The bioassay services market is estimated to be valued at USD 340 Mn in 2024 and is expected to reach USD 2,160 Mn by 2031, growing at a compound annual growth rate (CAGR) of 30.1% from 2024 to 2031.

The market for bioassay services has been witnessing strong growth over the past few years. Continuous technological advancements in the field of drug discovery along with growing research activities in the pharmaceutical industry have been the major factors influencing the demand for various bioassay services. Moreover, rising outsourcing of non-core research activities by biotechnology and pharmaceutical companies is expected to drive increased reliance on specialized bioassay laboratories.

Market Driver - Demand for outsourcing bioanalytical services due to complexity and cost

The development and commercialization process of biological drugs has become highly complex and resource intensive in recent years. Life science companies, particularly small to mid-sized biotech firms, are facing tremendous operational and financial pressure to deliver innovative therapies to patients within strict timelines. The soaring R&D costs have necessitated streamlining of internal operations and focusing core expertise on drug discovery and clinical development. Bioanalysis, being a specialized discipline requiring high-end infrastructure and technical skills, is one such non-core area that is increasingly being outsourced to contract service providers.

Outsourcing bioanalysis allows sponsor companies to leverage the extensive experience and economies of scale of large CROs. With dedicated bioanalytical laboratories operating round-the-clock and employing specialized scientist workforce, CROs are able to optimize resource utilization and turnaround times. They maintain state-of-the-art analytical platforms along with validated bioanalytical methods for different sample types. This helps sponsors save significant costs associated with setting up and maintaining in-house bioanalysis capabilities. Moreover, outsourcing mitigates risks of non-compliance during regulatory audits as CROs are expert in adhering to stringent global bioanalysis guidelines and standards.

The rising complexity of modern biotherapies has also boosted outsourcing trends. Biosimilars, cell and gene therapies, antibodies and other large molecule biologics require complex bioanalytical method development due to their unique structural properties. CROs offer valuable expertise in tackling analytical challenges presented by such novel modalities. Their adept handling of customized bioanalysis needs has attracted many early stage sponsors who earlier relied on in-house resources. The accelerating drug pipeline and emerging modalities are anticipated to continuously augment outsourcing demand in the foreseeable future.

Market Driver - Growth in approvals and development of cell and gene therapies

There has been a tectonic shift in drug development paradigm in last decade with cell and gene therapies emerging at the forefront of innovation. These transformative treatments offer unprecedented capabilities to target root causes of diseases by modifying genes or replacing malfunctioning cells. Sparked by breakthrough approvals and encouraging clinical evidence, cell and gene therapies have generated tremendous interest amongst researchers and investors globally. Government agencies are also prioritizing their review to help bring these novel therapies to patients expeditiously.

The first FDA approval of a gene therapy in 2017 marked the beginning of a new treatment era. Since then, approvals of several cell and gene therapies across indications like cancer, rare diseases and ophthalmology have validated the clinical potential of these modalities. The approvals momentum is further catalyzing investments into early stage pipeline. Market estimates point to over 3000 ongoing clinical trials, a majority of them in Phase 1 and Phase 2 development stages. As these candidates progress through various stages, they will generate unprecedented demand for sophisticated bioanalytical solutions to characterize intricate product profiles and release parameters.

Cell and gene therapy developers also heavily rely on CROs to assist complex developmental activities including assay development, validation, sample analysis and potency testing. Ensuring product safety and maintaining high standards of purity and identity testing require specialized bioanalytical skills which CROs are well equipped with. Their single-use bioprocessing facilities and expertise in handling unique cell and gene therapy samples gain them precedence in outsourcing.

Market Challenge - High operational costs in cell and gene therapy development

One of the major challenges faced by the players in the bioassay services market is the high operational costs associated with cell and gene therapy development. Cell and gene therapy requires specialized laboratory facilities, expensive equipment, and highly skilled staff which significantly adds to the overall R&D expenses. Maintaining cell lines, ensuring sterility and performing analytical testing of multiple candidate molecules under development is a costly affair. Moreover, the regulatory requirements for biosafety and aseptic manufacturing are very stringent for cell and gene therapies which mandates additional capital investments in facilities and processes. Outsourcing certain analytic testing requirements to bioassay service providers helps reduce costs to some extent however overall cell and gene therapy development costs are substantially high compared to conventional drug development. The exorbitant costs pose significant entry barriers for new players and scaling up of these advanced therapies remains a challenge. To address these issues, companies are exploring innovative financing options and collaborations with academic institutions.

Market Opportunity - Expansion into emerging regions like Asia-Pacific and MENA

One of the key opportunities for players in the bioassay services market lies in expanding into emerging healthcare markets in Asia-Pacific and Middle-East and North Africa regions. These regions offer high growth potential owing to rising healthcare spending, growing clinical research outsourcing industry and increasing focus on innovation-driven drug discovery. The Asia-Pacific market in particular stands to benefit from initiatives like making China a global hub for pharmaceutical innovation and development. Additionally, lowering manufacturing costs and availability of skilled resources in these regions provides an added advantage. Leading bioassay service providers can capitalize on this opportunity by establishing local laboratories, partnering with local CROs and investing in sales and marketing activities to raise awareness among pharmaceutical and biotech companies based in emerging markets. This will help drive future growth and diversify business risks for market players.

