21 May 2026

KAZAKHSTAN REGULATORY NEWS

Kazakhstani authorities introduced regulatory amendments. Registration fees for expertise of medicines and medical devices for MA applicants were changed (Regulation #46 as of 28.04.2026). New fees are approved by the Kazakhstani MoH.

Key new fees:

Registration fees for imported products got up:
— single-API medicine — 1,4 Mio Tenge (2 970 USD);
— immunobiological and biosimilar medicines — up to 1,65 Mio Tenge (3 500 USD).

Fees for domestic manufacturers are way lower:
— domestic medicine registration fee — 191 thousand - 235 thousand Tenge;
— immunobiological medicines — some 199 thousand Tenge.

DMF changes:
— imported medicines — up to 194 thousand Tenge;
— domestic medicines — some 32 thousand Tenge.

Benefit – risk analysis:
— medicines — 90 thousand Tenge;
— medical devices class II-b and III — 30 thousand Tenge.
Clinical trial report expertise — 385 thousand Tenge per application.

The Regulation also keeps a framework of discounts for local manufacturers in effect:
— discounts up to 78% for selected services;
— reduced coefficients for clinical trials;
— discounts for extra strengths.

New fees may impact launch expenses for imported and biological medicines inKazakhstan.

15 May 2026

PHARMALICENSING ONE ATTENDED “HEALTHCARE-2026” EXHIBITION AND TRADE SHOW IN MINSK, BELARUS

Pharmalicensing One, LLC, a boutique specialized consulting company in healthcare sector in Eastern Europe and Central Asia, attended this year’s annual healthcare trade show in Minsk, Belarus, May 12-15.

This prestigious and reputable exhibition and trade show event has been happening in Belarus for 20+ years. The event brings together and sets business networking and connection for domestic and international healthcare products and service providers. Sectors participating include medical devices, equipment, pharmaceuticals, hospitals including transplantology and medical tourism, healthcare services, educational institutions, R&D and startups, professional publishing and media. 

"This year’s exhibition was dominated by medical equipment manufacturers, outnumbering other sectors, and occupying 50%+ of booths. A great selection of items — dental, hospital, surgery, etc. hints the Belarus healthcare sector has been growing and consuming more capital investment items such as equipment. Belarus is strong in pharmaceuticals, too. A number of international companies set roots here operating their own facilities or manufacturing at Belarus pharmaceutical factories under the CMO framework," — commented V. Krasnikov, Managing partner of Pharmalicensing One, LLC, a specialized boutique consulting company for in/out-licensing, M&A, and BD in ex-USSR area.

The exhibition received a warm welcome from local professional healthcare community who attended the event in great numbers at the Belexpo ultra-modern exhibition facility erected as a joint project of Belarus and United Arab Emirates.

The event has proven its value and success bridging local and international business for productive and rewarding business operations. 

"The next annual event will happen in 2027, and it welcomes all professional participants. Registration and other details are available from the Healthcare Belarus website through Google," — stated V. Krasnikov.

5 May 2026

BINNOPHARM APPLIED FOR EXTERNAL MANAGEMENT INTRODUCTION FOR AKRIKHIN

Binnonpharm, JS (Russia) claimed Polpharma Group of Poland, the owner of Akrikhin, JS (Russia), sends earning from Russia to support Ukraine in war against Russia. Binnonpharm applied to the President of Russia Office Chief, Mr. VAINO, Anton, to impose external management to Akrikhin.

The application mentioned a transfer of 100% share in Akrikhin along with transferring management authority to Binnonpharm, plus all IP such as trademarks, patents etc.

The move was justified by risks arising from Polpharma’s transfer of earnings from Russia to support Ukraine in its war against Russia, and free supply of medicines to Ukraine military as Polpharma highlighted on its website.

Akrikhin was set in 1935 as a government-owned pharmaceutical factory in USSR. Polpharma acquired 17.33% stake in 2007 and 79% more in 2011, now owning 100% through its Dutch affiliate Polpharma Group, B. V. Akrikhin re-registered trademarks in the Netherlands that may expose Russia to risks of banning production of its medicines in Russia. Binnonpharm believes that constitutes a threat to national pharmaceutical supply security.

Akrikhin quoted they act strategically in Russia viewing that market as a major business such as quadrupling Polpharma’s investment in Russia within last 3 years: 310 Mio RUB in 2023, 831 Mio RUB in 2024, and 1.242 billion RUB in 2025. Akrikhin indicated it has no intentions to cut pharmaceutical supply to Russian market. Akrikhin portfolio in Russia includes 200+ products. 40%+ are on the list of essential life-saving products.

The industry’s speaker association — Association of Russian Pharmaceutical Manufacturers — denounced Binnonpharm’s move suspecting Binnopharm of an intention to hostile take-over of Akrikhin.

"Akrikhin continues to stay owned by Polpharma. That is a strong indicator of respect of ownership right by Russian government and respect of foreign investments. If a foreign-owned company abides Russian laws, the government leaves things „business as usual“. That case sends a strong positive signal to potential international investors who would like to get their peace of cake in lucrative Russian market, one of top ten pharmaceutical markets in Europe", — commented V. Krasnikov, Partner of Prestige Brands Capital, a specialized boutique consulting company for in/out-licensing, M&A, and BD in ex-USSR area.

