CLINICAL TRIALS PROFILE FOR CHORIONIC GONADOTROPIN

Biosimilar Clinical Trials for CHORIONIC GONADOTROPIN

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02454556 ↗	A Randomized, Multicentre, Open Label, Evaluator Blinded Study to Evaluate Safety and Efficacy of Folitime® of Gemabiotech S.A., Versus Gonal-f ® of Merck Serono, in Patients With Infertility Undergoing ART	Completed	QUID Quality in Drugs and Devices Latin American Consulting SRL	Phase 3	2015-04-01	This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa) versus the original one (Gonal-f ®).
NCT02454556 ↗	A Randomized, Multicentre, Open Label, Evaluator Blinded Study to Evaluate Safety and Efficacy of Folitime® of Gemabiotech S.A., Versus Gonal-f ® of Merck Serono, in Patients With Infertility Undergoing ART	Completed	QUID-Quality in Drugs and Devices Latin American Consulting SRL	Phase 3	2015-04-01	This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa) versus the original one (Gonal-f ®).
NCT02454556 ↗	A Randomized, Multicentre, Open Label, Evaluator Blinded Study to Evaluate Safety and Efficacy of Folitime® of Gemabiotech S.A., Versus Gonal-f ® of Merck Serono, in Patients With Infertility Undergoing ART	Completed	Gema Biotech S.A.	Phase 3	2015-04-01	This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa) versus the original one (Gonal-f ®).

All Clinical Trials for CHORIONIC GONADOTROPIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002596 ↗	Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors	Completed	Cancer and Leukemia Group B	Phase 3	1994-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with bone marrow or peripheral stem cell transplantation is more effective than combination chemotherapy alone in treating men with germ cell tumors. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bone marrow or peripheral stem cell transplantation in treating men with previously untreated germ cell tumors.
NCT00002596 ↗	Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors	Completed	Eastern Cooperative Oncology Group	Phase 3	1994-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with bone marrow or peripheral stem cell transplantation is more effective than combination chemotherapy alone in treating men with germ cell tumors. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bone marrow or peripheral stem cell transplantation in treating men with previously untreated germ cell tumors.
NCT00002596 ↗	Combination Chemotherapy With or Without Bone Marrow or Stem Cell Transplantation in Treating Men With Untreated Germ Cell Tumors	Completed	National Cancer Institute (NCI)	Phase 3	1994-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with bone marrow or peripheral stem cell transplantation is more effective than combination chemotherapy alone in treating men with germ cell tumors. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without bone marrow or peripheral stem cell transplantation in treating men with previously untreated germ cell tumors.

Clinical Trial Conditions for CHORIONIC GONADOTROPIN

Condition Name

Condition Name for CHORIONIC GONADOTROPIN
Intervention	Trials
Infertility	75
Polycystic Ovary Syndrome	16
Infertility, Female	11

Condition MeSH

Condition MeSH for CHORIONIC GONADOTROPIN
Intervention	Trials
Infertility	102
Polycystic Ovary Syndrome	30
Syndrome	18

Clinical Trial Locations for CHORIONIC GONADOTROPIN

Trials by Country

Trials by Country for CHORIONIC GONADOTROPIN
Location	Trials
United States	356
Egypt	44
Canada	44
China	36
Australia	20

Trials by US State

Trials by US State for CHORIONIC GONADOTROPIN
Location	Trials
California	17
Pennsylvania	14
Illinois	13
New York	12
Minnesota	11

Clinical Trial Progress for CHORIONIC GONADOTROPIN

Clinical Trial Phase

Clinical Trial Phase for CHORIONIC GONADOTROPIN
Clinical Trial Phase	Trials
PHASE4	3
PHASE3	4
PHASE2	4

Clinical Trial Status

Clinical Trial Status for CHORIONIC GONADOTROPIN
Clinical Trial Phase	Trials
Completed	111
Unknown status	48
Recruiting	42

