Owing to the complexities associated with the production of biologics, biopharmaceutical developers are likely to continue relying on contract service providers for various aspects of their respective product development programs
Roots Analysis has announced the addition of the “Biopharmaceutical Contract Manufacturing Market, (4th Edition), 2020-2030” report to its list of offerings.
Given the rising popularity of biologics and the 8,000+ such product candidates under clinical investigation, the opportunity for contract manufacturing service providers engaged in this domain, is high and anticipated to persist in the mid-long term, as well. In fact, since 2000, over 120 new CMOs have been established, offering a variety of cost-efficient manufacturing services and solutions to biologic developers.
Key Market Insights
Presently, 225 CMOs, possessing over 380 manufacturing facilities, claim to offer manufacturing services for biopharmaceutical products
The manufacturing services market for biopharmaceuticals is highly fragmented, featuring a mix of small, mid-sized, large and very large players. It is worth mentioning that more than 60% of CMOs mentioned in the report, have the necessary capabilities to manufacture biologics across all scales of operation.
More than 65% of service providers offer manufacturing services for recombinant proteins and peptides
Close to 58% of CMOs claim to have the required capabilities to offer antibody manufacturing services. It is worth mentioning that a number of biologics manufacturers are presently offering services related to the niche and emerging classes of biologics.
Over 620 partnerships were established in this domain, during the period 2015-2020
Majority of the deals (~24%) recorded in the report, were established in 2020, primarily driven by the investigational biologic drugs against COVID-19. Further, a large number (~35%) of the partnerships were observed to be focused on the manufacturing of biologics, followed by product development and manufacturing agreements (22%).
Currently, the installed biopharmaceutical contract manufacturing capacity is estimated to be ~3.9 million liters, which is gradually being expanded
In order to meet the growing demand for biologics, 177 expansion projects were undertaken by CMOs between 2016 and 2020 Of the aforementioned initiatives, more than 40% were focused on the establishment of new facilities, followed by the expansion of existing manufacturing facilities (24%).
North America and Europe are anticipated to capture 75% share (in terms of service revenues) of the market, by 2030
At present, close to 90% of the total revenues are generated from projects involving commercialized biologic products, and this trend is unlikely to change significantly in the short to mid-term. Further, it is worth mentioning that the contract biomanufacturing market for biologics in the Middle East and North Africa is anticipated to grow at a relatively faster rate (13.6%), followed by the Asia-Pacific market (11.2%).
Key Questions Answered
- Who are the leading players offering contract manufacturing services for biologics?
- What percentage of the manufacturing operations for biopharmaceutical are presently outsourced?
- What factors should be taken into consideration while deciding whether the manufacturing operations for biologics should be kept in-house or outsourced?
- What is the current, installed capacity for contract manufacturing for biopharmaceuticals?
- What is the current, global demand for biologics and how is it likely to evolve in the foreseen future?
- What are the key (geographical) manufacturing hubs for biologics?
- What kind of partnership models are commonly adopted by stakeholders engaged in this domain?
- What are the different biopharmaceuticals focused initiatives undertaken by big pharma players in the recent past?
- How is the current and future market opportunity likely to be distributed across key market segments?
The USD 34.2 billion (by 2030) financial opportunity within the biopharmaceutical contract manufacturing market has been analyzed across the following segments:
Commonly outsourced business operations
Types of Expression Systems Used
Scale of Operation
- Preclinical / Clinical
- Large / Very Large
Types of Biologics Manufactured
- Antibody Therapeutics
- Cell Therapies
- Other Biologics
Key Geographical Regions
- North America
- Latin America
- Middle East and North Africa
Read More about:
The report features inputs from eminent industry stakeholders, over 50% operations related to both API and FDF manufacturing of biologics are outsourced to third party service providers. The report includes detailed transcripts of discussions held with the following experts:
- Andrea Conforto (Sales & Marketing, Bioservices Director, Olon)
- Astrid Brammer (Senior Manager Business Development, Richter-Helm)
- Birgit Schwab (Senior Market Intelligence Manager, Rentschler Biotechnologie)
- Christian Bailly (Director of CDMO, Pierre Fabre)
- Claire Otjes (Marketing Manager, Batavia Biosciences)
- David C Cunningham (Director Corporate Development, Goodwin Biotechnology)
- Dietmar Katinger(Chief Executive Officer, Polymun Scientific)
- Denis Angioletti (Chief Commercial Officer, Cerbios-Pharma)
- Jeffrey Hung (Chief Commercial Officer, Vigene Biosciences)
- Kevin Daley (Market Director Pharmaceuticals, Novasep)
- Max Rossetto (General Manager – Business Development, Luina Bio)
- Nicolas Grandchamp (R&D Leader, GEG Tech)
- Raquel Fortunato (Chief Executive Officer, GenIbet Biopharmaceuticals)
- Sebastian Schuck (Director Global Business Development, WACKER Biotech)
- Stephen Taylor (Senior Vice President Commercial, FUJIFILM Diosynth Biotechnologies)
- Marco Schmeer (Project Manager, PlasmidFactory) and Tatjana Buchholz (ex-Marketing Manager, PlasmidFactory)
The report includes profiles of key players (listed below) each profile features an overview of the company, information related to its biologics focused service portfolio, manufacturing facilities, recent developments, and an informed future outlook.
- AGC Biologics
- Boehringer Ingelheim
- Cytiva (GE Healthcare)
- FUJIFILM Diosynth Biotechnologies
- KBI Biopharma
- Kemwell Biopharma
- Luina Bio
- Piramal Pharma Solutions
- Takara Bio
- WuXi AppTec (WuXi Biologics)