Biotechnology & Pharmaceutical Services Outsourcing Market Size, Share & Trends Analysis Report By Service (Consulting, Regulatory Affairs), By End-use (Pharma, Biotech), And Segment Forecasts, 2021 - 2028

Report Overview

The global biotechnology and pharmaceutical services outsourcing market size was valued at USD 61.2 billion in 2020 and is expected to grow at a compound annual growth rate (CAGR) of 5.2% over the forecast period. Rising pricing pressure, lack of internal capabilities, low-cost service offering by Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs), and access to the industry expertise, are expected to drive the market over the forecast period. In addition, rising drug development costs coupled with higher failure rates and growing regulatory pressure also have a significant impact on market dynamics. Furthermore, well-established CROs, regulatory outsourcing firms, management consulting firms, and contract manufacturers are catering to the complex demand of pharmaceutical and biotechnological sectors.

Contract research and manufacturing companies are investing in personnel, infrastructure, and technology to acquire a significant revenue share of the healthcare outsourcing market. An increasing number of end-to-end service providers to meet the rising demand for low-cost drug development and manufacturing is anticipated to propel the market growth. Moreover, novel drug delivery mechanisms and new product launches are anticipated to drive the outsourcing demand.

Many companies are opting for outsourcing owing to increasing competition in the healthcare industry. For instance, in August 2020, Pfizer Inc. signed a three-year agreement with PPD, Inc. to provide drug development services. Technological advancements and focus on customized care shorten a product’s life cycle, which leads to the rapid development of new products. Increasing R&D activities for new drug development, combination products, and other advanced medicines have increased the demand for contract biotechnology and pharmaceutical services.

Currently, the global pharmaceutical industry has the second-highest R&D intensity measures of any sector, which indicates that the spending on R&D is increasing and the overall spending is likely to grow during the forecast period. Thus, increasing R&D spending is expected to drive the market during the forecast period.

The coronavirus outbreak is having a considerable impact on biotech/pharma services outsourcing. Restrictions on movement & stay-at-home orders are helping reduce the spread of COVID-19. However, this is creating an obstacle in clinical trials and other services intended to find effective treatments for various diseases. The integrity of over 330,000 clinical trials registered on Clinicaltrials.gov remains vulnerable as the novel coronavirus continues to spread worldwide.

In March 2020, at least 18 pharma or biotech companies reported disturbance in drug development as a result of the pandemic. The shift in focus of biopharmaceutical companies on developing vaccines and therapies in response to COVID-19 has resulted in unintended consequences that may potentially disrupt outsourcing. For instance, IQVIA’s Q1 results revealed that nearly 80% of its sites were inaccessible. However, the company accessed nearly 70% of its sites in Q2 and gained full access by Q4. Furthermore, the company projected 10% less revenue in 2020, as compared to the previous year’s guidance.

Service Insights

The consulting services segment accounted for the largest revenue share of over 19% in 2020 and will retain its leading position throughout the forecast period. This growth can be attributed to the increasing M&A activities and constantly changing regulatory protocols. For instance, the government of China issued a notification to upgrade the quality of generic drugs, remove the backlog of drug applications, improve the quality and transparency of the review and approval process, and encourage new drug R&D in line with global development. Moreover, pharma and biotech markets have witnessed the continuous entry of new players, such as Signa Medical Writing, bioSyntagma, and Fieve Clinical Research, Inc.

These companies need to be compliant with set standards and norms, for which consulting is essential as new entrants lack such capabilities. Consulting services comprise regulatory compliance, remediation, quality management systems consulting, and other services. However, the other services segment is expected to register the fastest CAGR over the forecast period owing to the rising outsourcing of generics and biosimilar manufacturing as CMOs are offering services at lower costs. The other services segment is inclusive of contract manufacturing, product upgrade, and IT consulting.

End-use Insights

The pharma end-use segment led the global biotech and pharma services outsourcing market in 2020 and accounted for a revenue share of over 55%. The segment will grow further at the fastest CAGR over the forecast period. Contract service providers are recognized as an effective strategic decision to curb the issues of drug shortfall and high production costs, as well as meet the growing demand.

Lack of resources has prompted many pharmaceutical companies to outsource drug development and manufacturing to CROs and CMOs. The CROs and CMOs offer highly sophisticated development and manufacturing services, such as preclinical development, clinical development, commercial manufacturing, clinical manufacturing, precision injection molding, high-speed automation, assembly, fill/finish, and others for a range of pharma products.

Regional Insights

North America accounted for the highest market share of over 54% in 2020 owing to the presence of several established CROs and CMOs, such as Covance Inc., and growing R&D investments by life sciences and pharmaceutical companies in the region. In addition, the expansion of foreign CMOs and CROs into the region is expected to propel market growth. For instance, in September 2019, Bora Pharmaceuticals received FDA approval for its CMO services, and in October 2019, it opened a sales office in Delaware to expand its business outside Asia.

Asia Pacific is anticipated to be the fastest-growing regional market over the forecast period. The low cost of drug development and manufacturing and availability of a skilled workforce are the key factors driving the market in this region. Moreover, economic policy reforms in countries, such as China, are anticipated to create a balanced economy, which presents ample opportunity for market players to invest in this region. In July 2017, Novotech expanded its site management services in Korea with the launch of Novotech SMO Korea Co. Ltd.

Key Companies & Market Share Insights

Companies are adopting merger and acquisition, regional expansion, service portfolio expansion, and competitive pricing as the key strategies to sustain in the highly competitive environment and acquire a higher market share. In February 2018, Charles River Laboratories acquired MPI research. This is expected to increase its offerings in the analytical testing domain.

The growing complexities are expected to lead to discrepancies in understanding between the healthcare industries; to help minimize the discrepancy, educating personnel is of utmost importance. For instance, NSF International, in February 2017 formed a partnership with the Indian Drug Manufacturers’ Association (IDMA). As part of the agreement, NSF International will offer a customizable program for Pharmaceutical Quality Management (PQM) education in India. Some prominent players in the global biotechnology and pharmaceutical services outsourcing market include:

• The Quantic Group

• IQVIA

• Parexel International Corporation

• Lachman Consultant Services, Inc.

• GMP Pharmaceuticals Pty Ltd.

• Concept Heidelberg GmbH

• Covance Inc.

• Charles River Laboratories

• PRA Health Sciences

• ICON plc 

Biotechnology & Pharmaceutical Services Outsourcing Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2028. For the purpose of this study, Grand View Research has segmented the global biotechnology and pharmaceutical services outsourcing market report on the basis of service, end-use, and region:

• Service Outlook (Revenue, USD Million, 2016 - 2028)

  • Consulting

    • Regulatory Compliance

    • Remediation

    • Quality Management Systems Consulting

    • Others

  • Auditing & 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

• End-use Outlook (Revenue, USD Million, 2016 - 2028)

  • Pharma Companies

  • Biotech Companies

• Regional Outlook (Revenue, USD Million, 2016 - 2028)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE