Driven by the growing demand for biologics, the biopharmaceutical contract manufacturing market is expected to grow at an annualized rate of 8.1%, predicts Roots Analysis
Roots Analysis has announced the addition of “Biopharma Contract Manufacturing Market (3rd Edition), 2019-2030” report to its list of offerings.
Souvik Mohanta, the principal analyst, stated, “Since 2000, more than 115 new CMOs, focused on biopharmaceuticals, have been established. The current biopharmaceutical contract manufacturing landscape features the presence of several established and emerging CMOs, with a diverse set of production capabilities.”
The report presents opinions on several key aspects of the market. Among other elements, it includes:
- A detailed review of the overall landscape of the biopharmaceutical contract manufacturing market, featuring a comprehensive list of over 235 CMOs and detailed analysis of the manufacturing service providers based on a number of parameters, such as scale of operation (preclinical, clinical and commercial), type of biologics manufactured (peptides / proteins, antibodies, vaccines, cell therapies, gene therapies, antibody drug conjugates, vectors, biosimilars, nucleic acids and others), type of expression systems used (mammalian, microbial and others), year of establishment, employee strength, geographical location of the CMO, number of manufacturing facilities, as well as the location of these facilities, GMP compliance, affiliations to regulatory agencies, type of bioreactors used (single-use bioreactors and stainless steel bioreactors), mode of operation of bioreactors (batch, fed-batch and perfusion) and bioprocessing capacity. It is important to mention that majority of these firms offer services for proteins and peptides (140+), antibodies (125+), and vaccines (80+).
- A discussion on the key enablers in this domain, including certain niche product classes, such as antibody drug conjugates (ADCs), bispecific antibodies, cell therapies, gene therapies and viral vectors, which are likely to have a significant impact on the growth of the contract services market. It is worth mentioning that antibody-based therapies, such as antibody drug conjugates (180+ candidates) and bispecific antibodies (150+ candidates), along with the more complex cell therapies (600+ candidates) and gene therapies (350+ candidates), require specialized infrastructure and handling expertise, thereby, causing innovator companies to rely more on specialty CMOs for their development and manufacturing. CMOs, such as (in alphabetical order, no selection criteria) apceth Biopharma, Brammer Bio, Cell and Gene Therapy Catapult, KBI Biopharma, Waisman Biomanufacturing and WuXi AppTec, claim to specialize in offering services for complex biologics.
- An informed capacity analysis, taking into consideration the individual development and manufacturing capacities of various stakeholders in the market, using data from both secondary and primary research. The study examines the distribution of global biopharmaceutical manufacturing capacity by scale of operation (preclinical / clinical, commercial), size of company (small-sized, mid-sized, large and very large), and geography (North America (the US and Canada), Europe (Italy, Germany, France, Spain, the UK and rest of Europe), Asia and Middle East (China, India, Japan, South Korea and rest of the Asia and Middle East), and rest of the world (including Australia)). It is worth mentioning that the current installed contract manufacturing capacity is over 4.5 million litres and is well distributed across various geographies. Currently, more than 50% of the capacity is captured by mammalian expression systems. The remaining share is occupied with microbial and other expression systems.
- An analysis of the partnerships and collaborations focused on contract manufacturing of biologics, featuring a comprehensive set of analyses based on various parameters, such as the headquarters of partner companies, year of partnership, type of partnership, therapeutic area, most active players and geographical location. Over the last six years, close to 450 strategic partnerships have been inked between stakeholders in the biopharmaceutical contract manufacturing market. It is worth noting that 50% of these agreements were product-based deals signed for various purposes, including the development, manufacturing and commercialization of biologics. In addition, of the total number of partnership instances, majority were signed for cell therapies (25%) and antibodies (20%).
- A detailed analysis of the various mergers and acquisitions that have taken place in this domain, highlighting the trend in the number of companies acquired between 2013-2018. The analysis also depicts the relationship between important deal multiples based on the revenue, number of employees and experience of the acquired companies. Over 50 strategic mergers and acquisitions have recently taken place between different CMOs. It is important to highlight that 23% of the total acquisitions were signed for vaccines, followed by those signed for peptides / proteins (16%) and cell therapies (16%).