Source: RBC Business News Agency.

1 April 2026

KAZAKHSTANI AUTHORITIES APPROVED A CONSTELLATION OF MAJOR INVESTMENT
PROJECTS TOTALLING 700+ BILLION TENGE.

Pharmaceutical industry turned a large beneficiary of that: reportedly Khan Tengri BioPharma Corporation will build a hi-tech biopharmaceutical factory. The total investment is estimated at 103+ billion Tenge. The factory will create 180 jobs in the industry.

As indicated by news sources close to the matter, that project will start a major biopharmaceutical manufacturing cluster in the nation. It will include R&D, manufacturing, storage, logistics facilities, and social establishments. The time frame is 5 years whereas the terrain exceeds 100 hectares.

The ultimate goal is to set a full manufacturing cycle site and localize production of biopharmaceuticals in Kazakhstan along with medical devices and veterinary products, simultaneously establishing proper R&D and CT support facilities. The project assumes construction of both industrial facilities and residential communities for top notch professionals employed at the site.

As per the plan rolled out, the first stage (2025-2026) will lead to commissioning the main production site of Khan Tengri Biopharma for making biopharmaceuticals, a control and analytical lab, and the management establishment. Those facilities will spread out at 22+ hectares and create first professional jobs.

Stage 2 (2026-2027) assumes an expansion of the production zone: a contract manufacturing facility to be built for Key Pharma, assembly facilities for medical devices and equipment to be operated by major global brands such as Cannon, Fuji, Wan Dong, etc. That installment will occupy 25 hectares.

Stage 3 (2027 – 2028) will bring in play a logistics facility capable of storing products at various temperatures, a railway, and customs office.

Stage 4 (2028 – 2029) will start a veterinary medicines manufacturing site, dialysis solutions, and a multi-specialty medical clinic under GCP to run clinical trials.

Should the workforce availability and job demand go smoothly, stage 5 (2029 – 2030) will expand into building a residential neighborhood with an aparthotel, sports facility, shopping malls and a recreational area.

All construction is to be finished by 2030. Meanwhile, from year 1, the project will make the difference to the local economy by generating production in high demand both in Almaty region and beyond.

The government emphasized the project will empower the government’s strategy to reduce import dependence and secure Kazakhstani market is properly supplied with innovative and high-tech medicines.

13 March 2026

KYRGYZSTAN ORPHAN MEDICINE MARKET IN 2024-2025 AND BEYOND

The Kyrgyzstan orphan medicine sales vary heavily subject to a strong dependence on government-reimbursed plans, supply through international organizations, and special importation regulations. 2,700+ organizations are involved in the country in supplying medicines to Kyrgyz patients. However, the orphan products are the most complex sector due to a number of factors:

Regulatory:

• Simplified importation: the Law «On circulation of medicines» (ed.2024) allows importation of no MA certificate medicines if lifesaving to specific patients or a group of patients with rare diseases.
• Government-reimbursed treatment plans: A significant share of life-important essential medicines is supplied through UNO entities such as PRUNO, UNICEF, and UNFPA. That reduces the price burden to Kyrgyzstan and secures quality.
• Private importation: Natural persons are allowed to import medicines they need for their private use even if no MA certificate in Kyrgyzstan. 

Financing and Support:

• Hitech Aid Foundation: Kyrgyzstan MoH initiated setting a dedicated foundation for treatment of orphan patients under the management of the MoH.
• Government Bonds Program: Patients may be entitled for free or partially subsidized supply of medicines under the Government Bonds Program, which sets a framework of treatment aid to patients.
• Public budget: The total nation’s budget for 2026 is approved and accounts for 550.8 billion Soms (~12.6 billion USD). It is assumed to proliferate social programs financing, including healthcare ones. 

Growth Challenges:

• High costs: Orphan medicines are quite often the most pricy items for healthcare and require generous financing.
• Regulatory: MA certificates are valid for 5 years in Kyrgyzstan. After that, they can turn eternal (no expiry date) if quality is confirmed.
• Investments: The Kyrgyzstan government prioritizes healthcare equipment modernization and lab services quality improvements for diagnosing orphan diseases early. Ways to do so also include state-private partnerships.

Orphan medicine business in Kyrgyzstan is growing, driven by improved healthcare access, increasing demand for specialty treatments, and a general expansion of the country's pharmaceutical market. While generic drugs are favored, there is an increasing, albeit challenging, need for innovative rare disease therapies within the Eurasian Economic Union regulatory framework.

19 February 2026

TOP 10 PHARMACEUTICAL MAJORS IN R&D EXPENDITURES

Fierce Biotech reviewed R&D expenses by international pharmaceutical majors.

The ongoing leader in 2025 stayed Merck&Co. (15.79 billion USD, -12% vs 2024). The drop was attributed to less acquisitions while internal R&D spendings escalated by 700 Mio USD hitting 10.8 billion USD. The Merch R&D team is 24 700 staffs strong. A number of products are under developments to assume the heat from Keytruda whose
patent will expire soon.

