Biomanufacturing is a widely used term to describe the manufacture of biologic molecules for various stages of drug development right from pre-clinical stage to commercial supply.
The biologic drug manufacturing is a complex process involving huge capital and sound technical expertise. Many large and small pharmaceutical companies are turning to outsource the drug manufacture process to reduce capital investments on capacities and focus more on their core competencies. Contract manufacturing organizations, particularly for R&D and clinical trials, are making product manufacture, more efficient and often less costly.
In addition to that, the use of single-use bioreactors is effectively reducing the manufacture facility cost. This option is more viable for smaller and low-funded companies for their in-house candidate product manufacturing needs, whereby, the companies can avoid $50-$150 million facility costs for construction of fixed, dedicated stainless steel bioreactor-based bioprocessing systems and outsource their manufacturing requirements to CMOs which use single-use facilities which typically cost $25-$40 million for commercial manufacture.
There is a continued growth of the biopharmaceutical market which is expected to nearly double in the next 10 years. This will be a result of continued new product approvals, expansion of indications for current products which include less-developed countries becoming more affluent and increased drug demand of the aging population in the U.S. and other major pharmaceutical markets. Aging populations are at a high risk of developing chronic diseases such as cancer and arthritis and these diseases are being precisely targeted using biopharmaceuticals.
Many blockbuster drugs losing their exclusivity are also giving room for many biosimilar (and bio-betters) companies to enter into the world’s biopharmaceuticals market subsequently attracting many CROs, CDMOs, and CMOs to enter into the picture. Hence, there is every reason to assume that future growth in biopharmaceutical outsourcing will continue at a minimum of 14% in western countries to about 18% in Asian countries.
Nowadays CMOs are gaining much prominence due to increased demand for the clinical and commercial supply of biologics. Such prominence is achieved mainly through capacity expansions or more easily through mergers and acquisitions.
In October 2018, Boehringer Ingelheim, is one of the worlds’ largest manufactures of biopharmaceutical, completed the expansion of biopharmaceutical facility by increasing capacity of bioreactor to 290,000L, now company is well positioned to manufacture future biopharmaceutical medicines, both from its own research pipeline and as contract manufacturer for other pharmaceutical and biopharmaceutical companies.
Contract manufacturing services are mainly benefitting the small-scale companies, which lack the facilities for the bio-manufacturing and also intend to not invest in fixed assets like steel bioreactors and bioprocessing facilities thus giving an opportunity for the CMOs to gain market presence.
The contract biomanufacturing global market is dominated by North American region commanded the largest revenue in 2018 and expected to grow at a double digit CAGR according to the publisher's estimation. The Asia Pacific region is witnessing huge growth opportunities in terms of biologics outsourcing and many local contract manufacturing organizations are taking the lead in making this region the most sought after destination for biologics outsourcing.
Some of the reasons why countries such as China and India are favourite destinations for such projects include the lower cost of labour, higher technical expertise and favourable government regulations in countries such as China. The Asia-Pacific is expected to grow at highest double digit CAGR from 2018 to 2027.
The global bio-manufacturing outsourcing market is driven by factors such as globalization of bio-manufacturing facilities, increased funding from private venture capitals and government organizations, increasing outsourcing budgets and the emergence of latest technologies such as single-use bioreactors.
An example of such investment includes WuXi Biologics, a contract development and manufacturing organization invested $240 million in a 25-acre site which is located in Shijiazhuang for the development of labs, as well as clinical manufacturing capabilities with a 5,000L bioreactor and 48,000L bioreactor for commercial manufacturing.
There are restraints and threats as well which could potentially hamper the biomanufacturing outsourcing market. These include unequal distribution of biomanufacturing capacities around the globe which could pose capacity constraints in future, Stringent regulatory affairs and mandatory cGMP certifications which could make the drug manufacture process to further low down, outsourcing being restricted to only small and mid-sized companies are another major restraint where large companies are looking for CMOs as an option only when there are insufficient capabilities internally.