- An analysis on the recent trends within biopharmaceutical contract manufacturing industry, highlighting various facility and capability expansions. In addition, it provides information on the technology advancements related to biomanufacturing. Over 135 recent expansions were reported between 2013-2018; of these, 75% were focused on the addition of new facilities, or expansion of existing facilities.
- An analysis of the annual demand for biologics, taking into account the top 20 biologics, based on various relevant parameters, such as target patient population, dosing frequency and dose strength of the abovementioned products. Currently, the demand of biologics that are being marketed / investigated is primarily driven by patient segments of oncological disorders and infectious disorders, accounting for ~40% of the total demand.
- A case study on the growing global biosimilars market, highlighting the opportunities for biopharmaceutical CMOs and CDMOs. With over 900 biosimilars under development, the market is highly likely to witness a surge in the demand for contract service providers.
- A comprehensive market forecast analysis, based on parameters, such as growth of the overall biopharmaceutical market, cost of goods sold, and direct manufacturing costs, along with an informed estimate of the likely evolution of the market in the short to mid-term and mid to long-term, for the period 2019-2030. The report features likely distribution of the current and forecasted opportunity across the following segments:
- Commonly outsourced business operations (active pharmaceutical ingredients (APIs) and finished dosage formulations (FDFs))
- Types of expression systems (mammalian, microbial and others)
- Size of the company (small-sized, mid-sized and large / very large)
- Scale of operation (preclinical, clinical and commercial)
- Key geographical regions (North America (the US and Canada), Europe (the UK, France, Germany, Italy and Spain), Asia (China and India) and rest of the world (Australia))
- North America currently holds the larger share (40%) of the market and is anticipated to grow at an annualized growth rate of 7.4%. However, markets in the Asia-Pacific are expected to grow at a significantly higher rate (8.9%), owing to inherent advantages, such as relatively low labor costs and less stringent regulatory constraints.
- A discussion on affiliated trends, key drivers and challenges, under a comprehensive SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall pharmaceutical industry.
- A survey analysis featuring inputs solicited from various experts who are directly / indirectly involved in providing CMO services to medical device developers. It is worth mentioning that one-third of the responders were at CXO level, 42% formed a part of senior management and 25% responders
- A discussion on challenges related to in-house manufacturing, featuring a brief overview of the various parameters that a drug / therapy developer may need to take into consideration while deciding whether to manufacture its products in-house or outsource.
The report features inputs from several eminent industry stakeholders. Mohanta remarked, “Most industry experts concur that the current bioprocessing challenges can be addressed / mitigated by the integration of emerging technologies, such as single-use technologies, resulting in enhanced productivity levels.” The report also features detailed transcripts of discussions held with the following experts:
- Astrid Brammer (Senior Manager Business Development, Richter-Helm Biotec)
- Birgit Schwab (Senior Manager Strategic Marketing, Rentschler Biotechnologie)
- Christian Bailly (Director of CDMO, Pierre Fabre)
- Claire Otjes (Assistant 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 (Director Pharmaceuticals, Novasep)
- Mark Wright (Site Head, Grangemouth, Piramal Healthcare)
- Nicolas Grandchamp (R&D Leader, GEG Tech)
- Raquel Fortunato (Chief Executive Officer, GenIbet Biopharmaceuticals)
- Sebastian Schuck (Head of Business Development, Wacker Biotech)
- Stephen Taylor (Senior Vice President Commercial, FUJIFILM Diosynth Biotechnologies)
- Tatjana Buchholz (Marketing Manager, PlasmidFactory) and Marco Schmeer (Project Manager, PlasmidFactory)
- Tim Oldham (Chief Executive Officer, Cell Therapies)
The research covers detailed profiles and assesses service portfolios of several companies (illustrative list below); each profile provides an overview of the company, its financial performance (if available), information related to its service portfolio, manufacturing facilities, and details on partnerships, recent developments (expansions), as well as an informed future outlook.
- 3P Biopharmaceuticals
- Albany Molecular Research
- Baxter International
- BioXcellence™ (Boehringer Ingelheim)
- CEPiA - Sanofi
- Charles River Laboratories
- Cobra Biologics
- Cytovance Biologics
- Grand River Aseptic Manufacturing
- IDT Biologika
- Kemwell Biopharma
- LFB Biomanufacturing
- Meridian Life Science
- Pfizer CentreOne
- Piramal Pharma Solutions
- Thermo Fisher Scientific
- Vetter Pharma International
- WuXi Biologics
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