Biologics Contract Research Organization Market: Overview
As per Roots Analysis, the global biologics contract research organization market valued at USD 36 billion in the current year and is anticipated to reach USD 126 billion by 2035, growing at a lucrative CAGR of 13% during the forecast period.
The market sizing and opportunity analysis has been segmented across the following parameters:
Type of Biologic
- Vaccines
- Cell Therapy
- Gene Therapy
- Antibodies
- Recombinant Proteins / Peptides
- Others
Scale of Operation
- Clinical Operations
- Preclinical Operations
Therapeutic Area
- Oncological Disorders
- Cardiovascular Disorders
- Inflammatory Disorders
- Neurological Disorders
- Other Therapeutic Areas
Geography
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East and North Africa
- Rest of the World
Biologics Contract Research Organization Market: Growth and Trends
Biologics are among the fastest expanding sectors within the pharmaceutical industry. This
can be linked to the swift advancement in this area, fueled by the demand for efficient and tailored pharmacological solutions. The increased need for biologics including monoclonal antibodies, gene therapies, and cell therapies is driven by their success in addressing chronic and complex ailments such as cancer, autoimmune diseases, and neurological disorders. This need is intensified by an expanding biologics pipeline and elevated approval rates. Nonetheless, the development and clinical evaluation of biologics is a very intricate and expensive procedure that requires specialized knowledge and cutting-edge bioprocessing technologies. Consequently, numerous biopharmaceutical firms are opting to delegate their drug discovery and clinical research activities.
At present, biopharmaceutical firms are adopting a business model wherein development processes are contracted to external service providers, while the firm itself oversees the R&D of these biologics. The biologics contract research organization sector is experiencing growth fueled by the rising research on innovative medications and illnesses. R&D of biologics is labor-intensive and pharmaceutical companies need significant technological knowledge and specialized expertise, which increases the overall expense of drugs. Moreover, strict regulatory standards and the approval process can delay the approval of drugs, resulting in a drug supply shortfall in the market.
To simplify these intricate processes and address related challenges, leading pharmaceutical companies are progressively delegating their biologics research and development efforts to specialized contract research organizations (CROs). This strategic outsourcing enables them to utilize external knowledge, speed up drug discovery and clinical trials, and ultimately launch innovative biologics to market more effectively. In addition, the integration of AI can speed up drug discovery, enhance clinical trials (such as patient recruitment), and boost manufacturing yields. The domain presents numerous opportunities in implementing automation for bioprocessing and decentralized / virtual clinical trials, which lower expenses and improve data quality. As a result, the biologics contract research organization market is expected to grow steadily to meet the increasing R&D needs of biopharmaceutical sponsors.
Biologics Contract Research Organization Market: Key Insights
The report delves into the current state of the biologics contract research organization market and identifies potential growth opportunities within industry. Some key findings from the report include:
- Presently, 160 players claim to have the necessary capabilities to offer contract research services and clinical trial support for different types of biopharmaceutical products.
- About 50% of all the players offer only clinical services; of these, 12% CROs provide all the services associated with clinical research of biologics.

- The current market landscape is fragmented, featuring a mix of well-established players and specialty service providers, having extensive portfolios to support preclinical and clinical research.
- It is estimated that big pharma players presently outsource close to 45% of their internal R&D operations to CROs.
- More than two-thirds of the contract research service providers are based in North America and Europe; most of these players are small and mid-sized companies.
- In order to gain a competitive edge, companies are actively expanding their existing capabilities in order to further augment their respective offerings and also comply with evolving industry benchmarks.

- Over 8,000 product candidates are currently being evaluated / under development biologic drug developers, presenting opportunities in the biologics contract research organization market.
- The growing interest of stakeholders in this field is also reflected in the increase in partnership activity in the recent past; since 2016, industry players have signed multiple deals with sponsor and / or other CROs.
- Close to 20% of the CROs provide research services for biologics at the clinical and preclinical scales.
- With the rising demand for one-stop shops, industry stakeholders are actively consolidating their capabilities related to biopharmaceutical research, mostly through mergers and acquisitions, and internal expansions.
- The market is expected to grow at a CAGR of ~13% in the coming decade; the opportunity is likely to be well distributed across therapeutic areas, scales of operation, types of biologics, end users and geographical regions.
Biologics Contract Research Organization Market: Key Segments
Clinical Segment is Likely to Hold the Highest Share in the Biologics Contract Research Organization Market
In terms of the scale of operation, the global market for biologics contract research organization market is segmented into discovery, preclinical and clinical. Currently, majority share of the share is captured by clinical scale of operation, followed by preclinical and discovery segments.
North America is Anticipated to Capture the Maximum Biologics Contract Research Organization Market Share
In terms of geographical regions, the global market is segmented into North America, Europe and Asia-Pacific. Amongst these, North America is likely to capture majority (50%) of the market share, followed by Europe (32%) and Asia-Pacific (16%).
Example Players in the Biologics Contract Research Organization Market
- Biocon
- Covance
- ICON
- Medpace
- Pharmaron
- PPD
- PRA Health Sciences
- Syneos Health
- Vimta Labs
- WuXi AppTec
Biologics Contract Research Organization Market: Research Coverage
- Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the global biologics contract research organization market, focusing on key market segments, including [A] type of biologic, [B] scale of operation, [C] therapeutic area and [D] geography.
- Market Landscape: A comprehensive evaluation of the biopharmaceutical services market, based on several relevant parameters, such as [A] year of establishment, [B] company size, [C] location of headquarters, [D] types of biologics manufactured, [E] scale of operation and [F] types of services offered (including clinical services and preclinical services).
- Company Profiles: In-depth profiles of CROs engaged in offering biopharmaceutical related services, focusing on [A] overview of the company, [B] financial information (if available), [C] service portfolio and [D] recent developments and an informed future outlook.
- Benchmarking Analysis: A comprehensive benchmark analysis of players engaged in biologics contract research organization market based on the [A] capabilities of companies within a peer group with an aim to gain a competitive edge.
- Partnerships and Collaborations: An insightful analysis of the deals inked by stakeholders in the biologics contract research organization market, based on several parameters, such as [A] year of partnership, [B] type of partnership, [C] most active players (in terms of number of partnerships signed), [D] scale of operation and [E] geography.
- Mergers and Acquisitions: An in-depth analysis of the mergers and acquisitions undertaken in this domain, based on relevant parameters, such as [A] year of acquisition, [B] type of collaboration, [C] geography, [D] most active acquirers, [E] ownership change matrix, [F] key value drivers and [G] acquisition deal multiples.
- Attractiveness Competitiveness Matrix: A comprehensive acquisition target analysis, considering the historical trend of the activity of companies that have acquired other firms since 2016, and providing a means for other industry players to identify potential acquisition targets.
- SWOT Analysis: An analysis of industry affiliated trends, opportunities and challenges, which are likely to impact the evolution of biologics contract research organization market; it includes a Harvey ball analysis, assessing the relative impact of each SWOT parameter on industry dynamics.
Key Questions Answered in this Report
- How many companies are currently engaged in this market?
- Which are the leading companies in this market?
- What factors are likely to influence the evolution of this market?
- What is the current and future market size?
- What is the CAGR of this market?
- How is the current and future market opportunity likely to be distributed across key market segments?
Reasons to Buy this Report
- The report provides a comprehensive market analysis, offering detailed revenue projections of the overall market and its specific sub-segments. This information is valuable to both established market leaders and emerging entrants.
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