Biologics Contract Manufacturing Market Highlights Key Development Factors and Upcoming Trends During forecast 2022-2030
Demand for RNA-based COVID-19 Vaccines Creates Revenue Opportunities for Contact Manufacturers
Epidemiological studies indicate that patients with asthma are not at an increased risk of severe COVID-19. Although the severity of coronavirus in patients with asthma is dependent on many factors, currently, there is scarce information on the risks associated with COVID-19 in patients with severe asthma that consume biologics. Nevertheless, companies in the biologics contract manufacturing market are tapping revenue opportunities in vaccine production in order to reduce incidences of the novel infection.
Companies in the global biologics contract manufacturing market are shifting their focus to RNA-based COVID-19 vaccines. In order to meet the demands of the patients, an increasing number of pharmaceutical and biotech companies are entering into mergers & agreements with contract manufacturers to develop COVID-19 vaccines.
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Process Intensification Holds Promising Potentials to Accelerate Business of Life-altering Therapeutics
In order to leverage value-grab opportunities in biologic therapies, it has become imperative to eliminate manufacturing bottlenecks with the help of process intensification (PI). Sartorius AG – an international pharmaceutical and laboratory equipment supplier, covering the segments of bioprocess solutions and lab products & services, is offering solutions for process intensification to accelerate the business of life-altering therapeutics during the ongoing pandemic.
Biologics complexities and long production cycles are fueling the need for PI. Such trends are contributing to the expansion of the biologics contract manufacturing market. PI is helping contract manufacturers to meet key regulatory deadlines, which is crucial for staying ahead in competition. This trend is essential in the manufacturing of biosimilars that need to be produced in several successive batches in a compressed timeline.
Commercialization of Ublituximab for Blood Cancer Treatment
The biologics contract manufacturing market is expected surpass US$ 47.3 Bn by 2031. Monoclonal antibodies are emerging as an important therapeutic approach for blood cancer treatment. TG Therapeutics, Inc. – a clinical-stage biopharmaceutical company, has announced to expand its contract manufacturing deal with Samsung Biologics – a South Korean biotechnology company, to support the production of its investigational anti-CD20 monoclonal antibody, ublituximab.
Companies in the biologics contract manufacturing market are entering into multiple collaborations to increase the availability of ublituximab and enable its commercialization. Companies are re-evaluating their supply needs and securing long-term capacity to meet the global demand for ublituximab.
Glass Containment Solutions and Drug Delivery Devices Ideal for Next-gen Biologics
The biologics contract manufacturing market is projected to clock a CAGR of 12.2% during the forecast period. Stevanato Group – a specialist in world-class systems, processes, and services for pharmaceutical & healthcare industry, is providing novel glass drug containment solutions and drug delivery devices ideal for next-gen drugs.
With the help of state-of-the-art analytical services, reliable technology, and manufacturing equipment, companies in the biologics contract manufacturing market are able to capitalize on incremental opportunities. Biotech drugs such as recombinant proteins and monoclonal antibodies are fueling the demand for glass drug containment solutions and drug delivery devices. The high prevalence of rheumatoid arthritis and osteoporosis is triggering the demand for biologics.
Analysts’ Viewpoint
Due to very low margin for error in the production of life-altering therapeutics for COVID-19 treatment and prevention, companies in the biologics contract manufacturing market should adopt process intensification to avoid production failure. Companies are setting their collaboration wheels in motion to enable long-standing R&D activities involving monoclonal antibodies for blood cancer treatment. Since biologics are challenging to stabilize and administrate, especially in a syringe or a drug delivery device owing to their viscosity, complexity, and sensitivity, companies are using glass drug containment solutions to commercialize biologics. These solutions are necessary since biologics undergo stringent regulatory assessments as compared to generic drugs.
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Biologics Contract Manufacturing Market: Overview
According to Transparency Market Research’s latest market report on the global biologics contract manufacturing market for the historical period of 2017–2019 and forecast period from 2021 to 2031, growth of the biopharmaceutical industry and promising drug pipeline are projected to drive the global biologics contract manufacturing market during the forecast period
According to the report, the global biologics contract manufacturing market was valued at US$ 13.3 Bn in 2020 and is anticipated to expand at a CAGR of 12.2% from 2021 to 2031
Growth of Biopharmaceutical Industry and Promising Drug Pipeline: Key Drivers
Increase in biopharmaceutical sales and pipeline drugs drive the need of biologics clinical development and manufacturing services, from pre-clinical services to commercial manufacturing
Over 3,500 recombinant proteins and antibodies are in pre-clinical and clinical trials, including treatments that have been approved
An increasing number of pipeline molecules are being developed by small and virtual biotech companies. These do not normally have the in-house manufacturing capacity and expertise to bring their candidates to market, and therefore, have a higher propensity to outsource. Presently, these emerging biopharma companies constitute around 80% of the development pipeline.
