Biotechnology & Pharmaceutical Services Outsourcing Market by Services (Consulting [Regulatory Compliance, Remediation, Quality Management Systems Consulting, and Others], Auditing & Assessment, Regulatory Affairs [Clinical Trial Applications & Product Registration, Regulatory Writing & Publishing, Legal Representation, and Others], Product Maintenance, Product Design & Development, Product Testing & Validation, Training & Education, and Others), End-Users (Pharma and Biotech), and Regions (Asia Pacific, North America, Latin America, Europe and Middle East & Africa)- Global Industry Analysis, Growth, Share, Size, Trends, and Forecast 2021 – 2028

The global biotechnology & pharmaceutical services outsourcing market size was valued at USD 61.1 billion in 2020 and is anticipated to expand at a CAGR of 5.1% during the forecast period, 2021-2028. The growth of the market is attributed to the increasing price pressure, low-cost service offered by the Contract Research Organizations or the CROs and the Contract Manufacturing Organizations or the CMOs, lack of certain internal abilities, and the access to industry expertise.
 

Pharmaceutical organizations have started to outsource research & development activities of drugs & treatments at an exponential rate through private and academic CROs as their main strategy to become competitive in this unstable economic environment. The research and development tasks that these firms are willing to outsource includes a wide variety of activities from the introductory & basic research to the late-stage development involving genetic engineering, assay development, efficacy & safety tests in animal models, clinical trials that involves humans, target validation, and lead optimization plus hit exploration using candidates as a service. According to the WHO report survey of 2020, the international CRO market, which is the backbone of the pharmaceutical industry, is expecting to become a 50 billion industry by 2023, which is an exponential increase even higher than the analysts predicted on their forecast period. One in every three pharmaceutical company is outsourcing all the activities excluding the marketing, finance and supply chain. The analysts stated that the main reason for this drastic increase was the COVID-19 pandemic.

The coronavirus lockdown had made a significant impact on the biotech pharma services outsourcing, owing to the social distancing and restrictions involving travel that created unnecessary hurdles for the clinical trials and other services provided by the CROs. However, the shift began when the hospital, government authorities and administration bodies decided to increase their investments and funding to the CROs to focus their activities on the coronavirus vaccine. This in turn benefitted the pharmaceutical industry as they had access and played a crucial role in the supply chain management of the vaccination. This along with the further investment by the pharmaceutical & biotech firms in artificial intelligence & machine learning becomes a major reason for the boosting of the biotechnology and pharmaceutical services outsourcing market.

Market Trends, Drivers, Restraints, and Opportunities

• Increase in spending and investing on CRO services is the primary reason for the projection of boosting the global biotechnology & pharmaceutical services outsourcing market growth during the forecast period, 2021-2028.
• There has been major changes in the drug approval process by their respective regional administration bodies, making it more lenient and swift. In the United States, the Century Cures bill was passed on the primary notion of increasing the pace of launch in medical devices and breakthrough drugs. These modifications in the approval processes are major factors boosting the global biotechnology & pharmaceutical services outsourcing market growth.
• High prices for the development of preclinical CROs, high cost of services from the company’s perspective and high maintenance cost for assuring the quality of the services from these CROs, is anticipated to hinder the global biotechnology & pharmaceutical services outsourcing market growth. This becomes extremely difficult to function in developing countries such as India, South Africa and Brazil where there is limited healthcare infrastructure that cannot hold on to biotechnology & pharmaceutical services outsourcings which has no short-term benefits.
• Lack of standardization in the biotechnology & pharmaceutical Services outsourcings does not necessarily comply with the international regulatory requirements that can lead to quality issues and thereby can present as main challenges that can restrict the market expansion in the coming years.
• R&D investment and technological advancement are expected to offer significant opportunities for the market players. Researchers and scientists have now discovered advanced diagnostic techniques such as customized care that can shorten any product’s life cycle which can thereby lead to rapid development of latest drug products and derivatives.

Scope of the Report

The report on the global biotechnology & pharmaceutical services outsourcing market size includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

Global Biotechnology & Pharmaceutical Services Outsourcing Market Segment Insights

Consulting segment is projected to represent a large market share
Based on services, the global biotechnology & pharmaceutical services outsourcing market is divided into consulting, auditing & assessment, regulatory affairs, product maintenance, product design & development, product testing & validation, training & education, and others. The consulting segment is further divided into regulatory compliance, remediation, quality management systems consulting, and others. The regulatory affairs segment is divided into clinical trial applications & product registration, regulatory writing & publishing, legal representation, and others. The consulting segment is expected to constitute a major share of 18.8% of the market during the forecast years, 2021-2028 owing to the increase in merger & acquisition activities with respect to the constant change of regular protocols. There has also been a significant development on the activities which fall under the consulting segment including the upgradation of quality genetic drugs, improvement of transparency and quality in the approval and review processes, and the removal of backlog in certain drug applications. Meanwhile the others segment are anticipated to grow the fastest during this forecast period owing to the increasing outsource of newer developments and projects such as the biosimilar and genetics manufacturing, contract manufacturing, IT consulting, and product upgrade.

 Pharma segment is anticipated to register a major market share
Based on end-users, the global biotechnology & pharmaceutical services outsourcing market is bifurcated into pharma and biotech. The pharma segment is expected to constitute a major share of 54.8% of the market during the forecast years, 2021-2028 owing to the increasing demand of contract service providers which are recognized to be effective in every strategic decision that the pharmaceutical firms decide to limit the shortfall of drugs issue. The pharma segment benefits from these course of actions the most, and thereby has the highest CAGR in this market.
 

 North America is anticipated to dominate the market
On the basis of regions, the global biotechnology & pharmaceutical services outsourcing market is categorized as Asia Pacific, North America, Latin America, Europe and Middle East & Africa. The market in North America is expected to constitute a major share of 53.8% in 2019. This regional market growth can be attributed to the growing research & development expenditure along with the rising in adoption of the latest technology. The demand of biotechnology & pharmaceutical services outsourcing services is increasing rapidly in this region due to the frequent occurrences of chronic diseases. However, the market in Asia Pacific is anticipated to expand at a significant CAGR during the forecast period, 2021-2028, as they have prioritized the cost-efficiency perspective of biotechnology & pharmaceutical services outsourcings combined with their growing population.
 

Segments

Segments Covered in the Report
The global biotechnology & pharmaceutical services outsourcing market size has been segmented in terms of

Services

• 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-Users

• Pharma
• Biotech

Regions

• Asia Pacific
• North America
• Latin America
• Europe
• Middle East & Africa

Key Players

• NSF International
• The Quantic Group
• IQVIA
• PARAXEL International Corporation
• Lachman Consultant Services Inc
• GMP Pharmaceuticals Pvt Ltd
• Concept Heidelberg GmbH
• Covance Inc
• Charles River Laboratories
• PRA Health Sciences
• ICON plc

Competitive Landscape

Major players competing in the global biotechnology & pharmaceutical services outsourcing market are NSF International; The Quantic Group; IQVIA; PARAXEL International Corporation; Lachman Consultant Services Inc; GMP Pharmaceuticals Pvt Ltd; Concept Heidelberg GmbH; Covance Inc; Charles River Laboratories; PRA Health Sciences; and ICON plc. These market players are involved in several business strategies such as mergers, acquisitions partnerships, collaborations, capacity expansion, and product launches to enhance their market shares.

Charles River Laboratories have acquired several small CROs which specialize in specific activities and in February 2018, they obtained MPI research. In February 2017, NSF International established a collaboration with the IDMA (Indian Drug Manufacturers Association) for a period of five years involving the education of Pharmaceutical Quality Management or the PQM in India.