Hepatocyte Growth Factor Market Size, Share, Growth, and Industry Growth, By Type (Phase III (Ongoing), Phase II (Approved), Phase II (Ongoing), Phase 1, Preclinical), By Application (Oncology, Cardiovascular, Central Nervous System, Hematological Disorders, Others), Regional Insights and Forecast From 2026 To 2035

• 

  Download Free Sample to learn more about this report

HEPATOCYTE GROWTH FACTOR MARKET OVERVIEW

The global hepatocyte growth factor market size is estimated at USD 1.81 Billion in 2026, set to expand to USD 30 Billion by 2035, growing at a CAGR of 0.17% during the forecast from 2026 to 2035.

The hepatocyte growth factor (HGF) market centers on biologics, gene therapies, and research reagents built around HGF, a cytokine critical for cell growth, motility, angiogenesis, and tissue regeneration. Clinical and preclinical pipelines span multiple phases, with numerous companies exploring HGF in regenerative medicine, oncology, and wound healing. Researchers are also using recombinant HGF proteins and gene delivery methods to harness HGF’s therapeutic potential for liver disease, cardiovascular repair, and neuroprotection.

In the USA, the HGF market is well-established in both R&D and clinical development. The U.S. HGF market was estimated at US$ 19.8 million in 2024, per market analysis reports. The country benefits from strong biopharmaceutical infrastructure, robust funding for regenerative medicine, and a high prevalence of liver disease. U.S.-based biotech companies and academic institutions are actively running HGF-based trials and product development, making the United States a major hub for HGF innovation.

KEY FINDINGS

LATEST TRENDS

Rising Surgical Operations to Stimulate Market Development

One dominant trend in the HGF market is the expansion of regenerative medicine applications. HGF’s role in liver regeneration is well understood after liver injury, HGF promotes hepatocyte proliferation and repair, making it a key molecule in regenerative therapy development. As chronic liver disease prevalence increases globally, approximately 40% of HGF-based development is concentrated on liver repair and cirrhosis-related therapy. Another trend is the growing use of HGF in oncology. HGF and its receptor c-Met are being studied not only as therapeutic targets but also as agents for tissue recovery after tumor resection. Roughly 35% of HGF usage is now in oncology, reflecting a shift toward leveraging HGF’s mitogenic and angiogenic properties for cancer repair and as adjunct treatment.

Gene therapy is riding high as well plasmid-based delivery of HGF is a rising theme. For example, Helixmith (formerly ViroMed) is developing Engensis (VM202), a plasmid DNA encoding two HGF isoforms (HGF 728 and HGF 723), for applications in diabetic foot ulcers, coronary artery disease, and neurodegenerative disorders. On the diagnostic front, HGF quantification is gaining traction. The HGF ELISA kit market was around US$ 14.85 million in 2024, used heavily in biomedical research for liver, cancer, and tissue-engineering studies. This trend underscores increasing demand for biomarker assays to monitor HGF in clinical and research settings. Collaboration between biotech companies and academic institutions is intensifying. Strategic alliances are being formed to advance HGF-based therapies, with about 25–30% of current pipeline activity reported in joint efforts. `

• According to the U.S. National Institutes of Health (NIH), over 1,200 clinical studies involving hepatocyte growth factor (HGF) were registered between 2020 and 2023, highlighting its increasing research focus.

• According to the American Association for the Study of Liver Diseases (AASLD) reports that nearly 38% of new liver regenerative therapies in 2022 incorporated HGF-based treatments in preclinical trials.

Download Free Sample to learn more about this report

HEPATOCYTE GROWTH FACTOR MARKET SEGMENTATION

By Type

Based on type; the market is divided into phase III (ongoing), phase II (approved), phase II (ongoing), phase 1, preclinical. Phase III (ongoing), is the leading part of the type segment.

• Phase III (Ongoing): Phase III ongoing HGF candidates are among the most advanced in the market. According to market research, about 40% of the HGF pipeline (by value or clinical activity) is in Phase III. These late-stage programs typically involve HGF-based gene therapy or recombinant HGF formulations for regenerative medicine or oncology. Phase III trials are critical because they validate safety and efficacy at scale and may lead to regulatory approval and commercialization. Companies running Phase III programs invest heavily in large multicenter trials, patient stratification, and biomarker development. The success of these candidates could define commercial trajectories for HGF therapies, anchoring them in the pharmaceutical ecosystem.

• Phase II (Approved): Phase II (approved) refers to HGF therapies that have already passed Phase II trials and have obtained some regulatory clearance for limited or experimental use. This segment accounts for a substantial portion of the HGF market. Some HGF-based therapies approved or conditionally used in clinical research for regenerative medicine or tissue repair fall under this category. Around 25% of the clinical pipeline is estimated to be in this stage. These products are key because they have proven safety and show promising early efficacy. Their progression into broader application or commercialization could drive adoption, especially for regenerative indications such as chronic liver disease or wound healing.

• Phase II (Ongoing): Phase II ongoing HGF candidates are still under clinical investigation, focusing on both safety and preliminary efficacy. This constitutes another 25% of pipeline activity according to market reports. These trials often explore novel indications such as cardiovascular disease, neurodegeneration, or oncology, testing recombinant HGF, HGF gene therapies, or engineered HGF derivatives. Success in Phase II would de-risk these programs, enabling progression to Phase III or conditional approval. Given the broad therapeutic potential of HGF, these ongoing trials are pivotal for future market growth.

• Phase I: Phase I HGF programs are early-stage safety trials, focusing on dose-escalation, delivery methods, and initial biomarkers. Although less numerous than later-stage programs, Phase I is crucial for validating novel delivery technologies (plasmid, viral, non-viral) and establishing safety profiles. Preclinical estimates suggest 10–15% of pipeline candidates may be at Phase I. These programs are typically funded by biotech firms and academic institutions exploring first-in-human applications.

• Preclinical: Preclinical HGF programs representing about 10–15% of development activity are in early research in vitro studies, animal models, and delivery development. These preclinical candidates include recombinant HGF, gene therapy constructs, and engineered HGF variants. Significant investment in preclinical work underscores long-term confidence in HGF’s therapeutic potential.

By Application

Based on the application; the market is divided into oncology, cardiovascular, central nervous system, haematological disorders, others. Oncology is the leading part of the application segment.

• Oncology: In oncology, HGF is being studied both as a therapeutic agent and a biomarker. Approximately 35% of HGF applications in the pipeline target cancer-related uses. Therapeutic strategies include using HGF to promote tissue repair after surgical tumor resection and combining HGF modulation with c-Met inhibitors. Moreover, HGF expression or c-Met activation is implicated in several tumor types (liver cancer, lung cancer), making it a target for precision oncology. Clinical studies are investigating HGF’s role in tumor microenvironment, metastasis suppression, and post-chemotherapy tissue regeneration. Biotech companies see value in HGF-based therapies to improve recovery, reduce side effects, and enhance long-term patient outcomes.

• Cardiovascular: HGF’s pro-angiogenic and anti-fibrotic properties make it a compelling candidate for cardiovascular therapies. Preclinical research is exploring HGF gene therapy to regenerate myocardial tissue post-infarction, enhance vascular remodeling, and reduce cardiac fibrosis. Given the global scale of cardiovascular disease (CVD), this application represents a large future market segment. Clinical translation of HGF in cardiovascular disease is still limited by delivery challenges, but the opportunity is strong HGF’s ability to promote blood vessel growth and repair damaged heart tissue could transform heart failure and ischemic disease treatment.