Many leading players have focused on offering specialized bioassay services to gain domain expertise. For example, Charles River Laboratories focused only on drug discovery and safety assessment bioassays after it spun off its earlier research services division in the 1990s. This strategy helped Charles River become a market leader in preclinical outsourcing. Similarly, MPI Research only offers safety pharmacology and toxicology assays. Such specialization has enabled these players to gain deep expertise that attracts more clients.

Rather than trying to offer services across all therapeutic areas, some players target key niche disease categories where the demand is high. For example, BioScreen concentrates on oncology and immunology bioassays due to high research activity in cancer and unmet medical needs in immunology. Likewise, WuXi AppTec focuses on cell and gene therapy as that is an emerging area with immense potential. Targeting niche areas allows players to develop customized capabilities to serve clients better.

Multiple players have grown significantly through strategic acquisitions that enhance their services portfolio and geographical reach. For instance, in 2015, Charles River acquired Blue Stream Laboratories, a provider of advanced cell-based assay services. This expanded Charles River's cell biology capabilities. Similarly, in 2020, WuXi AppTec acquired Pharmerge to augment its presence in Europe. Such acquisitions have enabled players to cross-sell integrated services to a larger client base globally.

Leading providers continuously invest in automated platforms, data analytics, and AI-enabled technologies to deliver higher-quality and faster assays. For example, Charles River embarked on a multi-year investment plan since 2018 to apply machine learning approaches for.

Insights, By Type of Therapy: Emerging potential of regenerative medicine

In terms of type of therapy, cell therapy sub-segment contributes the highest share of 53.4% in the market owing to the emerging potential of regenerative medicine. Cell therapy has emerged as one of the most promising areas in regenerative medicine and an expanding field of the biomedical sciences. The increasing clinical successes of cell therapy in the treatment of various oncological and non-oncological indications like cardiovascular diseases and diabetes are driving more research and development activities in this segment. Conditions that were previously untreatable are now amenable to cell-based interventions, offering new hope to patients.

Some key factors fostering the growth of cell therapy segment include - the ability of cells to regenerate damaged or lost tissues; wider therapeutic applications of stem cells in treating both acquired and genetic disorders; development of advanced cell processing techniques for isolation, propagation and characterization of various cell types; growing orphan drug designation and approvals for cell therapy products in the treatment of rare diseases; and establishment of specialized regenerative medicine centers offering cell-based services and clinical trials. Additionally, the collaborative efforts between biotech and pharmaceutical companies and research institutes in developing off-the-shelf allogenic cell therapy solutions are further propelling the cell therapy market.

Insights, By Therapeutic Area: Increasing cancer incidence and unmet clinical needs

Oncological disorders sub-segment contributes the highest share of 27.9% in the market owing to increasing cancer incidence and unmet clinical needs. The rising global cancer burden coupled with the lack of effective treatment options for various cancer types is a major driver for oncology disorders segment in the bioassay services market. As per recent statistics by WHO, cancer incidences are projected to increase by over 50% in the next two decades. Despite significant advances, conventional cancer therapies like chemotherapy, radiation and targeted drug therapy have limitations like drug resistance, off-target toxicity and low survival rates in certain cancers. This has created a palpable need for developing improved diagnostic, prognostic and treatment monitoring capabilities.

Bioassay services especially help in cancer drug development by evaluating the efficacy and safety of oncology pipeline molecules. Cell-based and biochemical assays are extensively used during various stages of preclinical and clinical development for oncology compounds. Biomarker identification and validation bioassays also aid in selecting appropriate patient population for clinical trials and help determine treatment responses in a personalized manner. Such capabilities are crucial for developing precision medicine-based solutions for cancers with poor clinical outcomes. Overall, growing emphasis on targeted therapies and companion diagnostics make oncology disorders the largest application segment for bioassay services industry.

• The bioassay services market for cell and gene therapy is positioned for substantial growth, driven by the increasing demand for advanced therapeutic modalities that can address serious clinical conditions at their roots. The market is particularly propelled by the complexity and cost of developing these therapies, making outsourcing to specialized contract research organizations (CROs) a strategic choice for many biopharmaceutical companies.
• Over 30 cell and gene therapies have been approved, and more than 1,200 therapeutic leads are under evaluation, showcasing the rapid expansion and importance of this therapeutic segment.
• Nearly USD 20 billion is invested annually in the bioassay services market for cell and gene therapy by both public and private institutions, highlighting the sector's growth potential and importance.

The major players operating in the bioassay services market include CCRM, Nexelis, Pacific BioLabs, PPD Laboratories, WuXi Advanced Therapies, AnaBioTec, Intertek Pharmaceutical Services, Lonza, and Porton Bio.

• In September 2023, GTP Bioways partnered with Texcell to extend process development and GMP manufacturing of biopharmaceuticals, including viral testing, viral clearance, and bioassays. This partnership is expected to enhance their service offerings and strengthen their position in the market.
• In September 2022, KCAS acquired Active Biomarkers to add world-class bioanalytical expertise and a European footprint, enhancing their large molecule and cell/gene therapy bioassay services.

• By Type of Therapy
  • Cell Therapy
  • Gene Therapy
• By Therapeutic Area
  • Oncological Disorders
  • Infectious Diseases
  • Autoimmune Disorders
  • Rare / Genetic Disorders
  • Cardiovascular Disorders
  • Metabolic Disorders
  • Blood Disorders
  • Neurological Disorders
  • Ophthalmic Disorders