizations offers marketing, regulatory and analytical expertise to the clients.
Biopharmaceutical Contract Manufacturing Market: Drivers and Restraints
Global biopharmaceutical contract manufacturing market is continue to witness positive growth owing to growing demand for outsourced services in pharmaceutical industry and rising investments by pharmaceutical and biotechnological companies in research and developmental activities for biologics would expected to fuel demand for biopharmaceutical outsourcing over the forecast period. The market for biopharmaceutical outsourcing driven by both biologics and biosimilars. Exiting developmental pipeline across multiple therapies, rise in venture capital funding, increasing regulatory approvals for biologics and orphan drugs will help to bolster growth of biopharmaceutical contract manufacturing market. Increasing pressure from governments, patient groups, and general public for affordable and sustainable model of pricing, which prompt developer to outsource the development process to reduce cost of development and this in turn boost the biopharmaceutical contract manufacturing market positively over forecasted period. However, increasingly stringent regulations, which increases the overhead cost, time to market and meagre venture funding for early stage clinical development companies may hamper the growth of the biopharmaceutical outsourcing market over the forecast period.
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Biopharmaceutical Contract Manufacturing Market: Segmentation
Global biopharmaceutical contract manufacturing market has been segmented on the basis of manufacturing process, services, drug type, and molecule type, phase of development, end user and region.
Based on the manufacturing process, the global biopharmaceutical contract manufacturing market is segmented into the following:
- Mammalian Based Manufacturing
- Microbial Based Manufacturing
Based on the services, the global biopharmaceutical contract manufacturing market is segmented into the following:
- Fill and Finish Services
- Cell banking
- Analytical Services
- Down streaming Process
- Process Development
Based on the drug type, the global biopharmaceutical contract manufacturing market is segmented into the following:
- New Biological Entities (NBE)
Based on the molecule type, the global biopharmaceutical contract manufacturing market is segmented into the following:
- Large Molecules
- Small Molecule Biologics
Based on the phase of development, the global biopharmaceutical contract manufacturing market is segmented into the following:
- Phase I
- Phase II
- Phase III
- Phase IV (Post Marketing Surveillance)
Based on the end user, the global biopharmaceutical contract manufacturing market is segmented into the following:
- Bio-Pharmaceutical companies
- Pharmaceutical Companies
- Drug Discovery Companies
Biopharmaceutical Contract Manufacturing Market: Overview
Global biopharmaceutical contract manufacturing market is highly competitive where the speed to market is imperative along with efficient process and low costs. Market for biopharmaceutical contract manufacturing is consistently witnessing newer challenges as several drug discovery and biopharmaceutical companies increasingly demanding for newer services like production, formulation, analytical services apart from conventional services. As there is growing demand for drugs for smaller indications (like orphan) players in the market need to create small production batches which creates flexibility in the manufacturing process.
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Biopharmaceutical Contract Manufacturing Market: Region-wise Outlook
Geographically, biopharmaceutical contract manufacturing market is segmented into regions viz. North America, Latin America, Western Europe, Eastern Europe, Asia-Pacific excluding Japan, Japan, Middle East and Africa. North America and Europe will remain key markets for biopharmaceutical contract manufacturing market. Europe region is expected to witness strong growth owing to increased approval of biosimilars by the regulators in the market. Asia Pacific is anticipated to register positive growth owing to presence of several small players offering different services, low cost of development, and availability of skilled manpower and expertise in the region.
Biopharmaceutical Contract Manufacturing Market: Key Players
Some players in biopharmaceutical contract manufacturing market include Lonza Group Ltd., Boehringher ingelheim, Sandoz, Fujifilm Diosynth Biotechnology, Rentschler Biotechnologie, Celonic GmbH, BIOMEVA GmbH, ProBioGen AG to name a few.