Global Biologics Outsourcing Market - 2023-2030

Global Biologics Outsourcing Market - 2023-2030

Global biologics outsourcing market reached US$ YY million in 2022 and is expected to reach US$ YY million by 2030, growing at a CAGR of YY% during the forecast period 2023-2030.

Biologics outsourcing is a practice where pharmaceutical and biotechnology companies hire specialized third-party organizations, commonly known as Contract Development and Manufacturing Organizations (CDMOs) or Contract Research Organizations (CROs), to take care of different aspects of biologic drug development, manufacturing, and testing.

Biologics are large, complex therapies that are derived from living organisms. They require significant expertise and infrastructure, which makes outsourcing an efficient and cost-effective option. Outsourcing partnerships can cover a wide range of services, including research and development, clinical trial support, process development, and commercial-scale manufacturing. By collaborating with external partners, companies can leverage their capabilities and experience, accelerate drug development, reduce costs, and focus on their core competencies. This ultimately enables the development of innovative biological therapies and brings them to market more effectively.

Market Dynamics: Drivers and Restraints

The biologics outsourcing market is being driven by the increasing demand for biologic drugs. These drugs are derived from living organisms, such as cells or proteins, and are gaining immense importance in healthcare. There are several factors behind this surge in demand.

Biologics offer innovative and highly effective treatment options for a wide range of medical conditions, including cancer, autoimmune diseases, and rare genetic disorders. Monoclonal antibodies, gene therapies, vaccines, and other complex biological products have demonstrated remarkable success in treating previously untreatable or poorly managed diseases. Biologics are becoming more popular among patients and healthcare providers because they offer targeted and personalized treatment approaches.

For instance, in 2022, the US Food and Drug Administration approved 43 new biologics. Monoclonal antibodies were the most common modality for new drugs, and most new drugs on the market were oncology drugs.

In addition, to manage the scale and complexity of these endeavours, many companies are turning to specialized contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) for their expertise and capabilities.

Furthermore, the rising therapeutic value of biologics, increasing partnership and expansion among market players are the other factors expected to drive the market over the forecast period.

Restraint:

The biologics outsourcing market faces multiple challenges that hamper its growth and efficiency. These challenges include the intricate nature of biologic drug manufacturing, strict regulatory requirements, concerns about intellectual property, the necessity of a dependable supply chain, and external factors such as geopolitical dynamics and economic conditions.

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Segment Analysis

The global biologics outsourcing market is segmented based on product, service, source, application, end-user and region.

The analytical testing from the service segment accounted for approximately 42.4% of the biologics outsourcing market share

Analytical testing plays a crucial role in the biologics outsourcing industry. It involves a comprehensive analysis of biopharmaceutical products, ensuring their quality, purity, safety, and efficacy. This encompasses a broad spectrum of tests, including assays for protein structure, impurities, and potency. Outsourcing analytical testing provides access to specialized expertise, and state-of-the-art equipment, and guarantees compliance with strict regulatory requirements. This reduces the burden on biopharmaceutical companies to maintain these capabilities in-house.

The market for biologics is being driven by several factors including the increasing complexity of these products, evolving regulatory standards, and the need for efficient and cost-effective quality control. Key players in this field are established CROs (Contract Research Organizations) and CMOs (Contract Manufacturing Organizations) that specialize in analytical testing. There are also dedicated analytical testing laboratories that have a strong focus on biologics.

For instance, Catalent has been expanding its analytical laboratory capacity and capabilities at both its global manufacturing and standalone analytical facilities. These expansions include investing in equipment to meet the additional analytical needs of advanced therapies, such as viral vectors, cell therapies, mRNA, and protein therapeutics. They are also hiring and developing talented professionals who can address the scientific challenges of biologics.

Geographical Analysis

North America accounted for approximately 43.6% of the market share in 2022

North America is expected to hold the largest market share, owing to the growing product launches, increasing FDA biologics license applications (BLAs), and increasing expansion of the plants.

For instance, on June 08, 2023, Vertex Pharmaceuticals Incorporated and CRISPR Therapeutics announced that the U.S. Food and Drug Administration (FDA) accepted the Biologics License Applications (BLAs) for the investigational treatment exagamglogene autotemcel (exa-cel) for two blood disorders - severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The FDA has granted Priority Review for SCD and Standard Review for TDT. Additionally, the Prescription Drug User Fee Act (PDUFA) target action dates have been assigned, with December 8, 2023, being the target date for SCD and March 30, 2024, for TDT.

Additionally, on July 4, 2023, Biocon Biologics launched Hulia (adalimumab-fkjp) injection, a biosimilar to Humira, in the US market after gaining 5 years of experience in Europe and 2 years in Canada. Adalimumab is a monoclonal antibody that is used to treat debilitating diseases like rheumatoid arthritis and psoriatic arthritis. Biocon Biologics has garnered approvals for multiple biosimilars in over 100 countries including the US and Europe.

