The U.S. Biotechnology & Pharmaceutical Services Outsourcing market size was valued at US$ 4.1 billion in 2021 and is expected to hit US$ 6.9 billion by 2030, growing at a compound annual growth rate (CAGR) of 8.2% from 2022 to 2030.
The U.S. Biotechnology & Pharmaceutical Services Outsourcing market size was valued at US$ 4.1 billion in 2021 and is expected to hit US$ 6.9 billion by 2030, growing at a compound annual growth rate (CAGR) of 8.2% from 2022 to 2030.
Growth Factors:
This is due to growing drug development costs coupled with high clinical development failure rates and increasing outsourcing of R&D activities. Patents of many drugs are expected to expire in the near future, which is anticipated to drive the biosimilars market. This, in turn, is anticipated to boost R&D activities of companies for commercializing a generic version of drugs. The launch of generics in the market in a feasible timeline and cost is anticipated to drive the demand for CROs.
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Outsourcing has evolved into a multibillion-dollar industry. The majority of spending is directed toward early development, with roughly two-thirds of yearly expenditures being outsourced. Small and midsized biopharmaceuticals companies spend approximately 90%, accounting for 75% of the new drugs pipeline. The benefits of outsourcing include costs which is a primary concern for many companies and advanced technologies that help to increase the quality of the preformulation process, resulting in a higher-quality final formulation.
Pharmaceutical and biotech companies recruit CROs to provide legal representation. Due to the complicated and fast-changing healthcare rules, there has been substantial growth in the demand for legal representation in recent years, particularly in Europe. For instance, clinical trials in Europe cannot be conducted by sponsors without a registered entity in the EU. There is a mandatory requirement of legal representation provided by companies based in Europe to conduct clinical trials in any of the EU member states. Therefore, legal representative services are provided by various small and large companies, including CROs, to assist non-EU sponsors in conducting clinical trials in Europe.
Regulatory business regulations have been more stringent in recent years. Due to government support for generics over branded drugs, demand for generics has significantly increased. This trend is driving a rising number of small and mid-sized biopharmaceutical and medical device companies to the U.K., leading to an increase in the demand for regulatory support services. As a result, these companies are unable to establish their own regulatory department due to a lack of expertise and financial support. Furthermore, Brexit is predicted to have a substantial influence on the UK’s regulatory environment, as it may result in the EMA’s headquarters being relocated to another nation.
Report Scope of the U.S. Biotechnology & Pharmaceutical Services Outsourcing Market
Report Coverage | Details |
Market Size in 2021 | USD 4.1 Billion |
Revenue Projection By 2030 | USD 6.9 Billion |
Growth Rate | CAGR of 8.2% from 2022 to 2030 |
Base Year | 2021 |
Historical data | 2017 - 2020 |
Forecast Period | 2022 to 2030 |
Segments Covered | Service, End-use |
Companies Mentioned | The Quantic Group; IQVIA Holdings; Parexel International Corporation; Lachman Consultant Services; GMP Pharmaceuticals; Concept Heidelberg GMBH; Covance Inc.; PRA Health Sciences; Charles River Laboratories; Icon Plc |
Service Insights
Based on service, the consulting service segment led the market for biotechnology and pharmaceutical services outsourcing and accounted for the largest revenue share of 24.7% in 2021. The consolidated nature of the market, which leads to an increase in the number of joint ventures, takeovers, acquisitions, and mergers is boosting demand for consulting services. Consulting companies offer various services to meet regulatory compliance, quality assurance, and remediation challenges as well as strategic consulting requirements.
For a pharmaceutical company, the level of expertise and years of experience are crucial factors that are considered for determining outsourcing partners. An increase in the number of fraudulent cases, discrepancies in intellectual property rights, and rise in technological innovations are some of the challenges faced by pharmaceutical/biotechnological companies. Hence, these companies opt for outsourcing partners to help them manage these services, which will allow them to focus on primary goals.
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End-use Insights
The pharmaceutical segment dominated the U.K. biotechnology and pharmaceutical services outsourcing market and held the largest revenue share of 56.6% in 2021.Increase in R&D spending by pharmaceutical companies for development of potential novel products and rise in investments by CROs for the development of core capabilities are expected to drive the market for biotechnology and pharmaceutical services outsourcing in the region in the coming years. In addition, the stringent regulatory scenarios in and Europe are driving the outsourcing of regulatory writing and publishing, legal representation, clinical trial applications and product registration, and consulting services in the market.
The biotech segment is anticipated to register significant growth over the forecast period. Continuous efforts for enhancing productivity and efficiency are driving biotech companies to focus on core competencies and outsource functions that could be handled by CROs, such as regulatory affairs and product design and development services. In addition, lack of capacity and capability in performing regulatory affairs functions and the presence of stringent regulatory requirements in developed countries are expected to propel the growth of biotech companies over the forecast period.
Key Companies & Market Share Insights
Mergers and acquisitions, regional expansion, service portfolio expansion, and competitive pricing are among the key strategies companies are adopting to keep solvent in a highly competitive market and increase market share. For instance, in April 2021, Paraxel International Corporation formed a strategic partnership with Veeva to accelerate clinical trials by leveraging technology and process innovation. The collaboration can help improve study efficiency and accelerate the delivery of new therapies to patients.
The COVID-19 pandemic continues to have a negative impact on a variety of industries, particularly in terms of developments. The impact of the pandemic on the biotechnology industry was relatively minor in the first quarter of 2020. The majority of important metrics, such as venture capital firm new funds raised, clinical trial pace, mergers and acquisitions, and regulatory approval, did not change significantly. On Western Exchange, there were more biotech Initial Public Offerings (IPOs) in the first quarter of 2019 than in the previous quarter.Some of the prominent players in the U.K. biotechnology and pharmaceutical services outsourcing market include:
- The Quantic Group
- IQVIA Holdings
- Parexel International Corporation
- Lachman Consultant Services
- GMP Pharmaceuticals
- Concept Heidelberg GMBH
- Covance Inc.
- PRA Health Sciences
- Charles River Laboratories
- Icon Plc
Segments Covered in the Report
This research report offers market revenue, sales volume, production assessment and prognoses by classifying it on the basis of various aspects. Further, this research study investigates market size, production, consumption and its development trends at U.S. for the period of 2017 to 2030
- By Service
- Consulting
- Regulatory Compliance
- Remediation
- Quality Management Systems Consulting
- Others
- Auditing And Assessment
- Regulatory Affairs
- Clinical Trial Applications & Product Registration
- Regulatory Writing & Publishing
- Legal Representation
- Others
- Product Maintenance
- Product Design & Development
- Product Testing & Validation
- Training & Education
- Others
- Consulting
- By End-use
- Pharmaceutical
- Biotech
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Key Questions Answered in U.K. Biotechnology & Pharmaceutical Services Outsourcing Market Report
- What will be the sales/revenue generated by U.K. Biotechnology & Pharmaceutical Services Outsourcing across all regions during the forecast period?
- What are the opportunities in the U.K. Biotechnology & Pharmaceutical Services Outsourcing 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 application is expected to generate the highest revenue U.S. in 2030?
- Which segment is projected to expand at the highest CAGR during the forecast period?
- What is the market position of different companies operating in the U.S. market?
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