The second position was held by Roche with 14.73 billion USD (-6%). Roche proliferated through ranks of the top players list from position 3 a year before. While keeping its efforts in oncology as usual, Roche strongly added a breakthrough in obesity management by developing a dual agonist of  GLP-1/GIP CT-388. That product showed promising results in phase 2, comparable with Zepbound of Eli Lilly.

Number 3: Johnson & Johnson with $14.66 billion (-14,9%). J&J slid to position 3 from position 2 a year before due to cutting internal R&D costs by 15% while acquiring more from outside the company, such as Intra-Cellular Therapies Halda Therapeutics. Also, J&J spin-off its orthopedic division DePuy Synthes.

Number 4 : AstraZeneca, $14.23 billion (+5%). The Britain-based major modestly poured more in R&D vs a year before, though R&D budget accounted to a hefty stake of 24.2% of their total revenue. Despite a number of failed products, the company invested in Chinese research operations and in-licensed obesity management products from CSPC Pharmaceutical.

Number 5: Eli Lilly, $13.34 billion (+21,4%). Eli Lilly unleashed its R&D spending instincts in 2025 gaining to lines in the ranking of R&D investments. Its marvelous launch of tirzepatide, the product which overtook Keytruda, turned Eli Lilly from a regular duck in the first beautiful swan that gained 1 trillion USD capitalization. The revenue spree allowed to add 21% to its R&D budget for launching the LillyPod (with Nvidia), acquiring Adverum, a biotech company, and boosting AI R&D platform with Insilico Medicine and XtalPi.

Number 6: Novartis, $11.2 billion (+12%). The biggest advance through the ranks of R&D leaders came from Novartis, who spent heavily on M&A front: swallowed Avidity Biosciences for 12 billion USD and MorphoSys for 2.9 billion. At the same time, Novartis cut off low progress in-house developments.

Pfizer came 7 th in the R&D race with $10.44 billion (-4%) spent in 2025. Despite cutting that budget in 2025, Pfizer climbed to position 7 after acquiring Metsera for $10 billion (a biotech company) after defeating Novo Nordisk’s efforts to buy that obesity management biotech. Also, Pfizer in-licensed a GLP-1 product from Fosun Pharmaceutical for $1.9 billion.

Bristol Myers Squibb, number 8, with $9.95 billion (-11%). BMS played Scrooge through imposing severe spending reduction measures to save 1.5 USD billion within 20 months. Its R&D budget had to pay a price, too.

AbbVie finished 9 th with $9.1 billion (-28,9%). After a spectacular growth by 66% in 2024, AbbVie slowed down in 2025 with its R&D chequebook. Cerevel, an 8.7 billion USD acquisition, failed in phase 2, wiping off 3.5 billion from the company’s balance. Though, AbbVie paid 2.1 billion USD for Gilgamesh. In-house R&D suffered hefty cuts. Sanofi made it 10 th with R&D investments of $8.85 billion in 2025 (+6%). The spendings grew but multiple drug candidates failed. The Board lost patience and Paul Hudson, CEO, retired to give the steering wheel to Belen Garicho, the ex-CEO of Merck KGaA.

“A great growth in R&D and in-licensing expenditures in 2025 among most prominent market players sets the trend for the entire industry and explicitly articulates new products and in-licensing as the key growth driver”, - commented Vladimir V. Krasnikov, CEO and Founder of  Prestige Brands Capital LLC, a specialty consulting boutique specialized in M&A, in/out-licensing, and BD in the pharmaceutical industry.

9 February 2026

MAJOR M&A TRANSACTIONS IN BIOPHARMACEUTICAL INDUSTRY IN 2025:
JOHNSON&JOHNSON

In 2025, an M&A slowdown in the biopharmaceutical industry got over and a bounce back rush started.
The industry trend is to consolidate business for accumulating more perspective products, developments, and promising upside markets.

«That activity outbreak keeps rising since the year start. I expect that it continues through the entire 2026 generating promising advances for coming years», -stated Vladimir V.Krasnikov, Partner and Founder of  Prestige Brands Capital LLC, a specialty consulting boutique specialized in M&A, in/out-licensing, and BD in the pharmaceutical industry.

The largest in value acquisition in 2025 was executed by Johnson&Johnson, who swallowed Intra—Cellular Therapies in a transaction worth $14,6 billion. Intra—Cellular Therapies developed innovative medicines for CNS disease treatment.

J&J got access to original promising medicines for CNS disease treatment through that deal, including Caplyta (lumateperone), the crown jewel of Intra—Cellular, used for psychotic conditions treatment in schizophrenia and bipolar depression patients. Caplyta will solidify J&J’s product portfolio (which already has Spravato, excetamin, a nasal ketamin-based spray FDA-approved for resistant depression treatment in adult and underage patients with suicidal risk) in the depression treatment. Sales forecasts for Caplyta go to as far as 5 billion USD per annum. 

