Clinical-Stage Biotechnology Market Report 2025

The clinical-stage biotechnology market size has grown rapidly in recent years. It will grow from $40.65 billion in 2024 to $47.14 billion in 2025 at a compound annual growth rate (CAGR) of 16%. Growth in the historic period was driven by rising prevalence of chronic diseases, increasing demand for targeted therapies, growing investment in biotechnology research, greater adoption of precision medicine, and heightened emphasis on personalized medicine.

The clinical-stage biotechnology market size is expected to see rapid growth in the next few years. It will grow to $84.17 billion in 2029 at a compound annual growth rate (CAGR) of 15.6%. Growth in the forecast period is expected to result from rising clinical trial activities, increasing regulatory approvals, expanded government funding for biotechnology, growing patient awareness of novel therapies, and higher adoption of innovative treatments. Primary trends anticipated for the forecast period include advancements in gene editing technologies, development of personalized therapeutics, innovation in RNA-based treatments, progress in cell and gene therapies, and strengthened collaborations between academia and industry.

The increasing focus on personalized medicine is expected to drive the growth of the clinical-stage biotechnology market in the coming years. Personalized medicine involves customizing medical treatments based on the unique characteristics of individual patients, particularly through the use of genetic, biomarker, and molecular data. This approach is gaining traction as it enables doctors to adapt cancer treatments according to a patient's genetic makeup, leading to more effective treatments and fewer side effects. Clinical-stage biotechnology plays a crucial role in personalized medicine by developing targeted therapies that are aligned with a patient's genetic profile, thus enhancing both treatment effectiveness and safety. For example, in February 2024, the Personalized Medicine Coalition, a US-based non-profit organization, reported that in 2023, the FDA approved 16 new personalized therapies for patients with rare diseases, a significant rise from just six approvals in 2022. As a result, the increasing emphasis on personalized medicine is likely to drive market growth in the clinical-stage biotechnology sector.

Leading companies in the clinical-stage biotechnology market are focusing on offering innovative services, such as clinical trial services, to expedite drug development, enhance patient recruitment and retention, and improve regulatory compliance. Clinical trial services provide professional support for designing, managing, and conducting clinical studies to assess the safety and efficacy of new drugs or therapies. For instance, in November 2023, Ichor Life Sciences, Inc., a US-based biotechnology firm, launched a new division called Ichor Clinical Trial Services. This service expands their contract research organization (CRO) offerings, assisting biotechnology and pharmaceutical clients throughout the entire drug development journey, from early-stage preclinical trials to late-stage clinical studies and FDA approval. Ichor Clinical Trial Services offers customized solutions, including protocol design, site identification and qualification, recruitment strategies, and full CRO support. This unit aims to address specific challenges faced by clients, such as resolving enrollment or operational issues in ongoing trials, by adopting a flexible and personalized approach.

In June 2025, BioNTech SE, a Germany-based biotechnology company, acquired CureVac N.V. for $1.25 billion. This acquisition allows BioNTech to significantly strengthen its oncology pipeline by integrating CureVac's advanced mRNA technology and extensive asset library. The move is intended to solidify BioNTech's position in the competitive cancer therapeutics market and expand its ability to develop innovative treatments. CureVac N.V. is a Germany-based clinical-stage biopharmaceutical company specializing in the development of mRNA-based therapeutics and vaccines for cancer and infectious diseases.

Major players in the clinical-stage biotechnology market are Sarepta Therapeutics Inc., BioAge Labs Inc., PTC Therapeutics Inc., Evotec SE, Ultragenyx Pharmaceutical Inc., Rocket Pharmaceuticals Inc., Ventyx Biosciences Inc., Sangamo Therapeutics Inc., REGENXBIO Inc., Galapagos NV, Arvinas Inc., Editas Medicine Inc., Zymeworks Inc., CureVac N.V., Precision BioSciences Inc., 4D Molecular Therapeutics Inc., Domain Therapeutics S.A., ProQR Therapeutics N.V., Tonix Pharmaceuticals Holding Corp., Gilgamesh Pharmaceuticals Inc., T-Cure Bioscience Inc., Opna Bio Inc., EXUMA Biotech Inc., and Prime Medicine Inc.

North America was the largest region in the clinical-stage biotechnology market in 2024. The regions covered in clinical-stage biotechnology report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the clinical-stage biotechnology market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

Clinical-stage biotechnology refers to the phase of biotechnology development in which a drug, therapy, or medical product has progressed from preclinical research into human clinical trials. At this stage, the focus is on evaluating safety, efficacy, and appropriate dosing in patients through structured trial phases. This phase represents the transition from laboratory and animal testing to real-world human assessment.

The primary types of products in clinical-stage biotechnology include therapeutics, diagnostics, vaccines, and others. Therapeutics are medical products and treatments developed to prevent, manage, or cure diseases by targeting biological processes within the body. These products progress through various trial phases, such as phase I, phase II, and phase III, and are applied in areas including oncology, infectious diseases, cardiovascular diseases, neurology, and others. Primary end users include hospitals, research institutes, diagnostic centers, and others.

The clinical-stage biotechnology market research report is one of a series of new reports that provides clinical-stage biotechnology market statistics, including clinical-stage biotechnology industry global market size, regional shares, competitors with a clinical-stage biotechnology market share, detailed clinical-stage biotechnology market segments, market trends and opportunities, and any further data you may need to thrive in the clinical-stage biotechnology industry. This clinical-stage biotechnology market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The clinical-stage biotechnology market includes sales of gene therapies, cell therapies, drug delivery systems, small molecule drugs, and regenerative medicines. Values in this market are ‘factory gate’ values, that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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