Cell and Gene Therapy Bioanalytical Testing Services Market Size, Share, and Trends 2024 to 2034

Cell and Gene Therapy Bioanalytical Testing Services Market Size and Forecast 2024 to 2034

The global cell and gene therapy bioanalytical testing services market size is projected to reach around USD 1,113.86 million in 2034 from USD 548.55 million in 2024, at a CAGR of 7.34% between 2024 and 2034. The North America cell and gene therapy bioanalytical testing services market size reached USD 209.53 million in 2023.

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Cell and Gene Therapy Bioanalytical Testing Services Market Key Takeaways

• North America dominated the cell & gene therapy bioanalytical testing services market with the largest market share of 41% in 2023.
• Asia Pacific is expected to expand at a solid CAGR of 7.72% during the forecast period.
• By test type, the bioavailability & bioequivalence studies segment accounted for the biggest market share of 37% in 2023.
• By test type, the pharmacokinetics segment is expected to witness considerable growth in the global market over the forecast period.
• By product type, the cell therapy segment held the largest share of the market in 2023 and is expected to sustain its position throughout the forecast period.
• By product type, the gene-modified cell therapy segment is expected to grow significantly in the market during the forecast period.
• By stage of development by product type, the non-clinical segment held the dominating share of the market in 2023.
• By stage of development by product type, the clinical segment is expected to grow at a notable rate in the market during the forecast period.
• By indication, the oncology segment held the largest share of the market in 2023.
• By indication, the rare diseases segment is expected to grow at the fastest rate in the market during the forecast period.

U.S. Cell and Gene Therapy Bioanalytical Testing Services Market Size and Growth 2024 to 2034

The U.S. cell and gene therapy bioanalytical testing services market size was exhibited at USD 157.14 million in 2023 and is projected to be worth around USD 349 million by 2034, poised to grow at a CAGR of 7.52% from 2024 to 2034.

North America held the dominant share of the cell and gene therapy bioanalytical testing services market in 2023. The region is observed to witness prolific growth during the forecast period. Several factors accelerate the growth of the market in the North American region. This region is the home to numerous biotech companies involved in the process of developing and commercializing cell and gene therapies. The region has also been an early adopter of advanced medical therapies, including cell and gene therapies. Renowned universities, medical centers, and research institutions in the region are aggressively working to be at the forefront of cell and gene therapy research. The surge in research activities is boosting the demand for bioanalytical testing services to support preclinical and clinical studies.

The United States is the major contributor to the market and has a sophisticated and vibrant biotechnology industry. Regulatory bodies such as the U.S. FDA have created regulatory pathways for cell and gene therapies. Cell & gene therapy is gaining rapid popularity for several diseases, including heart disease, cancer, cystic fibrosis, hemophilia A, sickle cell disease, and others. CAR T-cell therapy is one of the most prevalent types among developed genetically modified cell therapies and represents 52 percent of the pipeline.

Per Evaluate, CGT made up 10% of all U.S. FDA novel approvals in 2023, up from 7% and 6% in 2022 and 2021, respectively. With the rise in approvals, such as the first CRISPR-based therapeutic approved for marketing in the U.S.

• In June 2024, Anixa Biosciences dosed the sixth patient in its phase 1 clinical trial (NCT05316129), evaluating its novel follicle-stimulating hormone receptor (FSHR)-targeting chimeric endocrine receptor (CER) T-cell therapy for the treatment of recurrent ovarian cancer. The patient is expected to be the final patient in the trial’s second cohort.
• In May 2024, CABA-201 received clearance from the FDA for a phase 1/2 clinical trial (RESET-MG; NCT06359041) in generalized myasthenia gravis and phase 1/2 clinical trial (RESET-SSc; NCT06328777) in systemic sclerosis (SSc). Cabaletta Bio expects to report initial clinical data from these two trials in the second half of this year.

Asia Pacific is observed to expand notably in the cell & gene therapy bioanalytical testing services market during the forecast period. The market is experiencing remarkable economic growth, which results in significant investment in sophisticated healthcare infrastructure and improvement in research activities. The rise in the number of clinical trials for cell and gene therapies is conducted in the Asia Pacific region, which increases the need for extensive bioanalytical testing to assess efficacy and safety and comply with regulatory guidelines.

Developing nations such as India, China, Singapore, South Korea, and Japan are emerging as hubs for pioneering research. The rise in investments from governments and private institutions has helped in the establishment of state-of-the-art facilities and the rapid adoption of groundbreaking technologies. The regulatory improvements offer a predictable environment for testing services and commercialization. Such factors are propelling the region’s market revenue.

Market Overview

Bioanalytical testing refers to the process of identifying and quantifying drugs and metabolites within several biological matrices, including plasma, blood, cerebrospinal fluid, urine serum, and saliva. These tests are generally carried out in pathological labs, diagnostic centers, and research laboratories. They are conducted during the development of drugs and also assist in the drug’s commercialization. Cell and gene treatments are highly preferred in treating autoimmune illnesses, cancer, genetic diseases, and other health conditions. Cell & gene therapy bioanalytical testing services involve robust analysis and evaluation of cellular and genetic therapies to ensure efficacy, safety, and quality. Bioanalytical testing services comply with stringent regulatory guidelines to guarantee the integrity and consistency of results.

Cell and Gene Therapy Bioanalytical Testing Services Market Growth Factors

• The rising R&D investment by pharmaceutical and biopharmaceutical companies is anticipated to fuel the market’s expansion during the forecast period.
• The rise in life-threatening and rare diseases is expected to support the cell & gene therapy bioanalytical testing services market growth during the forecast period.
• regulatory agencies such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) impose stringent requirements on cell and gene therapies to identify safety, quality, and efficacy, driving the cell & gene therapy bioanalytical testing services market growth expansion in the coming years.
• The rapid technological advancements in bioanalytical testing methods are expected to contribute to the growth of the cell & gene therapy bioanalytical testing services market during the forecast period.
• The adoption of cell and gene therapies in emerging markets creates significant growth opportunities for bioanalytical testing services during the forecast period.
• The rapid expansion of cell and gene therapy pipelines contributes to the growth of the cell & gene therapy bioanalytical testing services market.

Cell and Gene Therapy Bioanalytical Testing Services Market Scope

Market Dynamics

Driver

Increasing prevalence of chronic disorders

The increasing incidence of chronic disorders is anticipated to boost the growth of the cell & gene therapy bioanalytical testing services market during the forecast period. The market has witnessed a high burden of chronic diseases, which increases the demand for cell & gene therapies. Cell and gene therapies are gaining significant popularity for the effective treatment of cancer, rheumatoid arthritis, diabetes, Parkinson's disease, Alzheimer's disease, rare diseases, autoimmune diseases, and other chronic disorders. In recent years, these therapies have shown remarkable results in patients' clinical conditions, owing to the numerous cell and gene therapy drug candidates in the pipeline. Therefore, strengthening the pathways for cell and gene therapies boosts the expansion of the market during the forecast period.

• According to the data published by the National Organization for Rare Disorders in February 2024, 1 out of every 10 Americans is living with a rare disease. There are more than 300 million people with rare diseases globally. Rare diseases often are difficult to diagnose and it may take years.
• According to the CDC data published in May 2024, every year in the United States, 1.7 million people are diagnosed with cancer, and more than 600,000 die from it, making it the second leading cause of death.

Restraint

Lack of standardization

The lack of standardization is expected to slow down the growth of the cell and gene therapy bioanalytical testing services market. Cell and gene therapies are complex and involve intricate cellular and genetic modifications. This complexity can lead to challenges in developing accurate and standardized testing methods. Regulatory bodies require rigorous testing to ensure the quality, efficacy, and safety of cell and gene therapies. Meeting these strict regulatory standards takes time. Moreover, the scarcity of skilled professionals with expertise in diverse scientific fields in middle and lower-income countries may limit the global market's expansion.

Opportunities

Increasing investment in cell and gene therapies

The significant rise in investment in cell and gene therapies is projected to offer significant growth opportunities to the cell & gene therapy bioanalytical testing services market in the coming years. Several private and government organizations are aggressively investing in cell and gene therapy-based research. These therapies are developed by research institutions and academic and biopharma companies and have progressed from preclinical research to being evaluated in patients in clinical settings. Cell and gene therapies are a wide group of medicines, such as cell-based immunotherapies, gene therapies, cell therapies, and tissue-engineered products for treating chronic disorders.