«The deal ran through quite fast: first touching base by the parties in December 2024 while in early 2025, the deal was agreed upon. That indicates that the innovative product market is believed to have a significant upside through in-licensing/ acquiring such products to add value to the product portfolio and gain growth momentum from synergies with existing products», - highlighted Vladimir V. Krasnikov. Mr. Krasnikov suggested the deal was first in arow of similar acquisitions then by other pharmaceutical majors to gain control of perspective innovative products.  
We will continue our coverage of the matter.  

Source: Fierce Pharma

19 January 2026

RUSSIAN PHARMA MARKET: A RECKLESS VISION FOR THE LAST 5 YEARS

In 2025, international pharmaceutical manufacturers maintain 60% MS of Russian pharma market value despite sanctions and rumors of them leaving that market, as it was a media narrative disseminated widely since 2022.

As per a Prestige Brands Capital forecast, the MS of international pharma companies in the original products segment would be around 90% in value and 80-85% in volume. That cancels out forecasts of massive supply disruption and indicates of no market turmoil.

16 January 2026

PHARMALICENSING ONE, LLC ANNOUNCED ITS TEAM EXPANSION: JONAS TRYGGVASON JOINED THE COMPANY AS A MANAGING PARTNER

Pharmalicensing One, LLC announced its team expansion through recruiting a top- notch international pharma industry manager and experienced executive Jonas Tryggvason since January 15th, 2026. Jonas’ highlights: a seasoned C-level executive with extensive experience in pharmaceuticals, healthcare, and international markets, specialising in commercial strategy, business transformation, and multi-market operations across Europe, CEE, and CIS. Jonas brings deep expertise in P&L leadership, market expansion, M&A, and go-to-market execution, with a strong track record in driving revenue growth, optimising portfolios, and building scalable commercial organisations. He has proven capability in leading complex transformations, integrating acquisitions, and delivering sustainable performance in dynamic and highly regulated environments. Jonas is recognised for hands-on, results-driven leadership with the ability to build aligned, high-performing teams and navigate complex stakeholder landscapes. He combines strategic vision with pragmatic execution, influencing boards, investors, and senior leadership to deliver long-term value. Mr. Tryggvason is known for fostering collaboration, driving accountability, and translating strategy into measurable outcomes across diverse international markets. Jonas speaks 6 languages.

He led Aristo Pharma, LLC (a company of Aristo Pharma, GmbH) as their General Manager Russia & CIS 2020-2025. Jonas led full P&L and end-to-end business transformation across Russia and 11 CIS markets, and Mongolia, repositioning the organisation for sustainable growth. He directed commercial strategy, portfolio optimisation, and go-to-market execution while transitioning operations from a representative office to a local legal entity. Jonas built and aligned a new leadership team, strengthened sales operations, and improved financial discipline across the business. He drove expansion into new markets and enhanced operational efficiency across supply chain and commercial functions. Jonas accomplished +200% revenue growth by restructuring the organisation, optimising the product portfolio, driving new product launches and geographical expansion.

In Actavis Group of Companies as Executive Vice President, Central Eastern Europe & Asia, and MENA, Iceland Jonas built and led a regional commercial organisation across target markets following major M&A activity. Defined and executed growth strategies across markets, aligning S&M, and operational structures and managed sales force operations and implemented performance-driven commercial systems. Led M&A initiatives, including due diligence, negotiations, and post-merger integration.

“No doubt, Jonas’ competences and experience will generate extra value added for Pharmalicensing One’s customers. Jonas already got involved in current and coming projects. Welcome, Jonas!” — articulated V. Krasnikov, Founder and Partner of Pharmalicensing One, LLC, a specialized boutique consulting company for in/out- licensing, BD, and M&A in ex-USSR area and RoW.

12 January 2026

RUSSIAN PHARMA MARKET SNAPSHOT’2025 (PRESTIGE BRANDS CAPITAL HIGHLIGHTS)

According to the Prestige Brands Capital estimate, the Russian pharma market maintained its sustained growth in 2025 with an annual growth forecasted at 9-10% approaching 3 trillion RUB (26 billion EUR/30 billion USD).

Key trends: domestic products market share grew (to app. 65% in volume), retail spendings for medicines grew (especially for generic medicines), still dependent on imported innovative products. The market growth is due to both retail and reimbursement segments, Rx products drive the growth.

The domestic products market share rose a bit in value, though international companies enjoyed a solid sales growth vs 2024. All of 10 top companies (8 international and 2 domestic (Biocad and Nizhpharm)) in Russia grew their sales vs 2024. The top 10 companies’ market share hit 27% in value. Out of that, the market share of 2 domestic manufacturers accounts for less than 5% (source: IQVIA).

12 December 2025

Pharmalicensing One, LLC Attended the Largest Russian Healthcare Industry Event Russian Healthcare Week-2025

Pharmalicensing One, LLC attended the largest Russian healthcare industry event called “Russian Healthcare Week-2025” (Moscow, Dec.8-11, 2025).
It showcased industry participants from public and private healthcare, production of machinery and components/supplies, and medical science.

At that event, Pharmalicensing One, LLC pursued:

1. New clients search.
2. Collecting EAEU market updates/insights.

Accomplishments: preliminary agreed on sale the asset - CMO of medical devices and dietary supplements in the EAEU; signed agreement with a cosmetics certification agency.

Pharmalicensing One, LLC is keen to maintain in-person contacts with its clients along with digital contact media and ways since in-person contacts build trust and turn business to long term collaboration.

28 November 2025

Pharmalicensing One Managing Partners Attended Pharmtech & Ingredients - 2025

Pharmalicensing One, LLC managing partners attended Pharmtech & Ingredients industry exhibition (Moscow, Nov.24-27, 2025). In the EAEU, that exhibition is the largest to showcase machinery, ingredients, and technologies for pharmaceutical industry.

Multiple business contacts happened. Pharmalicensing One, LLC participated in workshops and presentations. Takeaways:

1. Met in person multiple industry participants, key players, suppliers, clients, and experts.
2. Effectively communicated services offered to target client categories, established new business contacts, updated market and trend knowledge.
3. Maintain contacts with clients and target growth/synergy opportunities.

At that event, Pharmalicensing One, LLC concluded out-licensing of a medical device for EAEU markets from a research-based medical device manufacturer.

31 October 2025

Pharmalicensing One, LLC showcased at CPhI-2025 its business services offered to actual and potential clients. The industry show happened October 28-20, 2025, in Frankfurt-am-Main, Germany.  

Participating successfully in CPhI events stands for showcasing BD&L services, strengthening partnerships, and engaging with industry leaders in the pharmaceutical sector. A successful participation generates valuable contacts, secures leads, and creates heightened awareness for the company and its services offered. This builds connections for future collaborations and business projects.

What Pharmalicensing One, LLC accomplished at CPhI-2025:

• Showcased our services offered, generated potential business projects leads. 
• Enlarged our business networking and partnerships with our actual and potential clients.
• Plotted and boosted new business leads with potential customers and partners.
• Boosted awareness of us among business community incumbants through strong presence at the event.
• Exchanged the industry’s insights through engagement with business managers, regulatory experts, researchers, and other executives.

22 September 2025

7 July 2025

22 June 2025

12 June 2025

12 May 2025

2 April 2025

Eurasia. Pharmaceutical Market Review in Kazakhstan, Uzbekistan and Belarus for the Period October 2023 - November 2024 According to IQVIA Eurasia

In Kazakhstan, from November 2023 to October 2024, the pharmaceutical market of Kazakhstan amounted to 2.5 billion US dollars and in national currency the pharmaceutical market grew by 20%, in packages by 3%.

TOP 3 pharmaceutical companies in the Kazakh market with market share:

1. Santo — 4.67%.
2. Johnson & Johnson — 4.28%.
3. Sanofi — 4.05%.

In Uzbekistan, from November 2023 to October 2024, the volume of sales of medicines amounted to 1.6 billion dollars and in national currency there was an increase of 13%, decrease in packages 8%.

TOP 3 pharmaceutical companies in the Uzbek market with market share:

1. KRKA — 3.96%.
2. World Medicine — 3.44%.
3. Menarini — 2.88%.

In Belarus, from November 2023 to October 2024, sales volume amounted to $ 1.2 billion and the increase in drug sales was 21%, in packages, growth was 7%.

TOP 3 pharmaceutical companies in the Belarusian market with market share:

Belmedpreparaty — 5.56%.
Borisov Plant of Medicines, its share is 5.34%.
Lekpharm with 5.13%.

In 2025, a Pilot Project For Labeling Dietary Supplements Will Be Implemented in Kazakhstan

A huge range of dietary supplements is sold in Kazakhstan, most of which are not registered in the EAEU and do not have information for the consumer in Kazakh or Russian.

The regulator is confident that digital identification codes on dietary supplements guarantee the consumer the purchase of legal, certified products. In 2025, a pilot stage of labeling dietary supplements will begin, which will take up to 1.5 years, and only after its successful completion will the possibility of introducing mandatory labeling be considered - until 2027.
The introduction of mandatory labeling is taking place in several stages. First a pilot project. First, a pilot project. Labeling is tested on those companies that want to participate in the "pilot" and technical capabilities are tested, selecting optimal solutions. Then there is public discussion and analysis (3-6 months), hearings with market participants and the public. After - approval: coordination with the Atameken National Chamber of Entrepreneurs and entry into force of the decision.

According to the Ministry of Trade of Kazakhstan, 8.3 million drug packages were labeled in Kazakhstan in 2023. In 2024 - 175.2 million packages. At the moment, 65.5 million drugs are in circulation, of which 36.8 million are imported, and 28.7 million are domestic. 7.24 million drugs have been withdrawn from circulation.

Source: Kazakhstan Pharmaceutical Bulletin

All Pharmacies and Clinics in Uzbekistan Will Become VAT Payers From April 2025

From April 2025, all pharmacies and clinics in Uzbekistan will be transferred to the payment of value added tax. VAT reports will be generated automatically by tax authorities.

From April 1, 2025, all legal entities selling pharmaceutical products or providing medical services in Uzbekistan will be required to pay VAT, regardless of income level. This is provided for by the presidential decree of December 27. Tax authorities will automatically generate VAT reports based on data from virtual cash registers, online cash register receipts and electronic invoices, as well as other external and internal data.