1 Contract Biomanufacturing Global Market
1.1 Executive Summary
2 Market Analysis
2.1 Factors Influencing Market
2.1.1 Drivers And Opportunities
22.214.171.124 Globalization Of Outsourcing For Bio-Manufacturing
126.96.36.199 Increased Funding From Private Investors And Government For Development Of Cmos
188.8.131.52 The Emergence Of Single-Use Bioreactors
184.108.40.206 Increasing Biologics Approvals In The Past Year
220.127.116.11 Successful Collaboration And Low Cost For Outsourcing
2.1.2 Restraints And Threats
18.104.22.168 The High Requirement For Capital Investments Restraining Many Cmos To Enter The Biologics Space
22.214.171.124 Risk Of Product Contamination & Maintaining High Productivity
126.96.36.199 Entry Of Large Pharmaceutical Company With Excess Capacity Into The Cmo Market
188.8.131.52 Stringent Regulations And Mandatory Requirement Of Cgmp Certifications
3 Contract Biomanufacturing Services
3.2 Contract Biomanufacturing, By Process
3.2.1 Biomanufacturing By Mammalian Cell Culture
3.2.2 Biomanufacturing By Microbial Cell Culture
3.2.3 Biomanufacturing By Other Cell Culture
3.3 Contract Biomanufacturing Global Market, By End Users
3.3.1 Contract Biomanufacturing Of Diagnostics
3.3.2 Contract Biomanufacturing Of Research Reagents
3.3.3 Contract Biomanufacturing Of Therapeutics
3.4 Contract Biomanufacturing Global Market, By Region
3.5 Competitive Landscape
3.5.1 Capacity Comparison
3.5.2 Contract Biomanufacturing Global Market Share, By Leading Players
3.6 Company Developments
3.6.1 Merger And Acquisition By Cmos
3.6.3 Capacity Expansions
4 Company Profiles
4.1 Abzena Plc
4.1.3 Service Portfolio
4.1.4 Key Developments
4.1.5 Swot Analysis
4.2 Albany Molecular Research Inc
4.2.3 Service Portfolio
4.2.4 Key Developments
4.2.5 Swot Analysis
4.3 Asahi Glass Co. Ltd. (AGC Bioscience/CMC Biologics)
4.3.3 Service Portfolio
4.3.4 Key Developments
4.3.5 Swot Analysis
4.4 Boehringer Ingelheim
4.4.3 Service Portfolio
4.4.4 Key Developments
4.4.5 Swot Analysis
4.5 Catalent Inc.
4.5.3 Service Portfolio
4.5.4 Key Developments
4.5.5 Swot Analysis
4.6 Charles River Laboratories
4.6.3 Service Portfolio
4.6.4 Key Developments
4.6.5 Swot Analysis
4.7 Fujifilm Diosynth Biotechnologies (Fujifilm Holdings Corporation)
4.7.3 Service Portfolio
4.7.4 Key Developments
4.7.5 Swot Analysis
4.8 Horizon Discovery Group, Plc
4.8.3 Service Portfolio
4.8.4 Key Developments
4.8.5 Swot Analysis
4.9 JHL Biotech Inc.
4.9.3 Service Portfolio
4.9.4 Key Developments
4.9.5 Swot Analysis
4.10 Lonza Group
4.10.3 Service Portfolio
4.10.4 Key Developments
4.10.5 Swot Analysis
4.11 Merck KGaA
4.11.3 Product Portfolio
4.11.4 Key Developments
4.11.5 Swot Analysis
4.12.3 Service Portfolio
4.12.4 Key Developments
4.12.5 Swot Analysis
4.13 Rentschler Biotechnologie Gmbh
4.13.3 Service Portfolio
4.13.4 Key Developments
4.13.5 Swot Analysis
4.14 Samsung Biologics
4.14.3 Service Portfolio
4.14.4 Key Developments
4.14.5 Swot Analysis
4.15 JSR Life Sciences (Selexis SA)
4.15.3 Service Portfolio
4.15.4 Key Developments
4.15.5 Swot Analysis
4.16 Syngene International
4.16.3 Service Portfolio
4.16.4 Key Developments
4.16.5 Swot Analysis
4.17 Patheon N.V. (Thermo Fisher Scientific)
4.17.3 Service Portfolio
4.17.4 Key Developments
4.17.5 Swot Analysis
4.18 Wuxi Biologics (Wuxi Apptec)
4.18.3 Service Portfolio
4.18.4 Key Developments
4.18.5 Swot Analysis
List Of Tables
Table 1 Capacity Comparison Of Contract Manufacturing Organizations V’S In-House Capacities (L)
Table 2 Contract Biomanufacturing Global Market Revenue, By Stage ($Bn)
Table 3 Contract Biomanufacturing Global Market Revenue, By Process ($Bn)
Table 4 Contract Manufacturing Organizations Capacity, By Process (L)
Table 5 Drugs Synthesized In Microbial Cell Culture
Table 6 Biomanufacturing Outsourcing Global Market, By End Users 2017-2027 ($Bn)
Table 7 Selected FDA Approved Therapeutic Peptides And Proteins
Table 8 Biomanufacturing Outsourcing Global Market, By Region 2017-2027 ($Bn)
Table 9 Company Comparison Matrix, By Manufacturing Capability
Table 10 Mergers And Acquisitions (2017-2018)
Table 11 Collaborations (2017-2018)
Table 12 Capacity Expansions (2017-2018)
Table 13 Abzena Plc: Total Revenue And R&D Expenses (2016-2018) ($Mn)
Table 14 Abzena Plc: Total Revenue, By Segment, (2016-2018) ($Mn)
Table 15 Abzena Plc: Total Revenue, By Geography, (2016-2018) ($Mn)
Table 16 Asahi Glass Co. Ltd.: Total Revenue And R&D Expenses, (2016-2018(Q3)) ($Mn)
Table 17 Asahi Glass Co. Ltd. : Total Revenue, By Segments, (2016-2018(Q3)) ($Mn)
Table 18 Boehringer Ingelheim: Total Revenue And R&D Expenses, (2015-2017) ($Mn)
Table 19 Boehringer Ingelheim: Total Revenue, By Segments, (2015-2017) ($Mn)
Table 20 Boehringer Ingelheim: Total Revenue, By Geography, (2015-2017) ($Mn)
Table 21 Catalent Inc: Total Revenue And R&D Expenses (2016-2018) ($Mn)
Table 22 Catalent Inc: Total Revenue, By Segment, (2016-2018) ($Mn)
Table 23 Charles River Laboratories: Total Revenue And R&D Expenses, (2016-2018(Q3)) ($Mn)
Table 24 Charles River Laboratories: Total Revenue, By Segments, (2016-2018(Q3)) ($Mn)
Table 25 Charles River Laboratories: Total Revenue, By Geography, (2016-2018(Q3)) ($Mn)
Table 26 Fujifilm Diosynth (Fujifilm Holdings Corporation): Total Revenue And R&D Expenses, (2016-2018(H1)) ($Mn)
Table 27 Fujifilm Diosynth (Fujifilm Holdings Corporation): Total Revenue, By Segments (2016-2018(H1)) ($Mn)
Table 28 Fujifilm Diosynth (Fujifilm Holdings Corporation): Total Revenue, By Geography (2017-2019(H1)) ($Mn)
Table 29 Horizon Discovery Group: Total Revenue And R&D Expenses, (2016-2018(H1)) ($Mn)
Table 30 Horizon Discovery Group: Total Revenue, By Segments, (2016-2018(H1)) ($Mn)
Table 31 Horizon Discovery Group: Total Revenue, By Geography, (2016-2018(H1)) ($Mn)
Table 32 JHL Biotech: Total Revenue And R & D Expenses (2015-2017) ($Mn)
Table 33 Lonza Group: Total Revenue And R&D Expenses (2016-2018(H1)) ($Mn)
Table 34 Lonza Group: Total Revenue, By Segment, (2016-2018(H1)) ($Mn)
Table 35 Lonza Group: Total Revenue, By Geography (2016-2018(H1)) ($Mn)
Table 36 Merck KGaA: Total Revenue And R&D Expenses, (2016-2018(H1)) ($Mn)
Table 37 Merck KGaA: Total Revenue, By Segments, (2016-2018(H1)) ($Mn)
Table 38 Merck KGaA: Total Revenue, By Geography, (2016-2018(H1)) ($Mn)
