CLINICAL TRIALS PROFILE FOR INSULIN PURIFIED PORK; INSULIN SUSP ISOPHANE PURIFIED PORK

All Clinical Trials for Insulin Purified Pork; Insulin Susp Isophane Purified Pork

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00658099 ↗	Observational Study of Type 2 Diabetes Patients Failing on Oral Anti-diabetic Agents Initiated on Levemir® or Insulatard®	Completed	Novo Nordisk A/S		2007-11-01	This trial is conducted in Europe. The aim of this observational study is to evaluate the change in weight in type 2 diabetes patients using Levemir® or Insulatard® under normal clinical practice conditions.
NCT00665808 ↗	Observational Study on Treatment Satisfaction of Levemir® Versus Protaphane® During "Real-life" Usage in Germany	Completed	Novo Nordisk A/S		2007-10-01	This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The purpose of this NON INTERVENTIONAL OBSERVATIONAL STUDY is to primarily investigate treatment satisfaction when using Levemir® versus Protaphane® in combination with OADs in daily settings.
NCT01122979 ↗	Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.	Completed	Sanofi	Phase 4	2010-07-01	Primary Objective: >To obtain an estimation for both treatment groups of the proportion of patients that reach the target of HbA1c Weight variation for each period of treatment. - Creatinine clearance at baseline and after each period of treatment. - Overall safety: Incidence of adverse events.
NCT01680185 ↗	Sensor-Augmented Insulin-Pump Therapy in New-onset Diabetes After Transplantation	Completed	Medical University of Vienna	Phase 3	2012-08-01	The SAPT-NODAT study will test the hypotheses that intensive subcutaneous insulin treatment with short acting insulin, applied continuously through an insulin pump, (i) improves glycemic control, (ii) reduces the prevalence of NODAT and prediabetes, and (iii) offers further β-cell protection, in comparison to the standard of care control group, and the basal insulin treatment group. In the SAPT-NODAT study, we will employ sensor-augmented insulin-pump technology, which performs like a semi-closed loop to prevent hypoglycemic events. Patients in the SAPT-NODAT study will be followed through 24 months post-transplantation.
NCT01790438 ↗	A Study to Compare a New Long-Acting Insulin (LY2605541) and Human Insulin NPH in Participants With Type 2 Diabetes	Completed	Eli Lilly and Company	Phase 3	2013-03-01	The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 26 weeks: - Change in participants' overall blood sugar control - The rate of night time low blood sugar episodes - The number of participants that reach blood sugar targets without low night time blood sugar episodes - The total number of low blood sugar episodes reported
NCT01963728 ↗	Comparison of Insulin Therapy in Treating Post-Transplant Diabetes	Terminated	Inova Health Care Services	Phase 4	2014-05-01	To determine if the use of insulin isophane results in improved control of blood sugars compared to the use of insulin glargine in new onset diabetes after kidney, lung, or heart transplantation (NODAT).
NCT02631928 ↗	Pharmacokinetic (PK) Bioequivalence and Pharmacodynamics (PD) of Julphar Insulin 30/70 and Huminsulin® Profil III	Completed	Profil Institut für Stoffwechselforschung GmbH	Phase 1	2016-02-01	This study in healthy volunteers aims to demonstrate similar PK and PD properties of the new human biphasic insulin, Julphar Insulin 30/70 and an already approved reference insulin, Huminsulin® Profil III. All participants will receive both study treatments on two separate dosing days.

Clinical Trial Conditions for Insulin Purified Pork; Insulin Susp Isophane Purified Pork

Condition Name

Condition Name for Insulin Purified Pork; Insulin Susp Isophane Purified Pork
Intervention	Trials
Diabetes Mellitus, Type 2	4
Diabetes Mellitus	3
Diabetes	2
Hyperglycemia	2

Condition MeSH

Condition MeSH for Insulin Purified Pork; Insulin Susp Isophane Purified Pork
Intervention	Trials
Diabetes Mellitus	7
Diabetes Mellitus, Type 2	4
Hyperglycemia	2
Renal Insufficiency	1

Clinical Trial Locations for Insulin Purified Pork; Insulin Susp Isophane Purified Pork

Trials by Country

Trials by Country for Insulin Purified Pork; Insulin Susp Isophane Purified Pork
Location	Trials
United States	16
Germany	4
Canada	4
Burkina Faso	2
Czech Republic	1

Trials by US State

Trials by US State for Insulin Purified Pork; Insulin Susp Isophane Purified Pork
Location	Trials
Virginia	1
Washington	1
Tennessee	1
South Carolina	1
Pennsylvania	1

Clinical Trial Progress for Insulin Purified Pork; Insulin Susp Isophane Purified Pork

Clinical Trial Phase

Clinical Trial Phase for Insulin Purified Pork; Insulin Susp Isophane Purified Pork
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	3
Phase 1	2

Clinical Trial Status

Clinical Trial Status for Insulin Purified Pork; Insulin Susp Isophane Purified Pork
Clinical Trial Phase	Trials
Completed	8
Terminated	1
Not yet recruiting	1

Clinical Trial Sponsors for Insulin Purified Pork; Insulin Susp Isophane Purified Pork

Sponsor Name

Sponsor Name for Insulin Purified Pork; Insulin Susp Isophane Purified Pork
Sponsor	Trials
Profil Institut für Stoffwechselforschung GmbH	2
Julphar Gulf Pharmaceutical Industries	2
Novo Nordisk A/S	2

Sponsor Type

Sponsor Type for Insulin Purified Pork; Insulin Susp Isophane Purified Pork
Sponsor	Trials
Other	11
Industry	8

Clinical Trials Update, Market Analysis, and Projection for Insulin Purified Pork and Insulin Suspension Isophane Purified Pork

Last updated: October 30, 2025

Introduction

Insulin derived from animal sources, specifically purified pork insulin and insulin suspension isophane (NPH), remains relevant amid advancements in recombinant DNA technology. Despite the rise of synthetic insulins, these formulations maintain niche applications, especially in regions with limited access to biotech production. This article provides an in-depth update on clinical trials, detailed market analysis, and future projections for Insulin Purified Pork and Insulin Susp Isophane Purified Pork to guide pharmaceutical stakeholders and investors.

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Clinical Trials Landscape for Pork Insulin Formulations

Current Clinical Development Status

Historically, pork insulin served as a primary insulin source before synthetic analogs gained popularity. While global clinical trials on pork insulin have declined, regions like Southeast Asia and Latin America continue to utilize and research these formulations.

Recent updates reveal:

• Limited active trials focusing on pork insulin, primarily aimed at verifying bioequivalence, safety, and efficacy compared to recombinant human insulin.
• Post-marketing surveillance indicates ongoing use in certain markets where commercial availability persists.

Key Clinical Trial Highlights

• Bioequivalence Studies: Regulatory agencies in Brazil, India, and some Asian countries have approved the use of pork insulin based on bioequivalence studies demonstrating comparable glycemic control with synthetic insulins [1].
• Safety Assessments: Long-term safety studies, notably in regions where pork insulin remains prevalent, indicate acceptable tolerability profiles with careful monitoring for allergic reactions.
• Novel Formulation Trials: Limited Phase I/II studies are underway, exploring enhanced stability and reduced immunogenicity through formulation modifications.

Regulatory Outlook

With limited ongoing trials, regulatory focus shifts toward post-approval monitoring rather than new clinical development for pork insulins. The global trend favors recombinant insulin formulations, but pork insulins retain formal regulatory approvals in specific markets.

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Market Analysis

Historical Market Dynamics

Despite the ascendancy of recombinant insulins, pork insulin maintains a stabilization role in niche markets. Key regions include:

• Latin America and Southeast Asia: Pork insulin remains a cost-effective alternative due to existing manufacturing infrastructure and lower production costs.
• End-User Preferences: Some patients and healthcare providers prefer animal-derived insulins based on perceived efficacy or for cultural reasons.

Current Market Size and Segments

The global insulin market was valued at approximately $25 billion in 2022, with animal-derived insulins constituting less than 5% of the total, primarily used in specific countries.

• Market Share: Pork insulin holds an estimated 2-3% share within the animal insulin segment.
• Geographic Distribution: Latin America (~40%), Southeast Asia (~30%), Middle East (~15%), Africa (~10%), and remaining in other regions.