Additionally, Regulatory agencies such as the FDA (Food and Drug Administration) and EMA (European Medicines Agency) mandate strict requirements for the approval of cell and gene therapies. Bioanalytical testing services are important for demonstrating product safety, efficacy, and quality, as well as ensuring compliance with the regulatory framework. They necessitate rigorous testing to identify adverse effects, potential risks, and toxicity associated with cell and gene therapies. Such factors are driving the cell & gene therapy bioanalytical testing services market.

According to the IQVIA report in March 2024

• Expenses on cell and gene therapies are substantially rising over the period and reached USD 5.9 billion in 2023, rising 38 percent from 2022, although spending accounted for only 0.4% of the USD 1.6Tn spent on medicines globally in 2023.
• As of the end of 2023, 76 cell and gene therapies have been launched worldwide, more than double the number of therapies that had been launched by 2013.
• In the last five years, 3,285 trials were started to evaluate cell and gene therapies in patients across all sponsor types, including 631 in 2023.

Test Type Insights

The bioavailability & bioequivalence studies segment accounted for the dominating share of the cell & gene therapy bioanalytical testing services market in the year 2023 and is projected to continue its dominance over the forecast period. Bioavailability & bioequivalence studies are typically conducted for drug development. This test verifies the safety and efficacy of the drug during all stages of the trials. A surge in the number of biosimilar versions of cell & gene drugs entering the pipeline increases the demand for bioequivalence studies in the market. As biopharma companies strive for quality assurance and regulatory compliance, the demand for these tests continues to increase and boost the growth of the segment.

The pharmacokinetics segment is expected to witness considerable growth in the global cell & gene therapy bioanalytical testing services market over the forecast period. Pharmacokinetics is the study of the duration of the absorption, distribution, metabolism, and excretion (ADME) of a drug after its administration to the body. This study plays a crucial part in drug development, and it aids in identifying the drug's safety and efficacy in the body. Therefore, the rise in the pipeline of cell & gene products is expected to spur the demand for pharmacokinetics services during the forecast period.

Product Type Insights

The cell therapy segment held the largest share of the cell & gene therapy bioanalytical testing services market in 2023 and is expected to sustain its position throughout the forecast period. Cell therapy involves the transplantation of cells to replace or repair damaged cells or tissue for therapeutic purposes. The cells that will be transplanted into a patient depend on the situation and treatment. Cells can be autologous or allogeneic. Cell therapy is highly effective for the treatment of various diseases, such as cancers, autoimmune diseases, neurological disorders, and urinary problems, rebuilding damaged cartilage in joints, repairing spinal cord injuries, and other infectious diseases. A rise in the number of clinical research studies conducted in cell therapy increases the need for cell & gene therapy bioanalytical testing services across the globe and is expected to boost the growth of the segment.

The gene-modified cell therapy segment is expected to grow significantly in the cell & gene therapy bioanalytical testing services market during the forecast period. Gene-modified cell therapy includes CAR-NK cell therapy, CAR T-cell therapies, TCR-T cell therapy, and others. In recent years, CAR T-cell therapies have gained immense popularity as they are considered very effective against various types of cancer. CAR T cell therapy has shown tremendous results in the treatment of Lymphoma and Leukemia. The continuous advancements in genetic engineering fuel innovation in this field, thus propelling the growth of the gene-modified cell therapy segment in the coming years.

Stage of Development by Product Type Insights

The non-clinical segment held the dominating share of the cell & gene therapy bioanalytical testing services market in 2023 owing to the robust pipeline of cell and gene therapeutics in the non-clinical developmental stage. Pharmaceutical firms prioritize safety, quality, and efficacy in drug development. Moreover, the rising demand among researchers for transitioning the therapy into the clinical stage is accelerating the demand for non-clinical bioanalytical testing services.

The clinical segment is expected to grow at a notable rate in the cell & gene therapy bioanalytical testing services market during the forecast period. Clinical stages play an integral role in the development of new drugs and in determining their safety, efficacy, and optimal dosage forms before they are approved for patient use. During the clinical phase, human samples of plasma, urine, and serum are used for bioanalytical testing and provide researchers with useful insights into drug safety. Moreover, with the stringent regulatory standards, the demand for clinical trial services is anticipated to increase, driving the expansion of the segment.

