Biologics Regulatory Affairs Outsourcing Market Size | Companies
The global biologics regulatory affairs outsourcing market size was valued at USD 2.85 billion in 2023 and is anticipated to reach around USD 6.68 billion by 2033, growing at a CAGR of 8.89% from 2024 to 2033.
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Market growth can be attributed to the changing regulatory landscape, the need for companies to focus on core business activities, and economic & competitive pressures. The entry of biopharmaceutical companies into global markets and the evolution of new therapy areas such as orphan drugs, ATMPs, biosimilars, and personalized medicine are further predicted to accelerate market growth, as novel therapy areas require advanced technical expertise to comply with regulatory requirements.
Biopharmaceutical companies have to deal with continuous changes in regulatory requirements, which can differ based on business activities and geographies. Noncompliance with the changing regulatory requirement can result in penalties and delays, which may lead to loss of revenue. According to a survey sponsored by Genpact, 72.0% of executives from the life sciences industry consider regulatory compliance one of the top three challenges life sciences companies face. Regulatory departments often face the burden of handling multiple tasks simultaneously and must always ensure compliance with stringent regulatory standards. Increasing efforts by companies to expand their geographical reach and gain rapid approvals in global markets are expected to further contribute to the adoption of outsourcing models for biologics regulatory services.
Regulatory approval procedures among biologics are becoming increasingly stringent, and market players aim to receive product approvals in the first attempt to gain market share. Companies must have an in-house regulatory department or outsource their regulatory affairs due to stringent regulatory requirements in developed economies and changing regulations in developing nations. Establishing an in-house regulatory affairs department in offshore countries is not continuously feasible due to high capital investment and skilled expertise. Hence, companies tend to adopt different outsourcing models based on the size and priority of projects, thereby contributing to the global biologics regulatory affairs outsourcing market.
Moreover, several initiatives, such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), promote global harmonization of regulatory guidelines. This reduces complexity for companies operating in numerous markets but requires compliance with harmonized standards. Further, Mutual Recognition Agreements (MRAs) between key countries enable easier market access and reduce the need for unnecessary testing and inspections, streamlining regulatory processes. Thus, the growing adoption of new regulatory requirements, integration of advanced technologies, and availability of specialized expertise to navigate complex environments effectively are a few factors driving overall industry progression.
Continuous technological advancements in the regulatory affairs industry are one of the major factors driving the overall market growth opportunities. Increasing integration of several technologies, such as adopting advanced analytical techniques for product characterization and quality control, requires companies to upgrade their technology and expertise. In addition, the shift towards electronic submissions (eCTD) and digital platforms for regulatory processes enhances efficiency. However, it requires significant investment in new technologies and training, leading to a preference for outsourcing such services to third-party service providers, thereby driving the market demand. Furthermore, increasing reliance on Health Technology Assessment (HTA) to access market and reimbursement decisions contributes to effective regulatory strategies. Companies must align clinical and economic evidence to meet HTA requirements. Thus, the aforementioned factors are anticipated to drive global market growth.
| Report Attribute | Details |
| Market Size in 2024 | USD 3.10 Billion |
| Market Size by 2033 | USD 6.68 Billion |
| Growth Rate From 2024 to 2033 | CAGR of 8.89% |
| Base Year | 2023 |
| Forecast Period | 2024 to 2033 |
| Segments Covered | Service, phase, modality, phase by service, phase by modality, modality by service, and region |
| Market Analysis (Terms Used) | Value (US$ Million/Billion) or (Volume/Units) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Key Companies Profiled | Lonza AG; Wuxi Apptec Inc.; Thermo Fisher Scientific Inc.; Eurofins Scientific SE; Freyr solutions; Catalent Inc.; Piramal Group; AGC Biologics; ICON Plc; Charles River Laboratories International, Inc.; Labcorp; Parexel International; Medpace Holdings, Inc.; IQVIA; Syneos Health; SGS SA (SGS) |
The regulatory writing & publishing segment dominated the market and accounted for a share of 25.55% in 2023. The high segment growth is primarily attributable to growing R&D investment, upsurge in product pipeline across various therapeutic areas, and increased outsourcing of these services by low and midsized biopharmaceutical companies. Regulatory bodies require comprehensive documentation to ensure the safety, efficacy, and quality of biologics. This includes clinical study reports, investigator brochures, and regulatory submissions such as the Common Technical Document (CTD). Adhering to complex and evolving regulatory guidelines necessitates precise and accurate regulatory writing, stimulating the outsourcing trend among biopharmaceutical companies to seek specialized expertise with reduced procedural costs.