In addition, it is planned to cancel the excise tax on imported polyethylene raw materials (the excise tax on polyethylene granules today is 10%), which is used for the production of pharmaceutical products.

The draft law on amendments is to be developed by March 2025. After that, it must be approved by parliament and the president.

Source: Gazeta.UZ

Fund For Financing Start-Aps in the Pharmaceutical Industry to be Created in Uzbekistan

A specialized venture fund will be created in the Republic of Uzbekistan, aimed at supporting innovative startups in the field of biopharmaceuticals, cell technologies and oncological research. In parallel, an investment fund is created to finance promising thematic projects.

The decree also assigns a number of additional tasks to the Agency for the Development of the Pharmaceutical Industry of Uzbekistan:

- development of dietary supplement and cosmetic product markets, including the introduction of advanced foreign practices;
- monitoring and accounting of investment projects of regional pharmaceutical enterprises;
- digitalization of the pharmaceutical industry and the introduction of information programs.

By the end of 2025, the laboratory of the Center for Pharmaceutical Product Safety must undergo the WHO prequalification procedure.

In addition, in the medium term (by mid-2025), it is planned to form five reference plantations of medicinal plants - with the subsequent organization of processing industries (by the end of 2026).

The infrastructure development of the industry will be supplemented by the creation of the state organization Pharm Service, specializing in providing marketing support and consulting support for the implementation of modern standards in pharmaceutical production.

Source: GxP News

The legal turnover of the pharmaceutical market of Uzbekistan in 2024 reached 19.7 trillion soums (about $ 1.55 billion). At the same time, the market structure demonstrates a significant predominance of imported products, which account for 15.7 trillion soums, which is almost 80% of the total volume.

Domestic manufacturers provided supplies of medicines worth about 4 trillion soums, which indicates a significant import dependence of the country's pharmaceutical sector. Data from the statistics agency confirms the growing trend in imports of medical and pharmaceutical products, which increased by 8.1% compared to 2023 and reached $ 1.73 billion.

A regional analysis of drug consumption revealed significant differences between the regions of the country. Tashkent became the leader in sales with an indicator of 5 trillion soums, which is more than a quarter of the entire legal market. The capital is followed by Samarkand region with 2.6 trillion soums and Fergana region with 1.5 trillion soums. When calculating per capita expenditure, Tashkent also leads with an indicator of 1.7 million soums, significantly ahead of Bukhara (746 thousand soums) and Samarkand (660.7 thousand soums) regions.

The capital's high indicators are explained by the concentration of large medical institutions and a more developed healthcare infrastructure.

The system of fiscal receipts with product identification codes allows the Tax Committee to keep accurate records of the legal circulation of medicines and analyze consumer preferences of the population.

Arab Funds Are Ready To Finance Kazakhstan's Projects in Medicine

Four international financial institutions, members of the Arab Coordination Group, have expressed their readiness to invest in the development of Kazakhstan's medical infrastructure. The agreements were reached during a series of meetings between Health Minister AkmaralAlnazarova and representatives of the funds on the sidelines of a round table held in Astana.

The parties discussed prospects for cooperation and financing of priority projects.

The Kuwait Fund for Arab Economic Development is interested in implementing investment projects with its own funds.

The OPEC Fund for International Development has expressed its readiness to finance projects worth more than $2 billion over the next three years, including in the field of healthcare.

The Saudi Development Fund has expressed interest in the construction of a children's surgical center based on the UMC Corporate Fund, considering the possibility of co-financing the project.

The Qatar Development Fund has announced its readiness to support small projects worth $2-3 million annually.

Russia and Uzbekistan Agreed to Transfer Information on Drug Labeling Codes

Russia and Uzbekistan have agreed to cooperate to transfer information about drug labeling codes. Transfer of codes will make it possible not to apply additional labeling to medicines for export Russia and Uzbekistan undertake to mutually transfer the specified codes of drugs exported from the territory of one state after customs procedures for export to the territory of another state. This should strengthen measures to combat the production, trafficking and sale of counterfeit and falsified medicines.

Transferring codes will also eliminate the need to apply additional labeling to drugs for export, which will reduce the financial burden on pharmaceutical manufacturers. In addition, it will be possible to trace the entire chain "manufacturer - consumer" using one labeling code.

Pharmaceutical Market of Uzbekistan 2023 at a Glance

According to Proxima Research, the Pharmaceutical Market of Uzbekistan is actively developing, demonstrating an increase both in value and volume.

Based on the results of 2023, the retail sales of medicines and dietary supplements amounted to 20.8 trillion soum (equivalent is 1.8 billion US dollar). In terms of volume, pharmacy sales amounted to 646 million packages.

In Q1 2024, the sales volume in national currency amounted to 6.2 trillion soum and increased by 26% compared to the same period in 2023. In dollar terms, the increase was 15%, and in volume - 8%.

In the first quarter of 2024, top 3 companies in retail sales of medicines were KRKA, Stada and Yuria Pharm. Top 3 brands were recorded for Sodium Chloride, Tivortin and Rheosorbilac.