Furthermore, on October 16, 2023, Tanvex BioPharma USA Inc., a developer and manufacturer of biopharmaceuticals, launched Tanvex CDMO to provide comprehensive biologic contract development and manufacturing services, offering its experience and expertise to the biopharmaceutical industry.

COVID-19 Impact Analysis

The market for outsourced formulation development services has witnessed significant growth due to the COVID-19 pandemic, particularly in the area of specialized vaccines and treatments. The increasing focus on complex drug molecules for chronic diseases is also contributing to this growth.

The outsourcing of formulation development is driven by the need to create new drugs, advanced delivery systems, and a desire to reduce drug development timelines while managing costs. Large molecule development, particularly biologics, requires specialized expertise and infrastructure, leading to a growing demand for contract development and manufacturing organizations (CDMOs) with the necessary capabilities. The pandemic has accelerated this trend, resulting in closer collaboration with regulatory bodies.

Outsourcing partners play a critical role in providing scientific expertise, innovation, clear communication, and a solid reputation. Outsourcing formulation development can help in cost minimization, gaining a competitive advantage, and improved efficiency. As the demand for outsourced formulation services continues to rise, heavy investments and growth are expected in the sector, along with the adoption of data analytics technologies to aid in better decision-making.

In contrast, the pandemic had a negative impact on the global supply chains, which resulted in delays and shortages of essential raw materials that affected the biologics production process. Moreover, the pandemic has caused clinical trial disruptions and regulatory challenges, slowing down the pace of drug development. However, the biologics outsourcing market remains positive in the long term, as the industry adapts and innovates to overcome the challenges and utilize the opportunities presented by the ongoing public health crisis.

Market Segmentation:

By Product
• Antibodies
Monoclonal Antibodies
Polyclonal Antibodies
Antibody Drug Conjugates
Vaccines
• Vaccines
• Cell and Gene Therapies
• Recombinant Proteins
• Others

By Service
• Process Development
• Cell Development
• cGMP Manufacturing
• Analytical Testing
• Others

By Source
• Mammalian
Animals
Human
• Microorganisms

By Application
• Infectious Diseases
• Vaccine Development
• Cell And Gene Therapy
• Blood Related Product Development
• Stem Cell Research
• Oncology
• Immunological Disorders
• Others

By End-User
• Pharmaceutical Companies
• Biotechnology Companies
• Research Organizations and Academia
• Others

By Region
• North America
U.S.
Canada
Mexico
• Europe
Germany
U.K.
France
Spain
Italy
Rest of Europe
• South America
Brazil
Argentina
Rest of South America
• Asia-Pacific
China
India
Japan
Australia
Rest of Asia-Pacific
• Middle East and Africa

Competitive Landscape

The major global players in the biologics outsourcing market include AbbVie Inc., Thermo Fisher Scientific Inc., Boehringer Ingelheim GmbH, Lonza Group Ag, Catalent Inc., Sartorius Stedim Biotech S.A., Charles River Laboratories International Inc., WuXi Biologics Inc., Samsung Biologics Co. Ltd., Emergent BioSolutions Inc., CordenPharma GmbH, Ajinomoto Bio-Pharma Services, Syngene International Limited, Rentschler Biopharma SE, and Albany Molecular Research Inc. among others.

Key Development
• On June 08, 2023, Vertex Pharmaceuticals Incorporated and CRISPR Therapeutics announced that the Biologics License Applications (BLAs) for the investigational treatment exagamglogene autotemcel (exa-cel) have been accepted by the U.S. Food and Drug Administration (FDA) for severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). The FDA has granted Priority Review for SCD and Standard Review for TDT. The Prescription Drug User Fee Act (PDUFA) target action dates have been assigned as December 8, 2023, and March 30, 2024, respectively.
• On February 2, 2023, Asahi Kasei Medical's subsidiary in the United States, Bionova Scientific, is a full-service biologics Contract Development and Manufacturing Organization (CDMO) and has decided to expand its capacity for process development and GMP biologics manufacturing.
• On September 05, 2023, Enzene Biosciences opened a new lab in Pune and is now offering biologics discovery services to partners. Enzene, the biological arm of Alkem Laboratories, emphasized the importance of cost-effective discovery services for low-cost drugs that can benefit patients. EnzeneX technology, along with these services, can help partners create affordable drugs.

Why Purchase the Report?
• To visualize the global biologics outsourcing segmentation based on product, service, source, application, end-user and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of biologics outsourcing market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global biologics outsourcing market report would provide approximately 92 tables, 91 figures, and 189 Pages.

Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies