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Biologics Contract Manufacturing Market

Growth of novel biologics and biosimilar manufacturing will drive the global market over the forecast duration

Biologics Contract Manufacturing Demand Market Segmented By Monoclonal Antibodies, Vaccines, Growth Factors, Interferons, Recombinant Hormones, Insulin Product with Mammalian, Microbial Platform

Biologics Contract Manufacturing Market Outlook (2023-2033)

Worldwide revenue from the biologics contract manufacturing market stands at US$ 14.4 Bn in 2022, with the global market estimated to surge ahead at a CAGR of 8.6% to reach a valuation of US$ 42.1 Bn by the end of 2033.

Biologics Contract Manufacturing Market Size (2022)

US$ 14.4 Bn

Projected Market Value (2033)

US$ 42.1 Bn

Global Market Growth Rate (2023-2033)

8.6% CAGR

Market Share of Top 5 Countries

67.6%

As assessed by persistence market research, mammalian platforms held a market share of around 72.6% in the global market in 2022.

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Sales Analysis of the Global Biologics Contract Manufacturing from 2015 to 2022 Vs Market Outlook for 2023 to 2033

A company that offers comprehensive services from medication development through manufacturing to other businesses in the biopharmaceutical sector is known as biologics contract manufacturing.

To treat serious, life-threatening diseases, top industry companies are concentrating on the development and introduction of next-generation bio therapeutics. The pipeline of biologics supports an expectation for ongoing robust growth. Every year, the number of biotech patent applications has been increasing at a rate of about 23%.

More than 1,500 biomolecules are currently undergoing clinical trials; they are being tested for more than 100 different diseases, and so far, the success rate for biologics has been more than twice that of small-molecule products.

Biopharmaceuticals contract development and manufacturing services are expected to grow with double digit growth rate owing to huge pipeline of biopharmaceutical therapeutics with limited capability of biopharmaceutical developers. In addition, the big pharma companies has limited capacity for biologics production this incapability leads towards outsourcing of biologics production. Strong biologics pipeline to fuel the demand for the biologics contract manufacturing market.

According to the IMS Institute for Healthcare Informatics, biologic sales go off-patent by 2020 and will reach over $57 billion yearly.

The top worldwide CDMOs are concentrating on increasing their manufacturing capacity while maintaining high operational speed and flexibility. Modern single-use technologies enable businesses to reduce batch manufacturing and cleaning time.

This trend is expected to provide competitive-edge for the client companies in terms of capacity, low cost, convenience and high operational efficacy. Technological advancements to boost CDMOs capabilities which will increase the demand for biologics.

For instance, in June 2020, Lonza has developed the new innovative platform technology, New GSv9 TM media and feeds maximize yield and batch-to-batch consistency to support recombinant protein production scale-up. This provides a robust culturing platform that can reproducibly generate high-quality, stable proteins.

Leading CDMOs are concentrating on the expansion of their integrated capabilities from molecule to final product in light of improvements in contract solutions offerings. The trend is significant since the developers of biopharmaceutical treatments are increasingly depending on the acceleration of development and speed to market.

Additionally, one-stop contract services provide a great degree of cost, risk, and quality control flexibility in the development of final commercial goods. Rising adoption of single –use (disposable) bioreactor technology with high flexibility and cost effectiveness will grow the market in forecast period.

For instance, Avid Bioservices and Argonaut Manufacturing Services signed a contract in July 2020 to provide integrated process development, drug substance manufacturing, and drug product parenteral manufacturing to biotechnology and pharmaceutical clients in order to hasten the development and commercialization of biopharmaceutical therapeutics.

The global market is thus likely to show high growth over the coming years at a CAGR of 8.6% and reach a global market size of US$ 42.1 Bn by 2033.

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What Factors will drive the Market to Grow over Forecast Duration?

“Growth of Novel Biologic and Biosimilar Manufacturing

The global biopharmaceutical CMO market will also see more consolidation as participants look to inorganic growth strategies to offer integrated solutions to customers. In addition, scientific advancements in the biopharmaceuticals are boosting the opportunities for the technologically advanced CDMOs with potential capabilities.

For instance, In July 2020, Lonza Group AG has acquired a California facility from Shire plc. giving the Lonza drug developer another tool to grow its already lucrative mammalian manufacturing business. The facility is located in the San Francisco Bay Area, the 58,000-square-foot site adds 1,000 liter and 2,000 liter single-use bioreactors to Lonza's arsenal, as well as associated downstream capabilities.

In July 2020, AGC Biologics acquired Molecular Medicine S.p.A., a leading-edge cell & gene therapy company in Italy to add capability of plasmid production and end-to-end cell and gene therapy services. Novel biologic and biosimilar manufacturing present strong growth opportunities.

Focusing on reduction in operating costs through outsourcing of R&D and commercialization of biopharmaceuticals to CMOs/CDMOs could increase operational efficiency. Outsourcing at later stages of clinical development through identification and appointment of a strategic partner could improve efficiencies all along the value chain.