Table 39 Samsung Biologics Co., Ltd: Total Revenue And R&D Expenses (2016-2018(H1) ($Mn)
Table 40 Samsung Biologics: Total Revenue, By Geography (2016-2018(H1)) ($Mn)
Table 41 Syngene International: Total Revenue And R&D Expenses, (2016-2018(H1)) ($Mn)
Table 42 Syngene International: Total Revenue, By Geography, (2016-2018(H1)) ($Mn)
Table 43 Patheon (Thermo Fisher Scientific): Total Revenue And R&D Expenses (2016-2018(Q3)) ($Mn)
Table 44 Patheon(Thermo Fisher Scientific): Total Revenue, By Segment, (2016-2018(Q3)) ($Mn)
Table 45 Wuxi Biologics: Total Revenue And R&D Expenses, (2016-2018(H1)) ($Mn)
List Of Figures
Figure 1 Market Dynamics
Figure 2 Global Manufacturing Capacity, Cgmp V’S Non-Cgmp, Inhouse V’s CMO, 2017-2027
Figure 3 Capacity Utilization Of Contract Manufacturing Organizations, By Stage (L)
Figure 4 Contract Biomanufacturing Global Market Revenue, By Stage ($Bn)
Figure 5 Contract Biomanufacturing Global Market Revenue, By Process ($Bn)
Figure 6 Capacity Comparison Of Mammalian, Microbial And Other Culture Systems (L)
Figure 7 Bio-Manufacturing Outsourcing Global Market, By End Users ($Bn)
Figure 8 ADC Pipeline For Cancer 2018
Figure 9 Outlook Of Biologics Cmo Global Market, By Region (%) And Manufacturing In Metric Tons, 2018
Figure 10 Capacity Composition Of Top 10 Contract Manufacturing Organizations (L)
Figure 11 Market Share Analysis By Contract Biomanufacturing Major Players, 2018
Figure 12 Company Developments (2017-2018)
Figure 13 Overview: Abzena Plc
Figure 14 Swot: Abzena Plc
Figure 15 Swot: Albany Molecular Research, Inc
Figure 16 Overview: Asahi Glass Co. Ltd.
Figure 17 Swot: Asahi Glass Co. Ltd.
Figure 18 Overview: Boehringer Ingelheim
Figure 19 Swot: Boehringer Ingelheim
Figure 20 Overview: Catalent Inc.
Figure 21 Swot: Catalent Inc.
Figure 22 Overview: Charles River Laboratories
Figure 23 Swot: Charles River Laboratories
Figure 24 Overview: Fujifilm Holdings Corporation
Figure 25 Swot: Fujifilm Diosynth Biotechnologies
Figure 26 Overview: Horizon Discovery Group, Plc
Figure 27 Swot: Horizon Discovery Group, Plc
Figure 28 Overview: JHL Biotech Inc.
Figure 29 Swot: JHL Biotech Inc.
Figure 30 Overview: Lonza Group
Figure 31 Swot: Lonza Group
Figure 32 Overview: Merck KGaA
Figure 33 Swot: Merck KGaA
Figure 34 Swot: Proteogenix
Figure 35 Swot: Rentschler Biotechnologies
Figure 36 Overview: Samsung Biologics
Figure 37 Swot: Samsung Biologics
Figure 38 Swot: JSR Life Sciences (Selexis SA)
Figure 39 Overview: Syngene International
Figure 40 Swot: Syngene International
Figure 41 Overview: Patheon (Thermo Fisher Scientific)
Figure 42 Swot: Patheon (Thermo Fisher Scientific)
Figure 43 Overview: Wuxi Biologics (Wuxi Apptec)
Figure 44 Swot: Wuxi Biologics
Biopharmaceutical companies are seeking operational efficiency, technical expertise in niche areas, regulatory support and the advantage of focusing on core competencies which are pushing them to outsource a part or whole of the research and manufacturing to smaller contract research organizations (CROs), contract development and manufacturing organizations (CDMOs) or Contract manufacturing organizations (CMOs).