Production of New Radiopharmaceuticals to Be Launched in Almaty

The Institute of Nuclear Physics of the Ministry of Energy of the Republic of Kazakhstan plans to launch production of radiopharmaceuticals based on the actinium-225 isotope by the end of 2024. Memorandums of cooperation were signed with interested companies from Uzbekistan, China and Turkey.

One gram of actinium-225 costs $80 million. This price will continue to rise. Several Japanese companies have already confirmed their interest in purchasing finished products rather than raw materials.

Retail Pharmaceutical Market of Uzbekistan for 9 Months of 2024

According to the results of 9 months of 2024, the volume of retail sales of medicines in the Republic of Uzbekistan amounted to 17.3 trillion soums corresponds to 1.4 billion US dollars or 442 million packages. Compared to the same period of the previous year, the market volume increased by 15.7% in national currency and by 6.2% in dollar terms. In packages, consumption shows a decrease of 9.9%.

The top 3 pharma companies remain same KRKA, Stada and Yuria-Pharm. It should be noted that almost all companies that entered the top 20 demonstrated double-digit growth rates. In most cases, the main contribution to the increase in sales volume is provided by an increase in prices due to local inflation. 

Source: Proxima Research

Top 3 Kazakh Pharmaceutical Distributors for the First 9 Months of 2024

The pharmaceutical distributor market in Kazakhstan is a dynamically developing sector that adapts well to rapidly changing regulatory conditions, including integration with the EAEU legislation.

According to Vi-ORTIS, the TOP 3 distributors in the category "total sales" remain unchanged:

1. Amanat, LLP. Amanat managed to win the leading position this year (21.46%, +1.21%) with a small margin of 0.5%.
2. Medservice Plus, LLP.
3. Inkar, LLP.

The share of 3 distributors accounted for more than half of the market.

Source: Vi-ORTIS

2 September 2024

TOP 15 Pharmacy Chains in the Retail Market of Kazakhstan in the 1st Half of 2024

Kyrgyzpharmacy a state enterprise organization is now underway, plans to start purchasing medicines directly from Russian manufacturing plants in the near future. The first state pharmacies in Kyrgyzstan are already 65 across the country. The authorities plan to increase their number to 100 in 2024.

According to estimates by Pharmalicensing Group, LLC, more than 95% of medicines in the republic are imported with annual supplies of $190 million, and the number of private pharmacies is 1,900, most of which are located in cities. In some remote areas of the republic, there are neither private nor state pharmacies.

The planned pricing system in state pharmacies should be a 5% markup on the manufacturer's price, according to Kyrgyzpharmacy.

The average markup in private pharmacies ranges from 25-30% to 50% of the cost of medicines.

Annual Kyrgyz pharma market was valued 250 million US dollar MAT/2024/MTH02/ according IQVIA.

Information about the Republic of Kyrgyzstan:

Total health spending represented 4.5% GDP in 2019.

The Rules For Circulation of Veterinary Medicines Will Change in the EAEU

New rules for circulation of veterinary medicines will come into force in the Eurasian Economic Union on March 13, namely:

1. The rules establish uniform procedures for registration of veterinary medicines and other procedures related to registration (confirmation of registration, MA variations, etc.); uniform requirements for their quality, effectiveness and safety, as well as criteria for their assessment; a uniform format for information interaction in the implementation of control and supervisory activities in the field of circulation of veterinary medicines.

2. During the transition period, registration of veterinary medicinal products and other related procedures may be carried out in accordance with the national legislation of a member state of the EAEU from the date of entry into force of the EAEU Rules and until December 31, 2027 for the circulation of such medicines only in the territory of this member state (MA of such veterinary medicinal products will be valid in the territory of the relevant state for the next 5 years).

3. Registration certificates (MAs) for veterinary medicines issued before March 13, 2024, shall be valid in the customs territory of the EAEU for the periods established in accordance with national legislation, but not later than December 31, 2027.

Veterinary Market of Russia and Kazakhstan in 2023

The Russian veterinary medicines market grew by 37% in 2023 and reached 97.7 billion rubles (1.1 billion US dollars). The share of Russian producers reached 46%.

The veterinary medicines market in Russia was 60.7 billion rubles in 2019 and 70.1 billion rubles in 2020. Stocky animals still account for 66% of the veterinary medicine market, which is 64.6 billion rubles, of which 33.9 billion rubles are imported and 30.7 billion rubles are domestically produced.

According to the company, the veterinary market of Kazakhstan reached 131 million US dollars, which accounts for 70% of imported drugs. There are 19 manufacturers of veterinary drugs in the country.

The State Enterprise Kyrgyzpharmacy Was Established Under the MoH Of The Kyrgyz Republic

March 1st 2024, the state enterprise Kyrgyzpharmacy was established.

Goals and objectives of the enterprise:

1. Ensuring a fundamentally new approach to the implementation of state policy on providing state healthcare organizations.
2. Providing the population with medicines and medical products at the most affordable prices.
3. Reducing the cost of medicines and medical products purchased for state healthcare organizations through direct supply from manufacturers or distributors.

According to the local market regulator, the creation of Kyrgyzpharmacywill have a positive impact on the medicines market in the Kyrgyz Republic.