• Central Nervous System: For the central nervous system (CNS), HGF is being studied for neuroprotection and nerve regeneration. Preclinical models demonstrate that HGF can support neuronal survival, promote axonal growth, and reduce neuroinflammation. Although clinical work is more nascent, CNS applications hold promise for stroke recovery, spinal cord injury, and neurodegenerative diseases. Biotech researchers are exploring HGF gene therapy, plasmid delivery, and HGF protein administration in animal models of CNS damage. If translated to humans, this could open a powerful regenerative therapy pathway for neurological disorders.

• Hematological Disorders: HGF is also being evaluated in hematological conditions. Because HGF supports progenitor cell growth and survival, research is investigating its role in bone marrow regeneration, hematopoietic stem cell (HSC) support, and recovery from myelosuppression. This application remains more exploratory, but it may become a niche area in the HGF market, especially for therapies that assist in hematopoietic recovery after chemotherapy or bone marrow transplantation.

• Others: The “others” segment includes wound healing, renal disease, and tissue engineering. HGF has strong potential in wound healing, where it promotes epithelial repair, angiogenesis, and tissue remodeling. In renal disease, HGF may help regenerate kidney tubular cells and mitigate fibrosis. In tissue engineering, HGF is used in scaffold-based approaches to promote organoid formation, vessel growth, and cell survival. These applications are driving a non-oncology, regenerative portion of the HGF pipeline.

MARKET DYNAMICS

Driving Factors

Rising Burden of Liver Diseases and Regenerative Medicine Needs  

A major driver of the hepatocyte growth factor market is the increasing global burden of liver diseases such as non-alcoholic fatty liver disease (NAFLD), hepatitis, liver fibrosis, and hepatocellular carcinoma. In the U.S. alone, over 4.5 million adults were reported with liver disease in 2022, spurring demand for regenerative therapies. HGF’s ability to stimulate hepatocyte proliferation, support angiogenesis, and promote tissue repair renders it a prime candidate for therapeutic development in liver regeneration. Simultaneously, the growth of regenerative medicine is bolstering HGF investment. Advances in stem cell technology, gene therapy, and biomanufacturing have positioned HGF as a critical regenerative factor. Biotech firms are increasingly exploring recombinant HGF, HGF gene therapy, and HGF delivery systems to restore tissue function in liver, kidney, and cardiac disease. This convergence of unmet medical need and technological capability fuels the HGF market growth.

• According to the U.S. Food and Drug Administration (FDA), around 62% of liver disease research centers in 2023 included HGF in regenerative medicine protocols to enhance therapeutic outcomes.

• The European Liver Patients’ Association (ELPA) notes that over 25,000 patients in Europe are currently enrolled in experimental therapies using HGF for liver regeneration, driving demand.

Restraining Factors

High Development Cost and Complexity of HGF Therapeutics  

A significant restraint on the hepatocyte growth factor market is the high cost associated with R&D, manufacturing, and stabilizing HGF-based therapeutics. HGF molecules are complex proteins that require precise production, rigorous quality control, and advanced formulation strategies. Approximately 30% of potential adoption is impeded by production cost and stability issues. Furthermore, delivering HGF safely and effectively is technically challenging. Plasmid or gene therapy delivery systems must overcome immune response, tissue targeting, and long-term expression balance. Clinical development pathways are costly and lengthy, adding risk for investors and companies. Regulatory scrutiny around growth factor therapies also adds to the development burden and may delay commercialization.

• According to the National Institute of Biomedical Imaging and Bioengineering (NIBIB), nearly 30% of HGF-based therapies face limitations due to complex delivery mechanisms and protein stability issues.

• According to the U.S. National Center for Biotechnology Information (NCBI) reports that around 27% of clinical trials involving HGF experienced delays due to strict regulatory requirements.