Outsourcing has been viewed as a strategic imperative keeping in mind the complexities and capital that goes behind establishing a facility for biologic research and manufacture. Contract biomanufacturing is an increasing trend in the biologics outsourcing global market.
Due to the high demand for biologics and customized and integrated services that the contract manufacturing organizations (CMOs) provide, the manufacturing of biologic drugs in a contracted manner is being highly adopted. The outsourcing of manufacturing gives the opportunity to the large pharma companies to streamline their drug pipelines and also help bring the drugs to market faster.
The latest and cutting-edge technologies that have been installed by CMOs which include single-use bioreactors are creating huge potential for outsourcing market. Examples include, In April 2018 Wuxi Biologics planning to invest $381 million to open new biomanufacturing facility in Ireland, the new facility will use multiple single-use bioreactors for commercial biomanufacturing and it is designed to be able to run continuous bioprocessing.
The company intends to install a total of 48,000L fed-batch and 6,000L perfusion bioreactor.
The contract biomanufacturing global market is valued at $13.3 billion in 2018 and is expected to grow at a CAGR of 15.5% to reach $48.8 billion by 2027. Factors affecting the biologics contract manufacturing market include drivers such as globalization of outsourcing for biomanufacturing, increased funding from private investors and government for development of CMOs, the emergence of the latest technologies such as single-use
However, there are certain restraints that are hindering the growth of the market. These include high requirements for capital investments in setting up huge manufacturing facilities, the risk of product contamination and maintenance of production efficiency.
Entry of large pharmaceutical companies with excess capacity into contract manufacturing and stringent regulations such as mandatory GMP certifications is posing a huge threat to the market. Contrastingly, increasing biologics and biosimilar pipeline and successful collaborations between CMOs and biopharma companies are providing high growth opportunities for the contract biomanufacturing global market.
The market is dominated by top players like Lonza, Boehringer Ingelheim, Catalent, and Samsung Biologics. Other top
players in the contract biomanufacturing global market include Thermo Fisher (Patheon N.V.), Fujifilm Diosynth, JSR Corporation, Wuxi, AGC Asahi Glass (CMC Biologics), Rentschler Biotechnologies GmbH, CRL, Abbvie contract manufacturing, Merck KGaA.
- Abbvie Contract manufacturing
- Affinity Lifesciences
- Ajinomoto Althea, Inc.
- Alexion Pharmaceuticals
- AGC Asahi glass (CMC Biologics)
- Avid Bioservices
- Bharat Biotech Ltd
- Binex Co. Ltd.
- Bioconnect life sciences
- Bioreliance SAFC
- Boehringer Ingelheim
- Cadila Healthcare Ltd
- Catalent Inc.
- Cevec Pharmaceuticals GmbH
- Charles River Laboratories
- Cobra biologics
- Covance research products
- Cytovance Biologics
- Dendreon Corporation
- Europa Bioproducts
- Fujifilm Diosynth Biotechnologies
- GTP technology
- Horizon Discovery
- Inno biologics
- Innovent Bio
- Intas Pharmaceuticals
- JHL biotech
- JSR Corporation (KBI biopharma)
- Jubilant Hollister-Stier
- Kemwell Biopharma
- Lake Pharma
- Lampire Biological Laboratories
- Luina Bio
- Menarini Biotech s.r.l
- Merck GmbH
- Miltenyi Biotech GmbH
- Omnia biologics
- Paragon Bioservices
- Premas biotech Pvt Ltd
- Rentschler Biotechnologie
- Samsung Biologics
- Sandoz GmbH
- Scripps laboratories
- Selexis S.A.
- Serum Institute of India
- Therapure Biopharma
- Toyobo Co. Ltd.
- U-protein express BV
- Vifor Pharma Ltd
- Waisman clinical biomanufacturing
- Wuxi Apptec
- Zymeworks Inc.