Increase in Investment in Research & Development
Demand for the development of newer and technologically enhanced products is rising globally, owing to the treatment efficiency of drugs. Hence, major players operating in the market are investing in research & development programs in order to develop new drugs.
Recent intensive researches in novel and combination therapies have established the efficacy of biologics for treating a range of chronic diseases such as cancer, rheumatoid arthritis, macular degeneration, and hematological malignancies
According to CBO, R&D costs have increased by about 8.5% per year in the last decade
The 2020–2021 coronavirus pandemic has spurred the development of vaccines to halt the spread of COVID-19. In addition to R&D spending by the private sector, the federal government has provided support to the private sector to develop vaccines to address the pandemic.
Hence, increase in investment in research & development programs is likely to boost the growth of the market during the forecast period
High Cost of Treatment to Restrain Biologics Contract Manufacturing Market
Biologics are medicines made from living cells that treat common and serious diseases such as cancer, diabetes, rheumatoid arthritis, and other autoimmune diseases. These are highly targeted, efficacious, and have been widely adopted in the treatment of several diseases.
According to data from the IQVIA Institute, in 2017, biologic drugs represented 2% of all the U.S. prescriptions, but 37% of net drug spending
Traditional medicines (small molecules) have relatively simple chemical structures. For instance, Lipitor (atorvastatin), a best-selling cholesterol-lowering drug, comprises 76 atoms and is quite cheap to manufacture. However, biologic drugs (or large molecules) such as monoclonal antibodies are complex proteins, manufactured in living cells, which is a costlier process. Humira (adalimumab), the nation’s top drug in terms of revenue, contains 20,067 atoms.
Therefore, high cost of biologic drugs is likely to restrain the global market during the forecast period
Biologics Contract Manufacturing Market: Competition Landscape
This report profiles major players in the global biologics contract manufacturing market based on various attributes such as company overview, financial overview, product portfolio, business strategies, and recent developments
The biologics contract manufacturing market is fragmented, with the presence of large number of global players and many small players in regional markets
Prominent players operating in the global biologics contract manufacturing market include
- Lonza Group
- Samsung Biologics Co., Ltd.
- Patheon by Thermo Fisher Scientific, Inc.
- Cambrex Corporation
- Siegfried Holding AG
- Fujifilm Holding Corporation
- AbbVie, Inc.
- Boehringer Ingelheim
- Recipharm Pharmaceuticals.
- WuXi Biologics
- Catalent, Inc.
Biologics Contract Manufacturing Market: Key Developments
In August 2021, Catalent, Inc. acquired RheinCell Therapeutics GmbH, a developer and manufacturer of GMP-grade human induced pluripotent stem cells (iPSCs). Upon completion, the acquisition will build upon Catalent’s existing custom cell therapy process development and manufacturing capabilities with proprietary GMP cell lines for iPSC-based therapies.
In May 2021, Charles River Laboratories signed a definitive agreement to acquire U.S.-based gene therapy CDMO, Vigene Biosciences, for US$ 292.5 Mn
In March 2021, WuXi Biologics closed the acquisition of biologics drug substance and product facilities (MFG20/DP9/DP10) from Pfizer China located in Hangzhou, with 2 x 2,000L single-use bioreactors that can be expanded to 4 x 2,000L. The company also acquired CMAB, a biologics contract development and manufacturing organization (CDMO) with operations in Suzhou, China.
In December 2020, WuXi Biologics signed an agreement with Bayer to take over the operations and assets of a drug substance facility (MFG19) located in Wuppertal, Germany that will include 3 x 1,000L perfusion and 6 x 2,000L fed-batch capacity with independent downstream suites.
In August 2020, Samsung Biologics announced an investment of US$ 1.7 Bn for a new biomanufacturing plant, the company’s fourth, in Incheon, South Korea, and for a second bio complex
The report on the global biologics contract manufacturing market discusses individual strategies, followed by company profiles of biologics contract manufacturing providers. The competition landscape section has been included in the global biologics contract manufacturing market report to provide readers with a dashboard view of key market players operating in the global biologics contract manufacturing market.