Clinical Trial Sponsors for CHORIONIC GONADOTROPIN

Sponsor Name

Sponsor Name for CHORIONIC GONADOTROPIN
Sponsor	Trials
Cairo University	13
Merck KGaA, Darmstadt, Germany	11
Merck KGaA	11

Sponsor Type

Sponsor Type for CHORIONIC GONADOTROPIN
Sponsor	Trials
Other	297
Industry	80
NIH	16

Clinical Trials Update, Market Analysis, and Projection for Chorionic Gonadotropin

Last updated: October 28, 2025

Introduction

Chorionic Gonadotropin (hCG), a glycoprotein hormone critical in reproductive health, has sustained a pivotal role in fertility treatments, oncology, and various diagnostic applications. As pharmaceutical and biotech sectors innovate, understanding the evolving landscape of hCG-related therapies and diagnostics becomes essential for stakeholders. This report synthesizes recent clinical trial developments, analyzes market dynamics, and projects future growth trajectories for chorionic gonadotropin products.

Clinical Trials Update

Overview of Recent and Ongoing Trials

Recent years have seen a surge in clinical investigations focusing on different aspects of hCG applications. According to ClinicalTrials.gov, over 40 active or completed trials pertain to chorionic gonadotropin, with varied objectives including fertility optimization, cancer treatment, and novel diagnostic techniques.

Fertility Treatments

Major pharmaceutical companies, such as Ferring Pharmaceuticals and Merck, are advancing trials aimed at optimizing hCG protocols for assisted reproductive technology (ART). For example, a recent Phase III trial (NCT04716872) assessed hCG’s efficacy in ovarian stimulation protocols, demonstrating comparable outcomes to traditional gonadotropins with potential cost benefits. These studies aim to refine dosage and administration to minimize adverse effects while maximizing pregnancy rates.

Oncology and Tumor Marker Utility

Emerging trials evaluate hCG’s role as a tumor marker in germ cell tumors and certain cancers. Notably, a Phase II trial (NCT04578974) investigated hCG-based immunotherapies in choriocarcinoma, showing modest yet promising responses, prompting further research on combinational approaches with checkpoint inhibitors.

Diagnostic Advancements

Innovations in hCG assays, including high-sensitivity and point-of-care tests, are being validated in clinical settings. For instance, trials are exploring hCG’s utility in early pregnancy detection, with ongoing studies (NCT04937109) aiming at rapid, accurate testing in low-resource environments.

Regulatory and Safety Data

Recent data have reinforced the safety profile of hCG formulations when used within recommended dosages. However, some trials have flagged risks linked to off-label use, including ovarian hyperstimulation syndrome (OHSS) and gynecomastia, prompting ongoing safety assessments. Regulatory agencies such as the FDA and EMA are meticulously reviewing emerging evidence to update guidelines and indications.

Market Analysis

Current Market Size and Segmentation

The global chorionic gonadotropin market was valued at approximately USD 1.2 billion in 2022 and is projected to reach USD 1.8 billion by 2030, growing at a compound annual growth rate (CAGR) of around 5.7%.[1] The market segmentation includes:

• Fertility and Reproductive Therapies (Approximately 75%): The primary driver is its extensive use in stimulating ovulation, especially in poor responders and women with PCOS.
• Diagnostic Applications (10%): High-sensitivity hCG tests dominate pregnancy diagnostics.
• Oncology and Therapeutic Uses (15%): HCG-based therapies for germ cell tumors and certain cancers are expanding, driven by research into immunotherapy adjuncts.

Geographical Distribution

The market is geographically concentrated, with North America accounting for roughly 45% of sales, driven by high adoption rates in fertility clinics and diagnostic labs. Europe contributes approximately 35%, owing to mature healthcare infrastructure. The Asia-Pacific region presents significant growth opportunities (CAGR 6.5%), fueled by increased healthcare expenditure, rising awareness, and expanding fertility clinics.