The emerging CDMO business model, transformation in the pharmaceutical ecosystem, disruptive drug development and manufacturing technologies, and major growth opportunities in high potency and biopharmaceuticals manufacturing are driving differentiation strategies for the long-term profitability of CMOs. Adoption of CDMO and CMO business model in terms of product offering and reduction in operational cost

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Is there Any Impact on the Growth of the Biologics Contract Manufacturing Market?

Changing Regulatory Dynamics

Global regulatory policies, cGMP, and inspection regimes tightening, supply chain security issues across emerging countries have large impact on the cost of final products. The new entrants willing to enter into biopharmaceuticals contract manufacturing are facing financial challenges owing to aforementioned factors. This makes the market entry a costly decision for SMEs. Such changing regulatory dynamics are hampering the growth of biologics contract manufacturing.

In order to develop the economy and advance, the emerging region requires skilled professionals. Many companies have reported a sizable gap between the skilled professionals and the current workforce. Many governments want to promote the development of a mainstream biotech industry, to mirror the U.S. model, but progress has been slow. Inadequate funding, poor planning and a shortage of experienced individuals have hampered growth of the industry in most emerging countries.

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Country-wise Insights

Why is the U.S. Biologics Contract Manufacturing Market Booming?

“Growing Wellness Initiatives to Raise Public Awareness”

In the market for biologics contract manufacturing in North America in 2022, the U.S. held a market share of about 89.9%. Strong biologics pipelines that are boosting demand for CMOs, high corporate venture capital investments that are advancing biotechnology R&D, and the establishment of important manufacturers and research institutions with specialised programmes for contract manufacturing organisations are all factors driving the growth of this market in U.S.

Will Germany Be a Lucrative Market for Biologics Contract Manufacturing Market?

“More Research and Clinical Trials in Biopharmaceuticals”

In 2022, Germany's share of the European biologics contract manufacturing market was about 33.7%. The market for next-generation therapies in this region is anticipated to be driven more by biological than by pharmacological therapeutic options. As a result, the demand for the biopharmaceutical contract manufacturing market in Germany is increasing due to more research and clinical trials in biopharmaceuticals that are focused on outsourcing the majority of research activities to lower costs.

How is China Emerging as a Prominent Market for Biologics Contract Manufacturing?

“The Chinese Workforce Anticipates Financial Benefits”

In 2022, China had an approximate 18.2% market share of the East Asian biologics contract manufacturing market. The majority of pharma and biopharma companies are concentrating on capitalising on the growth, including seeking out opportunities to collaborate with local organisations, which is assisting this region to emerge and grow over the forecast period. As a result, the market for biopharmaceutical contract manufacturing in the country is growing.

Category-wise Insights

Which Product is driving the Growth of the Global Market?

“Increasing Demand for Antibody-Based Therapeutics”

At 40.7% in 2022, monoclonal antibodies had the biggest market share. The excellent specificity and favourable safety profile of monoclonal antibodies make them the most common type of biologics in the biopharmaceuticals contract research, development, and manufacturing sector. Following recombinant proteins and vaccines, increasing demand for antibody-based treatments is anticipated to fuel expansion in the biologics contract manufacturing industry. Bispecific antibodies and other more sophisticated monoclonal antibody variations are slowly gaining popularity in the pharmaceutical sector, which is anticipated to drive demand growth for biologics contract manufacturing over the projection periods.

Which platform Segment Gained Popularity in the Biologics Contract Manufacturing Market?

“Higher Efficiency and Less Time-Consuming Effort”

Because of the more efficient and takes less time to complete, the mammalian-based category is expected to have the biggest market share of 72.6% in 2022 and increase at a CAGR of roughly 9.2% throughout the forecast period. Mammalian-based cell culture, such as Chinese Hamster Ovary cells (CHO) and recombinant monoclonal antibodies, has been used extensively for the production of biopharmaceuticals as contrasted to other platforms.

Which Therapeutic Area has Gained Popularity in the Biologics Contract Manufacturing Market?

“Rising Incidences and Prevalence of the Targeted Diseases”

Oncology is expected to increase at a CAGR of 7.2% during the forecast period and hold a 24.8% revenue share in 2022. Due to the rising incidences and prevalence of the targeted diseases in the oncology segment around the world, the segment has the greatest revenue share. The engagement of several manufacturers releasing newer product lines in this area, as well as the large number of clinical research activities to discover new therapeutic choices, all contribute to the growth of this market.

Which Application Holds the Highest Share of the Biologics Contract Manufacturing Market?

In 2022, commercial application hold a 71.4% revenue share in the global market for biopharmaceutical contract manufacturing. Due to the rising demand for biologic medications and the substantial scale up facilities of contract manufacturing companies, the commercial segment revenue share is anticipated to increase over the course of the projection period with a growth rate of 9.0%.

Competition Landscape

Key players are concentrating on service updates and expansion in developing regions. Key organisations are strengthening their market presence even more through their expansion, service launches, agreements, partnerships, and developed online services.

Key instances include:

  • In 2021, Lonza Group Ag, disclosed its highest sale after selling Lonza Speciality Ingredients to Bain Capital Private Equity for $4.4B.
  • In November 2021, Abzena limited, a partner research organization for integrated discovery of cGMP and a manufacturer of biopharmaceuticals solutions collaborated with BiVictriX Therapeutics plc, a biotechnology company to manufacture the BiVictriX’s antibody-drug conjugates (ADC).
  • In September 2021 Novasep Company did an exclusive partnership with PharmaZell. The partnership is focussed to develop, manufacture and expand, complex small molecules and ADCs at a global scale.

Similarly, the team at Persistence Market Research has tracked recent developments related to companies offering biologics contract manufacturing services, which is available in the full report.

Industry Report Scope

Attribute

Details

Forecast Period

2023-2033

Historical Data Available for

2015-2022

Market Analysis

  • USD Billion for Value
  • Volume in KL

Key Countries Covered

  • U.S.
  • Canada
  • Mexico
  • Brazil
  • Argentina
  • Germany
  • Italy
  • France
  • U.K.
  • Spain
  • Russia
  • India
  • Indonesia
  • Malaysia
  • Thailand
  • China
  • Japan
  • South Korea
  • Australia
  • New Zealand
  • Turkey
  • GCC
  • South Africa

Key Market Segments Covered

  • Product
  • Platform
  • Therapeutic Area
  • Application
  • Region

Key Companies Profiled

  • BioXcellence (Boehringer Ingelheim)
  • Lonza Group AG
  • Samsung Biologics
  • Fujifilm Diosynth Biotechnologies
  • AbbVie CM (AbbVie Inc.)
  • WuXi Biologics (Cayman) Inc.
  • AGC Biologics
  • Patheon N.V. (Thermo Fisher Scientific Inc.)
  • Emergent BioSolutions Inc.
  • Ajinomoto Bio-Pharma
  • Avid Bioservices, Inc.
  • KBI Biopharma
  • Rentschler Biotechnologie GmbH
  • Merck KGaA
  • Catalent Inc.
  • Therapure Biopharma Inc.
  • Novasep
  • Abzena plc.
  • ProBioGen AG

Report Coverage

  • Market Forecast
  • Competition Intelligence
  • DROT Analysis
  • Market Dynamics and Challenges
  • Strategic Growth Initiatives

Customization & Pricing

Available upon Request

Key Segments Covered in Biologics Contract Manufacturing Industry Research

Product:

  • Monoclonal Antibodies
  • Recombinant Proteins
  • Vaccines
  • Insulin
  • Interferons
  • Growth Factors
  • Others

Platform:

  • Mammalian
  • Microbial

Therapeutic Area:

  • Oncology
  • Autoimmune Disease
  • Metabolic Disease
  • Ophthalmology
  • Cardiovascular Disease
  • Infectious Disease
  • Neurology
  • Respiratory Disorder
  • Others

Application:

  • Commercial
  • Clinical

Region:

  • North America
  • Latin America
  • Europe
  • South Asia
  • East Asia
  • Oceania
  • Middle East & Africa

- Companies Covered in This Report -

  • Samsung Biologics
  • BioXcellence (Boehringer Ingelheim)
  • Lonza Group AG
  • Fujifilm Diosynth Biotechnologies
  • AbbVie CM (AbbVie Inc.)
  • WuXi Biologics (Cayman) Inc.
  • AGC Biologics
  • Patheon N.V. (Thermo Fisher Scientific Inc.)
  • Emergent BioSolutions Inc.
  • Ajinomoto Bio-Pharma
  • Avid Bioservices, Inc.
  • KBI Biopharma
  • Rentschler Biotechnologie GmbH
  • Merck KGaA
  • Catalent Inc.
  • Therapure Biopharma Inc.
  • Novasep
  • Abzena plc.
  • ProBioGen AG

- Frequently Asked Questions -

The global market is currently valued at around US$ 14.4 Bn in 2022.

Sales of the market are set to witness growth at a CAGR of 8.6% and be valued at around US$ 42.1 Bn by 2033.

Demand for the market increased at an 8.6% CAGR from 2015 to 2022.

The U.S., South Korea, Germany, China and U.K. account for most demand for biologics contract manufacturing, currently holding around 67.6% market share.

The U.S. accounts for around 89.9% share of the North American market in 2022.

Latin America accounts for around 0.6% share of the global market in 2022.

China market held a share of about 18.2% in the East Asia biologics contract manufacturing market in 2022.

Germany held around 33.7% market share of the Europe market in 2022.

Brazil market is expected to grow at a 19.2% CAGR during the forecast period.

The market in India is set to expand at a 12.6% CAGR over the forecast period.

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