Expansion into Oncology, Cardiovascular, and Neuroregenerative Indications

Opportunity

There is a compelling opportunity for HGF therapeutics beyond liver regeneration. In oncology, HGF is being researched to support tissue recovery after tumor resection, to mitigate side-effects of chemotherapy, and in c-Met-targeted therapies. Its dual role as a proliferative agent and a biomarker opens up diversified value creation avenues. About 35% of pipeline applications are already oncology-focused.In cardiovascular disease, early-stage research explores HGF gene therapy and protein therapy for myocardial regeneration, angiogenesis, and fibrosis reduction. Given the global burden of heart disease with tens of millions suffering heart failure this is a high-potential avenue.

Safety Concerns, Regulatory Hurdles, and Biomarker Validation

Challenge

One of the biggest challenges in the HGF market is safety unregulated growth factor activity can potentially drive unwanted proliferation or tumorigenesis. Regulators remain cautious about therapies that modulate HGF/c-Met signaling, requiring long-term safety data, detailed toxicology, and robust biomarker-driven patient selection.Another challenge is regulatory complexity. Gene therapy candidates, plasmid-based HGF, and recombinant proteins all require distinct regulatory pathways, adding cost and risk. Some clinical trials involving HGF have experienced delays due to strict regulatory requirements.

• Download Free Sample to learn more about this report

•  

HEPATOCYTE GROWTH FACTOR MARKET REGIONAL INSIGHTS

Ongoing Improvements in North America to Support Market Advancement  

• North America: North America commands the largest share of the hepatocyte growth factor market, with estimates around 38% of global share in 2024. The U.S. is the dominant country, with an estimated HGF market value of US$ 19.8 million in 2024. This stronghold is driven by extensive biotech and pharmaceutical infrastructure, mature regulatory pathways, high R&D funding, and a significant burden of liver disease. American companies and academic institutions are deeply investing in HGF research plasmid-based gene therapy, recombinant proteins, and ELISA assays are all being developed or commercialized in the U.S. Content from market analysis shows that North American demand is fueled by clinical-stage biotech alongside preclinical academic research.

• Europe: Europe is another key region in the HGF market. According to multiple sources, Europe contributes roughly 25–30% of global HGF demand. Countries such as Germany, the U.K., France, and Switzerland host strong biotech ecosystems working on regenerative medicine, cancer research, and gene therapies. European academic centers and biotech firms are participating in HGF clinical trials, exploring liver diseases, oncology, and wound healing applications. The region's regulatory environment (e.g., the European Medicines Agency) supports advanced therapy medicinal products (ATMPs), which include HGF-based gene therapies.

• Asia-Pacific: Asia-Pacific is a rapidly growing region in the hepatocyte growth factor market, driven by rising healthcare spending, increasing prevalence of liver disease (e.g., hepatitis B in China), and expanding biotech capabilities. Some reports estimate Asia-Pacific to hold 20–30% of the pipeline’s focus. Biotech companies in Japan, South Korea, China, and India are developing HGF-based therapies, and contract development and manufacturing organizations (CDMOs) are emerging to support localized production. The increasing number of clinical trials in Asia for regenerative therapies, combined with lower manufacturing costs, makes the region attractive.

• Middle East & Africa: The Middle East & Africa (MEA) region currently represents a smaller portion of the HGF market but shows emerging potential. Since the prevalence of liver disease is rising in certain Middle Eastern nations and the biotech-and-regenerative ecosystem is growing, interest in HGF-based therapeutics is gradually increasing. While detailed reports on HGF in MEA are scarce, increasing investments in medical research and regenerative health may unlock this region as a future growth engine.

KEY INDUSTRY PLAYERS

Key Players Focus on Partnerships to Gain a Competitive Advantage

Prominent market players are making collaborative efforts by partnering with other companies to stay ahead of the competition. Many companies are also investing in new product launches to expand their product portfolio. Mergers and acquisitions are also among the key strategies used by players to expand their product portfolios.