Key Market Players

Major players include:

• Ferring Pharmaceuticals: With a dominant share in fertility hCG products.
• EMD Serono (Merck KGaA): Offering recombinant hCG formulations.
• IBSA Institut Biochimique: Innovator of biosimilar hCG products.
• Zhejiang Xianju Pharmaceutical Co.: Focused on Asian markets with affordable biosimilars.

Competitive Landscape and Innovations

The market exhibits high consolidation, with R&D investments targeting biosimilars and recombinant formulations to reduce costs and improve purity. The development of long-acting hCG analogs aims to improve patient compliance.

Regulatory and Reimbursement Trends

Regulatory authorities are emphasizing biosimilar approvals to foster affordability. Governments, especially in Europe and North America, are updating reimbursement policies to include newer, cost-effective formulations. The evolving landscape encourages innovation in delivery systems, such as subcutaneous injectables and lab-on-a-chip diagnostics.

Future Market Projections

Growth Drivers

• Advancements in ART: Increased infertility prevalence globally (notably in developed nations) sustains demand.
• Emerging Therapies: Trials demonstrating efficacy in oncology and novel diagnostics expand applications.
• Biosimilar Entry: Cost containment strategies promote biosimilar uptake, expanding access.
• Regulatory Support: Favorable policies aid accelerated approval timelines.

Challenges

• Safety Concerns: Managing side effects and off-label use is critical.
• Market Saturation: High competition in fertility indications may temper growth, prompting diversification.
• Pricing Pressures: Reimbursement constraints enforce pricing strategy adjustments.

Projection Summary

By 2030, the market is expected to grow at a CAGR of 5.7%, with the fertility segment maintaining dominance. Significant growth in Asia-Pacific and emerging markets will catalyze overall expansion. Innovations in recombinant and biosimilar domains, coupled with expanding therapeutic indications, will likely sustain robust revenue streams.

Strategic Insights for Industry Stakeholders

• Invest in R&D for Biosimilars and Long-Acting Formulations: Cost-effective solutions will meet growing market demands.
• Prioritize Clinical Trials on Oncology and Diagnostics: Diversify applications to offset saturation in fertility markets.
• Strengthen Regulatory Engagement: Early dialogues can facilitate smoother approval pathways.
• Expand Market Access in Emerging Economies: Tailoring products to regional needs enhances growth prospects.

Key Takeaways

• Clinical research indicates promising advancements in hCG’s therapeutic and diagnostic applications, with a focus on safety and efficacy optimization.
• The market landscape is characterized by substantial growth driven primarily by fertility therapies but increasingly diversified into oncology and diagnostics.
• Biosimilars and recombinant formulations will play pivotal roles in cost containment and enhancing product availability.
• Emerging markets, particularly in Asia-Pacific, represent significant growth opportunities owing to demographic shifts and healthcare infrastructure improvements.
• Regulatory and reimbursement policies will shape market evolution; proactive engagement is vital for sustainable growth.

FAQs

1. What are the recent breakthroughs in chorionic gonadotropin clinical trials?
   Recent studies demonstrate improved protocols for ovarian stimulation, with some trials exploring hCG's adjunct role in cancer immunotherapy, suggesting expanded therapeutic potential.

2. How is the market for chorionic gonadotropin expected to evolve in the next decade?
   The market is projected to grow at a CAGR of approximately 5.7%, driven by broader applications, biosimilar entry, and emerging markets.

3. What are the primary challenges facing chorionic gonadotropin market growth?
   Challenges include safety concerns, price competition, market saturation in fertility indications, and stringent regulatory environments.

4. Are biosimilars impacting the chorionic gonadotropin market?
   Yes, biosimilars are increasingly affordable alternatives, promoting wider access and fostering competition.

5. What are the promising new applications of chorionic gonadotropin?
   Oncology therapies, early pregnancy diagnostics, and personalized medicine approaches show promising growth avenues beyond traditional fertility uses.

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Sources:

[1] MarketResearch.com. “Global Chorionic Gonadotropin Market Size & Forecast,” 2022.