Specialty Cros Market Research, Industry Trends And Global Forecasts Report 2025-2035: Strong Focus On Preclinical, Biostatistics And Regulatory Services As US Remains Primary Hub

(MENAFN- GlobeNewsWire - Nasdaq) Specialty CROs can capitalize on unmet R&D outsourcing needs, focusing on niche therapeutic areas like oncology and CNS conditions. Growth is driven by tailored services, strategic geographic expansions, and offering diverse services like toxicology, medical writing, and data management.

Dublin, Sept. 30, 2025 (GLOBE NEWSWIRE) -- The "Specialty CROs Market Industry Trends and Global Forecasts to 2035 - Distribution by Target Therapeutic Area, Type of Service and Key Geographical Regions" report has been added to ResearchAndMarkets's offering.

The global specialty CROs market valued at USD 1.2 billion in 2025, is anticipated to grow at a lucrative CAGR of 8.6% during the forecast period.

Over the years, the biopharmaceutical industry has undergone a major transformation in its approach towards R&D outsourcing. Specialty contract research organizations (CROs) have become prominent players, addressing limitations often faced with traditional, full-service CROs.

While full-service providers offer a broad range of capabilities, they frequently struggle to tailor their services to the specific needs of small-scale biotech companies and start-ups contrast, specialty CROs focus on niche segments, delivering expertise in targeted clinical or preclinical services, while concentrating on a particular disease area such as oncology, heart diseases, metabolic disorders, and central nervous system (CNS) conditions.

Services commonly outsourced to these organizations include pharmacovigilance, target evaluation, formulation development, cell line development, data management, project management, biostatistics and others. Further, specialty CROs are also increasingly adopting strategic models to broaden their service offerings and expand geographically, aiming to better serve the evolving needs of the global biopharmaceutical sector.

Specialty CROS Market: Research Coverage

• Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the specialty CROs market, focusing on key market segments, including target therapeutic area, type of service and key geographical regions.
• Market Landscape: A comprehensive evaluation of specialty CROs, based on several relevant parameters, such as geographical location, year of establishment and R&D capabilities.
• Company Profiles: In-depth profiles of specialty CROs focused on specialized preclinical / clinical service offering and particular therapeutic area, based on overview of the company, service portfolio and recent developments and an informed future outlook.
• Case Study 1: A detailed discussion of the virtually integrated, cross-functional outsourcing approach implemented by virtual CROs.
• Case study 2: A detailed discussion of the one-stop-shop approach followed by traditional CROs.

Specialty CROs Market: Key Insights

• The wealth of services offered by CROs have made them an indispensable platform for drug development.
• Over 200 speciality CROs were identified after detailed due diligence of more than 1,000 CROs based on the specific capabilities and the range of services they provide.
• With 26% of the organizations specializing in preclinical services, the service portfolio of these CROs caters to a wide array of client requirements.
• Toxicology and pharmacology are the most popular preclinical services, with ~14% of the CROs offering the services related to toxicology and pharmacology in their respective portfolios.
• Nearly 32 companies specialize in test models and medical imaging / biomarker-based analysis.
• Over 40% of the speciality CROs offered biostatistics related services, followed by speciality CROs offering clinical monitoring and project management services.
• Notably, medical writing and regulatory management / submission is also frequently outsourced.
• Though the overall market is dominated by a handful of bigger CROs, the market within the speciality CRO segment is highly fragmented; US continues to remain the primary hub.
• Newer approaches / untapped opportunity areas are likely to emerge as key growth drivers in the long-term.
• Notably, as specialty CROs further establish their service portfolios, it is believed that the market is likely to sustain the growth momentum in the coming years.

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.
• Stakeholders can leverage the report to gain a deeper understanding of the competitive dynamics within the market. By analyzing the competitive landscape, businesses can make informed decisions to optimize their market positioning and develop effective go-to-market strategies.
• The report offers stakeholders a comprehensive overview of the market, including key drivers, barriers, opportunities, and challenges. This information empowers stakeholders to stay abreast of market trends and make data-driven decisions to capitalize on growth prospects.

SPECIALTY CROs: FOCUSED ON SERVICES

CROs Focused on Preclinical Service Capabilities

• BRI Biopharmaceutical Research
• BTS Research
• Dorizoe Lifesciencess
• Customized Services
• Fluofarma
• KIYATEC
• Redoxis
• Spirovation
• Velesco Pharmaceutical Services

CROs Focused on Clinical Service Capabilities

• Almedis
• Applied Healthcare Resource Management
• CMX Research
• MDappsT
• DZS Clinical Services
• EthosExcelT
• ICRC-Weyer
• Impact Pharmaceutical Services
• Research Dynamics Consulting
• SDS Clinical

SPECIALTY CROs: FOCUSED ON THERAPEUTIC AREAS

• Accelovance
• MedSource
• Novella Clinical

Specialty CROs Focused on Cardiovascular / Cardiology

• Cardialysis
• IonsGate Preclinical Services

Specialty CROs Focused on Metabolic Disorders

• Betagenex
• Physiogenex
• Profil Institute

Specialty CROs Focused on CNS

• Biospective
• RenaSci
• RxGen

CASE STUDY I: VIRTUAL CROs

• Frestedt
• InSymbiosis
• Osiris Pharma
• ProjectPharm
• The Harte Group
• VxP Pharma

CASE STUDY II: FULL SERVICE CROs

• Covance
• Medis Research Group
• Quintiles
• Triclinium Clinical Trial Project Management

FUTURE OPPORTUNITIES

• Chapter Overview
• The Changing Scenario of Outsourcing
• Health Economics and Outcomes Research (HEOR) Studies
• Adaptive Trial Design
• eClinical Solutions
• Risk Based Monitoring (RBM)
• Digital CRO (dCRO)

CONCLUSION

• A Widening Portfolio of Services Governed by Industry Constraints
• Closer Working Collaboration is the Key to Success
• Within Therapeutic Areas, Oncology is the Flagbearer
• Due to Several Niche Offerings, Specialty CRO Market Remains Fragmented
• The Market of Specialty CROs is Likely to Sustain the Growth Momentum
• Untapped Opportunity Areas will Emerge as Key Growth Drivers in the Long-Term
• Concluding Remarks

INTERVIEW TRANSCRIPTS

• Chapter Overview
• Raf Magar, President, CRO and Outcomes Research, AHRM
• Jeffrey P. Kiplinger, President, Averica Discovery Services

Target Therapeutic Area

• Oncological Disorders
• Metabolic Disorders
• Cardiovascular Disorders
• Diabetes
• Others

Type of Service

• Preclinical Services
• Clinical Services

Key Geographical Regions

• North America
• Europe
• Asia-Pacific
• Rest of the World

Additional Benefits

• Complimentary PPT Insights Packs
• Complimentary Excel Data Packs for all Analytical Modules in the Report
• 15% Free Content Customization
• Detailed Report Walkthrough Session with Research Team
• Free Updated report if the report is 6-12 months old or older

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• Specialty CROs - Novel Approaches

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