Sales of medicines from July 2023 to June 2024 in Kazakhstan amounted to 1.1 trillion tenge (2.3 billion US dollars), with an increase of 16% in value and 2% in volume.

Top 3 companies by sales:

1. Santo
2. Nobel-Aff
3. Sanofi

Source: IQVIA Eurasia

Kyrgyz Authorities Has Approved the National List of Vital Medicines and Medical Devices

The decision was signed by the Chairman of the Cabinet of Ministers Akylbek Japarov.

It is noted that ensuring access to safe and effective medicines is the main goal of global efforts to achieve universal health coverage.

The criteria for including medicines and medical devices in the specified list are safety, proven clinical efficacy and economic accessibility.

5.6 thousand MAs of medicines and APIs are registered in the republic, of which 1,686 are domestically produced: 1,578 are generic, 86 are original and 22 are innovative.

Source: National Agency of Investment and Privatization of the Republic of Belarus

Information about the Republic of Belarus:

Business Partner: Pharmaceutical Company with a Presence in Former USSR Republics

"We have been working with Vladimir’s Pharmalicensing Group One, LLC, for the past five years, and it’s been an incredibly valuable partnership for our company. Thanks to Vladimir’s impressive global network, we’ve been able to access unique and high-impact licensing opportunities that were perfect for our markets in the former USSR. Because of this, we successfully licensed an Rx non-steroid pain relief medicine and a cosmetic product with a global patent. Even after the deal is closed, Vladimir is always there to help us navigate any issues that come up with suppliers or licensors.
If you’re looking for someone who is deeply invested in your success and who brings a fresh perspective to the table, Vladimir is the proven person you want on your side.”

Former Owner of a Pharmaceutical Plant

“I had the privilege of working with Vladimir when we were in a challenging situation, trying to sell a pharmaceutical plant in Russia that hadn’t been operational for over three years. Vladimir stepped in and worked wonders. The plant was in a tough spot – no employees, outstanding bank debt, and seemingly no future. Vladimir didn’t shy away from the challenge. He managed to negotiate favorable terms with the bank and find a strategic foreign investor willing to take on the project. His dedication and strategic thinking turned what seemed like an impossible situation into a success. I couldn’t have asked for a better partner to help us through that process.”

Company with Operations Across EU, US, APAC, and ex-USSR

“Collaborating with Vladimir from Pharmalicensing One, LLC has been transformative to our business. His vast network in the industry is truly exceptional, leading to introductions to several key distributors across major markets in just a few months. What’s more, Vladimir’s deep understanding of the complex pharma landscape, combined with his knowledge of our product, resulted in strategic partnerships that have significantly expanded our market presence. His expertise in navigating regulatory channels has been, and continues to be, an indispensable asset for us. I strongly recommend Vladimir to any company looking to expand their licensing business or distributor and accelerate their growth in the pharmaceutical industry.”

International R&D and Manufacturing Company

"Our company has been working with Vladimir and his team at Russian Pharmalicensing Group , LLC and then Pharmalicensing One, LLC since 2015, and it’s been nothing short of transformative. When we were just starting in the CIS market nearly a decade ago, Vladimir guided us through launching new products and services in the region, and his advice on the regulatory landscape and market dynamics has been spot on. Thanks to his efforts, we’ve had a multitude of productive face-to-face meetings in the CIS and have successfully showcased our offerings at international exhibitions such as CPhI and ArabHealth. We continue to work with Vladimir to this day, trusting his advice on our five-year strategic plan."

Pharmaceutical Company with Global Operations

"Thanks to Vladimir’s extensive network in both the EU and ex-USSR pharmaceutical regions, we were able to successfully license our Rx hospital product to a top strategic partner across nine markets in the Balkans, CIS and Baltic states. His strategic approach and exceptional relationship-building skills allowed us to penetrate new markets and secure significant deals. Partnering with Vladimir has been one of the best strategic decisions we’ve made."

EU Pharmaceutical R&D and Manufacturing Company

“I’ve been working with Vladimir and his team for a few years now, and I can say without hesitation that his expertise has been a huge asset to our company. Vladimir is a master at identifying the right licensing opportunities. With his help, we’ve successfully launched Rx medicinal products in the CIS that perfectly complement our existing portfolio. What’s more, his ongoing contributions to our Business Development operations are invaluable; he scouts target molecules and products globally, not only for the CIS but also for our EU markets. Vladimir doesn’t stop at finding opportunities; he makes sure everything is aligned with our business goals.”

Chinese Company’s Greenfield Pharmaceutical Manufacturing Sites (Solids) in a Technology Park in a Major Central Russia City.

“Special thanks to Pharmalicensing One, LLC (PhL1) team who acted as the financial consultant to the deal. They productively concluded the sale of our greenfield investment manufacturing site in Central Russia. Vladimir and his team fine-tuned business processes and managed to conduct talks with 10+ potential buyers within a short period of time. That allowed to identify the right buyer followed by the DD.
Then, PhL1 facilitated business negotiations that made it possible to sign the sale agreement and following milestone payments.
The course of the deal since the first meet with the buyer until payments concluded in full and getting the regulatory approval took only 13 months. Great job!”