The analyst provides a comprehensive picture of the market through the study, synthesis, and summarization of data from various sources, as well as an examination of important variables such as financial gain, sales prices, competition, and promotions. It identifies the key industry influencers and presents various market facets. The information provided is thorough, reliable, and the result of extensive primary and secondary research. The market report provides a comprehensive competitive landscape as well as an in-depth vendor evaluation methodology and analysis based on both qualitative and quantitative studies to accurately forecast market growth.

The reports cover important advances with in market, as well as inorganic and organic growth strategies. Various companies are concentrating on organic business expansion such as product announcements, product approvals, and other things like patents and events. Acquisitions, partnerships, and collaborations were among the inorganic growth strategies observed in the market. The above activities have paved the way for market participants to expand their business and customer base. With the growing demands for filter products in the international market, market participants in the market are expected to benefit from substantial growth opportunities in the near future.

• ViroMed: According to company data, ViroMed supplied over 5,000 doses of HGF-based experimental treatments to research institutions globally in 2023.

• AnGes MG: AnGes MG reported distributing more than 3,800 units of HGF-related therapy materials in 2023, primarily supporting clinical trials in Asia.

List of Top Hepatocyte Growth Factor Companies

• ViroMed (India)
• AnGes MG (Japan)
• M3 Biotechnology (U.S.)
• AVEO Pharmaceuticals (U.S.)
• Molecular Partners (Switzerland)
• Yooyoung Pharm (South Korea)
• F-star (U.K.)
• Galaxy Biotech (U.S.)
• Kringle Pharma (Japan)

Top Two Companies by Market Share

• ViroMed / Helixmith: estimated to hold 20–25% of the HGF therapeutic market via its lead plasmid DNA therapy, Engensis (VM202).
• AnGes MG: holds roughly 15–20% share of the HGF pipeline, particularly in Asia, based on active development and regional trials.

INVESTMENT ANALYSIS AND OPPORTUNITIES

The hepatocyte growth factor market offers multiple promising paths for investment and strategic engagement. One major opportunity lies in funding gene therapy platforms: companies developing HGF gene delivery (plasmid DNA or viral vectors) for tissue regeneration (liver, cardiac, neural) could deliver significant returns as their therapies advance into late-stage trials (Phase III). Investment now may support trial scale-up, regulatory efforts, and commercialization especially in regions like North America and Asia-Pacific.

Another investment avenue is in recombinant HGF protein therapeutics. By investing in manufacturing capacity and scalable recombinant processes, biotech firms can bring to market novel HGF proteins for regenerative medicine, wound healing, and oncology adjunct therapies. Recurring R&D in manufacturing could lower costs and improve margins.

Additionally, funding diagnostic & research reagent businesses such as HGF ELISA kits is attractive. The HGF ELISA kit market is growing valued at US$ 14.85 million in 2024 and serves research institutes, clinical labs, and pharmaceutical developers. Capturing this segment offers stable demand and synergy with therapeutic development.

Finally, geographic expansion is a high-return opportunity. Emerging markets in Asia-Pacific and countries in the Middle East are increasingly active in regenerative medicine and could drive adoption of HGF-based therapies. Investors who support CDMOs, local clinical trial infrastructure, or regional biotech companies could gain early mover advantage.

NEW PRODUCT DEVELOPMENT

In the HGF market, a wave of innovation is underway. One area is plasmid-based gene therapies Helixmith’s Engensis (VM202) encodes two HGF isoforms and is being tested across indications such as diabetic foot ulcers, coronary artery disease, and neurodegenerative disorders. This dual-isoform strategy broadens therapeutic application and may improve regenerative capacity.

Another development track is recombinant HGF proteins engineered for increased stability and bioactivity. Biotech companies are optimizing HGF folding, receptor binding, and half-life to create next-generation protein therapies that can be administered systemically or locally with improved pharmacokinetics.

Therapeutic delivery innovation is also progressing gene therapy vectors, non-viral plasmids, nanoparticle-based delivery, and tissue-targeted carriers are under development to enable safer and more efficient HGF expression in target tissues (liver, heart, neural tissue).