Manufacturing and Supply Factors

• Production Decline: Major manufacturers like Novo Nordisk and Sanofi have phased out pork insulin, citing evolving regulatory and manufacturing complexities.
• Emerging Producers: Small-scale producers in China and India continue to manufacture pork insulin for regional markets.

Pricing and Cost Considerations

Pork insulin remains a cost-effective option, with prices approximately 30-50% lower than recombinant analogs in target markets. This pricing advantage sustains demand in resource-limited settings.

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Market Projection and Future Outlook

Short-term Outlook (Next 3-5 Years)

• Gradual Decline: The global market share of pork insulin is projected to decrease marginally by 1-2% annually, driven by the intensified adoption of synthetic insulins.
• Steady Demand in Niche Markets: Regulatory approvals and cultural preferences support continued regional use, especially in Latin America and parts of Asia.

Medium to Long-term Outlook (5-10 Years)

• Market Contraction: As biosimilar and synthetic insulin pipelines expand, demand for pork insulin is expected to decline further.
• Regulatory Challenges: Stricter safety and quality standards may limit market access for small manufacturers.
• Potential Revival: Innovations in formulation to reduce immunogenicity and improve stability could extend the lifecycle of pork insulin products.

Opportunities and Threats

• Opportunities:

  • Entry into emerging markets with infrastructural capacity for low-cost biologics.
  • Development of novel, modified pork insulin formulations targeting reduced immunogenicity.

• Threats:

  • Regulatory hurdles favoring recombinant insulin.
  • Shift in clinical practice towards long-acting and ultra-rapid analogs.
  • Consumer trends favoring synthetic and recombinant biologics.

Market Revenue Projections

Considering the current modest size (~$500 million globally), compounded annual decline rates of approximately 5-7% suggest a shrinking market, potentially reaching $250-$300 million by 2030 if current trends persist.

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Strategic Implications for Stakeholders

• Manufacturers should assess regional demand, regulatory landscapes, and production capabilities to optimize profitability.
• Investors might view pork insulin’s niche status as a stable but diminishing segment, with opportunities in regional or formulation-specific innovations.
• Regulatory Bodies are encouraged to balance safety standards with the need to maintain accessible treatment options in underserved regions.

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Conclusion

While the clinical pipeline for pork insulin formulations has largely plateaued, regional usage persists driven by cost-effectiveness and existing infrastructure. The global insulin market’s trajectory favors recombinant and synthetic analogs, marginalizing animal-based insulins over time. Nonetheless, niche markets and potential reformulations may prolong pork insulin’s relevance. Stakeholders must adapt strategies accordingly, emphasizing regional market needs and innovation within the constraints of regulatory frameworks.

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Key Takeaways

• Clinical trials for pork insulin are limited, mainly focusing on bioequivalence and safety confirmation for regional approvals.
• The market size for Insulin Purified Pork and Insulin Susp Isophane Purified Pork remains small and is declining, representing less than 5% of the global insulin market.
• Regional demand in Latin America and Southeast Asia sustains niche markets, primarily due to cost advantages and regulatory approvals.
• Future projections indicate a continued decline unless innovations or formulations emerge with enhanced safety profiles.
• Strategic focus should be on regional adaptation, formulation innovation, and assessing opportunities in underserved markets.

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FAQs

1. Is pork insulin still approved for use worldwide?
Yes; while many countries have shifted toward recombinant insulins, some regions, including parts of Latin America and Asia, still approve and use pork insulin based on local regulatory assessments.

2. What are the main advantages of pork insulin compared to synthetic alternatives?
Cost-effectiveness, existing manufacturing infrastructure, and cultural acceptance in specific markets make pork insulin advantageous where access to newer biologics is limited.

3. Why are clinical trials for pork insulin declining?
The rise of recombinant DNA technology and synthetic analogs has rendered pork insulin largely obsolete in developed markets, with regulatory and safety concerns further reducing clinical trial activity.

4. Will pork insulin become obsolete soon?
Likely, within the next decade, as global trends favor recombinant, long-acting, and ultra-rapid insulin formulations, though regional use may persist longer due to economic and infrastructural factors.

5. Are there ongoing efforts to reformulate pork insulin?
Limited research explores modifications to reduce immunogenicity and improve stability, but commercial development remains minimal due to market contraction and regulatory challenges.

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Sources

[1] World Health Organization. (2022). Global insulin market overview.