The product registration & clinical trial applications segment is anticipated to witness a lucrative CAGR over the forecast period. The segment growth is attributed to the increasing number of clinical trials globally, stringent regulations in developed markets, and legal/regulatory reforms in emerging markets, such as Asia Pacific and Latin America, which drive the outsourcing trend for product registration and clinical trial applications. A rise in competition among biotech companies encourages market players to outsource clinical trial activities to accelerate their approval process and gain a competitive edge. This is also anticipated to propel segment growth in the near future.
The clinical phase segment accounted for the largest share in 2023. The clinical phase segment is further divided into phase I, II, III, and IV. The high segmental revenue growth can be attributed to the increasing number of clinical trial registrations over the past few years. For instance, as per ClinicalTrials.gov, as of June 2024, there are more than 180,136 active clinical trials across the globe. Furthermore, the complexity of biologics, including gene therapies and monoclonal antibodies, demands sophisticated clinical trial designs and methodologies. In addition, adopting adaptive trial designs to optimize clinical development and respond to interim results adds to the complexity and the need for specialized regulatory expertise. Regulatory affairs outsourcing accelerates the clinical trial process by safeguarding timely and accurate submissions, reducing delays, and speeding up approvals. Thus, the above-mentioned factors are anticipated to accelerate segmental revenue growth.
The preclinical segment is anticipated to grow at the fastest CAGR over the forecast period. This can be attributed to the increasing demand for novel disease treatments, such as COVID-19, Zika virus, and Ebola, as well as the high prevalence of existing diseases, such as CVDs, cancer, and neurological diseases, among others. The high cost of animal models and associated facilities, as well as ethical issues, is anticipated to prompt several biotechnology and pharmaceutical companies to outsource these studies & related regulatory services. Increasing utilization of digital tools and platforms for data management, regulatory submissions, and communication with regulatory agencies offers a competitive edge to service providers in the preclinical regulatory affairs market.
The monoclonal antibodies (mAbs) segment held the largest share in 2023. A rise in the number of mAbs development to treat a wide range of diseases, including cancer, autoimmune disorders, and infectious diseases, supports the segment growth. Moreover, advancements in the development of next-generation mAbs, such as bispecific antibodies and antibody-drug conjugates, require compliance with specific regulatory requirements. In addition, advances in biomanufacturing technologies, such as single-use systems and continuous processing, require updated regulatory submissions and compliance, propelling segmental demand.
The cell and gene therapies segment is anticipated to grow at the fastest CAGR over the forecast period. The robust segment growth is owing to an expanding portfolio of cell and gene therapy products, increased researcher attention on rare diseases, rising research and development investments from both public and private sectors, growing demand for outsourced services related to cell and gene therapies, and increasing prevalence of chronic ailments such as cancer. According to the American Society of Gene & Cell Therapy (ASGCT), as of Q4 2023, more than 3,951 cell & gene and therapy candidates were under development, of which 2,111 are gene therapies and 878 are non-genetically modified cell therapies. The following table summarizes the global status of the gene therapy pipeline as of December 2023.
Furthermore, the globalization of clinical trials and the favorable momentum for accelerated approval pathways encourage biopharmaceutical companies to seek external partners to manage efficient regional regulatory requirements. The growing focus on personalized medicine and the distinctive challenges posed by gene editing technologies further accelerate the demand for specialized regulatory affairs outsourcing in a rapidly expanding segment.
The Nova One Advisor estimated an in-depth research analysis of the adoption of biologics regulatory affairs outsourcing services by development phase and modality. The key insights are as follows:
The biologics regulatory affairs outsourcing market in North America held the largest revenue share of 30.94% in 2023. The regional market growth is attributed to factors, such as a high number of clinical trials, increasing R&D activities, adoption of personalized medicines, and the strong presence of biopharmaceutical companies that outsource part of their regulatory functions to regulatory service providers. The high cost of R&D is a major challenge in the regional market, which has encouraged biopharmaceutical companies to outsource certain functions to service providers with a high level of expertise in the domain. Moreover, there is a growing trend of outsourcing regulatory affairs to specialized CROs and regulatory service providers to access advanced expertise, reduce time-to-market, and focus on core R&D activities.