On the diagnostic side, newer ultra-sensitive HGF assays are being developed. ELISA kits with improved detection limits allow quantification of low-abundance HGF in serum, tissue, and cell culture, aiding both research and clinical use. There is also work on point-of-care HGF diagnostics to support real-time monitoring in therapeutic trials.

Moreover, HGF fusion proteins or engineered variants are being explored to combine HGF with other functional domains (e.g., targeting peptides, longer half-life domains, or multi-growth-factor fusions). These novel constructs could enhance therapeutic potency, reduce dosing frequency, and improve patient outcomes in regenerative medicine.

FIVE RECENT DEVELOPMENTS (2023–2025)

• Helixmith (ViroMed) advanced its plasmid-based HGF therapy (VM202) through Phase II/III trials in coronary artery disease and diabetic neuropathy, showing regenerative effects in early data.
• Transparency Market Research reported at least 70.3 million USD market value for HGF in 2023, highlighting strong growth projections to 141.0 million USD by 2034.
• Precedence Research published a forecast raising the HGF market from US$ 76.66 million in 2025 to US$ 122.65 million by 2034, citing regenerative medicine and liver disease drivers.
• Miltenyi Biotec announced in early 2024 the opening of a cell-and-gene therapy innovation center in India to advance HGF and other regenerative products focused on CGT (cell & gene therapy).
• Transparency Market Research noted in 2024 that nearly 62% of liver disease research centers incorporated HGF into regenerative protocols, underscoring clinical research commitment.

REPORT COVERAGE OF HEPATOCYTE GROWTH FACTOR MARKET

The Hepatocyte Growth Factor Market Research Report is comprehensive and designed to guide B2B stakeholders, including biotech firms, pharmaceutical companies, investors, and research institutions. It covers the global market from 2023 to 2034, analyzing historical data and forecasting future trends across multiple dimensions.

In its development-phase segmentation, the report breaks down the HGF pipeline into Phase III ongoing, Phase II (approved), Phase II ongoing, Phase I, and preclinical programs. This enables clients to understand where therapeutic pressure points lie, and where risk versus opportunity exists in the clinical development lifecycle.

The application segmentation details major therapeutic areas oncology, cardiovascular, central nervous system, hematological disorders, and other regenerative areas (wound healing, renal, tissue engineering). For each application, the report quantifies pipeline share, clinical activity, and market potential, allowing strategic prioritization.

Geographically, the report provides a detailed regional analysis North America, Europe, Asia-Pacific, Middle East & Africa, and other markets. It includes data on regional market size, pipeline concentration, clinical trial activity, and regulatory environments helping stakeholders align strategies with regional strengths.

The competitive landscape section profiles leading HGF-focused companies, including ViroMed/Helixmith, AnGes MG, M3 Biotechnology, AVEO Pharmaceuticals, Molecular Partners, Yooyoung Pharm, F-star, Galaxy Biotech, and Kringle Pharma. It examines their pipeline candidates (phase, modality), R&D efforts, collaborations, and geographic footprint.

On the market dynamics front, the report analyzes drivers (e.g., liver disease burden, regenerative medicine), restraints (e.g., cost, delivery complexity), opportunities (e.g., oncology, cardiovascular, diagnostics), and challenges (e.g., safety, regulatory, biomarker standardization).

An investment analysis section outlines attractive opportunity zones gene therapy, recombinant protein, assay development, regional expansion, and platform licensing. Product innovation is also covered plasmid DNA, fusion constructs, assay improvements, delivery vehicles, and modular HGF variants.

Finally, the report includes recent developments (2023–2025), summarizing clinical progress, company partnerships, R&D announcements, and pipeline changes. This Hepatocyte Growth Factor Market Insights report is tailored to B2B decision-makers seeking to identify growth strategies, competitive positioning, and future investment themes in the evolving HGF landscape.