Roots Analysishas announced the addition of “Biopharma Contract Manufacturing Market (3rd Edition), 2019-2030” report to its list of offerings.
Souvik Mohanta, the principal analyst, stated, “Owing to the ever-increasing number of start-ups that are involved in R&D of novel biologics, there is an enormous opportunity for the CMOs in this domain. It is worth emphasizing that, since 2000, more than 115 new CMOs have been established in order to serve to the growing demand for novel biologics that have specific manufacturing requirements. The contemporary contract services market features a mix of large and small-sized CMOs and is characterized by multiple mergers and acquisitions as stakeholders strive to broaden their respective service portfolios. This has enabled several CMOs to offer end-to-end services, ranging from drug development, including preliminary R&D, preclinical and clinical trials, to commercial scale production and regulatory filings.”
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 size, 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+).
- Elaborate profiles of key players including Baxter International, Catalent, Lonza, Patheon, Piramal Pharma Solutions, Samsung Biologics and Wuxi Biologics (arranged in alphabetical order) that have a diverse range of capabilities for the development, manufacturing and packaging of biologics. 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 a comprehensive future outlook.
- A detailed 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, leading innovator companies to rely more on specialty CMOs for development and manufacturing. CMOs, such as (in alphabetical order, no selection criteria) apceth Biopharma, Batavia Biosciences, Brammer Bio, Cell and Gene Therapy Catapult, Cobra Biologics, KBI Biopharma, Waisman Biomanufacturing and WuXiAppTec, claim to specialize in offering services for complex biologics.
- A case study on the growing global biosimilars market, highlighting the opportunities for biopharmaceutical CMOs and CDMOs. With over 900 biosimilars under development, it is highly likely to result in a surge in the demand for contract service providers.
- A case study comparing the key characteristics of large molecule and small molecule drugs, along with details on the various steps involved in their respective manufacturing processes.
- 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.
- A detailed 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, year of establishment, type of partnership, type of therapeutic areas, most active players and geographical location. Over the last 6 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 development, manufacturing and commercialization of biologics. It is worth noting that, 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, along with the geographical distribution of this activity. The analysis also depicts the relationship between important deal multiples based on the revenue, number of employees and experience of the acquired company. Over 50 strategic mergers and acquisitions have recently signed between different CMOs. It is important to highlight that 23% of the total acquisitions were signed for vaccines followed by peptides/proteins and cell therapies both accounting for 16% of the total acquisitions.
- 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% of investments were focused on the addition of new facilities, or expansion of existing facilities. Recent additions include (in reverse chronological order, no selection criteria) ABL’s viral vector manufacturing capacity in France (November 2018), GE Healthcare’s manufacturing center in the UK (November 2018), VGXI’s production plant in the US for GMP manufacturing of RNA and DNA therapeutics (November 2018), Samsung BioLogics’ new production plant in South Korea (Oct 2018) and Novasep’s commercial viral vector manufacturing facility in Belgium (Oct 2018).
- A detailed capacity analysis, taking into consideration the individual development and manufacturing capacities of various stakeholders (small-sized, mid-sized, large and very large CMOs / CDMOs) 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 noteworthy to mention that the current installed contract manufacturing capacity is over 4.5 million litres and is well distributed across various geographies.
- An informed estimate of the annual demand for biologics, taking into account the top 20 biologics, based on a various relevant parameter, such as target patient population, dosing frequency and dose strength of the abovementioned products.
- A comprehensive market forecast analysis, based on theparameters, such as growth of the overall biopharmaceutical market, cost of goods sold, and direct manufacturing costs, we have provided 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 (US, Canada), Europe (UK, France, Germany, Italy and Spain), Asia (China and India) and rest of the world (Australia))
In this context, North America currently holds the larger share (40%) of the market and is anticipated to grow at an annualized growth rate of around 6%. However, markets in the Asia-Pacific are expected to grow at a significantly higher rate (more than 12%), owing to inherent advantages, such as relatively low labor costs and less stringent regulatory constraints, in developing countries.
- 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.
The report features inputs from several eminent industry stakeholders. Mohanta remarked, “Most industry experts concur with the idea of establishing a one stop solution and provide services from research to clinical manufacturing as they realized that a gap exists in the market in terms of the companies that provide outsourcing solutions ranging from candidate selection to clinical manufacturing” The report also features detailed transcripts of discussions held with the following experts:
- Astrid Brammer, Senior Manager Business Development, Richter-HelmMathias Schmidt (Chief Executive Officer, ArmaGen)
- 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 product portfolios of several companies, including (illustrative list, no selection criteria):
- 3P Biopharmaceuticals
- Albany Molecular Research
- BioXcellence (Boehringer Ingelheim)
- Charles River Laboratories
- Cobra Biologics
- Cytovance Biologics
- GE Healthcare
- Goodwin Biotechnology
- Grand River Aseptic Manufacturing
- IDT Biologika
- KBI BioPharma
- Kemwell Biopharma
- LFB Biomanufacturing
- Meridian Life Science
- Pfizer CentreOne
- Samsung BioLogics
- Sanofi, CEPiA
- Thermo Fisher Scientific
- Vetter Pharma International
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