U.S. Biologics Regulatory Affairs Outsourcing Market Trends
The U.S. biologics regulatory affairs outsourcing market held the largest share of the North American market in 2023. Strong demand for cost-effective generic and biosimilar products in the U.S. contributes to the market growth. For instance, as per Cardinal Health’s 2023 biosimilars report, in 2023, around 40 FDA-approved biosimilars were available in the U.S., 25 of which were commercially available in the market. Thus, increasing the development and approval of novel biosimilars is expected to propel the demand for regulatory services in the U.S., driving market growth. In addition, there is a significant rise in the import of generic and biosimilar products from emerging countries, increasing the demand for regulatory service providers in the region. Furthermore, the rising number of small- and medium-scale biotech companies, which may lack in-house regulatory expertise, is driving demand for outsourced regulatory services to navigate the approval process and commercialize drugs to market.
Europe Biologics Regulatory Affairs Outsourcing Market Trends
The biologics regulatory affairs outsourcing market in Europe is expected to grow significantly due to the stringent regulatory framework imposed by the European Medicines Agency (EMA), which requires specialized knowledge and compliance expertise, prompting companies to outsource these critical regulatory functions. Moreover, the market growth is driven by the need to navigate complex regulatory pathways for advanced biologics, such as gene therapies and biosimilars, which require thorough regulatory submissions and post-approval surveillance. Furthermore, the increasing adoption of digital tools for regulatory management, the growing emphasis on real-world evidence and patient-centric approaches, and the expansion of services to address the rising demand for personalized medicine are a few factors boosting regional market growth.
The Germany biologics regulatory affairs outsourcing market held the largest share in 2023 in Europe owing to a strong presence of the biopharmaceutical market and a skilled & experienced workforce.
The biologics regulatory affairs outsourcing market in the UK is anticipated to grow significantly over the forecast period. Changing regulatory scenario post Brexit in the UK is a driving factor for service providers that cater to specialized knowledge of EU and UK regulatory requirements to navigate complex pathways for biologics approvals, including advanced therapies and biosimilars.
Asia Pacific Biologics Regulatory Affairs Outsourcing Market Trends
The Asia Pacific biologics regulatory affairs outsourcing marketis expected to grow at a CAGR of 10.38% over the forecast period. The high market growth potential is attributed to an improved regulatory landscape, cost affordability, a growing number of clinical trials conducted in the region, and an increasing number of biopharmaceutical companies venturing into the region. Furthermore, the availability of a skilled workforce within the region at a lower cost than in the U.S. is another factor expected to propel growth.
The biologics regulatory affairs outsourcing market in China held the largest share in 2023. Rapid expansion in biologics development and manufacturing within China, coupled with evolving regulatory frameworks overseen by the National Medical Products Administration (NMPA), creates a demand for specialized regulatory expertise. Outsourcing regulatory affairs services influences local knowledge of regulatory processes, including registration, clinical trial applications, and compliance with emerging guidelines. The integration of digital solutions for efficient regulatory submissions, a rise of biosimilars & advanced therapies, and partnerships accelerating access to China's growing healthcare sector are expected to boost market growth. As China continues to solidify its position in biologics innovation, outsourcing regulatory affairs services becomes pivotal for global companies aiming to capitalize on this dynamic market.
The Japan biologics regulatory affairs outsourcing market is expected to grow over the forecast period due to the rising demand for new and cost-effective medicines, which may attract investments from biopharmaceutical companies in this region. Rising demand for generics due to government support and improvement in regulatory approval processes are expected to increase market entrants, thereby propelling the demand for regulatory services in this region.
The biologics regulatory affairs outsourcing market in India is anticipated to grow at the fastest CAGR over the forecast period owing to cost benefits, improved infrastructure facilities, and a large pool of technical expertise.