Indication Insights

The oncology segment held the largest share of the cell & gene therapy bioanalytical testing services market in 2023. The rapid growth of the segment is attributed to the rising burden of cancer globally, which increases the demand for cancer treatment. Cell and gene therapies represent a remarkable approach to cancer treatment. These therapies work by changing the DNA of a patient's existing cells, giving those cells new instructions that can assist in detecting and fighting against cancer. With the surge in cancer cases globally, there is an increasing demand for innovative and effective treatment options. Therefore, the oncology segment is anticipated to maintain its growth rate in the market.

• In April 2024, the American Cancer Society (ACS) released Global Cancer Statistics, 2024, the organization’s report on global cancer facts and trends. According to the findings, an estimated 20 million cancer cases were newly diagnosed in 2022, and 9.7 million people died from the disease worldwide. By 2050, the number of cancer cases is predicted to reach 35 million.

The rare diseases segment is expected to grow at the fastest rate in the cell & gene therapy bioanalytical testing services market during the forecast period owing to the significant progress in cell and gene therapy, including targeted and personalized treatment modalities for several incurable health conditions. Cell and gene therapies have shown remarkable efficacy in addressing clinical indications associated with rare diseases. These therapies have demonstrated promising results for patients with life-threatening rare diseases by targeting the underlying cause of the condition. As the research continues to expand in this field, more therapies are likely to advance through clinical trials. Thereby driving the segment’s growth.

• According to the data published by the NIH in February 2024, Progress in data science and an increased understanding of disease genetics lead experts to agree that more than an estimated 10,000 rare diseases are affecting about 30 million people in the United States. Most of these people are children. In all, nearly 10% of the U.S. population has a rare disease. Even after an accurate diagnosis, treatment is often not available because fewer than 500 rare diseases have FDA-approved treatments.

Cell and Gene Therapy Bioanalytical Testing Services Market Companies

• BioAgilytix Labs
• KCAS Bioanalytical Services
• Pharmaron
• Charles River Laboratories
• Syneos Health
• SGS SA
• Intertek Group Plc
• IQVIA, Inc.
• Laboratory Corporation of America Holdings
• Pharmaceutical Product Development, Inc. (Thermo Fisher Scientific Inc.)
• Prolytix

Recent Developments

• In March 2022, the U.S. Food and Drug Administration approval processes comprise numerous steps to ensure the safety and efficacy of new drugs, therapies, and treatments. Navigating the process can be complex and time-consuming, and as a result, the FDA is proactively looking for methods to accelerate the pace of approval.
• In March 2023, Clean Cells, part of the Clean Biologics group, a provider of biopharmaceutical product quality control services and manufacturer of starting materials, announced the launch of analytical activities at its new facility based in Montaigu-Vendée. With an investment of €22 million, €5.5 million of which is for new equipment, the site offers four times more laboratory space than the previous building.
• In July 2022, Alliance Pharma purchased Drug Development Solutions (DDS), a UK-based bioanalytical and material science testing contract research organization (CRO), from LGC. Ampersand Capital Partners, a global healthcare private equity firm, and KKR & Co. Inc., a global investment firm, are equal shareholders in the combined company.
• In February 2022, The Center for Breakthrough Medicines (CBM) opened its new analytical testing services laboratories to address growing capacity needs in the supply-constrained cell and gene therapy market.
• In July 2024, The PPD clinical research business of Thermo Fisher Scientific Inc. is expanding its central laboratory operations in Kentucky dedicated to accelerating pharmaceutical and biotech customers’ delivery of safe, effective medicines to patients. The business will expand its sample management and biorepository operations in a new 65,000-square-foot space in Covington, enabling further capability expansion at its existing site in nearby Highland Heights.

Segments Cover3ed in the Report

By Test Type

• Bioavailability & Bioequivalence Studies 
• Pharmacokinetics
• Pharmacodynamics
• Other Test Type

By Product Type

• Gene Therapy
  • Ex-vivo
  • In-vivo
• Gene-modified Cell Therapy
  • CAR T-cell Therapies
  • CAR-NK Cell Therapy
  • TCR-T Cell Therapy
  • Other
• Cell therapy

By Stage of Development by Product Type

• Non-clinical
  • Gene Therapy
  • Gene-modified Cell Therapy
  • Cell Therapy
• Clinical
  • Gene Therapy
  • Gene-modified Cell Therapy
  • Cell Therapy

By Indication

• Oncology
• Infectious Diseases
• Neurological Disorders
• Rare Diseases
• Others

By Geography

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