Key Questions Answered in Biologics Contract Manufacturing Market Report
- What is the sales/revenue generated by biologics contract manufacturing across all regions during the forecast period?
- What are the opportunities in the global biologics contract manufacturing market?
- What are the major drivers, restraints, opportunities, and threats in the market?
- Which regional market is set to expand at the fastest CAGR during the forecast period?
- Which type segment is expected to generate the highest revenue globally in 2031?
- Which segment is projected to expand at the highest CAGR during the forecast period?
- What are the market positions of different companies operating in the global market?
Biologics Contract Manufacturing Market – Segmentation
Type
- Monoclonal Antibodies
- Recombinant Proteins
- Vaccines
- Molecular Therapy
- Others (RNAi, Antisense RNA, etc.)
Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
TABLE OF CONTENT
1. Preface
1.1. Market Definition and Scope
1.2. Market Segmentation
1.3. Key Research Objectives
1.4. Research Highlights
2. Assumptions and Research Methodology
3. Executive Summary: Global Biologics Contract Manufacturing Market
4. Market Overview
4.1. Introduction
4.1.1. Segment Definition
4.2. Overview
4.3. Market Dynamics
4.3.1. Drivers
4.3.2. Restraints
4.3.3. Opportunities
4.4. Global Biologics Contract Manufacturing Market Analysis and Forecast, 2017–2031
4.4.1. Market Revenue Projections (US$ Mn)
5. Key Insights
5.1. Biologics Contract Manufacturing: Overview
5.2. Trends in Biopharma Contract Manufacturing
5.3. Key Industry Events (mergers, acquisitions, collaborations, approvals, etc.)
5.4. COVID-19 Pandemic Impact on Industry
6. Global Biologics Contract Manufacturing Market Analysis and Forecast, by Type
6.1. Introduction & Definition
6.2. Key Findings / Developments
6.3. Market Value & Volume Forecast, by Type, 2017–2031
6.3.1. Monoclonal Antibodies
6.3.2. Recombinant Proteins
6.3.3. Vaccines
6.3.4. Molecular Therapy
6.3.5. Others
6.4. Market Attractiveness Analysis, by Type
7. Global Biologics Contract Manufacturing Market Analysis and Forecast, by Region
7.1. Key Findings
7.2. Market Value & Volume Forecast, by Region
7.2.1. North America
7.2.2. Europe
7.2.3. Asia Pacific
7.2.4. Latin America
7.2.5. Middle East & Africa
7.3. Market Attractiveness Analysis, by Country/Region
8. North America Biologics Contract Manufacturing Market Analysis and Forecast
8.1. Introduction
8.1.1. Key Findings
8.2. Market Value & Volume Forecast, by Type, 2017–2031
8.2.1. Monoclonal Antibodies
8.2.2. Recombinant Proteins
8.2.3. Vaccines
8.2.4. Molecular Therapy
8.2.5. Others
8.3. Market Value & Volume Forecast, by Country, 2017–2031
8.3.1. U.S.
8.3.2. Canada
8.4. Market Attractiveness Analysis
8.4.1. By Type
8.4.2. By Country
9. Europe Biologics Contract Manufacturing Market Analysis and Forecast
9.1. Introduction
9.1.1. Key Findings
9.2. Market Value & Volume Forecast, by Type, 2017–2031
9.2.1. Monoclonal Antibodies
9.2.2. Recombinant Proteins
9.2.3. Vaccines
9.2.4. Molecular Therapy
9.2.5. Others
9.3. Market Value & Volume Forecast, by Country/Sub-region, 2017–2031
9.3.1. Germany
9.3.2. U.K.
9.3.3. France
9.3.4. Spain
9.3.5. Italy
9.3.6. Rest of Europe
9.4. Market Attractiveness Analysis
9.4.1. By Type
9.4.2. By Country/Sub-region
10. Asia Pacific Biologics Contract Manufacturing Market Analysis and Forecast
10.1. Introduction
10.1.1. Key Findings
10.2. Market Value & Volume Forecast, by Type, 2017–2031
10.2.1. Monoclonal Antibodies
10.2.2. Recombinant Proteins
10.2.3. Vaccines
10.2.4. Molecular Therapy
10.2.5. Others
10.3. Market Value & Volume Forecast, by Country/Sub-region, 2017–2031
10.3.1. China
10.3.2. Japan
10.3.3. India
10.3.4. Australia & New Zealand
10.3.5. Rest of Asia Pacific
10.4. Market Attractiveness Analysis
10.4.1. By Type
10.4.2. By Country/Sub-region
11. Latin America Biologics Contract Manufacturing Market Analysis and Forecast
11.1. Introduction
11.1.1. Key Findings
11.2. Market Value & Volume Forecast, by Type, 2017–2031
11.2.1. Monoclonal Antibodies
11.2.2. Recombinant Proteins
11.2.3. Vaccines
11.2.4. Molecular Therapy
11.2.5. Others
11.3. Market Value & Volume Forecast, by Country//Sub-region, 2017–2031
11.3.1. Brazil
11.3.2. Mexico
11.3.3. Rest of Latin America
11.4. Market Attractiveness Analysis
11.4.1. By Type
11.4.2. By Country/Sub-region
12. Middle East & Africa Biologics Contract Manufacturing Market Analysis and Forecast
12.1. Introduction
12.1.1. Key Findings
12.2. Market Value & Volume Forecast, by Type, 2017–2031
12.2.1. Monoclonal Antibodies
12.2.2. Recombinant Proteins
12.2.3. Vaccines
12.2.4. Molecular Therapy
12.2.5. Others
12.3. Market Value & Volume Forecast, by Country/Sub-region, 2017–2031
12.3.1. GCC Countries
12.3.2. South Africa
12.3.3. Rest of Middle East & Africa
12.4. Market Attractiveness Analysis
12.4.1. By Type
12.4.2. By Country/Sub-region
13. Competition Landscape
13.1. Company Profiles
13.1.1. Lonza Group
13.1.1.1. Company Overview (HQ, Business Segments, Employee Strength)
13.1.1.2. Product Portfolio
13.1.1.3. SWOT Analysis
13.1.1.4. Strategic Overview
13.1.2. Samsung Biologics Co., Ltd.
13.1.2.1. Company Overview (HQ, Business Segments, Employee Strength)
13.1.2.2. Product Portfolio
13.1.2.3. SWOT Analysis
13.1.2.4. Strategic Overview
13.1.3. Patheon by Thermo Fisher Scientific, Inc.
13.1.3.1. Company Overview (HQ, Business Segments, Employee Strength)
13.1.3.2. Product Portfolio
13.1.3.2. SWOT Analysis
13.1.3.3. Strategic Overview
13.1.4. Cambrex Corporation
13.1.4.1. Company Overview (HQ, Business Segments, Employee Strength)
13.1.4.2. Product Portfolio
13.1.4.3. SWOT Analysis
13.1.4.4. Strategic Overview
13.1.5. Siegfried Holding AG
13.1.5.1. Company Overview (HQ, Business Segments, Employee Strength)
13.1.5.2. Product Portfolio
13.1.5.3. SWOT Analysis
13.1.5.4. Strategic Overview
13.1.6. Fujifilm Holding Corporation
13.1.6.1. Company Overview (HQ, Business Segments, Employee Strength)
13.1.6.2. Product Portfolio
13.1.6.3. SWOT Analysis
13.1.6.4. Strategic Overview
13.1.7. AbbVie, Inc.
13.1.7.1. Company Overview (HQ, Business Segments, Employee Strength)
13.1.7.2. Product Portfolio
13.1.7.3. SWOT Analysis
13.1.7.4. Strategic Overview
13.1.8. Boehringer Ingelheim
13.1.8.1. Company Overview (HQ, Business Segments, Employee Strength)
13.1.8.2. Product Portfolio
13.1.8.3. SWOT Analysis
13.1.8.4. Strategic Overview
13.1.9. Recipharm Pharmaceuticals
13.1.9.1. Company Overview (HQ, Business Segments, Employee Strength)
13.1.9.2. Product Portfolio
13.1.9.3. SWOT Analysis
13.1.9.4. Strategic Overview
13.1.10. WuXi Biologics
13.1.10.1. Company Overview (HQ, Business Segments, Employee Strength)
13.1.10.2. Product Portfolio
13.1.10.3. SWOT Analysis
13.1.10.4. Strategic Overview
13.1.11. Catalent, Inc.
13.1.11.1. Company Overview (HQ, Business Segments, Employee Strength)
13.1.11.2. Product Portfolio
13.1.11.3. SWOT Analysis
13.1.11.4. Strategic Overview
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