Latin America Biologics Regulatory Affairs Outsourcing Market Trends
The Latin America biologics regulatory affairs outsourcing market is anticipated to grow substantially over the forecast period. Global biopharmaceutical companies outsource the manufacturing of biopharmaceutical products for clinical trials or sales in emerging countries such as Brazil and Argentina. The outsourcing trend in manufacturing is expected to increase the demand for regulatory services in the region by biopharmaceutical companies, thereby providing an opportunity for regulatory service providers or CROs to explore the market.
The biologics regulatory affairs outsourcing market in Brazil is anticipated to grow at a significant CAGR over the forecast period. Restrictive pricing policies, a complex regulatory framework, and a well-established generic industry are certain factors impacting the growth of this market.
MEA Biologics Regulatory Affairs Outsourcing Market Trends
The MEA biologics regulatory affairs outsourcing market is expected to grow substantially over the forecast period. The rising number of biopharmaceutical companies undertaking outsourcing clinical trials due to advancements in technology, cost-effectiveness, and an easy patient recruitment process contribute to the rising demand for biologics regulatory affairs services in the region.
The biologics regulatory affairs outsourcing market in South Africa is anticipated to grow at the fastest CAGR over the forecast period owing to increasing investments in biotechnology and healthcare infrastructure. Additionally, South Africa's strategic location offers access to diverse patient populations for clinical research, making it attractive for global biopharmaceutical firms seeking cost-effective regulatory solutions and accelerated market entry into the African continent.
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Biologics Regulatory Affairs Outsourcing market.
By Service
By Phase
By Modality
By Phase by Service
By Phase by Modality
By Modality by Service
By Region
Chapter 1. Methodology and Scope
1.1. Market Segmentation & Scope
1.1.1. Regional Scope
1.1.2. Estimates and Forecast Timeline
1.2. Research Methodology
1.3. Information Procurement
1.3.1. Purchased Database
1.3.2. nova one advisor Internal Database
1.3.3. Secondary Sources
1.3.4. Primary Research
1.4. Information or Data Analysis
1.4.1. Data Analysis Models
1.5. Market Formulation & Validation
1.5.1. Region Wise Market: Base Estimates
1.5.2. Global Market: CAGR Calculation
1.6. Model Details
1.6.1. Commodity Flow Analysis (Model 1)
1.6.2. Value-Chain-Based Sizing & Forecasting (Model 2)
1.6.3. QFD Model Sizing & Forecasting (Model 3)
1.6.4. Bottom-Up Approach (Model 4)
1.7. Market Definitions
1.8. List of Secondary Sources
1.9. List of Abbreviations
1.10. Objectives
1.10.1. Objective - 1:
1.10.2. Objective - 2:
1.10.3. Objective - 3:
1.10.4. Objective - 4:
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Outlook
2.2.1. Service Outlook
2.2.2. Phase Outlook
2.2.3. Modality Outlook
2.2.4. Phase by Service Outlook
2.2.5. Phase by Modality Outlook
2.2.6. Modality by Service Outlook
2.2.7. Regional Outlook
2.3. Competitive Insights
Chapter 3. Biologics Regulatory Affairs Outsourcing Market Variables, Trends & Scope
3.1. Market Lineage Outlook
3.1.1. Parent Market Outlook
3.1.2. Ancillary Market Outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.1.1. Growing Number of Clinical Trials
3.2.1.2. Increasing Adoption of the Personalized Medicine and Novel Therapeutics
3.2.1.3. Rising R&D Investment in the Healthcare Industry
3.2.1.4. Advancements in the Regulatory Affairs Market
3.2.2. Market Restraint Analysis
3.2.2.1. Compliance Issues While Outsourcing
3.2.2.2. Managing Relationships
3.3. Technological Advancements
3.3.1. Existing and Emerging Use of Technology and Preferred Tools
3.3.2. Differentiating In-House Tools Vs Widely Available
3.3.3. Key Technology Pillars
3.3.3.1. Digital Transformation and Data Integrity
3.3.3.2. Artificial Intelligence, Machine Learning/Automation
3.3.3.3. Data Analysis and Predictive Modeling
3.3.3.4. Automation of Routine Tasks
3.3.3.5. Compliance Monitoring
3.3.3.6. Discovery and Development
3.3.3.7. Regulatory Guidelines Related to AI/ML
3.3.4. Big Data and Analytics
3.3.5. RTP, Text Processing and Analytics
3.3.6. Speech and Video Analytics
3.3.7. IoT (Internet Of Things)
3.3.8. AI Tools
3.4. Pricing Model Analysis
3.5. Clinical Trials Volume Analysis, 2023
3.5.1. Total Number of Clinical Trials, by Region (2023)
3.5.2. Total Number of Clinical Trials, by Phase (2023)
3.5.3. Total Number of Clinical Trials, by Study Design (2023)
3.5.4. Total Number of Clinical Trials, by Key Therapeutic Area (2023)
3.6. Biologics Regulatory Affairs Outsourcing Market: Analysis Tools
3.6.1. Porter’s Five Forces Analysis
3.6.2. PESTEL Analysis
3.7. COVID-19 Impact Analysis
Chapter 4. Biologics Regulatory Affairs Outsourcing Market: Service Estimates & Trend Analysis
4.1. Segment Dashboard
4.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
4.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, by Service, 2021 to 2033 (USD Million)
4.3.1. Regulatory Consulting
4.3.1.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
4.3.1.2. Strategy & Development Planning
4.3.1.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
4.3.1.3. QA Consulting
4.3.1.3.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
4.3.1.4. Agent Services
4.3.1.4.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
4.3.1.5. Others
4.3.1.5.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
4.3.2. Legal Representation
4.3.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
4.3.3. Regulatory Writing & Publishing
4.3.3.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
4.3.4. Product Registration & Clinical Trial Applications
4.3.4.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
4.3.5. Regulatory Submissions
4.3.5.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
4.3.6. Regulatory Operations
4.3.6.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
4.3.7. Other Services
4.3.7.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
Chapter 5. Biologics Regulatory Affairs Outsourcing Market: Phase Estimates & Trend Analysis
5.1. Segment Dashboard
5.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
5.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, by Phase, 2021 to 2033 (USD Million)
5.3.1. Preclinical
5.3.1.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
5.3.2. Clinical
5.3.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
5.3.2.2. Phase I
5.3.2.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
5.3.2.3. Phase II
5.3.2.3.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
5.3.2.4. Phase III
5.3.2.4.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
5.3.2.5. Phase IV
5.3.2.5.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
Chapter 6. Biologics Regulatory Affairs Outsourcing Market: Modality Estimates & Trend Analysis
6.1. Segment Dashboard
6.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
6.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, by Modality, 2021 to 2033 (USD Million)
6.4. Monoclonal Antibodies (mAbs)
6.4.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
6.5. Recombinant Proteins
6.5.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
6.6. Vaccines
6.6.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
6.7. Cell & Gene Therapies
6.7.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
6.8. Biosimilars
6.8.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
6.9. Others
6.9.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
Chapter 7. Biologics Regulatory Affairs Outsourcing Market: Phase by Service Estimates & Trend Analysis
7.1. Segment Dashboard
7.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
7.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, Phase by Service, 2021 to 2033 (USD Million)
7.3.1. Preclinical
7.3.1.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
7.3.1.2. Regulatory Consulting
7.3.1.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
7.3.1.3. Legal Representation
7.3.1.3.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
7.3.1.4. Regulatory Writing & Publishing
7.3.1.4.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
7.3.1.5. Product Registration & Clinical Trial Applications
7.3.1.5.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
7.3.1.6. Regulatory Submissions
7.3.1.6.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
7.3.1.7. Regulatory Operations
7.3.1.7.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
7.3.1.8. Other Services
7.3.1.8.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
7.3.2. Clinical
7.3.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
7.3.2.2. Regulatory Consulting
7.3.2.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
7.3.2.3. Legal Representation
7.3.2.3.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
7.3.2.4. Regulatory Writing & Publishing
7.3.2.4.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
7.3.2.5. Product Registration & Clinical Trial Applications
7.3.2.5.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
7.3.2.6. Regulatory Submissions
7.3.2.6.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
7.3.2.7. Regulatory Operations
7.3.2.7.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
7.3.2.8. Other Services
7.3.2.8.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
Chapter 8. Biologics Regulatory Affairs Outsourcing Market: Phase by Modality Estimates & Trend Analysis
8.1. Segment Dashboard
8.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
8.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, Phase by Modality, 2021 to 2033 (USD Million)
8.3.1. Preclinical
8.3.1.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
8.3.1.2. Monoclonal Antibodies (mAbs)
8.3.1.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
8.3.1.3. Recombinant Proteins
8.3.1.3.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
8.3.1.4. Vaccines
8.3.1.4.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
8.3.1.5. Cell & Gene Therapies
8.3.1.5.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
8.3.1.6. Biosimilars
8.3.1.6.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
8.3.1.7. Others
8.3.1.7.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
8.3.2. Clinical
8.3.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
8.3.2.2. Monoclonal Antibodies (mAbs)
8.3.2.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
8.3.2.3. Recombinant Proteins
8.3.2.3.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
8.3.2.4. Vaccines
8.3.2.4.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
8.3.2.5. Cell & Gene Therapies
8.3.2.5.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
8.3.2.6. Biosimilars
8.3.2.6.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
8.3.2.7. Others
8.3.2.7.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
Chapter 9. Biologics Regulatory Affairs Outsourcing Market: Modality by Service Estimates & Trend Analysis
9.1. Segment Dashboard
9.2. Global Biologics Regulatory Affairs Outsourcing Market Movement Analysis
9.3. Global Biologics Regulatory Affairs Outsourcing Market Size & Trend Analysis, Modality by Service, 2021 to 2033 (USD Million)
9.3.1. Monoclonal Antibodies (mAbs)
9.3.1.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.1.2. Regulatory Consulting
9.3.1.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.1.3. Legal Representation
9.3.1.3.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.1.4. Regulatory Writing & Publishing
9.3.1.4.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.1.5. Product Registration & Clinical Trial Applications
9.3.1.5.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.1.6. Regulatory Submissions
9.3.1.6.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.1.7. Regulatory Operations
9.3.1.7.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.1.8. Other Services
9.3.1.8.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.2. Recombinant Proteins
9.3.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.2.2. Regulatory Consulting
9.3.2.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.2.3. Legal Representation
9.3.2.3.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.2.4. Regulatory Writing & Publishing
9.3.2.4.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.2.5. Product Registration & Clinical Trial Applications
9.3.2.5.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.2.6. Regulatory Submissions
9.3.2.6.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.2.7. Regulatory Operations
9.3.2.7.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.2.8. Other Services
9.3.2.8.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.3. Vaccines
9.3.3.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.3.2. Regulatory Consulting
9.3.3.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.3.3. Legal Representation
9.3.3.3.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.3.4. Regulatory Writing & Publishing
9.3.3.4.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.3.5. Product Registration & Clinical Trial Applications
9.3.3.5.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.3.6. Regulatory Submissions
9.3.3.6.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.3.7. Regulatory Operations
9.3.3.7.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.3.8. Other Services
9.3.3.8.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.4. Cell & Gene Therapies
9.3.4.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.4.2. Regulatory Consulting
9.3.4.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.4.3. Legal Representation
9.3.4.3.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.4.4. Regulatory Writing & Publishing
9.3.4.4.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.4.5. Product Registration & Clinical Trial Applications
9.3.4.5.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.4.6. Regulatory Submissions
9.3.4.6.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.4.7. Regulatory Operations
9.3.4.7.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.4.8. Other Services
9.3.4.8.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.5. Biosimilars
9.3.5.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.5.2. Regulatory Consulting
9.3.5.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.5.3. Legal Representation
9.3.5.3.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.5.4. Regulatory Writing & Publishing
9.3.5.4.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.5.5. Product Registration & Clinical Trial Applications
9.3.5.5.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.5.6. Regulatory Submissions
9.3.5.6.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.5.7. Regulatory Operations
9.3.5.7.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.5.8. Other Services
9.3.5.8.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.6. Others
9.3.6.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.6.2. Regulatory Consulting
9.3.6.2.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.6.3. Legal Representation
9.3.6.3.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.6.4. Regulatory Writing & Publishing
9.3.6.4.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.6.5. Product Registration & Clinical Trial Applications
9.3.6.5.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.6.6. Regulatory Submissions
9.3.6.6.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.6.7. Regulatory Operations
9.3.6.7.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
9.3.6.8. Other Services
9.3.6.8.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
Chapter 10. Biologics Regulatory Affairs Outsourcing Market: Regional Estimates & Trend Analysis
10.1. Regional Market Dashboard
10.2. Global Regional Market Snapshot
10.3. Market Size, & Forecasts Trend Analysis, 2021 to 2033:
10.4. North America
10.4.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.4.2. U.S.
10.4.2.1. Key Country Dynamics
10.4.2.2. Competitive Scenario
10.4.2.3. Regulatory Scenario
10.4.2.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.4.3. Canada
10.4.3.1. Key Country Dynamics
10.4.3.2. Competitive Scenario
10.4.3.3. Regulatory Scenario
10.4.3.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.4.4. Mexico
10.4.4.1. Key Country Dynamics
10.4.4.2. Competitive Scenario
10.4.4.3. Regulatory Scenario
10.4.4.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.5. Europe
10.5.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.5.2. UK
10.5.2.1. Key Country Dynamics
10.5.2.2. Competitive Scenario
10.5.2.3. Regulatory Scenario
10.5.2.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.5.3. Germany
10.5.3.1. Key Country Dynamics
10.5.3.2. Competitive Scenario
10.5.3.3. Regulatory Scenario
10.5.3.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.5.4. France
10.5.4.1. Key Country Dynamics
10.5.4.2. Competitive Scenario
10.5.4.3. Regulatory Scenario
10.5.4.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.5.5. Italy
10.5.5.1. Key Country Dynamics
10.5.5.2. Competitive Scenario
10.5.5.3. Regulatory Scenario
10.5.5.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.5.6. Spain
10.5.6.1. Key Country Dynamics
10.5.6.2. Competitive Scenario
10.5.6.3. Regulatory Scenario
10.5.6.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.5.7. Denmark
10.5.7.1. Key Country Dynamics
10.5.7.2. Competitive Scenario
10.5.7.3. Regulatory Scenario
10.5.7.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.5.8. Sweden
10.5.8.1. Key Country Dynamics
10.5.8.2. Competitive Scenario
10.5.8.3. Regulatory Scenario
10.5.8.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.5.9. Norway
10.5.9.1. Key Country Dynamics
10.5.9.2. Competitive Scenario
10.5.9.3. Regulatory Scenario
10.5.9.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.6. Asia Pacific
10.6.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.6.2. China
10.6.2.1. Key Country Dynamics
10.6.2.2. Competitive Scenario
10.6.2.3. Regulatory Scenario
10.6.2.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.6.3. Japan
10.6.3.1. Key Country Dynamics
10.6.3.2. Competitive Scenario
10.6.3.3. Regulatory Scenario
10.6.3.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.6.4. India
10.6.4.1. Key Country Dynamics
10.6.4.2. Competitive Scenario
10.6.4.3. Regulatory Scenario
10.6.4.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.6.5. Australia
10.6.5.1. Key Country Dynamics
10.6.5.2. Competitive Scenario
10.6.5.3. Regulatory Scenario
10.6.5.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.6.6. South Korea
10.6.6.2. Competitive Scenario
10.6.6.3. Regulatory Scenario
10.6.6.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.6.7. Thailand
10.6.7.1. Key Country Dynamics
10.6.7.2. Competitive Scenario
10.6.7.3. Regulatory Scenario
10.6.7.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.7. Latin America
10.7.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.7.2. Brazil
10.7.2.1. Key Country Dynamics
10.7.2.2. Competitive Scenario
10.7.2.3. Regulatory Scenario
10.7.2.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.7.3. Argentina
10.7.3.1. Key Country Dynamics
10.7.3.2. Competitive Scenario
10.7.3.3. Regulatory Scenario
10.7.3.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.8. MEA
10.8.1. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.8.2. South Africa
10.8.2.1. Key Country Dynamics
10.8.2.2. Competitive Scenario
10.8.2.3. Regulatory Scenario
10.8.2.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.8.3. Saudi Arabia
10.8.3.1. Key Country Dynamics
10.8.3.2. Competitive Scenario
10.8.3.3. Regulatory Scenario
10.8.3.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.8.4. UAE
10.8.4.1. Key Country Dynamics
10.8.4.2. Competitive Scenario
10.8.4.3. Regulatory Scenario
10.8.4.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
10.8.5. Kuwait
10.8.5.1. Key Country Dynamics
10.8.5.2. Competitive Scenario
10.8.5.3. Regulatory Scenario
10.8.5.4. Market Estimates and Forecast, 2021 to 2033 (USD Million)
Chapter 11. Competitive Landscape
11.1. Market Participant Categorization
11.1.1. Market Leaders
11.1.2. Emerging Players
11.2. Competitive Market share, by Industry (2023)
11.3. Competition Mapping by Service Type (2023)
11.4. Service Heat Map Analysis (a comparative analysis of the players together)
11.5. Company Profiles
11.5.1. Lonza AG
11.5.1.1. Company Overview
11.5.1.2. Financial Performance
11.5.1.3. Service Benchmarking
11.5.1.4. Strategic Initiatives
11.5.2. Wuxi Apptec Inc.
11.5.2.1. Company Overview
11.5.2.2. Financial Performance
11.5.2.3. Service Benchmarking
11.5.2.4. Strategic Initiatives
11.5.3. Thermo Fisher Scientific Inc.
11.5.3.1. Company Overview
11.5.3.2. Financial Performance
11.5.3.3. Service Benchmarking
11.5.3.4. Strategic Initiatives
11.5.4. Eurofins Scientific SE
11.5.4.1. Company Overview
11.5.4.2. Financial Performance
11.5.4.3. Service Benchmarking
11.5.4.4. Strategic Initiatives
11.5.5. Freyrsolutions
11.5.5.1. Company Overview
11.5.5.2. Financial Performance
11.5.5.3. Service Benchmarking
11.5.5.4. Strategic Initiatives
11.5.6. Catalent Inc.
11.5.6.1. Company Overview
11.5.6.2. Financial Performance
11.5.6.3. Service Benchmarking
11.5.6.4. Strategic Initiatives
11.5.7. Piramal Group
11.5.7.1. Company Overview
11.5.7.2. Financial Performance
11.5.7.3. Service Benchmarking
11.5.7.4. Strategic Initiatives
11.5.8. AGC Biologics
11.5.8.1. Company Overview
11.5.8.2. Financial Performance
11.5.8.3. Service Benchmarking
11.5.8.4. Strategic Initiatives
11.5.9. ICON Plc.
11.5.9.1. Company Overview
11.5.9.2. Financial Performance
11.5.9.3. Service Benchmarking
11.5.9.4. Strategic Initiatives
11.5.10. Charles River Laboratories International, Inc.
11.5.10.1. Company Overview
11.5.10.2. Financial Performance
11.5.10.3. Service Benchmarking
11.5.10.4. Strategic Initiatives
11.5.11. Labcorp
11.5.11.1. Company Overview
11.5.11.2. Financial Performance
11.5.11.3. Service Benchmarking
11.5.11.4. Strategic Initiatives
11.5.12. Parexel International
11.5.12.1. Company Overview
11.5.12.2. Financial Performance
11.5.12.3. Service Benchmarking
11.5.12.4. Strategic Initiatives
11.5.13. Medpace Holdings, Inc.
11.5.13.1. Company Overview
11.5.13.2. Financial Performance
11.5.13.3. Service Benchmarking
11.5.13.4. Strategic Initiatives
11.5.14. IQVIA
11.5.14.1. Company Overview
11.5.14.2. Financial Performance
11.5.14.3. Service Benchmarking
11.5.14.4. Strategic Initiatives
11.5.15. Syneos Health
11.5.15.1. Company Overview
11.5.15.2. Financial Performance
11.5.15.3. Service Benchmarking
11.5.15.4. Strategic Initiatives
11.5.16. SGS SA (SGS)
11.5.16.1. Company Overview
11.5.16.2. Financial Performance
11.5.16.3. Service Benchmarking
11.5.16.4. Strategic Initiatives
Cross-segment Market Size and Analysis for Mentioned Segments
Additional Company Profiles
(Upto 5 With No Cost)
Additional Countries (Apart
From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers